Department of Health and Human Services June 2, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Lloyd, Inc. The ANADA provides for the veterinary prescription use of butorphanol tartrate injectable solution in horses for the relief of pain.
Food Safety Research; Investigations Focused on Promoting the Safety of Produce
The Food and Drug Administration (FDA-Center for Food Safety and Applied Nutrition (CFSAN)) is announcing the availability of approximately $1.0 million in research funds for fiscal year (FY) 2008. It is anticipated that individual grants will receive a total of $250,000 to $500,000 to cover both direct and indirect costs. These funds will be used to support research efforts to advance the safe transportation and preparation of produce and to help reduce the incidence of foodborne illness that may be associated with fresh produce consumption. The award will provide 18 months of support. There will be no additional years of noncompetitive continuation support. A copy of the full text of this announcement will be posted in Grants.gov and on FDA's Center for Food Safety and Applied Nutrition Web site at https://www.cfsan.fda.gov/list.html. Key Dates: Receipt Date: Applications are due within 90 days after the publication of the funding opportunity in the Federal Register. I. Funding Opportunity Description
Guidance for Industry on Indexing Structured Product Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Indexing Structured Product Labeling.'' This guidance explains that the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) will index structured product labeling (SPL) in the product labeling for human drug and biologic products. This guidance also makes recommendations to industry on how to submit input regarding the indexing information in the SPL.
Medical Devices; Hearing Aids; Technical Data Amendments
The Food and Drug Administration (FDA) is amending its regulations governing hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. We are amending the regulations to require that manufacturers may use state-of-the-art methods to provide technical data in hearing aid labeling. FDA is also amending the regulations to update an address and remove an outdated requirement. FDA is amending the regulations in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment rulemaking to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.
Medical Devices; Hearing Aids; Technical Data Amendments
The Food and Drug Administration (FDA) is proposing to amend its regulations governing hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. We are proposing to amend the regulations to require manufacturers to use state-of-the-art methods to provide technical data in hearing aid labeling. FDA is also proposing to amend the regulations to update an address and remove an outdated requirement. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.
Designation of Medically Underserved Populations and Health Professional Shortage Areas
On April 21, 2008, HHS published a 30-day extension to the public comment period and provided clarification on the notice of proposed rulemaking, ``Designation of Medically Underserved Populations and Health Professional Shortage Areas'' (73 FR 21300). HHS and the Health Resources and Services Administration (HRSA) have received requests for a further extension to the comment period. In consideration of these requests, HHS is extending the comment period an additional 30 days, with a new closing date of June 30, 2008.
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