[Federal Register Volume 70, Number 214 (Monday, November 7, 2005)]
[Notices]
[Pages 67494-67495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22078]


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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, Office of the 
Director, 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: Women's Health Initiative (WHI) 
Observational Study. Type of Information Collection Request: Revision 
OMB 0925-0414 Exp: 04/06. Need for 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 years for 
ascertainment of medical history update forms will provide essential 
data for outcomes assessment for this population of aging women. 
Frequency of Response: On occasion. Affected Public: Individuals and 
physicians. Type of Respondents: Women, next-of-kin, and physician's 
office staff. The annual reporting burden is as follows:

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                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total annual
               Type of respondents                   number of     responses per     hours per     burden hours
                                                    respondents     respondent       response        requested
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OS Participants.................................          85,786               1           .21         18,195

[[Page 67495]]

 
Next-of-kin.....................................           1,483               1           .0835          124
Physician's Office Staff........................               4               1           .0835             .33
                                                 -----------------
    Total.......................................          87,273  ..............  ..............       18,319
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    The annualized cost burden to respondents is $290,230. There are no 
annual Capital Costs, Operating Costs and/or Maintenance Costs to 
report.
    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate whether the proposed collection is 
necessary for the proper performance of the function of the agency, 
including whether the information will have practical utility; (2) 
evaluate 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) enhance the quality, utility, and 
clarity of the information to be collected; and (4) 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: Dr. Linda Pottern, Project Officer, Women's 
Health Initiative Program Office, National Institutes of Health, 6701 
Rockledge Drive, 2 Rockledge Centre, Suite 8204, MSC 7935, Bethesda, MD 
20892-7935, or call 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: October 28, 2005.
Jacques Rossouw,
NHLBI, WHI Project Officer, National Institutes of Health.
[FR Doc. 05-22078 Filed 11-4-05; 8:45 am]
BILLING CODE 4140-01-P