Notice2023-20241
Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry; Availability
Primary source
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Published
September 19, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Regulatory Considerations for Prescription Drug Use-Related Software." This draft guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a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.
Full Text
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<title>Federal Register, Volume 88 Issue 180 (Tuesday, September 19, 2023)</title>
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[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64443-64444]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20241]
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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Software; Draft Guidance for Industry; Availability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.
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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the availability of a draft guidance for industry entitled ``Regulatory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 This draft
guidance describes FDA's application of its drug labeling authorities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DATES: Submit either electronic or written comments on the draft
guidance by December 18, 2023 to ensure that the Agency considers your
comments on this draft guidance before it begins work on the final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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#e0a3a4a5b2afadb0a0868481ce888893ce878f96"><span class="__cf_email__" data-cfemail="480b0c0d1a070518082e2c296620203b662f273e">[email protected]</span></a>; 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, <a href="/cdn-cgi/l/email-protection#6b0f020c021f0a07030e0a071f032b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="2d49444a44594c4145484c4159456d4b494c0345455e034a425b">[email protected]</span></a>.
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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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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