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a draft guidance for industry #272 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 This draft guidance 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
28020 Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Notices 

Scientific Review, 6107 Rockledge Drive, 

Bethesda, MD 20892, (301) 402–8559, 

jimok.kim@nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group Macromolecular Structure and 

Function B 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: Alexei A Yeliseev, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, 6701 Rockledge Drive, 

Bethesda, MD 20892, 301–443–0552, 

yeliseeva@mail.nih.gov. 

Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: May 4, 2022. 

David W Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–09965 Filed 5–9–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel NIAID Resource Related 

Research Projects (R24 Clinical Trial Not 

Allowed). 

Date: June 7, 2022. 

Time: 12:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G42, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Sandip Bhattacharyya, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G42, 

Rockville, MD 20852, (240) 292–0189, 

sandip.bhattacharyya@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: May 4, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–09988 Filed 5–9–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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: Heart, Lung, and 

Blood Initial Review Group; NHLBI 

Mentored Clinical and Basic Science Study 

Section. 

Date: June 23–24, 2022. 

Time: 10:30 a.m. to 6:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Heart, Lung, and Blood 

Institute, RKL1, 6705 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Rajiv Kumar, Ph.D., Chief, 

Office of Scientific Review/DERA, National 

Heart, Lung, and Blood Institute, 6705 

Rockledge Drive, Bethesda, MD 20892, (301) 

827–4612, rajiv.kumar@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: May 4, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–09963 Filed 5–9–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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: Heart, Lung, and 

Blood Initial Review Group; Clinical Trials 

Review Study Section. 

Date: June 23–24, 2022. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6705 

Rockledge Drive, Bethesda MD 20817 

(Virtual Meeting). 

Contact Person: Keary A. Cope, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, National Institutes of Health, 

6705 Rockledge Drive, Room 209–A, 

Bethesda, MD 20892–7924, (301) 827–7912, 

copeka@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: May 4, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–09962 Filed 5–9–22; 8:45 am] 

BILLING CODE 4140–01–P 


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