Center for Scientific Review; Notice of Closed Meetings, 55242-55243 [E9-25726]

Download as PDF 55242 Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices enter into only those voluntary research projects that lead to high-quality, peerreviewed scientific work. Additional details regarding the process for voluntary research are in the Federal Register Notices cited in this section. A. TSCA/FIFRA In developing and implementing SSARP, ATSDR and EPA established procedures to identify priority data needs of common interest to multiple federal programs. Where practicable, these data needs will be addressed through a program of toxicologic testing under TSCA or FIFRA. This part of the research will be conducted according to established TSCA/FIFRA procedures and guidelines. pwalker on DSK8KYBLC1PROD with NOTICES review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. If the proposed project is research involving human subjects, the applicants must comply with Department of Health and Human Services regulations (45 CFR part 46) and, if applicable, Food and Drug Administration regulations (21 CFR parts 50 and 56), regarding the protection of human subjects. The applicants must ensure that the project will be subject to initial and continuing review by the appropriate institutional review boards. Overall, by providing additional scientific information for the risk assessment process, data generated from this research will support other researchers conducting human health assessments involving these substances. Below are the mechanisms for implementing SSARP. The status of SSARP in addressing priority data needs of the first 60 priority hazardous substances through these mechanisms was described in a Federal Register Notice on December 13, 2005 (70 FR 73749). Dated: October 21, 2009. Ken Rose, Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E9–25776 Filed 10–26–09; 8:45 am] B. Private-Sector Voluntarism As part of SSARP, on February 7, 1992, ATSDR announced a set of proposed procedures for conducting voluntary research (57 FR 4758). Revisions based on public comments were published on November 16, 1992 (57 FR 54160). ATSDR strongly encourages private-sector organizations to propose research to address priority data needs at any time until ATSDR announces that research has already been initiated for a specific priority data need. Private-sector organizations may volunteer to conduct research to address specific priority data needs identified in this notice by submitting a letter of intent. The letter of intent should be a brief statement (1–2 pages) that identifies the priority data need(s) to be filled and the methods to be used. TASARC will review these proposals and recommend to ATSDR the voluntary research projects that should be pursued—and how they should be conducted—with the volunteer organizations. ATSDR will National Institutes of Health VerDate Nov<24>2008 16:45 Oct 26, 2009 Jkt 220001 C. CERCLA Those priority data needs not addressed by TSCA/FIFRA or initial voluntarism will be considered for funding by ATSDR through its CERCLA budget. Much of this research program is envisioned to be unique to CERCLA— for example, research on substances not regulated by other programs, or research needs specific to public health assessments. Mechanisms to address these priority data needs may include a second call for voluntarism. Again, scientific peer review of study protocols and results is a requirement for all research conducted under this auspice. ATSDR encourages private-sector organizations and other governmental programs to use ATSDR’s priority data needs to plan their research activities. BILLING CODE 4163–70–P National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 Alcohol Abuse and Alcoholism Special Emphasis Panel; AA–1 and AA–4 Study Sections Members Conflict. Date: November 10, 2009. Frm 00062 Fmt 4703 Dated: October 19, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–25623 Filed 10–26–09; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Time: 3 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892. (Telephone Conference Call.) Contact Person: Lorraine Gunzerath, PhD, MBA, Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, Office of Extramural Activities, Extramural Project Review Branch, 5635 Fishers Lane, Room 2121, Bethesda, MD 20892–9304, 301– 443–2369, Igunzera@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the securing of meeting attendees. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards, National Institutes of Health, HHS) Sfmt 4703 Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 Scientific Review Special Emphasis Panel; Member Conflicts in Language and Cognition. Date: November 12, 2009. Time: 3:30 p.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Dana Jeffrey Plude, PhD, Scientific Review Officer, Center for E:\FR\FM\27OCN1.SGM 27OCN1 Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3176, MSC 7848, Bethesda, MD 20892, 301–435– 2309, pluded@csr.nih.gov. Name of Committee: AIDS and Related Research Integrated Review Group; HIV/ AIDS Vaccines Study Section. Date: November 20, 2009. Time: 8 a.m. to 6 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: Mary Clare Walker, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD 20892, (301) 435– 1165, walkermc@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; AMCB, AIP and NAED Member Conflicts. Date: November 23, 2009. Time: 1 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Eduardo A. Montalvo, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC 7852, Bethesda, MD 20892, (301) 435– 1168, montalve@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: October 19, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–25726 Filed 10–26–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. pwalker on DSK8KYBLC1PROD with NOTICES ACTION: Notice. 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: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. VerDate Nov<24>2008 16:45 Oct 26, 2009 Jkt 220001 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 December 15, 2009, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/ Gaithersburg, Montgomery Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The hotel phone number is 301–977–8900. Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301– 827–7001, FAX: 301–827–6776, e-mail: diem.ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741– 8138 (301–443–0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/ phone line to learn about possible modifications before coming to the meeting. Agenda: On December 15, 2009, the subcommittee will consider and discuss: (1) FDA expectations regarding the development of pediatric formulations for cancer drugs, and (2) the development of dosing regimens in infants and toddlers with cancer. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https:// www.fda.gov/AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittee. Written submissions may be made to the contact person on or before December 1, 2009. Oral presentations from the public will be scheduled between approximately 10:45 a.m. to 11:15 a.m., and 3:15 p.m. to 3:45 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 20, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 23, 2009. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 55243 Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Diem-Kieu Ngo at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 22, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–25806 Filed 10–26–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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: Endocrinologic and Metabolic Drugs Advisory Committee. 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 December 15, 2009, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/ Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301–977–8900. Contact Person: Paul Tran, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, FAX: 301–827–6776, e-mail: paul.tran@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741– 8138 (301–443–0572 in the Washington, DC area), code 3014512536. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely E:\FR\FM\27OCN1.SGM 27OCN1

Agencies

[Federal Register Volume 74, Number 206 (Tuesday, October 27, 2009)]
[Notices]
[Pages 55242-55243]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), 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 Scientific Review Special Emphasis 
Panel; Member Conflicts in Language and Cognition.
    Date: November 12, 2009.
    Time: 3:30 p.m. to 5:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Dana Jeffrey Plude, PhD, Scientific Review 
Officer, Center for

[[Page 55243]]

Scientific Review, National Institutes of Health, 6701 Rockledge 
Drive, Room 3176, MSC 7848, Bethesda, MD 20892, 301-435-2309, 
pluded@csr.nih.gov.

    Name of Committee: AIDS and Related Research Integrated Review 
Group; HIV/AIDS Vaccines Study Section.
    Date: November 20, 2009.
    Time: 8 a.m. to 6 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: Mary Clare Walker, PhD, Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD 
20892, (301) 435-1165, walkermc@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; AMCB, AIP and NAED Member Conflicts.
    Date: November 23, 2009.
    Time: 1 p.m. to 3 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Eduardo A. Montalvo, PhD, Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5108, MSC 7852, Bethesda, MD 
20892, (301) 435-1168, montalve@csr.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

    Dated: October 19, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-25726 Filed 10-26-09; 8:45 am]
BILLING CODE 4140-01-P
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