30-day FRN

30-day FRN2016-14057.pdf

Women's Health Initiative Observational Study (NHLBI)

30-day FRN

OMB: 0925-0414

Document [pdf]
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39058

Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Notices

would constitute a clearly unwarranted
invasion of personal privacy.

ehiers on DSK5VPTVN1PROD with NOTICES

Name of Committee: AIDS and Related
Research Integrated Review Group; AIDS
Immunology and Pathogenesis Study
Section.
Date: July 7, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Mayflower Park Hotel, 405 Olive
Way, Seattle, WA 98101.
Contact Person: Shiv A. Prasad, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Mechanisms of Aging.
Date: July 7, 2016.
Time: 1:00 p.m. to 5:00 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: Thomas Beres, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Dr., Rm. 5201, MSC
7840, Bethesda, MD 20892, 301–435–1175,
[email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Biobehavioral Regulation Learning
and Ethology.
Date: July 11, 2016.
Time: 1:00 p.m. to 5:00 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: 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, 301–915–
6298, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: HIV/AIDS Innovative Research
Applications.
Date: July 13, 2016.
Time: 3:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street NW., Washington, DC 20037.
Contact Person: Barna Dey, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3184,
Bethesda, MD 20892, 301–451–2796, bdey@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–OD–
16–004: Environmental Influences on Child
Health Outcomes (ECHO) Pediatric Cohorts.
Date: July 14–15, 2016.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.

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Place: The St. Regis Washington, DC, 923
16th Street NW., Washington, DC 20006.
Contact Person: Suzanne Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 435–
1712, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Dermatology and Cell/Molecular
Biology.
Date: July 15, 2016.
Time: 8:00 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
(Virtual Meeting).
Contact Person: Baljit S. Moonga, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7806, Bethesda, MD 20892, 301–435–
1777, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR13–390:
Indo-US Collaborative Program in Affordable
Medical Devices.
Date: July 15, 2016.
Time: 9:00 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
(Virtual Meeting).
Contact Person: Craig Giroux, Ph.D.,
Scientific Review Officer, BST IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5150,
Bethesda, MD 20892, 301–435–2204,
[email protected].
(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: June 9, 2016.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–14053 Filed 6–14–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Women’s Health
Initiative (NHLBI)
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

SUMMARY:

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collection was previously published in
the Federal Register on April 4, 2016,
Pages: 19207–19208. No comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Heart, Lung and
Blood Institute (NHLBI), 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.
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, submit
comments in writing, or request more
information on the proposed project,
contact: Shari Ludlam, 6701 Rockledge
Drive, MSC 7936, Bethesda, MD 20892,
or call non-toll-free number (301) 435–
6667, or Email your request to:
[email protected]. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: The Women’s
Health Initiative, 0925–0414, Revision,
Exp. 7/31/2016, National Heart, Lung,
and Blood Institute (NHLBI), the
National Institutes of Health (NIH).
Need and Use of Information
Collection: This proposal is to extend
the Women’s Health Initiative (WHI),
which comprises a group of research
studies that will address critical issues
about the most common causes of
frailty, disability, and death among postmenopausal women aged 50 to 79 years.
This Initiative is comprised of two main
investigational approaches: (1) A large
clinical trial (CT) to evaluate the clinical
efficacy of promising, but unproven
preventive approaches for specific
diseases common among older women;
and (2) a companion observational
study (OS) comprised of women
ineligible or unwilling to participate in
the CT, to evaluate risk factors for
chronic diseases by following this large
cohort of women and relating
subsequent disease development to
baseline assessments of historical,

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39059

Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Notices
physical, and physiologic
characteristics. The WHI provides new
information on health and risk of
disease among older post-menopausal
women to inform development of
approaches to disease prevention. The
specific objectives of the OS are to
provide reliable estimates of the extent
to which known risk factors predict
heart disease, cancers and fractures;
identify new risk factors for these and
other diseases in women; compare risk

assessed based on current and future
hypotheses related to clinical endpoints.
The WHI study/protocol allows for
analysis and presentation of results in
aggregate form only, thus all data
including biological samples are void of
personal identifiers.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
10,796.

factors, presence of disease at the start
of the study, and new occurrences of
disease during the WHI in all study
components; and create a future
resource to identify biological indicators
of disease, especially substances and
factors found in the blood. Continued
follow-up of medical outcome
occurrences will enhance achievement
of the WHI original goals and increase
the range of scientific issues that can be
examined. Specific biomarkers will be

ESTIMATED ANNUALIZED BURDEN HOURS
Total
annual
burden
hours

Medical History Update ........................................
Activities of Daily Life ...........................................
Personal Information Update ................................
Initial Notification of Death ...................................
Initial Notification of Death ...................................

Participants ...................
Participants ...................
Participants ...................
Next of Kin ....................
Physician/Office Staff ...

40,203
40,203
40,203
900
15

1
1
1
1
1

7/60
6/60
3/60
5/60
5/60

4,690
4,020
2,010
75
1

Total ...............................................................

.......................................

41,118

121,524

........................

10,796

Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
2C212, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Carmen Moten, MPH,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301–402–7703,
[email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)

Dated: June 9, 2016.
Valery Gheen,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2016–14057 Filed 6–14–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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.
ehiers on DSK5VPTVN1PROD with NOTICES

Average
burden
per response
(in hours)

Type of
respondent

Name of Committee: National Institute on
Aging Special Emphasis Panel; Stress and
Resilience to Address Health Disparities in
the United States.
Date: July 12, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.

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Number of
respondents

Number of
responses per
respondent

Form name

Dated: June 9, 2016
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–14054 Filed 6–14–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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

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applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; NIGMS Postdoctoral T32 Review.
Date: July 15, 2016.
Time: 8:00 a.m. to 3:00 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: Brian R. Pike, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN18, Bethesda, MD
20892, 301–594–3907, [email protected].
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of Support of Competitive
Research (SCORE) applications.
Date: July 21, 2016.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Room 3AN12K, 45 Center
Drive, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Nina Sidorova, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3An.22, Bethesda, MD
20892–6200, 301–594–3663, sidorova@
nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,

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