Department of Health and Human Services August 13, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Yokohama, Japan'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Yokohama, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Yokohama, Japan, October 27 through November 1, 2007, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Wednesday, October 10, 2007, from 12:30p.m. to 3 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd floor, Conference Room D and E, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 12:20 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room D and E. Contact Person: All participants must register with Tammie Bell, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, by e-mail: Tammie.Bell2@fda.hhs.gov or fax: 301-827-0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by October 8, 2007. If you need special accommodations due to a disability, please contact Tammie Bell at least 7 days in advance. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page.

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 G. C. Hanford Manufacturing Co. The ANADA provides for the use of ampicillin sodium powder in aqueous solution by injection in horses for the treatment of various bacterial infections.

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 Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for International Cooperation on Cosmetics Regulations (ICCR) Meeting in Brussels, Belgium'' to provide information on the process and receive comments on issues that may be relevant to discussions being held at the ICCR meeting in Brussels, Belgium. The purpose of the meeting is to solicit public input prior to the first meeting of this group in Brussels on September 27, 2007. Date and Time: The meeting will be held on Tuesday, August 28, 2007, from 2 p.m. to 3:30 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd fl., Chesapeake Conference Room, Rockville, MD 20857. For security reasons, all attendees must preregister and are asked to arrive no later than 1:50 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to the Chesapeake Conference Room. Contact Person: All participants must register with Michelle Limoli, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, by e-mail: michelle.limoli@fda.hhs.gov or FAX: 301-827-0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), and written material and requests to make oral presentations, to the contact person by August 21, 2007. If you need special accommodations due to a disability, please contact Michelle Limoli at least 7 days in advance. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page.

This notice announces the 18th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)

This notice announces the 13th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92- 463, 5 U.S.C., App.).

This notice announces the eighth meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This proposed rule would amend the definition of Medicaid rehabilitative services in order to provide for important beneficiary protections such as a person-centered written rehabilitation plan and maintenance of case records. The proposed rule would also ensure the fiscal integrity of claimed Medicaid expenditures by clarifying the service definition and providing that Medicaid rehabilitative services must be coordinated with but do not include services furnished by other programs that are focused on social or educational development goals and available as part of other services or programs. These services and programs include, but are not limited to, foster care, child welfare, education, child care, prevocational and vocational services, housing, parole and probation, juvenile justice, public guardianship, and any other non-Medicaid services from Federal, State, or local programs.