The Federal Register

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Nov 30 2007 11:00:00 GMT

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the renewal of the generic information collection project: ``AHRQ Grants Reporting System (GRS).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

Medicaid Integrity Program; Limitation on Contractor Liability

Fri, Nov 30 2007 11:00:00 GMT

The Medicaid Integrity Program (the Program) provides that the Secretary promote the integrity of the Medicaid program by entering into contracts with contractors that will review the actions of individuals or entities furnishing items or services (whether feefor service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of the plan approved under section 1115 of the Social Security Act; audit claims for payment of items or services furnished, or administrative services furnished, under a State plan; identify overpayments of individuals or entities receiving Federal funds; and educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This final rule will provide for limitations on a contractor's liability while performing these services under the Program.

The final rule will, to the extent possible, employ the same or comparable standards and other substant

Medicare Program; Home Health Prospective Payment System Refinement and Rate Update for Calendar Year 2008;

Fri, Nov 30 2007 11:00:00 GMT

This document corrects typographical and technical errors that appeared in the August 29, 2007 Federal Register, entitled ``Medicare Program; Home Health Prospective Payment System Refinement and Rate Update for Calendar Year 2008.''

Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Corrections

Fri, Nov 30 2007 11:00:00 GMT

This document corrects technical errors that appeared in the August 3, 2007 Federal Register, entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2008; Final Rule.''

Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Rule for

Fri, Nov 30 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulations (exemption for certain drugs limited by newdrug applications to prescription sale, and warning and caution statements required by regulations for drugs) by removing the entries for carbetapentane citrate. This action is associated with FDA's determination that carbetapentane citrate has not been shown to be effective at the overthecounter (OTC) doses stated in the exempting regulation. FDA made this determination in 1987 as part of its ongoing review of OTC drug products.

Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device

Fri, Nov 30 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle. [[Page 67641]]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Nov 30 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional

Fri, Nov 30 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is reopening to January 15, 2008, the comment period for the notice of public hearing that published in the Federal Register of July 20, 2007. In the notice of public hearing, FDA requested comments on the use of symbols to communicate nutrition information on food labels. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated

Fri, Nov 30 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle'' dated November 2007. The guidance document serves as the special control for the automated blood cell separator device operating on a centrifugal or filtration separation principle intended for the routine collection of blood and blood components, and describes a means by which the device may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify the automated blood cell separator device operating by centrifugal separation principle into class II (special controls).

Meeting of the National Biodefense Science Board

Fri, Nov 30 2007 11:00:00 GMT

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding its inaugural meeting. The meeting is open to the public.

National Committee on Vital and Health Statistics: Meeting

Fri, Nov 30 2007 11:00:00 GMT

Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting.

Name: National Committee on Vital and Health Statistics (NCVHS).

Time and Date: November 27, 2007 9 a.m.3:45 p.m. November 28, 2007 10 a.m.3 p.m.

Place: Hilton Embassy Row Hotel, 2015 Massachusetts Avenue NW., Washington, DC, 2022651600.

Status: Open.

Purpose: At this meeting the Committee will hear presentations and hold discussions on several health data policy topics. On the morning and afternoon of the first day the Committee will hear updates from the Department and status reports from its
subcommittees as well as a presentation from the Robert Graham Center on harmonizing primary care standards.

On the morning of the second day the Committee will hear an update from the Office of the National Coordinator for Health Information Technology (ONCHIT) followed by Committee actions on selected topics from the subcommittee

National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of

Fri, Nov 30 2007 11:00:00 GMT

CERHR announces the availability of the final bisphenol A expert panel report on November 26, 2007, from the CERHR Web site (http://cerhr.niehs.nih.gov) or in print from CERHR (see ADDRESSES below). The expert panel report is an evaluation of the reproductive and developmental toxicity of bisphenol A conducted by an independent, 12member expert panel composed of scientists from the public and private sectors convened by CERHR. CERHR invites the submission of public comments on this report (see SUPPLEMENTARY INFORMATION below). The expert panel met twice in public session (March 57, 2007 and August 68, 2007) to review and revise the draft expert panel report and reach conclusions regarding whether exposure to bisphenol A is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs.

Amendment to January 26, 2007 Declaration Under the Public Readiness and Emergency Preparedness Act

Fri, Nov 30 2007 11:00:00 GMT

Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d6d) to provide targeted liability protections for pandemic countermeasures based on a credible risk that avian influenza viruses spread and evolve into strains capable of causing a pandemic of human influenza.

Amendment: Whereas, the H7 and H9 subtypes of avian influenza viruses are viewed as likely candidates to evolve into an influenza virus strain capable of causing a pandemic of human influenza; and

Whereas, in accordance with section 319F3(b)(6) of the Public Health Service Act (42 U.S.C. 247d6d(b)) (``the Act''), I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of these additional medical countermeasures with respect to the category of diseases and populatio

Submission for OMB Review; Comment Request; Pretesting of NIAID's HIV Vaccine Research Communications Messages

Fri, Nov 30 2007 11:00:00 GMT

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on August 28, 2007, page 49282 and allowed 60days for public comment. One public comment was received and was addressed in the OMB request. The purpose of this notice is to allow an additional 30 days for public comment.

Proposed Collection: Title: Pretesting of NIAID's HIV Vaccine Research Communications Messages. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for clearance to pretest messages, materials and program activities produced for the NIAID HIV Vaccine Research Education Initiative (NHVREI). The primary objectives of the p

Proposed Collection; Comment Request; Process Evaluation of the Global Health Research Initiative Program for New

Fri, Nov 30 2007 11:00:00 GMT

In compliance with the requirement of section 3506(copyright)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Fogarty International Center (FIC), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Proposed Collection: Title: Process evaluation of the Global Health Research Initiative Program for New Foreign Investigators (GRIP). Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will assess the outputs of the Global Health Research Initiative Program for New Foreign Investigators (GRIP) to date, assess the programs alignment with new strategic goals of the FIC, and identify potential directions for program enhancement. The primary objectives of the study are to determine if GRIP awards (1) promote productive reentry of NIHtrained foreign investig

Government-Owned Inventions; Availability for Licensing

Fri, Nov 30 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.

Government-Owned Inventions; Availability for Licensing

Fri, Nov 30 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 United States 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 Human Genome Research Institute; Notice of Closed Meetings

Fri, Nov 30 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 Inherited Disease Research Access Committee.

Date: January 1011, 2008.

Time: 7 a.m. to 3:45 p.m.

Agenda: To review and evaluate grant applications and/or proposals.

Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015.

Contact Person: Jerry Roberts, PhD., Scientific Review Officer, Sc

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

Fri, Nov 30 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, Immune Pathogenesis in Chronic HIV Infection.

Date: December 17, 2007.

Time: 9 a.m. to 12 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Rockledge 6700, 6700B Rockledge Drive, Room 3133, Bethesda, MD 20817 (Telephone Confe

National Institute of General Medical Sciences; Notice of Closed Meeting

Fri, Nov 30 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, NIH Pathway to Independence Awards (K99/R00).

Date: December 67, 2007.

Time: 7 p.m. to 3:30 p.m.

Agenda: To review and evaluate grant applications.

Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

Contact Person: Meredit

National Institute on Drug Abuse; Notice of Closed Meetings

Fri, Nov 30 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 Drug Abuse Special Emphasis Panel, B/START Review.

Date: December 14, 2007.

Time: 1 p.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6101 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).

Contact Person: Mark Swieter, PhD, Chief, Training and Special Pro

Center for Scientific Review; Notice of Closed Meeting

Fri, Nov 30 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: Center for Scientific Review Special Emphasis Panel, ZRG RUS F 51 Nephrology Applications.

Date: December 1011, 2007.

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

Agenda: To review and evaluate grant applications.

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

Contact Person: Ryan G. Morris, PhD, Scientific Review

Prospective Grant of Exclusive License: Development of FDA Approved HIV Resistance Diagnosis Kit

Fri, Nov 30 2007 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the invention embodied in U.S. Patent No. 5,714,313, issued February 03, 1998, entitled ``Simple Method For Detecting Inhibitors Of Retroviral Replication'' (HHS Ref. E0541991/ 1US01) (Inventors: David Garfinkel, Joan Curcio, Dwight Nissley and Jeffrey Strathern) (NCI), to AmiKana.BioLogics (Hereafter AmiKana), having a place of business in France. The patent rights in these inventions have been assigned to the United States of America.