The Federal Register

Medicare Program; Revisions to the Medicare Advantage and Part D Prescription Drug Contract Determinations, Appeals,

Wed, Dec 5 2007 11:00:00 GMT

This rule with comment period finalizes the Medicare program provisions relating to contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors, including eliminating the reconsideration process for review of contract determinations, revising the provisions related to appeals of contract determinations, and clarifying the process for MA organizations and Part D plan sponsors to complete corrective action plans. In this final rule with comment period, we also clarify the intermediate sanction and civil money penalty (CMP) provisions that apply to MA organizations and Medicare Part D prescription drug plan sponsors, modify elements of their compliance plans, retain voluntary selfreporting for Part D sponsors and implement a voluntary self reporting recommendation for MA organizations, and revise provisions to ensure HHS has access to the books and records of MA organizations and Part D plan sponsors' first tier, downstream, and relate

Submission for OMB Review; Comment Request

Wed, Dec 5 2007 11:00:00 GMT

Title: Child Care and Development Fund Annual Financial Report for Tribes (ACF696T).

OMB No.: 09700195.

Description: The Child Care and Development Fund (CCDF) annual financial reporting form (ACF696T) provides a mechanism for Indian Tribes to report expenditures under the CCDF program. The CCDF program provides funds to Tribes, as well as States and Territories, to assist lowincome families in obtaining child care so that they can work or attend training/education, and to improve the quality of care. Information collected via the ACF696T allows the Administration for Children and Families (ACF) to monitor Tribal expenditures and to estimate outlays, and may be used to prepare ACF budget submissions to Congress. Office of Management and Budget (OMB) approval for the existing form expires on April 30, 2008.

Respondents: Indian Tribes and Tribal Organizations that are CCDF grantees.
Annual Burden Estimates

Oral Dosage Form New Animal Drugs; Carprofen

Wed, Dec 5 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the [[Page 68478]]
animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Belcher Pharmaceuticals, Inc. The ANADA provides for veterinary prescription use of carprofen caplets in dogs.

New Animal Drugs For Use in Animal Feeds; Monensin

Wed, Dec 5 2007 11:00:00 GMT

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 Elanco Animal Health. The supplemental NADA revises the concentration of monensin in twoway Type B and Type C medicated feeds containing monensin and tylosin to cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature.

New Animal Drugs For Use in Animal Feeds; Monensin USP

Wed, Dec 5 2007 11:00:00 GMT

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 Elanco Animal Health. The supplemental NADA removes the requirement for 30day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Wed, Dec 5 2007 11:00:00 GMT

Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 4431129.

The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995:
Proposed Project: Data System for Organ Procurement and Transplantation Network (42 CFR Part 121, OMB No. 09150184): Extension

The operation of the Organ Procurement and Transplantation Network (OPTN) necessitates certain recordkeeping and reporting requirements in order to perform the functions related to organ transplantation under contract to HHS. This is a request for an extension of the current recordkeeping and reporting requirements associated with the OPTN. T

Submission for OMB Review; Comment Request; the Cardiovascular Health Study (CHS)

Wed, Dec 5 2007 11:00:00 GMT

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on September 12, 2007, page 52155, and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, any information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Proposed Collection: Title: The Cardiovascular Health Study. Type of Information Request: Reinstatement (OMB No. 09250334). Need and Use of Informati

Government-Owned Inventions; Availability for Licensing

Wed, Dec 5 2007 11:00:00 GMT

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 federallyfunded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

National Center for Complementary & Alternative Medicine; Amended Notice of Meeting

Wed, Dec 5 2007 11:00:00 GMT

Notice is hereby given of a change in the meeting of the National Center for Complementary and Alternative Medicine Special Emphasis Panel, December 7, 2007, 8 a.m. to December 7, 2007, 5 p.m., Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD, 20814 which was published in the Federal Register on November 13, 2007, 72FR63915.

This meeting is being amended to change the format to a telephone conference and to change the date from December 7, 2007 to December 18, 2007. The meeting is closed to the public.

Dated: November 27, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 075928 Filed 120407; 8:45 am]
BILLING CODE 414001M

National Eye Institute; Notice of Closed Meeting

Wed, Dec 5 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 Board of Scientific Counselors, National Eye Institute. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Eye Institute, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: Board of Scientific Counselors, National Eye Institute.

Date: December 911, 2007.

Time: 7 p.m. to 1 p.m.

Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators.

Place: National Institutes of Health, Building 31, 31 C

National Institute of Child Health and Human Development; Notice of Closed Meeting

Wed, Dec 5 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 Child Health and Human Development Special Emphasis Panel; Health and Healthcare
Trajectories.

Date: December 11, 2007.

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

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6100 Executive Boulevard, 5B01, Rockville, MD 20852 (Telephone Conference Call).

Contact

National Library of Medicine; Notice of Meeting

Wed, Dec 5 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 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.

The portions of the meeting devoted to the review and evaluation of journals for potential indexing by the National Library of Medicine will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as amended. Premature disclosure of the titles of the journals as potential titles to be indexed by the National Library of Medicine, the discussions, and the presence of individuals associated with these publications could significantly frustrate the review and evaluation of individual j

Center for Scientific Review; Notice of Closed Meetings

Wed, Dec 5 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: Center for Scientific Review Special Emphasis Panel; Kidney Monitoring and Therapeutics Small Business Review.

Date: December 18, 2007.

Time: 2 p.m. to 4 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

Contact Person: Krystyn