[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] ----------------------------------------------------------------------- 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