[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]


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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
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                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)     burden hours
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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
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    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