Department of Health and Human Services May 11, 2011 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.

The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research's (CDER's) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the sponsor for Avastin. Genentech and CDER are the parties to the hearing. The issues to be discussed and resolved at the hearing relate directly to the statutory and regulatory standard for FDA to withdraw accelerated approval of the metastatic breast cancer (MBC or breast cancer) indication for Avastin.

NIH is further extending the period for public comments on (1) NIH's adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service (PHS) support for activities involving animals; and (2) if NIH decides to adopt the eighth edition of the Guide, NIH's proposed implementation plan, which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012. NIH will consider comments on (1) The adoption of the Guide and (2) the implementation plan. The notice on the proposed adoption and implementation plan for the eighth edition of the Guide was published in the Federal Register on February 24, 2011 (76 FR 10379). The comment period is extended by an additional 30 days and thus will end on May 24, 2011. Additionally, character limits on the comment form fields have been removed.