Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 34879 

information can be found at https://

www.fda.gov/advisory-committees/ 

psychopharmacologic-drugs-advisorycommittee/psychopharmacologic-drugsadvisory-committee-charter or by 

contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12366 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–2013–N–1425] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Mitigation 

Strategies To Protect Food Against 

Intentional Adulteration 

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, 

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 0910–0812. 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. 

Mitigation Strategies To Protect Food 

Against Intentional Adulteration—21 

CFR Part 121 

OMB Control Number 0910–0812— 

Extension 

Under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) certain 

provisions protect against the 

intentional adulteration of food. Section 

418 of the FD&C Act (21 U.S.C. 350g) 

addresses intentional adulteration in the 

context of facilities that manufacture, 

process, pack, or hold food and are 

required to register under section 415 of 

the FD&C Act (21 U.S.C. 350d). Section 

419 of the FD&C Act (21 U.S.C. 350h) 

addresses intentional adulteration in the 

context of fruits and vegetables that are 

raw agricultural commodities. Section 

420 of the FD&C Act (21 U.S.C. 350i) 

addresses intentional adulteration in the 

context of high-risk foods and exempts 

farms except for farms that produce 

milk. These provisions are codified at 

21 CFR part 121 (part 121) and include 

requirements that an owner, operator, or 

agent in charge of a facility must: 

• Prepare and implement a written 

food defense plan that includes a 

vulnerability assessment to identify 

significant vulnerabilities and 

actionable process steps, mitigation 

strategies, and procedures for food 

defense monitoring, corrective actions, 

and verification (§ 121.126); 

• identify any significant 

vulnerabilities and actionable process 

steps by conducting a vulnerability 

assessment for each type of food 

manufactured, processed, packed, or 

held at the facility using appropriate 

methods to evaluate each point, step, or 

procedure in a food operation 

(§ 121.130); 

• identify and implement mitigation 

strategies at each actionable process step 

to provide assurances that the 

significant vulnerability at each step 

will be significantly minimized or 

prevented and the food manufactured, 

processed, packed, or held by the 

facility will not be adulterated. For each 

mitigation strategy implemented at each 

actionable process step, include a 

written explanation of how the 

mitigation strategy sufficiently 

minimizes or prevents the significant 

vulnerability associated with the 

actionable process step (§ 121.135); 

• establish and implement mitigation 

strategies management components, as 

appropriate to ensure the proper 

implementation of each such mitigation 

strategy, taking into account the nature 

of the mitigation strategy and its role in 

the facility’s food defense system 

(§ 121.138); 

• establish and implement food 

defense monitoring procedures, for 

monitoring the mitigation strategies, as 

appropriate to the nature of the 

mitigation strategy and its role in the 

facility’s food defense system 

(§ 121.140); 

• establish and implement food 

defense corrective action procedures 

that must be taken if mitigation 

strategies are not properly implemented, 

as appropriate to the nature of the 

actionable process step and the nature 

of the mitigation strategy (§ 121.145); 

• establish and implement specified 

food defense verification activities, as 

appropriate to the nature of the 

mitigation strategy and its role in the 

facility’s food defense system 

(§ 121.150); 

• conduct a reanalysis of the food 

defense plan (§ 121.157); 

• ensure that all individuals who 

perform required food defense activities 

are qualified to perform their assigned 

duties (§ 121.4); and 

• establish and maintain certain 

records, including the written food 

defense plan (vulnerability assessment, 

mitigation strategies and procedures for 

food defense monitoring, corrective 

actions, and verification) and 

documentation related to training of 

personnel. All records are subject to 

certain general recordkeeping and 

record retention requirements 

(§§ 121.301 through 121.330). 

Under the regulations, an owner, 

operator, or agent in charge of a facility 

must prepare, or have prepared, and 

implement a written food defense plan, 

including written identification of 

actionable process steps, written 

mitigation strategies, written procedures 

for defense monitoring, written food 

defense corrective actions, and written 

food defense verification procedures. 

The purpose of the information 

collection is to ensure compliance with 

the provisions under part 121 related to 

protecting food from intentional 

adulteration. The regulations are 

intended to address hazards that may be 

intentionally introduced to foods, 

including by acts of terrorism, with the 

intent to cause widespread harm to 

public health. Under the regulations, 


khammond on DSKJM1Z7X2PROD with NOTICES
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, 


khammond on DSKJM1Z7X2PROD with NOTICES