Department of Health and Human Services June 4, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 20 of 20
Office of Biotechnology Activities; Recombinant DNA Research: Amended Notice of Meeting
Notice of a discussion of a proposed action under Section III- A-1 published on May 24, 2010 (75 FR 28811) is withdrawn. The discussion that was to be held at the June 16-17, 2010 meeting of the NIH Recombinant DNA Advisory Committee has been deferred at the request of the principal investigator.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the United States in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Substances Generally Recognized as Safe Added to Food for Animals; Notice of Pilot Program
The Food and Drug Administration (FDA) is seeking participants for a voluntary pilot program whereby persons submit to FDA notices of claims that a particular use of a substance in food for animals is exempt from the statutory premarket approval requirements based on the notifier's determination that such use is generally recognized as safe (GRAS). FDA intends to evaluate these notices and will inform each participant (notifier) in writing either that the notice provides a sufficient basis for the GRAS determination or that FDA has identified questions as to whether the intended use of the substance is GRAS.
Determination That Cysteine Hydrochloride Injection, USP, 7.25%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that Cysteine Hydrochloride Injection, USP, 7.25% (Cysteine HCl), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Cysteine HCl if all other legal and regulatory requirements are met.
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions-Statement of Investigator (Form FDA 1572); Availability
The Food and Drug Administration (FDA) is announcing the availability of an information sheet guidance entitled, ``Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked QuestionsStatement of Investigator (Form FDA 1572).'' This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This information sheet guidance provides FDA's responses to the most frequently asked questions.
Indian Self-Determination Act Contracts and Annual Funding Agreements-Appeal Procedures
The Bureau of Indian Affairs (BIA) in the Department of the Interior (DOI) and the Indian Health Service (IHS) in the Department of Health and Human Services (HHS) are making limited technical amendments to their joint regulations governing contracts and annual funding agreements under the Indian Self-Determination and Education Assistance Act to update the appeals procedures.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
