Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices 9067 

1https://www.fda.gov/tobacco-products/research/ 

research-priorities. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0132] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food and Drug 

Administration’s Study of How 

Consumers Use Flavors To Make 

Inferences About Electronic Nicotine 

Delivery System Product Qualities and 

Intentions To Use (Phase 2) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing that a proposed 

collection of information has been 

submitted to the Office of Management 

and Budget (OMB) for review and 

clearance under the Paperwork 

Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by March 21, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The title 

of this information collection is ‘‘Food 

and Drug Administration’s Study of 

How Consumers Use Flavors to Make 

Inferences About Electronic Nicotine 

Delivery System Product Qualities and 

Intentions to Use (Phase 2).’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Food and Drug Administration’s 

Study of How Consumers Use Flavors to 

Make Inferences About Electronic 

Nicotine Delivery System (ENDS) 

Product Qualities and Intentions to Use 

(Phase 2) 

OMB Control Number 0910—NEW 

ENDS, also called electronic 

cigarettes, e-cigarettes, and vaporizers, 

are deemed tobacco products and fall 

under FDA’s regulatory scope. FDA has 

the authority under the Family Smoking 

Prevention and Tobacco Control Act 

(Pub. L. 111–31, H.R. 1256) to regulate 

and restrict the marketing of tobacco 

products. However, given the recency of 

ENDS products to the market, limited 

research exists to inform the regulation 

of certain aspects of their marketing. 

Research to understand ‘‘marketing 

influences on youth experimentation, 

initiation, use and cessation of tobacco 

products’’ is a regulatory priority for the 

FDA Center for Tobacco Products 

(CTP).1

Flavors are a unique and important 

aspect of ENDS. ENDS use a liquid (‘‘eliquid’’ or ‘‘e-juice’’) that can span a 

diverse range of flavors, from tobacco 

flavor, menthol, mint, fruit flavors, nonfruit sweet flavors (e.g., cre`me brulee, 

gummi bears), spices (e.g., cinnamon, 

vanilla), alcohol (e.g., strawberry 

daiquiri, bourbon, Irish cream), and 

‘‘concept flavors.’’ Flavors are a 

regulatory area of interest, and FDA has 

issued an advance notice of proposed 

rulemaking (Docket No. FDA–2017–N– 

6565) ‘‘to obtain information related to 

the role that flavors play in tobacco 

products,’’ with a specific interest in 

how flavors may spur youth product 

initiation. 

This study of ‘‘How Consumers Make 

Inferences About ENDS’’ is voluntary 

research. The primary goal of the study 

is to understand whether flavor-related 

imagery, descriptors, and flavor name 

modifiers affect product appeal, 

curiosity about the product, interest in 

using the product, and product 

perceptions among youth and young 

adults. The project will examine three 

features identified in the research team’s 

prior work: The use of flavor-related 

imagery, the use of flavor descriptors 

(e.g., ‘‘cool,’’ ‘‘fresh’’), and the use of 

flavor name modifiers (e.g., Cherry 

Crush). 

The study will collect data from two 

groups of consumers: 2,500 youth (aged 

13 to 17 years old) and 2,500 young 

adults (aged 18 to 24 years old). The 

sample will be stratified by ENDS and 

cigarette use, so that 625 participants in 

each age group will be (a) noncigarette 

and non-ENDS users (N=625), (b) 

cigarette users only (N=625), (c) ENDS 

users only (N=625), and (d) dual ENDS 

and cigarette users (N=625). Participants 

will participate in a repeated measure 

experiment in which they will be asked 

to view five ads and report their liking 

of the ad, curiosity about using the 

product (an important precursor to use), 

and interest in using the product. 

Participants will also report additional 

perceptions of product qualities. This 

study is not meant to inform or guide 

other public health agencies’ policies 

and messaging regarding the role of 

flavors in ENDS. This study will 

contribute to scientific knowledge 

regarding the use of flavors in ENDS 

marketing. Thus, other agencies may 

learn about the findings from our study 

through manuscripts published in peerreviewed journals, for example, but this 

study is not intended to specifically 

influence their policies and messaging. 

Study Overview: In this study, youth 

noncigarette and non-ENDS users, 

current cigarette smokers, ENDS only 

users, and dual users of ENDS and 

cigarettes, as well as young adult 

noncigarette and non-ENDS users, 

current cigarette smokers, ENDS only 

users, and dual users of ENDS and 

cigarettes will be recruited from two 

existing internet online panels and 

screened for inclusion into the study. 

Youth will also be recruited through 

their parent panelists (parents who are 

members of the existing online panel) 

and screened for inclusion into the 

study. 

All recruited participants must 

complete a double opt-in procedure, 

and parents of youth panelists must 

consent for their child to be on the 

online panel. For this study, youth will 

provide assent and young adults will 

provide consent to participate in the 

surveys. Per institutional review board 

approval, parental consent was waived 

given that this study is minimal risk, 

documentation of parental consent 

would create an identifier, and 

verification of parental consent is 

difficult and could potentially bias the 

sample towards participants who have 

parents readily available and able to 

consent. The survey platform can detect 

and prevent duplicate responses by 

scanning for duplicate cookies and 

internet protocol (IP) addresses. 

Participants who meet the inclusion 

criteria will be randomized to view five 

ads across five conditions to report their 

liking of the ad, curiosity about using 

the product (an important precursor to 

use), and interest in using the product. 

The order of ad presentation will be 

randomized. These procedures will 

minimize order effects as well as the 

likelihood of a demand characteristic in 

which a participant guesses the purpose 

of the experiment and intentionally or 

unintentionally alters their response. 

Participants will receive a small 


lotter on DSK11XQN23PROD with NOTICES1
9068 Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices 

incentive as a token of appreciation in 

exchange for their survey participation. 

Study outcomes include comparisons 

to assess the extent to which presence 

or absence of a flavor-representing 

image, name modifier, or descriptor will 

be associated with increased or 

decreased (a) product appeal, (b) 

curiosity about the product, (c) interest 

in using the product, and (d) increased 

positive product perceptions compared 

to a control condition ad (without or 

with flavor features). 

In the Federal Register of March 3, 

2021 (86 FR 12468), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received nine 

comments, four of which were PRArelated. 

(Comment 1) One commenter 

supports FDA’s proposed collection of 

information and stated that research on 

the advertising of flavored e-cigarettes 

and its impact on the perceptions of 

nonusers, e-cigarette users, cigarette 

smokers, and dual users is important. 

The commenter also noted that the 

proposed study length is acceptable and 

comprises typical burden for 

respondents in this type of research. 

(Response) FDA agrees with this 

comment and believes the study will 

contribute to our understanding of how 

consumers interpret flavor features on 

product labeling to make inferences 

about ENDS product qualities and 

intentions to use. We also believe the 

study’s burden estimate aligns with 

previous research studies of this kind. 

(Comment 2) One commenter stated 

that FDA should research the role of 

flavored noncombustible tobacco 

products in converting adult smokers 

from cigarettes. 

(Response) This study focuses on the 

appeal of the selected advertising tactics 

on youth and young adults. Expanding 

the sample to include older adults (or 

all adults) is beyond the scope of the 

study. 

(Comment 3) FDA received a 

comment suggesting the Agency 

consider separating underage 

individuals from those who are of legal 

age to purchase tobacco products. 

(Response) The aim of this study 

centers around appeal of the selected 

advertising tactics on youth and young 

adults. The selection of the advertising 

tactics to be studied was grounded in 

research conducted when the Federal 

legal age to purchase tobacco was 18 

years of age. Thus, we intend to sample 

youth aged 13–17 and young adults 

aged 18–24. However, as resources 

allow, we will plan to conduct 

supplementary analyses to account for 

the new Federal legal age (e.g., under 21 

years vs. 21+ years). 

(Comment 4) FDA received a 

comment suggesting the Agency expand 

the sample to include tobacco users 

aged 25 and older. 

(Response) This study focuses on 

appeal of the selected advertising tactics 

on youth and young adults. Expanding 

the sample to include older adults is 

beyond the scope of the study. 

(Comment 5) FDA received a 

comment suggesting the Agency include 

a range of flavor name modifiers. 

(Response) The flavor name modifiers 

used in the study were selected based 

on careful review of prior research 

analyzing the tactics that ENDS 

companies use to advertise flavor. Our 

assessment is that the selected name 

modifiers are consistent with that 

research. 

(Comment 6) One commenter stated 

that using generalized data to support 

premarket determinations for specific 

products on specific applications is 

scientifically inappropriate. The 

commenter stated that the public should 

have the opportunity to provide 

comment on any proposed regulations. 

Additionally, the commenter stated any 

proposed de facto category-wide 

restriction on the manufacture, 

marketing, and distribution of tobacco 

products should undergo the 

appropriate notice and comment 

rulemaking procedures. 

(Response) The primary goal of the 

study is to understand whether flavorrelated imagery, descriptors, and flavor 

name modifiers affect product appeal, 

curiosity about the product, interest in 

using the product, and product 

perceptions among youth and young 

adults. This study will not produce 

product-specific data; thus, it would not 

form the sole basis for any premarket 

determinations, but the results could be 

taken into consideration more broadly 

as part of premarket review. 

Additionally, this study might inform 

FDA’s thinking regarding possible 

rulemaking but it will not provide sole 

support for any rulemaking. FDA’s 

consideration of any future rulemaking 

would follow the appropriate notice and 

comment rulemaking procedures, which 

would include an explanation of the 

scientific basis for the proposed rule. 

The scientific basis would consider all 

relevant science, not just the results of 

this one study. Lastly, this study does 

not indicate FDA’s intent to propose 

such a rule. The intent is to advance 

scientific knowledge broadly regarding 

the use of flavors in ENDS marketing. 

(Comment 7) FDA received a 

comment expressing concern about 

exposing youth to ENDS 

advertisements. 

(Response) Our study protocol 

includes measures to minimize risk of 

youth exposure to ENDS 

advertisements. Before participating in 

the study, participants are informed that 

they will be shown five ENDS 

advertisements. All participants are free 

to stop participation at any time and for 

any reason. At the end of the survey, 

participants will view a ‘‘debrief’’ 

screen containing information about the 

risks of ENDS and references to FDA 

and others’ ENDS education and 

prevention campaigns. 

The Johns Hopkins Bloomberg School 

of Public Health’s Institutional Review 

Board reviewed and approved this 

study. We amended our recruitment 

process to further address this concern. 

We will also recruit youth aged 13–17 

through their parent panelists (parents 

who are members of an existing online 

panel). Recruitment emails will be sent 

to parent panelists inviting them to have 

their child aged 13–17 participate in the 

study. Parents who are interested in 

having their child participate can have 

their child click the survey link in the 

recruitment email. This means that 

youth will be recruited to participate 

through two ways. First, we will recruit 

current youth panel members. Second, 

we will recruit youth through their 

parent panelists (parents who are 

members of the existing online panel). 

(Comment 8) FDA received a 

comment expressing that the study does 

not provide data that would inform 

‘‘conclusions regarding the role of 

flavors in youth attractiveness’’ and that 

the study does not distinguish between 

characterizing and noncharacterizing 

flavors. 

(Response) The objective of this study 

is to examine the effect of flavor 

advertising tactics on consumer product 

perceptions and intentions to use, not 

the effect of actual flavors and flavor 

use. Therefore, this comment is out of 

scope for the proposed study. 

(Comment 9) FDA received a 

comment inquiring about whether ‘‘the 

survey will representatively sample/ 

oversample for certain subpopulations— 

with a particular lens on race/ethnicity 

and other priority populations.’’ 

(Response) The current sample was 

designed with a primary focus of 

sampling adequate numbers of youth 

and young adults across a variety of 

cigarette and ENDS use statuses 

(noncigarette and non-ENDS users; 

cigarette users only; ENDS users only; 

dual ENDS and cigarette users), and we 

are not able to do additional 

oversampling given that some of these 

groups are of low frequency in the 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices 9069 

general population. However, we will be 

able to identify how our sample 

compares to national data, and our data 

will be weighted to be proportionally 

reflective of the U.S. population by race/ 

ethnicity. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Participant subgroup Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

No. to read the survey invitation 

Youth (aged 13–17) .......................... 125,000 1 125,000 0.016 (1 minute) ............................... 2,084 

Young adults (aged 18–24) .............. 125,000 1 125,000 0.016 (1 minute) ............................... 2,084 

Total ........................................... 250,000 ........................ ........................ ........................................................... 4,168 

No. to complete the consent and screener 

Youth (aged 13–17) .......................... 3,750 1 3,750 0.116 (7 minutes) ............................. 438 

Young adults (aged 18–24) .............. 3,750 1 3,750 0.116 (7 minutes) ............................. 438 

Total ........................................... 7,500 ........................ ........................ ........................................................... 876 

No. to complete main study 

Youth (aged 13–17) .......................... 2,500 1 2,500 0.333 (20 minutes) ........................... 834 

Young adults (aged 18–24) .............. 2,500 1 2,500 0.333 (20 minutes) ........................... 834 

Total .................................... 5,000 ........................ ........................ ........................................................... 1,668 

Total .................................................. ........................ ........................ ........................ ........................................................... 6,712 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA’s burden estimate is based on 

prior experience with research that is 

similar to this proposed study (OMB 

control number 0910–0848). Applying 

assumptions from previous experience 

in conducting similar studies, 

approximately 250,000 respondents 

from an internet panel will be recruited 

via an email invitation, which is 

estimated to take 1 minute to read and 

respond. An estimated 7,500 (3,750 

youth and 3,750 young adults) 

respondents will provide assent and 

consent and be screened to yield the 

desired sample size of 5,000 total (2,500 

youth and 2,500 young adults) 

participants. The consent/screening 

process is estimated to take an average 

of 7 minutes per respondent. 

Participants that qualify for the study 

will be automatically directed to begin 

the online survey, which is estimated to 

take an average of 20 minutes per 

respondent. 

The total estimated burden for the 

data collection is 6,712 hours. 

Dated: February 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03387 Filed 2–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

Section 2112(b)(2) of the Public Health 

Service (PHS) Act, as amended. While 

the Secretary of HHS is named as the 

respondent in all proceedings brought 

by the filing of petitions for 

compensation under the Program, the 

United States Court of Federal Claims is 

charged by statute with responsibility 

for considering and acting upon the 

petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 

Court, United States Court of Federal 

Claims, 717 Madison Place NW, 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

Program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 08N146B, 

Rockville, Maryland 20857; (301) 443– 

6593, or visit our website at: https://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the United States Court of Federal 

Claims and to serve a copy of the 

petition to the Secretary of HHS, who is 

named as the respondent in each 

proceeding. The Secretary has delegated 

this responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the Table) set forth at 42 CFR 

100.3. This Table lists for each covered 

childhood vaccine the conditions that 

may lead to compensation and, for each 

condition, the time period for 

occurrence of the first symptom or 


lotter on DSK11XQN23PROD with NOTICES1