Department of Health and Human Services 2008 – Federal Register Recent Federal Regulation Documents

This notice announces the availability of the final toxicological profile for perchlorates, which completes the nineteenth set prepared by ATSDR. The announcement of seven toxicological profiles for the nineteenth set was published in the Federal Register on October 25, 2005 (70 FR 61622).

AHRQ and OCR are announcing the availability of the guidance entitled ``Implementing the Patient Safety and Quality Improvement Act of 2005 Including How to Become a Patient Safety Organization.'' The Interim Guidance document explains how the Department of Health and Human Services (HHS) will begin implementing the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), how an entity can become a Patient Safety Organization (PSO), and how information may be protected as Patient Safety Work Product (PSWP) in the interim period prior to the promulgation of a final regulation. To access the Interim Guidance, visit AHRQ's PSO Web site at https://www.pso.ahrq.gov.

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 seventeenth meeting. The meeting will be open to the public.

The NTP announces the availability of the draft background document for cobalt-tungsten carbide powders and hard metals by October 10, 2008 on the RoC Web site (https://ntp.niehs.nih.gov/go/29679) or in printed text from the RoC (see ADDRESSES below). The NTP invites the submission of public comments on the draft background document for cobalt-tungsten carbide powders and hard metals. The expert panel will meet on December 9-10, 2008, at the Sheraton Chapel Hill Hotel, One Europa Drive, Chapel Hill, NC 27514 to peer review the draft background document for cobalt-tungsten carbide powders and hard metals and, once completed, make a recommendation regarding the listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for cobalt-tungsten carbide powders and hard metals in the 12th Edition of the RoC (12th RoC). The RoC expert panel meeting is open to the public with time scheduled for oral public comments. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the NTP will post the final background document and the expert-panel peer review report on the RoC Web site.

The National Institutes of Health (NIH) is issuing standards to implement provisions of the Chimpanzee Health Improvement, Maintenance, and Protection Act (CHIMP Act) authorizing the Secretary of the Department of Health and Human Services (HHS) to develop and publish standards of care for chimpanzees held in the sanctuary system supported by federal funds authorized under the CHIMP Act. This regulation applies to only those facilities receiving federal funds as a part of the federally funded chimpanzee sanctuary system.

Through this interim final rule, the Secretary removes the category of vaccines containing live, oral, rhesus-based rotavirus, Category XII, from the Vaccine Injury Table (Table). The Table includes a list of covered vaccines under the National Vaccine Injury Compensation Program (VICP). The VICP provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This interim final rule is technical in nature. Even prior to the publication of this final rule, Category XII, the category that is being removed from the Table, only applied to vaccines that were administered on or before August 26, 2002. Given the applicable statute of limitations and the fact that Category XII limited its application to vaccines administered on or before August 26, 2002, the Secretary believes that no persons have claims that could be pursued under that category. Petitioners may still be able to file petitions relating to rotavirus vaccines under Category XI of the Table, the category of ``rotavirus vaccines,'' which does not include any associated injuries. Although the Secretary believes that the changes made in this interim final rule are noncontroversial as they do not affect the rights of any potential petitioners with the VICP, the Department is seeking public comment on this interim final rule. Written comments must be submitted on or before November 10, 2008. The Department will consider the comments received and will decide whether to amend the Table based on such comments.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.