Department of Health and Human Services September 19, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document (GFI187) entitled ``Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs.'' This draft guidance is intended to clarify FDA's requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. The draft guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the act) apply with respect to GE animals, including FDA's intent to exercise enforcement discretion regarding requirements for certain GE animals. Elsewhere in this same issue of the Federal Register, the Animal and Plant Health Inspection Service (APHIS) is soliciting public comment on any potential implications of activities such as the importation or interstate movement of GE animals on the health of the U.S. livestock population under the authority of the Animal Health Protection Act (AHPA).

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Establishing Benchmarks for the Medical Office Survey on Patient Safety.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.