Department of Health and Human Services January 3, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2006.

HHS proposes to remove Part 72 of Title 42, Code of Federal Regulations, which governs the interstate shipment of etiologic agents, because the U.S. Department of Transportation (DOT) already has in effect a more comprehensive set of regulations applicable to the transport in commerce of infectious substances. DOT harmonizes its transport requirements with international standards adopted by the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods for the classification, packaging, and transport of infectious substances. Rescinding the rule will eliminate duplication of the more current DOT regulations that cover intrastate and international, as well as interstate, transport. HHS replaced those sections of Part 72 that deal with select biological agents and toxins with a new set of regulations found in Part 73 of Title 42. HHS anticipates that removal of Part 72 will alleviate confusion and reduce the regulatory burden with no adverse impact on public health and safety.

The Food and Drug Administration (FDA) is announcing the availability of, and is requesting comment on, a draft risk assessment on animal cloning. FDA's Center for Veterinary Medicine (CVM) developed this draft risk assessment to evaluate the health risks to animals involved in the process of cloning and to evaluate the food consumption risks that may result from edible products derived from animal clones or their progeny. FDA is also announcing the availability of, and is requesting comment on, a proposed risk management plan for animal clones and their progeny. The proposed risk management plan takes into account the risks identified in the draft risk assessment and sets out proposed measures that FDA might use to manage those risks. In addition, FDA is announcing availability of draft guidance for industry 179 for public comment. This draft guidance describes FDA's recommendations regarding the use of edible products from animal clones and their progeny in human food or in animal feed.