[Federal Register Volume 71, Number 250 (Friday, December 29, 2006)]
[Notices]
[Pages 78445-78446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-22348]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Genetic Studies in 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 Cancer Institute, 
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: 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 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

[[Page 78446]]

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 who complete 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
                   Type of respondent                       respondents    Frequency of     respondents    Average hours    Total hours     Annual hour
                                                              (3 yr)         response         (3 yr)       per 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.

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 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: December 20, 2006.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
 [FR Doc. E6-22348 Filed 12-28-06; 8:45 am]
BILLING CODE 4101-01-P