[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]
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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
[[Page 9011]]
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
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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
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Genetic Studies/Risk Factor Survey and Blood Collection
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Sub-Cohort.................. 10,000 1 10,000 1.66666 16,666 5,555
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Medical Validation
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Hospitals/ Physicians....... 2,700 1 2,700 0.08333 225 75
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Total:.................. 12,700 ........... 12,700 ........... 16,891 5,630
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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