Agency Information Collection Activities; Proposed Collection; Comment Request: Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products, 68888-68890 [2014-27283]
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Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices
annualized burden of 607 hours per
year.
There are no costs to participants
other than the time.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Private companies ..........................................
EXCEL data template ....................................
28
260
5/60
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–27350 Filed 11–18–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Numbers: 93.592]
Announcing the Award of a SingleSource Program Expansion
Supplement Grant to the National
Resource Center on Domestic Violence
(NRCDV) in Harrisburg, PA
Family and Youth Services
Bureau, ACYF, ACF, HHS.
ACTION: Notice of the award of a singlesource program expansion supplement
grant under the Family Violence
Prevention and Services Act (FVPSA)
Technical Assistance (TA) Project to the
National Resource Center on Domestic
Violence to support training and
technical assistance activities.
AGENCY:
The Administration for
Children and Families (ACF),
Administration on Children, Youth and
Families (ACYF), Family and Youth
Services Bureau (FYSB), Division of
Family Violence and Prevention
Services (DFVPS) announces the award
of $236,000 as a single-source program
expansion supplement to the National
Resource Center on Domestic Violence
in Harrisburg, PA. The grantee, funded
under the Family Violence Protection
and Services Act (FVPSA) program, is a
technical assistance (TA) provider that
assists FVPSA service providers to build
the capacity of domestic violence
programs.
DATES: The period of support for the
single-source program expansion
supplement is September 30, 2014
through September 29, 2015.
FOR FURTHER INFORMATION CONTACT:
Shawndell Dawson, Senior Program
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SUMMARY:
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Specialist, Family Violence Prevention
and Services Program, 1250 Maryland
Avenue SW., Suite 8219, Washington,
DC 20024. Telephone: 202–205–1476;
Email: Shawndell.Dawson@acf.hhs.gov.
SUPPLEMENTARY INFORMATION:
Supplemental award funds will support
the grantee in providing training and
technical assistance to domestic
violence service providers. A portion of
the supplemental award is contributed
by the Centers for Disease Control (CDC)
and Prevention’s National Center for
Injury Prevention and Control (NCIPC),
Division of Violence Prevention (DVP).
This award will expand the scope of
the NRCDV’s technical assistance
activities to include additional activities
concerning the prevention of intimate
partner violence (IPV) by: (1)
Coordinating engagement with nationallevel partners, including foundations,
for the purpose of enhancing
communication related to IPV
prevention; 2) engaging in planning to
facilitate dialogue that will include the
sharing of tools and lessons learned
among state domestic violence
coalitions engaged in IPV primary
prevention efforts; 3) continuing to
identify and disseminate information on
lessons learned and key findings from
state domestic violence coalitions that
have implemented IPV primary
prevention activities through
www.PreventIPVorg, and other means;
4) maintaining a virtual workspace to
assist in the sharing of resources among
state and territorial domestic violence
coalitions that are engaged in IPV
primary prevention activities; and 5)
facilitating regular, ongoing
communication between the IPV
Prevention Council, ACF/DFVPS, and
CDC/DVP.
In addition to the prevention
activities, the grantee will coordinate an
accessibility and sustainability peer-topeer technical assistance collaborative
with three to five state domestic
violence coalitions, which may involve
activities such as: (1) Identifying state
coalitions with experience in addressing
organizational accessibility challenges
(i.e. mental health, substance use, men,
and adolescent boys), or sustainability
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challenges (i.e. fiscal management or
board management); (2) coordinating
support to domestic violence
organizations or coalitions experiencing
accessibility or sustainability
challenges; and (3) developing peerinformed accessibility and sustainability
tools and resources, and a discussion
forum, for use by all domestic violence
coalitions.
Statutory Authority: Section 310 of the
Family Violence Prevention and Services
Act, as amended by Section 201 of the
CAPTA Reauthorization Act of 2010, Pub. L.
111–320. The statutory authority for the
additional funds from the Centers for Disease
Control and Prevention is 42 U.S.C.
247b(k)(2) and 42 USC 280b–1 of the Public
Health Service Act.
Christopher Beach,
Senior Grants Policy Specialist, Division of
Grants Policy, Office of Administration.
[FR Doc. 2014–27390 Filed 11–18–14; 8:45 am]
BILLING CODE 4184–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1855]
Agency Information Collection
Activities; Proposed Collection;
Comment Request: Experimental
Studies on Consumer Perceptions of
Modified Risk Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
Experimental Studies on Consumer
Perceptions of Modified Risk Tobacco
Products (MRTPs).
SUMMARY:
E:\FR\FM\19NON1.SGM
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Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices
Submit either electronic or
written comments on the collection of
information by January 20, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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Experimental Studies on Consumer
Perceptions of Modified Risk Tobacco
Products—(OMB Control Number 0910–
NEW)
FDA’s Center for Tobacco Products
proposes to conduct experimental
studies to develop generalizable
scientific knowledge to help inform its
implementation of section 911 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 387k), wherein
FDA will be evaluating information
submitted to the Agency about how
consumers understand and perceive
tobacco products marketed as MRTPs.
Section 911 of the FD&C Act authorizes
FDA to grant orders to persons to allow
the marketing of MRTPs. The term
‘‘modified risk tobacco product’’ means
any tobacco product that is sold or
distributed for use to reduce harm or the
risk of tobacco-related disease
associated with commercially marketed
tobacco products. FDA must issue an
order authorizing the marketing of an
MRTP if the Agency determines that the
product, as it is actually used by
consumers, will significantly reduce
harm and the risk of tobacco-related
disease to individual tobacco users and
benefit the health of the population as
a whole taking into account both users
of tobacco products and persons who do
not currently use tobacco products
(section 911(g)(1) of the FD&C Act).
FDA may also issue an order
authorizing the marketing of an MRTP
that reduces or eliminates exposure to a
harmful substance if, among other
requirements, the Agency determines
that the order would be appropriate to
promote the public health, the issuance
of the order is expected to benefit the
population as a whole taking into
account both users and nonusers of
tobacco products, and the existing
evidence demonstrates that a
measurable and substantial reduction in
morbidity and mortality among
individual tobacco users is reasonably
likely to be shown in subsequent studies
(section 911(g)(2) of the FD&C Act). In
addition, section 911 requires that any
advertising or labeling concerning
modified risk products enable the
public to comprehend the information
concerning modified risk and to
understand the relative significance of
such information in the context of total
health and in relation to all of the
diseases and health related conditions
associated with the use of tobacco
products (section 911(h)(1) of the FD&C
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68889
Act). The proposed research will inform
the Agency’s efforts to implement the
provisions of the FD&C Act related to
MRTPs.
FDA proposes to conduct
experimental studies in order to develop
generalizable scientific information to
better understand how consumers
perceive and understand these products,
how exposure to claims about modified
risk or exposure influence intentions to
try or purchase the product (i.e.,
product adoption), and how individual
characteristics such as current tobacco
use and/or brand loyalty might
influence these outcomes. Moreover,
information from the experimental
studies may assist FDA to determine the
appropriate methods and measures for
gathering such information from
consumers.
The impact of different claims
pertaining to modified risk or exposure
on understanding, perceptions, and
potential product adoption (i.e.,
intention to try) will be evaluated by
conducting a series of three studies that,
in turn, will examine: The impact of
claims about cigarette (Study 1) or
smokeless tobacco products (Study 2)
among young adult and adult current,
former, or never users of tobacco; and
the impact of claims on adolescents
currently using, or susceptible to using,
tobacco (Study 3). All three studies will
assess individual-level factors that
might influence the impact of claims on
consumer responses, including: Brand
loyalty, tobacco use history and
behavior, concerns about health risks,
and openness to new products.
Across all studies, participants will be
randomized to either see modified risk
claims or not (control condition). In
Studies 1 and 2, modified risk claims
will be displayed on mock tobacco
product packages and ads. For ethical
reasons, adolescents (Study 3) will see
modified risk claims displayed as
statements alone, not attached to
product packaging or ads. Consumer
reactions to claims will be evaluated by
measuring constructs such as:
Comprehension of the modified risk
information in the claims, perceived
benefits of the product, perceptions of
harm and risk, misbeliefs about the
product, quit intentions, and
willingness to try or purchase the
product.
FDA estimates the burden of this
collection of information as follows:
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68890
Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Adult Screener .....................................................
Study 1 (Adults) ...................................................
Study 2 (Adults) ...................................................
24,000
1,800
600
1
1
1
24,000
1,800
600
0.03 (2 minutes) ............
0.333 (20 minutes) ........
0.333 (20 minutes) ........
720
599
200
Total adult hours ...........................................
........................
........................
........................
.......................................
1,519
Youth Screener ....................................................
Study 3 (Youth) ....................................................
6,000
600
1
1
6,000
600
0.03 (2 minutes) ............
0.333 (20 minutes) ........
180
200
Total youth hours ..........................................
........................
........................
........................
.......................................
380
Total Hours ............................................
........................
........................
........................
.......................................
1,899
FDA’s burden estimate is based on
prior experience with research that is
similar to this proposed study.
Approximately 30,000 respondents will
complete a screener to determine
eligibility for participation in a study,
estimated to take approximately 2
minutes (0.03 hours), for a total of 900
hours for screening activities. Three
thousand respondents will complete a
full study, estimated to last 20 minutes
(0.333 hours), for a total of 999 hours for
completion of both adult studies and
one youth study. The estimated total
hour burden of the collection of
information is 1,899 hours.
Dated: November 12, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–27283 Filed 11–18–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1840]
Electronic Study Data Submission;
Data Standards; Validation Rules for
Study Data Tabulation Model
Formatted Studies; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA) Center for Drug
Evaluation and Research (CDER) is
announcing the availability of a
document entitled ‘‘Validation Rules for
Study Data Tabulation Model (SDTM)
Formatted Studies.’’ CDER is making
this document available to improve the
standardization and quality of clinical
data submitted to CDER, as well as to
improve the predictability of data
quality and usefulness.
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FOR FURTHER INFORMATION CONTACT:
Office of Strategic Programs, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1192,
Silver Spring, MD 20993, email: edata@
fda.hhs.gov.
CDER
supports the regulatory submission of
standardized clinical study data based
on the Clinical Data Interchange
Standards Consortium SDTM. Upon
receipt of the data, CDER validates the
data using a set of validation rules. The
‘‘Validation Rules for SDTM Formatted
Studies’’ is an Excel file that provides a
human readable description of a rule set
for validation. Submitters of clinical
study data can use this information to
understand how FDA validates the data.
The file is available on FDA’s Study
Data Standards Resources Web page at
https://www.fda.gov/ForIndustry/
DataStandards/StudyDataStandards/
default.htm. It contains a combination
of conformance rules (i.e., how well the
data conform to the standard) and
business rules (i.e., quality checks; how
well the data may support useful
analysis). The rules may be updated
periodically as new or updated
validation rules are developed. The
Change History tab will provide a
descriptive change history of the
document.
SUPPLEMENTARY INFORMATION:
Dated: November 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–27384 Filed 11–18–14; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–1120]
Vaginal Microbicides: Development for
the Prevention of Human
Immunodeficiency Virus Infection;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Vaginal Microbicides:
Development for the Prevention of HIV
Infection.’’ The purpose of this guidance
is to assist sponsors in all phases of
development of vaginal microbicides,
defined as vaginal drug products that
prevent human immunodeficiency virus
(HIV) acquisition. The guidance outlines
the types of nonclinical studies and
clinical trials recommended throughout
the drug development process to
support approval of vaginal
microbicides. This guidance finalizes
the draft guidance issued on November
23, 2012.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
SUMMARY:
E:\FR\FM\19NON1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Pages 68888-68890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27283]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1855]
Agency Information Collection Activities; Proposed Collection;
Comment Request: Experimental Studies on Consumer Perceptions of
Modified Risk Tobacco Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Experimental Studies on Consumer
Perceptions of Modified Risk Tobacco Products (MRTPs).
[[Page 68889]]
DATES: Submit either electronic or written comments on the collection
of information by January 20, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA'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 respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Experimental Studies on Consumer Perceptions of Modified Risk Tobacco
Products--(OMB Control Number 0910-NEW)
FDA's Center for Tobacco Products proposes to conduct experimental
studies to develop generalizable scientific knowledge to help inform
its implementation of section 911 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 387k), wherein FDA will be
evaluating information submitted to the Agency about how consumers
understand and perceive tobacco products marketed as MRTPs. Section 911
of the FD&C Act authorizes FDA to grant orders to persons to allow the
marketing of MRTPs. The term ``modified risk tobacco product'' means
any tobacco product that is sold or distributed for use to reduce harm
or the risk of tobacco-related disease associated with commercially
marketed tobacco products. FDA must issue an order authorizing the
marketing of an MRTP if the Agency determines that the product, as it
is actually used by consumers, will significantly reduce harm and the
risk of tobacco-related disease to individual tobacco users and benefit
the health of the population as a whole taking into account both users
of tobacco products and persons who do not currently use tobacco
products (section 911(g)(1) of the FD&C Act).
FDA may also issue an order authorizing the marketing of an MRTP
that reduces or eliminates exposure to a harmful substance if, among
other requirements, the Agency determines that the order would be
appropriate to promote the public health, the issuance of the order is
expected to benefit the population as a whole taking into account both
users and nonusers of tobacco products, and the existing evidence
demonstrates that a measurable and substantial reduction in morbidity
and mortality among individual tobacco users is reasonably likely to be
shown in subsequent studies (section 911(g)(2) of the FD&C Act). In
addition, section 911 requires that any advertising or labeling
concerning modified risk products enable the public to comprehend the
information concerning modified risk and to understand the relative
significance of such information in the context of total health and in
relation to all of the diseases and health related conditions
associated with the use of tobacco products (section 911(h)(1) of the
FD&C Act). The proposed research will inform the Agency's efforts to
implement the provisions of the FD&C Act related to MRTPs.
FDA proposes to conduct experimental studies in order to develop
generalizable scientific information to better understand how consumers
perceive and understand these products, how exposure to claims about
modified risk or exposure influence intentions to try or purchase the
product (i.e., product adoption), and how individual characteristics
such as current tobacco use and/or brand loyalty might influence these
outcomes. Moreover, information from the experimental studies may
assist FDA to determine the appropriate methods and measures for
gathering such information from consumers.
The impact of different claims pertaining to modified risk or
exposure on understanding, perceptions, and potential product adoption
(i.e., intention to try) will be evaluated by conducting a series of
three studies that, in turn, will examine: The impact of claims about
cigarette (Study 1) or smokeless tobacco products (Study 2) among young
adult and adult current, former, or never users of tobacco; and the
impact of claims on adolescents currently using, or susceptible to
using, tobacco (Study 3). All three studies will assess individual-
level factors that might influence the impact of claims on consumer
responses, including: Brand loyalty, tobacco use history and behavior,
concerns about health risks, and openness to new products.
Across all studies, participants will be randomized to either see
modified risk claims or not (control condition). In Studies 1 and 2,
modified risk claims will be displayed on mock tobacco product packages
and ads. For ethical reasons, adolescents (Study 3) will see modified
risk claims displayed as statements alone, not attached to product
packaging or ads. Consumer reactions to claims will be evaluated by
measuring constructs such as: Comprehension of the modified risk
information in the claims, perceived benefits of the product,
perceptions of harm and risk, misbeliefs about the product, quit
intentions, and willingness to try or purchase the product.
FDA estimates the burden of this collection of information as
follows:
[[Page 68890]]
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Adult Screener................ 24,000 1 24,000 0.03 (2 minutes) 720
Study 1 (Adults).............. 1,800 1 1,800 0.333 (20 599
minutes).
Study 2 (Adults).............. 600 1 600 0.333 (20 200
minutes).
---------------------------------------------------------------------------------
Total adult hours......... .............. .............. .............. ................ 1,519
----------------------------------------------------------------------------------------------------------------
Youth Screener................ 6,000 1 6,000 0.03 (2 minutes) 180
Study 3 (Youth)............... 600 1 600 0.333 (20 200
minutes).
---------------------------------------------------------------------------------
Total youth hours......... .............. .............. .............. ................ 380
=================================================================================
Total Hours........... .............. .............. .............. ................ 1,899
----------------------------------------------------------------------------------------------------------------
FDA's burden estimate is based on prior experience with research
that is similar to this proposed study. Approximately 30,000
respondents will complete a screener to determine eligibility for
participation in a study, estimated to take approximately 2 minutes
(0.03 hours), for a total of 900 hours for screening activities. Three
thousand respondents will complete a full study, estimated to last 20
minutes (0.333 hours), for a total of 999 hours for completion of both
adult studies and one youth study. The estimated total hour burden of
the collection of information is 1,899 hours.
Dated: November 12, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27283 Filed 11-18-14; 8:45 am]
BILLING CODE 4164-01-P
