Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Rules and Regulations 14169 

AIRAC date State City Airport FDC No. FDC date Subject. 

21–Apr–22 .... KS Emporia .................. Emporia Muni .......................... 2/3952 1/13/22 RNAV (GPS) RWY 19, Orig-B. 

21–Apr–22 .... KS Emporia .................. Emporia Muni .......................... 2/3953 1/13/22 RNAV (GPS) RWY 1, Orig-B. 

21–Apr–22 .... TN Humboldt ................ Humboldt Muni ........................ 2/6094 2/22/22 RNAV (GPS) RWY 4, Orig-A. 

21–Apr–22 .... OK Tahlequah ............... Tahlequah Muni ...................... 2/6583 2/28/22 RNAV (GPS) RWY 35, Amdt 1B. 

21–Apr–22 .... MN Wheaton ................. Wheaton Muni ......................... 2/9026 2/11/22 RNAV (GPS) RWY 34, Orig-A. 

21–Apr–22 .... MN Wheaton ................. Wheaton Muni ......................... 2/9028 2/11/22 RNAV (GPS) RWY 16, Orig-A. 

21–Apr–22 .... MN Roseau ................... Roseau Muni/Rudy Billberg 

Fld.

2/9034 2/14/22 VOR RWY 16, Amdt 8. 

21–Apr–22 .... MN Roseau ................... Roseau Muni/Rudy Billberg 

Fld.

2/9036 2/14/22 VOR RWY 34, Amdt 1. 

[FR Doc. 2022–05281 Filed 3–11–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 112, 117, 121, and 507 

[Docket No. FDA–2021–D–0563] 

Current Good Manufacturing Practice 

and Preventive Controls, Foreign 

Supplier Verification Programs, 

Intentional Adulteration, and Produce 

Safety Regulations: Enforcement 

Policy Regarding Certain Provisions; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Current 

Good Manufacturing Practice and 

Preventive Controls, Foreign Supplier 

Verification Programs, Intentional 

Adulteration, and Produce Safety 

Regulations: Enforcement Policy 

Regarding Certain Provisions.’’ This 

guidance states Agency policy regarding 

enforcement of certain requirements 

related to supply-chain programs for 

contract manufacturers/processors, the 

intentional adulteration regulation, and 

supplier approval and verification 

requirements in the Current Good 

Manufacturing Practice and Preventive 

Controls Regulations and the Foreign 

Supplier Verification Programs (FSVP) 

Regulation. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on March 14, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2021–D–0563 for ‘‘Current Good 

Manufacturing Practice and Preventive 

Controls, Foreign Supplier Verification 

Programs, Intentional Adulteration, and 

Produce Safety Regulations: 

Enforcement Policy Regarding Certain 

Provisions.’’ Received comments 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. 


jspears on DSK121TN23PROD with RULES1
14170 Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Rules and Regulations 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

For questions relating to CGMP, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food: 

Jenny Scott, Center for Food Safety and 

Applied Nutrition (HFS–300), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2166. 

For questions relating to CGMP, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Food for 

Animals: Jennifer Erickson, Center for 

Veterinary Medicine (HFV–200), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 240–402– 

7382. 

For questions relating to Foreign 

Supplier Verification Programs for 

Importers of Food for Humans and 

Animals: Kevin Kwon, Center for Food 

Safety and Applied Nutrition (HFS– 

600), Food and Drug Administration, 

5001 Campus Dr., College Park, MD 

20740, 703–785–1125. 

For questions relating to Mitigation 

Strategies to Protect Food Against 

Intentional Adulteration: Ryan Newkirk, 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–3712. 

For questions relating to Standards 

for the Growing, Harvesting, Packing, 

and Holding of Produce for Human 

Consumption: Samir Assar, Center for 

Food Safety and Applied Nutrition 

(HFS–317), Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1636. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled 

‘‘Current Good Manufacturing Practice 

and Preventive Controls, Foreign 

Supplier Verification Programs, 

Intentional Adulteration, and Produce 

Safety Regulations: Enforcement Policy 

Regarding Certain Provisions.’’ We are 

issuing the guidance consistent with our 

good guidance practices regulation (21 

CFR 10.115). We are implementing the 

guidance without prior public comment 

because we have determined that prior 

public participation is not feasible or 

appropriate (§ 10.115(g)(2)). We made 

this determination because the guidance 

presents a less burdensome policy 

consistent with the public health. 

Although this guidance is immediately 

in effect, it remains subject to comment 

in accordance with FDA’s good 

guidance practices regulation. 

This guidance concerns five of the 

seven foundational rules that we have 

established in Title 21 of the Code of 

Federal Regulations (21 CFR) as part of 

our implementation of the FDA Food 

Safety Modernization Act (Pub. L. 111– 

353). The five final rules are entitled 

‘‘Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food’’ 

(published in the Federal Register of 

September 17, 2015, 80 FR 55908) (part 

117); ‘‘Current Good Manufacturing 

Practice, Hazard Analysis, and RiskBased Preventive Controls for Food for 

Animals’’ (published in the Federal 

Register of September 17, 2015, 80 FR 

51670) (part 507); ‘‘Foreign Supplier 

Verification Programs for Importers of 

Food for Humans and Animals’’ 

(published in the Federal Register of 

November 27, 2015, 80 FR 74226) (FSVP 

regulation); ‘‘Mitigation Strategies to 

Protect Food Against Intentional 

Adulteration’’ (published in the Federal 

Register of May 27, 2016, 81 FR 34166) 

(IA regulation or part 121); and 

‘‘Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption’’ (published in the 

Federal Register of November 27, 2015, 

80 FR 74354) (https://www.fda.gov/ 

food/guidanceregulation/fsma/ 

ucm334114.htm) (Produce Safety 

regulation or part 112). 

In the guidance we state that, at this 

time and based on our current 

understanding of the risks, we do not 

intend to enforce certain regulatory 

requirements for certain entities and/or 

activities covered by these five rules: 

• Extension of FDA’s intent not to 

take enforcement action in certain 

circumstances against a receiving 

facility that is a contract manufacturer/ 

processor not in compliance with 

certain supply-chain program 

requirements for food manufactured for 

a brand owner. 

• Under the intentional adulteration 

regulation: 

Æ Intent not to enforce the intentional 

adulteration regulation requirements for 

facilities under the preexisting farmactivity related enforcement policy, and 

Æ Intent not to enforce the 

requirement for reanalysis in certain 

circumstances, for example, when there 

is a single failure that is addressed 

through implementation of corrective 

action procedures. 

• Intent not to enforce the supplier 

approval and verification requirements 

in parts 117 and 507 and the FSVP 

regulation with regard to supplier 

compliance with requirements that are 

already associated with an enforcement 

discretion policy. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in part 117 have been 

approved under OMB control number 

0910–0751. The collections of 

information in part 507 have been 

approved under OMB control number 

0910–0789. The collections of 

information in 21 CFR part 1, subpart L 

have been approved under OMB control 

number 0910–0752. The collections of 

information in 21 CFR part 121 have 

been approved under OMB control 

number 0910–0812. The collections of 

information in part 112 have been 

approved under OMB control number 

0910–0816. 

III. Electronic Access 

Persons with access to the internet 

may obtain the document at either 

https://www.fda.gov/ 

RegulatoryInformation/Guidances/ 

default.htm, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: March 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05315 Filed 3–11–22; 8:45 am] 

BILLING CODE 4164–01–P 


jspears on DSK121TN23PROD with RULES1