Department of Health and Human Services April 7, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Agency Information Collection Activities; Proposed Collection; Comment Request; Semi-Annual and Final Reporting Requirements for Older Americans Act Title IV Discretionary Grant Program
The Administration on Aging (AoA) 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 the information collection requirements relating to the continuation of an existing collection for Performance Progress Reports for Older Americans Act Title IV grantees.
Generic New Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2009 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for a generic new animal drug, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2009.
Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards
The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a guidance document entitled, ``Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards.'' The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on the OHRP Web site at https://www.hhs.gov/ohrp/humansubjects/guidance/gina.html and https://www.hhs.gov/ohrp/humansubjects/guidance/gina.pdf, is intended primarily for investigators who conduct, and institutional review boards (IRB) that review, non-exempt human subjects research involving genetic testing or collection of genetic information (hereinafter referred to as ``genetic research''). The guidance document provides background on protections provided by the Genetic Information Nondiscrimination Act of 2008 (GINA) and discusses some of the implications of GINA for investigators who conduct, and IRBs that review, genetic research, particularly with respect to the criteria for IRB approval of research and the requirements for obtaining informed consent under the Department of Health and Human Services (HHS) regulations for the protection of human subjects (45 CFR part 46).
Sodium Shale Oil Sulfonate Eligibility for Inclusion in Monograph; Over-the-Counter Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products for Human Use; Request for Safety and Effectiveness Data
As part of our ongoing review of over-the-counter (OTC) drug products, we (Food and Drug Administration (FDA)) are announcing a call-for-data for safety and effectiveness information for sodium shale oil sulfonate (SSOS), 0.5 to 2.0 percent, as a rinse-off treatment for dandruff. We have reviewed a time and extent application (TEA) for SSOS and determined that it is eligible for consideration in our OTC drug monograph system. We will evaluate the submitted data and information to determine whether SSOS can be generally recognized as safe and effective (GRASE) as an OTC rinse-off treatment for dandruff.
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