Health Resources and Services Administration September 2006 – Federal Register Recent Federal Regulation Documents

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the eleventh meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on November 2, 2006, and from 9 a.m. to 3 p.m. on November 3, 2006, at the Bethesda DoubleTree Hotel, 8120 Wisconsin Avenue, Bethesda, MD 20814. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

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.

The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) published in the Federal Register of May 12, 2006 (71 FR 27606), a direct final rule to amend the regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation; and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products. The comment period closed July 26, 2006. HRSA and FDA are withdrawing the direct final rule because FDA received significant adverse comment. The agencies will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published as a companion to the direct final rule (71 FR 27649).

The Health Resources and Services Administration published a document in the Federal Register on August 11, 2006, concerning changes to the organization and functions of the Office of the Administrator (RA) and the HIV/AIDS Bureau (RV). The document omitted information regarding movement of the Center for Quality and also erroneously included the Telehealth function within the HIV/AIDS Bureau, which was moved to the Office of Health Information Technology (RT) on 12/27/05 (70 FR 76463-76465).