The Federal Register

Agency Information Collection Activities: Proposed Collection; Comment Request

Mon, Nov 19 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: ``Voluntary Customer Surveys Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 10413 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

This proposed information collection was previously published in the Federal Register on August 3, 2007 and allowed 60 days for public comment. No comments were received. A 30day Federal Register notice was published on October 11th, 2007 to allow an additional 30 days for public comment. No comments were received. However, changes to the estimated annual respondent burden hours and the methodologies that will be used for the data collection require an additional 30 days for public comment.

Proposed Data Collections Submitted for Public Comment and Recommendations

Mon, Nov 19 2007 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
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requests, call the CDC Reports Clearance Officer at (404) 6395960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3956974. Written comments should be received within 30 days of this notice.

Proposed Project

Qualitative Evaluation of HIV Counseling, Testing, and Referral Services in NonHealth Care Settings: Eliciting Consumer ViewsNew National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Coordinating Center for Infectious Diseases (CCID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Historically, HIV prevention efforts have tar

Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access

Mon, Nov 19 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's recordkeeping and records access requirements for food facilities.

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

Mon, Nov 19 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.
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Mon, Nov 19 2007 11:00:00 GMT

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

Mon, Nov 19 2007 11:00:00 GMT

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

Mon, Nov 19 2007 11:00:00 GMT

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

Mon, Nov 19 2007 11:00:00 GMT

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

Mon, Nov 19 2007 11:00:00 GMT

ARCH Chemicals, Inc.; Withdrawal of Food Additive Petition FAP 6B4764

Mon, Nov 19 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 6B4764) proposing that the food additive regulations be amended to provide for the safe use of poly
(iminoimidocarbonyliminoimidocarbonyliminohexamethylene) hydrochloride (CAS Reg No. 32289580) as an antimicrobial agent in the manufacture of foodcontact paper and paperboard.

Memorandum of Understanding Between the Food and Drug Administration and the Association of American Feed Control

Mon, Nov 19 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Association of American Feed Control Officials (AAFCO). The purpose of this MOU is to facilitate FDA's collaboration with AAFCO in the AAFCO New and Modified Ingredient Definition Process by clarifying the responsibilities of FDA and AAFCO in defining feed ingredients, in providing mechanisms for resolving disputes that may arise, and in providing mechanisms for modifying the ingredient definition process when required.

Draft Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff:

Mon, Nov 19 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document for FDA advisory committee members and FDA staff entitled, ``Voting Procedures for Advisory Committee Meetings.'' This draft document is intended to provide guidance on advisory committee voting procedures that can be used for the voting process when votes are taken during advisory committee meetings. It does not to define when votes should be taken.

National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of

Mon, Nov 19 2007 11:00:00 GMT

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Kellex/Pierpont, Jersey City, New Jersey, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

Facility: Kellex/Pierpont.

Location: Jersey City, New Jersey.

Job Titles and/or Job Duties: All workers.

Period of Employment: January 1, 1943 through December 31, 1953.

National Institute of Child Health and Human Development; Proposed Collection; Comment Request; Formative Research

Mon, Nov 19 2007 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 National Institute of Child Health and Human Development (NICHD), 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: Formative Research and Pilot Studies for the National Children's Study. Type of Information Collection Request: NEW. Need and use of information collection: The NICHD seeks to obtain OMB's generic approval to conduct pilot and formative research to be used in the development of instruments, materials, and procedures for the National Children's Study (NCS). The NCS is a long term cohort study of environmental influences on child health and development authorized under the Children's Health Act of 2000. The Act specifies a broad definition of environme

National Institute of Environmental Health Sciences; Division of Extramural Research and Training; Submission for OMB

Mon, Nov 19 2007 11:00:00 GMT

Summary: Under the provision of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 9, 2007, page 26399 and allowed 60 days for public comment. No public comments were 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, an 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: Program Assessment and Evaluations for NIEHSAsthma Research. Type of Information Collection Reques

National Institute of Child Health and Human Development; Proposed Collection; Comment Request; Pilot Study for the

Mon, Nov 19 2007 11:00:00 GMT

Proposed Collection: Title: Pilot Study for the National Children's Study, Type of Information Collection Request: NEW, Affected entities: Households and individuals. Types of respondents: People potentially affected by this action are pregnant women, women age 1849 years of age, their husbands or partners, and their children who live in selected areas within the seven (7) National Children's Study Vanguard sites enumerated below. A small number of health care professionals, community leaders, and child care personnel are also potential respondents. Frequency of Response: On o

Notice of Establishment

Mon, Nov 19 2007 11:00:00 GMT

Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Director, National Institutes of Health (NIH), announces the establishment of the Emerging Neuroscience and Training Integrated Review Group.

The Emerging Neuroscience and Training Integrated Review Group shall
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provide advice and recommendations to the Director, NIH, and the Director, Center for Scientific Review (CSR), on the scientific and technical merit of applications for grantsinaid for research, research training or researchrelated grants and cooperative agreements, or contact proposals relating to (1) the crosscutting technologies that serve all of the neurosciences, including neuroinformatics and imaging and molecular neurogenetics; (2) crosscutting emerging science in the small business area for all of the neurosciences; and (3) the training areas for all of the neurosciences.

Duration of this committee is continuing unless formally determined by the Director, NIH, that term

National Heart, Lung, and Blood Institute; Notice of Closed Meetings

Mon, Nov 19 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 Heart, Lung, and Blood Institute Special Emphasis Panel, Clinical Trial Registry.

Date: December 4, 2007.

Time: 12 p.m. to 3 p.m.

Agenda: To review and evaluate contract proposals.

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

Contact Person: Youngsuk Oh, PhD, Scientifi

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

Mon, Nov 19 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, 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; Community Health Program In Rehabilitation

Date: December 12, 2007.

Time: 11:30 a.m. to 1 p.m.

Agenda: To review and evaluate contract proposals.

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

National Institute of Environmental Health Sciences; Notice of Closed Meeting

Mon, Nov 19 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: Environmental Health Sciences Review Committee.

Date: November 2829, 2007.

Time: 8:30 a.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: Sheraton Chapel Hill Hotel, One Europa Drive, Chapel Hill, NC 27517.

Contact Person: Linda K. Bass, PhD, Scientific Review Administrator, Nat'l Institute of Environmental Health Scienc

National Institute of Environmental Health Sciences; Notice of Closed Meeting

Mon, Nov 19 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 Environmental Health Sciences Special Emphasis Panel, Working Education Training Program.

Date: December 5, 2007.

Time: 12 p.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: NIEHS/National Institutes of Health, Building 4401, East Campus, 79 T.W. Alexander Drive, Research Triangle Park, NC 27709, (Tele

National Institute of General Medical Sciences; Notice of Closed Meeting

Mon, Nov 19 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, MBRS Support of Competitive Research.

Date: November 2627, 2007.

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

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892, (Virtual Meeting).

Contact Person: C. Cr

National Institute of Mental Health; Notice of Closed Meetings

Mon, Nov 19 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 of Mental Health Special Emphasis Panel, RAPID Application Dealing with Stigma.

Date: November 26, 2007.

Time: 10 a.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

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

Contact

National Institute on Aging; Notice of Closed Meeting

Mon, Nov 19 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 on Aging Special Emphasis Panel; ``Prion Diseases''

Date: December 6, 2007.

Time: 1 p.m. to 4:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, 2C212, Bethesda, MD 20814, (Telephone Conference Call).

Contact Person: Ramesh Vemuri, PhD, Sc

National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting

Mon, Nov 19 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 on Deafness and Other Communication Disorders Special Emphasis Panel, NIDCD Clinical Center Review.

Date: December 10, 2007.

Time: 12 p.m. to 2:15 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call).

Contact Per

Prospective Grant of Exclusive License: Use of Anti-TAG72 Monoclonal Antibodies as a Tumor-Specific Imaging Agent and

Mon, Nov 19 2007 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 inventions embodied in the following patents or patent applications U.S. Provisional Patent Application Nos. 60/106,534 and 60/106,757 filed October 31, 1998 and November 2, 1998; U.S. Patent No. 6,818,749 issued November 16, 2004; and U.S. Patent Application 10/927,433 filed August 25, 2004 as well as issued and pending foreign counterparts [HHS Ref. No. E2591998/0, /1, and /2]; U.S. Provisional Patent Application No. 60/498,903 filed August 29, 2003 and U.S. Patent Application No. 10/570,220 filed February 28, 2006 as well as issued and pending foreign counterparts [HHS Ref. No. E3232003/0]; U.S. Patent Application Nos. 07/510,697 filed July 17, 1990; 07/964,536 filed October 20, 1992; 08/261,354 filed June 16, 1994 and issued as U.S. Patent No. 5,976,531