Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 4625 

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.’’ 

estimates that one establishment will 

initially submit one report annually at 2 

hours per report, for a total of 2 hours. 

Submissions under section 904(c) of 

the FD&C Act are for any new product 

that is not yet on the market (e.g., if on 

the market due to deeming compliance 

period), deemed product manufacturers 

should have submitted under section 

904(a)(1) of the FD&C Act. This includes 

any statutorily regulated product that 

would receive a marketing authorization 

and any new deemed product not 

subject to the deeming compliance 

period. For deemed product categories, 

while we anticipate receiving a large 

number of premarket applications, there 

is a portion of these applicants who will 

have reported their ingredients under 

section 904(a)(1) of the FD&C Act as 

most of these submissions are expected 

to be for products subject to the 

deeming compliance period. 

Based on FDA’s experience and the 

number of new products authorized to 

be introduced or delivered for 

introduction into interstate commerce 

submitted over the past 3 years, FDA 

estimates that 35 establishments will 

each submit 10 reports (1 every 6 

months). FDA also estimates that the 

confirmation or updating of product 

(ingredient) listing information 

(required by section 904(c) of the FD&C 

Act) is expected to take 0.40 hours (24 

minutes) for a total 140 burden hours. 

FDA estimates that obtaining a data 

universal numbering system (DUNS) 

number will take 30 minutes. FDA 

assumes that all new establishment 

facilities that will be required to 

initially register under section 905 of 

the FD&C Act would obtain a DUNS 

number. FDA estimates that up to 100 

establishments that would need to 

obtain this number each year. The total 

industry burden to obtain a DUNS 

number is 50 hours. 

FDA estimates the total burden for 

this collection to be 764 hours. We have 

adjusted our burden estimate, which has 

resulted in a decrease of 66 hours to the 

currently approved burden. Based on 

data we reviewed from the past 3 years, 

we note a decrease in the number of 

establishments submitting a renewal 

registration listing, an increase of the 

number of applications received for 

deemed products and potential 

modifications to those, and by 

projecting the number of remaining 

establishments that have not registered 

and submitted product ingredient 

listings, we revised the number of 

respondents and burden hours in this 

information collection. 

Dated: January 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01798 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3037] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Clearance 

for Quantitative Testing for the 

Development of Food and Drug 

Administration Communications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, 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 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 

28, 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 OMB 

control number for this information 

collection is 0910–0865. 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. 

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. 


jspears on DSK121TN23PROD with NOTICES1
4626 Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 

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. 

In the Federal Register of September 

9, 2021 (86 FR 50544), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited and, therefore, will not be 

discussed in this document. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE 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: January 20, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01730 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0520] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Substances 

Prohibited From Use in Animal Food or 

Feed; Animal Proteins Prohibited in 

Ruminant Feed 

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 the recordkeeping 

requirements regarding animal proteins 

prohibited in ruminant feed. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 29, 2022. 

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 March 29, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 29, 2022. 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 


jspears on DSK121TN23PROD with NOTICES1