Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry; Availability, 64443-64444 [2023-20241]

Download as PDF 64443 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 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 Average burden per recordkeeping Total hours 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Number of record per recordkeepers § 11.10; controls for closed systems ................................... § 11.30; controls for open systems ...................................... § 11.50; signature manifestations ........................................ § 11.300; controls for identifications and passwords ........... 2,500 2,500 5,000 5,000 1 1 1 1 2,500 2,500 5,000 5,000 20 20 20 20 50,000 50,000 100,000 100,000 Total .............................................................................. ........................ ........................ ........................ ........................ 300,000 21 CFR section 1 There 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. 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Drug Administration [Docket No.FDA–2023–D–2482] Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry; Availability Food and Drug Administration, HHS. ddrumheller on DSK120RN23PROD with NOTICES1 ACTION: Notice of availability. 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 SUMMARY: VerDate Sep<11>2014 18:21 Sep 18, 2023 Jkt 259001 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 [FR Doc. 2023–20233 Filed 9–18–23; 8:45 am] AGENCY: Total annual records 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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 E:\FR\FM\19SEN1.SGM 19SEN1 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-201509-18/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 VerDate Sep<11>2014 18:21 Sep 18, 2023 Jkt 259001 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 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 E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64443-64444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20241]


-----------------------------------------------------------------------

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 drug-
led, 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

[[Page 64444]]

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, [email protected]; 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, [email protected].

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 use-related 
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 use-related 
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/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-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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