34880 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 

domestic and foreign food facilities that 

are required to register under the FD&C 

Act are required to identify and 

implement mitigation strategies to 

significantly minimize or prevent 

significant vulnerabilities identified at 

actionable process steps in a food 

operation. 

In an effort to reduce burden and 

assist respondents, FDA offers tools and 

educational materials related to 

protecting food from intentional 

adulteration, including FDA’s Food 

Defense Plan Builder, a user-friendly 

tool designed to help owners and 

operators of food facilities develop a 

personalized food defense plan, and the 

Mitigation Strategies Database, a 

database for the food industry providing 

a range of preventative measures that 

firms may choose to implement. These 

and other informational resources are 

available at https://www.fda.gov/food/ 

food-defense/food-defense-toolseducational-materials. FDA also offers a 

small entity compliance guide entitled 

‘‘Mitigation Strategies to Protect Food 

Against Intentional Adulteration’’ 

(August 2017) to inform domestic and 

foreign food facilities about compliance 

with regulations to protect against 

intentional adulteration. Further, FDA 

developed two draft guidance 

documents entitled ‘‘Mitigation 

Strategies to Protect Food Against 

Intentional Adulteration: Draft 

Guidance for Industry’’ (March 2019) 

and ‘‘Supplemental Draft Guidance for 

Industry: Mitigation Strategies to Protect 

Food Against Intentional Adulteration’’ 

(February 2020). Once finalized, the 

draft guidance documents would assist 

the food industry in developing and 

implementing the elements of a food 

defense plan. These guidance 

documents are available at https://

www.fda.gov/food/food-defense. All 

Agency guidance documents are issued 

in accordance with our good guidance 

practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

Description of Respondents: The 

respondents to this information 

collection are manufacturers, 

processors, packers, and holders of 

retail food products marketed in the 

United States. 

In the Federal Register of December 

17, 2021 (86 FR 71646), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Exemption for food from very small businesses; 

§ 121.5.

18,080 1 18,080 0.5 (30 minutes) ..... 9,040 

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

Certain facilities may qualify for an 

exemption under the regulations. 

Because these facilities must provide 

documentation upon request to verify 

their exempt status, we have 

characterized this as a reporting burden. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity; 21 CFR Section Number of recordkeepers 

No. of records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

Food Defense Plan; § 121.126 ............ 3,247 1 3,247 23 ........................... 74,681 

Actionable Process Steps; § 121.130 .. 9,759 1 9,759 20 ........................... 195,180 

Mitigation Strategies; § 121.135(b) ...... 9,759 1 9,759 20 ........................... 195,180 

Monitoring Corrective Actions, 

Verification; §§ 121.140(a), 

121.145(a)(1), and 121.150(c).

9,759 1 9,759 175 ......................... 1,707,825 

Training;§ 121.160 ............................... 367,203 1 367,203 0.67 (40 minutes) .. 246,026 

Records; §§ 121.305 and 121.310 ...... 9,759 1 9,759 10 ........................... 97,590 

Total .............................................. .............................. .............................. .............................. ................................ 2,516,482 

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 other than to increase the 

burden estimate by 1,224 hours due to 

a corrected calculation for the estimate 

related to training (§ 121.160). 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12361 Filed 6–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0482] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; New Animal Drug 

Applications and Veterinary Master 

Files 

AGENCY: Food and Drug Administration, 

Health and Human Services (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. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by July 8, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 


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Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 34881 

1Available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/cvmgfi-152-evaluating-safety-antimicrobial-new-animaldrugs-regard-their-microbiological-effects. 

2Animal drugs intended for use in minor species, 

minor use in major species, or for serious or lifethreatening conditions or unmet animal or human 

health needs where a demonstration of effectiveness 

would require a complex or particularly difficult 

study or studies. 

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 0910–0032. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

New Animal Drug Applications and 

Veterinary Master Files 

OMB Control Number 0910–0032— 

Extension 

This information collection supports 

implementation of section 512 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360b), which 

governs new animal drugs. Agency 

regulations in 21 CFR part 514 and 

associated regulations in 21 CFR part 

558, establish format and content 

requirements regarding new animal 

drug application (NADA) submissions, 

as well as provide for preapplication 

submissions, amended applications, and 

application supplements. This 

information collection also supports 

implementation of section 571 of the 

FD&C Act (21 U.S.C. 360ccc) regarding 

application for conditional approval of 

new animal drug (CNADA) submissions. 

As set forth in the FD&C Act and 

Agency regulations, requisite elements 

include safety and effectiveness data, 

proposed labeling, product 

manufacturing information, and, where 

necessary, complete information on 

food safety (including microbial food 

safety) and any methods used to 

determine residues of drug chemicals in 

edible tissue from food producing 

animals. Applications must be prepared 

as appropriate to support the particular 

submission. Respondents to the 

information collection are persons 

developing, manufacturing, and/or 

researching new animal drugs. 

We developed Form FDA 356v 

(Application for Approval of a New 

Animal Drug (or Submission to Support 

New Animal Drug Approval)) to provide 

a uniform format for submitting 

requisite information and to ensure 

efficient processing by the Agency. 

Form FDA 356v is available for 

download from our website at https://

www.fda.gov/about-fda/reportsmanuals-forms/forms. We also develop 

Agency guidance documents that may 

assist respondents with understanding 

NADA/CNADA requirements and 

related information collection activity. 

This includes FDA Guidance #152,1

which outlines a risk assessment 

approach for evaluating the microbial 

food safety of antimicrobial new animal 

drugs and includes Agency 

recommendations in this regard. 

Under section 512(b)(3) of the FD&C 

Act, any person intending to file a 

NADA or supplemental NADA or a 

request for an investigational exemption 

under section 512(j) of the FD&C Act 

may request a conference prior to 

making a submission. Section 514.5 of 

our regulations (21 CFR 514.5) sets forth 

procedures for presubmission 

conferences and describes 

documentation associated with making 

requests, and preparing for and 

conducting meetings. We recommend 

submission of data supporting discrete 

technical sections during the 

investigational phase, rather than 

submitting all data for review as part of 

a complete application. This ‘‘phased 

review’’ of data submissions creates 

efficiencies in the review process for 

both FDA and the animal 

pharmaceutical industry. 

We also encourage, as appropriate, the 

submission of a veterinary master file 

(VMF). For more information on VMFs, 

we invite you to visit https://

www.fda.gov/animal-veterinary/ 

development-approval-process/ 

veterinary-master-files. A VMF provides 

detailed information used in support of 

application submissions. Questions 

regarding VMF submissions may be 

directed to our Center for Veterinary 

Medicine at cvmesubmitter@

fda.hhs.gov. We have found that 

utilizing VMFs has increased the 

efficiency of the animal drug 

development and animal drug review 

processes for FDA and the animal 

pharmaceutical industry, providing for 

the confidential exchange of 

information with FDA and a process for 

reporting information outside of a 

NADA/CNADA or an investigational 

new animal drug file, as well as an 

opportunity for increased 

communication with FDA during the 

early stages of product development. A 

holder of a VMF may also authorize 

other parties to reference information 

included in the VMF without disclosing 

information in the file to those parties. 

VMFs can be used as repositories for 

information that can be referenced in 

multiple submissions to the Agency. 

Section 558.5(i) of FDA regulations 

(21 CFR 558.5(i)) describes the 

procedure for requesting a waiver of the 

labeling requirements in § 558.5(h) in 

the event that there is evidence to 

indicate that it is unlikely a new animal 

drug would be used in the manufacture 

of a liquid medicated feed. 

Finally, section 571 of the FD&C Act 

establishes requirements for the 

conditional approval of certain drugs 2

and the procedures for submitting 

applications for conditional approval. 

Although FDA receives fewer than one 

application submission under section 

571 of the FD&C Act annually when 

averaged over a 3-year period, we use a 

placeholder of one response and 1 hour 

annually to account for the burden 

associated with these submissions. 

Information collection associated with 

NADAs/CNADAs and related 

submissions is necessary to ensure that 

new animal drugs are in compliance 

with sections 512(b)(1) and 571 of the 

FD&C Act. We review the information, 

including data, labeling, and 

manufacturing controls and procedures, 

to evaluate the safety and effectiveness 

of the proposed new animal drug. 

In the Federal Register of March 2, 

2022 (87 FR 11713), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

but did not pertain to the information 

collection requirements. 

FDA estimates the burden of this 

collection of information as follows: 


khammond on DSKJM1Z7X2PROD with NOTICES
34882 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

§§ 514.1 and 514.6; applications and amended applications.187 0.07 13 212 ......................... 2,756 

§§ 514.1(b)(8) and 514.8(c)(1); 2 evidence to establish safety and effectiveness.187 0.44 82 90 ........................... 7,380 

§ 514.5(b), (d), and (f); requesting presubmission 

conferences.

187 0.67 125 50 ........................... 6,250 

§ 514.8(b); manufacturing changes to an approved 

application.

187 2 374 35 ........................... 13,090 

§ 514.8(c)(1); labeling and other changes to an approved application.187 0.06 11 71 ........................... 781 

§ 514.8(c)(2) and (3); labeling and other changes to 

an approved application.

187 0.84 157 20 ........................... 3,140 

§ 514.11; submission of data studies and other information.187 0.13 24 1 ............................. 24 

§ 558.5(i); requirements for liquid medicated feed ...... 187 0.01 2 5 ............................. 10 

Applications for conditional approval submitted under 

section 571 of the FD&C Act.

1 1 1 1 ............................. 1 

Form FDA 356V .......................................................... 187 36.5 6,825 0.75 (45 minutes) ... 5,118 

VMF submissions ........................................................ 15 1 15 20 ........................... 300 

Total ...................................................................... ........................ ........................ 7,628 ................................ 38,849 

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

2 NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as 

part of the overall preapproval safety evaluation. 

Although we have characterized the 

information collection activity as a 

reporting burden, we include in our 

estimate time required for searching 

data sources, and preparing and 

maintaining necessary and applicable 

records. As stated above, although we 

receive fewer than one submission 

annually when averaged over a 3-year 

period, we attribute one response and 1 

hour annually to account for CNADA 

submissions. 

We have adjusted our estimate of the 

information collection to reflect a 

decrease in burden associated with 

application submissions in 

acknowledgement of respondents’ 

preference in using FDA’s ‘‘eSubmitter’’ 

system, which automatically generates 

Form FDA 356v and allows respondents 

to complete the form and submit 

applications and associated information 

electronically. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12355 Filed 6–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1192] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Substances 

Generally Recognized as Safe: 

Notification Procedure 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 July 8, 

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 0910–0342. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Substances Generally Recognized as 

Safe: Notification Procedure—21 CFR 

Part 170, Subpart E and 21 CFR Part 

570, Subpart E 

OMB Control Number 0910–0342— 

Extension 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) requires that all food 

additives (as defined by section 201(s) 

(21 U.S.C. 321(s)) be approved by FDA 

before they are marketed. Section 409 of 

the FD&C Act (21 U.S.C. 348) 

establishes a premarket approval 

requirement for ‘‘food additives.’’ 

Section 201(s) of the FD&C Act provides 

an exclusion to the definition of food 

additive and, thus, from the premarket 

approval requirement for uses of 

substances that are generally recognized 

as safe (GRAS) by qualified experts. The 

GRAS provision of section 201(s) of the 

FD&C Act is implemented in parts 170 


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