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a draft guidance for industry GFI #286 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
4958 Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 

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–0092 for ‘‘Revising ANDA 

Labeling Following Revision of the RLD 

Labeling.’’ 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 Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Hughes, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1688, 

Silver Spring, MD 20993–0002, 301– 

796–9291, Jonathan.Hughes@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Revising ANDA Labeling Following 

Revision of the RLD Labeling.’’ This 

guidance provides recommendations for 

updating labeling for ANDAs following 

revisions to the labeling of an 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. 

A generic drug is generally required to 

have the same labeling as the RLD, 

except for changes required because of 

differences approved under a suitability 

petition (see section 505(j)(2)(C) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act)) (21 U.S.C. 355(j)(2)(C) and 

21 CFR 314.93) or because the generic 

drug and the RLD are produced or 

distributed by different manufacturers 

(see e.g., section 505(j)(2)(A)(v) of the 

FD&C Act and § 314.94(a)(8)(iv) (21 CFR 

314.94(a)(8)(iv))). FDA will refuse to 

approve an ANDA if, among other 

things, it does not include such 

information regarding the proposed 

labeling (see e.g., § 314.127(a)(7)). FDA 

regulations provide examples of 

permissible differences in labeling that 

may result when a proposed generic 

drug and the RLD are ‘‘produced or 

distributed by different manufacturers,’’ 

including the omission of an indication 

or other aspect of labeling protected by 

patent or exclusivity and ‘‘labeling 

revisions made to comply with current 

FDA labeling guidelines or other 

guidance’’ (§ 314.94(a)(8)(iv)). 

An ANDA holder is expected to 

update its labeling after FDA has 

approved relevant changes to the 

labeling for the corresponding RLD. 

Prompt revision, submission to the 

Agency, and implementation of revised 

labeling are important to ensure that the 

generic drug continues to be as safe and 

effective as the corresponding RLD. 

Because the labeling of a generic drug 

must be the same as the labeling for the 

RLD, except for permissible differences, 

the revision should be made at the 

earliest time possible. 

In this guidance, FDA is providing 

information on how ANDA applicants 

and holders should monitor for changes 

to RLD labeling, procedures for the 

electronic submission of labeling 

updates, information describing the type 

of submission that should be made to 

FDA, as well as other considerations for 

submitting a labeling update to FDA. 

This guidance finalizes the draft 

guidance for industry of the same title 

issued on January 27, 2022 (87 FR 

4252). The January 2022 draft guidance 

revised the final guidance for industry 

entitled ‘‘Revising ANDA Labeling 

Following Revision of the RLD 

Labeling’’ issued in April 2000. FDA 

considered comments received on the 

January 2022 draft guidance as the 

guidance was finalized. Minor revisions 

from the draft to the final guidance were 

made to improve clarity. 

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 on ‘‘Revising ANDA 

Labeling Following Revision of the RLD 

Labeling.’’ 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 (PRA) (44 U.S.C. 

3501–3521). 

The collections of information in part 

314 (21 CFR part 314) for the 

submission of ANDAs (including the 

content and format of ANDAs and 

supplements and amendments) have 

been approved under OMB control 

number 0910–0001 and in part 314 

(included under the 21 CFR parts 10 

through 16 hearing regulations) under 

OMB control number 0910–0191. 

The collections of information 

pertaining to the electronic submission 

of labeling changes have been approved 

under OMB control number 0910–0045. 

The collections of information 

pertaining to the content and format 

requirements for human prescription 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 4959 

drugs and biological products and the 

submission of such labeling have been 

approved under OMB control number 

0910–0572. 

III. Electronic Access 

Persons with access to the internet 

may obtain the 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: January 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01442 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–E–0448] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; VOCABRIA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for VOCABRIA and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by March 25, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

July 23, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 25, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

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–E–0448 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; VOCABRIA.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 § 10.20 (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. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biologic product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 


khammond on DSKJM1Z7X2PROD with NOTICES