Department of Health and Human Services January 25, 2005 – Federal Register Recent Federal Regulation Documents
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Establishment of Vaccination Clinics; User Fees for Investigational New Drug (IND) Influenza Vaccine Services and Vaccines
We are amending 42 CFR part 70 to establish vaccination clinics and a user fee in connection with the administration of vaccination services and vaccine. On December 7, 2004, HHS Secretary Tommy G. Thompson announced the purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to areas most in need as determined by State public health authorities. The Fluarix vaccine has been approved in seventy-eight foreign countries, and FDA has recently reviewed extensive manufacturing and summary clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine, although not licensed in the United States, is suitable for use under an Investigational New Drug application (IND). The Food and Drug Administration (FDA) reviewed GSK's IND application as well as the clinical protocol and manufacturing data. CDC and CDC's Institutional Review Board approved the GSK flu vaccine response protocol including the informed consent document. To ensure that the vaccine is properly administered to individuals identified to be most at risk and facilitate compliance with IND requirements, CDC is establishing vaccination clinics. CDC is proceeding without delay because of the unprecedented nature of this season's influenza vaccine shortage caused by contamination problems with Chiron Corporation's production facility in the United Kingdom, which effectively cut in half the expected United States supply of inactivated influenza vaccine. A user fee is being established in order to recoup the costs associated with administering the vaccine and for the vaccine itself. All individuals, other than those who are enrolled in Medicare Part B, will be required to pay the user fee.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
In the Federal Register notice of April 13, 2004 (69 FR 19644), the Department of Health and Human Services (``HHS'' or ``Department'') published final changes to the Mandatory Guidelines for Federal Workplace Drug Testing Programs. These changes established specimen validity testing standards and reporting procedures for Federal agency urine specimens collected under the Mandatory Guidelines for Federal Workplace Drug Testing Programs. These changes to the Mandatory Guidelines were subject to further comment only on the creatinine criterion that is part of the requirement to report a urine specimen as substituted because the Department based this criterion on information received after the comment period on the proposed changes published on August 21,2001 closed. After reviewing the comments received regarding this issue, the Department has concluded that the 2 mg/dL creatinine criterion established in the April 13, 2004, Federal Register notice (69 FR 19644) for a substituted specimen is the appropriate cutoff concentration to use for reporting a urine specimen as substituted.
2005 White House Conference on Aging Policy Committee
Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given of the fourth Policy Committee meeting concerning planning for the 2005 White House Conference on Aging. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person listed below in advance of the meeting.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Biomedical Imaging and Bioengineering; Notice of Public Comment Period
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is developing its first 5-year strategic plan (2005-2009), and invites the public to provide input regarding NIBIB's areas of scientific emphasis, operational emphasis, and strategic priorities. The public is invited to provide comments via the NIBIB Web site.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. This meeting is open to the public. A description of the Council's functions is included also with this notice.
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