[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Notices]
[Pages 24220-24221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09730]


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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 Observational Study

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Heart, Lung, and Blood Institute 
(NHLBI),0020the National Institutes of Health, 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 February 
5, 2013 on pages 8152-8153 and allowed 60-days for public comment. One 
comment was received and an appropriate response was made. The purpose 
of this notice is to allow an additional 30 days for public comment. 
The 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, or request more information on the 
proposed project contact: Shari Eason Ludlam, Project Officer, Women's 
Health Initiative Program Office, 6701 Rockledge Drive, 2 Rockledge 
Centre, Room 9188, MSC 7913, Bethesda, MD 20892-7936, or call (301) 
402-2900 or Email your request, including your address to: 
[email protected]. Formal requests for additional plans and 
instruments must be requested in writing.
    Proposed Collection: Women's Health Initiative Observational Study. 
Revision--OMB No. 0925-0414, Expiration Date: 07/31/2013. National 
Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health 
(NIH).
    Need and Use of Information Collection: This study will be used by 
the NIH to evaluate risk factors for chronic disease among older women 
by developing and following a large cohort of postmenopausal women and 
relating subsequent disease development to baseline assessments of 
historical, physical, psychosocial, and physiologic characteristics. In 
addition, the observational study will complement the clinical trial 
(which has received clinical exemption) and provide additional 
information on the common causes of frailty, disability and death for 
postmenopausal women, namely, coronary heart disease, breast and

[[Page 24221]]

colorectal cancer, and osteoporotic fractures. Continuation of follow-
up years for ascertainment of medical history update forms will provide 
essential data for outcomes assessment for this population of aging 
women.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time, which is estimated at $308,218 for 
all respondents. The total estimated annualized burden hours are 
14,022.

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                                                                     Number of    Average burden
               Type of respondent*                   Number of     responses per   per response    Total annual
                                                    respondents      response       (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
OS Participants.................................          41,495               1           20/60          13,929
Next of kin.....................................             936               1           .6/60              92
Physician/Office Staff..........................              17               1            5/60               1
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* Annual burden is placed on health care providers and respondent relatives/informants through requests for
  information which will help in the compilation of the number and nature of new fatal and nonfatal events.


    Dated: April 9, 2013.
Michael S. Lauer,
Director, Division of Cardiovascular Sciences, NHLBI, National 
Institutes of Health.
    Dated: April 11, 2013.
Lynn W. Susulske,
Government Information Specialist, Freedom of Information and Privacy 
Act Branch, NHLBI, National Institutes of Health.
[FR Doc. 2013-09730 Filed 4-23-13; 8:45 am]
BILLING CODE 4140-01-P