81 FR 39058 - Submission for OMB Review; 30-Day Comment Request; Women's Health Initiative (NHLBI)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 115 (June 15, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 115 (June 15, 2016)
| Page Range | 39058-39059 | |
| FR Document | 2016-14057 |
[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)] [Notices] [Pages 39058-39059] From the Federal Register Online [www.thefederalregister.org] [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, [email protected] 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 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
![39058 Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Notices
would constitute a clearly unwarranted Place: The St. Regis Washington, DC, 923 collection was previously published in
invasion of personal privacy. 16th Street NW., Washington, DC 20006. the Federal Register on April 4, 2016,
Contact Person: Suzanne Ryan, Ph.D., Pages: 19207–19208. No comments were
Name of Committee: AIDS and Related Scientific Review Officer, Center for
Research Integrated Review Group; AIDS Scientific Review, National Institutes of
received. The purpose of this notice is
Immunology and Pathogenesis Study Health, 6701 Rockledge Drive, Room 3139, to allow an additional 30 days for public
Section. MSC 7770, Bethesda, MD 20892, (301) 435– comment. The National Heart, Lung and
Date: July 7, 2016. 1712, ryansj@csr.nih.gov. Blood Institute (NHLBI), National
Time: 8:00 a.m. to 6:00 p.m. Institutes of Health, may not conduct or
Agenda: To review and evaluate grant Name of Committee: Center for Scientific
applications. Review Special Emphasis Panel; Member sponsor, and the respondent is not
Place: Mayflower Park Hotel, 405 Olive Conflict: Dermatology and Cell/Molecular required to respond to, an information
Way, Seattle, WA 98101. Biology. collection that has been extended,
Contact Person: Shiv A. Prasad, Ph.D., Date: July 15, 2016. revised, or implemented on or after
Scientific Review Officer, Center for Time: 8:00 a.m. to 6:00 p.m. October 1, 1995, unless it displays a
Scientific Review, National Institutes of Agenda: To review and evaluate grant
applications.
currently valid OMB control number.
Health, 6701 Rockledge Drive, Room 5220, Direct Comments to OMB: Written
MSC 7852, Bethesda, MD 20892, 301–443– Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892 comments and/or suggestions regarding
5779, prasads@csr.nih.gov.
(Virtual Meeting). the item(s) contained in this notice,
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Contact Person: Baljit S. Moonga, Ph.D., especially regarding the estimated
Conflict: Mechanisms of Aging. Scientific Review Officer, Center for public burden and associated response
Date: July 7, 2016. Scientific Review, National Institutes of time, should be directed to the: Office
Time: 1:00 p.m. to 5:00 p.m. Health, 6701 Rockledge Drive, Room 4214, of Management and Budget, Office of
Agenda: To review and evaluate grant MSC 7806, Bethesda, MD 20892, 301–435– Regulatory Affairs, OIRA_submission@
applications. 1777, moongabs@mail.nih.gov.
omb.eop.gov or by fax to 202–395–6974,
Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific Attention: NIH Desk Officer.
Rockledge Drive, Bethesda, MD 20892 Review Special Emphasis Panel; PAR13–390:
Indo-US Collaborative Program in Affordable
Comment Due Date: Comments
(Telephone Conference Call).
Contact Person: Thomas Beres, Ph.D., Medical Devices. regarding this information collection are
Scientific Review Officer, Center for Date: July 15, 2016. best assured of having their full effect if
Scientific Review, National Institutes of Time: 9:00 a.m. to 1:00 p.m. received within 30-days of the date of
Health, 6701 Rockledge Dr., Rm. 5201, MSC Agenda: To review and evaluate grant this publication.
7840, Bethesda, MD 20892, 301–435–1175, applications. FOR FURTHER INFORMATION CONTACT: To
berestm@mail.nih.gov. Place: National Institutes of Health, 6701 obtain a copy of the data collection
Name of Committee: Center for Scientific Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
plans and instruments, submit
Review Special Emphasis Panel; Member
Contact Person: Craig Giroux, Ph.D., comments in writing, or request more
Conflict: Biobehavioral Regulation Learning
and Ethology. Scientific Review Officer, BST IRG, Center information on the proposed project,
Date: July 11, 2016. for Scientific Review, National Institutes of contact: Shari Ludlam, 6701 Rockledge
Time: 1:00 p.m. to 5:00 p.m. Health, 6701 Rockledge Drive, Room 5150, Drive, MSC 7936, Bethesda, MD 20892,
Agenda: To review and evaluate grant Bethesda, MD 20892, 301–435–2204, or call non-toll-free number (301) 435–
applications. girouxcn@csr.nih.gov. 6667, or Email your request to:
Place: National Institutes of Health, 6701 (Catalogue of Federal Domestic Assistance ludlams@mail.nih.gov. Formal requests
Rockledge Drive, Bethesda, MD 20892 Program Nos. 93.306, Comparative Medicine; for additional plans and instruments
(Telephone Conference Call). 93.333, Clinical Research, 93.306, 93.333, must be requested in writing.
Contact Person: Mark Lindner, Ph.D., 93.337, 93.393–93.396, 93.837–93.844,
Scientific Review Officer, Center for Proposed Collection: The Women’s
93.846–93.878, 93.892, 93.893, National
Scientific Review, National Institutes of Institutes of Health, HHS)
Health Initiative, 0925–0414, Revision,
Health, 6701 Rockledge Drive, Room 3182, Exp. 7/31/2016, National Heart, Lung,
MSC 7770, Bethesda, MD 20892, 301–915– Dated: June 9, 2016. and Blood Institute (NHLBI), the
6298, mark.lindner@csr.nih.gov. Carolyn Baum, National Institutes of Health (NIH).
Name of Committee: Center for Scientific Program Analyst, Office of Federal Advisory Need and Use of Information
Review Special Emphasis Panel; Small Committee Policy. Collection: This proposal is to extend
Business: HIV/AIDS Innovative Research [FR Doc. 2016–14053 Filed 6–14–16; 8:45 am] the Women’s Health Initiative (WHI),
Applications. BILLING CODE 4140–01–P which comprises a group of research
Date: July 13, 2016. studies that will address critical issues
Time: 3:00 p.m. to 6:00 p.m. about the most common causes of
Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND frailty, disability, and death among post-
applications. HUMAN SERVICES
Place: The Fairmont Washington, DC, 2401
menopausal women aged 50 to 79 years.
M Street NW., Washington, DC 20037. This Initiative is comprised of two main
National Institutes of Health investigational approaches: (1) A large
Contact Person: Barna Dey, Ph.D.,
Scientific Review Officer, Center for clinical trial (CT) to evaluate the clinical
Submission for OMB Review; 30-Day
Scientific Review, National Institutes of efficacy of promising, but unproven
Health, 6701 Rockledge Drive, Room 3184,
Comment Request; Women’s Health
preventive approaches for specific
Bethesda, MD 20892, 301–451–2796, bdey@ Initiative (NHLBI)
diseases common among older women;
mail.nih.gov. SUMMARY: Under the provisions of and (2) a companion observational
Name of Committee: Center for Scientific
ehiers on DSK5VPTVN1PROD with NOTICES
Section 3507(a)(1)(D) of the Paperwork study (OS) comprised of women
Review Special Emphasis Panel; RFA–OD– Reduction Act of 1995, the National ineligible or unwilling to participate in
16–004: Environmental Influences on Child
Health Outcomes (ECHO) Pediatric Cohorts.
Institutes of Health (NIH) has submitted the CT, to evaluate risk factors for
Date: July 14–15, 2016. to the Office of Management and Budget chronic diseases by following this large
Time: 8:30 a.m. to 5:30 p.m. (OMB) a request for review and cohort of women and relating
Agenda: To review and evaluate grant approval of the information collection subsequent disease development to
applications. listed below. This proposed information baseline assessments of historical,
VerDate Sep<11>2014 15:15 Jun 14, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\15JNN1.SGM 15JNN1](https://thefederalregister.org/doc/81_FR_39173/page/1.svg)
![Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Notices 39059
physical, and physiologic factors, presence of disease at the start assessed based on current and future
characteristics. The WHI provides new of the study, and new occurrences of hypotheses related to clinical endpoints.
information on health and risk of disease during the WHI in all study The WHI study/protocol allows for
disease among older post-menopausal components; and create a future analysis and presentation of results in
women to inform development of resource to identify biological indicators aggregate form only, thus all data
approaches to disease prevention. The of disease, especially substances and including biological samples are void of
specific objectives of the OS are to factors found in the blood. Continued personal identifiers.
provide reliable estimates of the extent follow-up of medical outcome OMB approval is requested for 3
to which known risk factors predict occurrences will enhance achievement years. There are no costs to respondents
heart disease, cancers and fractures; of the WHI original goals and increase other than their time. The total
identify new risk factors for these and the range of scientific issues that can be estimated annualized burden hours are
other diseases in women; compare risk examined. Specific biomarkers will be 10,796.
ESTIMATED ANNUALIZED BURDEN HOURS
Average Total
Number of
Type of Number of burden annual
Form name responses per
respondent respondents per response burden
respondent (in hours) 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 Staff ... 15 1 5/60 1
Total ............................................................... ....................................... 41,118 121,524 ........................ 10,796
Dated: June 9, 2016. Place: National Institute on Aging, applications, the disclosure of which
Valery Gheen, Gateway Building, 7201 Wisconsin Avenue, would constitute a clearly unwarranted
2C212, Bethesda, MD 20892, (Telephone invasion of personal privacy.
NHLBI Project Clearance Liaison, National
Conference Call).
Institutes of Health. Name of Committee: National Institute of
Contact Person: Carmen Moten, MPH,
[FR Doc. 2016–14057 Filed 6–14–16; 8:45 am] National Institute on Aging, Gateway General Medical Sciences Special Emphasis
BILLING CODE 4140–01–P Building, 7201 Wisconsin Avenue, Suite Panel; NIGMS Postdoctoral T32 Review.
2C212, Bethesda, MD 20892, 301–402–7703, Date: July 15, 2016.
cmoten@mail.nih.gov. Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
DEPARTMENT OF HEALTH AND (Catalogue of Federal Domestic Assistance applications.
HUMAN SERVICES Program Nos. 93.866, Aging Research, Place: Hyatt Regency Bethesda, One
National Institutes of Health, HHS) Bethesda Metro Center, 7400 Wisconsin
National Institutes of Health Dated: June 9, 2016 Avenue, Bethesda, MD 20814.
Melanie J. Gray, Contact Person: Brian R. Pike, Ph.D.,
National Institute on Aging; Notice of Scientific Review Officer, Office of Scientific
Closed Meeting Program Analyst, Office of Federal Advisory Review, National Institute of General Medical
Committee Policy. Sciences, National Institutes of Health, 45
Pursuant to section 10(d) of the [FR Doc. 2016–14054 Filed 6–14–16; 8:45 am] Center Drive, Room 3AN18, Bethesda, MD
Federal Advisory Committee Act, as BILLING CODE 4140–01–P 20892, 301–594–3907, pikebr@mail.nih.gov.
amended (5 U.S.C. App.), notice is Name of Committee: National Institute of
hereby given of the following meeting. General Medical Sciences Special Emphasis
DEPARTMENT OF HEALTH AND Panel; Review of Support of Competitive
The meeting will be closed to the HUMAN SERVICES Research (SCORE) applications.
public in accordance with the Date: July 21, 2016.
provisions set forth in sections National Institutes of Health Time: 11:00 a.m. to 4:00 p.m.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: To review and evaluate grant
as amended. The grant applications and National Institute of General Medical applications.
the discussions could disclose Place: National Institutes of Health,
Sciences; Notice of Closed Meetings
Natcher Building, Room 3AN12K, 45 Center
confidential trade secrets or commercial Drive, Bethesda, MD 20892, (Telephone
property such as patentable material, Pursuant to section 10(d) of the
Conference Call).
and personal information concerning Federal Advisory Committee Act, as
Contact Person: Nina Sidorova, Ph.D.,
individuals associated with the grant amended (5 U.S.C. App.), notice is Scientific Review Officer, Office of Scientific
applications, the disclosure of which hereby given of the following meetings. Review, National Institute of General Medical
would constitute a clearly unwarranted The meetings will be closed to the Sciences, National Institutes of Health, 45
invasion of personal privacy. public in accordance with the Center Drive, Room 3An.22, Bethesda, MD
provisions set forth in sections 20892–6200, 301–594–3663, sidorova@
Name of Committee: National Institute on nigms.nih.gov.
ehiers on DSK5VPTVN1PROD with NOTICES
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Aging Special Emphasis Panel; Stress and (Catalogue of Federal Domestic Assistance
Resilience to Address Health Disparities in
as amended. The grant applications and
Program Nos. 93.375, Minority Biomedical
the United States. the discussions could disclose Research Support; 93.821, Cell Biology and
Date: July 12, 2016. confidential trade secrets or commercial Biophysics Research; 93.859, Pharmacology,
Time: 1:00 p.m. to 4:00 p.m. property such as patentable material, Physiology, and Biological Chemistry
Agenda: To review and evaluate grant and personal information concerning Research; 93.862, Genetics and
applications. individuals associated with the grant Developmental Biology Research; 93.88,
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Document Created: 2016-06-15 02:21:14
Document Modified: 2016-06-15 02:21:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. | |
| 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. | |
| FR Citation | 81 FR 39058 |
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