Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88633 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: December 19, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28289 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–2021–D–0548] 

Data Standards for Drug and Biological 

Product Submissions Containing RealWorld Data; 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 ‘‘Data 

Standards for Drug and Biological 

Product Submissions Containing RealWorld Data.’’ This guidance provides 

recommendations to sponsors to help 

support compliance with the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) when submitting study data 

derived from real-world data (RWD) 

sources in applicable regulatory 

submissions using standards specified 

in the Data Standards Catalog. FDA is 

publishing this guidance as part of a 

series of guidance documents under its 

program to evaluate the use of realworld evidence (RWE) in regulatory 

decision making. This guidance 

finalizes the draft guidance of the same 

title issued on October 22, 2021. 

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– 

2021–D–0548 for ‘‘Data Standards for 

Drug and Biological Product 

Submissions Containing Real-World 

Data.’’ 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 this 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: 

Dianne Paraoan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3326, 

Silver Spring, MD 20993–0002, 301– 

796–3161; or James Myers, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Data 

Standards for Drug and Biological 

Product Submissions Containing RealWorld Data.’’ Section 3022 of the 21st 

Century Cures Act (Cures Act) amended 

the FD&C Act to add section 505F, 

Utilizing Real World Evidence (21 

U.S.C. 355g). In addition, under the 

Prescription Drug User Fee 

Amendments of 2017 (PDUFA VI), FDA 

committed to publishing draft guidance 

on how RWE can contribute to the 

assessment of safety and effectiveness in 


ddrumheller on DSK120RN23PROD with NOTICES1
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