Department of Health and Human Services March 9, 2007 – Federal Register Recent Federal Regulation Documents

This Final Rule sets forth the Secretary's decision to include intestines within the definition of organs covered by the regulations governing the operations of the Organ Procurement and Transplantation Network. The Secretary under the authority granted by section 301 of the National Organ Transplant Act, as amended, further effects a corresponding change to the definition of human organs covered in the statute with this Final Rule.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two new animal drug applications (NADAs) filed by Bayer HealthCare LLC. The NADAs provide for the topical use by veterinary prescription of topical solutions containing imidacloprid and two strengths of moxidectin, one for use on dogs and the other for use on cats, for the prevention of heartworm disease, the treatment of flea infestations, and the treatment and control of several internal parasites.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADA provides for over-the-counter (OTC) marketing status for oral use of oxfendazole suspension in cattle.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. 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.

The National Institute for Occupational Safety and Health (NIOSH) announces the following availability of opportunity for the public to provide input regarding the draft document, ``Explosion Pressure Design Criteria for New Seals in U.S. Mines.'' NIOSH is the Federal agency responsible for conducting research and making recommendations for the prevention of occupational injuries and illnesses, including those occurring in the mining industry. Federal Mine Safety and Health Act, 30 U.S.C. 951. Seals are dam-like structures constructed in underground coal mines throughout the U.S. to isolate abandoned mining panels or groups of panels from the active workings. Historically, mining regulations required seals to withstand a 140 kPa (20 psi) explosion pressure; however, the 2006 MINER Act requires MSHA to increase this design standard by the end of 2007. This report provides a sound scientific and engineering justification to recommend a three-tiered explosion pressure design criteria for new seals in coal mines in response to the MINER Act. Much of the information contained in this report also applies to existing seals. A copy of the draft document can be found at: https://www.cdc.gov/ niosh/review/public/mineseal/. Comments should be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, M/S C-34, Cincinnati, OH 45226, telephone 513/533-8450, fax 513/533-8285, nioshdocket@cdc.gov. Comments may also be submitted directly through the Web site https:// www.cdc.gov/niosh/review/public/mineseal/comments.html. The document will remain available for comment until March 12, 2007. Comments should reference docket number NIOSH-100 in the subject heading. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226.