Department of Health and Human Services January 4, 2006 – Federal Register Recent Federal Regulation Documents

Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E5-8238
Type: Notice
Date: 2006-01-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E5-8231
Type: Notice
Date: 2006-01-04
Agency: Office of the Secretary, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E5-8230
Type: Notice
Date: 2006-01-04
Agency: Office of the Secretary, Department of Health and Human Services
University of Arkansas/Food and Drug Administration Food Labeling; Public Workshop
Document Number: E5-8225
Type: Notice
Date: 2006-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas (UA), is announcing a public workshop entitled ``UA/FDA Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on April 5, 2006, from 8 a.m. to 5 p.m., and on April 6, 2006, from 8 a.m. to 3 p.m. Location: The public workshop will be held at the Continuing Education Center, 2 East Center St., Fayetteville, AR (located downtown). Contact: Steven C. Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575-4221, FAX: 479-575-2165, or e-mail: seideman@uark.edu. For information on accommodation options, contact Steven C. Seideman (see Contact). Registration: You are encouraged to register by March 21, 2006. The University of Arkansas has a $150 registration fee to cover the cost of facilities, materials, speakers, and breaks. Seats are limited, please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $200 payable to: ``The University of Arkansas.'' If you need special accommodations due to a disability, please contact Steven C. Seideman (see Contact) at least 7 days in advance. Registration Form Instructions: To register, please complete the following form and submit along with a check or money order for $150 payable to the ``The University of Arkansas.'' Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704. Name: Affiliation: Mailing Address: City: State: Zip Code: Phone: ( ) FAX: ( ) E-mail: ( ) Special Accommodations Required: Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested at cost through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.
Guidance for Industry and Review Staff on Recommended Approaches to Integration of Genetic Toxicology Study Results; Availability
Document Number: E5-8224
Type: Notice
Date: 2006-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and review staff entitled ``Recommended Approaches to Integration of Genetic Toxicology Study Results.'' This guidance is intended to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in genetic toxicology assays during drug development. The guidance provides recommendations on how to proceed with clinical studies while ensuring the safety of study participants when results in genotoxicity studies suggest a potential cancer or genetic hazard.
Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals; Availability
Document Number: E5-8223
Type: Notice
Date: 2006-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (123) entitled ``Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals.'' This guidance provides recommendations regarding the development of target animal safety and effectiveness data to support approval of veterinary non-steroidal anti-inflammatory drugs (NSAIDs), specifically cyclooxygenase (COX) inhibitors.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision); Request for Comments; Availability
Document Number: E5-8222
Type: Notice
Date: 2006-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (92) entitled ``Impurities in New Veterinary Drug Substances (Revision)'' VICH GL10(R). This draft revised guidance, which updates a final guidance on the same topic for which a Notice of Availability was published in the Federal Register of July 7, 2000 (the 2000 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The draft revised document is intended to provide guidance for registration applicants on the content and qualification of impurities in new veterinary drug substances produced by chemical syntheses and not previously registered in a country, region, or member state.
Proposed Information Collection Activity; Comment Request
Document Number: 06-18
Type: Notice
Date: 2006-01-04
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
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