Department of Health and Human Services July 2009 – Federal Register Recent Federal Regulation Documents
Results 301 - 344 of 344
Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twentieth meeting. The meeting will be open to the public.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold two teleconference meetings. The meetings are open to the public. Pre- registration is required for both public attendance and comment. Individuals who wish to attend the meetings and/or participate in the public comment session should either e-mail nvpo@hhs.gov or call 202- 690-5566 to register.
Medical Examination of Aliens-Removal of Human Immunodeficiency Virus (HIV) Infection From Definition of Communicable Disease of Public Health Significance
The Centers for Disease Control and Prevention (CDC), within the U.S. Department of Health and Human Services (HHS), is proposing to revise the Part 34 regulation to remove ``Human Immunodeficiency Virus (HIV) infection'' from the definition of ``communicable disease of public health significance.'' HHS/CDC is also proposing to remove references to ``HIV'' from the scope of examinations in its regulations. Aliens infected with a ``communicable disease of public health significance'' are inadmissible into the United States under the Immigration and Nationality Act (INA).
Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. This guidance describes how FDA will comply with the FDAAA requirement and procedures for application holders to update the labeling of antibacterial drug products and antimicrobial susceptibility testing (AST) devices.
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).
Submission for OMB Review; Comment Request; Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information From NCI Cancer Information Service (CIS) Clients (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 1, 2009, (Vol. 74, No. 83, p. 20320) and allowed 60 days for public comment. One public comment was received on May 1, 2009 requesting a copy of the data collection plans. An e-mail response was sent on May 5, 2009, which included the Supporting Statements and the screenshots of the surveys. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
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.
Prospective Grant of Exclusive License: Pain Control by Selective Ablation of Pain-Sensing Neurons by Administration of Resiniferatoxin
This is notice, in accordance with 35 U.S.C. 209(c)(l) and 37 CFR Part 404.7(a)(l)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in PCT Patent Application PCT/US2001/09425 [HHS Ref. E-109-2000/0-PCT-01], US Patent Application 10/472,874 [HHS Ref. E-109-2000/0-US-02], both entitled ``Molecular Neurochirurgerie for Pain Control Administering Locally Capsaicin or Resiniferatoxin'', and Canadian Patent Application 2442049 [HHS Ref. E-109-2000/0-CA-03] entitled ``Selective Ablation of Pain-Sensing Neurons by Administration of a Vanilloid Receptor Agonist'', and all continuing applications and foreign counterparts, to Sherrington Pharmaceuticals, which has offices in New York, N.Y. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.
Regulation of Tobacco Products; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket to obtain information on the implementation of the Family Smoking Prevention and Tobacco Control Act. FDA is establishing this docket in order to provide an opportunity for all interested parties to provide information and share views on the implementation of the new law.
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