The Federal Register

Proposed Data Collections Submitted for Public Comment and Recommendations

Thu, Dec 8 2005 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 4046394766 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

Thu, Dec 8 2005 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 4046394766 or 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.

[30Day-06-05BF)

Thu, Dec 8 2005 11:00:00 GMT

Agency Forms Undergoing Paperwork Reduction Act Review

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) 6394766 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

Human Smoking BehaviorNewNational Center for Chronic Disease and Public Health Promotion (NCDDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), in a joint venture with the National Center for Environmental Health (NCEH), pr

Food Additives Permitted for Direct Addition to Food for Human Consumption; Synthetic Fatty Alcohols

Thu, Dec 8 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of noctanol (noctyl alcohol) produced by a new manufacturing process, the hydrodimerization of 1,3butadiene. This action is in response to a petition filed by Kuraray International Corp.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Enforcement

Thu, Dec 8 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Enforcement Notifications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally

Thu, Dec 8 2005 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 procedures used for submitting a Generally Recognized as Safe (GRAS) notice stating that a particular use of a substance is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the act).

Draft Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for

Thu, Dec 8 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens.'' This draft guidance document is being issued to provide guidance on the types of information and data to consider when preparing or reviewing premarket submissions for nucleic acid based in vitro diagnostic devices for the detection of microbial pathogens.

Meeting of the Advisory Committee on Blood Safety and Availability

Thu, Dec 8 2005 11:00:00 GMT

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public.

National Vaccine Injury Compensation Program; List of Petitions Received

Thu, Dec 8 2005 11:00:00 GMT

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards--Extension of Comment Period

Thu, Dec 8 2005 11:00:00 GMT

On November 28, 2005, we published a notice and comment period seeking comments from interested parties on draft compliance program guidance (CPG) developed by the Office of Inspector General (OIG) for recipients of extramural research awards from the National Institutes of Health and other agencies of the U.S. Public Health Service (PHS) (70 FR 71312). To facilitate public comment, we are extending the comment period.

Notice of Establishment

Thu, Dec 8 2005 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 Board of Scientific Counselors, National Center for Biotechnology Information, National Library of Medicine (Board).

The Board shall advise the Director, NIH; the Deputy Director for Intramural Research, NIH; the Director, National Library of Medicine (NLM); and the Director, National Center for Biotechnology Information (NCBI), concerning the intramural research and development programs of the NCBI, NLM through regularly scheduled visits to the NLM for assessment of the research and development programs in progress at the NCBI, assessments of proposed programs and evaluation of the productivity and performance of staff scientists.

The Board shall consist of 8 members, including the Chair, appointed by the Director, NIH, from authorities knowledgeable in the fields of health sciences, computer sciences, information sci

National Center for Research Resources; Notice of Meeting

Thu, Dec 8 2005 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 National Advisory Research Resources Council.

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 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/or contact 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, the disclosure of which would constitute a clearly unwarranted invasion o

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

Thu, Dec 8 2005 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 Heart, Lung, and Blood Institute Special Emphasis Panel. Review of Institutional National Research Service Awards (T32s).

Date: December 14, 2005.

Time: 4:15 p.m. to 5:15 p.m.

Agenda: To review and evaluate grant applications.

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

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

Thu, Dec 8 2005 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, NIAID.

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 Institute of Allergy and Infectious 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, NIAID. Division of Intramural Research, Board of Scientific Counselors.

Date: December 57, 2005.

Time: December 6, 2005, 8 a.m. to 5 p.m.

Agenda: To review and evaluate review of intramural laboratories.

Place: National Instit

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

Thu, Dec 8 2005 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 [[Page 73017]]
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 Arthritis and Musculoskeletal and Skin Diseases Special Emphasis Panel, Research Program Projects.

Date: December 6, 2005.

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

Agenda: To review and evaluate grant applications.

Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817.

Contact Person: Helen Lin, Ph.D.

National Institute of Environmental Health Sciences; Notice of Closed Meeting

Thu, Dec 8 2005 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 Environmental Health Sciences Special Emphasis Panel Mentored PatientOriented Research Career Development Award (K23).

Date: December 15, 2005.

Time: 2 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 T

National Institute on Drug Abuse; Notice of Meeting

Thu, Dec 8 2005 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 National Advisory Council on Drug Abuse.

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 Advis

National Institute on Drug Abuse; Notice of Closed Meeting

Thu, Dec 8 2005 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 on Drug Abuse Special Emphasis Panel. Hurricane Katrina Time Sensitive Review.

Date: December 16, 2005.
[[Page 73018]]

Time: 11 a.m. to 6 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6101 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

Contact Person: M

National Library of Medicine; Notice of Meeting

Thu, Dec 8 2005 11:00:00 GMT

Notice is hereby given of the first meeting of the Working Group on Chemical Information Resource Coordination under the National Library of Medicine's (NLM) Board of Scientific Counselors, National Center for Biotechnology Information (NCBI).

The meeting 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 below in advance of the meeting.

The mission of the Working Group on Chemical Information Resource Coordination is to advise the Board of Scientific Counselors, NCBI, on interactions with private sector information providers in the development of the PubChem database. PubChem is a publicly available database that includes information about the biological activities of chemical compounds, and is designed to facilitate more integrated access to these information resources for biomedical researc

National Library of Medicine; Notice of Meetings

Thu, Dec 8 2005 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 Board of Regents of the National Library of Medicine.

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 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:

Suspension of a Laboratory Which No Longer Meets Minimum Standards To Engage in Urine Drug Testing for Federal

Thu, Dec 8 2005 11:00:00 GMT

The Department of Health and Human Services routinely publishes a list of laboratories in the Federal Register that are currently certified to meet standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (69 FR 19644) dated April 13, 2004. This notice informs the public that effective November 15, 2005, the following laboratory's certification is suspended: Sciteck Clinical Laboratories, Inc., 317 Rutledge Rd., Fletcher, NC 28732.