Department of Health and Human Services May 2009 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 332
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).
New Animal Drugs; Gentamicin and Betamethasone Spray
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by American Pharmaceuticals and Cosmetics, Inc. The ANADA provides for the veterinary prescription use of gentamicin sulfate and betamethasone valerate topical spray in dogs.
Small Entity Compliance Guide: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and OsteoporosisSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is being issued for a final rule published in the Federal Register of September 29, 2008, as corrected on November 12, 2008, and it is intended to set forth in plain language the legal requirements of the regulation and to help small businesses understand the regulation.
Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees
The Food and Drug Administration (FDA) is requesting nominations for voting consumer representatives to serve on the Food Advisory Committee. This advisory committee is under the purview of the Center for Food Safety and Applied Nutrition (CFSAN).
Hospital Preparedness Program (HPP)
This notice sets forth the Secretary's decision to require Hospital Preparedness Program [HPP] cooperative agreement recipients to contribute non-Federal matching funds starting with the FY 2009 funding cycle and each year thereafter. The amount of the cost sharing requirement in FY 2009 will be five percent of the award amount and in FY 2010 and each year thereafter the amount of match will be ten percent of the award amount.
Proposed Collection; Comment Request; The Impact of Continuing Medical Education on Physician Practice
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Clinical Center, the National Institutes of Health will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget for review and approval.
Determination of Regulatory Review Period for Purposes of Patent Extension; SENSIPAR
The Food and Drug Administration (FDA) has determined the regulatory review period for SENSIPAR 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.
Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (199) entitled ``Animal Generic Drug User Fees and Fee Waivers and Reductions.'' The purpose of this document is to provide guidance to industry on the Animal Generic Drug User Fee Act of 2008 (AGDUFA). FDA is issuing this final guidance document for immediate implementation consistent with the agency's good guidance practices (GGPs). Interested persons may submit comments on agency guidances at any time.
Determination That DECADRON Tablets and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the 10 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
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