Department of Health and Human Services May 5, 2009 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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.
Implantation or Injectable Dosage From New Animal Drugs; Change of Sponsor; Repository Corticotropin Injection
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Summit Hill Laboratories to Putney, Inc.
Master Plan for Rocky Mountain Laboratories Record of Decision
The National Institutes of Health (NIH), an operating division of the Department of Health and Human Services (HHS), has decided, after completion of a Final Environmental Impact Statement (FEIS) and a thorough consideration of the public comments on the Draft EIS and the Final EIS, to implement the Proposed Action, which is identified as the Preferred Alternative in the FEIS. This action involves the establishment of a long-range physical Master Plan for Rocky Mountain Laboratories (RML) in Hamilton, Montana to guide future development of the campus. This alternative accounts for potential growth in RML personnel, possible land acquisitions, and consequent construction of new administrative and research-related space over the 20-year planning period.
New Animal Drugs; Change of Sponsor's Name
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from IVX Animal Health, Inc., to Teva Animal Health, Inc.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Revision of the Requirements for Publication of License Revocation
The Food and Drug Administration (FDA) is clarifying the regulatory procedures for notifying the public about the revocation of a biologics license to be consistent with current practices. FDA is amending the regulations in accordance with the agency's direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment rulemaking to provide a procedural framework to finalize the rule in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
Revision of the Requirements for Publication of License Revocation; Companion Document to Direct Final Rule
The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license to be consistent with current practices. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.
Substances Prohibited From Use in Animal Food or Feed; Confirmation of Effective Date of Final Rule; Correction
The Food and Drug Administration (FDA) is correcting a final rule; confirmation of effective date, that appeared in the Federal Register of Friday, April 24, 2009 (74 FR 18626) (the April 24, 2009, final rule; confirmation of effective date). That document had confirmed the effective date of April 27, 2009, for a final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ``Substances Prohibited From Use in Animal Food or Feed.'' In the April 24, 2009, final rule; confirmation of effective date, the agency also established a compliance date of October 26, 2009, in order to allow additional time for renderers to comply with the new requirements. The April 24, 2009, final rule; confirmation of effective date was published with an inadvertent error in the ``Background'' section. This document corrects that error.
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