Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices 37817 

FDA receives reports through the 

MedWatch website (https://

www.fda.gov/Safety/MedWatch/ 

HowToReport/default.htm), which are 

then entered into the FDA Adverse 

Event Reporting System for subsequent 

analysis. Because the volume of reports 

is large and because reporting entities 

(product manufacturers and the 

professional or lay public) need only 

suspect a possible link between product 

exposure and an adverse event, FDA 

employs specific tools and strategies to 

assess postmarket safety reports and 

potential signals that arise from review 

of these reports. The process for receipt 

and assessment of such postmarket 

safety information is referred to as 

pharmacovigilance. 

FDA has a specific regulatory 

mandate to perform pediatric 

pharmacovigilance and to present or 

make available the results of such 

pediatric pharmacovigilance to the 

Pediatric Advisory Committee. 

II. Topics for Discussion at the Public 

Workshop 

In this workshop, FDA will gather 

information on the latest developments 

in pediatric pharmacovigilance from the 

perspective of various stakeholders and 

expand the conversation to include the 

utility and challenges of emerging 

pharmacovigilance tools, including 

specific challenges associated with 

pediatric data tools. 

III. Participation in the Public 

Workshop 

Registration: Persons interested in 

attending this public workshop must 

register online at https://

www.eventbrite.com/e/advancing-thedevelopment-of-pediatric-therapeutics5-adept5-tickets-46654530958 by 

Thursday, September 6, 2018, midnight 

Eastern Time. Please provide complete 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone. Onsite 

registration will not be available. 

Registration for onsite participation or 

via webcast is free and based on space 

availability, with priority given to early 

registrants. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. 

If you need special accommodations 

due to a disability, please contact 

Denise Pica-Branco (denise.picabranco@

fda.hhs.gov) or Meshaun Payne 

(meshaun.payne@fda.hhs.gov) no later 

than Thursday, September 6, 2018. 

Streaming Webcast of the Public 

Workshop: Webcast information will be 

provided after participants have 

registered for the workshop. If you have 

never attended a Connect Pro event 

before, test your connection at https://

collaboration.fda.gov/common/help/en/ 

support/meeting_test.htm. To get a 

quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. 

FDA has verified the website 

addresses in this document, as of the 

date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

Dated: July 27, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16524 Filed 8–1–18; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 


daltland on DSKBBV9HB2PROD with NOTICES
37818 Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices 

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, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

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 Webbased 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 (crosssectional) 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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices 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

Respondent type and activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

Venue Owners and Managers .............................. 660 1 660 0.083 (5 minutes) ......... 55 

General Population: Pilot test of Procedures in 

Bars.

27 1 27 0.083 (5 minutes) ......... 2 

General population—outcome screener (in person).11,239 1 11,239 0.083 (5 minutes) ......... 933 

General population—outcome screener (social 

media).

3,539 1 3,539 0.083 (5 minutes) ......... 294 

LGBT young adults outcome baseline (social 

media).

263 1 263 0.500 (30 minutes) ....... 132 

LGBT young adults outcome baseline (in person) 788 1 788 0.500 (30 minutes) ....... 394 

LGBT young adults outcome follow-up questionnaire (social media).1,752 1 1,752 0.667 (40 minutes) ....... 1,169 

LGBT young adults outcome follow-up questionnaire (in person).5,378 1 5,378 0.667 (40 minutes) ....... 3,587 

Totals ............................................................. ........................ ........................ ........................ ....................................... 6,566 

1There 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 


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