Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88631 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information for the De 

Novo Classification Process (Evaluation 

of Automatic Class III Designation) have 

been approved under OMB control 

number 0910–0844; and the collections 

of information in the guidance 

document entitled ‘‘Requests for 

Feedback and Meetings for Medical 

Device Submissions: The Q-Submission 

Program’’ have been approved under 

OMB control number 0910–0756. The 

collections of information in 21 CFR 

part 314 (Applications for FDA 

Approval to Market a New Drug) and 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 numbers 0910–0001 and 

0910–0338, respectively. The 

collections of information in 21 CFR 

parts 50 and 56 (Protection of Human 

Subjects: Informed Consent; 

Institutional Review Boards) have been 

approved under OMB control number 

0910–0130. 

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/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances,https://

www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: December 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28262 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–1146] 

Real-World Data: Assessing Registries 

To Support Regulatory DecisionMaking for Drug and Biological 

Products; 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 ‘‘RealWorld Data: Assessing Registries to 

Support Regulatory Decision-Making for 

Drug and Biological Products.’’ This 

guidance provides considerations for 

sponsors proposing to design a registry 

or to use an existing registry to support 

regulatory decision-making about a 

drug’s effectiveness or safety. FDA is 

issuing this guidance as part of its RealWorld Evidence (RWE) Program and to 

satisfy, in part, the mandate under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) to issue guidance on the use 

of RWE in regulatory decision-making. 

This guidance finalizes the draft 

guidance of the same title issued on 

November 30, 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–1146 for ‘‘Real-World Data: 

Assessing Registries to Support 

Regulatory Decision-Making for Drug 

and Biological 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 


ddrumheller on DSK120RN23PROD with NOTICES1
88632 Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 

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, or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 3128, 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. 3226, 

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 ‘‘RealWorld Data: Assessing Registries to 

Support Regulatory Decision-Making for 

Drug and Biological Products.’’ FDA is 

issuing this guidance as part of its RWE 

Program and to satisfy, in part, the 

mandate under section 505F of the 

FD&C Act (21 U.S.C. 355g) to issue final 

guidance about the use of RWE in 

regulatory decision-making. Topics 

covered in this guidance include: 

• Considerations regarding a 

registry’s fitness-for-use in regulatory 

decision-making, focusing on attributes 

of a registry that support the collection 

of relevant and reliable data; 

• Considerations when linking a 

registry to another data source for 

supplemental information, such as data 

from medical claims, electronic health 

records, digital health technologies, or 

other registries; and 

• Considerations for supporting FDA 

review of submissions that include 

registry data. 

Section 3022 of the 21st Century 

Cures Act (Cures Act) (Pub. L. 114–255) 

amended the FD&C Act to add section 

505F, Utilizing Real World Evidence. In 

addition, the Prescription Drug User Fee 

Amendments of 2017 (PDUFA VI) 

committed FDA to publish draft 

guidance on how RWE can contribute to 

the assessment of safety and 

effectiveness in regulatory submissions. 

In 2018, FDA created an RWE 

Framework and 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 support or satisfy 

postapproval study requirements. In late 

2021, FDA utilized the RWE Program to 

issue draft guidances outlining 

considerations for the use of real-world 

data and RWE in regulatory decisionmaking to satisfy the Cures Act mandate 

and the PDUFA VI commitment. 

This guidance finalizes the draft 

guidance of the same title issued on 

November 30, 2021 (86 FR 67956). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to the 

final guidance include noting that 

sponsors proposing to use registry data 

to support regulatory decision-making 

by FDA are responsible for ensuring that 

attributes of the registry support the 

collection of relevant and reliable data, 

including in situations where the data 

are from a registry not managed or 

designed by the sponsor, and sponsors 

should have access to the metadata 

associated with the registry data. In 

addition, statements were added to note 

that registry data are sometimes used to 

evaluate a drug received during routine 

medical practice, such as to evaluate 

clinical outcomes in populations 

underrepresented in clinical trials, to 

note that registries should have a plan 

to reduce missing assessments and 

minimize loss to followup of 

participants, and to provide additional 

considerations related to linkage to 

other data sources. Examples of 

pregnancy-related information that may 

be collected by a registry were removed 

because this information is addressed in 

a separate guidance. Terms that may be 

defined differently by different 

stakeholders were removed from the 

guidance if they were not necessary to 

understand the content of the guidance. 

Other relevant definitions were 

transferred from the glossary to the text. 

In addition, editorial changes 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 ‘‘Real-World Data: 

Assessing Registries to Support 

Regulatory Decision-Making for Drug 

and Biological 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 11 have been approved 

under OMB control number 0910–0303. 

The collections of information in 21 

CFR parts 50 and 56 have been 

approved under OMB control number 

0910–0130. The collections of 

information in 21 CFR 201.56 and 

201.57 have been approved under OMB 

control number 0910–0572. The 

collections of information in 21 CFR 

parts 310 and 314 have been approved 

under OMB control number 0910–0230. 

The collections of information in 21 

CFR parts 310, 314, and 600 have been 

approved under OMB control number 

0910–0291. The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. The collections of 

information in 21 CFR part 600 have 

been approved under OMB control 

number 0910–0308. The collections of 

information resulting from formal 

meetings between sponsors or 

applicants and FDA have been approved 

under OMB control number 0910–0001. 

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/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 


ddrumheller on DSK120RN23PROD with NOTICES1
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