12468 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

regulations enable a common 

understanding of the regulatory process 

by describing requirements to be 

followed by drug manufacturers, 

applicants, and FDA. Under part 211 (21 

CFR part 211; see 21 CFR 211.94(e)(1)), 

specific requirements for medical gas 

containers and closures are also found 

in the regulations. Finally, the 

information collection also supports 

regulations codified under parts 610 and 

680 (21 CFR parts 610 and 680), which 

reference certain CGMP regulations in 

part 211 (see §§ 610.12(g), 610.13(a)(2), 

610.18(d), 680.2(f), and 680.3(f)). 

These regulations set forth 

information collection requirements that 

allow FDA to meet its public health 

protection responsibilities. Products 

that fail to comply with CGMP 

requirements may be rendered 

adulterated under section 501(a)(2)(B) of 

the FD&C Act. To demonstrate that their 

products comply with the requirements 

of section 501(a)(2)(B), API 

manufacturers must maintain CGMP 

records; therefore, we have counted 

them among respondents who incur 

burden for the information collection. In 

the table below, we have included an 

additional 1,260 respondents to reflect 

API manufacturers not included in our 

previous submission for renewal. 

To assist respondents with the 

information collection requirements for 

medical gases, we developed a draft 

guidance for industry entitled ‘‘Current 

Good Manufacturing Practice for 

Medical Gases.’’ This guidance, when 

finalized will discuss our 

recommendations regarding compliance 

with applicable requirements found in 

the regulations as they apply to these 

products. The guidance is available for 

download from our internet site at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/current-goodmanufacturing-practice-medical-gases. 

We believe the recommendations, if 

followed, will help respondents focus 

their information collection activities 

most efficiently with regard to 

demonstrating regulatory compliance. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN—APIS, FINISHED PHARMACEUTICALS, AND MEDICAL GASES 1 2

Section 501(a)(2)(B) of the FD&C 

Act; parts 210 and 211 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records Average burden per recordkeeping Total hours 

CGMP API Manufacturers ................ 1,260 256 322,560 0.82 (49.2 minutes) .......................... 264,499 

CGMP Finished Pharmaceuticals 

Manufacturers (excludes medical 

gases).

3,270 299 977,730 0.64 (38 minutes) ............................. 625,747 

CGMP Medical Gases Manufacturers.2,284 280 639,520 0.62 (37 minutes) ............................. 396,502 

Total ........................................... ........................ ........................ 1,939,810 ........................................................... 1,286,748 

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

2 Records and burden per activity have been averaged and rounded. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 29,073 hours and 

1,762 records annually for CGMP for 

finished pharmaceutical manufacturers, 

excluding those manufacturers of 

medical gases. Our estimated burden for 

the information collection also reflects 

an overall decrease of 486 hours and 

1,574 records annually for medical gas 

manufacturers. Our inclusion of API 

manufacturers in this collection 

represents an addition of 264,499 hours 

and 322,560 records prepared. 

Dated: February 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04380 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0132] 

Agency Information Collection 

Activities; Proposed Collection; 

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 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 and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on FDA’s 

investigation of how consumers use 

flavors to make inferences about 

Electronic Nicotine Delivery System 

(ENDS) product qualities and intentions 

to use. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 3, 2021. 

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 May 3, 2021. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 3, 2021. 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:// 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 12469 

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

research-priorities. 

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– 

2021–N–0132 for ‘‘Food and Drug 

Administration’s Investigation of How 

Consumers Use Flavors to Make 

Inferences About Electronic Nicotine 

Delivery System (ENDS) Product 

Qualities and Intentions to Use (Phase 

2).’’ 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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240-402-7500. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), 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 

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 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 (e.g., ‘‘Heliomilk’’, 

‘‘Sungrazer’’). 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 


jbell on DSKJLSW7X2PROD with NOTICES
12470 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

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) non-cigarette 

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. 

Findings from this study will inform 

FDA rulemaking regarding the 

marketing and presence of flavor 

features in ENDS and be used to guide 

other public health agencies’ policies 

and messaging regarding the role of 

flavors in ENDS. 

Study Overview: In this study, youth 

non-cigarette 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. All recruited 

participants must complete a double 

opt-in procedure, and parents of youth 

participants must consent for their child 

to be on the panel. Youth will provide 

assent and young adults will provide 

consent to participate in the surveys. 

Per institutional review board approval, 

parental consent has been waived and 

will not be required for youth to 

participate in this study. The survey 

platform can detect and prevent 

duplicate responses by scanning for 

duplicate cookies and internet protocol 

(IP) addresses. Participants will receive 

a small incentive as a token of 

appreciation in exchange for their 

survey participation. 

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. 

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). 

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 

Number 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 

Number 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 

Number 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 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04372 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 


jbell on DSKJLSW7X2PROD with NOTICES