The Federal Register

National Institute of Allergy and Infectious Diseases; Notice of Meetings

Wed, Dec 26 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 meetings of the National Advisory Allergy and Infectious Diseases Council.

The meetings 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 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/or 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 grant applications and/or contract proposals,
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the disclosure of which would constitute a c

National Institute of Allergy and Infectious Diseases; Notice of Meetings

Wed, Dec 26 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 meetings of the AIDS Research Advisory Committee, NIAID.

The meetings will be open to the public, 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 blow in advance of the meeting.

Name of Committee: AIDS Research Advisory Committee, NIAID.

Date: January 28, 2008.

Time: 1 p.m. to 5:30 p.m.

Agenda: Reports from the Division Director and other staff.

Place: National Institutes of Health, Natcher Building, 45 Center Drive, Conference Rooms E1/E2, Bethesda, MD 20892.

Contact Person: Rona L. Siskind, Executive Secretary, AIDS Research Advisory Committee, Division of AIDS, NIAID/NIH, 6700B Rockledge Drive, Room 4139, Bethesda, MD 208927601, 3014353732. [[Page 73037]]

Name of Committee

Office of the National Coordinator for Health Information Technology; American Health Information Community

Wed, Dec 26 2007 11:00:00 GMT

This notice announces the 11th meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.).

National Institute of Arthritis And Musculoskeletal And Skin Diseases; Notice of Closed Meeting

Wed, Dec 26 2007 11:00:00 GMT

Pursuant to section 19(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, NIAMS.

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 other conducted by the National Institute of Arthritis and Musculoskeletal And Skin Diseases, 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, NIAMS.

Date: January 2223, 2008.

Time: 9:20 a.m. to 5 p.m.

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

Place: National Institutes of Health, Building 31, 31 Center D

Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer

Wed, Dec 26 2007 11:00:00 GMT

This notice announces the 22nd meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.)

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

Wed, Dec 26 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) 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, International Extramural Associates Research Development Awards (IEARDA).

Date: January 10, 2008.

Time: 2 p.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6100 Executive Boulevard, 5B01, Rockville, MD 20852, (Teleph

Office of the National Coordinator for Health Information Technology; American Health Information Community

Wed, Dec 26 2007 11:00:00 GMT

This notice announces the 16th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.).

National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

Wed, Dec 26 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 policy.

Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel, Review R01.

Date: January 17, 2008.

Time: 11 a.m. to 12 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call).

Contact Person: Jon

Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic

Wed, Dec 26 2007 11:00:00 GMT

This notice announces the 21st meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.).

National Institute of Dental & Craniofacial Research; Notice of Meetings

Wed, Dec 26 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 meetings of the National Advisory Dental and Craniofacial Research Council.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552(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 Commit

Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic

Wed, Dec 26 2007 11:00:00 GMT

This notice announces the 21st meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.)

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting

Wed, Dec 26 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 Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; The NIDDK Central Data Repository Contract Review.

Date: January 22, 2008.

Time: 11 a.m.to 12:30 p.m.

Agenda: To review and evaluate contract proposals.

Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (

Office of the National Coordinator for Health Information Technology; American Health Information Community Population

Wed, Dec 26 2007 11:00:00 GMT

This notice announces the 22nd meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee act (Pub. L. 92463, 5 U.S.C., App.)

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings

Wed, Dec 26 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 meetings of the National Diabetes and Digestive and Kidney Diseases Advisory Council.

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.

Nam

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

Wed, Dec 26 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 Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, GI Tract Program Projects.

Date: February 25, 2008.

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

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call)

National Institute of Mental Health; Notice of Closed Meeting

Wed, Dec 26 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 Mental Health Special Emphasis Panel, Conte Centers for the Neuroscience for Mental Disorders.

Date: February 22, 2008.

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

Agenda: To review and evaluate grant applications.

Place: RitzCarlton Hotel at Pentagon City, 1250 South Hayes Street, Arlington, VA 22201.

Contact Person: Vinod Charles, PhD,

National Institute of Mental Health; Notice of Closed Meeting

Wed, Dec 26 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 Mental Health Special Emphasis Panel, MTA Followup.

Date: January 16, 2008.

Time: 1 p.m. to 3 p.m.

Agenda: To review and evaluate contract proposals.

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

Contact Person: David I. Sommers, Ph

National Institute of Mental Health; Notice of Closed Meetings

Wed, Dec 26 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 Mental Health Initial Review Group, Interventions Committee for Disorders Related to Schizophrenia, Late Life, or Personality.

Date: February 8, 2008.

Time: 9 a.m. to 4 p.m.

Agenda: To review and evaluate applications.

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

Center for Scientific Review; Notice of Closed Meetings

Wed, Dec 26 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: Musculoskeletal, Oral and Skin Sciences Integrated Review Group, Arthritis, Connective Tissue and Skin Study Section.

Date: January 1718, 2008.

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

Agenda: To review and evaluate grant applications.

Place: Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

Contact Person: Aftab A. Ansari, PhD, Scientific Review Admi

Agency Forms Undergoing Paperwork Reduction Act Review

Wed, Dec 26 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 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

Experimental and Theoretical Study of Early Detection and Isolation of InfluenzaNewThe National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description

The Federal Occupational Safety and Health Act of 1970, section 501, enables NIOSH to carry out research relevant to the health and safety of workers. Some diseases like i

Agency Forms Undergoing Paperwork Reduction Act Review

Wed, Dec 26 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 requests, call the CDC Acting Reports Clearance Officer at 4046395960 and 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) 395 6974. Written comments should be received within 30 days of this notice.

Proposed Project

The Effectiveness of Teen Safe Driving Messages and Creative Elements on Parents and TeensNewNational Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Car crashes are the number one killer of teens, accounting for approximately onethird of all deaths within this age group. The National Center for Health Stati

Agency Forms Undergoing Paperwork Reduction Act Review

Wed, Dec 26 2007 11:00:00 GMT

Conduct a Chronic Fatigue Syndrome Registry Pilot Test (Bibb County, Georgia)NewNational Center for Zoonotic, Vectorborne, and Enteric Diseases (NCZVED), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is tasked with establishing a registry of chronic fatigue syndrome (CFS) and other fatiguing illnesses. The objective of the registry is to identify persons with

New Animal Drugs; Change of Sponsor's Name

Wed, Dec 26 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the [[Page 72921]]
animal drug regulations to reflect a change of sponsor's name from Altana, Inc., to Nycomed US, Inc.

Statement of Organization, Functions, and Delegations of Authority

Wed, Dec 26 2007 11:00:00 GMT

Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 6777276, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 72 FR 67308, dated November 28, 2007) is amended to reflect the reorganization of the Division of Healthcare Quality Promotion, National Center for Preparedness, Detection and Control of Infectious Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention.

Section CB, Organization and Functions, is hereby amended as follows: Delete in their entirety the functional statements for the Division of Healthcare Quality Promotion (CVKD), and insert the following:

Division of Healthcare Quality Promotion (CVKD). The mission of the Division of Healthcare Quality Promotion (DHQP) is to protect patients; protect healthcare personnel; and promote safety, quality, and value

Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug,

Wed, Dec 26 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 12, 2007 (72 FR 70599). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995. The document was published with an error. This document corrects that error.

Submission for OMB Review; Comment Request

Wed, Dec 26 2007 11:00:00 GMT

Title: National Survey of Child and Adolescent WellBeingSecond Cohort (NSCAW II).

OMB No.: 09700202.

Description: The Department of Health and Human Services (HHS) intends to collect data on a new sample of children and families for the National Survey of Child and Adolescent WellBeing (NSCAW). The NSCAW was authorized under Section 427 of the Personal Responsibility and Work Opportunities Reconciliation Act of 1996. The original survey began in November 1999 with a national sample of 5,501 children, ages 014, who had been the subject of investigation by Child Protective Services during the baseline data collection period, which extended from November 1999 through April 2000. Direct assessments and interviews were conducted with the children themselves, their primary caregivers, their caseworkers, and, for schoolaged children, their teachers; agency directors also were interviewed at baseline. Followup data collections were conducted 12 months, 18 months, and 36 months postbaseline,

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

Wed, Dec 26 2007 11:00:00 GMT

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of December 4, 2007 (72 FR 68166). The document announced 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.

Submission for OMB Review; Comment Request

Wed, Dec 26 2007 11:00:00 GMT

Title: Compassion Capital Fund Impact Evaluation Process Study.

OMB No.: New Collection.

Description: The information collection activity proposed under this notice will obtain information about intermediary grantee agencies providing capacity building assistance to faithbased and community organizations under the Compassion Capital Fund (CCF) Demonstration program. The information gathered under this data collection activity will be used to describe the approach and methods used by
intermediaries to provide the services that are being evaluated in the CCF impact evaluation. Information collection will be through informal discussions and observations onsite at the organizations, using uniform protocols.

Respondents: Directors and staff providing technical assistance and related services to faithbased and community organizations and directors and staff in faithbased and community organizations that have received capacity building assistance.

Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop

Wed, Dec 26 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in clinical trial design for communityacquired pneumonia. This public workshop is intended to provide information for and to gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for communityacquired pneumonia, including diagnosis of communityacquired pneumonia, effect of antimicrobial treatment for communityacquired pneumonia, endpoints for trials of community acquired pneumonia, and statistical issues in analysis of results of trials in communityacquired pneumonia. The input from this public workshop will help in developing topics for further discussion.

Date and Time: The public workshop will be held on January 17, 2008, from 8 a.m. to 6 p.m. and on January 18, 2008, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Crowne Plaza H

Division of Loan Repayment; Proposed Collection; Comment Request; National Institutes of Health Loan Repayment

Wed, Dec 26 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 Division of Loan Repayment, 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: National Institutes of Health Loan Repayment Programs. Type of Information Collection Request: Revision of currently approved collection (OMB No. 09250361, expiration date 6/30/ 08). Form Numbers: NIH 26741, NIH 26742, NIH 26743, NIH 26744, NIH 26745, NIH 26746, NIH 26747, NIH 26748, NIH 26749, NIH 267410, NIH 267411, NIH 267412, NIH 267413, NIH 267414, NIH 267415, NIH 267416, NIH 267417, NIH 267418, and NIH 267419. Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., D.D.S., D.M.D., D.P.M.,

Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle; Public

Wed, Dec 26 2007 11:00:00 GMT

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public workshop entitled ``Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle.'' The purpose of the public workshop is to solicit information and views from interested persons on research approaches and methods associated with the best ways to assess the public health benefit of collecting and reporting all adverse events (AEs). The input from this workshop will be used to publish a request for information to determine the types of outside organizations that would be interested in, and have the capability to conduct, the research described in this paragraph, followed by a request for proposal (RFP).

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

Wed, Dec 26 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 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 Heart, Lung, and Blood Institute Special Emphasis Panel, Blood Substitute Study.

Date: January 15, 2008.

Time: 1 p.m. to 4 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, Scientific