Proposed Collection; 60 Day Comment Request; Women's Health Initiative (NHLBI), 19207-19208 [2016-07487]
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Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Precision
Medicine Initiative Cohort Program Biobank.
Date: April 18, 2016.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Lorien Hotel & Spa, 1600 King
Street, Alexandria, VA 22314.
Contact Person: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
MSC 7770, Bethesda, MD 20892, 301–435–
0684, olufokunbisamd@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 29, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–07489 Filed 4–1–16; 8:45 am]
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; Extramural Loan Repayment
Program for Clinical Research (LRP–CR)
NOT–OD–15–121 and Extramural Loan
Repayment Program for Clinical Research
(LRP–PR) NOT–OD–15–122.
Date: April 24–30, 2016.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Annie Walker-Abbey,
Scientific Review Officer, Scientific Review
Program, NIAID/NIH/DHHS, 5601 Fishers
Lane, Room 3E70A, Rockville, MD 20852,
240–627–3390, aabbey@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Planning Grant (R34) and Implementation
Cooperative Agreement (U01).
Date: May 3, 2016.
Time: 12:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
NIAID 4H100 Resource Library, 5601 Fishers
Lane, Rockville, MD 20892 (Telephone
Conference Call).
Contact Person: Maryam Feili-Hariri,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institutes of Health/
NIAID, 5601 Fishers Lane, Rockville, MD
20852, 240–669–5026, haririmf@
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).
Dated: March 28, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–07498 Filed 4–1–16; 8:45 am]
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National Institutes of Health
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National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
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
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
National Institutes of Health
VerDate Sep<11>2014
19:03 Apr 01, 2016
Jkt 238001
Proposed Collection; 60 Day Comment
Request; Women’s Health Initiative
(NHLBI)
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
PO 00000
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Fmt 4703
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19207
for opportunity for public comment on
proposed data collection projects, the
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to the Office of Management
and Budget (OMB) for review and
approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) 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) 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)
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 those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: 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: ludlams@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
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
E:\FR\FM\04APN1.SGM
04APN1
19208
Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
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,
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
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
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.
A.12–1—ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Form
Form
Form
Form
Form
Number of
respondents
Type of respondent
Number of
responses per
respondent
Average
burden per
response
(In hours)
Total annual
burden hours
33 Medical History Update ..................
151 Activities of Daily Life ...................
20 Personal Information Update .........
120 Initial Notification of Death ...........
120 Initial Notification of Death ...........
OS Participants ....................
OS Participants ....................
OS Participants ....................
Next of Kin ............................
Physician/Office Staff ...........
40203
40203
40203
900
15
1
1
1
1
1
7/60
6/60
3/60
5/60
5/60
4690
4020
2010
75
1
Total .......................................................
...............................................
41,118
41,118
........................
10,796
Dated: March 23, 2016.
Valery Gheen,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2016–07487 Filed 4–1–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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Office of the Director, National
Institutes of Health; Notice of Meeting
Notice is hereby given of a meeting of
the Big Data to Knowledge MultiCouncil Working Group.
The teleconference meeting will be
open to the public as indicated below.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Working Group: Big Data to
Knowledge Multi-Council Working
Group.
Date: April 25, 2016.
Open: 11:00 a.m. to 12:30 p.m.
Agenda: April 2016 MCWG Open
Session, Discussion will review current
Big Data to Knowledge (BD2K) activities
and newly proposed BD2K initiatives.
Place: Teleconference, Join WebEx
meeting, Telephone Number: 1–877–
VerDate Sep<11>2014
19:03 Apr 01, 2016
Jkt 238001
668–4493, Meeting Number: 622 421
867.
Note: This portion of the meeting is
open to the public but is being held by
teleconference only. No physical
meeting location is provided for any
interested individuals to listen to
committee discussions. Any individual
interested in listening to the meeting
discussions must call: 1–877–668–4493
and use Meeting number: 622 421 867
for access to the meeting. Participants
can also join in on the viewing the
presentation by clicking the following
link Join WebEx meeting.
Any interested person may file
written comments with the working
group or submit questions by sending an
email to the Contact Person listed on
this notice. The email should include
the name, addresses, telephone number
and when applicable, the business or
professional affiliation of the interested
person.
Closed: 12:30 p.m.–3:30 p.m.
Agenda: April 2016 MCWG Closed
Session, Discussion will focus on
review of proposed Funding Plans for
BD2K Funding Opportunity
Announcements.
Place: Teleconference.
Contact Person: Tonya Scott,
Scientific Program Analyst, Office of the
Associate Director of Data Science
(ADDS), National Institutes of Health, 1
Center Drive, Room 325, Bethesda, MD
20892, email: tonya.scott@nih.gov,
Telephone: 301–402–9817.
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Additional information on data
science is available at: https://
datascience.nih.gov/index and
additional information on the Working
Group is available at: https://
datascience.nih.gov/bd2k/about/org/
MCWG.
Dated: March 29, 2016.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–07542 Filed 4–1–16; 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
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
E:\FR\FM\04APN1.SGM
04APN1
Agencies
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19207-19208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07487]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60 Day Comment Request; Women's Health
Initiative (NHLBI)
Summary: In compliance with the requirement of Section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity
for public comment on proposed data collection projects, the National
Heart, Lung, and Blood Institute (NHLBI), the National Institutes of
Health (NIH), will publish periodic summaries of proposed projects to
the Office of Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
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) 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) 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 those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
To Submit Comments and for Further Information: 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:
ludlams@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
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 post-menopausal
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
[[Page 19208]]
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, 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 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 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.
A.12-1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondent respondents responses per response (In burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Form 33 Medical History Update OS Participants. 40203 1 7/60 4690
Form 151 Activities of Daily OS Participants. 40203 1 6/60 4020
Life.
Form 20 Personal Information OS Participants. 40203 1 3/60 2010
Update.
Form 120 Initial Notification Next of Kin..... 900 1 5/60 75
of Death.
Form 120 Initial Notification Physician/Office 15 1 5/60 1
of Death. Staff.
---------------------------------------------------------------
Total..................... ................ 41,118 41,118 .............. 10,796
----------------------------------------------------------------------------------------------------------------
Dated: March 23, 2016.
Valery Gheen,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2016-07487 Filed 4-1-16; 8:45 am]
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