00-32234. Submission for OMB Review; Comment Request; The Family Health Study (Validation of a Family History of Cancer Questionnaire for Risk Factor Surveillance)

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 7, 2000, page 36149-36159 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: The Family Health Study (Validation of a Family History of Cancer Questionnaire for Risk Factor Surveillance).

Type of Information Collection Request: NEW.

Need and Use of Information Collection: In this methodologic pilot study, the NCI will develop a family history of cancer questionnaire for use in cancer risk factor surveillance, and will evaluate how accurately individuals in the general population can report major cancers occurring in their immediate and extended family. This study is needed because there are currently no validated questionnaires with which to collect comprehensive data for assessing the burden of family history of cancer in the U.S. population, and no general population estimates of reporting error for the major cancers that affect families. The results on reporting accuracy will be used to determine whether the quality of data is sufficient to justify conducting a comprehensive national prevalence study of family history of cancer. The questionnaire will be administered in a telephone survey of adults, age 25 to 64 years who will be randomly selected from households in Connecticut. Respondents will be asked to report about family structure and cancer diagnoses occurring in their first and second degree relatives. Positive and negative reports of five major cancer sites (i.e breast, prostate, colorectal, lung, and ovarian cancers) will be validated for approximately three relatives per respondent through data linkage to state and federal health registries or by review of death certificates and medical records. Living relatives and next-of-kin of deceased relatives may be interviewed as part of the validation process. Information about the accuracy of reports and factors associated with reporting error will help to evaluate the feasibility of conducting surveys on family history of cancer.

Frequency of Response: One-time study.

Affected Public: Individuals or households.

Type of Respondent: Adults, age 25 to 64, who reside in the state of Connecticut and their selected adult relatives over age 25 or the relative's next-of-kin. The annual reporting burden is presented in the table below. The annualized cost to respondents is estimated at $18,671. There are no capital costs to report. There are no Operating or Maintenance Costs to report.

Type of respondents	Estimated No. of respondents	Estimated No. of responses per respondent	Average burden hours per response	Estimated total annual burden hours requested
Respondents, age 25 to 64	1800	1	0.6179	1112
Adult relatives of respondents or their next-of-kin	5190	0.67	0.2171	755
Total				1867

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.

Direct Comments to OMB

Written comments and/or suggestions regarding the items(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, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Louise Wideroff, Project Officer, Applied Research Program, National Cancer Institutes, 6130 Executive Blvd, EPN 4010, Bethesda, MD 20892, or call non-toll-free number [phone] or E-mail your request, including your address to [e-mail].

COMMENTS DUE DATE:

Comments regarding this information collection are best assured of having their full effect if received before January 18, 2001.

Dated: December 7, 2000.

Reesa Nichols,

NCI Project Clearance Liaison.