The Federal Register

Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; Reopening of the Comment

Tue, Dec 11 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is reopening until February 11, 2008, the comment period for the proposed rule published in the Federal Register of October 19, 2005 (70 FR 60751), (herein after referred to as the 2005 proposed rule). In that document, FDA proposed to amend its regulations to provide for the use of fluid ultrafiltered (UF) milk in the manufacture of standardized cheeses and related cheese products. FDA received a number of comments that were opposed to the proposed requirement to declare fluid UF milk, when used, as ``ultrafiltered milk'' or ``ultrafiltered nonfat milk,'' as appropriate, in the ingredient statement of the finished cheese. FDA is reopening the comment period on the 2005 proposed rule to seek further comment only on two specific issues raised by the comments concerning the proposed ingredient declaration.

Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals

Tue, Dec 11 2007 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Communicating

Tue, Dec 11 2007 11:00:00 GMT

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Mental Models Study of Communicating With Health Care Providers About the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women With Chronic Conditions. Together with other information being collected, the results from this study will be used to help inform FDA about how health care providers use prescription drug labeling and other available information in making treatment decisions and how that use differs from how agency experts believe such information is used. It will also contribute to FDA's ability to p

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Dec 11 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Dec 11 2007 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Dec 11 2007 11:00:00 GMT

Establishment of Fiscal Year 2008 User Fee Rates for Advisory Review of Direct-to-Consumer Television Advertisements

Tue, Dec 11 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing this notice, as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), to establish the fiscal year (FY) 2008 fees that will be charged for each FY 2008 advisory review submission to FDA and to fund the operating reserve established under FDAAA. The Federal Food, Drug, and Cosmetic Act (the act), as amended by FDAAA, authorizes FDA to collect user fees for certain directtoconsumer (DTC) television advertisements submitted to FDA for advisory review.

Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Tue, Dec 11 2007 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Drug Safety and Risk Management Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on February 1, 2008, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Silver Spring, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301 5895200.

Contact Person: Teresa Watkins, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email: Teresa.Watkins@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code

Advisory Committees; Filing of Closed Meeting Reports

Tue, Dec 11 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2007.