4956 Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: January 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01439 Filed 1–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4761] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; Good 

Manufacturing Practice for Active 

Pharmaceutical Ingredients Used in 

Veterinary Medicinal Products; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry (GFI) #286 (VICH 

GL60) entitled ‘‘Good Manufacturing 

Practice for Active Pharmaceutical 

Ingredients Used in Veterinary 

Medicinal Products.’’ This draft 

guidance has been developed for 

veterinary use by the International 

Cooperation on Harmonisation of 

Technical Requirements for Registration 

of Veterinary Medicinal Products 

(VICH). The objective of this draft 

guidance is to provide 

recommendations regarding good 

manufacturing practice (GMP) for the 

manufacturing of active pharmaceutical 

ingredients (APIs) under an appropriate 

system for managing quality. It is also 

intended to help ensure that APIs meet 

the requirements for quality and purity 

that they purport or are represented to 

possess. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 25, 2024 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– 

2023–D–4761 for ‘‘Good Manufacturing 

Practice for Active Pharmaceutical 

Ingredients Used in Veterinary 

Medicinal Products.’’ 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 4957 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: Mai 

Huynh, Center for Veterinary Medicine 

(HFV–140), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0669, 

mai.huynh@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry GFI #286 

(VICH GL60) entitled ‘‘Good 

Manufacturing Practice for Active 

Pharmaceutical Ingredients Used in 

Veterinary Medicinal Products.’’ The 

objective of this guidance is to provide 

recommendations regarding GMP for the 

manufacturing of APIs under an 

appropriate system for managing 

quality. It is also intended to help 

ensure that APIs meet the requirements 

for quality and purity that they purport 

or are represented to possess. 

FDA has participated in efforts to 

enhance international harmonization 

and is committed to seeking 

scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify, and then 

reduce, differences in technical 

requirements for drug development 

among regulatory agencies in different 

countries. FDA has actively participated 

in the International Council for 

Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use to develop harmonized 

technical requirements for the approval 

of human pharmaceutical and biological 

products among the European Union, 

Japan, and the United States. The VICH 

is a parallel initiative for veterinary 

medicinal products. The VICH is 

concerned with developing harmonized 

technical requirements for the approval 

of veterinary medicinal products in the 

European Union, Japan, and the United 

States, and includes input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from the European Commission and 

European Medicines Agency; 

AnimalhealthEurope; FDA—Center for 

Veterinary Medicine and U.S. 

Department of Agriculture—Center for 

Veterinary Biologics; the U.S. Animal 

Health Institute; the Japanese Ministry 

of Agriculture, Forestry and Fisheries; 

and the Japanese Veterinary Products 

Association. There are 10 observers to 

the VICH Steering Committee: one 

representative from government and one 

representative from industry of 

Australia, New Zealand, Canada, South 

Africa, and the United Kingdom. The 

World Organisation for Animal Health 

is an associate member of the VICH. The 

VICH Secretariat, which coordinates the 

preparation of documentation, is 

provided by HealthforAnimals. 

This 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 ‘‘Good Manufacturing Practice for 

Active Ingredients Used in Veterinary 

Medicinal Products.’’ 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. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 514 have been approved 

under OMB control number 0910–0032; 

and the collections of information in 

section 512(n)(1) of the FD&C Act (21 

U.S.C. 360b(n)(1)) have been approved 

under OMB control number 0910–0669. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: January 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01441 Filed 1–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0092] 

Revising Abbreviated New Drug 

Application Labeling Following 

Revision of the Reference Listed Drug 

Labeling; Final Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Revising 

ANDA Labeling Following Revision of 

the RLD Labeling.’’ This guidance 

provides recommendations for updating 

labeling for abbreviated new drug 

applications (ANDAs) following 

revisions to the labeling of a reference 

listed drug (RLD), including information 

on how to identify RLD labeling updates 

and how to submit labeling updates to 

both unapproved and approved ANDAs 

to conform to RLD labeling updates. 

This guidance finalizes the draft 

guidance for industry of the same title 

issued on January 27, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 25, 2024. 

ADDRESSES: You may submit electronic 

or written comments on Agency 

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 


khammond on DSKJM1Z7X2PROD with NOTICES