Submission for OMB Review; 30-Day Comment Request; Women's Health Initiative (NHLBI), 39058-39059 [2016-14057]

Download as PDF 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, prasads@csr.nih.gov. 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, berestm@mail.nih.gov. 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, mark.lindner@csr.nih.gov. 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. VerDate Sep<11>2014 15:15 Jun 14, 2016 Jkt 238001 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, ryansj@csr.nih.gov. 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, moongabs@mail.nih.gov. 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, girouxcn@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: 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: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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: ludlams@mail.nih.gov. 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, E:\FR\FM\15JNN1.SGM 15JNN1 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 Average burden per response (in hours) Total annual burden hours Type of respondent 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, cmoten@mail.nih.gov. (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 ehiers on DSK5VPTVN1PROD 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 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 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. VerDate Sep<11>2014 15:15 Jun 14, 2016 Jkt 238001 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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, pikebr@mail.nih.gov. 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, E:\FR\FM\15JNN1.SGM 15JNN1

Agencies

[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Notices]
[Pages 39058-39059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14057]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; 30-Day Comment Request; Women's Health
Initiative (NHLBI)

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 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:
ludlams@mail.nih.gov. 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 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 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,

[[Page 39059]]

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.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Medical History Update........ Participants.... 40,203 1 7/60 4,690
Activities of Daily Life...... Participants.... 40,203 1 6/60 4,020
Personal Information Update... Participants.... 40,203 1 3/60 2,010
Initial Notification of Death. Next of Kin..... 900 1 5/60 75
Initial Notification of Death. Physician/Office 15 1 5/60 1
Staff.
---------------------------------------------------------------
Total..................... ................ 41,118 121,524 .............. 10,796
----------------------------------------------------------------------------------------------------------------

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

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