Department of Health and Human Services May 12, 2008 – Federal Register Recent Federal Regulation Documents

Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting
Document Number: E8-10513
Type: Notice
Date: 2008-05-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) are announcing a public technical meeting in preparation for a pilot program to enable pharmaceutical firms to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review. The purpose of the public technical meeting is to discuss a concept paper that describes the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA plans to formally issue the concept paper by the end of fiscal year (FY) 2008 and expects to begin enrollment in the pilot program in FY 2009.
Determination of Regulatory Review Period for Purposes of Patent Extension; VECTIBIX
Document Number: E8-10512
Type: Notice
Date: 2008-05-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for VECTIBIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-10474
Type: Notice
Date: 2008-05-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Development of Set 22 Toxicological Profiles
Document Number: E8-10472
Type: Notice
Date: 2008-05-12
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the development of Set 22 Toxicological Profiles. Set 22 Toxicological Profiles consists of one new draft and five updated drafts. These profiles will be available to the public for comment on or about October 17, 2008.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-10470
Type: Notice
Date: 2008-05-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Consumer Survey on the Impact of Perceptions of the 2006 Spinach Recall on Current Spinach Consumption
Document Number: E8-10467
Type: Notice
Date: 2008-05-12
Agency: Food and Drug Administration, Department of Health and Human Services
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 a proposed survey of how consumer perceptions of the 2006 spinach recall affect their current spinach consumption behaviors.
Determination of Regulatory Review Period for Purposes of Patent Extension; OMNARIS
Document Number: E8-10466
Type: Notice
Date: 2008-05-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for OMNARIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: E8-10460
Type: Notice
Date: 2008-05-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: E8-10330
Type: Notice
Date: 2008-05-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Meeting
Document Number: E8-10325
Type: Notice
Date: 2008-05-12
Agency: Department of Health and Human Services, National Institutes of Health