WorldWideScience

Sample records for approval ob-nda 00-0127

  1. Drugs Approved for Melanoma

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Melanoma This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Melanoma Aldesleukin Cobimetinib Cotellic (Cobimetinib) Dabrafenib Dacarbazine DTIC-Dome ( ...

  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. Drugs Approved for Thyroid Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

  4. 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 ... listed here. Drugs Approved for Non-Small Cell Lung Cancer Abitrexate (Methotrexate) Abraxane (Paclitaxel Albumin-stabilized Nanoparticle Formulation) ...

  5. 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.

  6. 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.

  7. 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 America,...

  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. 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.

  11. Pomalidomide: first global approval.

    Science.gov (United States)

    Elkinson, Shelley; McCormack, Paul L

    2013-05-01

    Pomalidomide (Pomalyst(®)) is a small molecule analogue of thalidomide under development with Celgene Corporation for the oral treatment of haematological and connective tissue diseases. Pomalidomide has been approved in the USA and is awaiting approval in the EU for use with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma that has progressed following at least two prior therapies, including lenalidomide and bortezomib. The efficacy and safety of pomalidomide as monotherapy in patients with relapsed and refractory multiple myeloma has also been evaluated in a phase III trial. The agent is in phase III clinical development for the treatment of myelofibrosis and in phase II development for systemic sclerosis. Pomalidomide is also being investigated in patients with amyloidosis, prostate cancer, small cell lung cancer, pancreatic cancer, graft-versus-host disease, and Waldenstrom's macroglobulinaemia. This article summarizes the milestones in the development of pomalidomide leading to this first global approval for relapsed and refractory multiple myeloma.

  12. Apremilast: first global approval.

    Science.gov (United States)

    Poole, Raewyn M; Ballantyne, Anita D

    2014-05-01

    Apremilast (Otezla(®)), an oral small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4), is under development with Celgene Corporation for the treatment of psoriatic arthritis, psoriasis, ankylosing spondylitis, Behçet's syndrome, atopic dermatitis, and rheumatoid arthritis. Apremilast is indicated for the treatment of active psoriatic arthritis in adults. Apremilast has received its first global approval for this indication in the USA. Regulatory submissions for approval in this indication are under review in Canada and Europe. Regulatory filings have also been submitted for apremilast in the treatment of plaque psoriasis in the USA and Europe. This article summarizes the milestones in the development of apremilast leading to its first approval for the treatment of psoriatic arthritis.

  13. FDA Approval for Imiquimod

    Science.gov (United States)

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  14. Heartland Winthrop Approval

    Science.gov (United States)

    This May 19, 2016 letter from EPA approves the petition from Heartland Corn Products regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS program.

  15. FHR Iowa Falls Approval

    Science.gov (United States)

    This October 22, 2015, letter from EPA approves the petition from Flint Hills Resources, LLC, regarding non-grandfathered ethanol produced through the FHR Iowa Falls Process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the R

  16. 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.

  17. Pitolisant: First Global Approval.

    Science.gov (United States)

    Syed, Yahiya Y

    2016-09-01

    Pitolisant (Wakix™) is an inverse agonist of the histamine H3 receptor that is being developed by Bioproject. Oral pitolisant is approved in the EU for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant has received a Temporary Authorization of Use in France for this indication in case of treatment failure, intolerance or contraindication to currently available treatment. Pitolisant has orphan drug designation in the EU and the USA. In the pivotal HARMONY I trial, pitolisant significantly decreased excessive daytime sleepiness versus placebo in adults with narcolepsy with or without cataplexy (primary endpoint). Pitolisant also significantly decreased cataplexy rate versus placebo in these patients. This article summarizes the milestones in the development of pitolisant leading to this first approval for narcolepsy.

  18. Baricitinib: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2017-03-13

    Baricitinib (Olumiant™) is an orally-administered, small-molecule, janus-associated kinase (JAK) inhibitor developed by Eli Lilly and Incyte Corporation for the treatment of rheumatoid arthritis (RA), atopic dermatitis and systemic lupus erythematosus. JAKs transduce intracellular signals from cell surface receptors for various cytokines and growth factors involved in inflammation and immune function, suggesting JAK inhibitors may be of therapeutic benefit in inflammatory conditions. In February 2017, baricitinib was approved in the EU, as monotherapy or in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Regulatory approval to market baricitinib as a treatment for RA has also been sought in the USA and Japan. This article summarizes the milestones in the development of baricitinib leading to this first global approval for the treatment for moderate to severe active RA in adult patients who have responded inadequately to, or are intolerant to one or more DMARDs.

  19. 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.

  20. 78 FR 66826 - Prior Label Approval System: Generic Label Approval

    Science.gov (United States)

    2013-11-07

    ... submitted for evaluation and approval before use under the final rule are: (1) Labels for chicken produced..., such as ``no antibiotics administered'' or ``vegetarian fed''; (4) instructional or...

  1. Obinutuzumab: first global approval.

    Science.gov (United States)

    Cameron, Fiona; McCormack, Paul L

    2014-01-01

    Obinutuzumab (Gazyva™) is an intravenously administered, humanized and glycoengineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. It is approved in the US for use in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukaemia (CLL), and has been filed for approval in the EU in this indication. The antibody is based on GlycArt Biotechnology's (later Roche Glycart AG) proprietary GlycoMAb® technology, which uses glycoengineered antibodies that specifically increase antibody-dependent cellular cytotoxicity and thereby increase immune-mediated target cell death. Obinutuzumab is a type II anti-CD20 antibody that induces enhanced direct cell death. The monoclonal antibody is in worldwide phase III development with Roche and its subsidiaries, Genentech and Chugai Pharmaceutical, as well as Biogen Idec, for diffuse large B-cell lymphoma and non-Hodgkin's lymphoma generally, and is also in phase III development in countries outside of the US and EU for CLL.

  2. Safinamide: first global approval.

    Science.gov (United States)

    Deeks, Emma D

    2015-04-01

    Safinamide (Xadago(®)) is an oral α-aminoamide derivative developed by Newron for the treatment of Parkinson's disease (PD). The drug has both dopaminergic properties (highly selective and reversible inhibition of monoamine oxidase-B) and non-dopaminergic properties (selective sodium channel blockade and calcium channel modulation, with consequent inhibition of excessive glutamate release). Safinamide is approved in the EU, Iceland, Lichtenstein and Norway, as an add-on therapy to stable-dose levodopa, alone or in combination with other PD therapies in mid- to late-stage fluctuating PD patients; regulatory submissions have also been filed in the USA and Switzerland for its use in this indication. Additional submissions have been made in the USA, Iceland, Lichtenstein, Norway and Switzerland for early-stage PD. Safinamide has also undergone phase II investigation in PD patients with drug-induced dyskinesia (France, Germany, Austria, Canada and South Africa) or cognitive impairment (USA and Spain). This article summarizes the milestones in the development of safinamide leading to its first approval for PD.

  3. Drugs Approved for Cervical Cancer

    Science.gov (United States)

    ... Human Papillomavirus (HPV) Nonavalent Vaccine Recombinant Human Papillomavirus (HPV) Quadrivalent Vaccine Drugs Approved to Treat Cervical Cancer Avastin (Bevacizumab) Bevacizumab Blenoxane (Bleomycin) Bleomycin Hycamtin (Topotecan ...

  4. FDA-Approved HIV Medicines

    Science.gov (United States)

    HIV Treatment FDA-Approved HIV Medicines (Last updated 2/27/2017; last reviewed 2/27/2017) Treatment with HIV medicines is ... approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in the ...

  5. 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,...

  6. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Types of respirators to be approved; scope of... Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.50 Types of respirators to be approved; scope of approval. Approvals shall be issued for the types of respirators...

  7. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

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

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Is It Really FDA Approved?

    Science.gov (United States)

    ... does not approve cosmetics. Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body ... and provide the agency with a notification before marketing a new formula. FDA conducts yearly inspections of ...

  17. Electronic Voucher Approval - Financial Management

    Data.gov (United States)

    US Agency for International Development — This process provides a workflow and eSignature capability which allows the CFO to router vouchers for review and electronic signature approval to COTRs in AIDW. It...

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. Elosulfase alfa: first global approval.

    Science.gov (United States)

    Sanford, Mark; Lo, Jin Han

    2014-04-01

    Elosulfase alfa (Vimizim™) is a recombinant form of N-acetylgalactosamine-6-sulfatase (GALNS) that was developed by BioMarin Pharmaceutical Inc. as an enzyme replacement therapy for patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome. Patients with MPS IVA have a GALNS deficiency, which results in serious musculoskeletal, cardiorespiratory and other system disturbances. Elosulfase alfa was approved by the US FDA on 14 February 2014 for the treatment of MPS IVA. The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recently recommended that elosulfase alfa be approved for use in the EU in the same indication. Within the last year, the manufacturer has also filed applications for approval for the use of elosulfase alfa in MPS IVA in Brazil, Australia, Canada and Mexico. This article summarizes the milestones in the development of elosulfase alfa leading to its first global approval in MPS IVA.

  5. Drugs Approved for Prostate Cancer

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for prostate cancer. The list includes generic ...

  6. Trulance Approved for Chronic Constipation

    Science.gov (United States)

    ... news/fullstory_163171.html Trulance Approved for Chronic Constipation Drug designed to stimulate upper gastrointestinal tract To ... U.S. Food and Drug Administration to treat persistent constipation of unknown (idiopathic) cause in adults. Some 42 ...

  7. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In...

  8. 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

  9. 77 FR 8865 - Public Water System Supervision Program Approval for the State of Illinois; Tentative Approval

    Science.gov (United States)

    2012-02-15

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Illinois; Tentative Approval... State of Illinois submitted a primacy application for its approved Public Water System...

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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...

  15. 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...

  16. 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....

  17. 12 CFR 611.510 - Approval procedures.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Approval procedures. 611.510 Section 611.510 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM ORGANIZATION Transfer of Authorities § 611.510 Approval procedures. (a) Upon receipt of approval of a resolution by the Farm...

  18. 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,

  19. Nelfinavir: fourth protease inhibitor approved.

    Science.gov (United States)

    1997-01-01

    The Food and Drug Administration (FDA) has granted accelerated approval to nelfinavir in both adult and pediatric formulations. Agouron, the manufacturer, used innovative computerized drug design techniques to discover, design, and refine the nelfinavir molecule. Nelfinavir is marketed under the trade name Viracept, and costs $5,000 per year. Early clinical trials find it to be as powerful as the other protease inhibitors, but with a different resistance profile. The drug has relatively few drug indications; however, several compounds have been contraindicated.

  20. 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.

  1. OMB Recommended vs Approved Operating Budget

    Data.gov (United States)

    Montgomery County of Maryland — This dataset includes the Fiscal Year 2015 County Executive Recommended and County Council Approved operating budgets for Montgomery County, for comparison purposes....

  2. Marketing Approval of Ethical Kampo Medicines.

    Science.gov (United States)

    Hakamatsuka, Takashi

    2017-01-01

     Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

  3. 30 CFR 18.81 - Field modification of approved (permissible) equipment; application for approval of modification...

    Science.gov (United States)

    2010-07-01

    ... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Machines Assembled With Certified or Explosion-Proof Components, Field Modifications of Approved Machines... and Certification Center, 765 Technology Drive, Triadelphia, WV 26059. (b) Proposed...

  4. 14 CFR 21.325 - 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. 21.325... AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Export Airworthiness Approvals § 21.325 Export airworthiness approvals. (a) Kinds of approvals. (1) Export airworthiness approval of Class I products is...

  5. 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...

  6. Obinutuzumab breaks through to FDA approval.

    Science.gov (United States)

    2014-01-01

    The U.S. Food and Drug Administration approved the monoclonal antibody obinutuzumab for use with chlorambucil in patients with previously untreated chronic lymphocytic leukemia. The drug is the first to receive approval under the agency's breakthrough therapy designation, created in July 2012.

  7. 46 CFR 154.1005 - Equipment approval.

    Science.gov (United States)

    2010-10-01

    ... carried. (b) Each submerged cargo pump motor installation must be specially approved by the Commandant (CG... FOR SELF-PROPELLED VESSELS CARRYING BULK LIQUEFIED GASES Design, Construction and Equipment Electrical § 154.1005 Equipment approval. (a) Electrical equipment that is required to be intrinsically safe...

  8. 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...

  9. 38 CFR 21.7220 - Course approval.

    Science.gov (United States)

    2010-07-01

    ...; Pub. L. 98-525) (b) Course approval criteria. In administering benefits payable under 38 U.S.C.... (1) Section 21.4250 (except paragraph (c)(1))—Jurisdiction for course and licensing and certification... study; and (12) Section 21.4268—Approval of licensing and certification tests. (Authority: 38...

  10. 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.

  11. 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.

  12. 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.

  13. FDA Approves First Immunotherapy for Lymphoma

    Science.gov (United States)

    The FDA has approved nivolumab (Opdivo®) for the treatment of patients with classical Hodgkin lymphoma whose disease has relapsed or worsened after receiving an autologous hematopoietic stem cell transplantation followed by brentuximab vedotin (Adcetris®)

  14. 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 ...

  15. 30 CFR 7.409 - Approval marking.

    Science.gov (United States)

    2010-07-01

    ... approval number in addition to the number and size (gauge) of conductors and cable type. For cables containing electric conductors, the marking shall also include the voltage rating. For splices, the...

  16. Drugs Approved for Kidney (Renal Cell) Cancer

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural Media ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for kidney (renal cell) cancer. The list ...

  17. Drugs Approved for Soft Tissue Sarcoma

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural Media ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for soft tissue sarcoma. The list includes ...

  18. Drugs Approved for Non-Hodgkin Lymphoma

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural Media ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for non-Hodgkin lymphoma. The list includes ...

  19. 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.

  20. 36 CFR 28.15 - Approval of local zoning ordinances.

    Science.gov (United States)

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Approval of local zoning... INTERIOR FIRE ISLAND NATIONAL SEASHORE: ZONING STANDARDS Federal Standards and Approval of Local Ordinances § 28.15 Approval of local zoning ordinances. (a) The Secretary shall approve local ordinances...

  1. 30 CFR 35.9 - Certificates of approval.

    Science.gov (United States)

    2010-07-01

    ... APPROVAL OF MINING PRODUCTS FIRE-RESISTANT HYDRAULIC FLUIDS General Provisions § 35.9 Certificates of approval. (a) Upon completion of an investigation of a hydraulic fluid MSHA will issue to the applicant... notification of approval will be issued. If a certificate of approval is issued, no test data or...

  2. Natural rates of teacher approval and disapproval in the classroom.

    Science.gov (United States)

    White, M A

    1975-01-01

    Sixteen classroom observational studies were conducted to determine natural rates of teacher verbal approval and disapproval in the classroom. Rates of teacher verbal approval and disapproval were measured by the Teacher Approval and Disapproval Observation Record (TAD) over Grades 1 through 12. Teacher verbal approval rates dropped over grade, with a marked drop after second grade. In every grade after second, the rate of teacher verbal disapproval exceeded the rate of teacher verbal approval. These rates are interpreted in terms of reinforcement theory.

  3. [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)…

  4. High Falls generation station expansion approvals process

    Energy Technology Data Exchange (ETDEWEB)

    Litschko, C. [Lakeland Holding, Bracebridge, ON (Canada)

    2005-07-01

    Lakeland Holding Ltd. is the parent company for Lakeland Power Distribution Ltd., Bracebridge Generation Ltd., and Lakeland Energy Ltd. This PowerPoint presentation highlighted the High Falls generation expansion process. During construction of the High Falls plant, a concrete foundation was built beside the plant for future expansion. The expansion process involves building a 1,500 kilowatt generator to supply electricity to as many as 1600 households. The presentation described the context and background for the expansion and presented information on the water power generation plants. It presented site specifications as well as the approvals process by which final approval was granted in 2004. Observations and lessons learned from the approval process were identified. figs.

  5. 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…

  6. 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...

  7. 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…

  8. 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...

  9. 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 §...

  10. 7 CFR 322.4 - Approved regions.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Approved regions. 322.4 Section 322.4 Agriculture Regulations of the Department of Agriculture (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE BEES, BEEKEEPING BYPRODUCTS, AND BEEKEEPING EQUIPMENT Importation of...

  11. 7 CFR 1425.4 - Approval.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE LOANS, PURCHASES, AND OTHER OPERATIONS COOPERATIVE MARKETING ASSOCIATIONS § 1425.4 Approval. (a) For a cooperative to gain CMA status to participate in a marketing assistance loan or Loan deficiency... prepared in accordance with generally accepted accounting principles; (3) A copy of the articles...

  12. 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…

  13. 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…

  14. 7 CFR 3565.103 - Approval requirements.

    Science.gov (United States)

    2010-01-01

    ... lender must provide the Agency with an annual audited financial statement conducted in accordance with... reserves, to have an acceptable level of financial soundness as determined by a lender rating service (such... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM Lender Requirements § 3565.103 Approval requirements....

  15. Approval of Spouse in Middle Age.

    Science.gov (United States)

    Troll, Lillian E.

    A strongly positive opinion of spouse in middle age tends to be associated with social conformity and family integration. Mutually approving couples were more often politically moderate, homogamous in religious background, and had more interpersonal power than their children. They also had more highly integrated family structures with low conflict…

  16. 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...

  17. 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...

  18. 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…

  19. 28 CFR 549.51 - Approval procedures.

    Science.gov (United States)

    2010-07-01

    ... SERVICES Plastic Surgery § 549.51 Approval procedures. The Clinical Director shall consider individually any request from an inmate or a BOP medical consultant. (a) In circumstances where plastic surgery is... the Clinical Director recommends plastic surgery for the good order and security of the...

  20. 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...

  1. 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)....

  2. 7 CFR 52.53 - Approved identification.

    Science.gov (United States)

    2010-01-01

    ...) When graded against a U.S. grade standard, meet the quality requirements for U.S Grade C or better; (5) Meet applicable fill weight and/or drained weight, Brix or other characteristics of a commodity related... approved by USDA inspection service prior to use. (b) Inspection (Continuous) grade and inspection...

  3. 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.

  4. 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...

  5. 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...

  6. FDA Approves New Treatment for Dust Mite Allergies

    Science.gov (United States)

    ... page: https://medlineplus.gov/news/fullstory_163882.html FDA Approves New Treatment for Dust Mite Allergies Odactra ... life," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "The approval ...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 33 CFR 115.70 - Advance approval of bridges.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Advance approval of bridges. 115... BRIDGES BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE PROCEDURES § 115.70 Advance approval of bridges. (a) The General Bridge Act of 1946 requires the approval of the location and plans of bridges...

  12. 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....

  13. 76 FR 53526 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-26

    ... 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..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

  14. 76 FR 42159 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-07-18

    ... 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..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

  15. 27 CFR 24.26 - Authority to approve.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS WINE Administrative and Miscellaneous Provisions Authorities § 24.26 Authority to approve. The appropriate TTB officer is authorized to approve, except as otherwise provided in... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Authority to approve....

  16. 48 CFR 32.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Recommendation for... Recommendation for approval. If recommending approval, the contracting officer shall transmit the following... authorization (see 32.410). (g) The recommendation for approval of the advance payment request....

  17. 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...

  18. 29 CFR 4211.21 - Changes subject to PBGC approval.

    Science.gov (United States)

    2010-07-01

    ... method or modification to an allocation method that is not permitted under § 4211.12 if the method or... 29 Labor 9 2010-07-01 2010-07-01 false Changes subject to PBGC approval. 4211.21 Section 4211.21... Subject to PBGC Approval § 4211.21 Changes subject to PBGC approval. (a) General rule. Subject to...

  19. 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...

  20. 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...

  1. 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....

  2. 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...

  3. Sincere Voting with Cardinal Preferences: Approval Voting

    OpenAIRE

    Ballester, Miguel Angel; Rey-Biel, Pedro

    2007-01-01

    We discuss sincere voting when voters have cardinal preferences over alter- natives. We interpret sincerity as opposed to strategic voting, and thus define sincerity as the optimal behaviour when conditions to vote strategically vanish. When voting mechanisms allow for only one message type we show that this op- timal behaviour coincides with an intuitive and common definition of sincerity. For voting mechanisms allowing for multiple message types, such as approval vot- ing (AV), there exists...

  4. Thiazolidinediones: a comparative review of approved uses.

    Science.gov (United States)

    Sood, V; Colleran, K; Burge, M R

    2000-01-01

    Thiazolidinediones are a powerful and clinically important new class of oral antidiabetic agents that act by improving insulin sensitivity. Troglitazone is the prototype drug in this class but was withdrawn from the market in March 2000 due to its association with idiosyncratic hepatotoxicity. Currently two thiazolidinediones, rosiglitazone and pioglitazone, are U.S. Food and Drug Administration (FDA) approved for treatment of type 2 diabetes. These agents bind to and activate peroxisome proliferator-activator receptor gamma (PPAR-gamma) and work by altering the expression of genes involved in glucose uptake, glucose disposal, and lipid metabolism. The drugs differ in receptor binding and potency due to differences in their side chain moieties. These agents are rapidly absorbed from the gastrointestinal tract and are metabolized mainly in the liver. Rosiglitazone is FDA approved for monotherapy and for use in combination therapy with metformin or sulfonylureas. Pioglitazone is FDA approved for monotherapy as well as for use in combination therapy with metformin, insulin, or sulfonylureas. These drugs may also cause significant changes in plasma lipid concentrations, and improved insulin sensitivity may improve ovulatory function and fertility in women with polycystic ovary syndrome. The most serious side effect of the thiazolidinediones is hepatotoxicity. Although rosiglitazone and pioglitazone were not associated with hepatotoxicity in premarketing clinical trials, there were two recent case reports of idiosyncratic hepatotoxicity in patients treated with rosiglitazone. In addition, these agents may be associated with edema and some hematological changes. The purpose of this review is to provide an overview of the two currently approved thiazolidinediones and to suggest an approach for their safe and rational use.

  5. 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.

  6. 21 CFR 814.118 - Denial of approval or withdrawal of approval of an HDE.

    Science.gov (United States)

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use...; (7) Any clinical investigation involving human subjects described in the HDE, subject to the institutional review board regulations in part 56 of this chapter or the informed consent regulations in part...

  7. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.

    Science.gov (United States)

    Yang, Brian W; Iorio, Matthew L; Day, Charles S

    2017-03-15

    The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.

  8. 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...

  9. 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

  10. 10 CFR 25.8 - Information collection requirements: OMB approval.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 25.8 Section 25.8 Energy NUCLEAR REGULATORY COMMISSION ACCESS AUTHORIZATION General Provisions § 25.8...), 25.21(c), 25.27(b), 25.29, and 25.31, SF-86 is approved under control number 3206-0007. (3) In §...

  11. Drugs Approved for Wilms Tumor and Other Childhood Kidney Cancers

    Science.gov (United States)

    ... Quiz Cancers by Body Location/System Childhood Cancers Late Effects of Childhood Cancer Treatment Pediatric Supportive Care Unusual Cancers of ... Research Drugs Approved for Wilms Tumor and Other Childhood Kidney Cancers ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and ...

  12. 32 CFR 644.135 - Lease authorization and approvals.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Lease authorization and approvals. 644.135... PROPERTY REAL ESTATE HANDBOOK Acquisition Acquisition by Leasing § 644.135 Lease authorization and approvals. (a) Title 10 Reports. Under the provisions of 10 U.S.C. 2662, a lease proposal or renewal with...

  13. 49 CFR 107.403 - Designation of approval agencies.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Designation of approval agencies. 107.403 Section 107.403 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS... MATERIALS PROGRAM PROCEDURES Designation of Approval and Certification Agencies § 107.403 Designation...

  14. 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)...

  15. 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...

  16. 7 CFR 319.37-9 - Approved packing material.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Approved packing material. 319.37-9 Section 319.37-9..., and Other Plant Products 1,2 § 319.37-9 Approved packing material. Any restricted article at the time of importation or offer for importation into the United States shall not be packed in a...

  17. 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…

  18. 13 CFR 302.18 - Post-approval requirements.

    Science.gov (United States)

    2010-01-01

    ... GENERAL TERMS AND CONDITIONS FOR INVESTMENT ASSISTANCE § 302.18 Post-approval requirements. (a) General. A... the terms and conditions of the Investment Assistance, including any special terms and applicable Federal cost principles (collectively, “Post-Approval Requirements”). A Recipient's failure to comply...

  19. 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...

  20. 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

  1. 78 FR 37848 - ASME Code Cases Not Approved for Use

    Science.gov (United States)

    2013-06-24

    ... COMMISSION ASME Code Cases Not Approved for Use AGENCY: Nuclear Regulatory Commission. ACTION: Draft... public comment draft regulatory guide (DG), DG-1233, ``ASME Code Cases not Approved for Use.'' This regulatory guide lists the American Society of Mechanical Engineers (ASME) Code Cases that the NRC...

  2. 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...

  3. 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...

  4. 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...

  5. 76 FR 66117 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-10-25

    ... 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..., described below, receiving approval for the consumptive use of water pursuant to the Commission's...

  6. 77 FR 4859 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-01-31

    ... 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..., described below, receiving approval for the consumptive use of water pursuant to the Commission's...

  7. 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...

  8. 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...

  9. 77 FR 59239 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-26

    ... 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...

  10. 77 FR 25010 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-26

    ... 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...

  11. 77 FR 21143 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-09

    ... 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...

  12. 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....

  13. 48 CFR 232.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Recommendation for approval. 232.409-1 Section 232.409-1 Federal Acquisition Regulations System DEFENSE ACQUISITION... for Non-Commercial Items 232.409-1 Recommendation for approval. Follow the procedures at PGI...

  14. 48 CFR 332.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Recommendation for approval. 332.409-1 Section 332.409-1 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Recommendation for approval. The Contracting Officer shall transmit the information in FAR 32.409-1 (or FAR...

  15. Additional safety risk to exceptionally approved drugs in Europe?

    NARCIS (Netherlands)

    Arnardottir, Arna H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; Eichler, Hans-Georg; de Graeff, Pieter A.; Mol, Peter G. M.

    2011-01-01

    AIMS Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear 'unmet medical need'. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of

  16. 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...

  17. For the approval process of GMOs: The Japanese case

    NARCIS (Netherlands)

    Ebata, A.; Punt, M.J.; Wesseler, J.H.H.

    2013-01-01

    This article reviews the approval process of genetically modified organisms (GMOs) in Japan. The purpose of this review is to explain the Japanese safety approval procedures for food, feed, and imported GMOs and place it in an international context through a comparison with the United States and the

  18. 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...

  19. Establishment approval in international trade of animal products

    NARCIS (Netherlands)

    Rau, M.L.; Ge, L.; Valeeva, N.I.; Wagenberg, van C.P.A.

    2012-01-01

    This report provides an overview of different approaches of establishment approval as well as its implementation and organisation in international agrifood trade. The focus is on animal products as establishment approval is particularly used for exporting these products. Based on trade data, 8 count

  20. 27 CFR 27.206 - Bottles not constituting approved containers.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Bottles not constituting approved containers. 27.206 Section 27.206 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX... officer that such bottle is not an approved container for distilled spirits for consumption in the...

  1. 28 CFR 512.17 - Monitoring approved research projects.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Monitoring approved research projects. 512.17 Section 512.17 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.17 Monitoring approved research projects. The...

  2. 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...

  3. 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...

  4. 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.

  5. 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...

  6. 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...

  7. 30 CFR 75.600-1 - Approved cables; flame resistance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved cables; flame resistance. 75.600-1 Section 75.600-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE... cables; flame resistance. Cables shall be accepted or approved by MSHA as flame resistant....

  8. 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...

  9. HyApproval - Handbook for the approval of hydrogen refuelling stations - First preliminary achievements

    Energy Technology Data Exchange (ETDEWEB)

    Wurster, R.; Vandendungen, G.; Guichard, J.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.; Landinger, H.

    2007-05-15

    The EU-funded project HyApproval [www.hyapproval.org] aims at developing a universal Handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe. The main goal of the HyApproval partnership with 22 partners from Europe and one each from China, Japan and the USA is to provide a Handbook of technical and regulatory requirements to assist authorisation officials, companies and organisations in the safe implementation and operation of HRS. Achievements during the first 15 months: analyses of HRS technology concepts and of equipment and safety distances/ Intermediate Design Paper/ Regulations, Codes and Standards (RCS) review and comparison/ first Handbook draft and first review sessions with HySafe experts/ safety matrix/ identification of accident scenarios/ agreement on safety documentation/ critical review of reliability data from collections and risk studies/ risk assessment (RA) criteria definition and RA/ matrix of acceptability and awareness levels/ database of Fire Associations and First Responders/ calendar of hydrogen events/ general description of CGH{sub 2} interfaces. (au)

  10. 77 FR 13294 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure...

    Science.gov (United States)

    2012-03-06

    ... National Institute of Standards and Technology Announcing Approval of Federal Information Processing... announces the Secretary of Commerce's approval of Federal Information Processing Standard (FIPS) Publication... announces the Secretary of Commerce's approval of Federal Information Processing Standard (FIPS)...

  11. 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

  12. 75 FR 39619 - Proposed Information Collection (Quarterly Report of State Approving Agency) Activities Activity...

    Science.gov (United States)

    2010-07-09

    ... expenses incurred in the approval and supervision of education and training programs. DATES: Written... collection. Abstract: VA reimburses SAAs for expenses incurred in the approval and supervision of...

  13. 75 FR 13337 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2010-03-19

    .... Security improvements. Snow equipment purchase--liquid deice truck. Brief Description of Project Approved... annual enplanements at Dallas Love Field. Brief Description of Projects Approved for Collection and...

  14. Phage approved in food, why not as a therapeutic?

    Science.gov (United States)

    Sarhan, Wessam A; Azzazy, Hassan M E

    2015-01-01

    Bacterial resistance is not only restricted to human infections but is also a major problem in food. With the marked decrease in produced antimicrobials, the world is now reassessing bacteriophages. In 2006, ListShield™ received the US FDA approval for using phage in food. Nevertheless, regulatory approval of phage-based therapeutics is still facing many challenges. This review highlights the use of bacteriophages as biocontrol agents in the food industry. It also focuses on the challenges still facing the regulatory approval of phage-based therapeutics and the proposed approaches to overcome such challenges.

  15. 24 CFR 990.145 - Dwelling units with approved vacancies.

    Science.gov (United States)

    2010-04-01

    ... and anti-crime initiatives. (b) On a project-by-project basis, subject to prior HUD approval and for... resulting from project modernization or unit modernization (such as work necessary to reoccupy vacant...

  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, the...

  17. 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...

  18. 40 CFR 35.940-3 - Costs allowable, if approved.

    Science.gov (United States)

    2010-07-01

    ... of compost residues which result from wastewater treatment, if EPA has approved a program for use of the compost. (d) Acquisition of an operable portion of a treatment works. This type of acquisition...

  19. 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),...

  20. 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...

  1. 75 FR 60617 - Review and Approval of Projects

    Science.gov (United States)

    2010-10-01

    ... fracking water. Also, people farther than a half mile may experience impacts to their water, air, and soil... fracking activity. Response: The Commission can find no evidence linking its approval of water...

  2. 34 CFR 668.144 - Application for test approval.

    Science.gov (United States)

    2010-07-01

    ... distribution of test scores for each edition, form, level, sub-test, or partial battery, for which approval is....147; (5) Documentation of test development, including a history of the test's use; (6) Norming...

  3. The Facts on Bipolar Disorder and FDA-Approved Treatments

    Science.gov (United States)

    ... Home For Consumers Consumer Updates The Facts on Bipolar Disorder and FDA-Approved Treatments Share Tweet Linkedin ... to top What to Do if You Suspect Bipolar Disorder If you suspect you have a bipolar ...

  4. 78 FR 59711 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-09-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE INTERIOR Bureau of Land Management Renewal of Approved Information Collection AGENCY: Bureau of Land Management... Management, Information Collection Clearance Officer. BILLING CODE 4310-84-P...

  5. 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 ...

  6. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

    ...: Kupetsky, ABR-201211010, Nicholson Township, Wyoming County, Pa.; Consumptive Use of Up to 7.500 mgd..., Nicholson Township, Wyoming County, Pa.; Consumptive Use of Up to 3.575 mgd; Approval Date: November...

  7. Approval times and the safety of new pharmaceuticals.

    Science.gov (United States)

    Rudholm, Niklas

    2004-12-01

    This study examined the relationship between the approval times for new pharmaceuticals and the number of adverse drug reactions reported to the Swedish Medical Products Agency. Yearly time-series data concerning the number of adverse drug reactions, as well as data concerning prices and quantities sold for 25 pharmaceutical substances during the period 1972-1996 were used. The results show that shorter approval times are associated with more adverse drug reactions, but also that the effects are quite small.

  8. Adapting drug approval pathways for bacteriophage-based therapeutics

    Directory of Open Access Journals (Sweden)

    Callum Cooper

    2016-08-01

    Full Text Available 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.

  9. 7 CFR 1427.1086 - Approval of warehouse, requests for reconsideration.

    Science.gov (United States)

    2010-01-01

    ... 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 warehouse, requests for reconsideration. (a) CCC will approve a warehouse if it determines that the warehouse...

  10. 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...

  11. 21 CFR 314.153 - Suspension of approval of an abbreviated new drug application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Suspension of approval of an abbreviated new drug... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... new drug application. (a) Suspension of approval. The approval of an abbreviated new drug...

  12. 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...

  13. 77 FR 21453 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to New Source...

    Science.gov (United States)

    2012-04-10

    ... and 2.. notice. A-I.B.10 D-II.A.5 Baseline Area Yes 51.166(b)(15)..... Approved by Fully approved... D-VIII Area Yes, with the 51.166(e)......... Approved by Fully approved * * Classifications... modified sources impacting attainment and non-attainment areas in the State. This action is being...

  14. 42 CFR 84.36 - Delivery of changed or modified approved respirator.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Delivery of changed or modified approved respirator... Approval and Disapproval § 84.36 Delivery of changed or modified approved respirator. An approved respirator for which a formal certificate of modification has been issued shall be delivered, with...

  15. 75 FR 65551 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2010-10-25

    ... Authority, Wichita, Kansas. Application Number: 10-07-C-00-ICT. Application Type: Impose and use a PFC. PFC... Disapprovals. In September 2010, there were four applications approved. This notice also includes information on seven applications, one approved in May 2009, two approved in July 2010, and four approved...

  16. Discrimination of approved drugs from experimental drugs by learning methods

    Directory of Open Access Journals (Sweden)

    Li Yixue

    2011-05-01

    Full Text Available Abstract Background To assess whether a compound is druglike or not as early as possible is always critical in drug discovery process. There have been many efforts made to create sets of 'rules' or 'filters' which, it is hoped, will help chemists to identify 'drug-like' molecules from 'non-drug' molecules. However, among the chemical space of the druglike molecules, the minority will be approved drugs. Classifying approved drugs from experimental drugs may be more helpful to obtain future approved drugs. Therefore, discrimination of approved drugs from experimental ones has been done in this paper by analyzing the compounds in terms of existing drugs features and machine learning methods. Results Four methodologies were compared by their performance to classify approved drugs from experimental ones. The best results were obtained by SVM, in which the accuracy is 0.7911, the sensitivity is 0.5929, and the specificity is 0.8743. Based on the results, consensus model was developed to effectively discriminate drugs, which further pushed the correct classification rate up to 0.8517, sensitivity up to 0.7242, specificity up to 0.9352. The applications on the Traditional Chinese Medicine Ingredients Database (TCM-ID tested the methods. Therefore this model has been proven to be a potent tool for identifying drug molecules. Conclusion The studies would have potential applications in the research of combinatorial library design and virtual high throughput screening for drug discovery.

  17. Reporting ethics committee approval in public administration research.

    Science.gov (United States)

    Jordan, Sara R; Gray, Phillip W

    2014-03-01

    While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.

  18. 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

  19. Duchenne muscular dystrophy drugs face tough path to approval.

    Science.gov (United States)

    Hodgkinson, L; Sorbera, L; Graul, A I

    2016-03-01

    Highly anticipated as new disease-modifying treatments for Duchenne muscular dystrophy (DMD), therapeutics by BioMarin Pharmaceutical (Kyndrisa™; drisapersen) and Sarepta Therapeutics (eteplirsen; AVI-4658) both recently received negative FDA reviews and are now facing battles for approval in the U.S. At present, BioMarin is committed to working with the FDA to forge a pathway to approval following the failure of its NDA, while Sarepta awaits the formal decision on its NDA, which is expected by late May 2016. Despite the critical nature of both reviews, analysts consider that there is still a narrow possibility of approval of both drugs. According to Consensus forecasts from Thomson Reuters Cortellis for Competitive Intelligence, Kyndrisa is forecast to achieve sales of USD 533.71 million in 2021.

  20. Need for Approval and Children's Well-Being

    OpenAIRE

    Rudolph, Karen D.; Caldwell, Melissa S.; CONLEY, COLLEEN S.

    2005-01-01

    This research examined the hypothesis that a tendency to base one's self-worth on peer approval is associated with positive and negative aspects of children's well-being. 153 4th - 8th graders (9.0 to 14.8 years) reported on need for approval (NFA), global self-worth, social-evaluative concerns, anxiety and depression, and exposure to victimization. Teachers reported on social behavior. Results confirmed that NFA is a two-dimensional construct composed of positive (enhanced self-worth in the ...

  1. 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).

  2. 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

  3. 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...

  4. FDA-approved small-molecule kinase inhibitors

    DEFF Research Database (Denmark)

    Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig

    2015-01-01

    Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...

  5. [Lake Mason and Soo Line Marsh project design approval

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This letter is the approval from the U.S. Fish and Wildlife Service of the designs created by Ducks Unlimited, Inc. for the Lake Mason and Soo Line Marsh National...

  6. Approval and Disapproval of Textbooks in the Late Ottoman Empire

    Science.gov (United States)

    Açikgöz, Betül

    2017-01-01

    During the rapidly changing political atmosphere of the 1910s, the practice of sanctioning scholastic knowledge began to be implemented in the yearly selection of textbooks due to political contingencies. The study shows the procedures of approval and disapproval practised by the Grand Council of Education and the Copyright and Translation Office…

  7. 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...

  8. 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...

  9. 42 CFR 403.318 - Approval of State systems.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Approval of State systems. 403.318 Section 403.318 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS SPECIAL PROGRAMS AND PROJECTS Recognition of State Reimbursement Control Systems §...

  10. 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...

  11. 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.

  12. 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....

  13. 14 CFR 21.500 - Approval of engines and propellers.

    Science.gov (United States)

    2010-01-01

    ... AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Approval of Engines, Propellers, Materials, Parts.... type certificate for an aircraft engine or propeller manufactured in a foreign country with which the... with each such aircraft engine or propeller imported into this country, a certificate of...

  14. Endoscopy: consensus on approving propofol sedation by nonanesthesiologists.

    Science.gov (United States)

    Riphaus, Andrea

    2010-04-01

    Propofol sedation by nonanesthesiologists is still a highly controversial issue despite the fact that numerous studies have approved this sedation regimen for gastrointestinal endoscopy. A new position statement from a collaboration of four different American gastroenterology and hepatology societies outlines the latest recommendations for nonanesthesiologist administration of propofol.

  15. Biosimilar agents in oncology/haematology: from approval to practice

    Science.gov (United States)

    Niederwieser, Dietger; Schmitz, Stephan

    2011-01-01

    The regulation of biosimilars is a process that is still developing. In Europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. It is now more than 3 years since the first biosimilar agents in oncology support, erythropoiesis-stimulating agents, were approved in the EU. More recently, biosimilar granulocyte colony-stimulating factors have received marketing approval in Europe. This review considers general issues surrounding the introduction of biosimilars and highlights current specific issues pertinent to their use in clinical practice in oncology. Information on marketing approval, extrapolation, labelling, substitution, immunogenicity and traceability of each biosimilar product is important, especially in oncology where patients are treated in repeated therapy courses, often with complicated protocols, and where biosimilars are not used as a unique therapy for replacement of e.g. growth hormone or insulin. While future developments in the regulation of biosimilars will need to address multiple issues, in the interim physicians should remain aware of the inherent differences between biosimilar and innovator products. PMID:21175852

  16. 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...

  17. 33 CFR 157.12g - Plan approval requirements.

    Science.gov (United States)

    2010-07-01

    ... things, the location and mounting of components, arrangements for maintaining the integrity of the... manufacturer's specific installation criteria. (g) A copy of the certificate of type approval for the oil... system and confirming the installation reflects the manufacturer's specific installation criteria....

  18. 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.

  19. 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. |

  20. 21 CFR 314.125 - Refusal to approve an application.

    Science.gov (United States)

    2010-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... study that is described in the application and that is essential to show that the drug is safe for use... adequately protected. (17) The applicant or contract research organization that conducted a...

  1. 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... Muscat Grand Noir Green Hungarian Grenache Grignolino Grillo Gros Verdot Helena Herbemont Higgins...

  2. 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...

  3. FDA Approvals of Brand-Name Prescription Drugs in 2015.

    Science.gov (United States)

    2016-03-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products.

  4. 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)...

  5. Biosimilar agents in oncology/haematology: from approval to practice.

    Science.gov (United States)

    Niederwieser, Dietger; Schmitz, Stephan

    2011-04-01

    The regulation of biosimilars is a process that is still developing. In Europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. It is now more than 3 years since the first biosimilar agents in oncology support, erythropoiesis-stimulating agents, were approved in the EU. More recently, biosimilar granulocyte colony-stimulating factors have received marketing approval in Europe. This review considers general issues surrounding the introduction of biosimilars and highlights current specific issues pertinent to their use in clinical practice in oncology. Information on marketing approval, extrapolation, labelling, substitution, immunogenicity and traceability of each biosimilar product is important, especially in oncology where patients are treated in repeated therapy courses, often with complicated protocols, and where biosimilars are not used as a unique therapy for replacement of e.g. growth hormone or insulin. While future developments in the regulation of biosimilars will need to address multiple issues, in the interim physicians should remain aware of the inherent differences between biosimilar and innovator products.

  6. 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...

  7. 19 CFR 134.45 - Approved markings of country name.

    Science.gov (United States)

    2010-04-01

    ... OF THE TREASURY COUNTRY OF ORIGIN MARKING Method and Location of Marking Imported Articles § 134.45 Approved markings of country name. (a) Language. (1) Except as otherwise provided in paragraph (a)(2) of this section, the markings required by this part shall include the full English name of the country...

  8. 46 CFR 160.077-6 - Approval procedures.

    Science.gov (United States)

    2010-10-01

    ... PFD of sufficiently similar design. (2) Engineering analysis showing that the test is not applicable...) Alternative Requirements. A PFD that does not meet requirements in this subpart may still be approved if the device— (1) Meets other requirements prescribed by the Commandant in place of or in addition...

  9. 30 CFR 75.700-1 - Approved methods of grounding.

    Science.gov (United States)

    2010-07-01

    ... conductors are a part of the system will be approved if a solid connection is made to the neutral conductor... low resistance to earth; (c) A solid connection to a grounding conductor, other than the neutral conductor of a resistance grounded system, extending to a low resistance ground field located on the...

  10. 30 CFR 77.700-1 - Approved methods of grounding.

    Science.gov (United States)

    2010-07-01

    ... in resistance grounded systems, where the enclosed conductors are a part of the system, will be approved if a solid connection is made to the neutral conductor; in all other systems, the following... earth; (b) A solid connection to a grounding conductor, other than the neutral conductor of a...

  11. 44 CFR 78.6 - Flood Mitigation Plan approval process.

    Science.gov (United States)

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Flood Mitigation Plan..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all...

  12. Psychodiagnostic Testing in APA-Approved Clinical Psychology Programs.

    Science.gov (United States)

    Piotrowski, Chris; Keller, John W.

    The utility and popularity of psychodiagnostic testing has been investigated in applied clinical settings, but little data exist concerning academicians' attitudes toward psychological testing. To assess attitudes toward psychodiagnostic training in doctoral, clinical psychology programs, all fully APA-approved (American Psychological Association)…

  13. 9 CFR 355.34 - Labels, approval of, by Administrator.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labels, approval of, by Administrator. 355.34 Section 355.34 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... be a complete reproduction of the label as it will appear on the package, including any color...

  14. 77 FR 15367 - Public Water System Supervision Program Approval for the State of Minnesota

    Science.gov (United States)

    2012-03-15

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Minnesota AGENCY: Environmental... of Minnesota is revising its approved public water system supervision program for four major...

  15. 77 FR 21099 - Public Water System Supervision Program Approval for the State of Ohio

    Science.gov (United States)

    2012-04-09

    ... AGENCY Public Water System Supervision Program Approval for the State of Ohio AGENCY: Environmental... has tentatively approved three revisions to the State of Ohio's public water system supervision... of Ohio's public water system supervision program, thereby giving Ohio EPA primary...

  16. 78 FR 18336 - Public Water System Supervision Program Approval for the State of Michigan

    Science.gov (United States)

    2013-03-26

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Michigan AGENCY: Environmental... has tentatively approved five revisions to the State of Michigan's public water system...

  17. 77 FR 76034 - Public Water System Supervision Program Approval for the State of Ohio

    Science.gov (United States)

    2012-12-26

    ... AGENCY Public Water System Supervision Program Approval for the State of Ohio AGENCY: Environmental... has tentatively approved revisions to the State of Ohio's public water system supervision program... public water system supervision program, thereby giving Ohio EPA primary enforcement responsibility...

  18. 78 FR 14791 - Public Water System Supervision Program Approval for the State of Indiana

    Science.gov (United States)

    2013-03-07

    ... AGENCY Public Water System Supervision Program Approval for the State of Indiana AGENCY: Environmental... has tentatively approved three revisions to the State of Indiana's public water system supervision... the State of Indiana's public water system supervision program, thereby giving IDEM...

  19. 75 FR 80493 - Public Water System Supervision Program Approval for the State of Wisconsin

    Science.gov (United States)

    2010-12-22

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Wisconsin AGENCY: Environmental... of Wisconsin submitted a primacy application for its approved Public Water System Supervision...

  20. 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.

  1. 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...

  2. 77 FR 6535 - Notice of Intent To Seek Approval To Collect Information

    Science.gov (United States)

    2012-02-08

    ... National Agricultural Library Notice of Intent To Seek Approval To Collect Information AGENCY: National... extend currently approved data collection form. Abstract: This Web-based form collects information to.... Information collected includes the following: Preference of workshop date, signature, name,...

  3. 76 FR 70807 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-11-15

    ... emergency radio dispatch system is used for both eligible (aircraft rescue and firefighting and aviation... Federal Aviation Administration Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Monthly notice of PFC approvals...

  4. 45 CFR 1801.31 - Approval of graduate programs by the Foundation.

    Science.gov (United States)

    2010-10-01

    ... approval. The graduate program proposed for approval may differ from that proposed by the Scholar when... statement of interest in a career in public service that specifies in detail how their graduate program...

  5. 75 FR 71177 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-11-22

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin... notice lists the projects, described ] below, receiving approval for the consumptive use of...

  6. 77 FR 24441 - Approval and Promulgation of Implementation Plans; California; Revisions to the California State...

    Science.gov (United States)

    2012-04-24

    ... Ninth Circuit Court of Appeals of EPA's 2009 approval of a revision to the California SIP related to..., the 9th Circuit Court of Appeals remanded the approval of PEST-1 to EPA with the instructions...

  7. 78 FR 56225 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Soil...

    Science.gov (United States)

    2013-09-12

    ... 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 Risk... measures necessary for reregistration eligibility for certain soil fumigant chemicals are...

  8. 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....

  9. 75 FR 32355 - Notice of Request for Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2010-06-08

    ... Agricultural Marketing Service Notice of Request for Revision of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request for comments. SUMMARY: In... Agricultural Marketing Service's (AMS) intention to request for revision of a currently approved...

  10. 78 FR 54232 - Notice of Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2013-09-03

    ...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service Notice of Request for Extension of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request... that the Agricultural Marketing Service (AMS) is requesting approval from the Office of Management...

  11. 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...

  12. 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...

  13. Results of Shipboard Approval Tests of Ballast Water Treatment Systems in Freshwater

    Science.gov (United States)

    2014-11-01

    Results of Shipboard Approval Tests of Ballast Water Treatment Systems in Freshwater Distribution Statement A: Approved for public release...distribution is unlimited. November 2014 Report No. CG-D-05-15 Results of Shipboard Approval Tests of BWT Systems in Freshwater ii...London, CT 06320 Results of Shipboard Approval Tests of BWT Systems in Freshwater iii UNCLAS//Public | CG-926 R&DC | Cangelosi, et al

  14. 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...

  15. 14 CFR 61.4 - Qualification and approval of flight simulators and flight training devices.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Qualification and approval of flight... GROUND INSTRUCTORS General § 61.4 Qualification and approval of flight simulators and flight training..., testing, or checking requirement under this chapter, must be qualified and approved by the...

  16. 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...

  17. 42 CFR 403.222 - State with an approved regulatory program.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false State with an approved regulatory program. 403.222 Section 403.222 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... Programs § 403.222 State with an approved regulatory program. (a) A State has an approved...

  18. 42 CFR 403.308 - State systems under demonstration projects-mandatory approval.

    Science.gov (United States)

    2010-10-01

    ...-mandatory approval. 403.308 Section 403.308 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... Reimbursement Control Systems § 403.308 State systems under demonstration projects—mandatory approval. CMS will... approval of a State system are met under § 403.304 (b)(1)-(10) and § 403.304(c), and, if appropriate §...

  19. 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...

  20. 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...

  1. 7 CFR 330.210a - Administrative instructions listing approved packing materials for plant pests.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Administrative instructions listing approved packing... Pests § 330.210a Administrative instructions listing approved packing materials for plant pests. (a) The following materials are approved as packing materials for use with any shipment of plant pests in...

  2. 76 FR 61999 - Policy Statement: Inappropriate Design Approval Holder (DAH) Restrictions on the Use and...

    Science.gov (United States)

    2011-10-06

    ... Federal Aviation Administration 14 CFR Part 21 Policy Statement: Inappropriate Design Approval Holder (DAH... the proposed policy statement addressing the action taken by some Design Approval Holders (DAH...(b) requires the holder of a design approval to furnish at least one set of complete Instructions...

  3. 43 CFR 45.74 - Has OMB approved the information collection provisions of this subpart?

    Science.gov (United States)

    2010-10-01

    ... OMB approved the information collection provisions of this subpart? Yes. This rule contains provisions that would collect information from the public. It therefore requires approval by the Office of... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Has OMB approved the...

  4. 13 CFR 302.8 - Pre-approval Investment Assistance costs.

    Science.gov (United States)

    2010-01-01

    ..., DEPARTMENT OF COMMERCE GENERAL TERMS AND CONDITIONS FOR INVESTMENT ASSISTANCE § 302.8 Pre-approval Investment Assistance costs. Project activities carried out before approval of Investment Assistance shall be carried... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Pre-approval Investment...

  5. 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…

  6. 34 CFR 668.143 - Approval of State tests or assessments.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false Approval of State tests or assessments. 668.143 Section... or assessments. (a) The Secretary approves tests or other assessments submitted by a State that the... assessment described in paragraph (a) of this section. (c) If the Secretary approves a State's tests...

  7. 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...

  8. 78 FR 57903 - Notice of Intent To Seek Approval To Renew an Information Collection

    Science.gov (United States)

    2013-09-20

    ... From the Federal Register Online via the Government Publishing Office NATIONAL SCIENCE FOUNDATION Notice of Intent To Seek Approval To Renew an Information Collection AGENCY: National Science Foundation.... Expiration Date of Approval: June 30, 2014. Type of Request: Intent to seek approval to renew an...

  9. 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...

  10. 14 CFR 414.31 - Monitoring compliance with the terms and conditions of a safety approval.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Monitoring compliance with the terms and conditions of a safety approval. 414.31 Section 414.31 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety Approval Review and Issuance §...

  11. 21 CFR 900.3 - Application for approval as an accreditation body.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Application for approval as an accreditation body... approval as an accreditation body. (a) Eligibility. Private nonprofit organizations or State agencies capable of meeting the requirements of this subpart A may apply for approval as accreditation bodies....

  12. 75 FR 71135 - Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug Application

    Science.gov (United States)

    2010-11-22

    ... HUMAN SERVICES Food and Drug Administration Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug... Administration (FDA) is withdrawing approval of a new drug application (NDA) for ACCUTANE (isotretinoin) Capsules... be marketed under approved abbreviated new drug applications (ANDAs). The holders of ANDAs...

  13. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Refusal to approve an abbreviated new drug... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.127 Refusal to approve an abbreviated new...

  14. 14 CFR 21.333 - Issue of export airworthiness approval tags for Class III products.

    Science.gov (United States)

    2010-01-01

    ... for Class III products. 21.333 Section 21.333 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... Approvals § 21.333 Issue of export airworthiness approval tags for Class III products. (a) An applicant is entitled to an export airworthiness approval tag for Class III products if that applicant shows, except...

  15. 42 CFR 422.256 - Review, negotiation, and approval of bids.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Review, negotiation, and approval of bids. 422.256... Information and Plan Approval § 422.256 Review, negotiation, and approval of bids. (a) Authority. Subject to... submitted under § 422.252 and conduct negotiations with MA organizations regarding these bids (including...

  16. 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... system control equipment. If a borrower's mortgage or loan contract requires the borrower to obtain approval from RUS before purchasing data processing equipment or system control equipment, such approval...

  17. 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...

  18. 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 §...

  19. 26 CFR 1.422-3 - Stockholder approval of incentive stock option plans.

    Science.gov (United States)

    2010-04-01

    ... 26 Internal Revenue 5 2010-04-01 2010-04-01 false Stockholder approval of incentive stock option... incentive stock option plans. This section addresses the stockholder approval of incentive stock option... such cases an incentive stock option plan must be approved: (a) By a majority of the votes cast at...

  20. 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...

  1. 30 CFR 72.710 - Selection, fit, use, and maintenance of approved respirators.

    Science.gov (United States)

    2010-07-01

    ... approved respirators. 72.710 Section 72.710 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... Selection, fit, use, and maintenance of approved respirators. In order to ensure the maximum amount of respiratory protection, approved respirators shall be selected, fitted, used, and maintained in...

  2. 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...

  3. 78 FR 57407 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Science.gov (United States)

    2013-09-18

    ... SECURITY U.S. Customs and Border Protection Approval of Altol Petroleum Product Service, as a Commercial... approval of Altol Petroleum Product Service, as a commercial gauger. SUMMARY: Notice is hereby given, pursuant to CBP regulations, that Altol Petroleum Product Service, has been approved to gauge...

  4. 78 FR 57406 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Science.gov (United States)

    2013-09-18

    ... SECURITY U.S. Customs and Border Protection Approval of Altol Petroleum Product Service, as a Commercial... approval of Altol Petroleum Product Service, as a commercial gauger. SUMMARY: Notice is hereby given, pursuant to CBP regulations, that Altol ] Petroleum Product Service, has been approved to gauge...

  5. 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...

  6. 78 FR 70566 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

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

  7. 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...

  8. 42 CFR 410.142 - CMS process for approving national accreditation organizations.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false CMS process for approving national accreditation... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving national accreditation organizations. (a) General rule. CMS may approve and recognize a nonprofit or...

  9. 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.

  10. 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.

  11. Implications of Recent Drug Approvals for Older Adults

    Science.gov (United States)

    Eisenhower, Christine; Koronkowski, Michael; Marcum, Zachary

    2016-01-01

    More than 100 medications were approved by the US Food and Drug Administration as new drugs or for new indications in 2014 and 2015. Several of the new drugs may benefit older adults, but adverse events and pharmacokinetic changes due to aging must be considered. This article will focus on three recently approved drugs that are marketed for chronic conditions that can affect older adults: suvorexant, for treatment of insomnia; edoxaban, for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for treatment of venous thromboembolism; and droxidopa, for treatment of symptomatic neurogenic orthostatic hypotension. Information about indications, mechanisms of action, dosing, efficacy, and safety are reviewed. The place of each agent in therapy for older adults is also discussed. PMID:27340374

  12. French approval procedures for pyrotechnical automotive safety equipments

    OpenAIRE

    Aufauvre, Lionel; Branka, Ruddy

    2005-01-01

    International audience; Pyrotechnical articles for civil uses may be subject to national procedures before placing on the market According to the French decree n°90-153, 16 February 1990 as modified; explosives that are dispensed with EC marking and that are not excluded of the decree application have to conform to approved types. Pyrotechnical automotive safety equipments such gas generators for airbag modules or seat-belt pretensioners, pyrotechnie relay compositions and/or igniters inside ...

  13. Approved but non-funded vaccines: accessing individual protection.

    Science.gov (United States)

    Scheifele, David W; Ward, Brian J; Halperin, Scott A; McNeil, Shelly A; Crowcroft, Natasha S; Bjornson, Gordean

    2014-02-07

    Funded immunization programs are best able to achieve high participation rates, optimal protection of the target population, and indirect protection of others. However, in many countries public funding of approved vaccines can be substantially delayed, limited to a portion of the at-risk population or denied altogether. In these situations, unfunded vaccines are often inaccessible to individuals at risk, allowing potentially avoidable morbidity and mortality to continue to occur. We contend that private access to approved but unfunded vaccines should be reconsidered and encouraged, with recognition that individuals have a prerogative to take advantage of a vaccine of potential benefit to them whether it is publicly funded or not. Moreover, numbers of "approved but unfunded" vaccines are likely to grow because governments will not be able to fund all future vaccines of potential benefit to some citizens. New strategies are needed to better use unfunded vaccines even though the net benefits will fall short of those of funded programs. Canada, after recent delays funding several new vaccine programs, has developed means to encourage private vaccine use. Physicians are required to inform relevant patients about risks and benefits of all recommended vaccines, publicly funded or not. Likewise, some provincial public health departments now recommend and promote both funded and unfunded vaccines. Pharmacists are key players in making unfunded vaccines locally available. Professional organizations are contributing to public and provider education about unfunded vaccines (e.g. herpes zoster, not funded in any province). Vaccine companies are gaining expertise with direct-to-consumer advertising. However, major challenges remain, such as making unfunded vaccines more available to low-income families and overcoming public expectations that all vaccines will be provided cost-free, when many other recommended personal preventive measures are user-pay. The greatest need is to

  14. 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).

  15. 25 CFR 224.71 - What standards will the Secretary use to decide to approve a final proposed TERA?

    Science.gov (United States)

    2010-04-01

    ... approve a final proposed TERA? 224.71 Section 224.71 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE... the Secretary use to decide to approve a final proposed TERA? The Secretary will consider the best... approve a final proposed TERA. The Secretary must approve a final proposed TERA if it contains...

  16. 42 CFR 84.35 - Changes or modifications of approved respirators; issuance of modification of certificate of...

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Changes or modifications of approved respirators... modifications of approved respirators; issuance of modification of certificate of approval. (a) Each applicant may, if he desires to change any feature of an approved respirator, request a modification of...

  17. ANSI / FM Approvals 2510 flood abatement equipment test standard

    Directory of Open Access Journals (Sweden)

    Kravetz Frédéric

    2016-01-01

    Full Text Available Natural hazards, including flooding, continue to be the leading cause of commercial and industrial property damage worldwide. Until recently, there has been a limited amount of readily available guidance on choosing flood abatement protection. FM Approvals, a division of FM Global, one of the world’s largest business property insurers, working together with the Association of State Floodplain Managers and the US Army Corps of Engineers have developed a National Flood Barrier Test Program after recognizing the urgent demand for reliable flood abatement products to mitigate potential losses. This lead to the ANSI/ FM2510 flood abatement equipment standard.

  18. 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.

  19. 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...

  20. [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.

  1. Commercial Approval Plan for Synthetic Jet Fuel from Hydrotreated Fats and Oils

    Science.gov (United States)

    2009-02-18

    qualification plan entitled "Commercial Approval Plan for Synthetic Jet Fuel from Hydrotreated Fats and Oils," produced by the subcontractor, Southwest...102 Enclosure 1 February 12, 2009 Fuel Qualification Plan; 3/27/07–4/24/09 Commercial Approval Plan for Synthetic Jet Fuel from Hydrotreated Fats and...Institute, Grand Forks, ND Southwest Research Institute, San Antonio, TX CLIN 0008 10 COMMERCIAL APPROVAL PLAN FOR SYNTHETIC JET FUEL FROM HYDROTREATED FATS

  2. A Needs Assessment of Marriage and Family Therapy Approved Supervision in Utah

    OpenAIRE

    2005-01-01

    This research presents data gathered through a needs assessment regarding approved supervision in Utah. A sample of ISO therapists in Utah gave descriptive facts about the current need for supervision in Utah as well as the number of therapists that are willing to provide supervision. Additionally, therapists that are not currently approved supervisors indicated whether or not they would be willing to become approved supervisors, what would make the designation more appealing, and what would ...

  3. 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.

  4. 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.

  5. Recently approved systemic therapies for acne vulgaris and rosacea.

    Science.gov (United States)

    Del Rosso, James Q

    2007-08-01

    Until recently, with the exception of oral isotretinoin for the treatment of severe recalcitrant nodular acne, systemic therapy for acne vulgaris and rosacea has been based on anecdotal support, clinical experience, and small clinical trials. Tetracycline derivatives are the predominant systemic agents that have been used for both disease states, prescribed in dose ranges that produce antibiotic activity. Anti-inflammatory dose doxycycline, a controlled-release (CR) 40-mg capsule formulation of doxycycline that is devoid of antibiotic activity when administered once daily, was US Food and Drug Administration (FDA)-approved for the treatment of inflammatory lesions (papules and pustules) of rosacea, based on large-scale phase 3 pivotal trials and long-term microbiologic and safety data. Also, an extended-release (ER) tablet formulation of minocycline was approved by the FDA for the treatment of inflammatory lesions of moderate to severe acne vulgaris in patients 12 years and older based on large-scale phase 3 clinical trials that evaluated efficacy and safety, dose-response analysis, and long-term data. This article discusses the studies and clinical applications related to the use of these agents.

  6. Japanese government takes steps toward approving birth control pill.

    Science.gov (United States)

    1995-10-27

    On September 12, 1995, the Central Pharmaceutical Affairs Council of Japan recommended approval of low-dose oral contraceptives as a method of family planning. Doctors should be able to prescribe the pills after the standing members of the Council, part of the Ministry of Health and Family Welfare, meet next March. High-dose oral contraceptives can be obtained currently to treat menstrual irregularities, although many of the 200,000 prescriptions written annually are used for family planning. Approval for the low-dose contraceptives has been slow because of concerns regarding a possible relaxation of sexual mores (1965); adverse side effects (until 1987 when the Japanese Ministry of Health initiated clinical trials that established the safety and efficacy of the contraceptives); increased rates of human immunodeficiency virus (HIV) infection (1992); a higher number of drug reimbursement claims under the national health insurance system; and a decline in Japan's birthrate. Japan's birthrate fell from 4.5 children per woman in 1947 to 1.5 in 1993. 80% of contraceptive users rely on condom; 22% use the rhythm method, usually in conjunction with the condom; 7% use the IUD; and less than 2% use sterilization. Sterilization is only permitted for married couples and only when the woman's life or health is in danger, or either spouse has a mental illness, leprosy, or a hereditary disorder.

  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 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.

  9. 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.

  10. 75 FR 55334 - Schmid Laboratories, Inc. et al.; Withdrawal of Approval of Five New Drug Applications

    Science.gov (United States)

    2010-09-10

    ... Five New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of five new drug applications (NDAs)...

  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. Repurposing FDA-approved drugs for anti-aging therapies.

    Science.gov (United States)

    Snell, Terry W; Johnston, Rachel K; Srinivasan, Bharath; Zhou, Hongyi; Gao, Mu; Skolnick, Jeffrey

    2016-11-01

    There is great interest in drugs that are capable of modulating multiple aging pathways, thereby delaying the onset and progression of aging. Effective strategies for drug development include the repurposing of existing drugs already approved by the FDA for human therapy. FDA approved drugs have known mechanisms of action and have been thoroughly screened for safety. Although there has been extensive scientific activity in repurposing drugs for disease therapy, there has been little testing of these drugs for their effects on aging. The pool of FDA approved drugs therefore represents a large reservoir of drug candidates with substantial potential for anti-aging therapy. In this paper we employ FINDSITE(comb), a powerful ligand homology modeling program, to identify binding partners for proteins produced by temperature sensing genes that have been implicated in aging. This list of drugs with potential to modulate aging rates was then tested experimentally for lifespan and healthspan extension using a small invertebrate model. Three protein targets of the rotifer Brachionus manjavacas corresponding to products of the transient receptor potential gene 7, ribosomal protein S6 polypeptide 2 gene, or forkhead box C gene, were screened against a compound library consisting of DrugBank drugs including 1347 FDA approved, non-nutraceutical molecules. Twenty nine drugs ranked in the top 1 % for binding to each target were subsequently included in our experimental analysis. Continuous exposure of rotifers to 1 µM naproxen significantly extended rotifer mean lifespan by 14 %. We used three endpoints to estimate rotifer health: swimming speed (mobility proxy), reproduction (overall vitality), and mitochondria activity (cellular senescence proxy). The natural decline in swimming speed with aging was more gradual when rotifers were exposed to three drugs, so that on day 6, mean swimming speed of females was 1.19 mm/s for naproxen (P = 0.038), 1.20 for fludarabine (P = 0

  14. The clinically approved antiviral drug sofosbuvir inhibits Zika virus replication

    Science.gov (United States)

    Sacramento, Carolina Q.; de Melo, Gabrielle R.; de Freitas, Caroline S.; Rocha, Natasha; Hoelz, Lucas Villas Bôas; Miranda, Milene; Fintelman-Rodrigues, Natalia; Marttorelli, Andressa; Ferreira, André C.; Barbosa-Lima, Giselle; Abrantes, Juliana L.; Vieira, Yasmine Rangel; Bastos, Mônica M.; de Mello Volotão, Eduardo; Nunes, Estevão Portela; Tschoeke, Diogo A.; Leomil, Luciana; Loiola, Erick Correia; Trindade, Pablo; Rehen, Stevens K.; Bozza, Fernando A.; Bozza, Patrícia T.; Boechat, Nubia; Thompson, Fabiano L.; de Filippis, Ana M. B.; Brüning, Karin; Souza, Thiago Moreno L.

    2017-01-01

    Zika virus (ZIKV) is a member of the Flaviviridae family, along with other agents of clinical significance such as dengue (DENV) and hepatitis C (HCV) viruses. Since ZIKV causes neurological disorders during fetal development and in adulthood, antiviral drugs are necessary. Sofosbuvir is clinically approved for use against HCV and targets the protein that is most conserved among the members of the Flaviviridae family, the viral RNA polymerase. Indeed, we found that sofosbuvir inhibits ZIKV RNA polymerase, targeting conserved amino acid residues. Sofosbuvir inhibited ZIKV replication in different cellular systems, such as hepatoma (Huh-7) cells, neuroblastoma (SH-Sy5y) cells, neural stem cells (NSC) and brain organoids. In addition to the direct inhibition of the viral RNA polymerase, we observed that sofosbuvir also induced an increase in A-to-G mutations in the viral genome. Together, our data highlight a potential secondary use of sofosbuvir, an anti-HCV drug, against ZIKV. PMID:28098253

  15. 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...

  16. 76 FR 55842 - Partial Approval and Partial Disapproval of Air Quality Implementation Plans; California; San...

    Science.gov (United States)

    2011-09-09

    ... October 2011. 2. Rule 4401--Steam Enhanced Crude Oil Production Wells--final limited approval/disapproval January 26, 2010 (75 FR 3996). Amendments submitted to EPA on July 28, 2011. 3. Rule 4402--Crude Oil Production Sumps--final limited approval/ disapproval July 7, 2011 (76 FR 39777). District...

  17. 75 FR 75548 - SI Financial Group, Inc., Willimantic, CT; Approval of Conversion Application

    Science.gov (United States)

    2010-12-03

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Office of Thrift Supervision SI Financial Group, Inc., Willimantic, CT; Approval of Conversion Application Notice is hereby given that on November 10, 2010, the Office of Thrift Supervision approved the application of SI Bancorp, MHC,...

  18. 78 FR 13661 - Energy Transfer Fuel, LP; Notice of Petition for Rate Approval

    Science.gov (United States)

    2013-02-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Energy Transfer Fuel, LP; Notice of Petition for Rate Approval Take notice that on February 15, 2013, Energy Transfer Fuel, LP filed for approval of rates for...

  19. 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 §...

  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. 75 FR 70935 - Accreditation and Approval of Intertek USA, Inc., as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2010-11-19

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of Intertek USA, Inc., as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security... A East Shore Parkway, New Haven, CT 06512, has been approved to gauge and accredited to...

  3. 38 CFR 21.4155 - Evaluations of State approving agency performance.

    Science.gov (United States)

    2010-07-01

    ... agreement with VA under § 21.4153(a) shall: (i) Apply qualification and performance standards based on the... qualification and performance standards for employees of State approving agencies. (1) VA shall: (i) Develop with the State approving agencies prototype qualification and performance standards; (ii)...

  4. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

    Science.gov (United States)

    2013-12-27

    ... Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of... holders of an approved drug or biological product to change the product labeling to reflect certain types... biological product to change the product labeling to reflect certain types of newly acquired information...

  5. 46 CFR 153.1101 - Procedures for getting a Surveyor: Approval of Surveyors.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 5 2010-10-01 2010-10-01 false Procedures for getting a Surveyor: Approval of Surveyors. 153.1101 Section 153.1101 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) CERTAIN BULK DANGEROUS CARGOES SHIPS CARRYING BULK LIQUID, LIQUEFIED GAS, OR COMPRESSED GAS HAZARDOUS MATERIALS Operations Approval of Surveyors...

  6. 78 FR 38714 - Public Water System Supervision Program Approval for the State of Illinois

    Science.gov (United States)

    2013-06-27

    ... AGENCY Public Water System Supervision Program Approval for the State of Illinois AGENCY: Environmental... of Illinois is revising its approved public water system supervision program for the Ground Water Rule, the Arsenic Rule and the ] new Public Water System Definition. EPA has determined that...

  7. 42 CFR 403.304 - Minimum requirements for State systems-discretionary approval.

    Science.gov (United States)

    2010-10-01

    ...-discretionary approval. 403.304 Section 403.304 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... Reimbursement Control Systems § 403.304 Minimum requirements for State systems—discretionary approval. (a... assurance and supporting data as required by § 403.320 to document that the payment limit is not...

  8. 42 CFR 403.306 - Additional requirements for State systems-mandatory approval.

    Science.gov (United States)

    2010-10-01

    ... approval. 403.306 Section 403.306 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF... Reimbursement Control Systems § 403.306 Additional requirements for State systems—mandatory approval. (a... State system if the system meets all of the requirements of § 403.304 and of paragraph (b) of...

  9. 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.

  10. 78 FR 76383 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2013-12-17

    ... Airport Authority, Mobile, Alabama. Application Number: 13-06-C-00-MOB. Application Type: Impose and use a... Regional Airport (MOB). Determination: Approved. Based on information submitted in the public agency's... annual enplanements at MOB. Brief Description of Projects Approved for Collection and Use:...

  11. 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)...

  12. 78 FR 2878 - Approval and Promulgation of Implementation Plans; Georgia: New Source Review-Prevention of...

    Science.gov (United States)

    2013-01-14

    ... Environmental protection, Air pollution control, Greenhouse gases, Incorporation by reference, Intergovernmental..., Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S... Deterioration'' to approve changes to Georgia's SIP-approved regulations entitled ``Air Quality Control Rule...

  13. 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...

  14. 75 FR 59084 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control Technique...

    Science.gov (United States)

    2010-09-27

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control...). ACTION: Direct final rule. SUMMARY: EPA is taking direct final action to approve a State Implementation Plan (SIP) revision submitted by the State of Maryland. This SIP revision pertains to the control...

  15. 76 FR 77550 - Extension of Approved Information Collection; OMB Control No. 1004-0162

    Science.gov (United States)

    2011-12-13

    ... Management and Budget (OMB) extend an existing approval to collect information from entities which conduct... Number: 1004-0162. Abstract: The BLM and FS collect this information in order to ensure that geophysical... Bureau of Land Management Extension of Approved Information Collection; OMB Control No. 1004-0162...

  16. 50 CFR 221.74 - Has OMB approved the information collection provisions of this subpart?

    Science.gov (United States)

    2010-10-01

    ... PRESCRIPTIONS IN FERC HYDROPOWER LICENSES Alternatives Process § 221.74 Has OMB approved the information collection provisions of this subpart? Yes. This rule contains provisions that would collect information from... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Has OMB approved the...

  17. 75 FR 34150 - Renewal of Approved Information Collection, OMB Control Number 1004-0168

    Science.gov (United States)

    2010-06-16

    ... Bureau of Land Management Renewal of Approved Information Collection, OMB Control Number 1004-0168 AGENCY... intention to request that the Office of Management and Budget (OMB) renew its approval to collect information from private landowners in western Oregon who are authorized to transport timber over...

  18. 75 FR 49930 - Stakeholder Meeting Regarding Re-Evaluation of Currently Approved Total Coliform Analytical Methods

    Science.gov (United States)

    2010-08-16

    ... AGENCY Stakeholder Meeting Regarding Re-Evaluation of Currently Approved Total Coliform Analytical... technical dialogue with stakeholders regarding re-evaluation of currently approved Total Coliform Rule (TCR) analytical methods. At these meetings, stakeholders will be given an opportunity to discuss...

  19. 28 CFR 901.3 - Approval of delayed fingerprint submission requests.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Approval of delayed fingerprint submission requests. 901.3 Section 901.3 Judicial Administration NATIONAL CRIME PREVENTION AND PRIVACY COMPACT COUNCIL FINGERPRINT SUBMISSION REQUIREMENTS § 901.3 Approval of delayed fingerprint...

  20. 75 FR 52065 - SharePlus Federal Bank, Plano, TX; Approval of Conversion Application

    Science.gov (United States)

    2010-08-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Office of Thrift Supervision SharePlus Federal Bank, Plano, TX; Approval of Conversion Application Notice is hereby given that on August 12, 2010, the Office of Thrift Supervision approved the application...

  1. 14 CFR 142.37 - Approval of flight aircrew training program.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Approval of flight aircrew training program... TRANSPORTATION (CONTINUED) SCHOOLS AND OTHER CERTIFICATED AGENCIES TRAINING CENTERS Aircrew Curriculum and Syllabus Requirements § 142.37 Approval of flight aircrew training program. (a) Except as provided...

  2. 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...

  3. 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...

  4. 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...

  5. 9 CFR 147.48 - Approval of conference recommendations by the Department.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approval of conference recommendations by the Department. 147.48 Section 147.48 Animals and Animal Products ANIMAL AND PLANT HEALTH... Department for incorporation into the provisions of the NPIP. The Department reserves the right to approve...

  6. 38 CFR 21.258 - Cost limitations on approval of self-employment plans.

    Science.gov (United States)

    2010-07-01

    ... approval of self-employment plans. 21.258 Section 21.258 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Vocational Rehabilitation and Employment Under 38 U.S.C. Chapter 31 Employment Services § 21.258 Cost limitations on approval of...

  7. 42 CFR 8.3 - Application for approval as an accreditation body.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Application for approval as an accreditation body... accreditation body. (a) Eligibility. Private nonprofit organizations or State governmental entities, or... an accreditation body. (b) Application for initial approval. Three copies of an accreditation...

  8. 77 FR 50121 - Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70

    Science.gov (United States)

    2012-08-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Hospira, Inc.; Withdrawal of Approval of a New Drug... Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for DEXTRAN 70...

  9. 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 Drug Application for MERIDIA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for...

  10. 78 FR 46984 - Pfizer, Inc.; Withdrawal of Approval of a New Drug Application for BEXTRA

    Science.gov (United States)

    2013-08-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pfizer, Inc.; Withdrawal of Approval of a New Drug... Administration (FDA) is withdrawing approval of a new drug application (NDA) for BEXTRA (valdecoxib) 10...

  11. 77 FR 50702 - Ranbaxy Laboratories Limited; Withdrawal of Approval of 27 Abbreviated New Drug Applications

    Science.gov (United States)

    2012-08-22

    ... Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 27 abbreviated new drug applications... introduction into interstate commerce of products without approved new drug applications violates section...

  12. Adolescent Perceptions of Maternal Approval of Birth Control and Sexual Risk Behavior.

    Science.gov (United States)

    Jaccard, James; Dittus, Patricia J.

    2000-01-01

    Used data from the Longitudinal Study of Adolescent health to examine the relationship between adolescent perception of maternal approval of the use of birth control and sexual outcomes over 12 months. Overall, adolescents' perceptions of maternal approval related to an increased likelihood of sexual intercourse in the next year and an increase in…

  13. 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...

  14. 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...

  15. 25 CFR 522.8 - Publication of class III ordinance and approval.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false Publication of class III ordinance and approval. 522.8... AND CLASS III ORDINANCES AND RESOLUTIONS SUBMISSION OF GAMING ORDINANCE OR RESOLUTION § 522.8 Publication of class III ordinance and approval. The Chairman shall publish a class III tribal...

  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... the purpose of engaging in Class III gaming activities on Indian lands. The Compact permits the...

  17. 25 CFR 522.6 - Approval requirements for class III ordinances.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false Approval requirements for class III ordinances. 522.6... AND CLASS III ORDINANCES AND RESOLUTIONS SUBMISSION OF GAMING ORDINANCE OR RESOLUTION § 522.6 Approval requirements for class III ordinances. No later than 90 days after the submission to the Chairman under §...

  18. 78 FR 4094 - Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices

    Science.gov (United States)

    2013-01-18

    ... Approval for Two Class III Preamendments Devices AGENCY: Food and Drug Administration, HHS. ACTION... the following two class III preamendments devices: Hip joint metal/metal semi- constrained, with a... class III (premarket approval). Under section 513 of the FD&C Act, devices that were in...

  19. 75 FR 9834 - Approval and Disapproval and Promulgation of Air Quality Implementation Plans; Montana; Revisions...

    Science.gov (United States)

    2010-03-04

    ... intended effect of this action is to propose to approve those ] portions of the rules that are approvable... effects on public health or facility safety. In addition, this exclusion is limited to only minor sources... either on its own, or at the request of an external party. This would minimize the time crunch...

  20. 77 FR 5611 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-02-03

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a..., 2012. I. Introduction On October 13, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA... change in a Regulatory Notice to be published no later than 90 days following Commission approval,...

  1. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-10-26

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving.... Introduction On August 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National... Regulatory Notice to be published no later than 90 days following this Commission approval. The...

  2. 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...

  3. 75 FR 4901 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-01-29

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin... notice lists the projects, described below, receiving approval for the consumptive use of water...

  4. 76 FR 50536 - Projects Approved or Rescinded for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-15

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved or Rescinded for Consumptive Uses of Water AGENCY: Susquehanna River Basin... projects, described below, receiving approval or rescission for the consumptive use of water pursuant...

  5. 75 FR 23837 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-05-04

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin... lists the projects, described below, receiving approval for the consumptive use of water pursuant to...

  6. 76 FR 33019 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-06-07

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin... lists the projects, described below, receiving approval for the consumptive use of water pursuant to...

  7. 77 FR 24585 - List of Approved Spent Fuel Storage Casks: HI-STORM 100, Revision 8

    Science.gov (United States)

    2012-04-25

    ... 3150-AJ05 List of Approved Spent Fuel Storage Casks: HI-STORM 100, Revision 8 AGENCY: Nuclear... amends the NRC's spent fuel storage regulations by revising the Holtec International HI-STORM 100 System... International HI-STORM 100 System listing within the ``List of Approved Spent Fuel Storage Casks'' to...

  8. 77 FR 9591 - List of Approved Spent Fuel Storage Casks: HI-STORM 100, Revision 8

    Science.gov (United States)

    2012-02-17

    ... COMMISSION 10 CFR Part 72 RIN 3150-AJ05 List of Approved Spent Fuel Storage Casks: HI-STORM 100, Revision 8... the Holtec International HI-STORM 100 dry cask storage system listing within the ``List of Approved... other aspects of the HI-STORM 100 dry storage cask system. Because the NRC considers this...

  9. 77 FR 22540 - Approval and Promulgation of State Implementation Plan Revisions; Infrastructure Requirements for...

    Science.gov (United States)

    2012-04-16

    ... particular, the data and analytical tools available at the time the state develops and submits the SIP for a...) authorizes EPA to correct errors in past actions, such as past approvals of SIP submissions.\\13... errors in past actions on SIP submissions related to PSD programs. See, ``Limitation of Approval...

  10. 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....

  11. 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...

  12. 7 CFR 1436.9 - Loan amount and loan application approvals.

    Science.gov (United States)

    2010-01-01

    ... fees, except for filing fees; environmental and historic review fees including archaeological study... wiring; electrical motors; off-farm paid labor; on-farm site preparation and construction equipment costs... facility loans, the agency approval officials may only approve loans, subject to available funds....

  13. 77 FR 68116 - TEAK Texana Transmission Company, LP; Notice of Petition for Rate Approval

    Science.gov (United States)

    2012-11-15

    ... Energy Regulatory Commission TEAK Texana Transmission Company, LP; Notice of Petition for Rate Approval Take notice that on November 2, 2012, TEAK Texana Transmission Company, LP (TEAK) filed a Petition for Rate Approval pursuant to 284.123(b)(2) of the Commissions regulations for firm and...

  14. 77 FR 68118 - TexStar Transmission, LP; Notice of Petition for Rate Approval

    Science.gov (United States)

    2012-11-15

    ... Federal Energy Regulatory Commission TexStar Transmission, LP; Notice of Petition for Rate Approval Take notice that on November 2, 2012, TexStar Transmission, LP (TexStar) filed a Petition for Rate Approval... transportation services, as more fully detailed in the petition. Any person desiring to participate in this...

  15. 21 CFR 814.45 - Denial of approval of a PMA.

    Science.gov (United States)

    2010-04-01

    ...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.45 Denial of approval of a... validity of the study; or (5) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in part 56 or informed consent regulations in...

  16. 21 CFR 814.46 - Withdrawal of approval of a PMA.

    Science.gov (United States)

    2010-04-01

    ...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.46 Withdrawal of approval... of the study. (4) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in part 56 or informed consent regulations in part...

  17. 33 CFR 157.210 - Approved Dedicated Clean Ballast Tanks Operations Manual.

    Science.gov (United States)

    2010-07-01

    ... RELATING TO TANK VESSELS CARRYING OIL IN BULK Dedicated Clean Ballast Tanks on Tank Vessels General § 157.210 Approved Dedicated Clean Ballast Tanks Operations Manual. If the manuals submitted under § 157.206... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Approved Dedicated Clean...

  18. 29 CFR 4211.11 - Changes not subject to PBGC approval.

    Science.gov (United States)

    2010-07-01

    ... amendment, any of the statutory allocation methods and any of the modifications set forth in §§ 4211.12 and... modifications to the presumptive rule set forth in § 4211.12 without the approval of the PBGC. ... 29 Labor 9 2010-07-01 2010-07-01 false Changes not subject to PBGC approval. 4211.11 Section...

  19. 78 FR 28005 - System Energy Resources, Inc.; Grand Gulf Nuclear Station; Order Approving Direct and Indirect...

    Science.gov (United States)

    2013-05-13

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION System Energy Resources, Inc.; Grand Gulf Nuclear Station; Order Approving Direct and Indirect Transfers of Early Site Permit and Approving Conforming Amendment I System Energy Resources, Inc. (SERI),...

  20. 76 FR 58079 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-09-19

    ... fencing and gates. Install fencing and gates. Brief Description of Projects Approved for Collection at ACV and Use at Murray Field (EKA): Design wildlife perimeter fencing. Design automated weather observing.... Design fencing and gates. Construct fencing and gates. Brief Description of Project Approved...

  1. 40 CFR 131.21 - EPA review and approval of water quality standards.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality Standards § 131.21 EPA review and approval of water quality standards. (a) After the State submits its... analysis. (b) The Regional Administrator's approval or disapproval of a State water quality standard...

  2. 78 FR 35018 - Dow Intrastate Gas Company; Notice of Petition for Rate Approval

    Science.gov (United States)

    2013-06-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Dow Intrastate Gas Company; Notice of Petition for Rate Approval Take notice that on May 31, 2013, Dow Intrastate Gas Company filed a petition for rate approval pursuant to...

  3. 77 FR 74181 - Dow Pipeline Company; Notice of Petition for Rate Approval

    Science.gov (United States)

    2012-12-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Dow Pipeline Company; Notice of Petition for Rate Approval Take notice that on November 30, 2012, Dow Pipeline Company filed a petition for rate approval pursuant to Section...

  4. 78 FR 6035 - Approval and Promulgation of Air Quality Implementation Plans; Ohio and Indiana; Cincinnati...

    Science.gov (United States)

    2013-01-29

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Ohio and Indiana; Cincinnati-Hamilton, OH; Ohio and Indiana 1997 8-Hour Ozone Maintenance Plan Revisions to Approved Motor..., 2010 and 77 FR 11394, February 27, 2012). The Ohio, Kentucky, Indiana Regional Council of...

  5. 77 FR 25474 - Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Florida

    Science.gov (United States)

    2012-04-30

    ... Programs; and Part 272--Approved State Hazardous Waste Management Programs. FDEP was notified of EPA's... AGENCY Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Florida AGENCY... State of Florida's request ] to revise/modify certain of its EPA-authorized programs to allow...

  6. 77 FR 58131 - Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Mississippi

    Science.gov (United States)

    2012-09-19

    ... Part 272--Approved State Hazardous Waste Management Programs. Specifically, EPA has approved the state's revision to its part 272 authorized program for electronic reporting of hazardous waste biennial... ``Regulatory Services Portal/Hazardous Waste Biennial Reporting'' for revisions/modifications of its...

  7. 77 FR 68770 - Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Vermont

    Science.gov (United States)

    2012-11-16

    ...--State Underground Injection Control Programs; Part 272--Approved State Hazardous Waste Management... AGENCY Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Vermont AGENCY... State of Vermont's request to revise/modify certain of its EPA-authorized programs to allow...

  8. 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...

  9. 42 CFR 488.60 - Special procedures for approving end stage renal disease facilities.

    Science.gov (United States)

    2010-10-01

    ... ENFORCEMENT PROCEDURES Special Requirements § 488.60 Special procedures for approving end stage renal disease... 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...

  10. 5 CFR 630.905 - Approval of application to become a leave recipient.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Approval of application to become a leave recipient. 630.905 Section 630.905 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS ABSENCE AND LEAVE Voluntary Leave Transfer Program § 630.905 Approval of application to become...

  11. 5 CFR 630.1007 - Approval of application to become a leave recipient.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Approval of application to become a leave recipient. 630.1007 Section 630.1007 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS ABSENCE AND LEAVE Voluntary Leave Bank Program § 630.1007 Approval of application to become...

  12. 76 FR 4601 - Determinations Concerning Need for Error Correction, Partial Approval and Partial Disapproval...

    Science.gov (United States)

    2011-01-26

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 RIN 2060-AQ66 Determinations Concerning Need for Error Correction, Partial Approval... Determination Concerning the Need for Error Correction, Partial Approval and Partial Disapproval, and...

  13. 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...

  14. 17 CFR 40.3 - Voluntary submission of new products for Commission review and approval.

    Science.gov (United States)

    2010-04-01

    ... transaction execution facility may request that the Commission approve a new or dormant product prior to... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Voluntary submission of new products for Commission review and approval. 40.3 Section 40.3 Commodity and Securities Exchanges...

  15. 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...

  16. 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...

  17. 40 CFR 725.288 - Revocation or modification of TERA approval.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Revocation or modification of TERA... for Research and Development Activities § 725.288 Revocation or modification of TERA approval. (a) Significant questions about risk. (1) If, after approval of a TERA under this subpart, EPA...

  18. 13 CFR 107.503 - Licensee's adoption of an approved valuation policy.

    Science.gov (United States)

    2010-01-01

    ... independent public accountant's report on your audited annual financial statements (SBA Form 468) must include a statement that your valuations were prepared in accordance with your approved valuation policy... approval of an alternative valuation policy. (c) Responsibility for valuations. Your board of directors...

  19. 75 FR 81632 - Australia Beef Imports Approved for the Electronic Certification System (eCERT)

    Science.gov (United States)

    2010-12-28

    ... SECURITY U.S. Customs and Border Protection Australia Beef Imports Approved for the Electronic... certification requirement for imports of beef from Australia subject to quantitative restraints will be... approval of the United States Government. DATES: The use of the eCERT process for all Australian...

  20. 78 FR 19128 - Approval and Promulgation of Air Quality Implementation Plans; Ohio; Particulate Matter Standards

    Science.gov (United States)

    2013-03-29

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Ohio; Particulate... particulate matter (PM) rules on February 23, 2012. The PM rule revisions being approved establish work... disclosure is restricted by statute. Certain other material, such as copyrighted material, will be...

  1. 77 FR 50576 - Fatigue Tolerance Evaluation of Metallic Structures; OMB Approval of Information Collection

    Science.gov (United States)

    2012-08-22

    ... Federal Aviation Administration 14 CFR Part 29 RIN 2120-AJ51 Fatigue Tolerance Evaluation of Metallic Structures; OMB Approval of Information Collection AGENCY: Federal Aviation Administration, DOT. ACTION: Final rule; OMB approval of information collection. SUMMARY: This document notifies the public of...

  2. 78 FR 10583 - Approval and Promulgation of Air Quality Implementation Plans; Massachusetts; Reasonably...

    Science.gov (United States)

    2013-02-14

    ...: Direct your comments to Docket ID No. EPA-R01-OAR- 2013-0028. EPA's policy is that all comments received... than the previously SIP-approved rule, even after accounting for the new exemption for motor vehicle... submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air...

  3. 28 CFR 33.3 - OMB approval of information collection requirements.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false OMB approval of information collection requirements. 33.3 Section 33.3 Judicial Administration DEPARTMENT OF JUSTICE BUREAU OF JUSTICE ASSISTANCE GRANT PROGRAMS Criminal Justice Block Grants General Provisions § 33.3 OMB approval of...

  4. 75 FR 65642 - Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride...

    Science.gov (United States)

    2010-10-26

    ...The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these...

  5. 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...

  6. 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...

  7. 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...

  8. 7 CFR 1724.54 - Requirements for RUS approval of plans and specifications.

    Science.gov (United States)

    2010-01-01

    ... specifications for transmission construction projects which are not based on RUS approved line design data or do... building design meets the Uniform Federal Accessibility Standards (See § 1724.51(e)(1)(i)). (g... DESIGN POLICIES AND PROCEDURES Electric System Design § 1724.54 Requirements for RUS approval of...

  9. 75 FR 18757 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Alternate Monitoring...

    Science.gov (United States)

    2010-04-13

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Indiana; Alternate Monitoring Requirements for Indianapolis Power and Light--Harding Street Station AGENCY: Environmental... approve as ] a revision to its State Implementation Plan (SIP) alternative monitoring requirements for...

  10. 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...

  11. 48 CFR 4.1302 - Acquisition of approved products and services for personal identity verification.

    Science.gov (United States)

    2010-10-01

    ... products and services for personal identity verification. 4.1302 Section 4.1302 Federal Acquisition... Verification 4.1302 Acquisition of approved products and services for personal identity verification. (a) In... products and services. (b) Agencies may acquire the approved products and services from the GSA,...

  12. 21 CFR 515.20 - Approval of medicated feed mill license applications.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Approval of medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.20 Approval of medicated feed mill license applications. Within 90 days after...

  13. 21 CFR 515.21 - Refusal to approve a medicated feed mill license application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Refusal to approve a medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.21 Refusal to approve a medicated feed mill license application. (a)...

  14. 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... mercury at 20 degrees Celsius. This rule also contains the appropriate test methods ] for determining...

  15. 78 FR 57631 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Ambient...

    Science.gov (United States)

    2013-09-19

    ... AGENCY Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Ambient...), Ambient Air Quality Surveillance (Renewal) (EPA ICR No. 0940.27, OMB Control No. 2060-0084) to the Office... approved under the Nitrogen Oxides Ambient Monitoring ICR (OMB 2060-0638, EPA ICR Number 2358.03) and...

  16. 75 FR 68447 - Approval and Promulgation of Implementation Plans; Albuquerque/Bernalillo County, NM; Interstate...

    Science.gov (United States)

    2010-11-08

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; Albuquerque/ Bernalillo County, NM; Interstate Transport of Pollution AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: The EPA is approving a revision to the Albuquerque/Bernalillo County, New Mexico...

  17. 75 FR 57478 - Accreditation and Approval of King Laboratories, Inc., as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2010-09-21

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of King Laboratories, 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 King Laboratories, Inc., as a commercial gauger...

  18. 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...

  19. 75 FR 3245 - Accreditation and Approval of King Laboratories, Inc., as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2010-01-20

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of King Laboratories, 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 King Laboratories, Inc., as a commercial gauger...

  20. 78 FR 6828 - Accreditation and Approval of King Laboratories, Inc., as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2013-01-31

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of King Laboratories, 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 King Laboratories, Inc., as a commercial gauger...

  1. 75 FR 70939 - Approval of SAYBOLT LP, as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2010-11-19

    ... SECURITY Customs and Border Protection Approval of SAYBOLT LP, as a Commercial Gauger and Laboratory AGENCY... and approval of Saybolt LP, as a commercial gauger and laboratory. SUMMARY: Notice is hereby given... this entity to conduct laboratory analyses and gauger services should request and receive...

  2. 77 FR 50523 - Accreditation and Approval of Amspec Services LLC, as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2012-08-21

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of Amspec Services LLC, as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security... service this entity is accredited or approved to perform may be directed to the U.S. Customs and...

  3. 77 FR 51041 - Approval of the Strawn Group, as a Commercial Gauger

    Science.gov (United States)

    2012-08-23

    ... SECURITY U.S. Customs and Border Protection Approval of the Strawn Group, as a Commercial Gauger AGENCY: U... gauger service this entity is approved to perform may be directed to the U.S. Customs and Border... CONTACT: Jonathan McGrath, Laboratories and Scientific Services, U.S. Customs and Border Protection,...

  4. 78 FR 6828 - Accreditation and Approval of Saybolt LP, as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2013-01-31

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of Saybolt LP, as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION...: Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services, U.S. Customs...

  5. 77 FR 34054 - Accreditation and Approval of Amspec Services LLC, as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2012-06-08

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of Amspec Services LLC, as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security... service this entity is accredited or approved to perform may be directed to the U.S. Customs and...

  6. 77 FR 14409 - Approval of Intertek USA, Inc., as a Commercial Gauger

    Science.gov (United States)

    2012-03-09

    ... SECURITY U.S. Customs and Border Protection Approval of Intertek USA, Inc., as a Commercial Gauger AGENCY... specific gauger service this entity is approved to perform may be directed to the U.S. Customs and Border... CONTACT: Dr. Mike McCormick, Laboratories and Scientific Services, U.S. Customs and Border...

  7. 76 FR 9809 - Approval of SGS North America, Inc., as a Commercial Gauger

    Science.gov (United States)

    2011-02-22

    ... AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of approval... service this entity is approved to perform may be directed to the U.S. Customs and Border Protection by..., Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW.,...

  8. 77 FR 14410 - Approval of INTERTEK USA, Inc., as a Commercial Gauger

    Science.gov (United States)

    2012-03-09

    ... SECURITY U.S. Customs and Border Protection Approval of INTERTEK USA, Inc., as a Commercial Gauger AGENCY... gauger service this entity is approved to perform may be directed to the U.S. Customs and Border... CONTACT: Dr. Mike McCormick, Laboratories and Scientific Services, U.S. Customs and Border...

  9. 77 FR 50522 - Accreditation and Approval of Amspec Services LLC, as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2012-08-21

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of Amspec Services LLC, as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security... service this entity is accredited or approved to perform may be directed to the U.S. Customs and...

  10. 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.

  11. Enterobacter aerogenes Hormaeche and Edwards 1960 (Approved Lists 1980) and Klebsiella mobilis Bascomb et al. 1971 (Approved Lists 1980) share the same nomenclatural type (ATCC 13048) on the Approved Lists and are homotypic synonyms, with consequences for the name Klebsiella mobilis Bascomb et al. 1971 (Approved Lists 1980).

    Science.gov (United States)

    Tindall, B J; Sutton, G; Garrity, G M

    2016-10-13

    Enterobacter aerogenes Hormaeche and Edwards 1960 (Approved Lists 1980) and Klebsiella mobilis Bascomb et al. 1971 (Approved Lists 1980) were placed on the Approved Lists of Bacterial Names and were based on the same nomenclatural type, ATCC 13048. Consequently they are to be treated as homotypic synonyms. However, the names of homotypic synonyms at the rank of species normally are based on the same epithet. Examination of the Rules of the International Code of Nomenclature of Bacteria in force at the time indicates that the name the epithet mobilis in Klebsiella mobilis Bascomb et al. 1971 (Approved Lists 1980) was illegitimate at the time the Approved Lists were published and according to the Rules of the current International Code of Nomenclature of Prokaryotes continues to be illegitimate.

  12. Why Is Cross-Sex-Role Behavior More Approved for Girls than for Boys? A Status Characteristic Approach.

    Science.gov (United States)

    Feinman, Saul

    1981-01-01

    Investigates approval/disapproval of behavioral performance in terms of the relative status of male and female role positions. Reports that male role behaviors are more highly approved than female role behaviors for both male and female college students. (ST)

  13. 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)

  14. 25 CFR 84.004 - Are there types of contracts and agreements that do not require Secretarial approval under this...

    Science.gov (United States)

    2010-04-01

    ... are exempt from Secretarial approval under the terms of a corporate charter authorized by 25 U.S.C...-Governance Act, 25 U.S.C. 458aa. (i) Contracts or agreements that are subject to approval by the...

  15. 25 CFR 30.113 - How does the Secretary review and approve an alternative definition of AYP?

    Science.gov (United States)

    2010-04-01

    ... EDUCATION ADEQUATE YEARLY PROGRESS Defining Adequate Yearly Progress Approval of Alternative Definition § 30.113 How does the Secretary review and approve an alternative definition of AYP? (a) The tribal... 25 Indians 1 2010-04-01 2010-04-01 false How does the Secretary review and approve an...

  16. 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,...

  17. 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...

  18. 78 FR 66748 - Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval of 14 New Drug Applications...

    Science.gov (United States)

    2013-11-06

    ... Approval of 14 New Drug Applications; Opportunity for a Hearing AGENCY: Food and Drug Administration, HHS... hearing on the Agency's proposal to withdraw approval of 14 new drug applications (NDAs) from multiple... to remove the products from the market. Any new drug product marketed without an approved new...

  19. 25 CFR 291.14 - How can Class III gaming procedures approved by the Secretary be amended?

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false How can Class III gaming procedures approved by the... ECONOMIC ENTERPRISES CLASS III GAMING PROCEDURES § 291.14 How can Class III gaming procedures approved by the Secretary be amended? An Indian tribe may ask the Secretary to amend approved Class III...

  20. 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...

  1. 14 CFR 135.105 - Exception to second in command requirement: Approval for use of autopilot system.

    Science.gov (United States)

    2010-01-01

    ...: Approval for use of autopilot system. 135.105 Section 135.105 Aeronautics and Space FEDERAL AVIATION...: Approval for use of autopilot system. (a) Except as provided in §§ 135.99 and 135.111, unless two pilots... second in command, if it is equipped with an operative approved autopilot system and the use of...

  2. 42 CFR 414.917 - Dispute resolution and process for suspension or termination of approved CAP contract and...

    Science.gov (United States)

    2010-10-01

    ... address the issue first through the approved CAP vendor's grievance process, and second through an... participating CAP physician may use the approved CAP vendor's grievance process. If the service or quality..., forward the issue to the approved CAP vendor's grievance process within 1 business day of the receipt...

  3. 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.

  4. 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

  5. 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].

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Characterization of spent fuel approved testing material--ATM-104

    Energy Technology Data Exchange (ETDEWEB)

    Guenther, R.J.; Blahnik, D.E.; Jenquin, U.P.; Mendel, J.E.; Thomas, L.E.; Thornhill, C.K.

    1991-12-01

    The characterization data obtained to date are described for Approved Testing Material 104 (ATM-104), which is spent fuel from Assembly DO47 of the Calvert Cliffs Nuclear Power Plant (Unit 1), a pressurized-water reactor. This report is one in a series being prepared by the Materials Characterization Center at Pacific Northwest Laboratory (PNL) on spent fuel ATMs. The ATMs are receiving extensive examinations to provide a source of well-characterized spent fuel for testing in the US Department of Energy Office of Civilian Radioactive Waste Management (OCRWM) Program. ATM-104 consists of 128 full-length irradiated fuel rods with rod-average burnups of about 42 MWd/kgM and expected fission gas release of about 1%. A variety of analyses were performed to investigate cladding characteristics, radionuclide inventory, and redistribution of fission products. Characterization data include (1) fabricated fuel design, irradiation history, and subsequent storage and handling history; (2) isotopic gamma scans; (3) fission gas analyses; (4) ceramography of the fuel and metallography of the cladding; (5) special fuel studies involving analytical transmission electron microscopy (AEM) and electron probe microanalyses (EPMA); (6) calculated nuclide inventories and radioactivities in the fuel and cladding; and (7) radiochemical analyses of the fuel and cladding.

  11. Characterization of spent fuel approved testing material---ATM-105

    Energy Technology Data Exchange (ETDEWEB)

    Guenther, R.J.; Blahnik, D.E.; Campbell, T.K.; Jenquin, U.P.; Mendel, J.E.; Thomas, L.E.; Thornhill, C.K.

    1991-12-01

    The characterization data obtained to data are described for Approved Testing Material 105 (ATM-105), which is spent fuel from Bundles CZ346 and CZ348 of the Cooper Nuclear Power Plant, a boiling-water reactor. This report is one in a series being prepared by the Materials Characterization Center at Pacific Northwest Laboratory (PNL) on spent fuel ATMs. The ATMs are receiving extensive examinations to provide a source of well-characterized spent fuel for testing in the US Department of Energy Office of Civilian Radioactive Waste Management (OCRWM) Program. ATM-105 consists of 88 full-length irradiated fuel rods with rod-average burnups of about 2400 GJ/kgM (28 MWd/kgM) and expected fission gas release of about 1%. Characterization data include (1) descriptions of as-fabricated fuel design, irradiation history, and subsequent storage and handling; (2) isotopic gamma scans; (3) fission gas analyses; (4) ceramography of the fuel and metallography of the cladding; (5) special fuel studies involving analytical transmission electron microscopy (AEM); (6) calculated nuclide inventories and radioactivities in the fuel and cladding; and (7) radiochemical analyses of the fuel and cladding. Additional analyses of the fuel are being conducted and will be included in planned revisions of this report.

  12. Evaluation of genotoxicity testing of FDA approved large molecule therapeutics.

    Science.gov (United States)

    Sawant, Satin G; Fielden, Mark R; Black, Kurt A

    2014-10-01

    Large molecule therapeutics (MW>1000daltons) are not expected to enter the cell and thus have reduced potential to interact directly with DNA or related physiological processes. Genotoxicity studies are therefore not relevant and typically not required for large molecule therapeutic candidates. Regulatory guidance supports this approach; however there are examples of marketed large molecule therapeutics where sponsors have conducted genotoxicity studies. A retrospective analysis was performed on genotoxicity studies of United States FDA approved large molecule therapeutics since 1998 identified through the Drugs@FDA website. This information was used to provide a data-driven rationale for genotoxicity evaluations of large molecule therapeutics. Fifty-three of the 99 therapeutics identified were tested for genotoxic potential. None of the therapeutics tested showed a positive outcome in any study except the peptide glucagon (GlucaGen®) showing equivocal in vitro results, as stated in the product labeling. Scientific rationale and data from this review indicate that testing of a majority of large molecule modalities do not add value to risk assessment and support current regulatory guidance. Similarly, the data do not support testing of peptides containing only natural amino acids. Peptides containing non-natural amino acids and small molecules in conjugated products may need to be tested.

  13. 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.

  14. FDA-Approved Natural Polymers for Fast Dissolving Tablets.

    Science.gov (United States)

    Alam, Md Tausif; Parvez, Nayyar; Sharma, Pramod Kumar

    2014-01-01

    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.

  15. [Approval of a bone bank: an institution's experience].

    Science.gov (United States)

    Jung, S; Wernerus, D; Reichel, H

    2012-03-01

    The new tissue laws of 2007 created a completely new situation for German musculoskeletal tissue banks. The objective of the new regulations in the recent German tissue act is to improve safety by reducing the risk of transmission of viral and nonviral diseases. Since 2007 tissue banks have to declare their intention to continue providing allografts to the local authorities until August 2011 based on the guidelines of the Federal Medical Association (Bundesärztekammer 2001) and according to § 144 of the Pharmaceutical Products Act (Arzneimittelgesetz). The Orthopedic University Clinic in Ulm applied for registration according to § 20 b and c of the Pharmaceutical Products Act in 2010. After submitting all the required documents, government officials controlled the equipment, distribution of responsible personnel, location of operating theatres and the laboratory and quality assurance documentation. After alluding to the lack of validation for the use of a hemoculture medium for testing ringer lactate solutions, permission according to § 20 b and c was granted with the obligation to transfer all serological and microbiological testing of tissue donors to another laboratory with its own approval under § 20 c of the Pharmaceutical Products Act.

  16. Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

    Science.gov (United States)

    Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

    2015-01-01

    Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

  17. Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule

    Directory of Open Access Journals (Sweden)

    Chia-Wei eTsai

    2015-12-01

    Full Text Available On December 14, 2012, the FDA approved raxibacumab, the first product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or Animal Rule. Raxibacumab is approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibiotic drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. The approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues.

  18. New, expanded, and modified use of approved antineoplastic agents in ovarian cancer.

    Science.gov (United States)

    Markman, Maurie

    2007-02-01

    Over the past several years, clinical research efforts in ovarian cancer employing a number of U.S. Food and Drug Administration (FDA)-approved antineoplastic agents have permitted the development of approaches that both improve the effectiveness and decrease the toxicities of systemic therapy of ovarian cancer. These initiatives, including prospective trials and retrospective examinations of large clinical experience, have involved agents previously approved by the FDA for use in ovarian cancer (e.g., cisplatin, paclitaxel, topotecan, and liposomal doxorubicin) and the development of new strategies for drugs approved for other malignant conditions (e.g., gemcitabine, docetaxel, etoposide, irinotecan, vinorelbine, and bevacizumab). It can be anticipated that future studies involving novel approved agents will further expand the oncologist's weapons against ovarian cancer.

  19. 75 FR 54940 - Agency Information Collection (IC) Activities; Revision of an Approved IC; Accident Recordkeeping...

    Science.gov (United States)

    2010-09-09

    ... Federal Motor Carrier Safety Administration Agency Information Collection (IC) Activities; Revision of an Approved IC; Accident Recordkeeping Requirements AGENCY: Federal Motor Carrier Safety Administration (FMCSA... revision of the Information Collection (IC) entitled, ``Accident Recordkeeping Requirements,''...

  20. 78 FR 40015 - Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants...

    Science.gov (United States)

    2013-07-03

    ... Pollutants; District of Columbia; Control of Emissions From Existing Hospital/Medical/Infectious Waste... taking direct final action to approve a negative declaration for hospital/medical/infectious waste... pollutants) at existing solid waste combustor facilities (designated facilities) whenever standards...

  1. Number of Drilling Permits Approved by Fiscal Year on Federal Lands by BLM

    Data.gov (United States)

    Bureau of Land Management, Department of the Interior — This table contains the total number of Applications for Permit to Drill (APDs) by state approved by the BLM each fiscal year. Oil and gas operators may not begin...

  2. 30 CFR 946.15 - Approval of Virginia regulatory program amendments.

    Science.gov (United States)

    2010-07-01

    ...) through (c); 702.5 defining Exemption for Coal Extraction Incidental to the Extraction of Other Minerals.... September 22, 2000 August 20, 2001 4 VAC 25-130-700.5 (partial approval); 800.21(a), (c)(1)...

  3. 78 FR 6829 - Approval of AmSpec Services, LLC, as a Commercial Gauger

    Science.gov (United States)

    2013-01-31

    ...Notice is hereby given, pursuant to CBP regulation, that AmSpec Services, LLC, has been approved to gauge petroleum, petroleum products, organic chemicals and vegetable oils for customs purposes for the next three years as of August 7,...

  4. 75 FR 64393 - Approval of Noise Compatibility Program for Chicago Executive Airport, Prospect Heights and...

    Science.gov (United States)

    2010-10-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Approval of Noise Compatibility Program for Chicago Executive Airport, Prospect Heights and Wheeling, IL AGENCY: Federal Aviation Administration, DOT. ACTION: Notice....

  5. 76 FR 77182 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; General Conformity...

    Science.gov (United States)

    2011-12-12

    ... Conformity Requirements for Federal Agencies Applicable to Federal Actions AGENCY: Environmental Protection... adopted by Virginia for the purpose of incorporating Federal general conformity requirements revisions... approving Virginia's general conformity SIP revision and if that provision may be severed from the...

  6. Burn Pre-Approval Area, Geographic NAD83, LOSCO (2000) [burn_preapproval_area_LOSCO_2000

    Data.gov (United States)

    Louisiana Geographic Information Center — This is a region dataset delineating the areas of offshore Louisiana having Regional Response Team VI (RRT 6) pre-approval for the use of in-situ burning, according...

  7. 77 FR 53249 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Science.gov (United States)

    2012-08-31

    ... and Budget (OMB) approval to renew an information collection. The FAA collects information from... monitoring. Information is collected in the application, and grant agreement amendments; financial management... projects. Frequency: Information is collected on occasion. Estimated Average Burden per Response:...

  8. 78 FR 52536 - Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin...

    Science.gov (United States)

    2013-08-23

    ...; Diethylcarbamazine; Nicarbazin; Penicillin; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Notice... withdraw approval of NADA 098-371 for use of nicarbazin, penicillin, and roxarsone in 3-way,...

  9. 76 FR 2151 - Notice of Intent To Seek Approval To Renew an Information Collection

    Science.gov (United States)

    2011-01-12

    ... From the Federal Register Online via the Government Publishing Office NATIONAL SCIENCE FOUNDATION Notice of Intent To Seek Approval To Renew an Information Collection AGENCY: National Science Foundation... renew an information collection. Abstract: Proposed Project: On September 11, 1993, President...

  10. Guanzhong-Tianshui Economic Zone Approved to Shore up Shaanxi Economy

    Institute of Scientific and Technical Information of China (English)

    Li Zhen

    2010-01-01

    @@ As a move to facilitate economic development, China's State Council approved the Guanzhong-Tianshui Economic Zone Development Plan to turn the country's north-western region as a base for advanced high-tech and agriculture industries by 2020.

  11. 36 CFR 1254.102 - What requests does NARA not approve?

    Science.gov (United States)

    2010-07-01

    ... ADMINISTRATION PUBLIC AVAILABILITY AND USE USING RECORDS AND DONATED HISTORICAL MATERIALS Microfilming Archival...; (2) We have approved for microfilming by another party; or (3) We plan to film as a NARA...

  12. 48 CFR 252.227-7024 - Notice and approval of restricted designs.

    Science.gov (United States)

    2010-10-01

    ... structures, machines, products, materials, construction methods, and equipment that are readily available through Government or competitive commercial channels, or through standard or proven production techniques, methods, and processes. Unless approved by the Contracting Officer, the Contractor shall not produce...

  13. 76 FR 68698 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revision to Nitrogen...

    Science.gov (United States)

    2011-11-07

    ...- 9487-7] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revision to Nitrogen... Commonwealth of Virginia that revises regulatory language that inadvertently ended its nitrogen oxides (NO...

  14. 78 FR 34306 - Approval and Promulgation of Air Quality Implementation Plans: North Carolina; Control Techniques...

    Science.gov (United States)

    2013-06-07

    ... nonattainment area. List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans: North Carolina; Control Techniques Guidelines and Reasonably Available Control Technology AGENCY: Environmental...

  15. 77 FR 52277 - Approval of Air Quality Implementation Plans; California; South Coast Air Quality Management...

    Science.gov (United States)

    2012-08-29

    ... submitted for the South Coast Air Quality Management District (District) portion of the California State... AGENCY 40 CFR Part 52 Approval of Air Quality Implementation Plans; California; South Coast Air Quality Management District; Prevention of Significant Deterioration; Greenhouse Gases AGENCY:...

  16. 76 FR 22713 - Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin...

    Science.gov (United States)

    2011-04-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin; Sulfamethazine; Correction AGENCY: Food and Drug Administration, HHS....

  17. Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

    Data.gov (United States)

    U.S. Department of Health & Human Services — A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved...

  18. 75 FR 4742 - Approval and Promulgation of Implementation Plans; State of California; Legal Authority

    Science.gov (United States)

    2010-01-29

    ..., Penal, Civil Procedure, Government, and Vehicle codes, as well as citations to (then) recently approved...), certain Penal Code sections, Senate Bill 678 (related to authority of attorney general to protect...

  19. 75 FR 30453 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-06-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers... National Association of Securities Dealers, Inc., the Financial Industry Regulatory Authority, Inc., or...

  20. 75 FR 70757 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-11-18

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a... 12, 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc... Kimmel, Executive Director, Financial Information Forum, to Elizabeth M. Murphy, Secretary,...

  1. 77 FR 55517 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-09-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a.... Introduction On May 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... General Counsel, Securities Industry and Financial Markets Association, dated June 26, 2012...

  2. 75 FR 62439 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-10-08

    ...-2010-043] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA..., 2010 (``Wiesenberg Letter''); Letter from Manisha Kimmel, Executive Director, Financial...

  3. 75 FR 61793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-10-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... Encrypted September 29, 2010. I. Introduction On June 2, 2010, the Financial Industry Regulatory Authority... Taunt, Chief Executive Officer, Regal Financial Group, to Elizabeth M. Murphy, Secretary,...

  4. 75 FR 40000 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change Relating to the Restated Certificate of Incorporation of Financial Industry Regulatory Authority, Inc. July 2, 2010. On May 21, 2010, Financial Industry Regulatory Authority, Inc....

  5. 76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-08-04

    .... Applicant Trade name Approval date P050050 FDA-2011-M-0323....... Small Bone Scandinavian total ankle May 27, 2009. Innovations, Inc. replacement system. P060004(S1) FDA-2011-M-0256... Carl Zeiss Meditec,...

  6. 75 FR 64724 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-10-20

    ... Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Performance... that perform chemical, microbiological and whole effluent toxicity (WET) analyses required in the NPDES... permitting responsibility and laboratories doing chemical/microbiological analysis and...

  7. 76 FR 46352 - Approval of Noise Compatibility Program for San Diego International, San Diego, CA

    Science.gov (United States)

    2011-08-02

    ... Federal program. The FAA does not substitute its judgment for that of the airport proprietor with respect... Attenuate Eligible Residential Units has been approved for homes or noncompatible development that...

  8. 77 FR 3213 - Approval and Promulgation of Implementation Plans; Tennessee; 110(a)(1) and (2) Infrastructure...

    Science.gov (United States)

    2012-01-23

    ... circumstances. In particular, the data and analytical tools available at the time the state develops and submits... correct errors in past actions, such as past approvals of SIP submissions.\\17\\ [[Page 3218

  9. 12 CFR 563b.555 - How do my members approve a charitable contribution?

    Science.gov (United States)

    2010-01-01

    ... charitable contribution as part of a second step stock conversion, you must also have your minority shareholders separately approve the charitable contribution by a majority of their total eligible votes....

  10. 78 FR 24990 - Approval and Promulgation of Implementation Plans; Ohio; Volatile Organic Compound Emission...

    Science.gov (United States)

    2013-04-29

    ... control technology (RACT) requirements of the Clean Air Act (Act). EPA proposed these rules for approval... roof tanks and external floating roof tanks.'', effective May 12, 2011. (D) Ohio Administrative...

  11. 77 FR 73560 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Redesignation of...

    Science.gov (United States)

    2012-12-11

    ..., redundant reductions on top of those achieved by CAIR. EPA believes this is precisely the type of irrational..., West Virginia currently has an approved NSR program, codified in 45 CSR 19. See 71 FR 64468 (November...

  12. 78 FR 72626 - Notice of Request for Renewal of a Currently Approved Information Collection (Pathogen Reduction...

    Science.gov (United States)

    2013-12-03

    ... Pathogen Reduction and HACCP Systems information collection. Respondents: Meat and poultry establishments... Approved Information Collection (Pathogen Reduction/HACCP) AGENCY: Food Safety and Inspection Service, USDA... pathogen reduction and Hazard Analysis and Critical Control Point (HACCP) Systems requirements because...

  13. 24 CFR 401.405 - Restructuring Commitment review and approval by HUD.

    Science.gov (United States)

    2010-04-01

    ... condition for approval, or reject the Plan. If the Plan is rejected, HUD will inform the PAE of the reasons for rejection, and the PAE will inform the owner. HUD's rejection of the Plan is subject to...

  14. 75 FR 13336 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2010-03-19

    ... Charge Expiration Date: August 1, 2020. Classes of Air Carriers not Required to Collect PFC'S: (1.... DETERMINATION: Partially approved. The FAA determined that the renovation of the Customs and Immigration...

  15. 75 FR 54419 - Notice: Elimination of Expiration Dates for Classification Approvals

    Science.gov (United States)

    2010-09-07

    ... implementation. For instance, explosives assigned EX numbers, and self-reactive materials and organic peroxide... to include all types of classification approvals, including explosives, oxidizing substances, organic peroxide materials and self- reactive substances. PHMSA is changing its policy and eliminating...

  16. 78 FR 72874 - Revision of a Currently Approved Information Collection for the Energy Efficiency and...

    Science.gov (United States)

    2013-12-04

    ... Revision of a Currently Approved Information Collection for the Energy Efficiency and Conservation Block... information and reporting guidance concerning the Energy Efficiency and Conservation Block Grant (EECBG...: ``Energy Efficiency and Conservation Block Grant (EECBG) Program Status Report''; (3) Type of...

  17. 77 FR 22571 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2012-04-16

    ...; search data sources; complete and review the collection of information; and transmit or otherwise... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Agency Information Collection Activities; Submission to OMB for Review and Approval;...

  18. 78 FR 13052 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2013-02-26

    ... information; search data sources; complete and review the collection of information; and transmit or otherwise... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Agency Information Collection Activities; Submission to OMB for Review and Approval;...

  19. 76 FR 64962 - Accreditation and Approval of Intertek USA, Inc., as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2011-10-19

    ... Pintail St., St. Rose, LA 70087, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions...

  20. 77 FR 12866 - Accreditation and Approval of Amspec Services LLC, as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2012-03-02

    ... Services LLC, 12154 B River Road, St. Rose, LA 70087, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes, in...