Department of Health and Human Services March 1, 2010 – Federal Register Recent Federal Regulation Documents
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Office of Dietary Supplements (ODS) 2010-2014 Strategic Plan
The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) has completed a strategic planning process resulting in the development of the ODS Strategic Plan for 2010-2014, entitled Strengthening Knowledge and Understanding of Dietary Supplements. The strategic plan is available in pdf format on the ODS Web site: https://ods.od.nih.gov/pubs/strategicplan/StrategicPlan2010- 2014.pdf.
Determination of Regulatory Review Period for Purposes of Patent Extension; FIRMAGON
The Food and Drug Administration (FDA) has determined the regulatory review period for FIRMAGON and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
Administration on Aging Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of a Currently Approved Information Collection; Program Announcement and Grant Application Instructions Template for the 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 standard Program Announcement and Grant Application Instructions template for Older Americans Act Title IV Discretionary Grant Program.
Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Non- Inferiority Clinical Trials.'' This draft guidance provides sponsors and review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) with the agency's interpretation of the underlying principles involved in the use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or therapeutic biologic product. The draft guidance offers advice on when NI studies can be interpretable, how to choose the NI margin, and how to analyze the results.
Agency Information Collection Activities; Proposed Collection; Comment Request; Pretesting of Tobacco Communications
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 pretesting of tobacco communications.
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
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 the information collection requirements relating to FDA regulations for human tissue intended for transplantation.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).
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