50544 Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3037] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Clearance 

for Quantitative Testing for the 

Development of Food and Drug 

Administration Communications 

AGENCY: Food and Drug Administration, 

Health and Human Services (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 the collection of 

information entitled ‘‘Generic Clearance 

for Quantitative Testing for the 

Development of FDA Communications,’’ 

which collects individual generic 

quantitative information (e.g., surveys, 

experimental studies) to test 

communications or educational 

messages on FDA-regulated food and 

cosmetic products, dietary supplements, 

and animal food and feed while they are 

being developed or are in review. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 8, 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 November 8, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 8, 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://

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– 

2018–N–3037 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Generic 

Clearance for Quantitative Testing for 

the Development of FDA 

Communications.’’ 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: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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, 

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 


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Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 50545 

1For example, collections that collect PII to 

provide remuneration for participants of focus 

groups and cognitive laboratory studies will be 

submitted under this request. All Privacy Act 

requirements will be met. 

2As defined in OMB and Agency Information 

Quality Guidelines, ‘‘influential’’ means that ‘‘an 

agency can reasonably determine that 

dissemination of the information will have or does 

have a clear and substantial impact on important 

public policies or important private sector 

decisions.’’ 

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. 

Generic Clearance for Quantitative 

Testing for the Development of FDA 

Communications 

OMB Control Number 0910–0865— 

Extension 

This notice requests extension of 

OMB approval of the FDA information 

collection for a generic clearance that 

allows FDA to use quantitative social/ 

behavioral science data collection 

techniques (i.e., surveys and 

experimental studies) to test consumers’ 

reactions to FDA communications or 

educational messaging about FDAregulated food and cosmetic products, 

dietary supplements, and animal food 

and feed. To ensure that 

communications activities and 

educational campaigns have the highest 

potential to be received, understood, 

and accepted by those for whom they 

are intended, it is important to assess 

communications while they are under 

development. Understanding 

consumers’ attitudes, motivations, and 

behaviors in response to potential 

communications and education 

messaging plays an important role in 

improving FDA’s communications. 

If the following conditions are not 

met, FDA will submit an information 

collection request to OMB for approval 

through the normal PRA process: 

• The collections are voluntary; 

• The collections are low burden for 

participants (based on considerations of 

total burden hours, total number of 

participants, or burden hours per 

participant) and are low cost for both 

the participants and the Federal 

Government; 

• The collections are 

noncontroversial; 

• Personally-identifiable information 

(PII) is collected only to the extent 

necessary 1 and is not retained; 

• Information gathered will not be 

used for the purpose of substantially 

informing influential policy decisions; 2

and 

• Information gathered will yield 

qualitative findings; the collections will 

not be designed or expected to yield 

statistical data or used as though the 

results are generalizable to the 

population of study. 

To obtain approval for an individual 

generic collection submission that meets 

the conditions of this generic clearance, 

an abbreviated supporting statement 

will be submitted to OMB along with 

supporting documentation (e.g., a copy 

of the survey or experimental design 

and stimuli for testing). 

FDA will submit individual 

quantitative collections under this 

generic clearance to OMB. Individual 

quantitative collections will also 

undergo review by FDA’s Research 

Involving Human Subjects Committee, 

senior leadership in the Center for Food 

Safety and Applied Nutrition, and PRA 

specialists. 

Respondents to this collection of 

information may include a wide range 

of consumers and other FDA 

stakeholders such as producers and 

manufacturers who are regulated under 

FDA-regulated food and cosmetic 

products, dietary supplements, and 

animal food and feed. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN BY ANTICIPATED DATA COLLECTION METHODS 1

Survey type Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden 

per response 

Total 

hours 

Cognitive Interviews Screener .............................. 720 1 720 0.083 (5 minutes) ......... 60 

Cognitive Interviews .............................................. 144 1 144 1 .................................... 144 

Pre-test Study Screener ....................................... 2,400 1 2,400 0.083 (5 minutes) ......... 199 

Pre-test Study ....................................................... 480 1 480 0.25 (15 minutes) ......... 120 

Self-administered Surveys/Experimental Studies 

Screener.

75,000 1 75,000 0.083 (5 minutes) ......... 6,225 

Self-administered Surveys/Experimental Studies 15,000 1 15,000 0.25 (15 minutes) ......... 3,750 

Total ............................................................... ........................ ........................ ........................ ....................................... 10,498 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. The 

total estimated annual burden is 10,498 

hours. Current estimates are based on 

both historical numbers of participants 

from past projects as well as estimates 

for projects to be conducted in the next 

3 years. The number of participants to 

be included in each new survey will 

vary, depending on the nature of the 

compliance efforts and the target 

audience. 

Dated: September 3, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19480 Filed 9–8–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


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