Center for Scientific Review; Notice of Closed Meetings, 15165-15166 [E8-5581]

Download as PDF 15165 Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices TABLE 2.—ESTIMATED BURDEN FOR VOLUNTARY REPORTING Number of respondents Type of respondents Drugs and Biologics ........................................ 5,400 Devices ........................................................... 545 Other ............................................................... 5,280 Total Voluntary ......................................... 11,225 The combined, recurring burden for mandatory and voluntary reporting would be the sum of the totals in Tables 1 and 2, or 348,910 hours. This figure would be expected to decline over time as registrants become more familiar with the registration processes and refine their data submission systems. During the first year of implementation, there will be an additional mandatory reporting burden associated with the collection of information for applicable trials of drugs, biologics, and devices that were ongoing as of December 26, 2007, but had been previously registered with Average time per response (hours) Frequency of response 1 8 1 8 1 8 Annual hour burden New ............................................................. Updates ....................................................... New ............................................................. Updates ....................................................... New ............................................................. Updates ....................................................... 7 2 7 2 7 2 37,800 86,400 3,815 8,720 36,960 84,480 ......................................................................... ........................ 258,175 ClinicalTrials.gov. These respondents have already provided information collected under the previous OMB clearance and will provide only the additional elements subject to this clearance. The number of trials subject to this requirement is estimated by searching the existing ClinicalTrials registry for ongoing, interventional Phase 2–4 studies of drugs, biologics, and devices. Doing so produces an estimate of 7,650 trials: 7,000 previously registered trials of drugs and biologics and 650 previously registered trials of devices. It is anticipated that information collection required to bring these trials into compliance with the new information collection requirements will be significantly less than for a new trial registration and is estimated as 3 hours. Information for these trials will need to be updated to reflect the continued progress of the trial. The number of updates is estimated to be 4, which is half of the updates estimated for new registrations. Each update is estimated to require 2 hours, consistent with the updates for newly registered trials. The total burden associated with the updating of information for ongoing trials is 84,150 hours, as shown in Table 3. TABLE 3.—ESTIMATED BURDEN FOR MANDATORY UPDATING OF INFORMATION FOR ONGOING TRIALS Frequency of response Average time per response (hours) 1 Compliance Update .................................... 4 Subsequent Updates .................................. 1 Compliance Update .................................... 4 Subsequent Updates .................................. ......................................................................... 3 2 3 2 ........................ Number of respondents Type of respondents Drugs and Biologics ........................................ 7,000 Devices ........................................................... 650 Total ................................................................ 7,650 Annual hour burden 21,000 56,000 1,950 5,200 84,150 mstockstill on PROD1PC66 with NOTICES There are no Capital Costs, Operating Costs or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. VerDate Aug<31>2005 18:33 Mar 20, 2008 Jkt 214001 Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Office of Management and Budget, Office of Regulatory Affairs. All comments should be sent via e-mail to OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: David Sharlip, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll free number 301–402–9680 or E-mail your request to sharlipd@mail.nih.gov. Comments Due Date: Comments regarding this information collection are PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 best assured of having their full effect if received within 15 days of the date of this publication. Dated: March 14, 2008. Betsy L. Humphreys, Deputy Director, National Library of Medicine, National Institutes of Health. [FR Doc. E8–5824 Filed 3–20–08; 8:45 am] BILLING CODE 4140–01–P 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. Appendix 2), notice is hereby given of the following meetings. E:\FR\FM\21MRN1.SGM 21MRN1 15166 Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices mstockstill on PROD1PC66 with NOTICES 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 Conflict: Primate, Cognition and Pain. Date: April 1, 2008. Time: 3 p.m. to 5 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: Edwin C. Clayton, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5095C, MSC 7844, Bethesda, MD 20892, (301) 402– 1304, claytone@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Review of ACE Member Conflict Applications. Date: April 2, 2008. Time: 12 p.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Mark P. Rubert, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1775, rubertm@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Biomaterials and Tissue Engineering. Date: April 3–4, 2008. Time: 8 a.m. to 8 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Alexander Gubin, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4196, MSC 7812, Bethesda, MD 20892, 301–435– 2902, gubina@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. VerDate Aug<31>2005 18:33 Mar 20, 2008 Jkt 214001 Name of Committee: Center for Scientific Review Special Emphasis Panel; Family Management and Food Allergy. Date: April 3, 2008. Time: 10 a.m. to 11 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Michael Micklin, PhD, Chief, RPHB IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3136, MSC 7759, Bethesda, MD 20892, (301) 435–1258, micklinm@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Channels, Receptors, and Synapses. Date: April 9, 2008. Time: 2:30 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: Joanne T. Fujii, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4184, MSC 7850, Bethesda, MD 20892, (301) 435– 1178, fujiij@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PBKD Member Conflicts. Date: April 16, 2008. Time: 11 a.m. to 1 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: Shirley Hilden, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4222, MSC 7814, Bethesda, MD 20892, (301) 435– 1198, hildens@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Dentistry-Related. Date: April 24–25, 2008. Time: 6 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: J. Terrell Hoffeld, DDS, PhD, USPHS Dental Director, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4116, MSC 7816, Bethesda, MD 20892, 301/435– 1781, th88q@nih.gov. Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Neurobiology of Motivated Behavior Study Section. Date: May 27–28, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Place: Washington Plaza, 10 Thomas Circle, NW., Washington, DC 20005. Contact Person: Edwin C. Clayton, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5095C, MSC 7844, Bethesda, MD 20892, (301) 402– 1304, claytone@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: March 13, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–5581 Filed 3–20–08; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting 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; Review of An Unsolicited T Cell Development P01 Application. Date: April 23, 2008. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health Rockledge 6700, 6700B Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Quirijn Vos, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892, 301–451–2666, qvos@niaid.nih.gov (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) E:\FR\FM\21MRN1.SGM 21MRN1

Agencies

[Federal Register Volume 73, Number 56 (Friday, March 21, 2008)]
[Notices]
[Pages 15165-15166]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5581]


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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. Appendix 2), notice is hereby given of the following 
meetings.

[[Page 15166]]

    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 Conflict: Primate, Cognition and Pain.
    Date: April 1, 2008.
    Time: 3 p.m. to 5 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: Edwin C. Clayton, PhD, Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5095C, MSC 7844, Bethesda, MD 
20892, (301) 402-1304, claytone@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.
    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Review of ACE Member Conflict Applications.
    Date: April 2, 2008.
    Time: 12 p.m. to 2 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Rockledge Drive, Bethesda, 
MD 20892, (Telephone Conference Call).
    Contact Person: Mark P. Rubert, PhD, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301-435-
1775, rubertm@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.
    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Biomaterials and Tissue Engineering.
    Date: April 3-4, 2008.
    Time: 8 a.m. to 8 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Alexander Gubin, PhD, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4196, MSC 7812, Bethesda, MD 20892, 301-435-
2902, gubina@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.
    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Family Management and Food Allergy.
    Date: April 3, 2008.
    Time: 10 a.m. to 11 a.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Michael Micklin, PhD, Chief, RPHB IRG, Center 
for Scientific Review, National Institutes of Health, 6701 Rockledge 
Drive, Room 3136, MSC 7759, Bethesda, MD 20892, (301) 435-1258, 
micklinm@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.
    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Channels, Receptors, and Synapses.
    Date: April 9, 2008.
    Time: 2:30 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: Joanne T. Fujii, PhD, Scientific Review 
Administrator, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4184, MSC 7850, Bethesda, MD 
20892, (301) 435-1178, fujiij@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PBKD Member Conflicts.
    Date: April 16, 2008.
    Time: 11 a.m. to 1 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: Shirley Hilden, PhD, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4222, MSC 7814, Bethesda, MD 20892, (301) 435-
1198, hildens@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Small Business: Dentistry-Related.
    Date: April 24-25, 2008.
    Time: 6 a.m. to 6 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: J. Terrell Hoffeld, DDS, PhD, USPHS Dental 
Director, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4116, MSC 7816, Bethesda, MD 
20892, 301/435-1781, th88q@nih.gov.

    Name of Committee: Integrative, Functional and Cognitive 
Neuroscience Integrated Review Group; Neurobiology of Motivated 
Behavior Study Section.
    Date: May 27-28, 2008.
    Time: 8 a.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Washington Plaza, 10 Thomas Circle, NW., Washington, DC 
20005.
    Contact Person: Edwin C. Clayton, PhD, Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5095C, MSC 7844, Bethesda, MD 
20892, (301) 402-1304, claytone@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: March 13, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
 [FR Doc. E8-5581 Filed 3-20-08; 8:45 am]
BILLING CODE 4140-01-M