Submission for OMB Review; 30-Day Comment Request; Evaluation of National Institutes of Health International Bilateral Programs (FIC, NCI, NIAAA, NIAID, NICHD, NIDA, NINDS, NIMH, OAR), 61646-61647 [2014-24437]
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61646
Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices
sites after this document is published in
the Federal Register.) Payment by major
credit card is accepted (Visa/
MasterCard/AMEX only). For more
information on the meeting registration,
or for questions on the workshop,
contact SoCRA (see Contact).
SUPPLEMENTARY INFORMATION: The
public workshop helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The public
workshop will provide those engaged in
FDA-regulated (human) clinical trials
with information on a number of topics
concerning FDA requirements related
informed consent, clinical investigation
requirements, institutional review board
inspections, electronic record
requirements, and investigator initiated
research Topics for discussion include
the following: (1) The Role of the FDA
District Office Relative to the
Bioresearch Monitoring Program
(BIMO); (2) Modernizing FDA’s Clinical
Trials/BIMO Programs; (3) What FDA
Expects in a Pharmaceutical Clinical
Trial; (4) Medical Device Aspects of
Clinical Research; (5) Adverse Event
Reporting—Science, Regulation, Error,
and Safety; (6) Working with FDA’s
Center for Biologics Evaluation and
Research; (7) Ethical Issues in Subject
Enrollment; (8) Keeping Informed and
Working Together; (9) FDA Conduct of
Clinical Investigator Inspections; (10)
Investigator Initiated Research; (11)
Meetings with FDA—Why, When, and
How; (12) Part 11 Compliance—
Electronic Signatures; (13) IRB
Regulations and FDA Inspections; (14)
Informed Consent Regulations; (15) The
Inspection is Over—What Happens
Next? Possible FDA Compliance
Actions; (16) Question and Answer
Session/Panel Discussion.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The public workshop helps to achieve
objectives set forth in section 406 of the
FDA Modernization Act of 1997 (21
U.S.C. 393), which includes working
closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The workshop also is consistent
with the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub.
L. 104–121), as outreach activities by
Government agencies to small
businesses.
Dated: October 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24307 Filed 10–10–14; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Evaluation of
National Institutes of Health
International Bilateral Programs (FIC,
NCI, NIAAA, NIAID, NICHD, NIDA,
NINDS, NIMH, OAR)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on March 13, 2014
(Vol. 79, P. 14256) and allowed 60-days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
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: NIH Desk Officer.
DATES: Comment 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.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Margaret Mary Bertram, Center
for Global Health, National Cancer
Institute, 9609 Medical Center Dr., Rm
3W264, Rockville MD, 20850 or call
non-toll-free number 240–276–5656 or
Email your request, including your
address to: margaret.bertram@nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Evaluation of
National Institutes of Health
International Bilateral Programs (FIC,
NCI, NIAAA, NIAID, NICHD, NIDA,
NINDS, NIMH, OAR), 0925–NEW,
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: This submission is a request
for OMB to approve the Evaluation of
National Institutes of Health (NIH)
International Bilateral Programs for
three years. The bilateral awards are
made through the Funding Opportunity
Announcement mechanism and
administrative supplements, meaning
they are funded by set-aside funds that
are separate from the general pool of
research program grant funds used to
support investigator initiated research at
NIH. The bilateral programs to be
evaluated are the U.S.-China Program
for Biomedical Research Cooperation,
U.S.-India Bilateral Collaborative
Research Partnerships on the Prevention
of HIV/AIDS and Co-morbidities, U.S.Russia Bilateral Collaborative Research
Partnerships on the Prevention and
Treatment of HIV/AIDS and Comorbidities, and U.S.-South Africa
Program for Collaborative Biomedical
Research. These programs are funded
and administered by various
combinations of the following institutes:
Fogarty International Center (FIC), the
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National Cancer
Institute (NCI), National Institute on
Alcohol Abuse and Alcoholism
(NIAAA), National Institute for Allergy
and Infectious Diseases (NIAID),
National Institute on Drug Abuse
(NIDA), National Institute of Mental
Health (NIMH), National Institute of
Neurological Disorders and Stroke
(NINDS), and the Office of AIDS
Research (OAR). While these programs
differ, their underlying concept is the
same; they require U.S. scientists to
collaborate with scientists from other
countries in order to conduct
scientifically meritorious investigations
of mutual interest to both countries. The
proposed evaluation requests
information about (1) accomplishments
of the awards, (2) unique findings or
opportunities due to the international
collaborations, and (3) successes and
challenges of these collaborations. The
information will be collected one year
into the award and at the end of the
award, when possible. This information
is needed to evaluate the effectiveness
of these programs across NIH.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
129.
E:\FR\FM\14OCN1.SGM
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Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Forms
Principal Investigators .................
Administrative Supplements ...................
Year 1 Survey ........................................
Final Year Survey ..................................
Telephone Script for Non-Responders ..
Dated: October 6, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2014–24437 Filed 10–10–14; 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
mstockstill on DSK4VPTVN1PROD with NOTICES
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:392:
New Computational Methods for
Understanding the Functional Role of DNA
Variants that are Associated with Mental
Disorder.
Date: October 29, 2014.
Time: 12:00 p.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: Alexander Gubin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6046B,
MSC 7892, Bethesda, MD 20892, 301–408–
9655, gubina@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Vascular
Biology and Hematology AREA.
Date: November 6, 2014.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
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24
52
52
16
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Larry Pinkus, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4132,
MSC 7802, Bethesda, MD 20892, (301) 435–
1214, pinkusl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Child Psychopathology and
Developmental Disabilities.
Date: November 10–11, 2014.
Time: 8:00 a.m. to 11:59 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Mark Lindner, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182,
MSC 7770, Bethesda, MD 20892, 301–435–
0913, mark.lindner@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Mechanisms of Emotion, Stress and
Health.
Date: November 10–11, 2014.
Time: 8:00 a.m. to 11:59 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Mark Lindner, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182,
MSC 7770, Bethesda, MD 20892, 301–435–
0913, mark.lindner@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Bacterial Biochemistry, Genetics,
and Evolution.
Date: November 10, 2014.
Time: 2:30 p.m. to 4:30 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: Barbara J. Thomas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2218,
MSC 7890, Bethesda, MD 20892, 301–435–
0603, bthomas@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
1
Average
burden per
response
(in hours)
1
1
1
3/60
Total annual
burden hours
24
52
52
1
Business: Non-HIV Anti-Infective
Therapeutics.
Date: November 12, 2014.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Alexandria Old
Town, 1456 Duke Street, Alexandria, VA
22314.
Contact Person: Kenneth M. Izumi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge, Rm 3204, MSC 7808,
Bethesda, MD 20892, 301–496–6980,
izumikm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA
Application Review.
Date: November 12, 2014.
Time: 9:30 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.
Contact Person: Liangbiao Zheng, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3202,
MSC 7808, Bethesda, MD 20892, 301–996–
5819, zhengli@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cell Biology.
Date: November 12, 2014.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Wallace Ip, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5128,
MSC 7840, Bethesda, MD 20892, 301–435–
1191, ipws@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Imaging and
Biomarkers for Early Cancer Detection:
PAR13–189.
Date: November 12, 2014.
Time: 10:00 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.
Contact Person: Chiayeng Wang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Room 5213, MSC 7852, Bethesda, MD 20892,
301–435–2397, chiayeng.wang@nih.gov.
E:\FR\FM\14OCN1.SGM
14OCN1
]]>Agencies
[Federal Register Volume 79, Number 198 (Tuesday, October 14, 2014)]
[Notices]
[Pages 61646-61647]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24437]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Evaluation of
National Institutes of Health International Bilateral Programs (FIC,
NCI, NIAAA, NIAID, NICHD, NIDA, NINDS, NIMH, OAR)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH), has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on March 13, 2014 (Vol. 79, P. 14256) and allowed 60-days for
public comment. No public comments were received. The purpose of this
notice is to allow an additional 30 days for public comment. The
National Cancer Institute (NCI), National Institutes of Health, may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
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: NIH Desk Officer.
DATES: Comment 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.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: Margaret Mary Bertram, Center for Global
Health, National Cancer Institute, 9609 Medical Center Dr., Rm 3W264,
Rockville MD, 20850 or call non-toll-free number 240-276-5656 or Email
your request, including your address to: margaret.bertram@nih.gov.
Formal requests for additional plans and instruments must be requested
in writing.
Proposed Collection: Evaluation of National Institutes of Health
International Bilateral Programs (FIC, NCI, NIAAA, NIAID, NICHD, NIDA,
NINDS, NIMH, OAR), 0925-NEW, National Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information Collection: This submission is a
request for OMB to approve the Evaluation of National Institutes of
Health (NIH) International Bilateral Programs for three years. The
bilateral awards are made through the Funding Opportunity Announcement
mechanism and administrative supplements, meaning they are funded by
set-aside funds that are separate from the general pool of research
program grant funds used to support investigator initiated research at
NIH. The bilateral programs to be evaluated are the U.S.-China Program
for Biomedical Research Cooperation, U.S.-India Bilateral Collaborative
Research Partnerships on the Prevention of HIV/AIDS and Co-morbidities,
U.S.-Russia Bilateral Collaborative Research Partnerships on the
Prevention and Treatment of HIV/AIDS and Co-morbidities, and U.S.-South
Africa Program for Collaborative Biomedical Research. These programs
are funded and administered by various combinations of the following
institutes: Fogarty International Center (FIC), the Eunice Kennedy
Shriver National Institute of Child Health and Human Development
(NICHD), National Cancer Institute (NCI), National Institute on Alcohol
Abuse and Alcoholism (NIAAA), National Institute for Allergy and
Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA),
National Institute of Mental Health (NIMH), National Institute of
Neurological Disorders and Stroke (NINDS), and the Office of AIDS
Research (OAR). While these programs differ, their underlying concept
is the same; they require U.S. scientists to collaborate with
scientists from other countries in order to conduct scientifically
meritorious investigations of mutual interest to both countries. The
proposed evaluation requests information about (1) accomplishments of
the awards, (2) unique findings or opportunities due to the
international collaborations, and (3) successes and challenges of these
collaborations. The information will be collected one year into the
award and at the end of the award, when possible. This information is
needed to evaluate the effectiveness of these programs across NIH.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 129.
[[Page 61647]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Forms Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Principal Investigators....... Administrative 24 1 1 24
Supplements.
Year 1 Survey... 52 1 1 52
Final Year 52 1 1 52
Survey.
Telephone Script 16 1 3/60 1
for Non-
Responders.
----------------------------------------------------------------------------------------------------------------
Dated: October 6, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-24437 Filed 10-10-14; 8:45 am]
BILLING CODE 4140-01-P
