[Federal Register Volume 75, Number 12 (Wednesday, January 20, 2010)]
[Notices]
[Page 3237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-974]


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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: Women, 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 hours    Annual hour
                Type of  response                   respondents      response      per response       burden
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Observational Study Participants................          42,550            1.12           .4155       19,800
Next of Kin \1\.................................             941            1              .083            79
Health Care Providers \1\.......................               8            1              .085              .63
                                                 ---------------------------------------------------------------
    Total.......................................          43,499  ..............  ..............       19,880
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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.

    The annualized cost to respondents is estimated at $397,617, 
assuming respondents time at the rate of $20 per hour and physician 
time at the rate of $50 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 E-mail 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 4, 2010.
Michael S. Lauer,
Director, Division of Cardiovascular Science, NHLBI, National 
Institutes of Health.
    Dated: January 6, 2010.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of Health.
[FR Doc. 2010-974 Filed 1-19-10; 8:45 am]
BILLING CODE 4140-01-P