Submission for OMB Review; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study, 12913-12914 [2016-05431]
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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
12914
Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
received within 60 days of the date of
this publication.
Proposed Collection: Methodological
Studies for the Population Assessment
of Tobacco and Health (PATH) Study
(NIDA), 0925–0675, expiration date 5/
31/2016—EXTENSION—NIDA, NIH, in
partnership with the Food and Drug
Administration (FDA).
Need and Use of Information
Collection: This is a request to continue
the Population Assessment of Tobacco
and Health (PATH) Study’s conduct of
Control Act. The methodological studies
under this extension will continue to
enhance the approaches used by the
PATH Study for data and biospecimen
collections to obtain high quality and
useful data; minimize respondent
burden; and achieve and maintain high
response, retention, and follow-up rates.
methodological studies in support of
improvements in the Study’s
approaches for data and biospecimen
collection. The PATH Study is a
national longitudinal cohort study of
tobacco use behavior and health among
the U.S. household population of adults
age 18 and older and youth ages 12 to
17; the Study conducts annual or
biannual interviews and collects
biospecimens from adults and youth to
inform FDA’s regulatory actions under
the Family Smoking Prevention and
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
annualized burden hours are 29,750.
ESTIMATED ANNUALIZED BURDEN HOURS
Data collection activity
Number of
respondents
Type of respondent
In-person surveys .........................................
Web surveys .................................................
Focus groups and individual in-depth qualitative interviews.
Biospecimen collection .................................
Adults
Youth
Adults
Youth
Adults
[FR Doc. 2016–05431 Filed 3–10–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Proposed Collection; 60-Day Comment
Request; The Clinical Trials Reporting
Program (CTRP) Database (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
VerDate Sep<11>2014
17:56 Mar 10, 2016
Jkt 238001
Total annual
burden hours
....................................
....................................
....................................
....................................
....................................
5,000
3,500
5,000
3,500
1,000
1
1
1
1
1
90/60
90/60
90/60
90/60
2
7,500
5,250
7,500
5,250
2,000
Youth ....................................
Adults ....................................
1,000
1,000
1
1
2
15/60
2,000
250
20,000
20,000
........................
29,750
Total .......................................................
Dated: March 7, 2016.
Genevieve deAlmeida-Morris,
Project Clearance Liaison. NIDA, NIH.
Average
burden per
response
(in hours)
Number of
responses per
respondent
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)
The quality, utility, and clarity of the
information to be collected; and (4)
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: Jose Galvez, MD, Office
of the Director, National Cancer
Institute, 9609 Medical Center Drive,
1W468, Rockville, MD 20852 or call
non-toll-free number 240–276–5206 or
Email your request, including your
address to: jose.galvez@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: The Clinical
Trials Reporting Program (CTRP)
Database, 0925–0600, Expiration Date
05/31/2016—EXTENSION, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The Clinical Trials Reporting
Program (CTRP) Database is an
electronic resource that serves as a
single, definitive source of information
about all NCI-supported clinical
research. This resource allows the NCI
to consolidate reporting, aggregate
information and reduce redundant
submissions. Information is submitted
by clinical research administrators as
designees of clinical investigators who
conduct NCI-supported clinical
research. The designees can
electronically access the CTRP Web site
to complete the initial trial registration.
Subsequent to registration, four
amendments and four study subject
accrual updates occur per trial annually.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The estimated
annualized burden hours are 18,000.
E:\FR\FM\11MRN1.SGM
11MRN1
]]>Agencies
[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12913-12914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05431]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 (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, 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
[[Page 12914]]
received within 60 days of the date of this publication.
Proposed Collection: Methodological Studies for the Population
Assessment of Tobacco and Health (PATH) Study (NIDA), 0925-0675,
expiration date 5/31/2016--EXTENSION--NIDA, NIH, in partnership with
the Food and Drug Administration (FDA).
Need and Use of Information Collection: This is a request to
continue the Population Assessment of Tobacco and Health (PATH) Study's
conduct of methodological studies in support of improvements in the
Study's approaches for data and biospecimen collection. The PATH Study
is a national longitudinal cohort study of tobacco use behavior and
health among the U.S. household population of adults age 18 and older
and youth ages 12 to 17; the Study conducts annual or biannual
interviews and collects biospecimens from adults and youth to inform
FDA's regulatory actions under the Family Smoking Prevention and
Control Act. The methodological studies under this extension will
continue to enhance the approaches used by the PATH Study for data and
biospecimen collections to obtain high quality and useful data;
minimize respondent burden; and achieve and maintain high response,
retention, and follow-up rates.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total annualized burden hours
are 29,750.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Data collection activity respondent respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
In-person surveys............. Adults.......... 5,000 1 90/60 7,500
Youth........... 3,500 1 90/60 5,250
Web surveys................... Adults.......... 5,000 1 90/60 7,500
Youth........... 3,500 1 90/60 5,250
Focus groups and individual in- Adults.......... 1,000 1 2 2,000
depth qualitative interviews.
Youth........... 1,000 1 2 2,000
Biospecimen collection........ Adults.......... 1,000 1 15/60 250
---------------------------------------------------------------
Total..................... 20,000 20,000 .............. 29,750
----------------------------------------------------------------------------------------------------------------
Dated: March 7, 2016.
Genevieve deAlmeida-Morris,
Project Clearance Liaison. NIDA, NIH.
[FR Doc. 2016-05431 Filed 3-10-16; 8:45 am]
BILLING CODE 4140-01-P
