Proposed Collection; 60-Day Comment Request Extension to May 31, 2016 Study To Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test-National Cancer Institute (NCI), 29875-29876 [2016-11254]
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Federal Register / Vol. 81, No. 93 / Friday, May 13, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request Extension to May 31, 2016
Study To Estimate Radiation Doses
and Cancer Risks From Radioactive
Fallout From the Trinity Nuclear Test—
National Cancer Institute (NCI)
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 nontoll-free number (240)-276–7371 or
SUMMARY:
Email your request, including your
address to: ssimon@mail.nih.gov.
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 by May 31, 2016.
Proposed Collection: Study to
Estimate Radiation Doses and Cancer
Risks from Radioactive Fallout from the
Trinity Nuclear Test, 0925–NEW, New,
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)
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 literaturederived 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.
mstockstill on DSK3G9T082PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Instrument
Individuals .................................................
Screener ...................................................
Consent Form ...........................................
Focus Groups ...........................................
Pre-Focus Group Guide ...........................
Key Informants and Academics Interview
VerDate Sep<11>2014
18:05 May 12, 2016
Jkt 238001
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Frequency
of response
300
150
120
120
30
1
1
1
1
1
E:\FR\FM\13MYN1.SGM
13MYN1
Average
time per
response
(in hours)
10/60
10/60
120/60
10/60
120/60
Annual
burden
hours
50
25
240
20
60
29876
Federal Register / Vol. 81, No. 93 / Friday, May 13, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Totals .................................................
[FR Doc. 2016–11254 Filed 5–12–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
mstockstill on DSK3G9T082PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Pathophysiological Basis of Mental
Disorders and Addictions Study Section.
Date: June 2–3, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Boris P Sokolov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892, 301–408–
9115, bsokolov@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Collaborative Applications: Behavioral
Genetics and Epidemiology.
Date: June 7, 2016.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
18:05 May 12, 2016
Jkt 238001
Frequency
of response
300
720
...................................................................
Dated: May 6, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, NIH.
VerDate Sep<11>2014
Number of
respondents
Instrument
Place: The St. Regis Washington DC, 923
16th Street NW., Washington, DC 20006.
Contact Person: George Vogler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3140,
MSC 7770, Bethesda, MD 20892, (301) 237–
2693, voglergp@csr.nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Infectious Diseases, Reproductive Health,
Asthma and Pulmonary Conditions, Study
Section.
Date: June 9–10, 2016
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Pier 2620 hotel fisherman Wharf,
2620 Jones Street, San Francisco, CA 94108.
Contact Person: Lisa Steele, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 257–
2638, steeleln@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Brain Injury and Neurovascular
Pathologies Study Section.
Date: June 9–10, 2016
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham Grand Chicago
Riverfront, 71 East Wacker Drive, Chicago, IL
60601.
Contact Person: Alexander Yakovlev,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5206,
MSC 7846, Bethesda, MD 20892, 301–435–
1254, yakovleva@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–3.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 9, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–11255 Filed 5–12–16; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Average
time per
response
(in hours)
Annual
burden
hours
....................
395
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel Request to Access
Parkinson’s Disease Related-Biospecimens
(X01) Review.
Date: May 19, 2016.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Joel Saydoff, Ph.D.,
Scientific Review Administrator, Scientific
Review Branch, NINDS/NIH/DHHS,
Neuroscience Center, 6001 Executive Blvd.,
Suite 3204, MSC 9529, Bethesda, MD 20892–
9529, 301–496–9223, joel.saydoff@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel, Blueprint Neurotherapeutics
Network (BPN): Small Molecule Drug
Discovery and Development for Disorders of
the Nervous System Review.
Date: June 10, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 240 Pennsylvania
Avenue, Washington, DC 20037.
Contact Person: Joel Saydoff, Ph.D.,
Scientific Review Administrator, Scientific
Review Branch, NINDS/NIH/DHHS,
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29875-29876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11254]
[[Page 29875]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request Extension to May 31,
2016 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: ssimon@mail.nih.gov. 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 by May 31,
2016.
Proposed Collection: Study to Estimate Radiation Doses and Cancer
Risks from Radioactive Fallout from the Trinity Nuclear Test, 0925-NEW,
New, 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) 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
----------------------------------------------------------------------------------------------------------------
Average
Number of Frequency time per Annual
Type of respondents Instrument respondents of response response burden
(in hours) hours
----------------------------------------------------------------------------------------------------------------
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 30 1 120/60 60
Academics Interview.
[[Page 29876]]
Totals.......................... ...................... 300 720 ........... 395
----------------------------------------------------------------------------------------------------------------
Dated: May 6, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-11254 Filed 5-12-16; 8:45 am]
BILLING CODE 4140-01-P
