[Federal Register Volume 68, Number 236 (Tuesday, December 9, 2003)]
[Notices]
[Pages 68636-68637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30495]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Submission for OMB Review; 
Comment Request; Request for Generic Clearance To Collect Medical 
Outcome and Risk Factor Data From 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 August 26, 2003, pages 
51275-51276 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: Request for 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. 
radiologic technologist 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 an the National Cancer Institute and the University of 
Minnesota have followed a nationwide cohort of 146,000 radiologic 
technologist 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 effects 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, separately 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. 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. The annual reporting burden is as follows: 
Estimated Number of Respondents: 59,200. Estimated Number of Responses 
Per Respondent: 1. Average Burden Hours per Response: 0.4983. Annual 
Burden Hours Requested: 29,500. 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 should address one or more of the 
following points: (1) Evaluate 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) 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.
    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 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 date 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

[[Page 68637]]

your request, including your address to: [email protected].
    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: December 1, 2003.
Reesa Nichols,
NCI Project Clearance Liaison.
[FR Doc. 03-30495 Filed 12-8-03; 8:45 am]
BILLING CODE 4140-01-M