Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 64443 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

§ 11.100; submission of nonrepudiation letters ................... 5,000 1 5,000 1 5,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

record per 

recordkeepers 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

§ 11.10; controls for closed systems ................................... 2,500 1 2,500 20 50,000 

§ 11.30; controls for open systems ...................................... 2,500 1 2,500 20 50,000 

§ 11.50; signature manifestations ........................................ 5,000 1 5,000 20 100,000 

§ 11.300; controls for identifications and passwords ........... 5,000 1 5,000 20 100,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 300,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have increased our 

estimated burden. We assume 5,000 

nonrepudiation letters will be submitted 

annually. We arrived at this figure by 

looking at the average number of 

nonrepudiation letters received through 

March 2023. We further assume that 

half of the estimated respondents will 

establish controls for open systems and 

half will establish controls for closed 

systems. Finally, we assume all 

respondents will establish controls for 

the remaining technical specifications 

required by the regulations. 

Dated: September 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20233 Filed 9–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No.FDA–2023–D–2482] 

Regulatory Considerations for 

Prescription Drug Use-Related 

Software; Draft Guidance for Industry; 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 draft 

guidance for industry entitled 

‘‘Regulatory Considerations for 

Prescription Drug Use-Related 

Software.’’ This draft guidance describes 

FDA’s application of its drug labeling 

authorities to certain software outputs 

that are disseminated by or on behalf of 

a drug sponsor for use with a 

prescription drug or a prescription drugled, drug-device combination product, 

which is assigned to the Center for Drug 

Evaluation and Research or the Center 

for Biologics Evaluation and Research as 

the lead center. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 18, 2023 to ensure that the 

Agency considers your comments on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any 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 

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– 

2023–D–2482 for ‘‘Regulatory 

Considerations for Prescription Drug 

Use-Related Software.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
64444 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 

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 draft 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, to the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002, or 

to 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 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Chris Wheeler, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3330, 

Silver Spring, MD 20993, 301–796– 

2500, CDEROMP@fda.hhs.gov; Anne 

Taylor, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7256, Silver Spring, 

MD 20993, 240–402–5683; or Sonja 

Fulmer, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5536, Silver Spring, 

MD 20993–0002, 240–402–5979, 

digitalhealth@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Regulatory Considerations for 

Prescription Drug Use-Related 

Software.’’ This draft guidance expands 

on and was developed in response to 

comments submitted in response to the 

Federal Register notice ‘‘Prescription 

Drug-Use-Related Software; 

Establishment of a Public Docket; 

Request for Comments’’ (November 20, 

2018; 83 FR 58574). As explained in this 

draft guidance, prescription drug userelated software generally includes 

software that: (1) is disseminated by or 

on behalf of a drug sponsor and (2) 

produces an end-user output that 

supplements, explains, or is otherwise 

textually related to one or more of the 

sponsor’s drug products. A software 

function is any distinct purpose of the 

software, and end-user output is any 

material (content) that the prescription 

drug use-related software presents to the 

end user (a patient, caregiver, or health 

care practitioner). As discussed in this 

draft guidance, FDA considers end-user 

output a type of prescription drug 

labeling. 

This draft guidance, when finalized, 

will clarify how FDA intends to apply 

its drug labeling authorities to end-user 

output of prescription drug use-related 

software, how FDA intends to treat 

certain prescription drug use-related 

software as FDA-required labeling, and 

when and how sponsors should submit 

end-user output to FDA. Generally, the 

recommendations provided in this draft 

guidance are intended to align with 

ongoing Agency initiatives across all 

product centers, including digital health 

initiatives at the Center for Devices and 

Radiological Health. This draft guidance 

considers existing Agency policies for 

the regulation of software to ensure 

efficient, coordinated review in 

instances when prescription drug userelated software is reviewed by the 

Agency as a device. 

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 ‘‘Regulatory Considerations for 

Prescription Drug Use-Related 

Software.’’ 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 new 

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 314 for new 

drug applications and abbreviated new 

drug applications have been approved 

under OMB control number 0910–0001. 

The collections of information in 21 

CFR 601.2 and 601.12 for biologics 

license applications and supplemental 

applications have been approved under 

OMB control number 0910–0338. The 

collections of information in Form FDA 

2253 have been approved under OMB 

control number 0910–0001. The 

collections of information for 

prescription drug product labeling 

requirements in 21 CFR 201.56 have 

been approved under OMB control 

number 0910–0572. The collections of 

information in 21 CFR 202.1 for 

prescription drug advertisements have 

been approved under OMB control 

number 0910–0686. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft 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: September 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20241 Filed 9–18–23; 8:45 am] 

BILLING CODE 4164–01–P 


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