Department of Health and Human Services September 21, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in regulations governing the use of radioactive drugs for basic informational research.

The Food and Drug Administration (FDA) is announcing a public meeting to solicit views and information from interested persons on issues concerning how the agency can best plan and apply information technology (IT) resources to support the process for the review of human drug applications. In particular, FDA is seeking views and information from interested persons to identify and prioritize IT solutions that will support the process for the review of human drug applications. To help solicit such information and views, FDA is seeking responses to specific questions (see section IV of this document).