Department of Health and Human Services February 24, 2009 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 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 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 (the PRA). Elsewhere in this issue of the Federal Register, FDA is announcing that a proposed collection of information regarding dietary supplement labeling requirements and recommendations has been submitted for OMB review.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dietary Supplement Labeling Requirements and Recommendations under the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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. Elsewhere in this issue of the Federal Register, FDA is announcing that a proposed collection of information regarding labeling requirements for nonprescription human drugs marketed without an approved application has been submitted to OMB for review.
Opportunity To Collaborate in the Evaluation of Rapid Diagnostic Tests for HIV and HCV
The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) at the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (DHHS) seeks one or more companies that have developed or are distributing rapid diagnostic tests for HIV or HCV and are interested in marketing the tests for use in the United States. The Division of HIV/AIDS Prevention and the Division of Viral Hepatitis are interested in evaluating such tests. The evaluation will include determination of sensitivity and specificity of the test, and may also evaluate the predictive value of two or more different tests used in combination in populations of low prevalence. This collaboration will have an expected duration of two (2) to three (3) years. The goals of the collaboration include the timely development of data to be used to determine whether the test could be used in screening and/or diagnosis for HIV or HCV in the United States, and to examine laboratory-based or rapid point-of-care tests. These tests require high sensitivity to detect persons with acute and longer-standing HIV infection; or high specificity to distinguish persons with acute infection from those with longer- standing infection; or high specificity for tests that can be used as to confirm HIV-1 or HIV-2 infection. Acute HIV infection is defined as the early infection period associated with a transient symptomatic illness, high viral load, and expansive immunologic response. For HCV testing, rapid tests to be used in the screening setting require high sensitivity and confirmatory tests with high specificity. Confidential proposals, preferably six pages or less (excluding appendices), are solicited from companies who have a product that is suitable for commercial distribution.
Public Meeting of the President's Council on Bioethics
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-sixth meeting; the primary focus of discussion will be the future of public bioethics and national bioethics commissions in the United States. The full agenda will be posted on the Council's Web site at https://www.bioethics.gov prior to the meeting. Subjects discussed at past Council meetings (although not on the agenda for the March 2009 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, personalized medicine, standards for the determination of death, children and bioethics, and lifespan-extension, among others. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004); Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004); Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005); Taking Care: Ethical Caregiving in Our Aging Society (September 2005); Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics (March 2008); The Changing Moral Focus of Newborn Screening: An Ethical Analysis by The President's Council on Bioethics (December 2008); and Controversies in the Determination of Death: A White Paper by The President's Council on Bioethics (December 2008). Reports are forthcoming on organ transplantation and health care reform.
Educational Development and Partnership Division, Office of Head Start
Notice is hereby given that the Administration for Children and Families (ACF), Educational Development and Partnership Division (EDPD) will award a non-competitive successor award to Southwestern Indian Polytechnic Institute (SIPI) a Tribal College federally charted and operated by the Bureau of Indian Education, Department of the Interior located in Albuquerque, NM. Southwestern Indian Polytechnic Institute (SIPI) will assume a grant award under the Head Start Career Advancement Partnership Program for the remainder of the project period January 22, 2009 to September 29, 2009. The Board of Regents, Southwestern Indian Polytechnic Institute, has relinquished the grant to its Federal entity to ensure greater internal controls.
Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator- Associated Pneumonia; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), the American College of Chest Physicians (ACCP), the Society of Critical Care Medicine (SCCM), and the American Thoracic Society (ATS) regarding scientific issues in clinical trial design for hospital- acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). This public workshop is intended to provide information about, and gain perspective from, health care providers, academia, and industry on various aspects of antimicrobial drug development for HAP and VAP, including diagnosis of HAP and VAP, effect of antimicrobial treatment for HAP and VAP, endpoints for trials of HAP and VAP, and statistical issues in analysis of results of trials in HAP and VAP. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on March 31, 2009, from 8 a.m. to 6 p.m. and on April 1, 2009, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited and available only on a first-come, first-served basis. Contact: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, Office of Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, Silver Spring, MD 20993- 0002, 301-796-1300. Registration: To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax numbers) to HAPwkshp@fda.hhs.gov by March 23, 2009. Persons without access to the Internet can call 301-796-1300 to register. Registration is free for the public workshop. Interested parties are encouraged to register early because space is limited. Seating will be available on a first-come, first-served basis. Persons needing a sign language interpreter or other special accommodations should notify Chris Moser or Lori Benner (see Contact) at least 7 days in advance.
Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of March 27, 2009, for the direct final rule that appeared in the Federal Register of November 12, 2008 (73 FR 66750). The direct final rule amends the agency's regulations to update the statutory citations regarding the new civil monetary penalties prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA), amends the regulations to include the new FDAAA penalties, and adjusts the preceding maximum civil penalty amounts for inflation as prescribed by the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA). This document confirms the effective date of the direct final rule.
Arthritis Advisory Committee; Notice of Postponement of Meeting
The Food and Drug Administration (FDA) is postponing the meeting of the Arthritis Advisory Committee scheduled for March 5, 2009. This meeting was announced in the Federal Register of January 29, 2009 (74 FR 5165). The postponement is due to the need to complete the review of additional data submitted by the applicant. Future meeting dates will be announced in the Federal Register.
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