82_FR_61249 82 FR 61003 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's `Fresh Empire' Multicultural Youth Tobacco Prevention Campaign

82 FR 61003 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's `Fresh Empire' Multicultural Youth Tobacco Prevention Campaign

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 246 (December 26, 2017)

Page Range61003-61006
FR Document2017-27712

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an extension of the time period for the outcome evaluation of FDA's multicultural youth tobacco public education campaign, the addition of two rounds of data collection with the original youth surveyed for the outcome evaluation, and recruitment of new youth to participate in those two additional surveys.

Federal Register, Volume 82 Issue 246 (Tuesday, December 26, 2017)
[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 61003-61006]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27712]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on an extension of the time period for the 
outcome evaluation of FDA's multicultural youth tobacco public 
education campaign, the addition of two rounds of data collection with 
the original youth surveyed for the outcome evaluation, and recruitment 
of new youth to participate in those two additional surveys.

DATES: Submit either electronic or written comments on the collection 
of information by February 26, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 26, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

[[Page 61004]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-2294 for ``Evaluation of the Food and Drug Administration's 
`Fresh Empire' Multicultural Youth Tobacco Prevention Campaign'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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, 
[email protected].

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, including 
each proposed extension of an existing 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.

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 (the 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.

[[Page 61005]]

    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-year-old youth who 
are 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 two post-test surveys have been 
conducted. A third post-test survey is currently underway. 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 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).
    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 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 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 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 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 and 
will be completed 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 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 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 screener and consents 
will be 6,700 and the total burden will be 111 hours.
    With these additions, the estimated number of 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 increase of 4,813 hours 
from the last approval.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 61006]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of
            Type of respondent                        Activity               Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth aged 12 to 17 in the United States..  Mail Screener and Consent             13,816               1          13,816          0.0833           1,151
                                             Process--Pre-test outcome
                                             survey.
                                            Mail Screener and Consent              9,869               1           9,869          0.0833             822
                                             Process--Post-test outcome
                                             survey.
Adults 18 and older in the United States..  Mail Screener and Consent             13,816               1          13,816          0.0166             229
                                             Process--Pre-test outcome
                                             survey.
                                            Online Screener and Consent              520               1             520          0.0166               9
                                             Process--Pre-test outcome
                                             survey.
                                            Mail Screener and Consent              9,869               1           9,869          0.0166             164
                                             Process--Post-test outcome
                                             survey.
                                            Online Screener and Consent            6,700               1           6,700          0.0166             111
                                             Process--Post-test outcome
                                             survey.
Multicultural Youth aged 12 to 17 in        Pre-test outcome evaluation            2,194               1           2,194             0.5           1,097
 select media markets.                       survey.
Longitudinal Cohort, age 13 to 18 years...  First post-test evaluation             1,722               1           1,722            0.75           1,292
                                             survey.
                                            Second post-test evaluation            1,752               1           1,752            0.75           1,314
                                             survey.
                                            Third post-test evaluation             1,365               1           1,365            0.75           1,024
                                             survey.
                                            Fourth post-test evaluation              600               1             600            0.75             450
                                             survey.
                                            Fifth post-test evaluation               600               1             600            0.75             450
                                             survey.
Cross-Sectional Refresher Sample, age 13    First post-test evaluation               682               1             682            0.75             512
 to 17 years.                                survey.                                 503               1             503            0.75             377
                                            Second post-test evaluation              735               1             735            0.75             551
                                             survey.                               1,500               1           1,500            0.75           1,125
                                            Third post-test evaluation             1,500               1           1,500            0.75           1,125
                                             survey.
                                            Fourth post-test evaluation
                                             survey.
                                            Fifth post-test evaluation
                                             survey.
Multicultural youth aged 13 to 17 in the    Pre-test online screener....           8,000               1           8,000          0.0833             666
 select media markets recruiting through    Post-test online screener...          32,000               1          32,000          0.0833           2,666
 social media and online panels.
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ............................         107,743  ..............  ..............  ..............          15,135
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27712 Filed 12-22-17; 8:45 am]
BILLING CODE 4164-01-P



                                                                          Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices                                                61003

                                               this collection of information, including                 Under the PRA (44 U.S.C. 3501–                         Dated: December 20, 2017.
                                               the necessity and utility of the proposed               3520), federal agencies must obtain                   William N. Parham, III
                                               information collection for the proper                   approval from the Office of Management                Director, Paperwork Reduction Staff, Office
                                               performance of the agency’s functions,                  and Budget (OMB) for each collection of               of Strategic Operations and Regulatory
                                               the accuracy of the estimated burden,                   information they conduct or sponsor.                  Affairs.
                                               ways to enhance the quality, utility, and               The term ‘‘collection of information’’ is             [FR Doc. 2017–27787 Filed 12–22–17; 8:45 am]
                                               clarity of the information to be                        defined in 44 U.S.C. 3502(3) and 5 CFR                BILLING CODE 4120–01–P
                                               collected, and the use of automated                     1320.3(c) and includes agency requests
                                               collection techniques or other forms of                 or requirements that members of the
                                               information technology to minimize the                  public submit reports, keep records, or               DEPARTMENT OF HEALTH AND
                                               information collection burden.                          provide information to a third party.                 HUMAN SERVICES
                                               DATES: Comments must be received by                     Section 3506(c)(2)(A) of the PRA
                                                                                                       requires federal agencies to publish a                Food and Drug Administration
                                               February 26, 2018.
                                                                                                       60-day notice in the Federal Register                 [Docket No. FDA–2014–N–2294]
                                               ADDRESSES: When commenting, please
                                                                                                       concerning each proposed collection of
                                               reference the document identifier or
                                                                                                       information, including each proposed                  Agency Information Collection
                                               OMB control number. To be assured
                                                                                                       extension or reinstatement of an existing             Activities; Submission for Office of
                                               consideration, comments and
                                                                                                       collection of information, before                     Management and Budget Review;
                                               recommendations must be submitted in
                                                                                                       submitting the collection to OMB for                  Comment Request; Evaluation of the
                                               any one of the following ways:
                                                                                                       approval. To comply with this                         Food and Drug Administration’s ‘Fresh
                                                 1. Electronically. You may send your
                                                                                                       requirement, CMS is publishing this                   Empire’ Multicultural Youth Tobacco
                                               comments electronically to http://
                                                                                                       notice.                                               Prevention Campaign
                                               www.regulations.gov. Follow the
                                               instructions for ‘‘Comment or                           Information Collection                                AGENCY:    Food and Drug Administration,
                                               Submission’’ or ‘‘More Search Options’’                   1. Type of Information Collection                   HHS.
                                               to find the information collection                      Request: Extension of a currently                     ACTION:   Notice.
                                               document(s) that are accepting                          approved collection; Title of
                                               comments.                                                                                                     SUMMARY:    The Food and Drug
                                                                                                       Information Collection: Appointment of
                                                 2. By regular mail. You may mail                                                                            Administration (FDA or Agency) is
                                                                                                       Representative; Use: The Appointment
                                               written comments to the following                                                                             announcing an opportunity for public
                                                                                                       of Representative form is completed by
                                               address: CMS, Office of Strategic                                                                             comment on the proposed collection of
                                                                                                       beneficiaries, providers and suppliers,
                                               Operations and Regulatory Affairs,                                                                            certain information by the Agency.
                                                                                                       and any party seeking to appoint a
                                               Division of Regulations Development,                                                                          Under the Paperwork Reduction Act of
                                                                                                       representative to assist them with their
                                               Attention: Document Identifier/OMB                                                                            1995 (PRA), Federal Agencies are
                                                                                                       initial determinations and filing
                                               Control Number lllll , Room C4–                                                                               required to publish notice in the
                                                                                                       appeals. Form Number: CMS–1696
                                               26–05, 7500 Security Boulevard,                                                                               Federal Register concerning each
                                                                                                       (OMB control number: 0938–0950);
                                               Baltimore, Maryland 21244–1850.                                                                               proposed collection of information,
                                                                                                       Frequency: Once; Affected Public:
                                                 To obtain copies of a supporting                                                                            including each proposed extension of an
                                                                                                       Individuals and Households, and the
                                               statement and any related forms for the                                                                       existing collection of information, and
                                                                                                       Private sector (Business or other for-
                                               proposed collection(s) summarized in                                                                          to allow 60 days for public comment in
                                                                                                       profits); Number of Respondents:
                                               this notice, you may make your request                                                                        response to the notice. This notice
                                                                                                       3,472,840; Total Annual Responses:
                                               using one of following:                                                                                       solicits comments on an extension of
                                                                                                       347,284; Total Annual Hours: 86,821.
                                                 1. Access CMS’ website address at                                                                           the time period for the outcome
                                                                                                       (For policy questions regarding this
                                               http://www.cms.hhs.gov/                                                                                       evaluation of FDA’s multicultural youth
                                                                                                       collection contact Katherine Hosna at
                                               PaperworkReductionActof1995.                                                                                  tobacco public education campaign, the
                                                                                                       410–786–4993.)
                                                 2. Email your request, including your                                                                       addition of two rounds of data
                                                                                                         2. Type of Information Collection
                                               address, phone number, OMB number,                                                                            collection with the original youth
                                                                                                       Request: Extension of a currently
                                               and CMS document identifier, to                                                                               surveyed for the outcome evaluation,
                                                                                                       approved collection; Title of
                                               Paperwork@cms.hhs.gov.                                                                                        and recruitment of new youth to
                                                                                                       Information Collection: Medicaid
                                                 3. Call the Reports Clearance Office at                                                                     participate in those two additional
                                                                                                       Eligibility and Enrollment (EE)
                                               (410) 786–1326.                                                                                               surveys.
                                                                                                       Implementation Advanced Planning
                                               FOR FURTHER INFORMATION CONTACT:                        Document (IAPD) Template; Use: To                     DATES: Submit either electronic or
                                               William Parham at (410) 786–4669.                       assess the appropriateness of states’                 written comments on the collection of
                                               SUPPLEMENTARY INFORMATION:                              requests for enhanced federal financial               information by February 26, 2018.
                                                                                                       participation for expenditures related to             ADDRESSES: You may submit comments
                                               Contents                                                Medicaid eligibility determination                    as follows. Please note that late,
                                                 This notice sets out a summary of the                 systems, we will review the submitted                 untimely filed comments will not be
                                               use and burden associated with the                      information and documentation to make                 considered. Electronic comments must
                                               following information collections. More                 an approval determination for the                     be submitted on or before February 26,
                                               detailed information can be found in                    advanced planning document. Form                      2018. The https://www.regulations.gov
                                               each collection’s supporting statement                  Number: CMS–10536 (OMB control                        electronic filing system will accept
                                               and associated materials (see                           number: 0938–1268); Frequency: Yearly,                comments until midnight Eastern Time
ethrower on DSK3G9T082PROD with NOTICES




                                               ADDRESSES).                                             once, and occasionally; Affected Public:              at the end of February 26, 2018.
                                               CMS–1696 Appointment of                                 State, Local, or Tribal Governments;                  Comments received by mail/hand
                                                    Representative                                     Number of Respondents: 56; Total                      delivery/courier (for written/paper
                                               CMS–10536 Medicaid Eligibility and                      Annual Responses: 168; Total Annual                   submissions) will be considered timely
                                                    Enrollment (EE) Implementation                     Hours: 2,688. (For policy questions                   if they are postmarked or the delivery
                                                    Advanced Planning Document                         regarding this collection contact Martin              service acceptance receipt is on or
                                                    (IAPD) Template                                    Rice at 410–786–2417.)                                before that date.


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                                               61004                      Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices

                                               Electronic Submissions                                  copies total. One copy will include the               for approval. To comply with this
                                                 Submit electronic comments in the                     information you claim to be confidential              requirement, FDA is publishing notice
                                               following way:                                          with a heading or cover note that states              of the proposed collection of
                                                 • Federal eRulemaking Portal:                         ‘‘THIS DOCUMENT CONTAINS                              information set forth in this document.
                                               https://www.regulations.gov. Follow the                 CONFIDENTIAL INFORMATION.’’ The                          With respect to the following
                                               instructions for submitting comments.                   Agency will review this copy, including               collection of information, FDA invites
                                               Comments submitted electronically,                      the claimed confidential information, in              comments on these topics: (1) Whether
                                               including attachments, to https://                      its consideration of comments. The                    the proposed collection of information
                                               www.regulations.gov will be posted to                   second copy, which will have the                      is necessary for the proper performance
                                                                                                       claimed confidential information                      of FDA’s functions, including whether
                                               the docket unchanged. Because your
                                                                                                       redacted/blacked out, will be available               the information will have practical
                                               comment will be made public, you are
                                                                                                       for public viewing and posted on                      utility; (2) the accuracy of FDA’s
                                               solely responsible for ensuring that your
                                                                                                       https://www.regulations.gov. Submit                   estimate of the burden of the proposed
                                               comment does not include any
                                                                                                       both copies to the Dockets Management                 collection of information, including the
                                               confidential information that you or a
                                                                                                       Staff. If you do not wish your name and               validity of the methodology and
                                               third party may not wish to be posted,
                                                                                                       contact information to be made publicly               assumptions used; (3) ways to enhance
                                               such as medical information, your or
                                                                                                       available, you can provide this                       the quality, utility, and clarity of the
                                               anyone else’s Social Security number, or
                                                                                                       information on the cover sheet and not                information to be collected; and (4)
                                               confidential business information, such
                                                                                                       in the body of your comments and you                  ways to minimize the burden of the
                                               as a manufacturing process. Please note
                                                                                                       must identify this information as                     collection of information on
                                               that if you include your name, contact
                                                                                                       ‘‘confidential.’’ Any information marked              respondents, including through the use
                                               information, or other information that
                                                                                                       as ‘‘confidential’’ will not be disclosed             of automated collection techniques,
                                               identifies you in the body of your
                                                                                                       except in accordance with 21 CFR 10.20                when appropriate, and other forms of
                                               comments, that information will be
                                                                                                       and other applicable disclosure law. For              information technology.
                                               posted on https://www.regulations.gov.
                                                                                                       more information about FDA’s posting
                                                 • If you want to submit a comment                                                                           Evaluation of the Food and Drug
                                                                                                       of comments to public dockets, see 80
                                               with confidential information that you                                                                        Administration’s ‘Fresh Empire’
                                                                                                       FR 56469, September 18, 2015, or access
                                               do not wish to be made available to the                                                                       Multicultural Youth Tobacco
                                                                                                       the information at: https://www.gpo.gov/
                                               public, submit the comment as a                                                                               Prevention Campaign (OMB Control
                                                                                                       fdsys/pkg/FR-2015-09-18/pdf/2015-
                                               written/paper submission and in the                                                                           Number 0910–0788—Extension)
                                                                                                       23389.pdf.
                                               manner detailed (see ‘‘Written/Paper                       Docket: For access to the docket to
                                               Submissions’’ and ‘‘Instructions’’).                                                                            The 2009 Family Smoking Prevention
                                                                                                       read background documents or the                      and Tobacco Control Act (Tobacco
                                               Written/Paper Submissions                               electronic and written/paper comments                 Control Act) (Pub. L. 111–31) amended
                                                                                                       received, go to https://                              the Federal Food, Drug, and Cosmetic
                                                 Submit written/paper submissions as
                                                                                                       www.regulations.gov and insert the                    Act (the FD&C Act) to grant FDA
                                               follows:
                                                                                                       docket number, found in brackets in the
                                                 • Mail/Hand delivery/Courier (for                                                                           authority to regulate the manufacture,
                                                                                                       heading of this document, into the                    marketing, and distribution of tobacco
                                               written/paper submissions): Dockets
                                                                                                       ‘‘Search’’ box and follow the prompts                 products to protect public health and to
                                               Management Staff (HFA–305), Food and
                                                                                                       and/or go to the Dockets Management                   reduce tobacco use by minors. Section
                                               Drug Administration, 5630 Fishers
                                                                                                       Staff, 5630 Fishers Lane, Rm. 1061,                   1003(d)(2)(D) of the FD&C Act (21
                                               Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                       Rockville, MD 20852.
                                                 • For written/paper comments                                                                                U.S.C. 393(d)(2)(D)) supports the
                                               submitted to the Dockets Management                     FOR FURTHER INFORMATION CONTACT:                      development and implementation of
                                               Staff, FDA will post your comment, as                   Amber Sanford, Office of Operations,                  FDA public education campaigns
                                               well as any attachments, except for                     Food and Drug Administration, Three                   related to tobacco use. Accordingly,
                                               information submitted, marked and                       White Flint North, 10A–12M, 11601                     FDA is currently developing and
                                               identified, as confidential, if submitted               Landsdown St., North Bethesda, MD                     implementing a youth-targeted public
                                               as detailed in ‘‘Instructions.’’                        20852, 301–796–8867, PRAStaff@                        education campaign (‘Fresh Empire’) to
                                                 Instructions: All submissions received                fda.hhs.gov.                                          help prevent tobacco use among
                                               must include the Docket No. FDA–                        SUPPLEMENTARY INFORMATION: Under the                  multicultural youth and thereby reduce
                                               2014–N–2294 for ‘‘Evaluation of the                     PRA (44 U.S.C. 3501–3520), Federal                    the public health burden of tobacco. The
                                               Food and Drug Administration’s ‘Fresh                   Agencies must obtain approval from the                campaign features events,
                                               Empire’ Multicultural Youth Tobacco                     Office of Management and Budget                       advertisements on television and radio
                                               Prevention Campaign’’ Received                          (OMB) for each collection of                          and in print, digital communications
                                               comments, those filed in a timely                       information they conduct or sponsor.                  including social media, and other forms
                                               manner (see ADDRESSES), will be placed                  ‘‘Collection of information’’ is defined              of media.
                                               in the docket and, except for those                     in 44 U.S.C. 3502(3) and 5 CFR                          Evaluation is an essential
                                               submitted as ‘‘Confidential                             1320.3(c) and includes Agency requests                organizational practice in public health
                                               Submissions,’’ publicly viewable at                     or requirements that members of the                   and a systematic way to account for and
                                               https://www.regulations.gov or at the                   public submit reports, keep records, or               improve public health actions.
                                               Dockets Management Staff between 9                      provide information to a third party.                 Comprehensive evaluation of FDA’s
                                               a.m. and 4 p.m., Monday through                         Section 3506(c)(2)(A) of the PRA (44                  multicultural public education
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                                               Friday.                                                 U.S.C. 3506(c)(2)(A)) requires Federal                campaign will be used to document
                                                 • Confidential Submissions—To                         Agencies to provide a 60-day notice in                whether the intended audience is aware
                                               submit a comment with confidential                      the Federal Register concerning each                  of and understands campaign messages,
                                               information that you do not wish to be                  proposed collection of information,                   and whether campaign exposure
                                               made publicly available, submit your                    including each proposed extension of an               influences specific cognitive outcomes
                                               comments only as a written/paper                        existing collection of information,                   related to tobacco use that are targeted
                                               submission. You should submit two                       before submitting the collection to OMB               by the campaign.


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                                                                          Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices                                            61005

                                                  FDA is in the process of evaluating                  measure the effectiveness and public                  that the sample composition is similar
                                               the effectiveness of its multicultural                  health impact of the campaign. Data                   across rounds of data collection. As was
                                               youth tobacco prevention campaign                       from the outcome evaluation are being                 done during the pre-test survey, parents
                                               through an outcome evaluation study                     used to estimate awareness of and                     or guardians will be asked to provide
                                               that follows the multiple, discrete waves               exposure to the campaign among youth                  consent and their contact information
                                               of media advertising planned for the                    in target markets where the campaign is               on this form. For the fourth post-test
                                               campaign. All information collected is                  active. Data are also being used to                   survey, the 5-minute youth screener and
                                               integral to that evaluation.                            examine statistical associations between              the 1-minute parental consent will be
                                                  FDA’s Fresh Empire youth tobacco                     exposure to the campaign and                          completed by 9,869 households for a
                                               public education campaign aims to                       subsequent changes in specific                        total of 822 burden hours for youth and
                                               reduce tobacco use among youth who                      outcomes of interest, which include                   an additional 164 hours for the parents
                                               affiliate with a hip-hop peer crowd,                    knowledge, attitudes, and beliefs related             or guardians. This method will not be
                                               predominantly among African                             to tobacco use.                                       used during the fifth post-test survey,
                                               American, Hispanic, and Asian/Pacific                      FDA requests OMB approval to                       for which new participants will be
                                               Islander youth. The outcome evaluation                  extend OMB approval of the evaluation                 recruited only via social media.
                                               of the campaign consists of a pre-test                  of FDA’s multicultural youth tobacco
                                               survey of youth aged 12 to 17 before                    public education campaign and to add                     We will continue to recruit new youth
                                               campaign launch followed by a series of                 two additional waves of data collection               through social media (e.g., Facebook,
                                               post-test surveys beginning                             with existing youth in the study. To                  Instagram) as a secondary strategy to
                                               approximately 6 months after the                        accommodate these two additional                      recruit youth 13 to 17. An online
                                               campaign launch. The post-test surveys                  surveys, FDA requests approval to                     version of the screener described above
                                               are conducted among youth who                           increase the number of burden hours                   will continue to be used to identify
                                               participated in one or more surveys (the                under the existing control number. The                eligible youth. The screener will take 5
                                               embedded longitudinal cohort) and new                   fourth post-test survey will begin in July            minutes and will be completed by an
                                               participants who are recruited to make                  2018. The fifth post-test survey will                 additional 4,000 youth during each of
                                               up for attrition. Eligible youth were                   begin in February 2019. As was done in                the fourth and fifth post-test surveys, for
                                               initially 12- to 17-year-old youth who                  earlier post-test surveys, new youth will             a total of 8,000 additional youth
                                               are influenced by the hip-hop peer                      be recruited to participate to make up                respondents and 666 total additional
                                               crowd. Youth in the embedded                            for attrition.                                        burden hours. The new total number of
                                               longitudinal cohort may reach the age of                   A total of 2,100 youth will complete               participants for the youth online post-
                                               18 over the course of the evaluation.                   questionnaires for the fourth post-test               test screener will be 32,000 and the total
                                                  To date, the pre-test and two post-test              survey, and the same number will                      burden will be 2,666 hours. This
                                               surveys have been conducted. A third                    complete questionnaires for the fifth                 includes the originally-approved 24,000
                                               post-test survey is currently underway.                 post-test survey. These respondents will              participants and 2,000 burden hours.
                                               Information has been collected about                    include existing youth who have                          As was done previously, eligible
                                               youth awareness of and exposure to                      participated in one or more surveys                   youth aged 13 to 14 who complete the
                                               campaign events and advertisements                      previously (‘‘Longitudinal Cohort’’) and              online screener will be asked to provide
                                               and about tobacco-related knowledge,                    new youth recruited via a mail-based                  their parents’ or guardians’ contact
                                               attitudes, beliefs, intentions, and use.                screener or social media ads (‘‘Cross-                information to provide parental consent
                                               Information has also been collected on                  Sectional Refresher Sample’’). Based on               for the main survey. The process of
                                               demographic variables including age,                    earlier response rates and longitudinal               parents and guardians providing
                                               sex, race/ethnicity, grade level, and                   respondents aging out of the eligibility              consent for eligible youth will take
                                               primary language.                                       criteria (over the age of 18), we expect              approximately 1 minute. For the fourth
                                                  All information is being collected                   to need to recruit a larger number of                 and fifth post-test surveys, we estimate
                                               through in-person and web-based                         cross-sectional respondents than in                   that an additional 700 adults will be
                                               questionnaires. Youth respondents were                  previous waves. We estimate that                      contacted to provide consent for eligible
                                               recruited from two sources: (1) A                       approximately 600 longitudinal youth                  youth for a total of 11 additional burden
                                               sample drawn from 30 U.S. media                         and 1,500 cross-sectional youth will                  hours. Added to the original 6,000
                                               markets gathered using an address-                      participate in each of the fourth and                 parents and 100 burden hours, the total
                                               based postal mail sampling of U.S.                      fifth post-test surveys. With an                      number of parental online screener and
                                               households for the outcome evaluation,                  estimated burden of 45 minutes per                    consents will be 6,700 and the total
                                               and (2) targeted social media (e.g.,                    respondent, this adds 450 hours for                   burden will be 111 hours.
                                               Facebook).                                              longitudinal respondents and 1,125
                                                  This study is being conducted in                     hours for cross-sectional respondents for                With these additions, the estimated
                                               support of the provisions of the Tobacco                each of the fourth and fifth post-test                number of respondents/responses for all
                                               Control Act that require FDA to protect                 evaluation surveys.                                   waves of data collection for the study is
                                               the public health and to educate the                       A mail-based screener was one of the               107,743, and the total burden is
                                               population about the risks and potential                methods used to identify eligible youth               estimated at 15,135 hours—an increase
                                               risks of tobacco use. The information                   for the pre-test survey. This method will             of 4,813 hours from the last approval.
                                               being collected is necessary to inform                  be used during the fourth post-test                      FDA estimates the burden of this
                                               FDA’s efforts towards these goals and to                survey to recruit new youth to ensure                 collection of information as follows:
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                                               61006                             Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices

                                                                                                          TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                               Number of re-                                          Average bur-
                                                                                                                                           Number of re-                                   Total annual
                                                    Type of respondent                                    Activity                                              sponses per                                            den per re-              Total hours
                                                                                                                                            spondents                                       responses
                                                                                                                                                                 respondent                                              sponse

                                               Youth aged 12 to 17 in the                 Mail Screener and Consent                               13,816                            1                  13,816                     0.0833               1,151
                                                 United States.                             Process—Pre-test out-
                                                                                            come survey.
                                                                                          Mail Screener and Consent                                 9,869                            1                  9,869                     0.0833                 822
                                                                                            Process—Post-test out-
                                                                                            come survey.
                                               Adults 18 and older in the                 Mail Screener and Consent                               13,816                             1                13,816                      0.0166                 229
                                                 United States.                             Process—Pre-test out-
                                                                                            come survey.
                                                                                          Online Screener and Con-                                       520                         1                      520                   0.0166                      9
                                                                                            sent Process—Pre-test
                                                                                            outcome survey.
                                                                                          Mail Screener and Consent                                 9,869                            1                  9,869                     0.0166                 164
                                                                                            Process—Post-test out-
                                                                                            come survey.
                                                                                          Online Screener and Con-                                  6,700                            1                  6,700                     0.0166                 111
                                                                                            sent Process—Post-test
                                                                                            outcome survey.
                                               Multicultural Youth aged 12                Pre-test outcome evaluation                               2,194                           1                   2,194                          0.5             1,097
                                                 to 17 in select media                      survey.
                                                 markets.
                                               Longitudinal Cohort, age 13                First post-test evaluation                                1,722                            1                  1,722                         0.75             1,292
                                                 to 18 years.                                survey.
                                                                                          Second post-test evaluation                               1,752                            1                  1,752                         0.75             1,314
                                                                                             survey.
                                                                                          Third post-test evaluation                                1,365                           1                   1,365                         0.75             1,024
                                                                                             survey.
                                                                                          Fourth post-test evaluation                                    600                         1                      600                      0.75                450
                                                                                             survey.
                                                                                          Fifth post-test evaluation                                     600                         1                      600                      0.75                450
                                                                                             survey.
                                               Cross-Sectional Refresher                  First post-test evaluation                                  682                           1                     682                        0.75                512
                                                 Sample, age 13 to 17                        survey.                                                  503                           1                     503                        0.75                377
                                                 years.                                   Second post-test evaluation                                 735                           1                     735                        0.75                551
                                                                                             survey.                                                1,500                           1                   1,500                        0.75              1,125
                                                                                          Third post-test evaluation                                1,500                           1                   1,500                        0.75              1,125
                                                                                             survey.
                                                                                          Fourth post-test evaluation
                                                                                             survey.
                                                                                          Fifth post-test evaluation
                                                                                             survey.
                                               Multicultural youth aged 13                Pre-test online screener .....                           8,000                            1                  8,000                      0.0833                 666
                                                to 17 in the select media                 Post-test online screener ...                           32,000                            1                 32,000                      0.0833               2,666
                                                markets recruiting through
                                                social media and online
                                                panels.

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


                                                 Dated: December 19, 2017.                                             DEPARTMENT OF HEALTH AND                                               STRIVERDI RESPIMAT and is
                                               Leslie Kux,                                                             HUMAN SERVICES                                                         publishing this notice of that
                                               Associate Commissioner for Policy.                                                                                                             determination as required by law. FDA
                                                                                                                       Food and Drug Administration                                           has made the determination because of
                                               [FR Doc. 2017–27712 Filed 12–22–17; 8:45 am]
                                                                                                                       [Docket No. FDA–2015–E–2582]                                           the submission of an application to the
                                               BILLING CODE 4164–01–P
                                                                                                                                                                                              Director of the U.S. Patent and
                                                                                                                       Determination of Regulatory Review                                     Trademark Office (USPTO), Department
                                                                                                                       Period for Purposes of Patent                                          of Commerce, for the extension of a
                                                                                                                       Extension; STRIVERDI RESPIMAT                                          patent which claims that human drug
ethrower on DSK3G9T082PROD with NOTICES




                                                                                                                                                                                              product.
                                                                                                                       AGENCY:            Food and Drug Administration,
                                                                                                                       HHS.                                                                   DATES:  Anyone with knowledge that any
                                                                                                                       ACTION:        Notice.                                                 of the dates as published (in the
                                                                                                                                                                                              SUPPLEMENTARY INFORMATION section) are
                                                                                                                       SUMMARY:   The Food and Drug                                           incorrect may submit either electronic
                                                                                                                       Administration (FDA) has determined                                    or written comments and ask for a
                                                                                                                       the regulatory review period for                                       redetermination by February 26, 2018.


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Document Created: 2017-12-23 03:08:19
Document Modified: 2017-12-23 03:08:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by February 26, 2018.
ContactAmber 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 Citation82 FR 61003 

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