Department of Health and Human Services September 18, 2009 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 14, 2009, pages 17195-17196, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995 unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines'' dated September 2009. The draft guidance document provides recommendations to sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine on critical clinical considerations for investigational studies of these products. The draft guidance applies to therapeutic cancer vaccines that are intended to be administered to patients with an existing cancer for the purpose of treatment. The draft guidance does not apply to products intended to be administered to patients to prevent or decrease the incidence of cancer and does not apply to adoptive immunotherapeutic products such as T cell or NK cell products.

HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PIN referenced above. Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments.