Center for Scientific Review; Notice of Closed Meetings, 17552-17553 [2014-06925]
Download as PDF
<![CDATA[
17552
Federal Register / Vol. 79, No. 60 / Friday, March 28, 2014 / Notices
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information listed set forth in this
document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Electronic Records; Electronic
Signatures—(OMB Control Number
0910–0303)—Extension
FDA regulations in part 11 (21 CFR
part 11) provide criteria for acceptance
of electronic records, electronic
signatures, and handwritten signatures
executed to electronic records as
equivalent to paper records. Under these
regulations, records and reports may be
submitted to FDA electronically
provided the Agency has stated its
ability to accept the records
electronically in an Agency-established
public docket and that the other
requirements of part 11 are met.
The recordkeeping provisions in part
11 (§§ 11.10, 11.30, 11.50, and 11.300)
require the following standard operating
procedures to assure appropriate use of,
and precautions for, systems using
electronic records and signatures: (1)
§ 11.10 specifies procedures and
controls for persons who use closed
systems to create, modify, maintain, or
transmit electronic records; (2) § 11.30
specifies procedures and controls for
persons who use open systems to create,
modify, maintain, or transmit electronic
records; (3) § 11.50 specifies procedures
and controls for persons who use
electronic signatures; and (4) § 11.300
specifies controls to ensure the security
and integrity of electronic signatures
based upon use of identification codes
in combination with passwords. The
reporting provision (§ 11.100) requires
persons to certify in writing to FDA that
they will regard electronic signatures
used in their systems as the legally
binding equivalent of traditional
handwritten signatures.
The burden created by the
information collection provision of this
regulation is a one-time burden
associated with the creation of standard
operating procedures, validation, and
certification. The Agency anticipates the
use of electronic media will
substantially reduce the paperwork
burden associated with maintaining
FDA required records. The respondents
are businesses and other for-profit
organizations, State or local
governments, Federal Agencies, and
nonprofit institutions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
11.100—General Requirements ..........................................
4,500
1
4,500
1
4,500
Average
burden per
recordkeeping
Total hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
11.10—Controls for closed systems ....................................
11.30—Controls for open systems ......................................
11.50—Signature manifestations .........................................
11.300—Controls for identification codes/passwords ..........
2,500
2,500
4,500
4,500
1
1
1
1
2,500
2,500
4,500
4,500
20
20
20
20
50,000
50,000
90,000
90,000
Total ..............................................................................
........................
........................
........................
........................
280,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–06918 Filed 3–27–14; 8:45 am]
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
BILLING CODE 4160–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
VerDate Mar<15>2010
18:57 Mar 27, 2014
Jkt 232001
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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; PAR Panel:
E:\FR\FM\28MRN1.SGM
28MRN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 60 / Friday, March 28, 2014 / Notices
Multidisciplinary Studies of HIV/AIDS and
Aging.
Date: April 3, 2014.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Robert Freund, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216,
MSC 7852, Bethesda, MD 20892, 301–435–
1050, freundr@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; Member
Conflict: AIDS and AIDS Related Research.
Date: April 8–9, 2014.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Robert Freund, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216,
MSC 7852, Bethesda, MD 20892, 301–435–
1050, freundr@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; AIDS and
AIDS Related Research.
Date: April 10, 2014.
Time: 10:00 a.m. to 11:30 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: Mark P Rubert, Ph.D.,
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; RFA RM13–
007: New Innovator Award.
Date: April 24–25, 2014.
Time: 8:00 a.m. to 5:00 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: Rajiv Kumar, Ph.D., Chief,
MOSS IRG, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 4216, MSC 7802, Bethesda, MD
20892, 301–435–1212, kumarra@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Skeletal
VerDate Mar<15>2010
18:57 Mar 27, 2014
Jkt 232001
Muscle Biology and Soft Tissue
Musculoskeletal Rehabilitation.
Date: April 25, 2014.
Time: 11:00 a.m. to 3:00 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: Daniel F McDonald, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4110,
MSC 7814, Bethesda, MD 20892, (301) 435–
1215, mcdonald@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 24. 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–06925 Filed 3–27–14; 8:45 am]
BILLING CODE 4140–01–P
17553
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Atherosclerosis and Inflammation
of the Cardiovascular System.
Date: April 1, 2014.
Time: 3:00 p.m. to 6:00 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: Natalia Komissarova,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5207,
MSC 7846, Bethesda, MD 20892, 301–435–
1206, komissar@mail.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.
(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)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 24, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
[FR Doc. 2014–06926 Filed 3–27–14; 8:45 am]
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
Conflict: AIDS and AIDS Related Research.
Date: April 1, 2014.
Time: 11:30 a.m. to 1:00 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: Robert Freund, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216,
MSC 7852, Bethesda, MD 20892, 301–435–
1050, freundr@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; 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 Eye Institute
Special Emphasis Panel; NEI Load
Repayment.
Date: April 16, 2014.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Bethesda, MD 20892.
Contact Person: Brian Hoshaw, Ph.D.,
Scientific Review Officer, National Eye
E:\FR\FM\28MRN1.SGM
28MRN1
]]>Agencies
[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Notices]
[Pages 17552-17553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06925]
-----------------------------------------------------------------------
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; PAR Panel:
[[Page 17553]]
Multidisciplinary Studies of HIV/AIDS and Aging.
Date: April 3, 2014.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892.
Contact Person: Robert Freund, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, 301-435-
1050, freundr@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; Member Conflict: AIDS and AIDS Related Research.
Date: April 8-9, 2014.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Robert Freund, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, 301-435-
1050, freundr@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; AIDS and AIDS Related Research.
Date: April 10, 2014.
Time: 10:00 a.m. to 11:30 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: Mark P Rubert, Ph.D., 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; RFA RM13-007: New Innovator Award.
Date: April 24-25, 2014.
Time: 8:00 a.m. to 5:00 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: Rajiv Kumar, Ph.D., Chief, MOSS IRG, Center for
Scientific Review, National Institutes of Health, 6701 Rockledge
Drive, Room 4216, MSC 7802, Bethesda, MD 20892, 301-435-1212,
kumarra@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Skeletal Muscle Biology and Soft Tissue Musculoskeletal
Rehabilitation.
Date: April 25, 2014.
Time: 11:00 a.m. to 3:00 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: Daniel F McDonald, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4110, MSC 7814, Bethesda, MD
20892, (301) 435-1215, mcdonald@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 24. 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-06925 Filed 3-27-14; 8:45 am]
BILLING CODE 4140-01-P
