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
Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 4627 

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– 

2013–N–0520 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Substances Prohibited from Use in 

Animal Food or Feed; Animal Proteins 

Prohibited in Ruminant Feed.’’ 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: 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: 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 

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. 

Substances Prohibited From Use in 

Animal Food or Feed; Animal Proteins 

Prohibited in Ruminant Feed—21 CFR 

589.2000(e)(1)(iv) 

OMB Control Number 0910–0339— 

Extension 

Section 701(a) (21 U.S.C. 371(a)) of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) gives us the authority to 

issue regulations for the efficient 

enforcement of the FD&C Act. Our 

regulation at 21 CFR 589.2000 provides 

that animal protein derived from 

mammalian tissue (with some 

exclusions) is not generally recognized 

as safe (GRAS) for use in ruminant feed 

and is a food additive subject to certain 

provisions of the FD&C Act (62 FR 

30936, June 5, 1997). 

This information collection was 

established because epidemiological 

evidence gathered in the United 

Kingdom suggested that bovine 

spongiform encephalopathy (BSE), a 

progressively degenerative central 

nervous system disease, is spread to 

ruminant animals by feeding protein 

derived from ruminants infected with 

BSE. This regulation places general 

requirements on persons that 

manufacture, blend, process, and 

distribute products that contain, or may 

contain, protein derived from 

mammalian tissue, and feeds made from 

such products. 

Specifically, this regulation requires 

renderers, feed manufacturers, and 

others involved in feed and feed 

ingredient manufacturing and 

distribution to maintain written 

procedures specifying the cleanout 

procedures or other means and 

specifying the procedures for separating 

products that contain or may contain 

protein derived from mammalian tissue 

from all other protein products from the 

time of receipt until the time of 

shipment. These written procedures are 

intended to help the firm formalize 

consistent processes, and then to help 

inspection personnel confirm that the 

firm is conducting these processes in 

compliance with the regulation. 

Inspection personnel will evaluate the 

written procedure and confirm it is 

being followed when they are 

conducting an inspection. 

These written procedures must be 

maintained if the facility is operating in 

a manner that necessitates the record, 

and if the facility makes changes to an 

applicable procedure or process the 

record must be updated. Written 

procedures required by this section 

shall be made available for inspection 

and copying by FDA. 

Description of Respondents: 

Respondents include renderers, feed 

manufacturers, and others involved in 

feed and feed ingredient manufacturing 

and distribution. 

FDA estimates the burden of this 

collection of information as follows: 


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4628 Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR part Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Written procedures; 589.2000(e)(1)(iv) ...................... 300 1 300 14 4,200 

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

We base our estimate of the number 

of recordkeepers on inspectional data. 

Based on a review of the information 

collection since our last request for 

OMB approval we have adjusted our 

burden estimate, which has resulted in 

a decrease to the currently approved 

burden. Review of our inspection data 

suggests that the number of facilities 

that need to conduct these separation 

practices is gradually decreasing, 

therefore we have decreased the number 

of facilities who must comply, as well 

as the total number of hours needed to 

comply with this burden. 

Dated: January 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01731 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2011–N–0742; 

FDA–2018–N–0180; FDA–2019–N–2854; 

FDA–2021–N–0515; FDA–2014–N–1960; 

FDA–2017–D–6069; and FDA–2019–N–3325] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

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: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control 

No. 

Date approval 

expires 

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution ............................................ 0910–0045 12/31/2024 

Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications ................ 0910–0810 12/31/2024 

Premarket Tobacco Product Applications and Recordkeeping Requirements ....................................................... 0910–0879 12/31/2024 

Postmarketing Adverse Experience Reporting and Recordkeeping ....................................................................... 0910–0230 1/31/2025 

MedWatch: Adverse Event and Product Experience Reporting System (Paper Based) ....................................... 0910–0291 1/31/2025 

De Novo Classification Process (Evaluation of Automatic Class III Designation) .................................................. 0910–0844 1/31/2025 

Laboratory Accreditation for Analyses of Foods ..................................................................................................... 0910–0898 1/31/2025 

Dated: January 20, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01692 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Biodefense Science Board 

AGENCY: Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The National Biodefense 

Science Board (NBSB or the Board) is 

authorized under Section 319M of the 

Public Health Service (PHS) Act, as 

added by Section 402 of the Pandemic 

and All-Hazards Preparedness Act of 

2006 and amended by Section 404 of the 

Pandemic and All-Hazards 

Preparedness Reauthorization Act. The 

Board is governed by the Federal 

Advisory Committee Act, which sets 

forth standards for the formation and 

use of advisory committees. The NBSB 

provides expert advice and guidance on 

scientific, technical, and other matters 

of special interest to the Department of 

Health and Human Services (HHS) 

regarding current and future chemical, 

biological, nuclear, and radiological 

agents, whether naturally occurring, 

accidental, or deliberate. Authority to 

manage and operate the NBSB, 

including to receive advice and 

recommendations from the Board, has 

been delegated by the Secretary of HHS 

to the Assistant Secretary for 

Preparedness and Response (ASPR). The 

NBSB will meet in public (virtually) on 

March 7, 2022, beginning at 12:30 p.m. 

Eastern time. ASPR invites stakeholders 

and the general public to attend and 

participate as appropriate. A detailed 

agenda and instructions to register to 

attend the meeting will be available on 

the NBSB meeting website https://

www.phe.gov/nbsb. 

Procedures for Public Participation: 

Members of the public may attend the 

meeting via a toll-free phone number or 

Zoom teleconference, which requires 

pre-registration. The meeting link to 

pre-register will be posted on the 

meeting website https://www.phe.gov/ 


jspears on DSK121TN23PROD with NOTICES1