The Federal Register

National Institutes of Allergy and Infectious Diseases; Notice of Closed Meeting

Tue, Dec 4 2007 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Organ Specific Innate Immunity.

Date: December 17, 2007.

Time: 2 p.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Rockledge 6700, 6700B Rockledge Drive, Room 3146, Bethesda, MD 20817 (Telephone Conference Call).

National Institute of Child Health and Human Development, Amended Notice of Meeting

Tue, Dec 4 2007 11:00:00 GMT

Notice is hereby given of a change in the meeting of the National Institute of Child Health and Human Development Special Emphasis Panel, December 4, 2007, 1 p.m. to December 4, 2007, 5 p.m., National Institutes of Health, 6100 Executive Boulevard, 5B01, Rockville, MD, 20852 which was published in the Federal Register on November 16, 2007, 72 FR 64658.

The meeting will be held on December 5, 2007. The meeting is closed to the public.

Dated: November 26, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 075914 Filed 12307; 8:45 am]
BILLING CODE 414001M

Medicaid Program; Optional State Plan Case Management Services

Tue, Dec 4 2007 11:00:00 GMT

This interim final rule with comment period revises current Medicaid regulations to incorporate changes made by section 6052 of the Deficit Reduction Act of 2005. In addition, it incorporates provisions of the Consolidated Omnibus Budget Reconciliation Act of 1985, the Omnibus Budget Reconciliation Act of 1986, the Tax Reform Act of 1986, the Omnibus Budget Reconciliation Act of 1987, and the Technical and Miscellaneous Revenue Act of 1988, concerning case management and targeted case management services. This interim final rule with comment period will provide for optional coverage of case management services or targeted case management services furnished according to section 1905(a)(19) and section 1915(g) of the Social Security Act. This interim final rule with comment period clarifies the situations in which Medicaid will pay for case management activities and also clarifies when payment will not be consistent with proper and efficient operation of the Medicaid program, and is not available

National Institute of General Medical Sciences; Notice of Closed Meeting

Tue, Dec 4 2007 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.

Name of Committee: National Institute of General Medical Sciences Special Emphasis Panel, MBRSRISE and SCORE.

Date: December 11, 2007.

Time: 3 p.m. to 4 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892, (Telephone Conference Call).

Contact Person: Lisa Dunbar, PhD

Medicare Program, Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase

Tue, Dec 4 2007 11:00:00 GMT

This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on September 5, 2007 entitled ``Medicare Program, Physicians'' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III).''

National Institute of Mental Health; Notice of Meeting

Tue, Dec 4 2007 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Mental Health Council.

The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

Name of Committee: National Advis

Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals

Tue, Dec 4 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under our usual noticeand comment rulemaking procedures, to provide a procedural framework to finalize the rule in the event the agency receives any

Proposed Information Collection Activity; Comment Request Proposed Project

Tue, Dec 4 2007 11:00:00 GMT

Title: Building Strong Families (BSF) Demonstration and EvaluationImpact Study Second Followup.

OMB No.: New Collection.

Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a data collection activity as part of the Building Strong Families (BSF) Demonstration and Evaluation. The proposed collection will consist of two elements: (1) A telephone survey to be administered to both partners in couples enrolled in the BSF research sample about 36 months after enrollment, and (2) observational assessments of BSF families and their children.

These data collections are part of the BSF evaluation, which is an important opportunity to learn if welldesigned interventions can help lowincome couples develop the knowledge and relationship skills that research has shown are associated with healthy marriages. BSF programs provide instruction and support to improve marriage and relationship skills and enhance couples' un

National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings

Tue, Dec 4 2007 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; NSDK Conflict Special Emphasis Panel.

Date: December 10, 2007.

Time: 1 p.m. to 4 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference

Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to

Tue, Dec 4 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend certain sections of the regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

National Institute on Aging; Notice of Closed Meetings

Tue, Dec 4 2007 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

Name of Committee: National Institute on Aging Special Emphasis Panel; Mitochondria in Neurodegenerative Disease.

Date: December 910, 2007.

Time: 6 p.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, MD 20814.

Contact Person: William Cruce, PhD., Health Scientist Administrator,

Current Good Manufacturing Practice; Amendment of Certain Requirements For Finished Pharmaceuticals; Withdrawal

Tue, Dec 4 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the [[Page 68112]]
withdrawal of a proposed rule published in the Federal Register of May 3, 1996 (61 FR 20103) (the May 1996 proposed rule). The May 1996 proposed rule would have amended certain requirements of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These proposed changes would have clarified certain manufacturing, quality control, and documentation requirements and would have updated the requirements for process and methods validation. In light of more recent scientific and technical advances and evolving quality systems and risk management concepts, FDA concludes that, at this time, it is appropriate to withdraw the May 1996 proposed rule and newly evaluate the issues raised in that proposal.

National Institute of Mental Health Draft Strategic Plan

Tue, Dec 4 2007 11:00:00 GMT

The National Institute of Mental Health (NIMH) is developing a strategic plan for the next 35 years, and invites the public to provide comments on a draft of this plan. The draft plan will be publicly available through the NIMH Draft Strategic Plan Web page (http://www.nimh.nih.gov/about/strategicplanningreports/nimhdraftstrategicplan.shtml ) from November 20, 2007 through December 21, 2007.
The public is invited to provide comments via the email address or the postal address listed on the NIMH Draft Strategic Plan Web page.

Background: NIMH is the lead Federal agency for research on mental and behavioral disorders and has as its mission to reduce the burden of these disorders through research on mind, brain, and behavior. The Institute's goal is to generate research that will transform the prevention of and recov

DSM Nutritional Products, Inc.; Filing of Color Additive Petition

Tue, Dec 4 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh.

Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies

Tue, Dec 4 2007 11:00:00 GMT

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).

A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines.

If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted fro