The Federal Register

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Dec 22 2006 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046395960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Dec 22 2006 11:00:00 GMT

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Dec 22 2006 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046395960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MSD74,
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Atlanta, GA 30333 or send an email to omb@cdc.gov.

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Dec 22 2006 11:00:00 GMT

Medicaid Program; Prescription Drugs

Fri, Dec 22 2006 11:00:00 GMT

This proposed rule would implement the provisions of the Deficit Reduction Act of 2005 (DRA) pertaining to prescription drugs under the Medicaid program. The DRA requires the Secretary of Health and Human Services to publish a final regulation no later than July 1, 2007. In addition, we would add to existing regulations certain established Medicaid rebate policies that are currently set forth in CMS guidance. This rule would bring together existing and new regulatory requirements in one, cohesive subpart.

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

Fri, Dec 22 2006 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Dec 22 2006 11:00:00 GMT

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--July Through September 2006

Fri, Dec 22 2006 11:00:00 GMT

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2006 through September 2006, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicareapproved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coveragerelated guidance documents, and special onetime notices regarding national coverage provi

Medicare Program; First Biannual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups--March 7,

Fri, Dec 22 2006 11:00:00 GMT

In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the first biannual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2007. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. CMS will consider the Panel's advice as we prepare the proposed and final rules that update the hospital Outpatient Prospective Payment System (OPPS) for CY 2008.

Meeting Dates: We are scheduling the first biannual meeting in 2007 for the following dates and times:

Wednesday, March 7, 2007, 1 p.m. to 5 p.m. (e.s.t.)

Thursday, March 8, 2007, 8 a.m. to 5 p.m. (e.s.t.)

Friday, March 9, 2007,

Medicare Program; Meeting of the Advisory Panel on Medicare Education, January 24, 2007

Fri, Dec 22 2006 11:00:00 GMT

In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92463), this notice announces a meeting of the Advisory Panel on
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Medicare Education (the Panel) on January 24, 2007. The Panel advises and makes recommendations to the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

Medicare Program; Town Hall Meeting on the Fiscal Year 2008 Applications for New Medical Services and Technologies

Fri, Dec 22 2006 11:00:00 GMT

This notice announces a Town Hall Meeting to discuss fiscal year (FY) 2008 applications for addon payments for new medical services and technologies under the Inpatient Prospective Payment System (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2008 new medical services and technologies applications meet the substantial clinical improvement criteria. Additionally, we will hold an Informational Workshop for all interested parties on the application process and criteria for new medical services and technologies addon payments under the IPPS, the transitional passthrough payment and new technology ambulatory payment classification (APC) assignment application processes under the Outpatient Prospective Payment System (OPPS) and the processes of DiagnosisRelated Group (DRG) assignment and requesting new ICD9 codes under the IPPS.

Administration for Children and Families

Fri, Dec 22 2006 11:00:00 GMT

Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) 42 U.S.C. 2992b1, ANA herein describes its proposed interpretive rules, statements of general policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental), Environmental Mitigation (hereinafter referred to as Mitigation), Improving the WellBeing of Children Native American Health Marriage Initiative (hereinafter referred to as Healthy Marriage) programs and any Special Initiatives. Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy and rules of agency procedure or practice and to give notice of the final adoption of such changes at least thirty (30) days

Implantation or Injectable Dosage Form New Animal Drugs; Gentamicin

Fri, Dec 22 2006 11:00:00 GMT

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 Sparhawk Laboratories, Inc. The ANADA provides for use of a gentamicin sulfate injectable solution in piglets for treatment of porcine colibacillosis.

Medical Device Regulations; Disqualification of a Clinical Investigator; Technical Amendment

Fri, Dec 22 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is amending a medical device regulation to include references to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). This regulation pertains to the disqualification of a clinical investigator. Currently, only a reference to the Center for Devices and Radiological Health is listed in this regulation. This action is being taken to ensure the accuracy of FDA's regulations.

Advisory Committee for Reproductive Health Drugs; Notice of Meeting

Fri, Dec 22 2006 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Advisory Committee for Reproductive Health Drugs.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on January 23, 2007, from 8:30 a.m. to 6 p.m. and on January 24, 2007, from 8:30 a.m. to 5:00 p.m.

Location: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.

Contact Person: Teresa Watkins, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email: Teresa.Watkins@fda.hhs.govor FDA Advisory Committee Infor

Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Referrals to

Fri, Dec 22 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations.'' This guidance is intended to assist clinical investigators, Institutional Review Boards (IRBs), sponsors, and other interested parties in understanding FDA's process for handling clinical investigations that include children as subjects and that
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have been referred to FDA for review under FDA regulations on additional safeguards for children in clinical investigations. The guidance describes the procedures FDA generally intends to follow in handling clinical investigations referred for review under Sec. 50.54 (21 CFR 50.54) and in reaching final determinations in accordance with these regulations. The guidance announced in this notice finalizes the draft guidance of the same title dated

National Cancer Institute; Notice of Closed Meetings

Fri, Dec 22 2006 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 Cancer Institute Special Emphasis Panel, Cellular and Tissue Biology Cluster.

Date: January 3031, 2007.

Time: 8 a.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: Bethesda North Marriott, 5701 Marinelli Road, Bethesda, MD 20852.

Contact Person: Shakeel Ahmad, PhD, Scientific Review Administrator, Research Pro

National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

Fri, Dec 22 2006 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 seth 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, Unsolicited Program Project (P01) Grant Application.

Date: January 10, 2007.

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

Agenda: To review and evaluate grant applications.

Place: National Institute of Health, Rockledge 6700, 6700B Rockledge Drive, Bethesda, MD 20817, (Telephone Conference

Center for Scientific Review; Notice of Closed Meetings

Fri, Dec 22 2006 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.,
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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, SAT Study Section Conflicts.

Date: January 23, 2007.

Time: 1 p.m. to 6:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

Contact Person: Dharam S. Dhindsa, DVM, PhD,

Prospective Grant of Exclusive License: Method of Treating or Preventing Cancer Using Radiosensitizing Agents

Fri, Dec 22 2006 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Provisional Patent Application No. 60/718,172, filed September 16, 2005, entitled ``Method of Treating or Preventing Cancer Using Pyridine Carboxaldehyde Pyridine Thiosemicarbazone Radiosensitizing Agents'' [E 3192005/0US01; E3192005/0PCT02], to Vion Pharmaceuticals, Inc., having a place of business in New Haven, Connecticut. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the Triapine as a radiosensitizer as claimed in the licensed patent rights for the treatment of cancer and other tumors.