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), 12912-12913 [2016-05426]
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Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
101.93 ..................................................................
1 There
Number of
responses per
respondent
2,200
Total annual
responses
1
2,200
0.75 (45 minutes) ..........
Total hours
1,650
are no capital costs or operating and maintenance costs associated with this collection of information.
We believe that there will be minimal
burden on the industry to generate
information to meet the notification
requirements of section 403(r)(6) of the
FD&C Act by submitting information
regarding section 403(r)(6) of the FD&C
Act statements on labels or in labeling
of dietary supplements. We also believe
that submission via FURLS will not
affect the burden estimates. We are
requesting only information that is
immediately available to the
manufacturer, packer, or distributor of
the dietary supplement that bears such
a statement on its label or in its labeling.
We estimate that, each year,
approximately 2,200 firms will submit
the information required by section
403(r)(6) of the FD&C Act. This estimate
is based on the average number of
notification submissions received by us
in the preceding 3 years. We estimate
that a firm will require 0.75 hours to
gather the information needed and
prepare a communication to us, for a
total of 1,650 hours (2,200 × 0.75).
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Division of Intramural
Research Board of Scientific Counselors,
NIAID.
Date: June 6–7, 2016.
Time: 7:30 a.m. to 10:30 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 50, Rooms 1227 and 1223, 50 Center
Drive, Rockville, MD 20852.
Contact Person: Hugh J. Auchincloss, MD,
Deputy Director, NIAID Deputy Director,
National Inst. of Allergy and Infectious
Diseases, National Institutes of Health,
Building 31, Room 7A03, MSC 2520,
Bethesda, MD 20892–2520, 301–496–9677,
auchinclossh@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Dated: March 7, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–05478 Filed 3–10–16; 8:45 am]
[FR Doc. 2016–05429 Filed 3–10–16; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Average burden per
response
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)
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Division of Intramural Research Board
of Scientific Counselors, NIAID.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES,
including consideration of personnel
qualifications and performance, and the
VerDate Sep<11>2014
17:56 Mar 10, 2016
Jkt 238001
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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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
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 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)
E:\FR\FM\11MRN1.SGM
11MRN1
12913
Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
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.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average time
per response
(in hours)
Frequency of
response
Annual burden
hours
Type of respondents
Instrument
Individuals ......................
Screener ..............................................................
Consent Form ......................................................
Focus Groups ......................................................
Pre-Focus Group Guide ......................................
Key Informants and Academics Interview ...........
300
150
120
120
30
1
1
1
1
1
10/60
10/60
120/60
10/60
120/60
50
25
240
20
60
Totals ......................
..............................................................................
300
720
........................
395
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK3SPTVN1PROD with NOTICES
National Institutes of Health
Submission for OMB Review; 60-Day
Comment Request; Population
Assessment of Tobacco and Health
(PATH) Study
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 Institute on Drug Abuse
VerDate Sep<11>2014
17:56 Mar 10, 2016
Jkt 238001
(NIDA), 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 on 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,
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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: Dr. Kevin P. Conway,
Deputy Director, Division of
Epidemiology, Services, and Prevention
Research, National Institute on Drug
Abuse, NIH, 6001 Executive Boulevard,
Room 5185, Rockville, MD 20852; or
call non-toll-free number (301) 443–
8755 or Email your request, including
your address, to: PATHprojectofficer@
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
E:\FR\FM\11MRN1.SGM
11MRN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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: 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 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Instrument Number of Frequency of per response Annual burden
respondents response (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 Academics Interview. 30 1 120/60 60
---------------------------------------------------------------
Totals..................................... ....................................... 300 720 .............. 395
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
