[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12912-12913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05426]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Study To Estimate
Radiation Doses and Cancer Risks From Radioactive Fallout From the
Trinity Nuclear Test--National Cancer Institute (NCI)
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.
Written comments and/or suggestions from the public and affected
agencies are invited to address one or more of the following points:
(1) 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) 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.
To Submit Comments and For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Steve
Simon, Dosimetry Unit Head and Staff Scientist, Radiation Epidemiology
Branch, Division of Cancer Epidemiology & Genetics, National Cancer
Institute, NIH, 9609 Medical Center Drive, MSC9778, Bethesda, MD 20892-
9778 or call non-toll-free number (240)-276-7371 or Email your request,
including your address to: [email protected]. Formal requests for
additional plans and instruments must be requested in writing.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: Study to Estimate Radiation Doses and Cancer
Risks from Radioactive Fallout from the Trinity Nuclear Test, 0925-NEW,
New Submission, National Cancer Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information Collection: This research plan is for a
radiation-related cancer risk projection study for the residents of the
state of New Mexico (NM) potentially exposed to radioactive fallout
from the Trinity nuclear test conducted in 1945. Data will be collected
on diet and lifestyle from three groups in NM (non-Hispanic white,
Hispanic, and Native American)
[[Page 12913]]
alive in the 1940s via focus groups and key informant interviews and
will be used to derive means and ranges of exposure-related parameters,
such as consumption of contaminated foodstuffs, collection and use of
water, time spend outdoors, and building materials. These parameter
values will be used with historical fallout deposition data in fallout
dose assessment models to estimate external and internal radiation
doses to typical persons in all counties in New Mexico by ethnicity and
age. The estimated doses will be used with literature-derived risk and
parameter values on risk/unit dose to project the excess cancers
expected (per 1,000 persons within each stratum) including uncertainty
on each estimate. Endpoints are leukemia, thyroid cancer, stomach
cancer, colon cancer, and all solid cancers combined.
This data collection is needed to accomplish the overall Trinity
Study goals, which are to: (1) Estimate external and internal radiation
dose to the four primary organs/tissues of interest (thyroid, stomach,
colon, and red bone marrow) from primary radionuclides in nuclear
testing fallout in each county of New Mexico as a result of the Trinity
test, stratified by age, gender, ethnicity, and conditions of exposure
(low, medium, high); (2) in each county, estimate the number of excess
cancer cases to organs of interest per 1,000 (hypothetical) persons
stratified by age, gender, ethnicity, and conditions of exposure (low,
medium, high).
The study data will be collected via focus group and individual
interview. Between 10 and 15 focus groups with up to 8 participants are
planned. These participants will be 70 years old and older, living in
New Mexico, who were alive at the time of the Trinity nuclear test and
living in any of 19 Native American pueblos/tribes or Hispanic/Latino
and non-Hispanic white communities in or near the fallout region in New
Mexico. Additionally, up to 30 individual interviews are planned with
key informants chosen to represent a variety of experiences and
expertise. Individuals who prefer not to take part in a focus group
will be interviewed individually as key informants. The investigators
will collaborate with community representatives who will recommend
potential participants for either the focus groups or interviews.
The objective of the focus groups and interviews is to collect
information directly from community members who were alive at the time
of the Trinity test, or with direct knowledge of specific life
circumstances, cultural patterns, and dietary practices of Native
Americans, Hispanics/Latinos, or non-Hispanic whites living in New
Mexico at this time. In this study, two interviewers, including one
with extensive experience working with tribal communities, will
moderate the focus groups and conduct in-depth interviews. Translators
and interpreters with experience in the study populations will be
presented when needed. Each focus group and interview will be scheduled
for no more than two hours and will take place in office settings,
community facilities, or municipal facilities.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 395.
Estimated Annualized Burden Hours
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Average time
Type of respondents Instrument Number of Frequency of per response Annual burden
respondents response (in hours) hours
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Individuals.................................... Screener............................... 300 1 10/60 50
Consent Form........................... 150 1 10/60 25
Focus Groups........................... 120 1 120/60 240
Pre-Focus Group Guide.................. 120 1 10/60 20
Key Informants and Academics Interview. 30 1 120/60 60
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Totals..................................... ....................................... 300 720 .............. 395
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Dated: March 1, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-05426 Filed 3-10-16; 8:45 am]
BILLING CODE 4140-01-P