28018 Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Notices 

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 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR parts 601 and 

610 have been approved under OMB 

control number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: May 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10030 Filed 5–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0173] 

Practices To Prevent Unsafe 

Contamination of Animal Feed From 

Drug Carryover; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a draft 

guidance for industry #272 entitled 

‘‘Practices to Prevent Unsafe 

Contamination of Animal Feed from 

Drug Carryover.’’ We are issuing this 

draft guidance to describe practices that 

medicated feed manufacturers can use 

to prevent unsafe contamination from 

drug carryover into a non-medicated 

animal feed or an animal feed 

containing a different approved new 

animal drug. Unsafe contamination of 

animal feed from drug carryover can 

pose a risk to human and animal health. 

When finalized, this guidance will 

replace Compliance Policy Guides 

(CPGs) Sec. 680.500 and 680.600. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 8, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2022–D–0173 for ‘‘Practices to Prevent 

Unsafe Contamination of Animal Feed 

from Drug Carryover.’’ 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. 

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 Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label 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: 

Kevin Klommhaus, Center for 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Notices 28019 

Veterinary Medicine (HFV–236), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 515–318– 

8075. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry #272 

entitled ‘‘Practices to Prevent Unsafe 

Contamination of Animal Feed from 

Drug Carryover.’’ This draft guidance 

contains much of the information found 

in the CPGs Sec. 680.500 ‘‘Unsafe 

Contamination of Animal Feed from 

Drug Carryover’’ and 680.600 

‘‘Sequencing as a Means to Prevent 

Unsafe Drug Contamination in the 

Production, Storage, and Distribution of 

Feeds’’ but includes updates and 

additional information. We intend to 

withdraw the CPGs after this guidance 

is finalized. Drug carryover generally 

occurs when a drug used in the 

manufacture of a batch of medicated 

feed, for which the drug is approved, 

gets inadvertently included in a 

subsequent batch of: (1) A nonmedicated feed, (2) a different 

medicated feed for which the drug is not 

approved (e.g., medicated feed for 

another species), or (3) a medicated feed 

that contains the same drug that can 

result in a higher drug level than is 

stated on the labeling. This carryover 

can occur for multiple reasons, 

including the use of the same 

equipment to manufacture both 

medicated and non-medicated feed, 

inadequate cleanout practices for 

manufacturing and distribution 

equipment between sequential batches, 

or human error. 

We understand that an absolute 

avoidance of all batch-to-batch drug 

carryover may not be possible. However, 

measures can be implemented to avoid 

unsafe contamination of animal feed 

from drug carryover. In this draft 

guidance, unsafe contamination of an 

animal feed refers to a degree of 

contamination, by a drug approved for 

a medicated feed use, that poses an 

unacceptable risk to human or animal 

health. Human health may be at risk if 

humans consume a product derived 

from animals that have consumed 

animal feed contaminated from drug 

carryover and there is drug residue in 

the edible tissues of that animal (e.g., 

milk, meat, or eggs). Unsafe 

contamination from drug carryover in 

animal feed can impact animal health 

when an animal consumes the 

contaminated feed, e.g., horses 

consuming feed contaminated with the 

drug monensin. Horses are sensitive to 

ionophore drugs like monensin, and 

ingestion can result in severe illness or 

death. 

Our regulation ‘‘Current Good 

Manufacturing Practice for Medicated 

Feeds,’’ 21 CFR part 225, contains 

requirements for equipment cleanout 

procedures to avoid unsafe 

contamination of feeds with drugs (see 

21 CFR 225.65 and 225.165). In this 

guidance, we provide information on 

some ways to comply with these 

requirements to help prevent unsafe 

contamination of animal feed from drug 

carryover. 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on some practices that 

can be used in feed mills manufacturing 

medicated feed to prevent unsafe 

contamination of animal feed from drug 

carryover. 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 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. 

Dated: May 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09939 Filed 5–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center For Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group Developmental Brain Disorders Study 

Section 

Date: June 8–9, 2022. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Pat Manos, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5200, 

MSC 7846, Bethesda, MD 20892, (301) 408– 

9866, manospa@csr.nih.gov. 

Name of Committee: Bioengineering 

Sciences & Technologies Integrated Review 

Group Nanotechnology Study Section. 

Date: June 9–10, 2022. 

Time: 9:30 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Joseph Thomas Peterson, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4118, 

MSC 7814, Bethesda, MD 20892, 301–408– 

9694, petersonjt@csr.nih.gov. 

Name of Committee: Cardiovascular and 

Respiratory Sciences Integrated Review 

Group Integrative Myocardial Physiology/ 

Pathophysiology B Study Section. 

Date: June 14–15, 2022. 

Time: 9:00 a.m. to 8:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Kirk E Dineley, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 806E, 

Bethesda, MD 20892, (301) 867–5309, 

dineleyke@csr.nih.gov. 

Name of Committee: Cell Biology 

Integrated Review Group Maximizing 

Investigators’ Research Award C Study 

Section. 

Date: June 14–15, 2022. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Jimok Kim, Ph.D., 

Scientific Review Officer, Center for 


lotter on DSK11XQN23PROD with NOTICES1