[Federal Register Volume 68, Number 165 (Tuesday, August 26, 2003)]
[Notices]
[Pages 51275-51276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Generic Clearance To 
Collect Medical Outcome and Risk Factor Data From a Cohort of U.S. 
Radiologic Technologists

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 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: Generic Clearance to Collect Medical 
Outcome and Risk Factor Data from a Cohort of U.S. Radiologic 
Technologists. Type of Information Collection Request: Reinstatement 
with change of a previously approved collection (OMB No. 0925-0405 
expired 09/30/1999). Need and Use of Information Collection. The 
primary aim of this project is to substantially increase knowledge 
about the long-term health affects associated with protracted low- to 
moderate-dose radiation exposures. With this submission, the NIH, 
Office of Communications and Public Liaison, seeks to obtain OMB's 
generic approval to conduct occasional surveys of a cohort of U.S. 
radiologists to ascertain incident cancers, benign conditions 
associated with high risk of cancer, and selected other health 
outcomes, as well as demographic, lifestyle, reproductive, employment, 
and other characteristics that may influence health risks. Researchers 
at the National Cancer Institute and the University of Minnesota have 
followed a nationwide cohort of 146,000 radiologists since 1982, of 
whom 110,000 completed at least one of two prior questionnaire surveys 
and 17,000 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. Primary objectives are to quantify radiation 
dose-response for: (1) Cancers of the breast, thyroid, other radiogenic 
sites or histologies, and other cancers; (2) benign breast disease, 
thyroid nodules, and other benign conditions associated with increased 
cancer risk; and (3) other selected health outcomes that may be related 
to radiation exposure (e.g., cardiovascular disease). Findings from 
this study will address an important gap in the scientific 
understanding of radiation dose-rate affects, i.e., whether cumulative 
exposures of the same magnitude have the same health affects when 
received in single or a few doses over a very short period of time (as 
in atomic bomb or therapeutic exposures) or in many small doses over a 
protracted period of time (as in medical or nuclear occupational 
settings). The first survey will be mailed in 2004 to approximately 
100,000 living cohort members who completed at least one prior survey 
and will collect information on: (1) Medical outcomes (as described 
above) to assess radiation-related risks; (2) detailed job-specific 
frequency of performing high-dose procedures (e.g., handling isotopes), 
use of protective measures (e.g., using lead aprons or standing behind 
shields), and other work practices (e.g., holding patients for x-rays) 
to refine the organ dose estimates and associated uncertainty 
distributions; and (3) behavioral, susceptibility, and residential 
histories for refining estimates of lifetime ultraviolet (UV) radiation 
exposure to assess in greater detail the risks of melanoma and non-
melanoma skin cancer associated with UV and ionizing radiation 
exposures, separated and jointly. Subsequent surveys will collect 
updated information on medical outcomes and risk factors of interest at 
that time. All surveys will be in optical-read format for computerized 
data capture. The annual reporting burden is as follows: Frequency of 
Response: On occasion. Affected Public: U.S. radiologic technologists 
who have willingly participated in earlier investigations to quantify 
the carcinogenic risks of protracted low- to moderate-dose occupational 
radiation exposures. Estimated Number of Respondents: 56,000. Estimated 
Number of Responses Per Respondent: 1. Average Burden Hours Per 
Response: 0.50. Annual Burden Hours Requested: 28,200. Total cost to 
respondents is estimated at $654,804. There are no capital costs, 
operating costs and/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 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; (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 additional information on 
the proposed collection of information 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. You

[[Page 51276]]

may also e-mail your request to [email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of this publication.

    Dated: August 18, 2003.
Reesa Nichols,
NCI Project Clearance Liaison.
[FR Doc. 03-21693 Filed 8-25-03; 8:45 am]
BILLING CODE 4140-01-M