E7-1282. Proposed Collection; Comment Request; Phase II of a Prospective Cohort Study of Diet and Cancer in Members of the American Association of Retired Persons

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, the National Cancer Institute (NCI), 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: Phase II of A Prospective Cohort Study of Diet and Cancer in Members of the American Association of Retired Persons. Type of Information Collection Request: New. Need and Use of Information Collection: The specific objectives of the current study are to: (1) Examine prospectively the relation between diet and major cancers (especially those of the breast, colorectal, prostate, and non-Hodgkin's lymphoma; (2) in a series of pilot studies, evaluate the quality and completeness of dietary data collected from automated web-based dietary assessment instruments, individually and collectively, in a large cohort, and; (3) in a calibration substudy, compare energy expenditure (measured by doubly labeled water) and protein and potassium intakes (measured by 24-hour urinary nitrogen and potassium excretion) with intakes of energy, protein, and potassium as reported on web-based, automated 24-Hour Dietary Record (24HR), an automated Diet History Questionnaire (DHQ), and an automated DHQ adjusted by automated 7-Day Food Lists (7DFLs) to assess measurement error structure in the instruments.

The proposed study will build on the existing Prospective Study of Diet and Cancer in members of the American Association of Retired Persons by updating exposure information in the existing cohort and allowing for continued tracking and follow-up; (2) expanding the cohort by recruiting additional participants and surveying their diet and other exposures. In addition to the 566,403 persons from the original cohort, a new cohort of 2.5 million 50-59 year olds from the same states as the original AARP cohort, and 4 million 50-69 year olds from 8 new states will be contacted as part of the recruitment and data collection effort. Phase II will apply the latest technology to use web-based data collection instruments for economical and efficient assessment of dietary exposures of study participants. This uniquely designed cohort study has a capacity greater than that of any previous study for evaluating connections between dietary factors and major cancers.

Frequency of Response: The frequency of response is dependent on the instrument and the portion of the study that the respondent is participating in (pilot, main study, and/or calibration substudy), as described in the table below. Affected Public: Individuals. Type of Respondents: U.S. adults (person ages 50-85).

The annual reporting burden is as follows:

Table A.—Annualized Burden Estimates for the Phase II NIH-AARP Diet and Health Study Data Collection

Type of response	Estimated number of respondents	Frequency of response	Average time per response	Annual hour burden
Pilot Studies:
Personal characteristics Questionnaire (PCQ)	Completed one time; counted in main study.
Diet History Questionnaire (DHQ)	Completed one time; counted in main study.
24-Hour Food Recall	1,500	3	0.42	1,890
7-Day Food List	1,500	1	1.75	2,625
Other Dietary Assessment Instruments	1,500	1	0.25	75
Pilot Study Total	1,500			4,590
Main Study:
PCQ	1,710,403	1	0.25	427,601
DHQ	1,710,403	1	1.0	1,710,403
24-Hour Food Recall	1,710,403	6	0.42	4,310,216
7-Day Food List	1,710,403	1	1.75	2,993,205
Other Dietary Assessment Instruments	1,710,403	1	.25	427,601
Main Study Total	1,710,403			9,869,026
Calibration Substudy:
PCQ	Completed one time; counted in main study.
DHQ	Completed one time; counted in main study.
24-Hour Food Recall	400	2	0.42	1344
7-Day Food List	400	1	1.75	1400
Physical Activity Questionnaire	400	1	0.25	100
Calibration Substudy Total	400			2,844

There are no Capital, Operating, or Maintenance Costs to report.

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.

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 Arthur Schatzkin, M.D., Dr. P.H., Nutritional Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, NIH, DHHS, 6120 Executive Blvd., EPS-MSC 7242, Bethesda, MD, 20892, U.S.A. or call non-toll-free number 301-594-2931 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 within 60 days of the date of this publication.

Dated: January 16, 2007.

Rachelle Ragland-Greene,

NCI Project Clearance Liaison, National Institutes of Health.