Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88629 

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: December 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28244 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–1128] 

Digital Health Technologies for Remote 

Data Acquisition in Clinical 

Investigations; Guidance for Industry, 

Investigators, and Other Stakeholders; 

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, investigators, and 

other stakeholders entitled ‘‘Digital 

Health Technologies for Remote Data 

Acquisition in Clinical Investigations.’’ 

This guidance provides 

recommendations on the use of digital 

health technologies (DHTs) to acquire 

data remotely from participants in 

clinical investigations that evaluate 

medical products. DHTs for remote data 

acquisition in clinical investigations can 

include hardware and/or software to 

perform one or more functions. Use of 

DHTs as recommended in this guidance 

may improve the efficiency of clinical 

trials for sponsors, investigators, and 

other stakeholders and may increase the 

opportunities for individuals to 

participate in research and make 

participation more convenient. This 

guidance finalizes the draft guidance of 

the same title issued on December 23, 

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–1128 for ‘‘Digital Health 

Technologies for Remote Data 

Acquisition in Clinical Investigations.’’ 

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; 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; or the Office of Policy, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 


ddrumheller on DSK120RN23PROD with NOTICES1
88630 Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 

1PDUFA VII: Fiscal Years 2023–2027 | FDA 

available at https://www.fda.gov/media/151712/ 

download?attachment. 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Kunkoski, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3332, 

Silver Spring, MD 20993–0002, 301– 

796–6439, Elizabeth.Kunkoski@

fda.hhs.gov; 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, James.Myers@

fda.hhs.gov; Matthew Diamond, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

5540, Silver Spring, MD 20993–0002, 

301–796–5386, Matthew.Diamond@

fda.hhs.gov; or Paul Kluetz, Oncology 

Center of Excellence, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2223, Silver Spring, 

MD 20993, 301–796–9567, Paul.Kluetz@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Digital 

Health Technologies for Remote Data 

Acquisition in Clinical Investigations.’’ 

This guidance addresses requirements 

set forth in section 3607(a) of the Food 

and Drug Omnibus Reform Act of 2022 

(FDORA) and meets a Prescription Drug 

User Fee Act (PDUFA) Reauthorization 

Performance Goal to finalize guidance 

on DHTs (section IV.C.5.b of the PDUFA 

VII commitment letter).1 This guidance 

provides recommendations for ensuring 

that a DHT is fit-for-purpose (i.e., that 

the level of validation associated with 

the DHT is sufficient to support its use, 

including the interpretability of its data 

in the clinical investigation), which 

involves considerations of both the 

DHT’s form (i.e., design) and function(s) 

(i.e., distinct purpose within an 

investigation). DHTs may rely on or 

work with other technologies, such as 

general-purpose computing platforms 

(e.g., smartphones) and communication 

networks, for remote data acquisition in 

a clinical investigation. Compared to 

intermittent trial visits, the use of DHTs 

to remotely collect data from trial 

participants may allow for continuous 

or more-frequent data collection. This 

may provide a broader picture of how 

participants feel or function in their 

daily lives. DHTs provide opportunities 

to record data directly from trial 

participants (e.g., biomarkers, 

performance of activities of daily living, 

sleep, vital signs) wherever the 

participants may be (e.g., home, school, 

work, outdoors). The data collection 

may involve passive monitoring by the 

DHT or the acquisition of data while 

participants are actively interacting with 

the DHT. 

This guidance outlines 

recommendations intended to facilitate 

the use of DHTs in a clinical 

investigation as appropriate for the 

evaluation of medical products. The 

guidance provides recommendations on, 

among other things: (1) selection of 

DHTs that are suitable for use in clinical 

investigations; (2) the description of 

DHTs in regulatory submissions; (3) 

verification and validation of DHTs for 

use in clinical investigations; (4) use of 

DHTs to collect data for trial endpoints; 

(5) identification and management of 

risks associated with the use of DHTs 

during clinical investigations; (6) 

retention and protection of data 

collected by DHTs; and (7) the roles of 

sponsors and investigators related to the 

use of DHTs in clinical investigations. 

This guidance finalizes the draft 

guidance of the same title issued on 

December 23, 2021 (86 FR 72981). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to the 

final guidance include clarification 

regarding the meaning of DHT 

function(s) for the purposes of the 

guidance; further explanation of 

regulatory considerations for DHTs that 

meet the definition of a device under 

section 201(h) of the Federal Food, 

Drug, and Cosmetic Act; clarification 

regarding the use of participants’ own 

DHTs or other technologies in clinical 

investigations; inclusion of references to 

Form FDA 1571 and Form FDA 356h for 

tracking submissions that include DHT 

data; revisions to the verification, 

validation and usability evaluations 

section; clarification on DHT record 

protection and retention; clarification 

on the sponsor and investigator’s roles; 

and further recommendations on 

handling DHT updates and other 

changes during clinical investigations. 

In addition, editorial changes were 

made to improve clarity. 

Section 3607(a) of FDORA requires 

FDA to, within 1 year of enactment, 

issue or revise draft guidance regarding 

the appropriate use of DHTs in clinical 

trials. This provision of FDORA further 

requires that, not later than 18 months 

after the end of the public comment 

period on the draft guidance, FDA must 

issue a revised draft guidance or final 

guidance. This guidance revises and 

finalizes a draft guidance on use of 

DHTs in clinical trials issued December 

23, 2021. Most of the content required 

to be included in guidance under 

FDORA section 3607(a) was included in 

the draft version of this guidance that 

was open to public comment and such 

comments were considered in finalizing 

this guidance. The few additions to 

address the remaining FDORA section 

3607(a) content requirements are minor. 

As noted above, you may submit 

comments on a guidance at any time. As 

with any guidance, FDA will consider 

comments received and issue any 

further revisions that we determine to 

be appropriate, consistent with 21 CFR 

10.115. To ensure that the Agency 

considers your comments in 

determining if any further revisions to 

this guidance are appropriate, submit 

your comments by February 20, 2024. 

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 ‘‘Digital Health 

Technologies for Remote Data 

Acquisition in Clinical Investigations.’’ 

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 11 have been 

approved under OMB control number 

0910–0303; the collections of 

information in 21 CFR part 312, 

including submissions under subpart E, 

and 21 CFR 312.41, 312.57, 312.58, 

312.62, and 312.120 have been 

approved under OMB control number 

0910–0014; the collections of 

information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485; the collections of 

information under 21 CFR part 807, 

subpart E, have been approved under 

OMB control number 0910–0120; the 

collections of information under 21 CFR 

part 814, subparts A through E, have 

been approved under OMB control 

number 0910–0231; the collections of 

information under 21 CFR part 814, 

subpart H, have been approved under 

OMB control number 0910–0332; the 


ddrumheller on DSK120RN23PROD with NOTICES1
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