88634 Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 

regulatory submissions. In 2018, FDA 

created an RWE Framework and 

Program (Program) to evaluate the 

potential use of RWE to help support 

the approval of a new indication for a 

drug already approved under the FD&C 

Act or to help to support or satisfy 

postapproval study requirements. In late 

2021, FDA utilized the Program to issue 

draft guidances outlining considerations 

for the use of RWD and RWE in 

regulatory decision-making to help 

satisfy the Cures Act mandate and the 

PDUFA VI commitment. 

This guidance finalizes the draft 

guidance entitled ‘‘Data Standards for 

Drug and Biological Product 

Submissions Containing Real-World 

Data’’ issued on October 22, 2021 (86 FR 

58672). FDA considered comments 

received on the draft guidance as the 

guidance was finalized. Changes from 

the draft to the final guidance include 

clarification of FDA’s understanding of 

challenges when using currently 

supported data standards for RWD 

sources and elaboration of available 

FDA resources for consultation about 

the use of data standards for study data 

submitted to FDA. In addition, editorial 

changes were made to improve clarity, 

including the movement of concepts 

from glossary entries to footnotes to the 

main document text. 

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 ‘‘Data Standards for 

Drug and Biological Product 

Submissions Containing Real-World 

Data.’’ 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 314 (Applications for FDA 

Approval to Market a New Drug) have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 312 

(Investigational New Drug Regulations) 

have been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 58 (Good 

Laboratory Practice Regulations for 

Nonclinical Laboratory Studies) have 

been approved under OMB control 

number 0910–0119; and the collections 

of information in 21 CFR part 601 

(General Licensing Provisions: Biologics 

License Application, Changes to an 

Approved Application, Labeling, 

Revocation and Suspension) have been 

approved under OMB control number 

0910–0338. 

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: December 19, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28291 Filed 12–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1997–D–0444] 

Special Considerations, Incentives, 

and Programs To Support the 

Approval of New Animal Drugs for 

Minor Uses and for Minor Species; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

final guidance for industry (GFI) #61 

entitled ‘‘Special Considerations, 

Incentives, and Programs to Support the 

Approval of New Animal Drugs for 

Minor Uses and for Minor Species.’’ 

This guidance is intended to assist those 

interested in pursuing FDA approval of 

new animal drugs intended for minor 

uses in major species or for use in minor 

species (MUMS drugs). It outlines the 

basic statutory and regulatory 

requirements and special considerations 

for these approvals and describes the 

incentives available to encourage the 

development of MUMS drugs. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 22, 2023. 

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– 

1997–D–0444 for ‘‘Special 

Considerations, Incentives, and 

Programs to Support the Approval of 

New Animal Drugs for Minor Uses and 

for Minor Species.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88635 

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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Dorothy Bailey, Center for Veterinary 

Medicine (HFV–50), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0565, 

dorothy.bailey@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 15, 

2020 (85 FR 42876), FDA published the 

notice of availability for draft GFI #61 

entitled ‘‘Special Considerations, 

Incentives, and Programs to Support the 

Approval of New Animal Drugs for 

Minor Uses and for Minor Species’’ 

giving interested persons until 

November 12, 2020, to comment on the 

draft guidance. In response to a request 

for an extension, the comment period 

was extended to January 11, 2021 (85 FR 

71659). FDA received 14 comments on 

the draft guidance and those comments 

were considered as the guidance was 

finalized. Changes to the final guidance 

include the following: 

• In our draft guidance we referred to 

Minor Use Determinations. Our 

experience has shown that our 

stakeholders frequently confuse 

‘‘MUMS Determination’’ with ‘‘MUMS 

Designation.’’ Therefore, the final 

guidance substitutes the word 

‘‘Assessment’’ for the word 

‘‘Determination.’’ 

• Section XII.C.3.a.i. ‘‘Anthelmintics 

and Ectoparasiticides for Terrestrial 

Minor Species’’ has been added to the 

final guidance in response to comments 

received requesting additional detail on 

this subject. This section also references 

the relevant ‘‘International Cooperation 

on Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH)’’ 

guidance. 

• CVM received many comments 

pertaining to aquaculture species 

grouping. Due to the complexity of this 

topic, CVM has removed examples of 

aquaculture species groupings in the 

final guidance. We continue to consider 

this topic and intend to work with 

individual drug sponsors wishing to use 

species groupings for new animal drug 

approvals to identify an appropriate 

species grouping strategy and 

subsequent data needs for specific 

projects. 

In addition, editorial changes were 

made to improve clarity. The guidance 

announced in this notice finalizes the 

draft guidance dated July 2020. 

This level 1 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 ‘‘Special 

Considerations, Incentives, and 

Programs to Support the Approval of 

New Animal Drugs for Minor Uses and 

for Minor Species.’’ 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 21 CFR part 511 have 

been approved under OMB control 

number 0910–0117; the collections of 

information in 21 CFR part 514 have 

been approved under OMB control 

numbers 0910–0032 and 0910–0284; 

and the collections of information in 21 

CFR part 516 have been approved under 

OMB control numbers 0910–0605. 

III. Electronic Access 

Persons with access to the internet 

may obtain the 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: December 19, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28287 Filed 12–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2023–N–1157; FDA– 

2022–D–0109; FDA–2020–N–0908; FDA– 

2022–D–0814; FDA–2022–D–0745; FDA– 

2023–N–1006; FDA–2023–N–1053; FDA– 

2023–N–2286; FDA–2023–N–1661; FDA– 

2013–N–1119; FDA–2023–N–2986; FDA– 

2009–N–0582; FDA–2023–N–1272; FDA– 

2023–N–2030; FDA–2023–N–1189] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 


ddrumheller on DSK120RN23PROD with NOTICES1