[Federal Register Volume 61, Number 214 (Monday, November 4, 1996)]
[Notices]
[Pages 56696-56697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28273]


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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 Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, which provides for an opportunity for public 
comment on proposed data collection projects, the Office of the 
Director (OD), 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: 6/97 Need for Use of Information Collection: This 
study will be used by 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. 
Frequency of Response: On occasion. Affected Public: Individuals and 
physicians. Type of Respondents: Women, next of kin, and physicians 
office staff. The annual reporting burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                                                            Estimated                 Estimated 
                                                              Estimated     number of     Average       total   
                    Type of respondents                       number of     responses      burden       annual  
                                                             respondents       per       hours per      hours   
                                                                           respondent     response    requested 
----------------------------------------------------------------------------------------------------------------
OS Participants............................................      100,000          1.06         .828       88,348
Next-of-Kin................................................        2,682          1            .084          225
Physician's Office Staff...................................          166          1            .084           14
                                                            ----------------------------------------------------
      Total................................................  ...........  ............  ...........       88,614
----------------------------------------------------------------------------------------------------------------

    The annualized cost burden is: $882,505.
    The estimated annual Capital Costs, Operating Costs and/or 
Maintenance Costs is: $10,342,000.

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 plan and instruments, contact: Dr. Loretta

[[Page 56697]]

Finnegan, Women's Health Initiative Program Office, 7550 Rockville 
Pike, Room 6A09, Bethesda, Maryland 20892-9110 or call non-toll-free 
number (301) 402-2900, or E-mail your request, including your address 
to: .

COMMENTS DUE DATE: Comments regarding this information collection are 
best assured of having their full effect if received on or before 
January 3, 1997.

    Dated: October 23, 1996.
Stephen Benowitz,
Executive Officer, OD.
[FR Doc. 96-28273 Filed 11-1-96; 8:45 am]
BILLING CODE 4140-01-M