[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Notices]
[Pages 8152-8153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02505]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request: Women's Health Initiative 
Observational Study

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 be submitted to the 
Office of Management and Budget (OMB) for review and approval.
    Proposed Collection: Title: The Women's Health Initiative (WHI) 
Observational Study. Type of Information Collection Request: Revision 
OMB 0925-0414. 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 colorectal cancer, and osteoporotic fractures. 
Continuation of follow-up for ascertainment of medical history update 
forms will provide essential data for outcomes assessment for this 
population of aging women. Frequency of Response: Annually. Affected 
Public: Individuals or households and health care providers. Type of 
Respondents: Study participants, next-of-kin, and physician's office 
staff. The annual reporting burden is as follows:

                                         Estimate of Annual Hour Burden
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                                                    Number of     Frequency of    Average time     Annual hour
               Type of respondent                  respondents      response      per response        burden
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OS Participants................................          41,495               1           20/60         13,929
Next of kin....................................             936               1            6/60             92
Physician/Office Staff.........................              17               1            5/60              1.4
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    Totals.....................................          42,448  ..............  ..............         14,023
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\1\ 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.


[[Page 8153]]

    The annualized cost to respondents is estimated at $308,218, 
assuming respondents time at the rate of $22 per hour and healthcare 
provider time at the rate of $53 per hour. There are no Capital Costs 
to report. There are no Operating or Maintenance Costs to report.
    Request for Comments: 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.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Ms. Shari Eason Ludlam, MPH, Project Officer, NIH, 
NHLBI, 6701 Rockledge Drive, MSC 7913, Bethesda, MD 20892-7934, or call 
non-toll-free number 301-402-2900 or Email your request, including your 
address to: [email protected].
    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.

    Dated: January 25, 2013.
Michael Lauer,
Director, Division of Cardiovascular Sciences, National Heart, Lung, 
and Blood Institute, National Institutes of Health.

    Dated: January 28, 2013.
Lynn W. Susulske,
Government Information Specialist. Freedom of Information and Privacy 
Act Branch, NHLBI, National Institutes of Health.
[FR Doc. 2013-02505 Filed 2-4-13; 8:45 am]
BILLING CODE 4140-01-P