[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)]
[Notices]
[Pages 37817-37819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16538]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2126]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food and Drug Administration's Research and Evaluation 
Survey for the Public Education Campaign on Tobacco Among the Lesbian 
Gay Bisexual Transgender Community

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 FDA's Research and Evaluation Survey for 
the Public Education Campaign on Tobacco (RESPECT) among the Lesbian 
Gay Bisexual Transgender (LGBT).

DATES: Submit either electronic or written comments on the collection 
of information by October 1, 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 October 1, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 1, 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.

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-2015-N-2126 for ``Food and Drug Administration's (FDA's) Research 
and Evaluation Survey for the Public Education Campaign on Tobacco 
(RESPECT) among LGBT.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those

[[Page 37818]]

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.gpo.gov/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.

Food and Drug Administration's (FDA's) Research and Evaluation Survey 
for the Public Education Campaign on Tobacco (RESPECT) Among LGBT

OMB Control Number 0910-0808-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. In May 2016, FDA began implementing a public 
education campaign to help prevent and reduce tobacco use among LGBT 
young adults and thereby reduce the public health burden of tobacco. 
The campaign continues to be implemented in 12 U.S. cities and features 
events, television and radio and print advertisements, digital 
communications, including videos, social media, and other forms of 
media. For the purpose of this notice, these campaign elements will be 
referred to as ``advertisements'' or ``ads.''
    In support of the provisions of the Tobacco Control Act that 
require FDA to protect the public health and to reduce tobacco use, FDA 
requests OMB approval to collect information needed to evaluate FDA's 
campaign to reduce tobacco use among LGBT young adults. Comprehensive 
evaluation of FDA's public education campaigns is needed to ensure 
campaign messages are effectively received, understood, and accepted by 
those for whom they are intended. Evaluation is an essential 
organizational practice in public health and a systematic way to 
account for and improve public health actions.
    To evaluate the effectiveness of FDA's RESPECT at reducing tobacco 
use among LGBT young adults aged 18 to 24, FDA contracted with RTI 
International (RTI) to conduct Web-based surveys with the target 
population in the 12 campaign cities and 12 comparison cities. The 
surveys include measures of tobacco-related knowledge, attitudes, 
beliefs, intentions, and use as well as measures of audience awareness 
of and exposure to campaign events and advertisements. The voluntary 
surveys also collect information on demographic variables, including 
sexual orientation, age, sex, race/ethnicity, education, and primary 
language. Baseline data collection for RESPECT was conducted between 
February and May 2016. Four subsequent waves of data collection were 
conducted with new (cross-sectional) and returning (longitudinal) 
respondents. This design facilitated analysis of relationships between 
individuals' exposure to campaign activities and baseline to follow-up 
changes in outcomes of interest between campaign and comparison cities. 
Information collection for baseline and the first four follow-ups was 
reviewed and approved by OMB.
    FDA will continue to implement RESPECT in 12 U.S. cities through 
April 2019. To complete the evaluation of RESPECT, FDA is requesting an 
extension of the previously approved information collection in order to 
conduct two additional waves of data collection with the target 
population. The proposed sixth and seventh waves of data collection 
(i.e., fifth and sixth follow-ups after baseline) will coincide with 
the official end of the campaign, and will serve as an assessment of 
the campaign at completion. Continued evaluation is necessary in order 
to determine the campaign's impact on outcomes of interest.
    As in previous waves, new and returning survey respondents will be

[[Page 37819]]

invited to complete the online questionnaire. New (or cross-sectional) 
respondents will be recruited at LGBT social venues and via social 
media (i.e., Facebook and Twitter). In-person recruitment will take 
place in a variety of LGBT venues. The owners or managers of potential 
recruitment sites will be asked a series of questions to determine the 
appropriateness of its clientele for participation in the study. For 
the fifth and sixth follow-ups, an estimated 60 new venues (20 
annualized) will be assessed at 5 minutes per assessment, for an 
additional 5 hours (1.67 annualized). A total of 1,980 venues (660 
annualized) will be assessed during the evaluation study, for a total 
of 165 hours (55 annualized).
    Our goal is to recruit 75 percent of the sample via intercept 
interviews and 25 percent via social media. To obtain the target number 
of completed fifth and sixth follow-up questionnaires, an additional 
11,904 adults (3,968 annualized) recruited in person and 2,736 adults 
(912 annualized) recruited via social media will complete screening 
questionnaires. For the entire evaluation study, a total of 33,717 
adults (11,239 annualized) recruited in person will complete screening 
questionnaires along with 10,617 adults (3,539 annualized) recruited 
via social media. The estimated burden to complete the screening 
questionnaire is 5 minutes (0.083 hour), for a total of 2,799 hours 
(933 annualized) for in-person recruits and 881 hours (294 annualized) 
for social media recruits.
    Based on analysis of response rates from prior waves of data 
collection, we expect 65 percent of intercept respondents will be 
deemed eligible and 50 percent of those will complete the fifth follow-
up questionnaire. We expect 30 percent of those recruited via social 
media will be deemed eligible and complete the fifth follow-up 
questionnaire. Lastly, we expect 50 percent of returning (or 
longitudinal) respondents to complete the fifth and sixth follow-up 
questionnaires. We estimate that approximately 2,100 new respondents 
(700 annualized) and 6,678 returning (2,226 annualized) respondents 
will complete the fifth and sixth follow-up questionnaires, for a total 
of 8,778 responses (2,926 annualized).
    OMB previously approved 3,156 (1,052 annualized) respondents 
recruited via social media and 9,456 (3,152 annualized) respondents 
recruited in person to complete the first four follow-up 
questionnaires. Adding the fifth and sixth follow-ups brings the total 
estimated number of follow up questionnaires completed by social media 
recruits to 5,256 (1,752 annualized) and by in-person recruits to 
16,134 (5,378 annualized). At 40 minutes per completed questionnaire, 
the total burden is 3,507 hours (1,169 annualized) for social media 
respondents and 10,761 hours (3,587 annualized) for in-person 
respondents.
    OMB also previously approved 393 hours (approximately 132 
annualized) for social media respondents and 1,182 hours (394 
annualized) for in-person respondents to complete baseline 
questionnaires. OMB also approved the pilot test of procedures in bars 
(6 hours [2 annualized]). As these study components are complete, the 
corresponding burden will not change. Lastly, the original study design 
included a media tracking component, which included a burden of 414 
hours (138 annualized) for completing a 5-minute screening 
questionnaire and 999 hours (333 annualized) for completing the media 
tracking questionnaire. However, this component was dropped from the 
study; hence, the related burden has been deducted from the total study 
burden.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                  Number of
 Respondent type and activity     Number of     responses per    Total annual    Average burden     Total hours
                                 respondents      respondent       responses      per response
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Venue Owners and Managers....             660               1              660  0.083 (5                      55
                                                                                 minutes).
General Population: Pilot                  27               1               27  0.083 (5                       2
 test of Procedures in Bars.                                                     minutes).
General population--outcome            11,239               1           11,239  0.083 (5                     933
 screener (in person).                                                           minutes).
General population--outcome             3,539               1            3,539  0.083 (5                     294
 screener (social media).                                                        minutes).
LGBT young adults outcome                 263               1              263  0.500 (30                    132
 baseline (social media).                                                        minutes).
LGBT young adults outcome                 788               1              788  0.500 (30                    394
 baseline (in person).                                                           minutes).
LGBT young adults outcome               1,752               1            1,752  0.667 (40                  1,169
 follow-up questionnaire                                                         minutes).
 (social media).
LGBT young adults outcome               5,378               1            5,378  0.667 (40                  3,587
 follow-up questionnaire (in                                                     minutes).
 person).
                              ----------------------------------------------------------------------------------
    Totals...................  ..............  ...............  ..............  ................           6,566
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    To accommodate the additional waves of data collection, FDA 
requests approval to increase the number of burden hours under the 
existing control number. The previous number of approved responses was 
53,967 (17,989 annualized), and the previous burden was 14,031 hours 
(4,677 annualized). The fifth and sixth follow-ups add 23,478 responses 
(7,826 annualized), which include responses to new venues assessments, 
screening questionnaires, and the follow-up questionnaires, for a total 
of 7,074 additional burden hours (2,357 annualized). Removing the media 
tracking component deducts 6,507 responses (2,169 annualized) and 1,413 
burden hours (471 annualized). The totals for the entire evaluation 
study are increasing by 16,971 responses (5,657 annualized) and 5,661 
hours (1,887 annualized) for a new total of 70,938 responses (23,646 
annualized) and 19,692 burden hours (approximately 6,566 annualized).

    Dated: July 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16538 Filed 8-1-18; 8:45 am]
 BILLING CODE 4164-01-P