Submission for OMB Review; Comment Request; Request for Genetic Studies in a Cohort of U.S. Radiologic Technologists, 9010-9012 [E7-3435]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 72, Number 39 (Wednesday, February 28, 2007)]
[Notices]
[Pages 9010-9012]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3435]


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

[[Page 9012]]

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