Department of Health and Human Services September 29, 2011 – Federal Register Recent Federal Regulation Documents
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Request for Notification From Industry Organizations Interested in Participating in the Selection Process and Request for Nominations for a Nonvoting Industry Representative on the Vaccines and Biological Products Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve the Vaccines and Related Biological Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies effective with this notice.
Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Time and Extent Applications for Nonprescription Drug Products.'' This guidance describes a two-step process on how to request that a new condition be added to the over-the-counter (OTC) drug monograph system. The process includes submitting a time and extent application (TEA) to determine whether a condition is eligible for inclusion in the OTC drug monograph system and, if the condition is found to be eligible, submitting safety and effectiveness data. This guidance is designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the draft guidance for industry entitled ``Time and Extent Applications'' published in the Federal Register on February 10, 2004 (69 FR 6309).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
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).
Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is opening a comment period for the notice of public workshop published in the Federal Register of July 28, 2011 (76 FR 45268). In that notice, FDA announced a public workshop regarding the approach of the Center for Drug Evaluation and Research to addressing drug shortages. FDA is opening a comment period in light of public interest in this topic and in order to gain additional insight about the causes and impact of drug shortages, and possible strategies for preventing or mitigating drug shortages.
Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and Submission; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (215) entitled ``Target Animal Safety and Effectiveness Protocol Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine, Office of New Animal Drug Evaluation. The recommendations included in this guidance are intended to reduce the time to protocol concurrence.
Prospective Grant of Exclusive License: Compositions and Method for Preventing Reactogenicity Associated with Administration of Immunogenic Live Rotavirus Compositions
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(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 U.S. Provisional Patent Application No. 60/178,689, filed January 28, 2000 [HHS Ref. No. E-088-2000/0-US-01], now expired; PCT Patent Application No. PCT/US01/02686 [HHS Ref. No. E-088-2000/0-PCT-02] filed January 26, 2001, which published as WO/2001/54718 on August 2, 2001, now expired; U.S. Patent No. 7,431,931 [HHS Ref. No. E-088-2000/0-US-06]; Australian Patent No. 784344 [HHS Ref. No. E-088-2000/0-AU-04]; German Patent No. 60141681.308 [HHS Ref. No. E-088-2000/0-DE-08]; French Patent No. 1251869 [HHS Ref. No. E-088-2000/0-FR-09]; United Kingdom Patent No. 1251869 [HHS Ref. No. E-088-2000/0-GB-10]; and Canadian Patent Application No. 2398428 [HHS Ref. No. E-088-2000/0-CA-05], entitled ``Compositions and Method for Preventing Reactogenicity Associated with Administration of Immunogenic Live Rotavirus Compositions,'' and all continuing applications to International Medica Foundation, having a place of business in Rochester, Minnesota. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to ``rhesus-based rotavirus therapeutic and/or prophylactic vaccines.''
Request for Information: Announcement of Carcinogen and Recommended Exposure Limit (REL) Policy Assessment
On August 23, 2011, the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) published a notice in the Federal Register (76 FR 52664) announcing its intent to ``review its approach to classifying carcinogens and establishing recommended exposure limits (RELs) for occupational exposures to hazards associated with cancer.'' As part of this effort, NIOSH requested initial input on issues, and answers to 5 questions. NIOSH has also created a new NIOSH Cancer and RELs Policy Web Topic Page [see https://www.cdc.gov/niosh/topics/cancer/ policy.html] to provide additional details about this effort and progress updates. Written comment was to be received by September 22, 2011. NIOSH has received a request to extend the comment period to permit the public more time to gather and submit information. NIOSH is extending the public comment period to Friday, December 30, 2011. Public Comment Period: Written or electronic comments must be received on or postmarked by Friday, December 30, 2011.
Patient Safety Organizations: Voluntary Relinquishment From Illinois PSO
Illinois PSO: AHRQ has accepted a notification of voluntary relinquishment from the Illinois PSO of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.
Patient Safety Organizations: Voluntary Relinquishment From HPI-PSO
HPI-PSO: AHRQ has accepted a notification of voluntary relinquishment from the HPI-PSO, a component entity of Healthcare Performance Improvement, LLC, of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.
Patient Safety Organizations: Voluntary Relinquishment From the Patient Safety Group
HPI-PSO: AHRQ has accepted a notification of voluntary relinquishment from The Patient Safety Group of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b- 21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.
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