Agency information collection activities; proposals, submissions, and approvals,

[Federal Register: February 28, 2007 (Volume 72, Number 39)]

[Notices]

[Page 9010-9012]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr28fe07-72]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; Comment Request; Request for Genetic Studies in a Cohort of U.S. Radiologic Technologists

SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, 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 December 29, 2006, pages 78445-78446 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: Genetic Studies in a Cohort of U.S. Radiologic Technologists (formerly known as ``Generic Clearance to Collect Medical Outcome and Risk Factor Data from a Cohort of U.S. Radiologic Technologists''). Type of Information Collection Request: Renewal with change of a previously approved collection (OMB No. 0925-0405, expiration 02/28/ 2007). Need and Use of Information Collection: The primary aim of this collection is to substantially increase knowledge about the possible modifying role of genetic variation on the long-term health effects associated with protracted low-to moderate-dose

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radiation exposures. With this submission, the NIH, Office of Communications and Public Liaison, seeks to obtain OMB's approval to collect biospecimens and risk factor data in this ongoing cohort study of U.S. radiologic technologists to assess genetic and molecular risk factors for cancer, and to evaluate possible modifying effects of genetic variation on radiation-cancer relationships. Researchers at the National Cancer Institute and The University of Minnesota have followed a nationwide cohort of 146,000 radiologic technologists since 1982, of whom 110,000 completed at least one of three prior questionnaire surveys and 18,400 are deceased. This cohort is unique because estimates of cumulative radiation dose to specific organs (e.g. breast) are available and the cohort is largely female, offering a rare opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive organ sites for radiation carcinogenesis in women. Overall study objectives are: (1) To quantify radiation dose-response for cancers of the breast, thyroid, and other radiogenic sites, and selected benign conditions related to cancer (e.g. thyroid nodules); (2) to assess cancer risk associated with genotypic, phenotypic, or other biologically measurable factors (e.g. serum levels of C-reactive protein, insulin growth factors or binding proteins); and (3) to determine if genetic variation modifies the radiation-related cancer risk. A third follow-up of this cohort was completed during the past three years. During 2003-2005, the ``Third Survey'' questionnaire was mailed or administered by telephone to 101,694 living cohort members who had completed at least one prior survey; 73,838 technologists (73% response) completed the survey. The questionnaire elicited information on: Medical outcomes to assess radiation-related risks; detailed employment data to refine the occupational radiation dose estimates; and behavioral and residential histories for estimating lifetime ultraviolet (UV) radiation exposure. Analyses of these data are currently underway and findings will address an important gap in the scientific understanding of radiation dose-rate effects, i.e., whether cumulative exposures of the same magnitude have the same health effects when received in a single or a few doses over a very short period of time (as in the atomic bomb or therapeutic exposures) or in many small doses over a protracted period of time (as in medical or nuclear occupational settings).

There are few, if any, other study populations in which both quantified breast radiation doses and blood samples are available for individuals with protracted low-dose radiation exposures. The current petition is for renewal with change of the previous clearance to administer a Genetic Studies Questionnaire and collect biospecimens from 10,000 cohort members who completed at least one prior survey. These individuals would serve as a comparison group for case-cohort studies of gene main effects and gene-radiation interactions. To improve statistical power to detect such associations, we plan to select the comparison sample based on dose; this is to ensure inclusion of sufficient numbers of high-dose individuals. The Genetic Studies Questionnaire will collect information on: Family history of cancer; reproductive history in women (e.g. pregnancy outcomes, menopause); personal medical radiation exposures (e.g. diagnostic x-rays, therapeutic irradiation); and personal history of chemotherapy. The survey will be in optical-read format for computerized data capture. A blood collection kit will be mailed to technologists along with the Genetic Studies Questionnaire; they will be asked to take the kit to a phlebotomist to have a single tube of blood drawn and returned to the study laboratory by pre-paid Federal Express overnight delivery. Ongoing efforts to medically validate self-reported cancers and other medical outcomes will continue. The annual reporting burden is as follows: Frequency of Response: On occasion. Affected Public: U.S. radiologic technologists who willingly participated in earlier investigations to quantify the carcinogenic risks of protracted low-to moderate-dose occupational radiation exposures. Estimated Number of Respondents: 4,233. Estimated Number of Responses per Respondent: 1. Average Burden Hours per Response: 1.3. Annual Burden Hours Requested: 5,630. Total cost to respondents is estimated at $157,471. There are no capital costs, operating costs and/or maintenance costs to report.

Respondent and Burden Estimate--OMB No. 0925-0405

Number of

Total

Average Type of respondent

respondents Frequency respondents hours per Total hours Annual hour (3 yr) of response (3 yr)

response (3 yr) burden

Genetic Studies/Risk Factor Survey and Blood Collection

Sub-Cohort..................

10,000

1

10,000 1.66666 16,666

5,555

Medical Validation

Hospitals/ Physicians.......

2,700

1

2,700 0.08333

225

75

Total:..................

12,700 ...........

12,700 ........... 16,891

5,630

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 functioning of the National Cancer Institute, 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 item(s) contained in this notice, especially regarding the estimated public burden and associated response

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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: Michele M. Doody, Radiation Epidemiology Branch, National Cancer Institute, Executive Plaza South, Room 7040, Bethesda, MD 20892-7238, or call non-toll-free at 301-594-7203 or e-mail your request, including your address to: doodym@mail.nih.gov.

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

Dated: February 16, 2007. Rachelle Ragland-Greene, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. E7-3435 Filed 2-27-07; 8:45 am]

BILLING CODE 4104-01-P