Department of Health and Human Services February 2011 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 322
Proposed Collection; Comment Request; National Institutes of Health Loan Repayment Programs
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Division of Loan Repayment, National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: National Institutes of Health Loan Repayment Programs. Type of Information Collection Request: Extension of a currently approved collection (OMB No. 0925-0361, expiration date 06/30/11). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674- 4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-14, NIH 2674- 15, NIH 2674-16, NIH 2674-17, NIH 2674-18, and NIH 2674-19. Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., PhD, Pharm.D., D.D.S., D.M.D., D.P.M., D.C., and N.D. degree holders, or the equivalent, who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees or scientists funded by domestic nonprofit organizations for a minimum of 2 years (3 years for the General Research Loan Repayment Program (LRP)) in research areas supporting the mission and priorities of the NIH. The AIDS Research LRP (AIDS-LRP) is authorized by section 487A of the Public Health Service Act (PHS Act) (42 U.S.C. 288-1), and the Clinical Research LRP for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by section 487E (42 U.S.C. 288-5). The General Research LRP (GR-LRP) is authorized by section 487C of the PHS Act (42 U.S.C. 288-3), and the Clinical Research LRP (LRP-CR) is authorized by section 487F (42 U.S.C. 288-5a). The Pediatric Research LRP (PR-LRP) is authorized by section 487F of the PHS Act (42 U.S.C. 288-6), and the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to section 487E (42 U.S.C. 288-5). The Contraception and Infertility Research LRP (CIR-LRP) is authorized by section 487B of the PHS Act (42 U.S.C. 288-2), and the Health Disparities Research LRP (HD- LRP) is authorized by section 485G (42 U.S.C. 287c-33). The Loan Repayment Programs can repay up to $35,000 per year toward a participant's extant eligible educational loans, directly to financial institutions. The information proposed for collection will be used by the Division of Loan Repayment to determine an applicant's eligibility for participation in the program. Frequency of Response: Initial application and one- or two-year renewal application. Affected Public: Individuals or households, nonprofits, and businesses or other for-profit. Type of Respondents: Physicians, other scientific or medical personnel, and institutional representatives. The annual reporting burden is as follows:
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Meleik Goodwill, Ph.D., Wadsworth Center, N.Y.S. Department of Health: Based on the Wadsworth Center report and the oversight review conducted by the Office of Research Integrity (ORI), the U.S. Public Health Service (PHS) found that Meleik Goodwill, Ph.D., former postdoctoral fellow, Wadsworth Center, N.Y.S. Department of Health, engaged in research misconduct in research supported by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), grant R21 ES013269-02. Specifically, PHS found that the Respondent engaged in research misconduct by the fabrication of data for growth curves presented in Figure 1 in the 2007 Journal of Neuroimmunology article (Goodwill, M.K., Lawrence, D.A., & Seegal, R.F. ``Polychlorinated biphenyls induce proinflammatory cytokine release and dopaminergic dysfunction: Protection in interleukin-6 knockout mice.'' Journal of Neuroimmunology 183(1-2):125-132, 2007), and by the use of composite images of Western- blot bands from unrelated experiments done in 2005 that were falsely labeled as if from different experiments to construct Figure 4A in the 2007 Journal of Neuroimmunology article. Figure 4B of the article also was falsified by use of identical sets of number for different treatments. The 2007 Journal of Neuroimmunology article was retracted in J. Neuroimmunol. 197(1):197, 2008. Dr. Goodwill has entered into a Voluntary Settlement Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on January 21, 2011:
Medical Device Innovation Initiative; Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of a document for public comment entitled ``Medical Device Innovation Initiative'' (the report). The report proposes potential actions for FDA's Center for Devices and Radiological Health (CDRH) to facilitate the development, assessment, and regulatory review of innovative medical devices.
Medical Device Innovation Initiative; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``CDRH's Medical Device Innovation Initiative Public Workshop.'' The purpose of the public meeting is to solicit feedback on select actions outlined in the Center for Devices and Radiological Health's (CDRH) document, ``Medical Device Innovation Initiative'' (report). FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and the proposed solutions. In addition, the Agency requests comments on the Innovation Pathway proposed under the report.
Determination That DECASPRAY (Dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX (Dexamethasone) Topical Aerosol, 0.01%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dexamethasone topical aerosol, 0.04% and 0.01%, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for dexamethasone topical aerosol, 0.04% and 0.01%, future applicants are advised that they may not be able to obtain DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, for bioequivalence testing because the products have not been commercially available for a number of years. An ANDA applicant who is unable to obtain DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect.
Food Additives Permitted in Feed and Drinking Water of Animals; Formic Acid
The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid as an acidifying agent in swine feed. This action is in response to a food additive petition filed by Kemira Oyj of Finland.
30-Day Submission Period for Requests for ONC-Approved Accreditor (ONC-AA) Status
This notice announces the 30-day period for submission of requests for ONC-Approved Accreditor (ONC-AA) status.
Statement of Organization, Functions, and Delegations of Authority; Office of the National Coordinator for Health Information Technology
The Office of the National Coordinator for Health Information Technology has reorganized one of its functions in order to more effectively meet the mission outlined by The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA). The reorganization affects two of the Director-level offices: The Office of the Chief Scientist and the Office of Economic Analysis and Modeling.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration Regulated Products)
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Presubmission Conferences, New Animal Drug Applications and Supporting Regulations, and Food and Drug Administration Form 356V
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on paperwork associated with applications for new animal drugs.
Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Drug Product Communications, as Used by the Food and Drug Administration
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a generic clearance to collect information to support communications used by FDA about drug products. This data collection will informally gauge public opinion on a variety of subjects related to consumer, patient, or healthcare professional perceptions and use of drug and biological products and related materials, including, but not limited to, direct-to-consumer prescription drug promotion, physician labeling of prescription drugs, Medication Guides, over-the-counter drug labeling, emerging risk communications, patient labeling, online sales of medical products, and consumer and professional education.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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