[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]


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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: 
[email protected]. 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
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    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]
 BILLING CODE 4140-01-P