WorldWideScience

Sample records for approval ob-nda 00-0127

  1. Drugs Approved for Leukemia

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Leukemia This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Acute Lymphoblastic Leukemia (ALL) Abitrexate (Methotrexate) Arranon (Nelarabine) Asparaginase Erwinia chrysanthemi ...

  2. Post-Approval Studies

    Data.gov (United States)

    U.S. Department of Health & Human Services — The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a...

  3. More New Medication Approvals.

    Science.gov (United States)

    Turkoski, Beatrice B

    2016-01-01

    In the past year, the Federal Drug Administration (FDA) approved many new drugs for treating a wide variety of patient health problems. In a previous article, examples of approvals for the early part of last year were addressed. In this article, selected new FDA approvals through January 2016 are discussed. Nurses who are knowledgeable and informed about these new drugs will be able to answer patients' questions, clarify misunderstandings, and reduce the potential for medication misadventures. PMID:27441881

  4. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Hodgkin Lymphoma This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Hodgkin Lymphoma Adcetris (Brentuximab Vedotin) Ambochlorin (Chlorambucil) Amboclorin (Chlorambucil) Becenum ( ...

  5. Drugs Approved for Malignant Mesothelioma

    Science.gov (United States)

    ... about Your Treatment Research Drugs Approved for Malignant Mesothelioma This page lists cancer drugs approved by the ... are not listed here. Drugs Approved for Malignant Mesothelioma Alimta (Pemetrexed Disodium) Pemetrexed Disodium Drug Combinations Used ...

  6. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Pancreatic Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Pancreatic Cancer Abraxane (Paclitaxel Albumin-stabilized Nanoparticle Formulation) Afinitor (Everolimus) ...

  7. Drugs Approved for Bone Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Bone Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Bone Cancer Abitrexate (Methotrexate) Cosmegen (Dactinomycin) Dactinomycin Denosumab Doxorubicin Hydrochloride ...

  8. Premarket Approvals (PMA)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

  9. FWS Approved Acquisition Boundaries

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This data layer depicts the external boundaries of lands and waters that are approved for acquisition by the U.S. Fish and Wildlife Service (USFWS) in North...

  10. Drugs Approved for Leukemia

    Science.gov (United States)

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  11. Drugs Approved for Melanoma

    Science.gov (United States)

    ... are not listed here. Drugs Approved for Melanoma Aldesleukin Cobimetinib Cotellic (Cobimetinib) Dabrafenib Dacarbazine DTIC-Dome (Dacarbazine) IL-2 (Aldesleukin) Imlygic (Talimogene Laherparepvec) Interleukin-2 (Aldesleukin) Intron A ( ...

  12. Drugs Approved for Retinoblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  13. Drugs Approved for Neuroblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  14. Pembrolizumab: first global approval.

    Science.gov (United States)

    Poole, Raewyn M

    2014-10-01

    Pembrolizumab [Keytruda(®) (US)], a humanized monoclonal antibody against the programmed death receptor-1 (PD-1) protein, has been developed by Merck & Co for the treatment of cancer. Pembrolizumab has received its first global approval for the treatment of advanced, unresectable or metastatic malignant melanoma in the US, for use in patients with disease progression after prior treatment with ipilimumab and, for BRAF V600 mutation-positive patients, a BRAF inhibitor. It is the first anti-PD-1 therapy to receive regulatory approval in the US, and is currently under regulatory review in the EU. This article summarizes the milestones in the development of pembrolizumab leading to this first approval for the treatment of malignant melanoma.

  15. Olodaterol: first global approval.

    Science.gov (United States)

    Gibb, Andrew; Yang, Lily P H

    2013-11-01

    Olodaterol (Striverdi(®) Respimat(®)) is a novel, long-acting, β2-adrenergic receptor agonist developed by Boehringer Ingelheim for the treatment of chronic obstructive pulmonary disease (COPD). The drug is delivered via the Respimat(®) Soft Mist™ inhaler. Olodaterol received its first global approval for the once-daily maintenance treatment of COPD in Canada and Russia, and submissions for regulatory approval have also been made in the USA, the EU and elsewhere. Phase II trials have been conducted in patients with asthma. The company is also developing a fixed-dose combination of olodaterol with tiotropium bromide, a long-acting anti-muscarinic agent, for the treatment of COPD. This article summarizes the milestones in the development of olodaterol leading to this first approval for COPD. PMID:24158691

  16. Brodalumab: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-09-01

    Brodalumab (Lumicef(®)) is a human monoclonal immunoglobulin G antibody that is being developed by Kyowa Hakko Kirin in Japan, where it has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. Brodalumab binds with high affinity to interleukin (IL)-17 receptor A, thereby inhibiting several pro-inflammatory cytokines from the IL-17 family. Regulatory applications for brodalumab in plaque psoriasis are also under review in the USA, EU and Canada. This article summarizes the milestones in the development of brodalumab leading to this first approval for the treatment of psoriasis. PMID:27577550

  17. Venetoclax: First Global Approval.

    Science.gov (United States)

    Deeks, Emma D

    2016-06-01

    Venetoclax (Venclexta™) is an oral selective inhibitor of the prosurvival protein BCL-2 and therefore restores the apoptotic ability of malignant cells. The drug arose from research by Abbott Laboratories (now AbbVie) during a collaboration with Genentech and is being co-developed by AbbVie and Genentech/Roche primarily for the treatment of haematological malignancies. Venetoclax is approved in the USA for use as monotherapy in patients with chronic lymphocytic leukaemia (CLL) with the 17p deletion (as detected by an approved FDA test) who have received at least one prior therapy, and is awaiting approval for similar indications in the EU and Canada. Venetoclax is also in phase I-III development as combination therapy for CLL, phase I/II development as monotherapy and/or combination therapy for non-Hodgkin lymphomas (including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma) and acute myeloid leukaemia, and phase I development for multiple myeloma, systemic lupus erythematosus and breast cancer. This article summarizes the milestones in the development of venetoclax leading to this first approval for CLL. PMID:27260335

  18. Drugs Approved for Skin Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Skin Cancer This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer, including drugs for basal cell carcinoma and melanoma. ...

  19. Linaclotide: first global approval.

    Science.gov (United States)

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

    Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  20. Obiltoxaximab: First Global Approval.

    Science.gov (United States)

    Greig, Sarah L

    2016-05-01

    Obiltoxaximab (Anthim(®), ETI-204) is a monoclonal antibody that is being developed by Elusys Therapeutics and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for the prevention and treatment of inhalational anthrax due to Bacillus anthracis. Obiltoxaximab has been designed to neutralize the free protective antigen of B. anthracis, thereby inhibiting the lethal effects of anthrax toxins. In March 2016, intravenous obiltoxaximab was approved in the USA for the treatment (in combination with appropriate antibacterial drugs) and prophylaxis of inhalational anthrax. Obiltoxaximab is being developed under the US FDA Animal Rule, in which marketing approval is based on its efficacy in relevant animal models and safety in phase I studies in healthy human volunteers. An intramuscular formulation of obiltoxaximab has also been evaluated in animal studies and a phase I study in healthy human volunteers. This article summarizes the milestones in the development of obiltoxaximab leading to this first approval for the treatment and prevention of inhalation anthrax. PMID:27085536

  1. Evolocumab: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2015-09-01

    Evolocumab (Repatha™) is a fully human monoclonal antibody developed by Amgen that has been approved as a treatment for hypercholesterolaemia in the EU, and is awaiting approval in the USA and Japan. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a negative regulator of low-density lipoprotein (LDL)-receptors-thereby improving the ability of the liver to bind LDL-cholesterol (LDL-C), leading to reduced LDL-C blood levels. The drug reduces LDL-C levels in patients with hypercholesterolaemia when used as monotherapy or in conjunction with a statin. This article summarizes the milestones in the development of evolocumab leading to this approval for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet with or without a statin and/or other lipid lowering therapies, and in adults and adolescents aged ≥12 years with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

  2. Ripasudil: first global approval.

    Science.gov (United States)

    Garnock-Jones, Karly P

    2014-12-01

    Ripasudil hydrochloride hydrate (Glanatec® ophthalmic solution 0.4 %; hereafter referred to as ripasudil) is a small-molecule, Rho-associated kinase inhibitor developed by Kowa Company, Ltd. for the treatment of glaucoma and ocular hypertension. This compound, which was originally discovered by D. Western Therapeutics Institute, Inc., reduces intraocular pressure (IOP) by directly acting on the trabecular meshwork, thereby increasing conventional outflow through the Schlemm's canal. As a result of this mechanism of action, ripasudil may offer additive effects in the treatment of glaucoma and ocular hypertension when used in combination with agents such as prostaglandin analogues (which increase uveoscleral outflow) and β blockers (which reduce aqueous production). The eye drop product has been approved in Japan for the twice-daily treatment of glaucoma and ocular hypertension, when other therapeutic agents are not effective or cannot be administered. Phase II study is underway for the treatment of diabetic retinopathy. This article summarises the milestones in the development of ripasudil leading to the first approval for glaucoma and ocular hypertension. PMID:25414122

  3. Drugs Approved for Lung Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Lung Cancer This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic and brand names. This page also lists common drug combinations used in lung ...

  4. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2004-01-01

    With a view to the simplification of administrative procedures, AS and FI Departments have completed the second phase of the new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. Phase II includes handling the electronic approval process of invoices whose amounts do not correspond exactly to those of the associated orders. In such cases, budgetary approval is required for the entire invoiced amount. Further information can be obtained at : http://ais.cern.ch/projs/AEF/help/F_help.htm Phase II of the procedure will be introduced gradually with effect from April 2004. Finance Department, Accounts Payable Section Tel: 72295 Organisation and Procedures Tel: 75885 Information Technologies Department,...

  5. Drugs Approved for Non-Hodgkin Lymphoma

    Science.gov (United States)

    ... about Your Treatment Research Drugs Approved for Non-Hodgkin Lymphoma This page lists cancer drugs approved by the ... are not listed here. Drugs Approved for Non-Hodgkin Lymphoma Abitrexate (Methotrexate) Adcetris (Brentuximab Vedotin) Ambochlorin (Chlorambucil) Amboclorin ( ...

  6. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Stomach (Gastric) Cancer This page lists cancer drugs approved ... that are not listed here. Drugs Approved for Stomach (Gastric) Cancer Cyramza (Ramucirumab) Docetaxel Doxorubicin Hydrochloride 5- ...

  7. Biosimilars approval process.

    Science.gov (United States)

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier.

  8. Approval plans issues and innovations

    CERN Document Server

    Katz, Linda S

    2013-01-01

    How can you, as an acquisition librarians, keep current on the output of hundreds of publishers? The answer, of course, is that you cannot. For over 30 years, approval plans have been used by librarians to acquire current titles, save staff time, and build core collections. Even today, these reasons seem appropriate, as libraries try to maintain up-to-date collections and control personnel and operating budgets. However, as shown in Approval Plans: Issues and Innovations, the use of approval plans is not so simple and straightforward; their use is subject to complex procedures and policies--an

  9. Drugs Approved for Vulvar Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  10. Drugs Approved for Bone Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  11. Drugs Approved for Penile Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  12. Drugs Approved for Endometrial Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  13. Drugs Approved for Esophageal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  14. Drugs Approved for Liver Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  15. Is It Really FDA Approved?

    Science.gov (United States)

    ... medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the ... Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic ...

  16. FDA-Approved HIV Medicines

    Science.gov (United States)

    ... and acronyms) Brand Name FDA Approval Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, an enzyme HIV ... AZT, ZDV) Retrovir March 19, 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter reverse ...

  17. Airworthiness Approval of Design Firms

    Directory of Open Access Journals (Sweden)

    Kanchan Biswas

    2006-01-01

    Full Text Available Aviation as a mode of transportation requires that the aircraft designed, developed, andoperated must be maintained under airworthy condition. The basic tenet of airworthiness is thatthe aircraft designed and developed are certified by the independent airworthiness regulatoryorganisations. This requires strict vigil during the development stages. With quantum jump inthe design and development activities, it has been extremely difficult for the regulatory bodiesto cope up with the demand of certification. Delegating this responsibility to a few approvedfirms prove very effective in maintaining the design control through approved agencies andpersonnel. Airworthiness approval of design firms taken up by the Centre for MilitaryAirworthiness & Certification, Bangalore, which is the airworthiness approval authority for militaryaircraft in India, is one such step. This paper discusses the scope and extent of such approvals.

  18. Drugs Approved for Vaginal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  19. Drugs Approved for Malignant Mesothelioma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  20. Drugs Approved for Lung Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  1. Drugs Approved for Wilms Tumor

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  2. Drugs Approved for Breast Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for breast cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  3. Drugs Approved for Kaposi Sarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  4. Drugs Approved for Skin Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  5. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  6. Drugs Approved for Bladder Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  7. 28 CFR 2.41 - Travel approval.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.41 Section 2.41..., YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel approval. (a) The probation officer may approve travel outside the district without approval of...

  8. 38 CFR 21.292 - Course approvals.

    Science.gov (United States)

    2010-07-01

    ... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only... rehabilitation services under Chapter 31. (Authority: 38 U.S.C. 3106) (b) General. VA staff in consultation with... approved by one of the agencies identified in paragraph (c) of this section, VR&E staff shall...

  9. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2003-01-01

    With a view to the simplification of administrative procedures, AS and FI Divisions have drawn up a new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. This new procedure, in its current phase, will be gradually implemented from 1 November 2003 onwards. For clarification and further information, please see: http://ais.cern.ch/projs/AEF/help/help.htm . Finance Division, Accounts Payable Tel.: 7.22.95

  10. 78 FR 66826 - Prior Label Approval System: Generic Label Approval

    Science.gov (United States)

    2013-11-07

    ... concern, economic fraud, or an unfair competitive advantage. Commenters also requested greater access to... the Agency (76 FR 75809). FSIS also proposed to combine the regulations that provide for the approval... Marketing Service, removing it from the realm of a special statement or claim. Also in response to...

  11. 76 FR 75809 - Prior Label Approval System: Generic Label Approval

    Science.gov (United States)

    2011-12-05

    ... the type of packaging material on which the label is printed; n. Brand name changes, provided that... poultry products will take effect January 1, 2012 (75 FR 82148, Dec. 29, 2010). These mandatory features..., location, and indication of final color. To obtain sketch label approval, domestic meat and...

  12. Drugs Approved for Testicular Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for testicular cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  13. Drugs Approved for Cervical Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for cervical cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  14. Alkylbenzene Project in Xinjiang Approved

    Institute of Scientific and Technical Information of China (English)

    Zhou Weiyong

    1996-01-01

    @@ The feasibility study on alkylbenzene project in Dushanzi, Xinjiang Uygur Autonomous Region, submitted jointly by the government of Xinjiang UygurAutonomous Region and China National Petroleum Corporation (CNPC), has been approved by State Council recently,after pass appraisa l by China International Engineering Consulting Corporation entrusted by State Planning Committee.

  15. Drugs Approved for Myeloproliferative Neoplasms

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  16. Drugs Approved for Multiple Myeloma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  17. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  18. Unilateral approval - Is it working?

    International Nuclear Information System (INIS)

    MDS Nordion, owned by Canadian based MDS Inc., designs, manufactures and uses transport packages for the distribution of radioactive materials used in the medical, research and sterilisation industries. Each of these packages must be proven to meet the International Atomic Energy Agency (IAEA) transport regulations. This paper will explore the unilateral approval concept as well as provide examples of its implementation. The IAEA transport regulations are recognised and implemented across the world. They include the unilateral approval concept of a single competent authority approval of the package design. Although the performance standards set by the IAEA regulations for Type B(U) packages have been accepted and implemented in national legislation, national authorities tend to require additional reviews of the safety analysis report. Case studies will be presented to demonstrate that the concept of unilateral approval is not applied consistently between all IAEA member states, and that this has impeded the efficient transport of radioactive material. The studies also show that these additional reviews have not resulted in changes to the design of a transport package. The lack of recognition of the IAEA unilateral approval for transport packages is a barrier to the effective transport of packages. These additional reviews require allocation of resources for both the company and the regulatory agency. As a responsible partner in a very unique industry, MDS Nordion encourages all IAEA member states to accept Type B(U) transport certificate from other jurisdictions without requiring additional review or endorsement. In this respect, the collaboration of the competent authorities is important to reduce this regulatory impediment and allowing the effective transport of radioactive material. (author)

  19. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Colon and Rectal Cancer This page ... and rectal cancer that are not listed here. Drugs Approved for Colon Cancer Avastin (Bevacizumab) Bevacizumab Camptosar ( ...

  20. Epclusa Approved for Chronic Hepatitis C

    Science.gov (United States)

    ... news/fullstory_159609.html Epclusa Approved for Chronic Hepatitis C Combination drug treats six major forms of ... to treat the six major strains of chronic hepatitis C virus (HCV). Epclusa combines sofosbuvir, FDA-approved ...

  1. 28 CFR 2.93 - Travel approval.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.93 Section 2.93... Travel approval. (a) A parolee's Supervision Officer may approve travel outside the district of... possibilities. (3) Recurring travel across a district boundary, not to exceed fifty miles outside the...

  2. 40 CFR 123.61 - Approval process.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a...; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process...

  3. 40 CFR 145.31 - Approval process.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Approval process. 145.31 Section 145.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE UIC PROGRAM REQUIREMENTS Program Approval, Revision and Withdrawal § 145.31 Approval process....

  4. 32 CFR 552.77 - Suspension approval.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Suspension approval. 552.77 Section 552.77 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY MILITARY RESERVATIONS AND....77 Suspension approval. The installation commander will personally approve all cases in...

  5. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

    ... testing known negative samples, as determined by the official NPIP procedures found in this part. If... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry... kits) may be approved through the following procedure: (1) The sensitivity of the kit will be...

  6. Hunan Rare Earth Group Approved

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

    <正>Following Guangdong,Guangxi,Fujian and Jiangxi,Hunan announced that it would consolidate its rare earth resources-the consolidation plan of Hunan Rare Earth Group has been approved. Consolidation of the rare earth industry of south China is in full swing.According to "Several Opinions of the State Council on Promoting the Sustainable and Healthy Development of Rare Earth Industry"(hereinafter referred to as "Several Opinions")released in 2011,

  7. Approval of radioactive consumer goods

    International Nuclear Information System (INIS)

    The 1980 Euratom Directive obliges the UK to draw up a system of prior authorization for the use of radioactive substances in a range of consumer products, and the Government intends to make regulations to fulfil the requirements of the Directive. These regulations will empower NRPB to approve such products prior to their supply to the public. In this brief article, the NRPB reviews the criteria against which to consider any proposed use of radioactive substances, considers radiological production standards for products and discusses the questions of the labelling of radioactive consumer goods. (UK)

  8. Repurposing of approved cardiovascular drugs.

    Science.gov (United States)

    Ishida, Junichi; Konishi, Masaaki; Ebner, Nicole; Springer, Jochen

    2016-09-20

    Research and development of new drugs requires both long time and high costs, whereas safety and tolerability profiles make the success rate of approval very low. Drug repurposing, applying known drugs and compounds to new indications, has been noted recently as a cost-effective and time-unconsuming way in developing new drugs, because they have already been proven safe in humans. In this review, we discuss drug repurposing of approved cardiovascular drugs, such as aspirin, beta-blockers, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, cardiac glycosides and statins. Regarding anti-tumor activities of these agents, a number of experimental studies have demonstrated promising pleiotropic properties, whereas all clinical trials have not shown expected results. In pathological conditions other than cancer, repurposing of cardiovascular drugs is also expanding. Numerous experimental studies have reported possibilities of drug repurposing in this field and some of them have been tried for new indications ('bench to bedside'), while unexpected results of clinical studies have given hints for drug repurposing and some unknown mechanisms of action have been demonstrated by experimental studies ('bedside to bench'). The future perspective of experimental and clinical studies using cardiovascular drugs are also discussed.

  9. E-Approval Plans in Research Libraries

    Science.gov (United States)

    Pickett, Carmelita; Tabacaru, Simona; Harrell, Jeanne

    2014-01-01

    Research libraries have long invested in approval plan services, which offer an economical way to acquire scholarly and scientific publications. Traditional approval plans have evolved and now enable libraries to expand their e-book offerings to better serve researchers. Publishers offer a myriad of e-book purchasing options. These range from…

  10. 24 CFR 214.103 - Approval criteria.

    Science.gov (United States)

    2010-04-01

    ... counseling staff must possess a working knowledge of HUD's housing and single-family mortgage insurance... COUNSELING PROGRAM Approval and Disapproval of Housing Counseling Agencies § 214.103 Approval criteria. The... counseling agencies, branches, and affiliates that are included in one application: (a) Nonprofit and...

  11. 77 FR 6560 - Pesticide Product Registration Approval

    Science.gov (United States)

    2012-02-08

    ... the Federal Register of June 10, 2009 (74 FR 27541) (FRL-8413-2), which announced that Lubrizol, 29400... AGENCY Pesticide Product Registration Approval AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces Agency approval of an application to register the...

  12. 40 CFR 52.1323 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Approval status. 52.1323 Section 52.1323 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED... on January 16, 1979 (44 FR 3274) are met. (b) The Administrator approves Rule 10 CSR 10-2.290...

  13. 46 CFR 249.7 - Approval.

    Science.gov (United States)

    2010-10-01

    ... UNDERWRITERS FOR MARINE HULL INSURANCE § 249.7 Approval. (a) Approval of the applicant will be based upon an.... hull insurance market, if U.S. insurers are denied similar access to the hull insurance market in the... to MARAD's attention any discriminatory laws or practices relating to the placement of marine...

  14. 30 CFR 28.2 - Approved fuses.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved fuses. 28.2 Section 28.2 Mineral... MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES General Provisions § 28.2 Approved fuses. (a) On and after the effective date...

  15. Ordinal Position, Approval Motivation, and Interpersonal Attraction

    Science.gov (United States)

    Nowicki, Stephen, Jr.

    1971-01-01

    Results of the study suggest that birth-order effects might be included within the wider framework of approval-dependency theory. Females tend to account for a significant share of birth-order effects. More particularly, firstborn females accounted for much of the differences in expressed attraction as well as need for social approval. (Author)

  16. 18 CFR 1304.7 - Conditions of approvals.

    Science.gov (United States)

    2010-04-01

    ... CONSTRUCTION IN THE TENNESSEE RIVER SYSTEM AND REGULATION OF STRUCTURES AND OTHER ALTERATIONS Procedures for Approval of Construction § 1304.7 Conditions of approvals. Approvals of applications shall contain...

  17. 5 CFR 7601.102 - Prior approval of outside employment.

    Science.gov (United States)

    2010-01-01

    ... prohibited by statute or Federal regulation, including 5 CFR part 2635. (c) Scope of approval. Approval will... employee's NARA position, the employee shall submit a revised request for approval. (d) Definition...

  18. FDA Approves First Fully Dissolvable Stent

    Science.gov (United States)

    ... newly approved stent is made from a biodegradable polymer that's commonly used in medical devices designed to ... the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, the U.S. Department ...

  19. Depression: FDA-Approved Medications May Help

    Science.gov (United States)

    ... Products For Consumers Home For Consumers Consumer Updates Depression: FDA-Approved Medications May Help Share Tweet Linkedin ... symptoms in some people. back to top Diagnosing Depression Diagnosis—which should be from a health care ...

  20. FDA Approves Eye Implant for Aging Boomers

    Science.gov (United States)

    ... medlineplus/news/fullstory_159648.html FDA Approves Eye Implant for Aging Boomers Tiny lens reshapes cornea to ... 2016 THURSDAY, June 30, 2016 (HealthDay News) -- An implant that helps the aging eye focus on small ...

  1. FDA Approves Implant to Battle Opioid Addiction

    Science.gov (United States)

    ... gov/medlineplus/news/fullstory_159050.html FDA Approves Implant to Battle Opioid Addiction Experts say steady dosing ... 26, 2016 (HealthDay News) -- A new long-acting implant that can help treat people addicted to heroin ...

  2. Drugs Approved for Gestational Trophoblastic Disease

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for gestational trophoblastic disease. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  3. 7 CFR 1421.403 - DMA approval.

    Science.gov (United States)

    2010-01-01

    ... the entity's financial condition. (3) The entity's tax identification number. (4) A copy of any... services for which the approval to perform is sought. (7) A narrative explaining how the proposed...

  4. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for use in colon cancer and rectal cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  5. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for stomach (gastric) cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  6. Drugs Approved for Head and Neck Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for head and neck cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  7. The dilemma of approving antidotes.

    Science.gov (United States)

    Steffen, Christian

    2007-04-20

    Clinical trials with antidotes are difficult to perform for a variety of practical, ethical, and financial reasons. As acute poisoning is a rare event, the commercial interest in basic and clinical research is low. Poisoned patients are usually not available for normal clinical trial procedures and, if they are, they cannot give informed consent. This situation results in a dilemma: antidotes are essential drugs. A resolution of the Council of Europe requests to guarantee the optimal availability of antidotes and the improvement of their use. As comprehensive data on the efficacy of antidotes are often missing, a marketing authorisation under exceptional circumstances according to Article 14(8) of Regulation (EC) No. 276/2004, will often be the only way to get an approval, as: (1) the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence ("orphan drug"), (2) in the present state of scientific knowledge, comprehensive information cannot be provided, or (3) it would be contrary to generally accepted principles of medical ethics to collect such data. Typically, data on antidotes are obtained from a patchwork of studies with animals, human tissue and a few observations from human poisoning corroborated with data from clinical observations and biochemistry. Generalisations from chemical and mechanistic similarities between groups of poisons are usual, but often lack scientific evidence. Current standards of good clinical practice can rarely be observed. Therefore, public funding and other financial support are necessary incentives to initiate trials in this important area. PMID:17207900

  8. 30 CFR 14.10 - Post-approval product audit.

    Science.gov (United States)

    2010-07-01

    ... to audit for cause at any time MSHA believes the approval holder product is not in compliance with... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Post-approval product audit. 14.10 Section 14... General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject...

  9. 7 CFR 1726.36 - Documents subject to RUS approval.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Documents subject to RUS approval. 1726.36 Section... subject to RUS approval. Unless otherwise indicated, the borrower shall make all contracts and amendments that are subject to RUS approval effective only upon RUS approval....

  10. 46 CFR 163.003-9 - Approval procedure.

    Science.gov (United States)

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL CONSTRUCTION Pilot Ladder § 163.003-9 Approval procedure. (a) General. A pilot ladder... testing. Each approval test must be conducted in accordance with § 163.003-21. (c) Approval of alternatives. A pilot ladder that does not meet the materials, construction, or performance requirements...

  11. 46 CFR 163.002-9 - Approval procedure.

    Science.gov (United States)

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL CONSTRUCTION Pilot Hoist § 163.002-9 Approval procedure. (a) General. A pilot hoist... testing. Each approval test must be conducted in accordance with § 163.002-21. (c) Approval of alternative designs. A pilot hoist that does not meet the materials, construction, or performance requirements of...

  12. 45 CFR 2400.42 - Approval of Plan of Study.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Approval of Plan of Study. 2400.42 Section 2400.42... FOUNDATION FELLOWSHIP PROGRAM REQUIREMENTS Graduate Study § 2400.42 Approval of Plan of Study. The Foundation must approve each Fellow's Plan of Study. To be approved, the plan must: (a) On a part-time or...

  13. 46 CFR 160.023-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.023-4 Section 160.023... Signals § 160.023-4 Approval and production tests. (a) Approval tests. The approval tests are those tests... independent laboratory accepted by the Commandant under § 159.010 of this chapter. (b) Production...

  14. 30 CFR 28.25 - Changes or modifications of approved fuses; issuance of modification of certificate of approval.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Changes or modifications of approved fuses... HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR... Approval and Disapproval § 28.25 Changes or modifications of approved fuses; issuance of modification...

  15. [State of Michigan Teacher Education Manual 1970, Sections I and II--Approval of Teacher Education Institutions and Approval of Teacher Education Programs at Approved Teacher Education Institutions].

    Science.gov (United States)

    Michigan State Dept. of Education, Lansing. Teacher Preparation and Professional Development Services.

    This document presents rules and regulations of the Michigan State Board of Education concerning procedures for the approval of teacher education institutions and teacher education programs. The first section details processes in institutional approval, presenting: (1) legislative authority; (2) characteristics of the Approved Program System; (3)…

  16. Program and Course Approval Handbook. Fifth Edition

    Science.gov (United States)

    California Community Colleges, Chancellor's Office, 2013

    2013-01-01

    This "Program and Course Approval Handbook" assists California Community College (CCC) administrators, faculty, and staff in the development of programs and courses and the submission of these proposals for review by the Chancellor's Office. By law, the Chancellor is required to prepare and distribute a handbook for program and course…

  17. 40 CFR 52.722 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... Air Act, as amended in 1977. (c) The Administrator finds that the carbon monoxide control strategy... National Ambient Air Quality Standards under section 110 of the Clean Air Act. Furthermore, the... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL...

  18. The Ethics and Politics of Ethics Approval

    Science.gov (United States)

    Battin, Tim; Riley, Dan; Avery, Alan

    2014-01-01

    The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…

  19. 40 CFR 1042.210 - Preliminary approval.

    Science.gov (United States)

    2010-07-01

    ... specific provisions that apply for deterioration factors. Decisions made under this section are considered... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Preliminary approval. 1042.210 Section 1042.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION...

  20. Perkins Bill is Approved by Congress

    Science.gov (United States)

    Cavanagh, Sean

    2006-01-01

    Career and technical education programs will face new pressure to show that they are academically rigorous and guiding high school students through a lineup of courses that prepares them for college or the workplace, under a bill approved by Congress. The reauthorization of the federal law known as the Perkins Act--dealing with what traditionally…

  1. 40 CFR 52.2522 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... provisions do not meet the requirements of 40 CFR 51.160 for scope. EPA also disapproves 45 CSR 13 section 9... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Approval status. 52.2522 Section 52.2522 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS...

  2. 40 CFR 52.373 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... approves the total suspended particulate regulation for foundry sand processes as submitted and identified... the particulate matter and not the requirement to emit not more than 0.75 pounds of particulate per ton of material cast, a provision which may be found in state regulation 19-508-18(f)(3)....

  3. Reflections on the Ethics-Approval Process

    Science.gov (United States)

    Murray, Lee; Pushor, Debbie; Renihan, Pat

    2012-01-01

    It is sometimes a difficult journey receiving ethics approval for research involving vulnerable populations, research involving our own children, or innovative research methodologies such as autoethnography. This autoethnographical account is a story about one student who wanted to write a PhD dissertation in a very different way and also the…

  4. 23 CFR 645.215 - Approvals.

    Science.gov (United States)

    2010-04-01

    .... 109, 111, and 116, and 23 CFR 1.23 and 1.27, and meet the requirements of this regulation, the FHWA... Accommodation of Utilities § 645.215 Approvals. (a) Each State transportation department shall submit a... the FHWA for prior concurrence, except when the proposed installation is not in accordance with...

  5. Approved Practices in Dairy Reproduction. Slide Script.

    Science.gov (United States)

    Roediger, Roger D.; Barr, Harry L.

    This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with approved practices in dairy reproduction. Included in the guide are narrations for use with 200 slides dealing with the following topics: the importance of good reproduction, the male and female roles in reproduction, selection of…

  6. 42 CFR 422.2266 - Deemed approval.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Deemed approval. 422.2266 Section 422.2266 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Medicare Advantage Marketing Requirements § 422.2266...

  7. 42 CFR 423.2266 - Deemed approval.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Deemed approval. 423.2266 Section 423.2266 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Part D Marketing Requirements §...

  8. 28 CFR 48.15 - Temporary approval.

    Science.gov (United States)

    2010-07-01

    ... Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) NEWSPAPER PRESERVATION ACT § 48.15 Temporary... temporary approval may do so by delivering a statement of protest or telephoning his views to an employee of the Department of Justice, whose name, address and telephone number shall be designated by...

  9. 7 CFR 3015.112 - Approval procedures.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Approval procedures. 3015.112 Section 3015.112 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF THE CHIEF FINANCIAL OFFICER, DEPARTMENT OF AGRICULTURE UNIFORM FEDERAL ASSISTANCE REGULATIONS Programmatic Changes and Budget...

  10. Side effects of cytokines approved for therapy.

    Science.gov (United States)

    Baldo, Brian A

    2014-11-01

    Cytokines, currently known to be more than 130 in number, are small MW (aldesleukin (rhIL-2), oprelvekin (rhIL-11), filgrastim and tbo-filgrastim (rhG-CSF), sargramostim (rhGM-CSF), metreleptin (rh-leptin) and the rh-erythropoietins, epoetin and darbepoietin alfa. Anakinra, a recombinant receptor antagonist for IL-1, is in the IL-1 family; recombinant interferons alfa-1, alfa-2, beta-1 and gamma-1 make up the interferon family; palifermin (rhKGF) and becaplermin (rhPDGF) are in the PDGF family; and rhBMP-2 and rhBMP-7 represent the TGFβ family. The main physicochemical features, FDA-approved indications, modes of action and side effects of these approved cytokines are presented. Underlying each adverse events profile is their pleiotropism, potency and capacity to release other cytokines producing cytokine 'cocktails'. Side effects, some serious, occur despite cytokines being endogenous proteins, and this therefore demands caution in attempts to introduce individual members into the clinic. This caution is reflected in the relatively small number of cytokines currently approved by regulatory agencies and by the fact that 14 of the FDA-approved preparations carry warnings, with 10 being black box warnings. PMID:25270293

  11. 7 CFR 1735.61 - Approval criteria.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE GENERAL POLICIES, TYPES OF LOANS, LOAN REQUIREMENTS-TELECOMMUNICATIONS PROGRAM Mortgage Controls... of its mortgage or loan contract to obtain RUS approval of a merger or acquisition, the borrower... economic and loan-repayment feasibility characteristics of the proposed system are satisfactory;...

  12. Trends in global approvals of biotech crops (1992-2014).

    Science.gov (United States)

    Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

    2015-01-01

    With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits. PMID:26039675

  13. Trends in global approvals of biotech crops (1992-2014).

    Science.gov (United States)

    Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

    2015-01-01

    With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.

  14. 30 CFR 28.20 - Certificates of approval; scope of approval.

    Science.gov (United States)

    2010-07-01

    ..., EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT... only for individual, completely fabricated fuses which have been examined, inspected, and tested...

  15. 77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Science.gov (United States)

    2012-05-04

    ... Maryland Department of the Environment (MDE). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM), sulfur oxides (SO X ), and...

  16. 46 CFR 162.050-23 - Separator: Approval tests.

    Science.gov (United States)

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Pollution Prevention Equipment § 162.050-23 Separator: Approval... hour, the separator must be inclined at an angle of 22.5° with the plane of its normal...

  17. 76 FR 30189 - Receipt of Application for Approval

    Science.gov (United States)

    2011-05-24

    ... program for the Swift Parrot (Lathamus discolor). The approval would be for the cooperative breeding program and all its members, including the applicant. If approved, the program will be overseen by...

  18. Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on...

  19. 46 CFR 131.710 - Approved work vests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Approved work vests. 131.710 Section 131.710 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS OPERATIONS Work Vests § 131.710 Approved work vests. Each buoyant work vest carried aboard must be approved under subpart...

  20. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

    ... COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule by the Susquehanna River Basin.... SUPPLEMENTARY INFORMATION: This notice lists the projects, described below, receiving approval for...

  1. 78 FR 11947 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-02-20

    ... COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION: Notice. SUMMARY: This notice lists the projects approved by rule by the Susquehanna River Basin.... SUPPLEMENTARY INFORMATION: This notice lists the projects, described below, receiving approval for...

  2. 46 CFR 164.007-3 - Conditions of approval.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Conditions of approval. 164.007-3 Section 164.007-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-3 Conditions of approval. (a)...

  3. 46 CFR 188.10-3 - Approved container.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Approved container. 188.10-3 Section 188.10-3 Shipping... PROVISIONS Definition of Terms Used in This Subchapter § 188.10-3 Approved container. This term means a container which is properly labeled, marked and approved by DOT for the commodity which it contains....

  4. 46 CFR 8.530 - Plan development and approval.

    Science.gov (United States)

    2010-10-01

    ... develop the CAP and VAP with guidance from the Coast Guard SIP Advisor for OCMI approval. (a) Company Action Plan. The CAP shall include at least the following: (1) A copy of the OCMI CAP approval letter (once the CAP is approved). (2) An organization commitment statement. (3) A company organization...

  5. 77 FR 4859 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-01-31

    ... to 7.500 mgd; Approval Date: October 11, 2011. 6. Seneca Resources Corporation, Pad ID: DCNR 100 Pad..., Wyoming County, Pa.; Consumptive Use of up to 7.500 mgd; Approval Date: October 20, 2011. 12. Seneca....; Consumptive Use of up to 4.000 mgd; Approval Date: October 20, 2011. 13. Seneca Resources Corporation, Pad...

  6. 10 CFR 52.143 - Staff approval of design.

    Science.gov (United States)

    2010-01-01

    ... the design in the form of a report available at the NRC Web site, http://www.nrc.gov. ... 10 Energy 2 2010-01-01 2010-01-01 false Staff approval of design. 52.143 Section 52.143 Energy... Standard Design Approvals § 52.143 Staff approval of design. Upon completion of its review of a...

  7. 44 CFR 78.9 - Planning grant approval process.

    Science.gov (United States)

    2010-10-01

    ... MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Planning grant approval process. 78.9 Section 78.9 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT...

  8. 7 CFR 1717.609 - RUS approval of general manager.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of general manager. 1717.609 Section... Operational Controls § 1717.609 RUS approval of general manager. (a) If a borrower's mortgage or loan contract grants RUS the unconditioned right to approve the employment and/or the employment contract of...

  9. 7 CFR 1717.308 - RUS approval of nonconforming rates.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of nonconforming rates. 1717.308 Section... Federal Pre-emption in Rate Making in Connection With Power Supply Borrowers § 1717.308 RUS approval of nonconforming rates. Borrowers may request and RUS may approve rates which do not conform with the...

  10. 8 CFR 207.6 - Control over approved refugee numbers.

    Science.gov (United States)

    2010-01-01

    ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Control over approved refugee numbers. 207... ADMISSION OF REFUGEES § 207.6 Control over approved refugee numbers. Current numerical accounting of approved refugees is maintained for each special group designated by the President. As refugee status...

  11. 50 CFR 15.26 - Approval of cooperative breeding programs.

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 1 2010-10-01 2010-10-01 false Approval of cooperative breeding programs... WILDLIFE AND PLANTS WILD BIRD CONSERVATION ACT Permits and Approval of Cooperative Breeding Programs § 15.26 Approval of cooperative breeding programs. Upon receipt of a complete application, the...

  12. 18 CFR 12.34 - Approval of independent consultant.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Approval of independent... PROJECT WORKS Inspection by Independent Consultant § 12.34 Approval of independent consultant. At least 60... Director of the Office of Energy Projects Licensing for approval, with a copy to the Regional Engineer,...

  13. 29 CFR 4221.14 - PBGC-approved arbitration procedures.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false PBGC-approved arbitration procedures. 4221.14 Section 4221... LIABILITY FOR MULTIEMPLOYER PLANS ARBITRATION OF DISPUTES IN MULTIEMPLOYER PLANS § 4221.14 PBGC-approved arbitration procedures. (a) Use of PBGC-approved arbitration procedures. In lieu of the procedures...

  14. 12 CFR 614.4470 - Loans subject to bank approval.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Loans subject to bank approval. 614.4470 Section 614.4470 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LOAN POLICIES AND OPERATIONS Loan Approval Requirements § 614.4470 Loans subject to bank approval. (a) The following...

  15. 25 CFR 286.16 - Grant approval authority.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Grant approval authority. 286.16 Section 286.16 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ECONOMIC ENTERPRISES INDIAN BUSINESS DEVELOPMENT PROGRAM § 286.16 Grant approval authority. Applications for grants require approval by the...

  16. 48 CFR 1845.607-170 - Contractor's approved scrap procedure.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Contractor's approved scrap... Contractor Inventory 1845.607-170 Contractor's approved scrap procedure. (a) When a contractor has an approved scrap procedure, certain property may be routinely disposed of in accordance with that...

  17. 28 CFR 551.11 - Authority to approve a marriage.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Authority to approve a marriage. 551.11... MISCELLANEOUS Marriages of Inmates § 551.11 Authority to approve a marriage. (a) The Warden may approve the marriage of a federal inmate confined in a federal institution. This authority may not be delegated...

  18. 14 CFR 21.269 - Export airworthiness approvals.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Export airworthiness approvals. 21.269 Section 21.269 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION....269 Export airworthiness approvals. The manufacturer may issue export airworthiness approvals....

  19. 46 CFR 160.040-5 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.040-5 Section 160.040... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... performance tests in paragraph (c) of this section. (b) Production inspections and tests....

  20. 46 CFR 160.037-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.037-4 Section 160.037... Approval and production tests. (a) Approval tests. The manufacturer must produce a lot of at least 100... chapter. (b) Production inspections and tests. Production inspections and tests of each lot of...

  1. 46 CFR 160.031-5 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.031-5 Section 160.031... Equipment) § 160.031-5 Approval and production tests. (a) Approval test. An independent laboratory accepted... operational test in paragraph (c) of this section. (b) Production inspections and tests....

  2. 46 CFR 160.022-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.022-4 Section 160.022... Minutes) § 160.022-4 Approval and production tests. (a) Approval tests. The manufacturer must produce a... Commandant under § 159.010 of this chapter. (b) Production inspections and tests. Production inspections...

  3. 46 CFR 160.028-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.028-4 Section 160.028... § 160.028-4 Approval and production tests. (a) Approval test. An independent laboratory accepted by the... paragraph (c) of this section. (b) Production inspections and tests. Production inspections and tests...

  4. 46 CFR 160.057-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval and production tests. 160.057-4 Section 160.057... Minutes) § 160.057-4 Approval and production tests. (a) Approval tests. The manufacturer must produce a... under § 159.010 of this chapter. (b) Production inspections and tests. Production inspections and...

  5. 7 CFR 996.22 - USDA-approved laboratory.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false USDA-approved laboratory. 996.22 Section 996.22 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing... laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology...

  6. Guangxi and Qinghai Delegated Mining Right Transfer Approval Right

    Institute of Scientific and Technical Information of China (English)

    2013-01-01

    <正>To ensure timely adjustment of mining right transfer approval authority according to the requirements of the Ministry of Land and Resources, recently, Guangxi and Qinghai Land and Resources Department decided: The mining right previously approved by city and county level land and resources bureaus, and the transfer approval authority previously exercised by Guangxi Land and Resources Department,

  7. 49 CFR 1522.109 - TSA review and approval.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 9 2010-10-01 2010-10-01 false TSA review and approval. 1522.109 Section 1522.109..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation Firms and Validators for the Certified Cargo Screening...

  8. 7 CFR 1710.206 - Approval requirements for load forecasts prepared pursuant to approved load forecast work plans.

    Science.gov (United States)

    2010-01-01

    ... pursuant to approved load forecast work plans. 1710.206 Section 1710.206 Agriculture Regulations of the... requirements for load forecasts prepared pursuant to approved load forecast work plans. (a) Contents of load forecasts prepared under an approved load forecast work plan. In addition to the minimum requirements...

  9. Three Newly Approved Analgesics: An Update

    OpenAIRE

    Saraghi, Mana; Hersh, Elliot V.

    2013-01-01

    Since 2008, three new analgesic entities, tapentadol immediate release (Nucynta) diclofenac potassium soft gelatin capsules (Zipsor), and bupivacaine liposome injectable suspension (EXPAREL) were granted US Food and Drug Administration (FDA) approval to treat acute pain. Tapentadol immediate-release is a both a mu-opioid agonist and a norepinephrine reuptake inhibitor, and is indicated for the treatment of moderate to severe pain. Diclofenac potassium soft gelatin capsules are a novel formula...

  10. Credit Risk Management - Loan Approval Process

    OpenAIRE

    Lulzim Rashiti; Branimir Kalas; Lazar Drec; Nino Stameski

    2016-01-01

    The aim of this study is on understanding the international regulations issued by Basel I, Basel II and Basel III to best supervise and manage credit risk management policies. Part of paper will focus on the description and impacts of the regulations and the pivotal importance they play in providing a sound banking system. Credit risk represents another important element that will be analysed considering that it lays the foundation during the loan consideration and approval process. The paper...

  11. Drug updates and approvals: 2015 in review.

    Science.gov (United States)

    Klibanov, Olga M; Phan, Diep; Ferguson, Kelli

    2015-12-12

    This article highlights important prescribing information for some drugs that received FDA approval within the past year. These include: atazanavir and cobicistat (Evotaz®), ceftazidime and avibactam (Avycaz®), edoxaban (Savaysa®), ivabradine (Corlanor®), liraglutide (rDNA origin) injection (Saxenda®), perindopril arginine and amlodipine besylate (Prestalia®), and secukinumab (Cosentyx®) subcutaneous injection. PMID:26545091

  12. Social desirability, approval and public good contribution

    OpenAIRE

    Daniel John Zizzo; Piers Fleming

    2009-01-01

    Behaviour in public good experiments is usually attributed partly to rational self-interest and partly to social norms and preferences. This paper examines if sensitivity to social desirability affects public good contribution and in what way. A pre-experimental measure of social desirability (SDS17) was used to match partners in a two-person public good game. Half the participants received experimenter approval based upon their investment. Contrary to predictions, the highest public good inv...

  13. Shareholders, creditors approve utility reorganization plan

    International Nuclear Information System (INIS)

    Shareholders and all classes of secured creditors of Public Service Company of New Hampshire voted overwhelmingly last month to approve Northeast Utilities' Chapter 11 reorganization plan for PSNH, the utility announced. PSNH filed for bankruptcy protection in January 1988. Under the reorganization plan, Connecticut-based NU would acquire the utility for $2.3 billion. While PSNH's preferred and common stockholders voted to accept the proposal, holders of warrants to purchase PSNH common stock rejected the plan. Except for the votes of a group of independent power producers, PSNH's unsecured creditors also voted to accept the plan

  14. Shanghai-Nanjing Intercity Railway Approved

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    @@ The feasibility study on Shanghai-Nanjing and Shanghai-Hangzhou Intercity Railways were approved officially by the National Reform and Development Commission (NRDC). The Shanghai-Nanjing Intercity Railway will be located briefly in parallel with the existing Shanghai-Nanjing Railway, starting from Shanghai and ending at Nanjing via Kunshan, Suzhou,Wuxi, Changzhou, Danyang and Zhenjiang, with a total length of 300 km for the main line, among which 32km will be in Shanghai and 268 km in Jiangsu Province.

  15. Levomilnacipran extended release: first global approval.

    Science.gov (United States)

    Hair, Philip; Cameron, Fiona; Garnock-Jones, Karly P

    2013-09-01

    Pierre Fabre and Forest Laboratories are developing levomilnacipran extended release (ER) [FETZIMA™], an enantiomer of milnacipran, for the treatment of major depressive disorder (MDD). In addition, Pierre Fabre (the originator of the compound) is developing the drug to improve recovery in patients with ischaemic stroke. Levomilnacipran ER exerts its effects by selectively inhibiting the reuptake of norepinephrine and serotonin (two neurotransmitters known to play an essential role in regulating mood) without directly affecting the uptake of dopamine or other neurotransmitters. The agent is being developed as an extended-release capsule formulation for once-daily dosing. Levomilnacipran ER is approved and launched in the US for the treatment of MDD; phase III development in this indication was completed in the US and Canada. In Europe, a phase II trial for MDD was completed, and development is in progress for improving functional recovery of patients with ischaemic stroke. A completed phase II trial in the US investigated levomilnacipran ER for the treatment of fatigue associated with MDD. This article summarizes the milestones in the development of levomilnacipran ER leading to the first approval for major depressive disorder. PMID:24000002

  16. 14 CFR 171.25 - Minimum requirements for approval.

    Science.gov (United States)

    2010-01-01

    ... (CONTINUED) NAVIGATIONAL FACILITIES NON-FEDERAL NAVIGATION FACILITIES Nondirectional Radio Beacon Facilities... met before the FAA will approve an IFR procedure for a non-Federal, nondirectional radio...

  17. ELECTRONIC COMPLIANCE AND APPROVAL PROJECT (ECAP)

    Energy Technology Data Exchange (ETDEWEB)

    Hope Morgan; Richard A. Varela; Deborah LaHood; Susan Cisco; Mary Ann Benavides; Donna Burks

    2002-11-01

    The Texas Railroad Commission (RRC), working in partnership with the United States Department of Energy and the oil and gas industry it regulates, is implementing a strategy for improving efficiency in regulations and significantly reducing administrative operating costs through the Electronic Compliance and Approval Process (ECAP). The project will streamline regulatory compliance and reporting by providing the ability to electronically submit, process, and query oil and gas applications and reports through the Internet-based ECAP system. Implementation of an ECAP drilling permit pilot project began September 1999 after funding resources were secured--a $700,000 grant from the U.S. Department of Energy and an appropriation of $1.4 million from the Texas Legislature. The pilot project involves creating the ability to file, review, and approve a well's drilling permit application through a completely electronic process. The pilot project solution will ultimately provide the infrastructure, technology, and electronic modules to enable the filing of all compliance permits and performance reports through the internet from a desktop computer. The pilot project was conducted in three phases. The first phase, implemented May 2000, provided the infrastructure that allows the electronic filing and approval of simple drilling permit applications, associated fees, and attachments. The official ''roll-out'' of ECAP and the first electronically filed drilling permit application occurred on May 11, 2000 in Dallas in conjunction with an Internet Workshop sponsored by the Petroleum Technology Transfer Council. After the completion of Phase I, the ECAP team conducted an extensive review of progress to date and analyzed requirements and opportunities for future steps. The technical team identified core infrastructure modifications that would facilitate and better support future development and expansion of the ECAP system and work began on database structure

  18. Council approves statement on natural hazards

    Science.gov (United States)

    As a scientific society, AGU may adopt positions of advocacy on geophysical science isues based on their intrinsic merits and needs. On December 18, 1996, the AGU Council approved a Union position statement regarding scientific research and education in natural hazards. The complete position statement follows and also is posted at the Union Web Site, http://www.agu.org. Other Union position statements and information about proposing a position statement are in the AGU Handbook and at the Union Web Site.Few locations on Earth are immune from droughts, storms, floods, fires, earthquakes, landslides, tsunamis, volcanic eruptions, sea level changes, water course changes, atmospheric electrical storms, and impacts from comets and asteroids. Humans and technological systems are also threatened by natural hazards that occur in space. The effects of space weather, for example, can wreak havoc with the satellites we use to provide communications, weather forecasts, and defense and positioning information.

  19. Consumer approval of irradiated meat still tentative

    International Nuclear Information System (INIS)

    Although the FDA has approved irradiation of red meat, consumers may not be so accepting of the use of this technology. Irradiation is a process used to improve food safety in food products susceptible to disease-causing microorganisms. The red meat ruling was widely praised by federal officials and food industry leaders, but consumers seem less sure. Indeed, on the night of the red meat announcement last December, CBS Evening News reported that over 70 percent of U.S. consumers would not knowingly eat irradiated food. There is hope, however, as a study by the Center for Consumer Research at the University of California, Davis, revealed that consumer interest in buying irradiated food can be substantially improved by providing consumers with information, thereby enabling them to see the benefits and to overcome the myths of irradiation

  20. 78 FR 28620 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-05-15

    ... Bureau of Land Management Renewal of Approved Information Collection AGENCY: Bureau of Land Management... Reduction Act, the Bureau of Land Management (BLM) invites public comments on, and plans to request approval..., competitive, and organized group recreational uses of the public lands, and individual use of special...

  1. 28 CFR 551.31 - Approval of an organization.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Approval of an organization. 551.31 Section 551.31 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MISCELLANEOUS Inmate Organizations § 551.31 Approval of an organization. (a) An inmate must submit a request...

  2. Waste Feed Delivery Environmental Permits and Approvals Plan

    Energy Technology Data Exchange (ETDEWEB)

    TOLLEFSON, K.S.

    2000-01-18

    This plan describes the environmental permits approvals, and other requirements that may affect establishment of a waste feed delivery system for the Hanford Site's River Protection Project. This plan identifies and screens environmental standards for potential applicability, outlines alternatives for satisfying applicable standards, and describes preferred permitting and approval approaches.

  3. 46 CFR 161.012-11 - Approval tests.

    Science.gov (United States)

    2010-10-01

    ... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL ELECTRICAL EQUIPMENT Personal Flotation Device Lights § 161.012-11 Approval tests. (a....012-7, except that technical data showing compliance with § 160.012-7(c) may be submitted with...

  4. 7 CFR 714.45 - Approval by Deputy Administrator.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 7 2010-01-01 2010-01-01 false Approval by Deputy Administrator. 714.45 Section 714... PENALTIES ERRONEOUSLY, ILLEGALLY, OR WRONGFULLY COLLECTED § 714.45 Approval by Deputy Administrator. The Deputy Administrator shall review each claim forwarded to him by the State committee to determine...

  5. 25 CFR 216.7 - Approval of mining plan.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Approval of mining plan. 216.7 Section 216.7 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS SURFACE EXPLORATION, MINING, AND RECLAMATION OF LANDS General Provisions § 216.7 Approval of mining plan. (a) Before surface mining...

  6. 43 CFR 23.8 - Approval of mining plan.

    Science.gov (United States)

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Approval of mining plan. 23.8 Section 23.8 Public Lands: Interior Office of the Secretary of the Interior SURFACE EXPLORATION, MINING AND RECLAMATION OF LANDS § 23.8 Approval of mining plan. (a) Before surface mining operations may commence...

  7. 14 CFR 135.419 - Approved aircraft inspection program.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Approved aircraft inspection program. 135.419 Section 135.419 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF... Maintenance, Preventive Maintenance, and Alterations § 135.419 Approved aircraft inspection program....

  8. 7 CFR 1735.62 - Approval of acquisitions and mergers.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Approval of acquisitions and mergers. 1735.62 Section 1735.62 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE... Mortgage Controls on Acquisitions and Mergers § 1735.62 Approval of acquisitions and mergers. (a) If...

  9. 76 FR 66117 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-10-25

    ... mgd; Approval Date: August 4, 2011. 8. Seneca Resources Corporation, Pad ID: Rich Valley Pad B, ABR... County, Pa.; Consumptive Use of up to 3.000 mgd; Approval Date: August 16, 2011. 31. Seneca Resources.... 38. Seneca Resources Corporation, Pad ID: DCNR 100 Pad G, ABR- 201108032, McIntyre Township,...

  10. 38 CFR 21.4263 - Approval of flight training courses.

    Science.gov (United States)

    2010-07-01

    ..., may seek an administrative review of their approval by the Director, Education Service. Requests for... number of hours should be approved. (ii) The Director, Education Service shall base her or his decision... AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Administration of Educational...

  11. 46 CFR 163.003-21 - Approval tests.

    Science.gov (United States)

    2010-10-01

    ... following approval tests must be conducted: (1) Step flexibility test. This test is performed on six... test must be conducted on a ladder of the longest length for which approval has been requested. If the... made. After a test failure and any design change, the failed test, and any other previously...

  12. 7 CFR 1717.608 - RUS approval of contracts.

    Science.gov (United States)

    2010-01-01

    ... requirements regarding RUS approval of such contracts are set forth in 7 CFR part 1724 for architectural and engineering services, and in 7 CFR part 1726 for construction and procurement. (b) Large retail power... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of contracts. 1717.608 Section...

  13. 21 CFR 1240.83 - Approval of watering points.

    Science.gov (United States)

    2010-04-01

    ... communicable diseases. (b) The Commissioner of Food and Drugs may base his approval or disapproval of a... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Approval of watering points. 1240.83 Section 1240.83 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  14. 77 FR 55892 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  15. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  16. 77 FR 66909 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-11-07

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  17. 77 FR 34455 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-06-11

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  18. 77 FR 16317 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-03-20

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  19. 7 CFR 272.9 - Approval of homeless meal providers.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 4 2010-01-01 2010-01-01 false Approval of homeless meal providers. 272.9 Section 272... AGENCIES § 272.9 Approval of homeless meal providers. The State food stamp agency, or another appropriate... does in fact serve meals to homeless persons. Where the State food stamp agency identifies...

  20. 50 CFR Appendix B to Part 404 - Approved VMS

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Approved VMS B Appendix B to Part 404... MARINE NATIONAL MONUMENT Pt. 404, App. B Appendix B to Part 404—Approved VMS I. VMS Mobile Transceiver Unit Thrane & Thrane Sailor 3026D Gold VMS The Thrane & Thrane Sailor 3026D Gold VMS (TT-3026D)...

  1. 18 CFR 154.6 - Acceptance for filing not approval.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Acceptance for filing... Provisions and Conditions § 154.6 Acceptance for filing not approval. The acceptance for filing of any tariff, contract or part thereof does not constitute approval by the Commission. Any filing which does not...

  2. Electronic Approval: Another Step toward a Paperless Office.

    Science.gov (United States)

    Blythe, Kenneth C.; Morrison, Dennis L.

    1992-01-01

    Pennsylvania State University's award-winning electronic approval system allows administrative documents to be electronically generated, approved, and updated in the university's central database. Campus business can thus be conducted faster, less expensively, more accurately, and with greater security than with traditional paper approval…

  3. 75 FR 13204 - Notice of Petition for Approval

    Science.gov (United States)

    2010-03-18

    ... (PSP) submitted pursuant to 49 CFR Part 236, subpart H. The individual petition is described below... approval of a revised version (version 3.0) of their already approved PSP for the Electronic Train Management System (ETMS). BNSF asserts that the revised PSP demonstrates that ETMS has been designed...

  4. 34 CFR 75.561 - Approval of indirect cost rates.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Approval of indirect cost rates. 75.561 Section 75.561 Education Office of the Secretary, Department of Education DIRECT GRANT PROGRAMS What Conditions Must Be Met... Education is the cognizant agency, the Secretary approves an indirect cost rate for a grantee other than...

  5. 34 CFR 76.561 - Approval of indirect cost rates.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Approval of indirect cost rates. 76.561 Section 76.561 Education Office of the Secretary, Department of Education STATE-ADMINISTERED PROGRAMS What Conditions Must.... (a) If the Department of Education is the cognizant agency, the Secretary approves an indirect...

  6. 40 CFR 1065.12 - Approval of alternate procedures.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Approval of alternate procedures. 1065.12 Section 1065.12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS ENGINE-TESTING PROCEDURES Applicability and General Provisions § 1065.12 Approval...

  7. 77 FR 25010 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-26

    ... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the time period specified above: Approvals by Rule Issued Under 18 CFR 806.22(f) 1. EXCO Resources (PA), LLC, Pad... 27, 2012. 28. Range Resources--Appalachia, LLC, Pad ID: Porter, Stephen, ABR- 201203028, Cogan...

  8. 42 CFR 433.117 - Initial approval of replacement systems.

    Science.gov (United States)

    2010-10-01

    ... and Information Retrieval Systems § 433.117 Initial approval of replacement systems. (a) A replacement system must meet all conditions of initial approval of a mechanized claims processing and information retrieval system. (b) The agency must submit a APD that includes— (1) The date the replacement system...

  9. 14 CFR 21.8 - Approval of articles.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval of articles. 21.8 Section 21.8 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS General § 21.8 Approval of articles. If an article is required to...

  10. 12 CFR 614.4460 - Loan approval responsibility.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Loan approval responsibility. 614.4460 Section 614.4460 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LOAN POLICIES AND OPERATIONS... approval of such loans by the appropriate bank board, or establishment of a policy under which...

  11. Hyapproval : final handbook for approval of hydrogen refuelling stations

    NARCIS (Netherlands)

    Wurster, R.; Landinger, H.; Machens, C.; Allidières, L.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.

    2006-01-01

    HyApproval is an EC co-financed Specific Targeted Research Project (STREP) to develop a Handbook facilitating the approval of Hydrogen Refuelling Stations (HRS). The project, started in October 2005, will be performed over 24 months by a balanced partnership including 25 partners from industry, SMEs

  12. Thirty-seven NSFC-KOSEF Cooperative Projects Approved

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    @@ Thrity seven bilateral projects (including 25 joint research projects and 12 joint seminars) between NSFC and KOSEF for FY 2008 were approved by the 12th Meeting of China-Korea Joint Committee for Basic Scientific Research held in Xiamen,China from May 21 to 24,2008.The approved joint research projects and seminars are listed below.

  13. 27 CFR 4.50 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Certificates of label approval. 4.50 Section 4.50 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Approval of Labels...

  14. 14 CFR 21.609 - Approval for deviation.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval for deviation. 21.609 Section 21.609 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT... deviation. (a) Each manufacturer who requests approval to deviate from any performance standard of a...

  15. 25 CFR 225.22 - Approval of minerals agreements.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Approval of minerals agreements. 225.22 Section 225.22 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS OIL AND GAS, GEOTHERMAL... with written findings forming the basis of the Secretary's intent to approve or disapprove the...

  16. 28 CFR 20.23 - Documentation: Approval by OJARS.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Documentation: Approval by OJARS. 20.23 Section 20.23 Judicial Administration DEPARTMENT OF JUSTICE CRIMINAL JUSTICE INFORMATION SYSTEMS State and Local Criminal History Record Information Systems § 20.23 Documentation: Approval by OJARS. Within...

  17. 12 CFR 918.5 - Approval by Finance Board.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Approval by Finance Board. 918.5 Section 918.5 Banks and Banking FEDERAL HOUSING FINANCE BOARD GOVERNANCE AND MANAGEMENT OF THE FEDERAL HOME LOAN BANKS BANK DIRECTOR COMPENSATION AND EXPENSES § 918.5 Approval by Finance Board. Payments made to...

  18. 46 CFR 160.076-25 - Approval testing.

    Science.gov (United States)

    2010-10-01

    ... constructed in accordance with the plans and specifications submitted with the application for approval. (b... 46 Shipping 6 2010-10-01 2010-10-01 false Approval testing. 160.076-25 Section 160.076-25 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND...

  19. 78 FR 27470 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-05-10

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  20. 78 FR 17281 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-03-20

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  1. 7 CFR 987.157 - Approved date product manufacturers.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Approved date product manufacturers. 987.157 Section... DATES PRODUCED OR PACKED IN RIVERSIDE COUNTY, CALIFORNIA Administrative Rules Qualification to Regulation § 987.157 Approved date product manufacturers. Any person, including date handlers,...

  2. 24 CFR 886.107 - Approval of applications.

    Science.gov (United States)

    2010-04-01

    ...) The Owner's Affirmative Fair Housing Marketing Plan is approvable. (b) The HUD-approved unit rents are.... Occupancy requirements are being met. Marketing and maintenance programs are being carried out in an... collection losses. (7) The Owner's plan for remedying any deferred maintenance, financial problems, or...

  3. 30 CFR 75.800-2 - Approved circuit schemes.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved circuit schemes. 75.800-2 Section 75... § 75.800-2 Approved circuit schemes. The following circuit schemes will be regarded as providing the necessary protection to the circuits required by § 75.800: (a) Ground check relays may be used...

  4. 76 FR 20070 - Commercial Space Transportation Safety Approval Performance Criteria

    Science.gov (United States)

    2011-04-11

    ... Federal Aviation Administration Commercial Space Transportation Safety Approval Performance Criteria... received, a safety approval for the ability of its Space Training System: Model 400 (STS-400) to replicate....19 (a)(4). NASTAR's ] STS-400 suborbital space flight simulator (a multi-axis centrifuge) is...

  5. 49 CFR 1522.115 - Renewal of TSA approval.

    Science.gov (United States)

    2010-10-01

    ... be subject to both civil and criminal penalties under 49 CFR part 1540 and 18 U.S.C. 1001. Failure to... 49 Transportation 9 2010-10-01 2010-10-01 false Renewal of TSA approval. 1522.115 Section 1522.115..., DEPARTMENT OF HOMELAND SECURITY SECURITY RULES FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION...

  6. Effect of Need for Approval and Situational Variables on the Viewing of Erotic Material

    Science.gov (United States)

    Kirschner, Neil M.

    1976-01-01

    The role of social desirability on willingness to view erotic materials under conditions of implicit approval and disapproval was studied. Low need-for-approval subjects were more influenced by situational cues than high need-for-approval subjects. (NG)

  7. Modelling seasonality in Australian building approvals

    Directory of Open Access Journals (Sweden)

    Harry M Karamujic

    2012-02-01

    Full Text Available The paper examines the impact of seasonal influences on Australian housing approvals, represented by the State of Victoria[1] building approvals for new houses (BANHs. The prime objective of BANHs is to provide timely estimates of future residential building work. Due to the relevance of the residential property sector to the property sector as whole, BANHs are viewed by economic analysts and commentators as a leading indicator of property sector investment and as such the general level of economic activity and employment. The generic objective of the study is to enhance the practice of modelling housing variables. In particular, the study seeks to cast some additional light on modelling the seasonal behaviour of BANHs by: (i establishing the presence, or otherwise, of seasonality in Victorian BANHs; (ii if present, ascertaining is it deterministic or stochastic; (iii determining out of sample forecasting capabilities of the considered modelling specifications; and (iv speculating on possible interpretation of the results. To do so the study utilises a structural time series model of Harwey (1989. The modelling results confirm that the modelling specification allowing for stochastic trend and deterministic seasonality performs best in terms of diagnostic tests and goodness of fit measures. This is corroborated with the analysis of out of sample forecasting capabilities of the considered modelling specifications, which showed that the models with deterministic seasonal specification exhibit superior forecasting capabilities. The paper also demonstrates that if time series are characterized by either stochastic trend or seasonality, the conventional modelling approach[2] is bound to be mis-specified i.e. would not be able to identify statistically significant seasonality in time series.According to the selected modeling specification, factors corresponding to June, April, December and November are found to be significant at five per cent level

  8. Project W-314 phase I environmental permits and approvals plan

    Energy Technology Data Exchange (ETDEWEB)

    TOLLEFSON, K.S.

    1999-02-24

    This document describes the range of environmental actions, including required permits and other agency approvals, for Project W-314 activities in the Hanford Site's Tank Waste Remediation System. This document outlines alternative approaches to satisfying applicable environmental standards, and describes selected strategies for acquiring permits and other approvals needed for waste feed delivery to proceed. This document also includes estimated costs and schedule to obtain the required permits and approvals based on the selected strategy. It also provides estimated costs for environmental support during design and construction based on the preliminary project schedule provided.

  9. 75 FR 62387 - Pesticide Product Registrations; Conditional Approval

    Science.gov (United States)

    2010-10-08

    ... AGENCY Pesticide Product Registrations; Conditional Approval AGENCY: Environmental Protection Agency (EPA...., to conditionally register the pesticide products Paladin Technical, Paladin, and Paladin EC... provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),...

  10. Number of patients studied prior to approval of new medicines

    DEFF Research Database (Denmark)

    Duijnhoven, Ruben G; Straus, Sabine M J M; Raine, June M;

    2013-01-01

    BACKGROUND: At the time of approval of a new medicine, there are few long-term data on the medicine's benefit-risk balance. Clinical trials are designed to demonstrate efficacy, but have major limitations with regard to safety in terms of patient exposure and length of follow-up. This study...... on Harmonisation's E1 guideline recommendations. METHODS AND FINDINGS: All medicines containing new molecular entities approved between 2000 and 2010 were included in the study, including orphan medicines as a separate category. The total number of patients studied before approval was extracted (main outcome......). In addition, the number of patients with long-term use (6 or 12 mo) was determined for chronic medication. 200 unique new medicines were identified: 161 standard and 39 orphan medicines. The median total number of patients studied before approval was 1,708 (interquartile range [IQR] 968-3,195) for standard...

  11. 7 CFR 1786.56 - Approval of applications.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE (CONTINUED) PREPAYMENT OF RUS GUARANTEED AND INSURED LOANS TO ELECTRIC AND TELEPHONE BORROWERS Special Discounted Prepayments on RUS Direct/Insured Loans § 1786.56 Approval of applications....

  12. Living with Fibromyalgia, Drugs Approved to Manage Pain

    Science.gov (United States)

    ... Consumers Home For Consumers Consumer Updates Living with Fibromyalgia, Drugs Approved to Manage Pain Share Tweet Linkedin ... syndrome, and depression. back to top What Causes Fibromyalgia? Scientists believe that the condition may be due ...

  13. 49 CFR 178.74 - Approval of MEGCs.

    Science.gov (United States)

    2010-10-01

    ... this chapter +to obtain approval of a new design. When a series of MEGCs is manufactured without change... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SPECIFICATIONS FOR...

  14. [Approval of predator management activities in North Dakota, 2005

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — Request from U.S. Fish and Wildlife Service and approval from North Dakota Game & Fish Department for predator management activities outside of the state...

  15. 46 CFR 160.054-7 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

    ... fully the construction, material specification, arrangement, and list of contents to the Commander of... the first-aid kit. At the time of selection of the pre-approval sample, the manufacturer shall...

  16. Clean Water Act Approved Total Maximum Daily Load (TMDL) Documents

    Data.gov (United States)

    U.S. Environmental Protection Agency — Information from Approved and Established TMDL Documents as well as TMDLs that have been Withdrawn. This includes the pollutants identified in the TMDL Document,...

  17. Possible FDA-approved drugs to treat Ebola virus infection

    OpenAIRE

    Yuan, Shu

    2015-01-01

    There is currently no effective treatment for the Ebola virus (EBOV) thus far. Most drugs and vaccines developed to date have not yet been approved for human trials. Two FDA-approved c-AbI1 tyrosine kinase inhibitors Gleevec and Tasigna block the release of viral particles; however, their clinical dosages are much lower than the dosages required for effective EBOV suppression. An α-1,2-glucosidase inhibitor Miglustat has been shown to inhibit EBOV particle assembly and secretion. Additionally...

  18. Catching Up on New Medications: New FDA Approvals.

    Science.gov (United States)

    Turkoski, Beatrice B

    2016-01-01

    Despite all efforts of the Federal Drug Administration to release timely and accurate information about new drug approvals, marketing and media announcements about new drugs may be incomplete, misinterpreted, or misunderstood. Informed and knowledgeable nurses are able to educate patients about new medications: they can clarify misunderstandings or misconceptions and significantly reduce the potential for harm. In this article, selected examples of new brand name drugs and first-time generics approved this year are discussed. PMID:26814007

  19. Adapting Drug Approval Pathways for Bacteriophage-Based Therapeutics.

    Science.gov (United States)

    Cooper, Callum J; Khan Mirzaei, Mohammadali; Nilsson, Anders S

    2016-01-01

    The global rise of multi-drug resistant bacteria has resulted in the notion that an "antibiotic apocalypse" is fast approaching. This has led to a number of well publicized calls for global funding initiatives to develop new antibacterial agents. The long clinical history of phage therapy in Eastern Europe, combined with more recent in vitro and in vivo success, demonstrates the potential for whole phage or phage based antibacterial agents. To date, no whole phage or phage derived products are approved for human therapeutic use in the EU or USA. There are at least three reasons for this: (i) phages possess different biological, physical, and pharmacological properties compared to conventional antibiotics. Phages need to replicate in order to achieve a viable antibacterial effect, resulting in complex pharmacodynamics/pharmacokinetics. (ii) The specificity of individual phages requires multiple phages to treat single species infections, often as part of complex cocktails. (iii) The current approval process for antibacterial agents has evolved with the development of chemically based drugs at its core, and is not suitable for phages. Due to similarities with conventional antibiotics, phage derived products such as endolysins are suitable for approval under current processes as biological therapeutic proteins. These criteria render the approval of phages for clinical use theoretically possible but not economically viable. In this review, pitfalls of the current approval process will be discussed for whole phage and phage derived products, in addition to the utilization of alternative approval pathways including adaptive licensing and "Right to try" legislation. PMID:27536293

  20. Drug lag for antineoplastic and immunomodulating agent approvals in India compared with the US and EU approvals

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2016-04-01

    Conclusions: This study confirms that India lag behind the US and EU regions in terms of total number of new drug approvals for antineoplastic and immunomodulating agents. There is a substantial approval delay in India compared to the US and EU regions. Further detailed analyses are necessary to find the reasons and impacts of drug lag for new antineoplastic and immunomodulating agents in India. [Int J Basic Clin Pharmacol 2016; 5(2.000: 335-340

  1. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    OpenAIRE

    Hatswell, Anthony J.; Baio, Gianluca; Berlin, Jesse A.; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from ...

  2. 30 CFR 285.614 - When may I begin conducting activities under my approved SAP?

    Science.gov (United States)

    2010-07-01

    ... approved SAP? 285.614 Section 285.614 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE... Plans and Information Requirements Activities Under An Approved Sap § 285.614 When may I begin conducting activities under my approved SAP? (a) You may begin conducting the activities approved in your...

  3. 10 CFR 52.145 - Finality of standard design approvals; information requests.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Finality of standard design approvals; information... approvals; information requests. (a) An approved design must be used by and relied upon by the NRC staff and... compliance with the current licensing basis of the standard design approval, information requests to...

  4. 7 CFR 1717.613 - RUS approval of data processing and system control equipment.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of data processing and system control... AND GUARANTEED ELECTRIC LOANS Operational Controls § 1717.613 RUS approval of data processing and... approval from RUS before purchasing data processing equipment or system control equipment, such approval...

  5. 21 CFR 316.31 - Scope of orphan-drug exclusive approval.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Scope of orphan-drug exclusive approval. 316.31... (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.31 Scope of orphan-drug exclusive approval. (a) After approval of a sponsor's marketing application for a designated...

  6. 12 CFR 516.280 - How will I know if my application has been approved?

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false How will I know if my application has been approved? 516.280 Section 516.280 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE... application has been approved? (a) OTS approval or denial. (1) OTS will approve or deny your...

  7. 49 CFR 1540.301 - Withdrawal of approval of a security program.

    Science.gov (United States)

    2010-10-01

    ... program approved or accepted by TSA under 49 CFR chapter XII, subchapter C. (b) Withdrawal of security program approval. TSA may withdraw the approval of a security program, if TSA determines continued... SECURITY: GENERAL RULES Responsibilities of Holders of TSA-Approved Security Programs § 1540.301...

  8. Testing (HIV). Quick test receives Singapore approval.

    Science.gov (United States)

    1996-04-22

    Hema-Strip HIV 1/2 is a rapid HIV antibody immunoassay developed by Saliva Diagnostic Systems, Inc. (SDS) which can be used by anyone who can read the product insert. The test kit is comprised of a small lancet for a finger stick, a cylindrical tube with a capillary tip and a SDS diagnostic strip inside, and a vial of buffer. Once blood is drawn by the lancet, the capillary tip is placed upon the blood droplet and the blood is automatically drawn into the tube. The tube is then inserted tip first into the vial of buffer. The buffer and blood migrate over the diagnostic strip inside, yielding stable results within 15 minutes. Studies have found Hema-Strip HIV 1/2 to have a sensitivity and specificity greater than 99.4%, as accurate as most conventional HIV tests which require the use of laboratory equipment and trained staff, and possibly hours to produce results. Moreover, the test kit requires neither refrigeration nor special storage. Hema-Strip HIV 1/2 has received a certificate of free sale from the Ministry of Health in Singapore and is now being submitted for regulatory approval in Brazil, China, Russia, India, Malaysia, Thailand, and the UK. SDS products in production include Sero-Strip HIV 1/2, a rapid serum-based HIV antibody test; Omni-SAL, a saliva collector which is the principal sample collection device used by British insurance companies for HIV testing with other confirmatory tests; Omni-Swab, a serrated swab which collects body fluids or cells; Saliva-Sampler, a saliva collection device used for general testing purposes; and Saliva Check, a test which checks the composition of saliva samples. SDS is in the final stages of developing Saliva-Strip HIV-1/2, a rapid saliva-based HIV antibody test. The company also intends to complete development in 1996 of a rapid blood-based antibody test for the Helicobacter pylori bacteria, a pathogen linked to 80% of peptic ulcers and gastric cancers. PMID:12290908

  9. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    Energy Technology Data Exchange (ETDEWEB)

    D.W. Markman

    1999-09-17

    Preliminary design concepts for the proposed Subsurface Repository at Yucca Mountain indicate extensive reliance on modern, computer-based, digital control technologies. The purpose of this analysis is to investigate the degree to which the U. S. Nuclear Regulatory Commission (NRC) has accepted and approved the use of digital control technology for safety-related applications within the nuclear power industry. This analysis reviews cases of existing digitally-based control systems that have been approved by the NRC. These cases can serve as precedence for using similar types of digitally-based control technologies within the Subsurface Repository. While it is anticipated that the Yucca Mountain Project (YMP) will not contain control systems as complex as those required for a nuclear power plant, the review of these existing NRC approved applications will provide the YMP with valuable insight into the NRCs review process and design expectations for safety-related digital control systems. According to the YMP Compliance Program Guidance, portions of various NUREGS, Regulatory Guidelines, and nuclear IEEE standards the nuclear power plant safety related concept would be applied to some of the designs on a case-by-case basis. This analysis will consider key design methods, capabilities, successes, and important limitations or problems of selected control systems that have been approved for use in the Nuclear Power industry. An additional purpose of this analysis is to provide background information in support of further development of design criteria for the YMP. The scope and primary objectives of this analysis are to: (1) Identify and research the extent and precedence of digital control and remotely operated systems approved by the NRC for the nuclear power industry. Help provide a basis for using and relying on digital technologies for nuclear related safety critical applications. (2) Identify the basic control architecture and methods of key digital control

  10. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    International Nuclear Information System (INIS)

    Preliminary design concepts for the proposed Subsurface Repository at Yucca Mountain indicate extensive reliance on modern, computer-based, digital control technologies. The purpose of this analysis is to investigate the degree to which the U. S. Nuclear Regulatory Commission (NRC) has accepted and approved the use of digital control technology for safety-related applications within the nuclear power industry. This analysis reviews cases of existing digitally-based control systems that have been approved by the NRC. These cases can serve as precedence for using similar types of digitally-based control technologies within the Subsurface Repository. While it is anticipated that the Yucca Mountain Project (YMP) will not contain control systems as complex as those required for a nuclear power plant, the review of these existing NRC approved applications will provide the YMP with valuable insight into the NRCs review process and design expectations for safety-related digital control systems. According to the YMP Compliance Program Guidance, portions of various NUREGS, Regulatory Guidelines, and nuclear IEEE standards the nuclear power plant safety related concept would be applied to some of the designs on a case-by-case basis. This analysis will consider key design methods, capabilities, successes, and important limitations or problems of selected control systems that have been approved for use in the Nuclear Power industry. An additional purpose of this analysis is to provide background information in support of further development of design criteria for the YMP. The scope and primary objectives of this analysis are to: (1) Identify and research the extent and precedence of digital control and remotely operated systems approved by the NRC for the nuclear power industry. Help provide a basis for using and relying on digital technologies for nuclear related safety critical applications. (2) Identify the basic control architecture and methods of key digital control

  11. Ethics approval: a challenge for public health researchers in India.

    Science.gov (United States)

    Nagaraja, Sharath Burugina; Menezes, Ritesh G; Zachariah, Rony; Wilson, Nevin

    2015-01-01

    There is increasing impetus, interest and opportunity for people working in public health programmes in India to carry out operational research (OR) around relevant programme issues and then publish that in peer-reviewed publications. These published researches are valuable in analysing, documenting and advocating for locally generated evidence to inform policy and practice. Ethics review and approval is an essential step in the process of OR but is often viewed as a barrier rather than a prerequisite of good practice in OR. Journals and peer reviewers are also increasingly requiring approvals from local institutional ethics committees (IECs).

  12. 2015 in review: FDA approval of new drugs.

    Science.gov (United States)

    Kinch, Michael S

    2016-07-01

    The myriad new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2015 reflected both the opportunities and risks associated with the development of new medicines. On the one hand, the approval of 45 NMEs was among the highest ever recorded. Likewise, the diversity underlying the mechanistic basis of new medicines suggests continued broadening relative to the predominate trends of the past few decades. On the other hand, closer inspection indicates that business model decisions surrounding orphan indications and consolidation could be placing the industry in an ever-more precarious position, with severe implications for the sustainability of the entire enterprise. PMID:27109618

  13. 75 FR 60617 - Review and Approval of Projects

    Science.gov (United States)

    2010-10-01

    ... COMMISSION 18 CFR Parts 806 and 808 Review and Approval of Projects AGENCY: Susquehanna River Basin Commission. ACTION: Final rule. SUMMARY: This document contains final rules that amend the project review... procedures for all project applications; clarify requirements for grandfathered projects increasing...

  14. 75 FR 36301 - Review and Approval of Projects

    Science.gov (United States)

    2010-06-25

    ... final at 71 FR 78570, December 29, 2006, updating and expanding the range of projects subject to... COMMISSION 18 CFR Parts 806 and 808 Review and Approval of Projects AGENCY: Susquehanna River Basin... proposed rules that would amend the project review regulations of the Susquehanna River Basin...

  15. 76 FR 60774 - Review and Approval of Projects

    Science.gov (United States)

    2011-09-30

    ..., 2011 (76 FR 41154) may be submitted to the Commission on or before November 10, 2011. ADDRESSES... 10, 2011, the written comment deadline for proposed rules that appeared in 76 FR 41154-41157 July 13... COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY: Susquehanna River Basin Commission....

  16. 77 FR 75915 - Review and Approval of Projects

    Science.gov (United States)

    2012-12-26

    ... COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY: Susquehanna River Basin Commission. ACTION... would amend the project review regulations of the Susquehanna River Basin Commission (Commission) to... is to make further modifications to the Commission's project review regulations relating to...

  17. 77 FR 8095 - Review and Approval of Projects

    Science.gov (United States)

    2012-02-14

    ... COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY: Susquehanna River Basin Commission. ACTION: Final rule. SUMMARY: This document contains final rules that would amend the project review regulations... hydrocarbon development project to an out-of- basin treatment or disposal facility; insert...

  18. 77 FR 14272 - Review and Approval of Projects

    Science.gov (United States)

    2012-03-09

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Part 806 Review and Approval of Projects CFR Correction In Title 18 of the Code of Federal Regulations, Part 400 to End, revised as of April 1, 2011, on page 118, in Sec. 806.6, (b)(1)(i) and (ii)...

  19. The Cost of Delaying Approval of Golden Rice

    OpenAIRE

    Wesseler, J.H.H.; Kaplan, S; Zilberman, D.

    2014-01-01

    More than 250,000 children go blind every year because of Vitamin A deficiency. Vitamin A intake can be enhanced by consuming Golden Rice—a genetically engineered variety of rice. It was available for commercialization in 2002, but approval has been delayed. We estimate that this delay has resulted in 600,000 to 1.2 million additional cases of blindness.

  20. The Cost of Delaying Approval of Golden Rice

    NARCIS (Netherlands)

    Wesseler, J.H.H.; Kaplan, S.; Zilberman, D.

    2014-01-01

    More than 250,000 children go blind every year because of Vitamin A deficiency. Vitamin A intake can be enhanced by consuming Golden Rice—a genetically engineered variety of rice. It was available for commercialization in 2002, but approval has been delayed. We estimate that this delay has resulted

  1. 24 CFR 58.77 - Effect of approval of certification.

    Science.gov (United States)

    2010-04-01

    ... applicable provisions of law cited in § 58.1(b). (b) Public and agency redress. Persons and agencies seeking redress in relation to environmental reviews covered by an approved certification shall deal with the responsible entity and not with HUD. It is HUD's policy to refer all inquiries and complaints to...

  2. 7 CFR 1822.273 - Actions subsequent to loan approval.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE LOANS AND GRANTS PRIMARILY FOR REAL ESTATE PURPOSES RURAL HOUSING LOANS AND GRANTS Rural Housing... 1822.273 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE.... After the loan is approved, actions to be taken will be in accordance with 7 CFR part 3560, subpart B....

  3. 7 CFR 1703.141 - Approved purposes for loans.

    Science.gov (United States)

    2010-01-01

    ... relating to the establishment or expansion of the phase of the project that is being financed with the loan... been approved. The applicant must show that financing such costs are necessary for the establishment or continued operation of the project and that financing is not available for such costs elsewhere,...

  4. 10 CFR 903.22 - Final rate approval.

    Science.gov (United States)

    2010-01-01

    ... would result in total revenues in excess of those required by law, the rate last previously confirmed... 10 Energy 4 2010-01-01 2010-01-01 false Final rate approval. 903.22 Section 903.22 Energy... Transmission Rate Adjustments and Extensions for the Alaska, Southeastern, Southwestern, and Western Area...

  5. 75 FR 5844 - Agency Information Collection Activity Seeking OMB Approval

    Science.gov (United States)

    2010-02-04

    ... TRANSPORTATION Federal Aviation Administration Agency Information Collection Activity Seeking OMB Approval AGENCY... safety and oversight rules for a broad variety of sightseeing and commercial air tour flights. DATES... hours annually. Abstract: This rule set safety and oversight rules for a broad variety of...

  6. NCI Community Oncology Research Program Approved | Division of Cancer Prevention

    Science.gov (United States)

    On June 24, 2013, the National Cancer Institute (NCI) Board of Scientific Advisors approved the creation of the NCI Community Oncology Research Program (NCORP). NCORP will bring state-of-the art cancer prevention, control, treatment and imaging clinical trials, cancer care delivery research, and disparities studies to individuals in their own communities. |

  7. 24 CFR 945.201 - Approval to designate housing.

    Science.gov (United States)

    2010-04-01

    ... part. The PHA is required to meet the requirements of 24 CFR part 960, subpart D. (2) A PHA that... existing or planned mixed population projects, reserved under 24 CFR part 960, subpart B, as additional... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Approval to designate housing....

  8. 75 FR 52737 - Pesticide Product Registrations; Unconditional and Conditional Approvals

    Science.gov (United States)

    2010-08-27

    ... AGENCY Pesticide Product Registrations; Unconditional and Conditional Approvals AGENCY: Environmental... the provisions of section 3(c)(5) and 3(c)(7) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), of registrations for pesticide products containing active ingredients that were not...

  9. Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for ovarian cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  10. 36 CFR 9.37 - Plan of operations approval.

    Science.gov (United States)

    2010-07-01

    ..., natural catastrophe, acts of God, etc., for inspection shall not be included when computing either this... determination regarding the impact of this operation and cumulative impacts of all proposed and existing... Preservations Act of 1966 as implemented by 36 CFR part 800. (f) Approval of each plan of operations...

  11. 9 CFR 590.435 - Wholesomeness and approval of materials.

    Science.gov (United States)

    2010-01-01

    ... materials. 590.435 Section 590.435 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... additive approved. (d) Containers and packing or packaging materials in which shell eggs are received into... of use as human food shall be clean, wholesome, and unadulterated. (b) The use of chemical...

  12. 29 CFR 1952.104 - Final approval determination.

    Science.gov (United States)

    2010-07-01

    ... dam construction projects; and private sector maritime employment on or adjacent to navigable waters... Final approval determination. (a) In accordance with Section 18(e) of the Act and procedures in 29 CFR... exception of temporary labor camps in agriculture, general industry, construction and logging) is at...

  13. 20 CFR 656.32 - Revocation of approved labor certifications.

    Science.gov (United States)

    2010-04-01

    ... Officer in consultation with the Chief, Division of Foreign Labor Certification may take steps to revoke... Intent to Revoke an approved labor certification which contains a detailed statement of the grounds for... relevant evidence presented in deciding whether to revoke the labor certification. (2) If rebuttal...

  14. Experts Approve Development of A Micro-DAFC System

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

    @@ Proposed research into a micro-power system for a direct alcohol fuel cell (DAFC)was approved by a panel of experts at an evaluation meeting held under the auspices of the CAS Bureau of High-tech Development on Oct. 28 in Dalian, Northeast China's Liaoning Province.

  15. A Document Imaging Technique for Implementing Electronic Loan Approval Process

    Directory of Open Access Journals (Sweden)

    J. Manikandan

    2015-04-01

    Full Text Available The image processing is one of the leading technologies of computer applications. Image processing is a type of signal processing, the input for image processor is an image or video frame and the output will be an image or subset of image [1]. Computer graphics and computer vision process uses an image processing techniques. Image processing systems are used in various environments like medical fields, computer-aided design (CAD, research fields, crime investigation fields and military fields. In this paper, we proposed a document image processing technique, for establishing electronic loan approval process (E-LAP [2]. Loan approval process has been tedious process, the E-LAP system attempts to reduce the complexity of loan approval process. Customers have to login to fill the loan application form online with all details and submit the form. The loan department then processes the submitted form and then sends an acknowledgement mail via the E-LAP to the requested customer with the details about list of documents required for the loan approval process [3]. The approaching customer can upload the scanned copies of all required documents. All this interaction between customer and bank take place using an E-LAP system.

  16. 78 FR 53474 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-08-29

    ... Reduction Act, the Bureau of Land Management (BLM) invites public comments on, and plans to request approval..., development, production, and utilization of geothermal resources on BLM-managed public lands, and on lands... the Paperwork Reduction Act, 44 U.S.C. 3501- 3521, require that interested members of the public...

  17. 77 FR 26037 - Renewal of Approved Information Collection

    Science.gov (United States)

    2012-05-02

    ... on January 24, 2012 (77 FR 3496), and the comment period ended March 26, 2012. The BLM received no... for oil and gas or geothermal resources. The Office of Management and Budget (OMB) previously approved... . SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act (44 U.S.C. 3501- 3521) and OMB regulations at 5 ]...

  18. 77 FR 29747 - Notice of Request for Information Collection Approval

    Science.gov (United States)

    2012-05-18

    ... published on April 11, 2000 (65 FR 19477) or you may visit http://DocketsInfo.dot.gov . Docket: For Internet.... Abstract: DOT will utilize the form to collect information necessary to process EEO discrimination... Office of the Secretary Notice of Request for Information Collection Approval AGENCY: Office of...

  19. 10 CFR 72.234 - Conditions of approval.

    Science.gov (United States)

    2010-01-01

    ... Spent Fuel Storage Casks § 72.234 Conditions of approval. (a) The certificate holder and applicant for a CoC shall ensure that the design, fabrication, testing, and maintenance of a spent fuel storage cask... that the design, fabrication, testing, and maintenance of spent fuel storage casks are conducted...

  20. 34 CFR 668.144 - Application for test approval.

    Science.gov (United States)

    2010-07-01

    ... school level criterion specified in § 668.146(b); (14) For performance-based tests or tests containing... quantitative skills; (9) If a test has been revised from the most recent edition approved by the Secretary, an...), and an analysis of the effects of time on performance; (11) A technical manual that includes— (i)...

  1. 76 FR 59863 - Application and Approval Process for New Programs

    Science.gov (United States)

    2011-09-27

    ... under the Higher Education Act of 1965, as amended (HEA), to streamline the application and approval... 600 Institutional Eligibility Under the Higher Education Act of 1965, as Amended We discuss... provides for the eligibility of institutions of higher education (20 U.S.C. 1099c). Current...

  2. 10 CFR 725.15 - Requirements for approval of applications.

    Science.gov (United States)

    2010-01-01

    ... engaged in a substantial effort to develop, design, build or operate a chemical processing plant or other... Secret Restricted Data in C-91, Nuclear Reactors for Rocket Propulsion, will be approved only if the... capable of making a contribution to research and development in the field of nuclear reactors for...

  3. 27 CFR 4.93 - Approval of grape variety names.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Approval of grape variety names. 4.93 Section 4.93 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE American Grape Variety Names §...

  4. 27 CFR 5.51 - Label approval and release.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Label approval and release. 5.51 Section 5.51 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Requirements for...

  5. 27 CFR 4.91 - List of approved prime names.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false List of approved prime names. 4.91 Section 4.91 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE American Grape Variety Names § 4.91...

  6. 27 CFR 4.40 - Label approval and release.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Label approval and release. 4.40 Section 4.40 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Withdrawal of Wine...

  7. 15 CFR 280.101 - Petitions for approval of documents.

    Science.gov (United States)

    2010-01-01

    ... requirements for the certification of manufacturing systems as fastener quality assurance systems by an..., shall approve such petition if the document provides equal or greater rigor and reliability as compared... information to allow the Director, NIST, to make this determination. (b) Accreditation. (1) A...

  8. 14 CFR 21.500 - Approval of engines and propellers.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval of engines and propellers. 21.500 Section 21.500 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... been subjected by the manufacturer to a final operational check....

  9. 21 CFR 514.111 - Refusal to approve an application.

    Science.gov (United States)

    2010-04-01

    ... shall consider, among other relevant factors: (i) The probable consumption of such drug and of any substance formed in or on food because of the use of such drug; (ii) The cumulative effect on man or animal... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Refusal to approve an application. 514.111...

  10. 9 CFR 112.5 - Review and approval of labeling.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND...

  11. 21 CFR 1004.6 - Approval of plans.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Approval of plans. 1004.6 Section 1004.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) RADIOLOGICAL... person who contests denial of a plan shall have an opportunity for a regulatory hearing before the...

  12. 19 CFR 151.13 - Approval of commercial gaugers.

    Science.gov (United States)

    2010-04-01

    ... requirements: (1) To comply with the requirements of part 151, Customs Regulations (19 CFR part 151), and to... approval to execute a bond in accordance with part 113, Customs Regulations (19 CFR part 113), and submit... Executive Director will determine the applicant's overall competence, independence, and character...

  13. 34 CFR 668.146 - Criteria for approving tests.

    Science.gov (United States)

    2010-07-01

    ... reference of this document has been approved by the Director of the Office of the Federal Register pursuant to the Director's authority under 5 U.S.C. 552(a) and 1 CFR part 51. The incorporated document is on... Independence Avenue, S.W., Washington, D.C. 20202 and at the National Archives and Records Administration...

  14. 30 CFR 918.10 - State regulatory program approval.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false State regulatory program approval. 918.10... INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE LOUISIANA § 918.10 State... and Mining Division, 625 N. 4th Street, P.O. Box 94275, Baton Rouge, LA 70804-9275. (b) Office...

  15. Pharmacovigilance of biologicals : dynamics in post-approval safety learning

    NARCIS (Netherlands)

    Vermeer, N.S.

    2015-01-01

    Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict inclusio

  16. 45 CFR 95.611 - Prior approval conditions.

    Science.gov (United States)

    2010-10-01

    ... at the enhanced matching rate authorized by 45 CFR 205.35, 45 CFR part 307 or 42 CFR part 433...) Automatic Data Processing Equipment and Services-Conditions for Federal Financial Participation (FFP) Specific Conditions for Ffp § 95.611 Prior approval conditions. (a) General acquisition requirements. (1)...

  17. 49 CFR 236.913 - Filing and approval of PSPs.

    Science.gov (United States)

    2010-10-01

    ... for Processor-Based Signal and Train Control Systems § 236.913 Filing and approval of PSPs. (a) Under... architectural concepts; the PSP describes a product that uses design or safety assurance concepts considered... the end of the system design review phase of product development and 180 days prior to...

  18. 21 CFR 601.12 - Changes to an approved application.

    Science.gov (United States)

    2010-04-01

    ... qualitative or quantitative formulation, including inactive ingredients, or in the specifications provided in... affect the process methodology or process operating parameters. (iv) Relaxation of an acceptance... Evaluation and Research or the Director, Center for Drug Evaluation and Research, may approve a...

  19. 32 CFR 644.135 - Lease authorization and approvals.

    Science.gov (United States)

    2010-07-01

    ... Services Administration (GSA) charges a Standard Level User Charge (SLUC) for furnishing space. For title... demand of and refusal by the lessor, the Government makes such repairs in order to utilize the property... repairs made after demand and a refusal by the lessor, without prior approval of DAEN-REA-L. (g)...

  20. 46 CFR 160.053-6 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

    ... independent laboratory accepted by the Coast Guard under 46 CFR 159.010. (c) If the work vest is of a non...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Work Vests, Unicellular Plastic Foam § 160.053-6 Procedure for... § 159.010-7 of this subchapter covering the in-water testing of personal flotation devices,...

  1. 29 CFR 500.160 - Approved State plans.

    Science.gov (United States)

    2010-07-01

    ... accordance with 29 CFR part 70. (c) Every enumerated delegated function shall be valid in all states. ... 29 Labor 3 2010-07-01 2010-07-01 false Approved State plans. 500.160 Section 500.160 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR REGULATIONS MIGRANT...

  2. Forecasting Housing Approvals in Australia: Do Forecasters Herd?

    DEFF Research Database (Denmark)

    Stadtmann, Georg; Pierdzioch; Rülke

    2012-01-01

    Price trends in housing markets may reflect herding of market participants. A natural question is whether such herding, to the extent that it occurred, reflects herding in forecasts of professional forecasters. Using more than 6,000 forecasts of housing approvals for Australia, we did not find...

  3. 75 FR 71421 - Notice Announcing OMB Approval of Information Collections

    Science.gov (United States)

    2010-11-23

    ...) announces that the Office of Management and Budget (OMB) has approved certain collections of information... expiration dates. FOR FURTHER INFORMATION CONTACT: For the Talent Search Program: Geraldine Smith, U.S... collection is June 30, 2013. OMB Control No. 1840-0818, Talent Search Grant Application. The expiration...

  4. 78 FR 41311 - Approval of Air Quality Implementation Plans; Indiana; Approval of “Infrastructure” SIP With...

    Science.gov (United States)

    2013-07-10

    ... Business Information or other information whose disclosure is restricted by statute. Certain other material.... FOR FURTHER INFORMATION CONTACT: Andy Chang, Environmental Engineer, Attainment Planning and... of IDEM's SIP-approved update to the definition of the 2006 PM 2.5 NAAQS? III. What action is...

  5. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Science.gov (United States)

    2010-10-01

    ... described at 42 CFR part 488, subpart A apply to transplant centers, including the periodic review of... are not Medicare-approved as of June 28, 2007. A transplant center, including a kidney transplant... Report and 1-year patient and graft survival data contained in the most recent Scientific Registry...

  6. 78 FR 65030 - Agency Requests for Renewal of a Previously Approved Information Collection(s): Approval of...

    Science.gov (United States)

    2013-10-30

    ... of Marine Hull Insurance AGENCY: Maritime Administration. ACTION: Notice and request for comments....gov . FOR FURTHER INFORMATION CONTACT: Michael Yarrington, Chief, Office of Marine Insurance, Maritime...: 2133-0517. Title: Approval of Underwriters of Marine Hull Insurance. Form Numbers: None. Type of...

  7. 12 CFR 211.24 - Approval of offices of foreign banks; procedures for applications; standards for approval...

    Science.gov (United States)

    2010-01-01

    ... and the Department of the Treasury at 31 CFR 103.121, which require a customer identification program. ... board of directors to approve the Bank Secrecy Act compliance program. (2) Customer identification... with customers or potential customers, beyond incidental contact with existing customers relating...

  8. When your words count: a discriminative model to predict approval of referrals

    Directory of Open Access Journals (Sweden)

    Adol Esquivel

    2009-12-01

    Conclusions Three iterations of the model correctly predicted at least 75% of the approved referrals in the validation set. A correct prediction of whether or not a referral will be approved can be made in three out of four cases.

  9. 5 CFR 7301.102 - Prior approval for outside teaching, speaking and writing.

    Science.gov (United States)

    2010-01-01

    ... or Federal regulation, including 5 CFR part 2635. ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside teaching... approval for outside teaching, speaking and writing. (a) Before engaging in outside teaching, speaking...

  10. 78 FR 16279 - HUD Healthcare Facility Documents: Notice Announcing Final Approved Documents and Assignment of...

    Science.gov (United States)

    2013-03-14

    ... the public review process for obtaining approval of changes to these specific healthcare facility... URBAN DEVELOPMENT HUD Healthcare Facility Documents: Notice Announcing Final Approved Documents and... Commissioner, HUD. ACTION: Notice. SUMMARY: This notice announces that the healthcare facility documents...

  11. 48 CFR 45.606-2 - Contractor without an approved scrap procedure.

    Science.gov (United States)

    2010-10-01

    ... approved scrap procedure. 45.606-2 Section 45.606-2 Federal Acquisition Regulations System FEDERAL... Contractor without an approved scrap procedure. The contractor shall submit an inventory disposal schedule for all scrap....

  12. 76 FR 22709 - Medicare and Medicaid Programs; Approval of the American Association for Accreditation of...

    Science.gov (United States)

    2011-04-22

    ... HUMAN SERVICES Centers for Medicare & Medicaid Services Medicare and Medicaid Programs; Approval of the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. for Deeming Authority for... decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities...

  13. 21 CFR 314.105 - Approval of an application and an abbreviated application.

    Science.gov (United States)

    2010-04-01

    ... labeling prior to marketing. (c) FDA will approve an application after it determines that the drug meets... not be introduced or delivered for introduction into interstate commerce until approval of...

  14. An overview of drugs approved in India from 1999 through 2015

    Directory of Open Access Journals (Sweden)

    Vihang S. Chawan

    2015-08-01

    Conclusions: Thus, the present study highlights the changing scenario of drug approval, with few drugs being approved for clinical practice in the last 3 years. [Int J Basic Clin Pharmacol 2015; 4(4.000: 697-700

  15. 75 FR 23837 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-05-04

    ... ID: Kepner 8503H, ABR-20100209, Shrewsbury Township, Lycoming County, Pa.; Approval Date: February 11...-20100211, Shrewsbury Township, Lycoming County, Pa.; Approval Date: February 12, 2010. 14. Fortuna...

  16. 13 CFR 107.440 - Standards governing prior SBA approval for a proposed transfer of Control.

    Science.gov (United States)

    2010-01-01

    ... prior SBA approval for a proposed transfer of Control. SBA approval is contingent upon full disclosure... assume, in writing, personal liability for your Leverage, effective only in the event of their direct...

  17. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    Science.gov (United States)

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  18. Contemplation on new drug approvals by U.S. FDA, 2011-2015

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2016-02-01

    Conclusions: For new drugs approved between 2011 and 2015, the U.S. FDA was first to approve majority of new drugs. There was upward trend of new drug approvals in antineoplastic therapeutic area. [Int J Basic Clin Pharmacol 2016; 5(1.000: 55-59

  19. Comparison of new drug approval by regulatory agencies of US, EU and India

    Directory of Open Access Journals (Sweden)

    Bhaven C. Kataria

    2016-02-01

    Conclusions: For new drugs approved between 2011 and 2015, India has lagged behind the US and the EU in approval of new drugs. There was no difference in the patterns of new drug approvals with respect to the therapeutic areas. [Int J Basic Clin Pharmacol 2016; 5(1.000: 112-115

  20. 25 CFR 290.5 - Who approves tribal revenue allocation plans?

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Who approves tribal revenue allocation plans? 290.5... REVENUE ALLOCATION PLANS § 290.5 Who approves tribal revenue allocation plans? The ABO will review and approve tribal revenue allocation plans for compliance with IGRA....

  1. 78 FR 2878 - Approval and Promulgation of Implementation Plans; Georgia: New Source Review-Prevention of...

    Science.gov (United States)

    2013-01-14

    ..., 2013, to approve changes to the Georgia State Implementation Plan (SIP) New Source Review Prevention of... ``Approval and Promulgation of Implementation Plans; Georgia: New Source Review-- Prevention of Significant... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; Georgia: New Source...

  2. 77 FR 21453 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to New Source...

    Science.gov (United States)

    2012-04-10

    ....166(i)(5)(i)... Approved by Fully approved * * ). Beryllium, Vinyl interstate * Because the chloride... action at 76 FR 21835, April 19, 2011). Colorado has a federally approved NSR program for new and.... Background for This Action On December 7, 2005 (70 FR 72744), EPA published a notice of proposed...

  3. The State and Local Curriculum Approval Process in Illinois Community and Junior Colleges.

    Science.gov (United States)

    Parcells, Frank E.

    The program approval process of the Illinois Community College Board (ICCB) and the local process of course and program approval used by Illinois community colleges are detailed in this report. Following an introduction and study overview, course and program approval processes at John A. Logan College and Shawnee College are described and…

  4. 7 CFR 1717.159 - Applications for RUS approvals of mergers.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Applications for RUS approvals of mergers. 1717.159... ELECTRIC LOANS Mergers and Consolidations of Electric Borrowers § 1717.159 Applications for RUS approvals of mergers. If a proposed merger requires RUS approval according to RUS regulations and/or the...

  5. 7 CFR 1751.104 - Obtaining RUS approval of a proposed Modernization Plan.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Obtaining RUS approval of a proposed Modernization... CRITERIA, AND PROCEDURES State Telecommunications Modernization Plan § 1751.104 Obtaining RUS approval of a proposed Modernization Plan. (a) To obtain RUS approval of a proposed Modernization Plan, the...

  6. 7 CFR 1717.611 - RUS approval of expenditures for legal, accounting, engineering, and supervisory services.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of expenditures for legal, accounting... COMMON TO INSURED AND GUARANTEED ELECTRIC LOANS Operational Controls § 1717.611 RUS approval of... contract requires the borrower to obtain approval from RUS before incurring expenses for legal,...

  7. 7 CFR 1717.612 - RUS approval of borrower's bank or other depository.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of borrower's bank or other depository... GUARANTEED ELECTRIC LOANS Operational Controls § 1717.612 RUS approval of borrower's bank or other depository. If a borrower's mortgage or loan contract gives RUS the authority to approve the bank or...

  8. 78 FR 70566 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

    ... Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for an arsanilic acid Type A...., P.O. Box 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008-019 for PRO... given that approval of NADA 008-019, and all supplements and amendments thereto, is hereby...

  9. 78 FR 70496 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

    ... approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at the.... Box 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008-019 for PRO-GEN... gave notice that approval of NADA 008-019, and all supplements and amendments thereto, is...

  10. 46 CFR 160.171-19 - Approval testing for child size immersion suit.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Approval testing for child size immersion suit. 160.171..., CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Immersion Suits § 160.171-19 Approval testing for child size immersion suit. A child size suit must pass the following tests: (a)...

  11. 75 FR 65567 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Particulate Matter Standards

    Science.gov (United States)

    2010-10-26

    ... revisions are being evaluated in separate rulemaking; see the June 27, 2005 proposed rule at 70 FR 36901... requirements for major sources, found at OAC 3745-31 (approved by EPA on January 10, 2003, 68 FR 1366), to... to Rule 9 since it was approved by EPA on May 27, 1994, 59 FR 27464. Ohio requested approval of...

  12. The Effect of Perceived Parental Approval of Drinking on Alcohol Use and Problems

    Science.gov (United States)

    Messler, Erick C.; Quevillon, Randal P.; Simons, Jeffrey S.

    2014-01-01

    The relationship between perceived parental approval of drinking and alcohol use and problems was explored with undergraduate students in a small midwestern university. Participants completed a survey measuring demographic information, perceived approval of drinking, and alcohol use and problems. Results indicated perceived parental approval of…

  13. 30 CFR 77.1901-1 - Methane and oxygen deficiency tests; approved devices.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Methane and oxygen deficiency tests; approved... AREAS OF UNDERGROUND COAL MINES Slope and Shaft Sinking § 77.1901-1 Methane and oxygen deficiency tests... means approved by the Secretary, and tests for methane shall be made with a methane detector approved...

  14. 28 CFR 2.206 - Travel approval and transfers of supervision.

    Science.gov (United States)

    2010-07-01

    ... supervision. 2.206 Section 2.206 Judicial Administration DEPARTMENT OF JUSTICE PAROLE, RELEASE, SUPERVISION... Supervised Releasees § 2.206 Travel approval and transfers of supervision. (a) A releasee's supervision officer may approve travel outside the district of supervision without approval of the Commission in...

  15. 14 CFR 125.297 - Approval of flight simulators and flight training devices.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Approval of flight simulators and flight... Flight Crewmember Requirements § 125.297 Approval of flight simulators and flight training devices. (a) Flight simulators and flight training devices approved by the Administrator may be used in...

  16. 48 CFR 1352.271-83 - Government review, comment, acceptance and approval.

    Science.gov (United States)

    2010-10-01

    ....271-83 Government review, comment, acceptance and approval. As prescribed in 48 CFR 1371.114, insert..., acceptance or approval by the Government as required under this contract and applicable specifications shall..., acceptance and approval. 1352.271-83 Section 1352.271-83 Federal Acquisition Regulations System DEPARTMENT...

  17. 17 CFR 240.14a-20 - Shareholder approval of executive compensation of TARP recipients.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Shareholder approval of... § 240.14a-20 Shareholder approval of executive compensation of TARP recipients. If a solicitation is... shareholder vote to approve the compensation of executives, as disclosed pursuant to Item 402 of Regulation...

  18. 48 CFR 45.606-1 - Contractor with an approved scrap procedure.

    Science.gov (United States)

    2010-10-01

    ... approved scrap procedure. 45.606-1 Section 45.606-1 Federal Acquisition Regulations System FEDERAL... Contractor with an approved scrap procedure. (a) The contractor may dispose of scrap resulting from production or testing under this contract without Government approval. However, if the scrap...

  19. 40 CFR 63.95 - Additional approval criteria for accidental release prevention programs.

    Science.gov (United States)

    2010-07-01

    ... accidental release prevention programs. 63.95 Section 63.95 Protection of Environment ENVIRONMENTAL... Additional approval criteria for accidental release prevention programs. (a) A State submission for approval... (“federally-listed chemicals”) that an approvable State Accidental Release Prevention program is...

  20. 7 CFR 319.8-11 - From approved areas of Mexico.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false From approved areas of Mexico. 319.8-11 Section 319.8... Conditions for the Entry of Cotton and Covers from Mexico § 319.8-11 From approved areas of Mexico. (a) Entry... in, and which were produced and handled only in approved areas of Mexico 5 may be authorized...

  1. 42 CFR 505.19 - Approval or denial of loan forgiveness.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Approval or denial of loan forgiveness. 505.19... INFRASTRUCTURE IMPROVEMENT PROGRAM Forgiveness of Indebtedness § 505.19 Approval or denial of loan forgiveness. (a) Approval of loan forgiveness. If CMS determines that a qualifying hospital has met the...

  2. 25 CFR 1200.15 - What is the approval process for management plans?

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false What is the approval process for management plans? 1200... INTERIOR AMERICAN INDIAN TRUST FUND MANAGEMENT REFORM ACT Withdrawing Tribal Funds From Trust § 1200.15 What is the approval process for management plans? The Secretary will approve or disapprove...

  3. 30 CFR 28.3 - Installation, use, and maintenance of approved fuses.

    Science.gov (United States)

    2010-07-01

    ... fuses. 28.3 Section 28.3 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT... maintenance of approved fuses. Approved fuses shall be installed and maintained in accordance with...

  4. 30 CFR 18.91 - Electric equipment for which field approvals will be issued.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Electric equipment for which field approvals... OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.91 Electric...

  5. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Science.gov (United States)

    2010-04-01

    ... DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a... feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When...

  6. 43 CFR 45.74 - Has OMB approved the information collection provisions of this subpart?

    Science.gov (United States)

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Has OMB approved the information... the Interior CONDITIONS AND PRESCRIPTIONS IN FERC HYDROPOWER LICENSES Alternatives Process § 45.74 Has... indicates OMB approval. OMB has reviewed the information collection in this rule and approved it under...

  7. 13 CFR 106.303 - Who has authority to approve and sign a Fee Based Record?

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Who has authority to approve and... Activities § 106.303 Who has authority to approve and sign a Fee Based Record? The Administrator, or upon his... consultation with the General Counsel (or designee), has the authority to approve and sign each Fee...

  8. 50 CFR 221.74 - Has OMB approved the information collection provisions of this subpart?

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Has OMB approved the information... PRESCRIPTIONS IN FERC HYDROPOWER LICENSES Alternatives Process § 221.74 Has OMB approved the information... it displays a currently valid OMB control number that indicates OMB approval. OMB has reviewed...

  9. 13 CFR 106.204 - Who has the authority to approve and sign a Cosponsorship Agreement?

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Who has the authority to approve... Cosponsored Activities § 106.204 Who has the authority to approve and sign a Cosponsorship Agreement? The... administrator, after consultation with the General Counsel (or designee), has the authority to approve...

  10. 39 CFR 501.8 - Postage Evidencing System test and approval.

    Science.gov (United States)

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Postage Evidencing System test and approval. 501.8... AND DISTRIBUTE POSTAGE EVIDENCING SYSTEMS § 501.8 Postage Evidencing System test and approval. (a) To receive Postal Service approval, each Postage Evidencing System must be submitted by the provider...

  11. 33 CFR 175.21 - Condition; size and fit; approval marking.

    Science.gov (United States)

    2010-07-01

    ...; and (c) Legibly marked with its approval number, as specified in 46 CFR part 160. ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Condition; size and fit; approval...; size and fit; approval marking. No person may use a recreational boat unless each PFD required by §...

  12. 75 FR 42672 - Approval and Promulgation of Implementation Plans; New Jersey; 8-hour Ozone Control Measures

    Science.gov (United States)

    2010-07-22

    ... conditionally approved. See 74 FR 22837 (May 15, 2009). If EPA approves this proposed SIP revision, the RACT... Subchapter 24 occurred on January 25, 2006 (71 FR 4045). EPA had previously approved Subchapter 24 provisions... addition, any contact adhesive, electronic cleaner, footwear or leather care product, general...

  13. 7 CFR 1710.209 - Approval requirements for load forecast work plans.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Approval requirements for load forecast work plans... LOANS AND GUARANTEES Load Forecasts § 1710.209 Approval requirements for load forecast work plans. (a... utility plant of $500 million or more must maintain an approved load forecast work plan. RUS...

  14. 7 CFR 4290.480 - Prior approval of changes to RBIC's business plan.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Prior approval of changes to RBIC's business plan... § 4290.480 Prior approval of changes to RBIC's business plan. Without the Secretary's prior written approval, no change in your business plan, upon which you were selected and licensed as a RBIC, may...

  15. 7 CFR 1427.1086 - Approval of warehouse, requests for reconsideration.

    Science.gov (United States)

    2010-01-01

    ... CFR part 780. When appealing under such regulations, the warehouseman shall be considered as a... 7 Agriculture 10 2010-01-01 2010-01-01 false Approval of warehouse, requests for reconsideration... Standards for Approval of Warehouses for Cotton and Cotton Linters § 1427.1086 Approval of...

  16. 77 FR 48167 - Approved Tribal-State Class III Gaming Compact; Indian Gaming

    Science.gov (United States)

    2012-08-13

    ... Bureau of Indian Affairs Approved Tribal--State Class III Gaming Compact; Indian Gaming AGENCY: Bureau of Indian Affairs, Interior. ACTION: Notice of Approved Tribal--State Class III Gaming Compact. SUMMARY: This notice publishes an approval of the gaming compact between the Eastern Band of Cherokee...

  17. 49 CFR 1522.121 - Security threat assessments for personnel of TSA-approved validation firms.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 9 2010-10-01 2010-10-01 false Security threat assessments for personnel of TSA... FOR ALL MODES OF TRANSPORTATION TSA-APPROVED VALIDATION FIRMS AND VALIDATORS TSA-Approved Validation... for personnel of TSA-approved validation firms. Each of the following must successfully complete...

  18. INDACATEROL: A NEW APPROVED MOLECULE TO TREAT COPD

    Directory of Open Access Journals (Sweden)

    Jaithlia Rajiv

    2011-05-01

    Full Text Available Indacaterol approved as once-daily bronchodilator for chronic obstructive pulmonary disease (COPD. Indacaterol is a new molecular entity in the β2-adrenergic agonist class taken only once a day unlike the currently available β2-adrenergic agonist that helps relax muscles around lung airways to prevent COPD symptoms, such as wheezing and breathlessness. It is approved only for the treatment of chronic obstructive pulmonary disease (COPD (long-term data in patients with asthma are thus far lacking. It is delivered as an aerosol formulation through a dry powder inhaler. The most commonly reported side effects/adverse effects in patients taking Indacaterol (> 2% and more common than placebo are runny nose, cough, sore throat, headache, and nausea. The main benefit, it is Long Acting β2-adrenergic agonist (LABA, once in a day dosing is sufficient.

  19. Digital repositories certification: the Data Seal of Approval

    Directory of Open Access Journals (Sweden)

    Stefano Allegrezza

    2015-09-01

    Full Text Available In recent years, it has become increasingly common to entrust records to digital repositories; this assumes an implicit confidence in the repositories reliability, and therefore is urgent to identify the criteria on which to evaluate them. The Data Seal of Approval is a set of sixteen criteria that can be used to ensure that archived data can still be found, understood and used in the future. It is a basic level of certification but it is very useful to highlight the strengths and weaknesses of the deposit; in any case, it constitutes a solid basis for further certification of compliance to ISO 16363 or DIN 31644. The aim of this article is to provide an overview of Data Seal of Approval in the wider context of digital repositories' certification.

  20. Assisted Death: The Risks and Benefits of Tribunal Approval.

    Science.gov (United States)

    Handelman, Mark

    2016-02-01

    Should every request for physician-assisted death require approval from some kind of independent tribunal? The benefits include consistent interpretation of statutory or judge-created guidelines from hospital to hospital, accurate reporting of assisted deaths, a process that protects vulnerable patients and health practitioners, and assurance to the public that the process has sufficient safeguards. On the other hand, such a process might cause delays for persons suffering intolerably. Accessibility might be a problem, and there is the risk that the patient's personal health information becomes fodder for media sensationalism. The author weighs these risks and benefits and concludes that a tribunal approval process is a transparent system capable of helping the law clearly gel in a way that provides guidelines, encourages trust in the healthcare process generally and the assisted death process specifically. I PMID:27169206

  1. Chinese Government Approves Nanhai Oil Refinery Project of CNOOC

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

    @@ The Nanhai Oil Refinery Project independently funded by CNOOC was approved by the related governmental departments in late July. The offshore oil giant builds the 12 million ton-per-year oil refinery in Guangdong Province in the next three years to tap the lucrative South China oil market.The investment in the project will total at least 16 billion yuan (US$1.93 billion).

  2. Should local research ethics committees monitor research they have approved?

    OpenAIRE

    Cave (née Pickworth), E.

    2000-01-01

    The function of local research ethics committees is to consider the ethics of research proposals using human participants. After approval has been given, there is no comprehensive system in place to monitor research and ensure that recommendations are carried out. Some suggest that research ethics committees are ideally placed to fulfil this function by carrying out random monitoring of research they have reviewed. The health service guideline creating local research ethics committees is unde...

  3. Possible FDA-approved drugs to treat Ebola virus infection.

    Science.gov (United States)

    Yuan, Shu

    2015-01-01

    There is currently no effective treatment for the Ebola virus (EBOV) thus far. Most drugs and vaccines developed to date have not yet been approved for human trials. Two FDA-approved c-AbI1 tyrosine kinase inhibitors Gleevec and Tasigna block the release of viral particles; however, their clinical dosages are much lower than the dosages required for effective EBOV suppression. An α-1,2-glucosidase inhibitor Miglustat has been shown to inhibit EBOV particle assembly and secretion. Additionally, the estrogen receptor modulators Clomiphene and Toremifene prevent membrane fusion of EBOV and 50-90% of treated mice survived after Clomiphene/Toremifene treatments. However, the uptake efficiency of Clomiphene by oral administration is very low. Thus, I propose a hypothetical treatment protocol to treat Ebola virus infection with a cumulative use of both Miglustat and Toremifene to inhibit the virus effectively and synergistically. EBOV infection induces massive apoptosis of peripheral lymphocytes. Also, cytolysis of endothelial cells triggers disseminated intravascular coagulation (DIC) and subsequent multiple organ failures. Therefore, blood transfusions and active treatments with FDA-approved drugs to treat DIC are also recommended. PMID:25984303

  4. Hybridoma-Derived Idiotype Vaccine for Lymphoma: Approval Must Wait

    Directory of Open Access Journals (Sweden)

    Maurizio Bendandi

    2010-03-01

    Full Text Available Hybridoma-derived idiotype vaccines have been used for the experimental treatment of human lymphoma over the last twenty years, providing evidence of biological efficacy, clinical efficacy and clinical benefit. However, the product that has come closer to regulatory approval is unlikely to clear that hurdle due to the insufficiently robust data obtained in a recently closed clinical trial. This review aims at discussing the reasons for hybridoma-derived idiotype vaccines, more difficult to produce but also more successful than recombinant idiotype vaccines so far, are unlikely to gain regulatory approval. In particular, it is necessary to examine the many peculiar features of this therapeutic approach in a broader context, with special attention to concepts like customized active immunotherapy and randomization. Most published trials based on hybridoma-derived idiotype vaccines are being analyzed, together with the yet non-peer reviewed data from the only randomized study conducted so far with this product, and with the main trials on recombinant idiotype vaccines for thorough comparison. All in all, the sole randomized trial ever conducted on hybridoma-derived idiotype vaccines failed to achieve its primary clinical end point because of an insufficient accrual and because the statistical significance achieved was not as stringent as required for regulatory approval.

  5. Navigating the Process of Ethical Approval: A methodological note

    Directory of Open Access Journals (Sweden)

    Eileen Carey, RNID, BSc. (hons, MSc.

    2010-12-01

    Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.

  6. Approved Antiviral Drugs over the Past 50 Years.

    Science.gov (United States)

    De Clercq, Erik; Li, Guangdi

    2016-07-01

    Since the first antiviral drug, idoxuridine, was approved in 1963, 90 antiviral drugs categorized into 13 functional groups have been formally approved for the treatment of the following 9 human infectious diseases: (i) HIV infections (protease inhibitors, integrase inhibitors, entry inhibitors, nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, and acyclic nucleoside phosphonate analogues), (ii) hepatitis B virus (HBV) infections (lamivudine, interferons, nucleoside analogues, and acyclic nucleoside phosphonate analogues), (iii) hepatitis C virus (HCV) infections (ribavirin, interferons, NS3/4A protease inhibitors, NS5A inhibitors, and NS5B polymerase inhibitors), (iv) herpesvirus infections (5-substituted 2'-deoxyuridine analogues, entry inhibitors, nucleoside analogues, pyrophosphate analogues, and acyclic guanosine analogues), (v) influenza virus infections (ribavirin, matrix 2 protein inhibitors, RNA polymerase inhibitors, and neuraminidase inhibitors), (vi) human cytomegalovirus infections (acyclic guanosine analogues, acyclic nucleoside phosphonate analogues, pyrophosphate analogues, and oligonucleotides), (vii) varicella-zoster virus infections (acyclic guanosine analogues, nucleoside analogues, 5-substituted 2'-deoxyuridine analogues, and antibodies), (viii) respiratory syncytial virus infections (ribavirin and antibodies), and (ix) external anogenital warts caused by human papillomavirus infections (imiquimod, sinecatechins, and podofilox). Here, we present for the first time a comprehensive overview of antiviral drugs approved over the past 50 years, shedding light on the development of effective antiviral treatments against current and emerging infectious diseases worldwide. PMID:27281742

  7. Procedures for the approval of oil spill treatment products

    International Nuclear Information System (INIS)

    The final report of the Government Review on the Testing, Approval and Use of Oil Dispersants (MAFF, 1996) made a number of recommendations affecting approval of oil dispersants. In addition toxicity testing protocols have recently been developed to assess new types of oil treatment products such as sorbents and bioremediation agents. This document reflects these changes. It supersedes Fisheries Research Technical Report No. 39 - New procedures for the toxicity testing of oil slick dispersants (Blackman et al., 1977). Until April 1996 all toxicity assessments were carried out by the MAFF, Directorate of Fisheries Research (DFR). However, from that date appropriate toxicity testing can be carried out by suitably accredited or recognised laboratories, as an alternative to DFR, and results submitted to MAFF for consideration. This document is designed as an aid to manufacturers and potential testing laboratories. Under the scheme there is a need to assess and approve all types of oil treatment products. At present four different groups are recognised; dispersants, sorbents, bioremediation agents and miscellaneous. (author)

  8. A viewpoint on the approval context of strategic environmental assessments

    International Nuclear Information System (INIS)

    A reflection on the last report from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application and effectiveness of the Directive on Strategic Environmental Assessment (SEA) is provided. It covers the inadequacies of the approval/permitting context of SEA, which appears to be increasingly applied by a significant number of Member States in recent years. A viewpoint is provided on the main deficiencies of such praxis. As a practical defence of the planning context of SEA, the authors propose that the EC should consider a clear recommendation to Member States to cease performing SEA in the approval/permitting context until proper amendments to the SEA Directive are made and implemented. - Highlights: ► Administrative and permitting context of SEA, has ousted the primary environmental impact assessment goal. ► The approval context moves from the environmental protection to the area of political power and economy. ► SEA and EIA are misused. ► Environmental evaluations should be used for improving the projects/plans/programmes and not for permitting them.

  9. Drug lag for antineoplastic and immunomodulating agent approvals in India compared with the US and EU approvals

    OpenAIRE

    Bhaven C. Kataria; Ashna S. Pandya; Ashwin K. Panchasara; Pavan J. Panchal; Mitul R. Parmar

    2016-01-01

    Background: There is a tremendous amount of research being conducted on development of new drugs for cancer therapies. The drug development of cancer therapies has dramatically increased over the past few decades. The present study was undertaken to assess the drug lag for new antineoplastic and immunomodulating agents in India compared with that in the United States (US) or European Union (EU). Methods: The new drugs approved in the US, EU and India between 2011 and 2015 were identified a...

  10. Coastal nonpoint pollution control program: Program development and approval guidance

    International Nuclear Information System (INIS)

    The document, developed by NOAA and EPA, contains guidance for states in developing and implementing their coastal nonpoint pollutant source programs. It describes the requirements that must be met, including: the geographic scope of the program; the pollutant sources to be addressed; the types of management measures used; the establishment of critical areas; technical assistance, public participation, and administrative coordination; and, the process for program submission and Federal approval. The document also contains the criteria by which NOAA and EPA will review the states' submissions

  11. STS safety approval process for small self-contained payloads

    Science.gov (United States)

    Gum, Mary A.

    1988-01-01

    The safety approval process established by the National Aeronautics and Space Administration for Get Away Special (GAS) payloads is described. Although the designing organization is ultimately responsible for the safe operation of its payload, the Get Away Special team at the Goddard Space Flight Center will act as advisors while iterative safety analyses are performed and the Safety Data Package inputs are submitted. This four phase communications process will ultimately give NASA confidence that the GAS payload is safe, and successful completion of the Phase 3 package and review will clear the way for flight aboard the Space Transportation System orbiter.

  12. How to Improve the Likelihood of CDM Approval?

    DEFF Research Database (Denmark)

    Brandt, Urs Steiner; Svendsen, Gert Tinggaard

    2014-01-01

    How can the likelihood of Clean Development Mechanism (CDM) approval be improved in the face of institutional shortcomings? To answer this question, we focus on the three institutional shortcomings of income sharing, risk sharing and corruption prevention concerning afforestation/reforestation (A....../R). Furthermore, three main stakeholders are identified, namely investors, governments and agents in a principal-agent model regarding monitoring and enforcement capacity. Developing countries such as West Africa have, despite huge potentials, not been integrated in A/R CDM projects yet. Remote sensing, however...

  13. Streamlining of building permit approval processing of town and country planning department in Ghana

    Directory of Open Access Journals (Sweden)

    Noriss Kweku Hammah

    2015-12-01

    Full Text Available To date, the Ghanaian development control system has proven unsuccessful in delivering quality planning application approvals in a timely manner and it is doubtful whether it is possible to achieve that basic goal in its current form. Planning application approval assessment is performed conjointly by various planning organizations spearheaded by Accra Town and Country Planning Department (TCPD. The success in delivering quality approvals in a timely manner therefore depends on the inter-organizational task interdependency, collaboration, and teamwork of the various planning agencies that form the Accra Metropolitan Assembly. The paper puts into perspective the TCPD organizational workflow and knowledge flow based on their strategies, size, leadership style, organizational complexities, and their competencies to contribute to the success of the approval process. Further, this paper examines the reasons behind the increasing amorphous planning and unapproved development/construction and identifies the various planning approval problems. Finally, it offers modalities to curtail planning approval delays.

  14. QbD implementation and Post Approval Lifecycle Management (PALM).

    Science.gov (United States)

    Ohage, Ettore; Iverson, Raquel; Krummen, Lynne; Taticek, Ron; Vega, Maria

    2016-09-01

    Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11) [1-3]. An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody. This chapter describes concepts for implementing the control strategy for a monoclonal antibody including a Design Space for routine commercial manufacturing, and the Post Approval Lifecycle Management (PALM) plan that is used to manage any remaining risks during the commercial lifecycle. The PALM plan is part of the submitted dossier in the regional section and serves as a regulatory agreement between the manufacturer and the health authority specifying how process and product attributes are monitored to ensure both remain within a controlled state post-approval, process parameter changes are managed within the design space, and the control system is updated as necessary based on further process and product knowledge.

  15. Enzymes approved for human therapy: indications, mechanisms and adverse effects.

    Science.gov (United States)

    Baldo, Brian A

    2015-02-01

    Research and drug developments fostered under orphan drug product development programs have greatly assisted the introduction of efficient and safe enzyme-based therapies for a range of rare disorders. The introduction and regulatory approval of 20 different recombinant enzymes has enabled, often for the first time, effective enzyme-replacement therapy for some lysosomal storage disorders, including Gaucher (imiglucerase, taliglucerase, and velaglucerase), Fabry (agalsidase alfa and beta), and Pompe (alglucosidase alfa) diseases and mucopolysaccharidoses I (laronidase), II (idursulfase), IVA (elosulfase), and VI (galsulfase). Approved recombinant enzymes are also now used as therapy for myocardial infarction (alteplase, reteplase, and tenecteplase), cystic fibrosis (dornase alfa), chronic gout (pegloticase), tumor lysis syndrome (rasburicase), leukemia (L-asparaginase), some collagen-based disorders such as Dupuytren's contracture (collagenase), severe combined immunodeficiency disease (pegademase bovine), detoxification of methotrexate (glucarpidase), and vitreomacular adhesion (ocriplasmin). The development of these efficacious and safe enzyme-based therapies has occurred hand in hand with some remarkable advances in the preparation of the often specifically designed recombinant enzymes; the manufacturing expertise necessary for commercial production; our understanding of underlying mechanisms operative in the different diseases; and the mechanisms of action of the relevant recombinant enzymes. Together with information on these mechanisms, safety findings recorded so far on the various adverse events and problems of immunogenicity of the recombinant enzymes used for therapy are presented.

  16. Vienna Agreement law 15.986 it approve Vienna Agreement for Protection ozone layer and annex

    International Nuclear Information System (INIS)

    The Agreement of Vienna is approved with respect to the protection of the Layer of Ozono, definitions,general duties, research and observations systematics, co-operation in the Spheres Scientific Juridical, and information, Technological Conference, transmission from the protocols, amends, secretariat, adoption to the agreement or the protocols, adoption and amendment of controversy, signing, ratify, approve annexes, solution or vote, relation approving, adhesion, rights between the present agreement and its protocols, entrance in vigor, reserves, retirement, deposition, exchange of information

  17. [Approval of ISO/IEC 17025 and quality control of laboratory testing].

    Science.gov (United States)

    Yamamoto, Shigeki; Asakura, Hiroshi; Machii, Kenji; Igimi, Shizunobu

    2010-01-01

    First section of Division of Biomedical Food Research, National Institute of Health Sciences (NIHS) was approved by ISO/IEC 17025 as a laboratory having an appropriate laboratory testing technique. NIHS is the first national laboratory approved by ISO/IEC 17025. NIHS has also been accepted the appropriate technique and facility for the BSL3 level pathogens by ISO/IEC 17025. NIHS is necessary to take an external audit almost every year. This approval is renewed every 4 years. PMID:21381399

  18. Technical Architecture of ONC-Approved Plans For Statewide Health Information Exchange

    OpenAIRE

    Barrows, Randolph C.; Ezzard, John

    2011-01-01

    ONC-approved state plans for HIE were reviewed for descriptions and depictions of statewide HIE technical architecture. Review was complicated by non-standard organizational elements and technical terminology across state plans. Findings were mapped to industry standard, referenced, and defined HIE architecture descriptions and characteristics. Results are preliminary due to the initial subset of ONC-approved plans available, the rapid pace of new ONC-plan approvals, and continuing advancemen...

  19. Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

    OpenAIRE

    Siriwardhana Chesmal; Athukorale Manjula; Lekamwattage Manura; Hewege Suwin; Siribaddana Sisira; Sumathipala Athula; Murray Joanna; Prince Martin

    2008-01-01

    Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri L...

  20. Evaluation of regulatory processes affecting nuclear power plant early site approval and standardization

    International Nuclear Information System (INIS)

    This report presents the results of a survey and evaluation of existing federal, state and local regulatory considerations affecting siting approval of power plants in the United States. Those factors that may impede early site approval of nuclear power plants are identified, and findings related to the removal of these impediments and the general improvement of the approval process are presented. A brief evaluation of standardization of nuclear plant design is also presented

  1. Translating Social Motivation into Action: Contributions of Need for Approval to Children’s Social Engagement

    OpenAIRE

    Rudolph, Karen D.; Bohn, Lauren E.

    2013-01-01

    This research examined how children’s need for approval (NFA) from peers predicted social behavior (prosocial behavior, aggression, social helplessness) and peer responses (acceptance, victimization, exclusion). Children (N = 526, M age = 7.95, SD = .33) reported on need for approval and teachers reported on social engagement. Approach NFA (motivation to gain approval) predicted more positive engagement and less conflictual engagement and disengagement. Conversely, avoidance NFA (motivation t...

  2. 76 FR 52917 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of Control...

    Science.gov (United States)

    2011-08-24

    ...; Adoption of Control Techniques Guidelines for Large Appliance and Metal Furniture Coatings AGENCY... same title, ``Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption...

  3. 75 FR 68315 - Notice of Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2010-11-05

    ... Agricultural Marketing Service's (AMS) intention to request approval, from the Office of Management and Budget... informed production and marketing decisions. In addition, several Government agencies that purchase...

  4. 77 FR 59888 - Notice of Request for Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2012-10-01

    ...-Cooperative Service's (RBS) intention to request an extension for a currently approved information collection... and loan guarantees to eligible agricultural producers and rural small businesses for the purchase...

  5. A practical guide to attaining research ethics approval in the U.K.

    Science.gov (United States)

    Tod, Angela Mary; Allmark, Peter; Alison, Althea

    This article examines the permissions and approvals required for nurses and other health professionals to conduct research in the NHS in the U.K. today. A fictitious example of a research study conducted by a nurse who did not obtain NHS research ethics committee (REC) approval is provided. The current position regarding the REC approval process, including the role of ethics in research governance, is explored. The differences between research, audit and service evaluation are explained. Finally, the main ethical issues to be addressed in an application for REC approval are summarised. PMID:19323124

  6. Announcement of Newly Approved National Standards of P. R. China 2006 No.11 (total No.98)

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ General Administration of Quality Supervision, Inspection and Quarantine of P.R. China and Standardization Administration of China have approved the following 220 national standards and publicize now.

  7. Announcement of Newly Approved National Standards of P. R. China 2006 No.13 (total No. 100)

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ General Administration of Quality Supervision, Inspection and Quarantine of P.R. China and Standardization Administration of China have approved the following 371 national standards and publicize now.

  8. Announcement of Newly Approved National Standards of P. R. China 2007 No.4 (total No. 104)

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ General Administration of Quality Supervision, Inspection and Quarantine of P.R. China and Standardization Administration of China have approved the following 114 national standards and publicize now.

  9. 78 FR 76389 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2013-12-17

    ... operating at Southwest Florida International Airport (RSW). Determination: Approved. Based on information... vehicles and equipment. Extend and rehabilitate apron (airline). Demolish old passenger terminal...

  10. Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC Approved Packages

    International Nuclear Information System (INIS)

    This directory contains a Report of NRC Approved Packages (Volume 1). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  11. 75 FR 45007 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2010-07-30

    ... of Renewed Approval of Information Collection(s): Verification of Authenticity of Foreign License...: Verification of Authenticity of Foreign License, Rating and Medical Certification. Form Numbers: FAA form...

  12. 78 FR 58598 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2013-09-24

    ... of Renewed Approval of Information Collection: Verification of Authenticity of Foreign License... INFORMATION: OMB Control Number: 2120-0724. Title: Verification of Authenticity of Foreign License,...

  13. 75 FR 4901 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-01-29

    ...; Approval Date: December 21, 2009. 55. XTO Energy Incorporated, Pad ID: King Unit, ABR-20091225, Shrewsbury.... XTO Energy Incorporated, Pad ID: Booth, ABR-20091226, Shrewsbury Township, Lycoming County,...

  14. The Complexity of Manipulating $k$-Approval Elections

    CERN Document Server

    Lin, Andrew

    2010-01-01

    An important problem in computational social choice theory is the computability and complexity of undesirable behavior among agents, such as control, manipulation, and bribery in election systems. These kind of voting strategies are often tempting at the individual level but disasterous for the agents as a whole. Creating election systems where the determination of such strategies is difficult is thus an important goal. Previous work in this area has demonstrated the complexity of misuse in cases involving a fixed number of candidates, and of specific election systems on unbounded number of candidates such as Borda. In contrast, we take the first step in generalizing the results of computational complexity of election misuse to cases of infinitely many systems on an unbounded number of candidates. Interesting families of systems include $k$-approval and $k$-veto elections, in which voters distinguish $k$ candidates from the candidate set. We also demonstrate a surprising connection between manipulation in ele...

  15. 1994 Characterization report for the state approved land disposal site

    International Nuclear Information System (INIS)

    This report summarizes the results of characterization activities at the proposed state-approved land disposal site (SALDS); it updates the original characterization report with studies completed since the first characterization report. The initial characterization report discusses studies from two characterization boreholes, 699-48-77A and 699-48-77B. This revision includes data from implementation of the Groundwater Monitoring Plan and the Aquifer Test Plan. The primary sources of data are two down-gradient groundwater monitoring wells, 699-48-77C and 699-48-77D, and aquifer testing of three zones in well 699-48-77C. The SALDS is located on the Hanford Site, approximately 183 m north of the 200 West Area on the north side of the 200 Areas Plateau. The SALDS is an infiltration basin proposed for disposal of treated effluents from the 200 Areas of Hanford

  16. The support of human genetic evidence for approved drug indications.

    Science.gov (United States)

    Nelson, Matthew R; Tipney, Hannah; Painter, Jeffery L; Shen, Judong; Nicoletti, Paola; Shen, Yufeng; Floratos, Aris; Sham, Pak Chung; Li, Mulin Jun; Wang, Junwen; Cardon, Lon R; Whittaker, John C; Sanseau, Philippe

    2015-08-01

    Over a quarter of drugs that enter clinical development fail because they are ineffective. Growing insight into genes that influence human disease may affect how drug targets and indications are selected. However, there is little guidance about how much weight should be given to genetic evidence in making these key decisions. To answer this question, we investigated how well the current archive of genetic evidence predicts drug mechanisms. We found that, among well-studied indications, the proportion of drug mechanisms with direct genetic support increases significantly across the drug development pipeline, from 2.0% at the preclinical stage to 8.2% among mechanisms for approved drugs, and varies dramatically among disease areas. We estimate that selecting genetically supported targets could double the success rate in clinical development. Therefore, using the growing wealth of human genetic data to select the best targets and indications should have a measurable impact on the successful development of new drugs. PMID:26121088

  17. 1994 Characterization report for the state approved land disposal site

    Energy Technology Data Exchange (ETDEWEB)

    Swanson, L.C.

    1994-09-19

    This report summarizes the results of characterization activities at the proposed state-approved land disposal site (SALDS); it updates the original characterization report with studies completed since the first characterization report. The initial characterization report discusses studies from two characterization boreholes, 699-48-77A and 699-48-77B. This revision includes data from implementation of the Groundwater Monitoring Plan and the Aquifer Test Plan. The primary sources of data are two down-gradient groundwater monitoring wells, 699-48-77C and 699-48-77D, and aquifer testing of three zones in well 699-48-77C. The SALDS is located on the Hanford Site, approximately 183 m north of the 200 West Area on the north side of the 200 Areas Plateau. The SALDS is an infiltration basin proposed for disposal of treated effluents from the 200 Areas of Hanford.

  18. 46 CFR 35.03-5 - Approved types of work vests-TB/ALL.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Approved types of work vests-TB/ALL. 35.03-5 Section 35.03-5 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY TANK VESSELS OPERATIONS Work Vests § 35.03-5 Approved types of work vests—TB/ALL. (a) Each buoyant work vest carried under the...

  19. 46 CFR 196.34-5 - Approved types of work vests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Approved types of work vests. 196.34-5 Section 196.34-5 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OCEANOGRAPHIC RESEARCH VESSELS OPERATIONS Work Vests § 196.34-5 Approved types of work vests. (a) Each buoyant work vest carried under...

  20. 46 CFR 78.36-5 - Approved types of work vests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 3 2010-10-01 2010-10-01 false Approved types of work vests. 78.36-5 Section 78.36-5 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PASSENGER VESSELS OPERATIONS Work Vests § 78.36-5 Approved types of work vests. (a) Each buoyant work vest carried under the...

  1. 46 CFR 97.34-5 - Approved types of work vests.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Approved types of work vests. 97.34-5 Section 97.34-5 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) CARGO AND MISCELLANEOUS VESSELS OPERATIONS Work Vests § 97.34-5 Approved types of work vests. (a) Each buoyant work vest carried under...

  2. 13 CFR 108.140 - SBA approval of initial Management Expenses.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false SBA approval of initial Management... VENTURE CAPITAL (âNMVCâ) PROGRAM Qualifications for the NMVC Program Organizing A Nmvc Company § 108.140 SBA approval of initial Management Expenses. A NMVC Company must have its Management Expenses...

  3. 13 CFR 107.140 - SBA approval of initial Management Expenses.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false SBA approval of initial Management... BUSINESS INVESTMENT COMPANIES Qualifying for an SBIC License Organizing An Sbic § 107.140 SBA approval of initial Management Expenses. If you plan to obtain Leverage, you must have your Management...

  4. 29 CFR 3.6 - Payroll deductions permissible with the approval of the Secretary of Labor.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Payroll deductions permissible with the approval of the Secretary of Labor. 3.6 Section 3.6 Labor Office of the Secretary of Labor CONTRACTORS AND SUBCONTRACTORS ON....6 Payroll deductions permissible with the approval of the Secretary of Labor. Any contractor...

  5. 76 FR 58512 - Information Collections Approved by the Office of Management and Budget (OMB)

    Science.gov (United States)

    2011-09-21

    ... COMMISSION Information Collections Approved by the Office of Management and Budget (OMB) AGENCY: Federal... Management and Budget (OMB) approval for the following public information collections pursuant to the..., 2011. OMB Expiration Date: September 30, 2014. Title: Formal Complaint Procedures, Preserving the...

  6. 76 FR 29747 - State Program Requirements; Proposal To Approve Maine's Base National Pollutant Discharge...

    Science.gov (United States)

    2011-05-23

    ... 28, 2001. 66 FR 12791. As described in the Federal Register, EPA approved the state's application to... state to regulate cooling water intake structures under CWA section 316(b) (33 U.S.C. 1326(b)). 66 FR at... AGENCY State Program Requirements; Proposal To Approve Maine's Base National Pollutant...

  7. 7 CFR 1485.14 - Application approval and formation of agreements.

    Science.gov (United States)

    2010-01-01

    ... resources, approve those applications which it considers to present the best opportunity for developing... opportunity, market strategy and management capability. (b) Approval criteria. In assessing the applications... degree of value-added processing in the U.S.; and (8) General administrative and overhead costs...

  8. 78 FR 23495 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Small Container...

    Science.gov (United States)

    2013-04-19

    ... resident. As a result of this comment, the direct final approval published on April 16, 2012, (77 FR 22497... 1 quart per 8-hour period or exceed 55 gallons/year for any rolling 12 month period. (61 FR 5511 on... for coating operations (See November 30, 2011 proposed approval at 76 FR 74014). During...

  9. Directory of certificates of compliance for radioactive materials packages: Summary report of NRC approved packages

    International Nuclear Information System (INIS)

    This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1). This directory makes available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volume 1

  10. 78 FR 56648 - Notice of a Request for a Reinstatement of a Currently Approved Information Collection

    Science.gov (United States)

    2013-09-13

    ... Foreign Agricultural Service Notice of a Request for a Reinstatement of a Currently Approved Information... Service (FAS) intends to reinstate a currently approved information collection procedure for the Trade... at the mail address listed above between 8:00 a.m. and 4:30 p.m., Monday through Friday,...

  11. 76 FR 68757 - Information Collection Approved by the Office of Management and Budget

    Science.gov (United States)

    2011-11-07

    ... COMMISSION Information Collection Approved by the Office of Management and Budget AGENCY: Federal... Office of Management and Budget (OMB) approval for the following public information collections pursuant... collection of information unless it displays a currently valid OMB control number, and no person is...

  12. 76 FR 40908 - Information Collection Approved by the Office of Management and Budget

    Science.gov (United States)

    2011-07-12

    ... COMMISSION Information Collection Approved by the Office of Management and Budget AGENCY: Federal... Management and Budget (OMB) approval for the following public information collection(s) pursuant to the... information unless it displays a currently valid OMB control number, and no person is required to respond to...

  13. 77 FR 50611 - Approval and Promulgation of Implementation Plans; State of Oregon; Regional Haze State...

    Science.gov (United States)

    2012-08-22

    ... approved certain provisions in Oregon's Regional Haze SIP submission. 76 FR 38997. This previous action... developing a LTS. 76 FR 38997. A detailed explanation of the Regional Haze Rule including the requirements... retrofit technology (BART). 76 FR 38997. On May 23, 2012, EPA proposed approving the remaining portion...

  14. 76 FR 50536 - Projects Approved or Rescinded for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-15

    ... the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the time period specified...; Approval Date: June 2, 2011. 2. EQT Production Company, Pad ID: Wohler, ABR-201106002, Chest Township...: June 27, 2011. 23. Chesapeake Appalachia, LLC, Pad ID: Lambs Farm, ABR-201106023, Smithfield...

  15. 30 CFR 75.1103-2 - Automatic fire sensors; approved components; installation requirements.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic fire sensors; approved components... Protection § 75.1103-2 Automatic fire sensors; approved components; installation requirements. (a) The components of each automatic fire sensor required to be installed in accordance with the provisions of §...

  16. 76 FR 66625 - Approval of Grape Variety Names for American Wines

    Science.gov (United States)

    2011-10-27

    ... (76 FR 3573) proposing to add a number of grape variety names to the list of approved names in Sec. 4... American Wines AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Final rule; Treasury... approved for use in designating American wines, and to include in the list several separate entries...

  17. 76 FR 51903 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revised Definitions...

    Science.gov (United States)

    2011-08-19

    ... VI.D.1 is approved. EPA is also approving one grammatical change the State made to Regulation 3 in... the State's increased workload from the processing of APENs and permits. One grammatical change was made by the State in Part A, Section I.B.9.d. in their Regulation 3. The grammatical change is...

  18. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false How do I obtain approval to drill a well? 250... OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a well? You must obtain...

  19. 14 CFR 91.1437 - CAMP: Authority to perform and approve maintenance.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false CAMP: Authority to perform and approve maintenance. 91.1437 Section 91.1437 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF... Ownership Operations Program Management § 91.1437 CAMP: Authority to perform and approve maintenance....

  20. 21 CFR 314.170 - Adulteration and misbranding of an approved drug.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Adulteration and misbranding of an approved drug... Applications and Abbreviated Applications § 314.170 Adulteration and misbranding of an approved drug. All drugs... subject to the adulteration and misbranding provisions in sections 501, 502, and 503 of the act. FDA...

  1. 42 CFR 488.60 - Special procedures for approving end stage renal disease facilities.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Special procedures for approving end stage renal disease facilities. 488.60 Section 488.60 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... ENFORCEMENT PROCEDURES Special Requirements § 488.60 Special procedures for approving end stage renal...

  2. 76 FR 28123 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-05-13

    .... Additionally, five approved amendments to previously approved applications are listed. SUMMARY: The FAA... requirements of Sec. 158.15(b). Decision Date: March 11, 2011. For Further Information Contact: Irene Porter... training upgrade. Pre-conditioned air hose upgrade (five boarding bridges). Brief Description of...

  3. 49 CFR 178.273 - Approval of Specification UN portable tanks.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Approval of Specification UN portable tanks. 178... FOR PACKAGINGS Specifications for Portable Tanks § 178.273 Approval of Specification UN portable tanks... and that it conforms to the requirements of this subchapter. (6) For UN portable tanks intended...

  4. 77 FR 1027 - Approval and Promulgation of State Implementation Plans; State of Colorado; Interstate Transport...

    Science.gov (United States)

    2012-01-09

    ... Beryllium, Vinyl provision. chloride. The deletion is consistent with section 112(b)(6) of the Act. See... proposed approval of changes to Colorado Regulation No. 3 (70 FR 72744) can be found in a docket under... published June 3 and November 22, 2010 (75 FR 31306; 75 FR 71029). EPA approved Colorado's...

  5. 30 CFR 14.1 - Purpose, effective date for approval holders.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Purpose, effective date for approval holders. 14.1 Section 14.1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... CONVEYOR BELTS General Provisions § 14.1 Purpose, effective date for approval holders. This...

  6. 40 CFR 125.99 - What are approved design and construction technologies?

    Science.gov (United States)

    2010-07-01

    ... construction technologies? 125.99 Section 125.99 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...) of the Act § 125.99 What are approved design and construction technologies? (a) The following technologies constitute approved design and construction technologies for purposes of § 125.94(a)(4):...

  7. 7 CFR 1717.610 - RUS approval of compensation of the board of directors.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of compensation of the board of... AND GUARANTEED ELECTRIC LOANS Operational Controls § 1717.610 RUS approval of compensation of the... from RUS for compensation provided to members of the borrower's board of directors, such requirement...

  8. 7 CFR 1717.603 - RUS approval of extensions and additions.

    Science.gov (United States)

    2010-01-01

    ... forth in other RUS regulations, e.g., in 7 CFR parts 1710 and 1726. ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of extensions and additions. 1717.603... ELECTRIC LOANS Operational Controls § 1717.603 RUS approval of extensions and additions. (a)...

  9. 75 FR 70140 - Approval and Promulgation of Implementation Plans; New York Prevention of Significant...

    Science.gov (United States)

    2010-11-17

    ... Reform Rule, it indicated that it would not approve State plans that did not include the ``reforms,'' and... regulations consistent with changes to the Federal NSR regulations published on December 31, 2002 (67 FR 80186... approval, as proposed (see 75 FR 43892 (July 27, 2010)), with the caveat that EPA is taking no action...

  10. 40 CFR 52.2027 - Approval status of Pennsylvania's Generic NOX and VOC RACT Rules.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Approval status of Pennsylvania's Generic NOX and VOC RACT Rules. 52.2027 Section 52.2027 Protection of Environment ENVIRONMENTAL PROTECTION...) Pennsylvania § 52.2027 Approval status of Pennsylvania's Generic NOX and VOC RACT Rules. (a) Effective...

  11. 75 FR 6305 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Removal of NOX

    Science.gov (United States)

    2010-02-09

    ... NO X SIP Call rules, approved into the West Virginia SIP on May 10, 2002 (67 FR 31733) and September 28, 2006 (71 FR 56881), established West Virginia's NO X Budget Trading Program and set forth...) that were ] included in 45CSR1 into 45CSR40. On August 4, 2009 (74 FR 38536), EPA approved...

  12. 77 FR 60442 - Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone...

    Science.gov (United States)

    2012-10-03

    ... (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the... approval of the NADA and ANADAs listed in table 1 of this document because the products are no longer manufactured or marketed. Table 1--NADA and ANADAs for Which Withdrawal of Approval Has Been Requested...

  13. 77 FR 74225 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2012-12-13

    ... Division Administrator an application for approval of a Work Study Program as one that does not interfere... and Hour Division. Title: Work-Study Program of the Child Labor Regulations (WSP) Regulations 29 CFR... Hour Division RIN 1235-0024 Proposed Extension of the Approval of Information Collection...

  14. 46 CFR 8.570 - Interim approval of prototype SIP company or vessel plans.

    Science.gov (United States)

    2010-10-01

    ... of 46 CFR part 2, subpart 2.01 of this chapter. ... 46 Shipping 1 2010-10-01 2010-10-01 false Interim approval of prototype SIP company or vessel... of prototype SIP company or vessel plans. (a) A company operating under an approved prototype...

  15. 14 CFR 121.407 - Training program: Approval of airplane simulators and other training devices.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Training program: Approval of airplane... Program § 121.407 Training program: Approval of airplane simulators and other training devices. (a) Each airplane simulator and other training device that is used in a training course permitted under §...

  16. 7 CFR 1724.54 - Requirements for RUS approval of plans and specifications.

    Science.gov (United States)

    2010-01-01

    ... and standard structures do not require RUS approval. Plans and specifications for related work, such... not use RUS standard structures must receive RUS approval prior to requesting bids on contracts or... application must show floor area and estimated cost breakdown between office building space and space...

  17. 77 FR 71145 - Approval and Promulgation of Implementation Plans; New Mexico; New Source Review (NSR...

    Science.gov (United States)

    2012-11-29

    ... at the State Air Agency listed below during official business hours by appointment: New Mexico.... EPA's Evaluation The current New Mexico SIP includes EPA-approved Part 72 provisions (see 62 FR 50514... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; New Mexico; New Source...

  18. 77 FR 18923 - Approval and Promulgation of Implementation Plans; New Mexico; Construction Permit Fees

    Science.gov (United States)

    2012-03-29

    ... at the State Air Agency listed below during official business hours by appointment: New Mexico... September 26, 1997 (62 FR 50518). Therefore, a direct comparison to the approved New Mexico SIP is... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; New Mexico; Construction...

  19. 7 CFR 1948.82 - Plan and State Investment Strategy approval procedure.

    Science.gov (United States)

    2010-01-01

    ... hired in coal or uranium development activities in each of the next three years within the approved... Impacted Area Development Assistance Program § 1948.82 Plan and State Investment Strategy approval... production, processing, or transportation in each of the next three calendar years within the area covered...

  20. 5 CFR 2471.6 - Investigation of request; Panel procedures; approval of binding arbitration.

    Science.gov (United States)

    2010-01-01

    ... procedures; approval of binding arbitration. 2471.6 Section 2471.6 Administrative Personnel FEDERAL LABOR... procedures; approval of binding arbitration. (a) Upon receipt of a request for consideration of an impasse... arbitration or mediation-arbitration (by a Panel designee or a private arbitrator). Following procedures...

  1. 5 CFR 2471.1 - Request for Panel consideration; request for Panel approval of binding arbitration.

    Science.gov (United States)

    2010-01-01

    ... for Panel approval of binding arbitration. 2471.1 Section 2471.1 Administrative Personnel FEDERAL... consideration; request for Panel approval of binding arbitration. If voluntary arrangements, including the... procedure, which they have agreed to adopt, for binding arbitration of the negotiation impasse by filing...

  2. 77 FR 20577 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Central Indiana...

    Science.gov (United States)

    2012-04-05

    ..., EPA will consider those comments received both at the state and Federal level. EPA is moving forward... October 19, 2007 (72 FR 59210), and the MOBILE6.2-based budgets were approved in that notice. When EPA... effective date of that final approval. See 75 FR 9411-9414 for background and section III.c below...

  3. 76 FR 64020 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control...

    Science.gov (United States)

    2011-10-17

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption... SIP revision meets the requirement to adopt Reasonably Available Control Technology (RACT) for sources... ozone. EPA is approving this revision concerning the adoption of the CTG requirements for plastic...

  4. 75 FR 2789 - Shareholder Approval of Executive Compensation of TARP Recipients

    Science.gov (United States)

    2010-01-19

    ... COMMISSION 17 CFR Part 240 RIN 3235-AK31 Shareholder Approval of Executive Compensation of TARP Recipients... financial assistance under the Troubled Asset Relief Program (``TARP'') to permit a separate shareholder... Emergency Economic Stabilization Act of 2008 (``EESA'').\\5\\ \\4\\ Shareholder Approval of...

  5. 13 CFR 108.380 - Final approval as a NMVC Company.

    Science.gov (United States)

    2010-01-01

    ... VENTURE CAPITAL (âNMVCâ) PROGRAM Evaluation and Selection of NMVC Companies § 108.380 Final approval as a... amount of Regulatory Capital set forth in its application, pursuant to § 108.310(a)(1); and (B) The... at least 30 percent of its Regulatory Capital if the Conditionally Approved NMVC Company— (i)...

  6. 78 FR 16619 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    Science.gov (United States)

    2013-03-18

    ...; ] NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 RIN 3150-AJ22 List of Approved Spent Fuel Storage Casks... Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the NAC... within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 3 to Certificate...

  7. 78 FR 78693 - List of Approved Spent Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS® Cask System

    Science.gov (United States)

    2013-12-27

    ... RIN 3150-AJ10 List of Approved Spent Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS Cask... final rule amended the NRC's spent fuel storage regulations by revising the Transnuclear, Inc. Standardized NUHOMS Cask System listing within the ``List of Approved Spent Fuel Storage Casks'' to...

  8. 75 FR 33678 - List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision 1

    Science.gov (United States)

    2010-06-15

    ... COMMISSION 10 CFR Part 72 RIN 3150-AI86 List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision... Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the NAC International Inc. (NAC) MAGNASTOR System listing within the ``List of Approved Spent Fuel Storage Casks''...

  9. 10 CFR 72.214 - List of approved spent fuel storage casks.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false List of approved spent fuel storage casks. 72.214 Section... STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE General License for Storage of Spent Fuel at Power Reactor Sites § 72.214 List of approved...

  10. 75 FR 33736 - List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision 1

    Science.gov (United States)

    2010-06-15

    ... COMMISSION 10 CFR Part 72 RIN 3150--AI86 List of Approved Spent Fuel Storage Casks: MAGNASTOR System... Regulatory Commission (NRC) is proposing to amend its spent fuel storage cask regulations by revising the NAC International, Inc. (NAC), MAGNASTOR System listing within the ``List of Approved Spent Fuel Storage Casks''...

  11. 78 FR 63408 - List of Approved Spent Fuel Storage Casks: Transnuclear, Inc. Standardized NUHOMS® Cask System

    Science.gov (United States)

    2013-10-24

    ... COMMISSION 10 CFR Part 72 RIN 3150-AJ10 List of Approved Spent Fuel Storage Casks: Transnuclear, Inc.... Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the Transnuclear, Inc. Standardized NUHOMS Cask System listing within the ``List of Approved Spent Fuel...

  12. 77 FR 4203 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System, Revision 2

    Science.gov (United States)

    2012-01-27

    ... 3150-AI91 List of Approved Spent Fuel Storage Casks: MAGNASTOR System, Revision 2 AGENCY: Nuclear... amended the NRC's spent fuel storage regulations by revising the NAC International, Inc. (NAC) MAGNASTOR System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 2...

  13. 23 CFR 810.308 - Approval of urban system nonhighway public mass transit projects.

    Science.gov (United States)

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Approval of urban system nonhighway public mass transit... PUBLIC TRANSPORTATION MASS TRANSIT AND SPECIAL USE HIGHWAY PROJECTS Federal-Aid Urban System Nonhighway Public Mass Transit Projects § 810.308 Approval of urban system nonhighway public mass transit...

  14. 7 CFR 58.50 - Approval and form of official identification.

    Science.gov (United States)

    2010-01-01

    ... Dairy Products Marking, Branding, and Identifying Product § 58.50 Approval and form of official... in a shield in the form and design indicated in Figures 1, 2, and 3 of this section or such other form, design, or wording as may be approved by the Administrator. EC25SE91.014 EC25SE91.015...

  15. 76 FR 39874 - Information Collection Approved by the Office of Management and Budget

    Science.gov (United States)

    2011-07-07

    ... COMMISSION Information Collection Approved by the Office of Management and Budget AGENCY: Federal... Management and Budget (OMB) approval for the following public information collection(s) pursuant to the... respondents as a result of a Commission order granting numerous carriers forbearance from compliance to...

  16. 7 CFR 400.707 - Presentation to the Board for approval or disapproval.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 6 2010-01-01 2010-01-01 false Presentation to the Board for approval or disapproval. 400.707 Section 400.707 Agriculture Regulations of the Department of Agriculture (Continued) FEDERAL... Policies, Provisions of Policies and Rates of Premium § 400.707 Presentation to the Board for approval...

  17. 77 FR 52708 - Request to Revise a Currently-Approved Data Collection

    Science.gov (United States)

    2012-08-30

    .... Energy Information Administration Request to Revise a Currently-Approved Data Collection AGENCY: U.S... and comment. SUMMARY: EIA has submitted a request to revise a currently-approved data collection under...). EIA proposes changes to the data collection requirements for the Forms EIA-861, ``Annual...

  18. 78 FR 78315 - Revision to the Idaho State Implementation Plan; Approval of Fine Particulate Matter Control...

    Science.gov (United States)

    2013-12-26

    ... AGENCY 40 CFR Part 52 Revision to the Idaho State Implementation Plan; Approval of Fine Particulate... particulate matter (PM 2.5 ) nonattainment area (Logan UT-ID). The EPA is proposing a limited approval of PM 2..., the disclosure of which is restricted by statute. Certain other material, such as copyrighted...

  19. 50 CFR 403.03 - Review and approval of State request for management authority.

    Science.gov (United States)

    2010-10-01

    ... management authority will not be approved unless it contains the following: (1) The scientific and common... management authority. 403.03 Section 403.03 Wildlife and Fisheries JOINT REGULATIONS (UNITED STATES FISH AND... TRANSFER OF MARINE MAMMAL MANAGEMENT AUTHORITY TO STATES § 403.03 Review and approval of State request...

  20. 7 CFR 1710.205 - Minimum approval requirements for all load forecasts.

    Science.gov (United States)

    2010-01-01

    ... format acceptable to RUS. (d) Document retention. The borrower must retain its latest approved load... per consumer projections from the load forecast to develop system design criteria. The assumptions and... forecast work plan must be retained as part of the approved load forecast. (e) Consultation with RUS....

  1. 78 FR 52429 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine...

    Science.gov (United States)

    2013-08-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 558 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin AGENCY: Food... amending the animal drug regulations to reflect the withdrawal of approval of three new animal...

  2. 14 CFR 43.7 - Persons authorized to approve aircraft, airframes, aircraft engines, propellers, appliances, or...

    Science.gov (United States)

    2010-01-01

    ..., airframes, aircraft engines, propellers, appliances, or component parts for return to service after..., REBUILDING, AND ALTERATION § 43.7 Persons authorized to approve aircraft, airframes, aircraft engines... Administrator, may approve an aircraft, airframe, aircraft engine, propeller, appliance, or component part...

  3. 78 FR 56225 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Soil...

    Science.gov (United States)

    2013-09-12

    ... activities as described in this ICR (77 FR 39699, July 5, 2012). EPA did not receive any public comments... AGENCY Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Soil...) for review and approval in accordance with the Paperwork Reduction Act: ``Soil Fumigant...

  4. 75 FR 80061 - Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for MERIDIA

    Science.gov (United States)

    2010-12-21

    ... HUMAN SERVICES Food and Drug Administration Abbott Laboratories, Inc.; Withdrawal of Approval of a New... (sibutramine hydrochloride (HCl)) oral capsules held by Abbott Laboratories, Inc. (Abbott), 100 Abbott Park Rd., Abbott Park, IL 60064. Abbott has voluntarily requested that approval of this application be...

  5. 76 FR 70809 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-11-15

    ... Federal Aviation Administration Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals.... Earliest Charge Effective Date: January 1, 2017. Estimated Charge Expiration Date: March 1, 2017. Class of... agency's application, the FAA has determined that the approved class accounts for less than 1 percent...

  6. 6 CFR 25.9 - Procedures for certification of approved products for Homeland Security.

    Science.gov (United States)

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Procedures for certification of approved products for Homeland Security. 25.9 Section 25.9 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY REGULATIONS TO SUPPORT ANTI-TERRORISM BY FOSTERING EFFECTIVE TECHNOLOGIES § 25.9 Procedures for certification of approved...

  7. 21 CFR 514.8 - Supplements and other changes to an approved application.

    Science.gov (United States)

    2010-04-01

    ... commercial or production batches according to an approved stability protocol or commitment. (iv... describing the specific tests and studies and acceptance criteria to be achieved to demonstrate the lack of... production batches according to an approved stability protocol or commitment; and (J) Any other...

  8. 7 CFR 319.56-4 - Approval of certain fruits and vegetables for importation.

    Science.gov (United States)

    2010-01-01

    ...) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOREIGN QUARANTINE NOTICES Fruits and Vegetables § 319.56-4 Approval of certain fruits and vegetables for importation. (a) Determination... 7 Agriculture 5 2010-01-01 2010-01-01 false Approval of certain fruits and vegetables...

  9. 30 CFR 75.601-2 - Short circuit protection; use of fuses; approval by the Secretary.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Short circuit protection; use of fuses; approval by the Secretary. 75.601-2 Section 75.601-2 Mineral Resources MINE SAFETY AND HEALTH... Trailing Cables § 75.601-2 Short circuit protection; use of fuses; approval by the Secretary. Fuses...

  10. 29 CFR 1956.80 - Description of the plan as initially approved.

    Science.gov (United States)

    2010-07-01

    ... with 29 CFR 1953.5. Any emergency temporary standards will be adopted within 30 days of Federal... procedures at 29 CFR 1905 within two years of plan approval. (d) Employee notice and discrimination... and the independence of the adjudicatory process within one year of plan approval. The Director...

  11. 46 CFR 160.077-19 - Approval Testing-Recreational Hybrid PFD's.

    Science.gov (United States)

    2010-10-01

    ... constructed in accordance with the plans and specifications in the application for approval. In each test only... 46 Shipping 6 2010-10-01 2010-10-01 false Approval Testing-Recreational Hybrid PFD's. 160.077-19 Section 160.077-19 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED)...

  12. 77 FR 11483 - Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2012-02-27

    ... AGENCY: Risk Management Agency, USDA. ACTION: Extension of approval of an information collection; comment request. Note: With this renewal submission of 0563-0067--Risk Management and Crop Insurance Education... approved information collection for Risk Management and Crop Insurance Education; Request for...

  13. 78 FR 51135 - Notice of Request for Extension and Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2013-08-20

    ... Agricultural Marketing Service Notice of Request for Extension and Revision of a Currently Approved Information... currently approved information collection. Abstract: Federal milk marketing order regulations (7 CFR parts... the classified pricing system and related requirements of each Federal order. A Federal milk...

  14. 30 CFR 75.1107-2 - Approved fire-resistant hydraulic fluids; minimum requirements.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved fire-resistant hydraulic fluids... Protection Fire Suppression Devices and Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1107-2 Approved fire-resistant hydraulic fluids; minimum requirements. Fire-resistant hydraulic fluids...

  15. 12 CFR 708a.3 - Board of directors' approval and members' opportunity to comment.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Board of directors' approval and members... REGULATIONS AFFECTING CREDIT UNIONS CONVERSION OF INSURED CREDIT UNIONS TO MUTUAL SAVINGS BANKS § 708a.3 Board of directors' approval and members' opportunity to comment. (a) A credit union's board of...

  16. 42 CFR 422.256 - Review, negotiation, and approval of bids.

    Science.gov (United States)

    2010-10-01

    ..., benefits, or cost-sharing structure. (ii) Transition period for MA organizations with new acquisitions... Information and Plan Approval § 422.256 Review, negotiation, and approval of bids. (a) Authority. Subject to paragraphs (a)(2), (d), and (e) of this section, CMS has the authority to review the aggregate bid...

  17. 40 CFR 63.91 - Criteria for straight delegation and criteria common to all approval options.

    Science.gov (United States)

    2010-07-01

    ... program. (B) A description of the organization and structure of the agency or agencies that will have... POLLUTANTS FOR SOURCE CATEGORIES Approval of State Programs and Delegation of Federal Authorities § 63.91.... The Administrator may, under the authority of section 112(l) and this subpart, also approve a...

  18. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Science.gov (United States)

    2010-04-01

    ... Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a biological product for which safety has... and ethical. Such postmarketing studies would not be feasible until an exigency arises. When...

  19. 45 CFR 2540.540 - Who has authority to approve use of national service insignia?

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Who has authority to approve use of national service insignia? 2540.540 Section 2540.540 Public Welfare Regulations Relating to Public Welfare... Use of National Service Insignia § 2540.540 Who has authority to approve use of national...

  20. 76 FR 4710 - Accreditation and Approval of Laboratory Service, Inc., as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2011-01-26

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of Laboratory Service, Inc., as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of accreditation and approval of Laboratory Service, Inc., as a commercial gauger...

  1. 13 CFR 120.427 - Will SBA approve a securitization application from a capital impaired Securitizer?

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Will SBA approve a securitization... securitization application from a capital impaired Securitizer? If a securitizer does not maintain the level of capital required by this subpart, SBA will not approve a securitization application from that securitizer....

  2. 75 FR 2915 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

    Science.gov (United States)

    2010-01-19

    ... COMMISSION Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...), 74 FR 64783 (``Notice''). II. Description of Proposal The Exchange proposes to amend its Schedule of... No. 56254 (August 15, 2007), 72 FR 47104 (August 22, 2007) (approving SR-ISE-2007-70). \\5\\...

  3. 40 CFR 262.88 - Pre-approval for U.S. Recovery Facilities. [Reserved

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Pre-approval for U.S. Recovery Facilities. 262.88 Section 262.88 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID... Hazardous Waste for Recovery within the OECD § 262.88 Pre-approval for U.S. Recovery Facilities....

  4. 44 CFR 350.10 - Public meeting in advance of FEMA approval.

    Science.gov (United States)

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Public meeting in advance of FEMA approval. 350.10 Section 350.10 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS REVIEW AND APPROVAL OF STATE AND LOCAL...

  5. 38 CFR 21.4155 - Evaluations of State approving agency performance.

    Science.gov (United States)

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Evaluations of State approving agency performance. 21.4155 Section 21.4155 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF...) Annual evaluations required. (1) VA shall conduct in conjunction with State approving agencies an...

  6. 36 CFR 1226.14 - What are the limitations in applying approved records schedules?

    Science.gov (United States)

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false What are the limitations in applying approved records schedules? 1226.14 Section 1226.14 Parks, Forests, and Public Property NATIONAL... relevant function. (c) Disposition authorities approved for one department or independent agency may not...

  7. 78 FR 55234 - Approval and Promulgation of Implementation Plans; Indiana; Volatile Organic Compound Emission...

    Science.gov (United States)

    2013-09-10

    ...On May 29, 2012, the Indiana Department of Environmental Management (IDEM) submitted revisions to its volatile organic compound (VOC) industrial solvent cleaning rule for manufacturers of coatings, inks, adhesives, and resins for approval into its State Implementation Plan (SIP). These revisions are approvable because they are consistent with EPA's Industrial Solvent Cleaning Control Technique......

  8. 75 FR 82363 - Approval and Promulgation of Implementation Plans; Ohio; Volatile Organic Compound Emission...

    Science.gov (United States)

    2010-12-30

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; Ohio; Volatile Organic Compound... printing volatile organic compound (VOC) rule for approval into the Ohio State Implementation Plan (SIP... review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4,...

  9. 77 FR 31265 - Approval and Promulgation of Implementation Plans; Ohio; Volatile Organic Compound Emission...

    Science.gov (United States)

    2012-05-25

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; Ohio; Volatile Organic Compound... (Ohio EPA) submitted several volatile organic compound (VOC) rules for approval into its State... review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4,...

  10. 30 CFR 77.1900 - Slopes and shafts; approval of plans.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Slopes and shafts; approval of plans. 77.1900... COAL MINES Slope and Shaft Sinking § 77.1900 Slopes and shafts; approval of plans. (a) Each operator of... slope or shaft that is commenced or extended after June 30, 1971. The plan shall be consistent...

  11. 47 CFR 64.2007 - Approval required for use of customer proprietary network information.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 3 2010-10-01 2010-10-01 false Approval required for use of customer proprietary network information. 64.2007 Section 64.2007 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... Proprietary Network Information § 64.2007 Approval required for use of customer proprietary...

  12. 77 FR 6711 - Approval and Promulgation of Implementation Plans; Arkansas; Infrastructure Requirements for the...

    Science.gov (United States)

    2012-02-09

    ... proposing to approve SIP revisions that modify the Arkansas PSD SIP to include nitrogen oxides (NO X ) as an... Greenhouse Gas Emitting-Sources in State Implementation Plans; Final Rule,'' 75 FR 82536 (December 30, 2010... Greenhouse Gas Tailoring Rule; Final Rule.'' 75 FR 31514 (June 3, 2010). The approved Arkansas SIP...

  13. 76 FR 9281 - Approval and Promulgation of Air Quality Implementation Plans; Massachusetts; Revised Carbon...

    Science.gov (United States)

    2011-02-17

    ... for the Lowell CO nonattainment area were approved by EPA on February 19, 2002 (67 FR 7272).) The... requirements, which was codified in 40 CFR part 58. (See 71 FR 61236.) That rule explicitly recognized that, in... replaced. (See 71 FR 61250 and 71 FR 61301.) As described above, this action is proposing to approve...

  14. 30 CFR 885.16 - After OSM approves my grant, what responsibilities do I have?

    Science.gov (United States)

    2010-07-01

    ... TRIBES § 885.16 After OSM approves my grant, what responsibilities do I have? (a) When we award your grant, we send you a written grant agreement stating the terms of the grant. (b) After you are awarded a... 30 Mineral Resources 3 2010-07-01 2010-07-01 false After OSM approves my grant,...

  15. 30 CFR 886.16 - After OSM approves my grant, what responsibilities do I have?

    Science.gov (United States)

    2010-07-01

    ... STATES AND INDIAN TRIBES § 886.16 After OSM approves my grant, what responsibilities do I have? (a) When we award your grant, we send you a written grant agreement stating the terms of the grant. (b) After... 30 Mineral Resources 3 2010-07-01 2010-07-01 false After OSM approves my grant,...

  16. 13 CFR 108.503 - NMVC Company's adoption of an approved valuation policy.

    Science.gov (United States)

    2010-01-01

    ... approved valuation policy. 108.503 Section 108.503 Business Credit and Assistance SMALL BUSINESS... Requirements § 108.503 NMVC Company's adoption of an approved valuation policy. (a) Valuation guidelines. You must prepare, document and report the valuations of your Loans and Investments in accordance with...

  17. 7 CFR 4290.503 - RBIC's adoption of an approved valuation policy.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false RBIC's adoption of an approved valuation policy. 4290... adoption of an approved valuation policy. (a) Valuation guidelines. You must prepare, document and report the valuations of your Loans and Investments in accordance with the Valuation Guidelines for...

  18. Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-02-01

    Full Text Available Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.

  19. Approval of high-risk medical devices in the US: implications for clinical cardiology.

    Science.gov (United States)

    Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

    2014-01-01

    Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.

  20. Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC approved packages

    International Nuclear Information System (INIS)

    This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  1. Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved packages

    International Nuclear Information System (INIS)

    This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective December 31, 1982. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  2. Directory of certificates of compliance for radioactive materials packages, Report of NRC approved packages

    International Nuclear Information System (INIS)

    This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Materials Packages effective October 1, 1990. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

  3. Situational Discrimination in Repressor-type and Sensitizer-type Approval Seekers and the Birth Order by Subject Sex Interaction

    Science.gov (United States)

    Becker, Gilbert

    1970-01-01

    Five experiments are reported. One conclusion in that repressor-type high need-for-approval subjects made the discrimination and permitted less favorable self-description, but sensitizer-type high need-for-approval subjects did not. (DB)

  4. 30 CFR 285.615 - What other reports or notices must I submit to MMS under my approved SAP?

    Science.gov (United States)

    2010-07-01

    ... MMS under my approved SAP? 285.615 Section 285.615 Mineral Resources MINERALS MANAGEMENT SERVICE... CONTINENTAL SHELF Plans and Information Requirements Activities Under An Approved Sap § 285.615 What other reports or notices must I submit to MMS under my approved SAP? (a) You must notify MMS in writing...

  5. 21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

    Science.gov (United States)

    2010-04-01

    ... supplement that quality control personnel approve for reprocessing? 111.525 Section 111.525 Food and Drugs... dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any... with § 111.70(e); and (b) Quality control personnel must approve or reject the release for...

  6. 13 CFR 108.420 - Prohibition on exercise of ownership or Control rights in NMVC Company before SBA approval.

    Science.gov (United States)

    2010-01-01

    ... as to such voting rights at any meeting of shareholders, partners or members); (c) Permit the... ownership or Control rights in NMVC Company before SBA approval. 108.420 Section 108.420 Business Credit and... ownership or Control rights in NMVC Company before SBA approval. Without prior written SBA approval,...

  7. 75 FR 28815 - Application and Re-certification Packages for Approval of Nonprofit Organizations in FHA Activities

    Science.gov (United States)

    2010-05-24

    ... URBAN DEVELOPMENT Application and Re-certification Packages for Approval of Nonprofit Organizations in... public comments on the subject proposal. In general, a nonprofit organization must be HUD-approved and meet specific requirements to maintain approval and remain on the Nonprofit Organization Roster...

  8. Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.

    Science.gov (United States)

    Xu, Kui; Coté, Timothy R

    2011-07-01

    Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation--that is, were found to be 'promising' for the treatment of a rare disease--and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N = 109); orphan-designated products with at least one marketing approval for a rare disease indication (N = 76); and orphan-designated products with marketing approvals for both common and rare disease indications (N = 51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients.

  9. Impressive Words: Linguistic Predictors of Public Approval of the U.S. Congress

    Science.gov (United States)

    Decter-Frain, Ari; Frimer, Jeremy A.

    2016-01-01

    What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a “big data” approach—the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC), we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996 and 2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping). A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition. PMID:26941691

  10. Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.

    Science.gov (United States)

    Xu, Kui; Coté, Timothy R

    2011-07-01

    Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation--that is, were found to be 'promising' for the treatment of a rare disease--and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N = 109); orphan-designated products with at least one marketing approval for a rare disease indication (N = 76); and orphan-designated products with marketing approvals for both common and rare disease indications (N = 51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients. PMID:21357612

  11. Impressive Words: Linguistic Predictors of Public Approval of the U.S. Congress

    Directory of Open Access Journals (Sweden)

    Ari eDecter-Frain

    2016-02-01

    Full Text Available What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a big data approach—the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC, we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996-2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping. A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition.

  12. Impressive Words: Linguistic Predictors of Public Approval of the U.S. Congress.

    Science.gov (United States)

    Decter-Frain, Ari; Frimer, Jeremy A

    2016-01-01

    What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a "big data" approach-the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC), we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996 and 2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping). A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition. PMID:26941691

  13. In-use vs. type-approval fuel consumption of current passenger cars in Europe

    International Nuclear Information System (INIS)

    In-use fuel consumption data of 924 passenger cars (611 petrol, 313 diesel) were collected from various European sources and were evaluated in comparison to their corresponding type-approval values. The analysis indicated that the average in-use fuel consumption was higher than the type-approval one by 11% for petrol cars and 16% for diesel cars. Comparison of this dataset with the Travelcard database in the Netherlands showed that the deviation increased for late model years and in particular for cars with low type-approval values. The deviation was higher than 60% for vehicles registered in 2012 within the 90–100 gCO2/km bin. Unrealistic vehicle resistances used in type-approval were identified as one of the prime reasons of the difference. A simplified linear model developed in the study may be used to predict in-use fuel consumption based on data publicly available. The model utilizes the fuel consumption measured in type-approval, the mass, and the engine capacity to provide in-use fuel consumption. This may be either used to correct fuel consumption factors currently utilized by emission models (e.g. COPERT, HBEFA, VERSIT+, and others) or could be used independently to make projections on how fuel consumption may develop on the basis of changing future passenger cars characteristics. - Highlights: • In-use fuel consumption of petrol and diesel passenger cars is 11% and 16% higher than type-approval, respectively. • The relative difference between in-use and type-approval increases for late model and vehicles with low consumption. • Unrealistically low vehicle resistances are identified as a prime reason of low type-approval fuel consumption. • A model developed predicts in-use consumption on the basis of type-approval consumption, vehicle mass, and engine capacity

  14. Gene therapy for cancer: regulatory considerations for approval.

    Science.gov (United States)

    Husain, S R; Han, J; Au, P; Shannon, K; Puri, R K

    2015-12-01

    The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA.

  15. AUDIT IN THE OFFICIAL CONTROL OF APPROVED PLANTS

    Directory of Open Access Journals (Sweden)

    E. Paladino

    2013-02-01

    Full Text Available The UE 882/04 Regulation has changed the approach of the official control on food business. The audit as a monitoring tool responds to a logic of making a less frequent but more global check and reported not only to what is possible to verify at the time but also to the system put in place by companies to prevent and manage hazards and risks. This study analyzes the results of an audit program implemented in 2008 to control approved plants assessing through numerical indicators the activity, the efficiency and the effectiveness. To this end a comparison with the monitoring data on the same plants made in 2005, has been done in order to evaluate the possible differences in results due to the use of audit as a monitoring tool. The results show a good degree of implementation of the program and a good effectiveness, assessed by the number of Non-Compliance detected. Compared to 2005 it results the increased effectiveness of control and the reduced number of used hours is evident.

  16. TASAR Certification and Operational Approval Requirements - Analyses and Results

    Science.gov (United States)

    Koczo, Stefan, Jr.

    2015-01-01

    This report documents the results of research and development work performed by Rockwell Collins in addressing the Task 1 objectives under NASA Contract NNL12AA11C. Under this contract Rockwell Collins provided analytical support to the NASA Langley Research Center (LaRC) in NASA's development of a Traffic Aware Strategic Aircrew Requests (TASAR) flight deck Electronic Flight Bag (EFB) application for technology transition into operational use. The two primary objectives of this contract were for Rockwell Collins and the University of Iowa OPL to 1) perform an implementation assessment of TASAR toward early certification and operational approval of TASAR as an EFB application (Task 1 of this contract), and 2) design, develop and conduct two Human-in-the-Loop (HITL) simulation experiments that evaluate TASAR and the associated Traffic Aware Planner (TAP) software application to determine the situational awareness and workload impacts of TASAR in the flight deck, while also assessing the level of comprehension, usefulness, and usability of the features of TAP (Task 2 of this contract). This report represents the Task 1 summary report. The Task 2 summary report is provided in [0].

  17. Prospective Activities outlined for Regulatory Approval in Ghana Overview

    Energy Technology Data Exchange (ETDEWEB)

    Abrefah, R.G.; Odoi, H.C.; Mo, S.C.; Morman, J.A.; Liaw, J.

    2015-01-01

    The Ghana Research Reactor-1 (GHARR-1) is one of Chinese’s Miniature Neutron Source Reactor (MNSR) which was purchased under a tripartite agreement between Ghana, China and the IAEA. The reactor was installed in 1994 and has since been in operation without any incident. It has been used chiefly for Neutron Activation Analysis (NAA) and Training of students in the field of Nuclear Engineering. The GHARR-1 has been earmarked for the Conversion of Core from HEU to LEU which is in accordance with the GTRI program and other related and/or associated programs. Over the past few years the National Nuclear Research Institute (NNRI), the Operating Organization of the Research Reactor for the Ghana Atomic Energy Commission (GAEC), has undertaken various tasks in order to implement the replacement of the reactor core. After completion, of the neutronic calculations, results showed that that an LEU fuel of 12.5% enrichment was desirable. However, recent developments have shown that an LEU fuel with 13% enrichment will be fabricated by the manufacturers, which is captured in a fuel specification document sent to NNRI by the CIAE. It is therefore imperative that all neutronic and thermal hydraulic calculation be done again to help acquire regulatory approval. Furthermore, the radiation exposure to personnel involved in the conversion must be estimated to help convince our regulators. This paper outlines the processes and activities that will enable us meet regulatory requirements.

  18. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    Directory of Open Access Journals (Sweden)

    Md Tausif Alam

    2014-01-01

    Full Text Available Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing, in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.

  19. Approved Site Treatment Plan, Volumes 1 and 2. Revision 4

    Energy Technology Data Exchange (ETDEWEB)

    Helmich, E.H.; Molen, G.; Noller, D.

    1996-03-22

    The US Department of Energy, Savannah River Operations Office (DOE-SR), has prepared the Site Treatment Plan (STP) for Savannah River Site (SRS) mixed wastes in accordance with RCRA Section 3021(b), and SCDHEC has approved the STP (except for certain offsite wastes) and issued an order enforcing the STP commitments in Volume 1. DOE-SR and SCDHEC agree that this STP fulfills the requirements contained in the FFCAct, RCRA Section 3021, and therefore, pursuant to Section 105(a) of the FFCAct (RCRA Section 3021(b)(5)), DOE`s requirements are to implement the plan for the development of treatment capacities and technologies pursuant to RCRA Section 3021. Emerging and new technologies not yet considered may be identified to manage waste more safely, effectively, and at lower cost than technologies currently identified in the plan. DOE will continue to evaluate and develop technologies that offer potential advantages in public acceptance, privatization, consolidation, risk abatement, performance, and life-cycle cost. Should technologies that offer such advantages be identified, DOE may request a revision/modification of the STP in accordance with the provisions of Consent Order 95-22-HW. The Compliance Plan Volume (Volume 1) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions (LDR). Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume 2) and is provided for information.

  20. Savannah River Site Approved Site Treatment Plan, 1998 Annual Update

    Energy Technology Data Exchange (ETDEWEB)

    Lawrence, B. [Westinghouse Savannah River Company, AIKEN, SC (United States); Berry, M.

    1998-03-01

    The U.S. Department of Energy, Savannah River Operations Office (DOE- SR),has prepared the Site Treatment Plan (STP) for Savannah River Site (SRS) mixed wastes in accordance with RCRA Section 3021(b), and SCDHEC has approved the STP (except for certain offsite wastes) and issued an order enforcing the STP commitments in Volume I. DOE-SR and SCDHEC agree that this STP fulfills the requirements contained in the FFCAct, RCRA Section 3021, and therefore,pursuant to Section 105(a) of the FFCAct (RCRA Section 3021(b)(5)), DOE`s requirements are to implement the plan for the development of treatment capacities and technologies pursuant to RCRA Section 3021.Emerging and new technologies not yet considered may be identified to manage waste more safely, effectively, and at lower cost than technologies currently identified in the plan. DOE will continue to evaluate and develop technologies that offer potential advantages in public acceptance, privatization, consolidation, risk abatement, performance, and life-cycle cost. Should technologies that offer such advantages be identified, DOE may request a revision/modification of the STP in accordance with the provisions of Consent Order 95-22-HW.The Compliance Plan Volume (Volume I) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions (LDR). Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume II) and is provided for information.