[Federal Register Volume 62, Number 75 (Friday, April 18, 1997)]
[Notices]
[Pages 19121-19122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9993]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission of OMB Review; Comment Request; Women's Health 
Initiative Observational Study

SUMMARY: Under the provisions of Section 3506(c)(2)(A) of the Paperwork

[[Page 19122]]

Reduction Act of 1995, the Office of the Director (OD), National 
Institutes of Health (NIH), 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 November 4, 1996 
(Volume 61, Number 214, Page 56696) and allowed 60-days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment. The 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.

PROPOSED COLLECTION: Title: Women's Health Initiative (WHI) 
Observational Study. Type of Information Collection Request: Revision 
of OMB #0925-0414. Exp: 6/30/97. 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 cause of frailty, disability and health 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. The annual reporting burden is as 
follows:

----------------------------------------------------------------------------------------------------------------
                                                                           Estimated                  Estimated 
                                                             Estimated     number of      Average       total   
                    Type of respondents                      number of     responses   burden hours     annual  
                                                            respondents       per      per response     hours   
                                                                          respondent                  requested 
----------------------------------------------------------------------------------------------------------------
OS Participants...........................................      100,000       1.06667         .819        87,360
Next-of-Kin...............................................        2,682       1               .0835          224
Physician.................................................          166       1               .0835           14
                                                           -----------------------------------------------------
      Total...............................................  ...........  ............  ............       87,598
----------------------------------------------------------------------------------------------------------------

    The annualized cost to respondents is: $876,525.
    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 functions 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 through the use of 
appropriate automated, electronic, mechanical, or other technological 
collection techniques or other forms of information technology.

Direct Comments to OMB

    Written comments and/or suggestions regarding 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, New Executive 
Office Building, Room 10235, Washington, D.C. 20503, Attention: Desk 
Officer for NIH. to request more information on the proposed project or 
to obtain a copy of the data collection plan and instruments, contact: 
Dr. Loretta 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: <FinnegaL@od31em1.od.nih.gov>.

COMMENTS DUE DATE: Comments regarding this information collection are 
best assured of having their full effect if received on or before May 
19, 1997.

    Dated: March 11, 1997.
Stephen Benowitz,
Executive Officer, Office of the Director, NIH.
[FR Doc. 97-9993 Filed 4-17-97; 8:45 am]
BILLING CODE 4140-01-M