Center for Scientific Review; Notice of Closed Meetings, 15165-15166 [E8-5581]
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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.
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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
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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]
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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.
E:\FR\FM\21MRN1.SGM
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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.
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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
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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]
-----------------------------------------------------------------------
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