83 FR 16863 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Fresh Empire Campaign on Tobacco

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 74 (April 17, 2018)

Page Range		16863-16865
FR Document		2018-07971

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

Federal Register, Volume 83 Issue 74 (Tuesday, April 17, 2018)

[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16863-16865]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-07971]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2294]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Evaluation of the
Fresh Empire Campaign on Tobacco

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by May 17,
2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0788.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed

[[Page 16864]]

collection of information to OMB for review and clearance.

Evaluation of the Food and Drug Administration's `Fresh Empire'
Multicultural Youth Tobacco Prevention Campaign

OMB Control Number 0910-0788--Extension

The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) to grant FDA authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect
public health and to reduce tobacco use by minors. Section
1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the
development and implementation of FDA public education campaigns
related to tobacco use. Accordingly, FDA is currently developing and
implementing a youth-targeted public education campaign (`Fresh
Empire') to help prevent tobacco use among multicultural youth and
thereby reduce the public health burden of tobacco. The campaign
features events, advertisements on television and radio and in print,
digital communications including social media, and other forms of
media.
Evaluation is an essential organizational practice in public health
and a systematic way to account for and improve public health actions.
Comprehensive evaluation of FDA's multicultural public education
campaign will be used to document whether the intended audience is
aware of and understands campaign messages, and whether campaign
exposure influences specific cognitive outcomes related to tobacco use
that are targeted by the campaign.
FDA is in the process of evaluating the effectiveness of its
multicultural youth tobacco prevention campaign through an outcome
evaluation study that follows the multiple, discrete waves of media
advertising planned for the campaign. All information collected is
integral to that evaluation.
FDA's Fresh Empire youth tobacco public education campaign aims to
reduce tobacco use among youth who affiliate with a hip-hop peer crowd,
predominantly among African American, Hispanic, and Asian/Pacific
Islander youth. The outcome evaluation of the campaign consists of a
pre-test survey of youth aged 12 to 17 before campaign launch followed
by a series of post-test surveys beginning approximately 6 months after
the campaign launch. The post-test surveys are conducted among youth
who participated in one or more surveys (the embedded longitudinal
cohort) and new participants who are recruited to make up for
attrition. Eligible youth were initially 12 to 17 years old and
influenced by the hip-hop peer crowd. Youth in the embedded
longitudinal cohort may reach the age of 18 over the course of the
evaluation.
To date, the pre-test and three post-test surveys have been
conducted. Information has been collected about youth awareness of and
exposure to campaign events and advertisements and about tobacco-
related knowledge, attitudes, beliefs, intentions, and use. Information
has also been collected on demographic variables including age, sex,
race/ethnicity, grade level, and primary language.
All information is voluntarily provided and is being collected
through in-person and web-based questionnaires. Youth respondents were
recruited from two sources: (1) A sample drawn from 30 U.S. media
markets gathered using an address-based postal mail sampling of U.S.
households for the outcome evaluation, and (2) targeted social media
(e.g., Facebook, Instagram).
This study is being conducted in support of the provisions of the
Tobacco Control Act that require FDA to protect the public health and
to educate the population about the risks and potential risks of
tobacco use. The information being collected is necessary to inform
FDA's efforts towards these goals and to measure the effectiveness and
public health impact of the campaign. Data from the outcome evaluation
are being used to estimate awareness of and exposure to the campaign
among youth in target markets where the campaign is active. Data are
also being used to examine statistical associations between exposure to
the campaign and subsequent changes in specific outcomes of interest,
which include knowledge, attitudes, and beliefs related to tobacco use.
FDA requests OMB approval to extend OMB approval of the evaluation
of FDA's multicultural youth tobacco public education campaign and to
add two additional waves of data collection with existing youth in the
study. To accommodate these two additional surveys, FDA requests
approval to increase the number of burden hours under the existing
control number. The fourth post-test survey will begin in July 2018.
The fifth post-test survey will begin in February 2019. As was done in
earlier post-test surveys, new youth will be recruited to participate
to make up for attrition.
A total of 2,100 youth will voluntarily complete questionnaires for
the fourth post-test survey, and the same number will complete
questionnaires for the fifth post-test survey. These respondents will
include existing youth who have participated in one or more surveys
previously (``Longitudinal Cohort'') and new youth recruited via a
mail-based screener or social media ads (``Cross-Sectional Refresher
Sample''). Based on earlier response rates and longitudinal respondents
aging out of the eligibility criteria (over the age of 18), we expect
to need to recruit a larger number of cross-sectional respondents than
in previous waves. We estimate that approximately 600 longitudinal
youth and 1,500 cross-sectional youth will voluntarily participate in
each of the fourth and fifth post-test surveys. With an estimated
burden of 45 minutes per respondent, this adds 450 hours for
longitudinal respondents and 1,125 hours for cross-sectional
respondents for each of the fourth and fifth post-test evaluation
surveys.
A mail-based screener was one of the methods used to identify
eligible youth for the pre-test survey. This method will be used during
the fourth post-test survey to recruit new youth aged 12 to 17 to
ensure that the sample composition is similar across rounds of data
collection. As was done during the pre-test survey, parents or
guardians will be asked to provide consent and their contact
information on this form. For the fourth post-test survey, the 5-minute
youth screener and the 1-minute parental consent will be completed by
9,869 households for a total of 822 burden hours for youth and an
additional 164 hours for the parents or guardians. This method will not
be used during the fifth post-test survey, for which new participants
will be recruited only via social media.
We will continue to recruit new youth through social media (e.g.,
Facebook, Instagram) as a secondary strategy to recruit youth aged 13
to 17. An online version of the screener described above will continue
to be used to identify eligible youth. The screener will take 5 minutes
to complete and will be taken by an additional 4,000 youth during each
of the fourth and fifth post-test surveys, for a total of 8,000
additional youth respondents and 666 total additional burden hours. The
new total number of voluntary participants for the youth online post-
test screener will be 32,000 and the total burden will be 2,666 hours.
This includes the originally approved 24,000 participants and 2,000
burden hours.
As was done previously, eligible youth aged 13 to 14 who complete
the

[[Page 16865]]

online screener will be asked to provide their parents' or guardians'
contact information to provide parental consent for the main survey.
The process of parents and guardians providing consent for eligible
youth will take approximately 1 minute. For the fourth and fifth post-
test surveys, we estimate that an additional 700 adults will be
contacted to provide consent for eligible youth for a total of 11
additional burden hours. Added to the original 6,000 parents and 100
burden hours, the total number of parental online screeners and
consents will be 6,700 and the total burden will be 111 hours.
With these additions, the estimated number of voluntary
respondents/responses for all waves of data collection for the study is
107,743, and the total burden is estimated at 15,135 hours--an
estimated increase of 4,813 hours from the last approval.
In the Federal Register of December 26, 2017 (82 FR 61003), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received; however, this
comment was not PRA related.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent/activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth Mail screener-outcome survey.......... 23,685 1 23,685 0.0833 (5 minutes)........................ 1,973
Cross-Sectional Youth Refresher Sample, Post- 4,920 1 4,920 0.75 (45 minutes)......................... 3,690
test and assent/consent process-outcome
surveys 1-5.
Youth Pre-test and assent/consent process- 2,194 1 2,194 0.50 (30 minutes)......................... 1,097
outcome survey.
Longitudinal Youth Cohort, Post-test and 6,039 1 6,039 0.75 (45 minutes)......................... 4,530
assent/consent process-outcome surveys 1-5.
Youth Online screener-outcome survey........ 40,000 1 40,000 0.0833 (5 minutes)........................ 3,332
Adult parental permission process-outcome 30,905 1 30,905 0.0166 (1 minute)......................... 513
survey.
------------------------------------------------ ---------------
Total................................... 107,743 .............. .............. .......................................... 15,135
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07971 Filed 4-16-18; 8:45 am]
BILLING CODE 4164-01-P`

Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices 16863

sooner as determined by CMS. DNV ability of the organization to provide able to acknowledge or respond to them
GL—Healthcare (DNV GL) current term continuing surveyor training. individually. We will consider all
of approval for their hospital ++ The comparability of DNV GL’s comments we receive by the date and
accreditation program expires processes to those of state agencies, time specified in the DATES section of
September 26, 2018. including survey frequency, and the this preamble, and, when we proceed
ability to investigate and respond with a subsequent document, we will
II. Provisions of the Proposed Notice appropriately to complaints against respond to the comments in the
A. Approval of Deeming Organizations accredited facilities. preamble to that document.
++ DNV GL’s processes and Dated: April 9, 2018.
Section 1865(a)(2) of the Act and our
procedures for monitoring a hospital
regulations at § 488.5 require that our Seema Verma,
found out of compliance with the DNV
findings concerning review and Administrator, Centers for Medicare &
GL’s program requirements. These
approval of a national accrediting Medicaid Services.
monitoring procedures are used only
organization’s requirements consider, [FR Doc. 2018–07982 Filed 4–16–18; 8:45 am]
when the DNV GL identifies
among other factors, the applying BILLING CODE 4120–01–P
noncompliance. If noncompliance is
accrediting organization’s requirements
identified through validation reviews or
for accreditation; survey procedures;
complaint surveys, the state survey
resources for conducting required DEPARTMENT OF HEALTH AND
agency monitors corrections as specified
surveys; capacity to furnish information HUMAN SERVICES
at § 488.9(c).
for use in enforcement activities;
++ DNV GL’s capacity to report Food and Drug Administration
monitoring procedures for provider
deficiencies to the surveyed facilities
entities found not in compliance with
and respond to the facility’s plan of
the conditions or requirements; and [Docket No. FDA–2014–N–2294]
correction in a timely manner.
ability to provide us with the necessary ++ DNV GL’s capacity to provide CMS
data for validation. Agency Information Collection
with electronic data and reports
Section 1865(a)(3)(A) of the Act Activities; Submission for Office of
necessary for effective validation and
further requires that we publish, within Management and Budget Review;
assessment of the organization’s survey
60 days of receipt of an organization’s Comment Request; Evaluation of the
process.
complete application, a notice Fresh Empire Campaign on Tobacco
++ The adequacy of DNV GL’s staff
identifying the national accrediting and other resources, and its financial AGENCY: Food and Drug Administration,
body making the request, describing the viability. HHS.
nature of the request, and providing at ++ DNV GL’s capacity to adequately
least a 30-day public comment period. ACTION: Notice.
fund required surveys.
We have 210 days from the receipt of a ++ DNV GL’s policies with respect to SUMMARY: The Food and Drug
complete application to publish notice whether surveys are announced or Administration (FDA) is announcing
of approval or denial of the application. unannounced, to assure that surveys are that a proposed collection of
The purpose of this proposed notice unannounced. information has been submitted to the
is to inform the public of DNV GL’s ++ DNV GL’s agreement to provide Office of Management and Budget
request for continued approval of its CMS with a copy of the most current (OMB) for review and clearance under
hospital accreditation program. This accreditation survey together with any the Paperwork Reduction Act of 1995
notice also solicits public comment on other information related to the survey (the PRA).
whether DNV GL’s requirements meet or as we may require (including corrective
exceed the Medicare conditions of DATES: Fax written comments on the
action plans). collection of information by May 17,
participation (CoPs) for hospitals.
C. Notice Upon Completion of 2018.
B. Evaluation of Deeming Authority Evaluation
Request ADDRESSES: To ensure that comments on
Upon completion of our evaluation, the information collection are received,
DNV GL submitted all the necessary including evaluation of public OMB recommends that written
materials to enable us to make a comments received as a result of this comments be faxed to the Office of
determination concerning its request for notice, we will publish a final notice in Information and Regulatory Affairs,
continued approval of its hospital the Federal Register announcing the OMB, Attn: FDA Desk Officer, Fax: 202–
accreditation program. This application result of our evaluation. 395–7285, or emailed to oira_
was determined to be complete on submission@omb.eop.gov. All
February 28, 2018. Under section III. Collection of Information comments should be identified with the
1865(a)(2) of the Act and our regulations Requirements OMB control number 0910–0788. Also
at § 488.5 (Application and re- This document does not impose include the FDA docket number found
application procedures for national information collection requirements, in brackets in the heading of this
accrediting organizations), our review that is, reporting, recordkeeping or document.
and evaluation of DNV GL will be third-party disclosure requirements.
FOR FURTHER INFORMATION CONTACT:
conducted in accordance with, but not Consequently, there is no need for
necessarily limited to, the following Amber Sanford, Office of Operations,
review by the Office of Management and
factors: Food and Drug Administration, Three
Budget under the authority of the
daltland on DSKBBV9HB2PROD with NOTICES

• The equivalency of DNV GL’s White Flint North, 10A–12M, 11601
Paperwork Reduction Act of 1995 (44
standards for hospitals as compared Landsdown St., North Bethesda, MD
U.S.C. Chapter 35).
with CMS’ hospital CoPs. 20852, 301–796–8867, PRAStaff@
• DNV GL’s survey process to IV. Response to Comments fda.hhs.gov.
determine the following: Because of the large number of public SUPPLEMENTARY INFORMATION: In
++ The composition of the survey comments we normally receive on compliance with 44 U.S.C. 3507, FDA
team, surveyor qualifications, and the Federal Register documents, we are not has submitted the following proposed

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Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices 16865

online screener will be asked to provide hours. Added to the original 6,000 hours—an estimated increase of 4,813
their parents’ or guardians’ contact parents and 100 burden hours, the total hours from the last approval.
information to provide parental consent number of parental online screeners and In the Federal Register of December
for the main survey. The process of consents will be 6,700 and the total 26, 2017 (82 FR 61003), FDA published
parents and guardians providing burden will be 111 hours. a 60-day notice requesting public
consent for eligible youth will take comment on the proposed collection of
With these additions, the estimated
approximately 1 minute. For the fourth information. One comment was
number of voluntary respondents/
and fifth post-test surveys, we estimate received; however, this comment was
that an additional 700 adults will be responses for all waves of data not PRA related.
contacted to provide consent for eligible collection for the study is 107,743, and FDA estimates the burden of this
youth for a total of 11 additional burden the total burden is estimated at 15,135 collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Type of respondent/activity responses per Total hours
respondents responses response
respondent

Youth Mail screener-outcome survey ...................... 23,685 1 23,685 0.0833 (5 minutes) .... 1,973
Cross-Sectional Youth Refresher Sample, Post-test 4,920 1 4,920 0.75 (45 minutes) ...... 3,690
and assent/consent process-outcome surveys 1–
5.
Youth Pre-test and assent/consent process-out- 2,194 1 2,194 0.50 (30 minutes) ...... 1,097
come survey.
Longitudinal Youth Cohort, Post-test and assent/ 6,039 1 6,039 0.75 (45 minutes) ...... 4,530
consent process-outcome surveys 1–5.
Youth Online screener-outcome survey .................. 40,000 1 40,000 0.0833 (5 minutes) .... 3,332
Adult parental permission process-outcome survey 30,905 1 30,905 0.0166 (1 minute) ...... 513

Total .................................................................. 107,743 ........................ ........................ .................................... 15,135
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: April 12, 2018. Information and Regulatory Affairs, of any person for information respecting
Leslie Kux, OMB, Attn: FDA Desk Officer, Fax: 202– the class in which a device has been
Associate Commissioner for Policy. 395–7285, or emailed to oira_ classified or the requirements applicable
[FR Doc. 2018–07971 Filed 4–16–18; 8:45 am] submission@omb.eop.gov. All to a device under the FD&C Act, the
BILLING CODE 4164–01–P
comments should be identified with the Secretary of Health and Human Services
OMB control number 0910–0705. Also shall provide such person a written
include the FDA docket number found statement of the classification (if any) of
DEPARTMENT OF HEALTH AND in brackets in the heading of this such device and the requirements of the
HUMAN SERVICES document. FD&C Act applicable to the device.
FOR FURTHER INFORMATION CONTACT: Regulations governing medical device
Food and Drug Administration Amber Sanford, Office of Operations, classification procedures are codified
[Docket No. FDA–2014–N–0913] Food and Drug Administration, Three under 21 CFR part 860.
White Flint North, 10A–12M, 11601 The guidance document entitled
Agency Information Collection Landsdown St., North Bethesda, MD ‘‘FDA and Industry Procedures for
Activities; Submission for Office of 20852, 301–796–8867, PRAStaff@ Section 513(g) Requests for Information
Management and Budget Review; fda.hhs.gov. Under the Federal Food, Drug, and
Comment Request; 513(g) Request for Cosmetic Act; Guidance for Industry
Information SUPPLEMENTARY INFORMATION: In and Food and Drug Administration
compliance with 44 U.S.C. 3507, FDA Staff’’ establishes procedures for
AGENCY: Food and Drug Administration, has submitted the following proposed submitting, reviewing, and responding
HHS. collection of information to OMB for to requests for information respecting
ACTION: Notice. review and clearance. the class in which a device has been
513(g) Request for Information classified or the requirements applicable
SUMMARY: The Food and Drug
to a device under the FD&C Act that are
Administration (FDA) is announcing OMB Control Number 0910–0705— submitted in accordance with section
that a proposed collection of Extension 513(g) of the FD&C Act. FDA does not
information has been submitted to the
This information collection supports review data related to substantial
Office of Management and Budget
Agency regulations and accompanying equivalence or safety and effectiveness
(OMB) for review and clearance under
guidance. Section 513(g) of the Federal in a 513(g) request for information.
the Paperwork Reduction Act of 1995.
Food, Drug, and Cosmetic Act (the FDA’s responses to 513(g) requests for
daltland on DSKBBV9HB2PROD with NOTICES

DATES: Fax written comments on the FD&C Act) (21 U.S.C. 360c(g)) provides information are not device classification
collection of information by May 17, a means for obtaining the Agency’s decisions and do not constitute FDA
2018. views about the classification and clearance or approval for marketing.
ADDRESSES: To ensure that comments on regulatory requirements that may be Classification decisions and clearance or
the information collection are received, applicable to a particular device. approval for marketing require
OMB recommends that written Section 513(g) provides that, within 60 submissions under different sections of
comments be faxed to the Office of days of the receipt of a written request the FD&C Act.

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Document Created: 2018-04-17 02:52:10
Document Modified: 2018-04-17 02:52:10

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by May 17, 2018.
Contact		Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation		83 FR 16863

83 FR 16863 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Fresh Empire Campaign on Tobacco

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 74 (April 17, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration