National Library of Medicine; Notice of Closed Meetings, 449 [E8-31379]
Download as PDF
<![CDATA[
mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 74, No. 3 / Tuesday, January 6, 2009 / Notices
registration information will be required
for 3,000 trials of drugs and biologics
and 445 trials of medical devices each
year.
Each initial registration is estimated
to take 7 hours and each of the
subsequent 8 updates to the record are
estimated to take 2 hours, resulting in
an annual burden of 79,235 hours. It is
estimated that there will be voluntary
submissions of registration information
for 6,000 trials of drugs and biologics,
545 trials of devices, and 5,280 trials of
other types of medical interventions.
Using the same hour estimates as for
mandatory registration, the burden
associated with voluntary registrations
is estimated at 271,975 hours, bringing
the total registration burden to 351,210
hours. In the first year of operation, it
is estimated that there will be an
additional burden of 84,150 hours
associated with the updating of
information for 7,000 trials of drugs and
biologics and 650 trials of medical
devices that were previously registered
in the databank and ongoing as of
December 26, 2007 (90 days after
enactment). It is estimated that such
trials will require one update of 3 hours
to bring them into compliance with the
new law (FDAAA) and 4 subsequent
updates of 2 hours each. Submisson of
results information is required only for
those applicable clinical trials of drugs,
biologics, and devices that are subject to
the mandatory registration requirements
of FDAAA and for which the product(s)
under study have been approved or
cleared by the FDA. It is estimated that
results reporting will be required for
1,645 trials of drugs and biologics and
375 trials of medical devices each year.
Initial submission of results information
is estimated to require 10 hours, and
each result submission is expected to
require two updates that take 5 hours
each. It is estimated that 2,345 trials per
year will submit certifications for
delayed reporting of results information
or a request for an extension of the
reporting deadline. Preparation and
submission of such information is
estimated to take 1 hour. The total
burden for results reporting is therefore
estimated at 42,745 hours per year.
There are no capital costs to report. The
operating and maintenance budget for
the Clinical Trials Registry Databank in
FY2009 is projected to be approximately
$3 million.
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
VerDate Nov<24>2008
16:52 Jan 05, 2009
Jkt 217001
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.
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,
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
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: December 17, 2008.
Betsy L. Humphreys,
Deputy Director, National Library of
Medicine, National Institutes of Health.
[FR Doc. E8–31448 Filed 1–5–09; 8:45 am]
449
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 Library of
Medicine, Special Emphasis Panel, G08/K99/
R01/R13 SEP.
Date: February 11, 2009.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine, 6705
Rockledge Drive, Suite 301, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Zoe E. Huang, MD,
Scientific Review Officer, Division of
Extramural Programs, National Library of
Medicine, National Institutes of Health, 6705
Rockledge Drive, Suite 301, MSC 7968,
Bethesda, MD 20892–7968, 301–594–4937,
huangz@mail.nih.gov.
Name of Committee: National Library of
Medicine Special Emphasis Panel; G13 SEP.
Date: February 20, 2009.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Zoe E. Huang, MD,
Scientific Review Officer, Division of
Extramural Programs, National Library of
Medicine, National Institutes of Health, 6705
Rockledge Drive, Suite 301, MSC 7968,
Bethesda, MD 20892–7968, (301) 594–4937,
huangz@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: December 22, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–31379 Filed 1–5–09; 8:45 am]
BILLING CODE 4140–01–M
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HOMELAND
SECURITY
National Institutes of Health
Coast Guard
National Library of Medicine; 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.
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,
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
[USCG–2008–0961]
Collection of Information Under
Review by Office of Management and
Budget: OMB Control Number: 1625–
0073
Coast Guard, DHS.
Thirty-day notice requesting
comments.
AGENCY:
ACTION:
SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, this
request for comments announces that
the U.S. Coast Guard is forwarding an
Information Collection Request (ICR),
abstracted below, to the Office of
E:\FR\FM\06JAN1.SGM
06JAN1
]]>Agencies
[Federal Register Volume 74, Number 3 (Tuesday, January 6, 2009)]
[Notices]
[Page 449]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31379]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Library of Medicine; 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.
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 Library of Medicine, Special
Emphasis Panel, G08/K99/R01/R13 SEP.
Date: February 11, 2009.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: National Library of Medicine, 6705 Rockledge Drive, Suite
301, Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Zoe E. Huang, MD, Scientific Review Officer,
Division of Extramural Programs, National Library of Medicine,
National Institutes of Health, 6705 Rockledge Drive, Suite 301, MSC
7968, Bethesda, MD 20892-7968, 301-594-4937, huangz@mail.nih.gov.
Name of Committee: National Library of Medicine Special Emphasis
Panel; G13 SEP.
Date: February 20, 2009.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road, NW., Washington, DC 20015.
Contact Person: Zoe E. Huang, MD, Scientific Review Officer,
Division of Extramural Programs, National Library of Medicine,
National Institutes of Health, 6705 Rockledge Drive, Suite 301, MSC
7968, Bethesda, MD 20892-7968, (301) 594-4937, huangz@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.879,
Medical Library Assistance, National Institutes of Health, HHS)
Dated: December 22, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-31379 Filed 1-5-09; 8:45 am]
BILLING CODE 4140-01-M
