Department of Health and Human Services February 15, 2008 – Federal Register Recent Federal Regulation Documents

This notice cancels the FY 2004 Wilson-Fish Discretionary Grant Program Standing Announcement (HHS-2004-ACF-ORR-RW-0005) that was published in the Federal Register of April 5, 2004 (69 FR 17692-01). The Wilson-Fish Announcement will be published in FY 2008 at the Administration for Children and Families' Grant Opportunities Web page at: https://www.acf.hhs.gov/grants/ and at https:// www.grants.gov. The title of the new Announcement will be the Wilson- Fish Alternative Program Standing Announcement. The new Standing Announcement and application packages will also be available at https:// www.grants.gov. Interested parties should register with https:// www.grants.gov to receive e-mail alerts announcing publication, application due dates, and application requirements.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses.'' FDA is issuing this draft guidance to inform industry and agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for in vitro diagnostic devices intended for the detection or detection and differentiation of influenza viruses.

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 present MedWatch Forms 3500 and 3500A (also known as MedWatch reporting forms) having an OMB expiration date of October 31, 2008. These forms are presently used to report to the agency about adverse events, product problems, and medication/device use errors that occur with FDA regulated products, including drugs, biologicals, medical devices, special nutritional products, dietary supplements, and non-prescription (over-the-counter (OTC)) human drug products marketed without an approved application.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Feasibility of secure messaging for pediatric patients with chronic disease: Pilot implementation in pediatric respiratory medicine.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.