```

[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1146-1150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31539]

[[Page 1146]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0053]

Communications From Firms to Health Care Providers Regarding 
Scientific Information on Unapproved Uses of Approved/Cleared Medical 
Products: Questions and Answers; Guidance for Industry; Availability; 
Agency Information Collection Activities; Submission for Office of 
Management and Budget Review; Comment Request

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 
``Communications From Firms to Health Care Providers Regarding 
Scientific Information on Unapproved Uses of Approved/Cleared Medical 
Products: Questions and Answers.'' This guidance describes FDA's 
enforcement policy regarding certain firm-initiated communications of 
scientific information on unapproved use(s) of the firm's approved/
cleared medical products to health care providers (HCPs) engaged in 
prescribing or administering medical products to individual patients. 
This guidance finalizes the revised draft guidance of the same title 
issued in October 2023. The October 2023 revised draft guidance revised 
and replaced the draft guidance entitled ``Distributing Scientific and 
Medical Publications on Unapproved New Uses--Recommended Practices,'' 
issued in March 2014, which itself revised the final guidance entitled 
``Good Reprint Practices for the Distribution of Medical Journal 
Articles and Medical or Scientific Reference Publications on Unapproved 
New Uses of Approved Drugs and Approved or Cleared Medical Devices,'' 
issued in January 2009. This guidance is not for current 
implementation, pending the Office of Management and Budget's (OMB's) 
decision on the collection of information.

DATES: The announcement of the guidance is published in the Federal 
Register on January 7, 2025. Submit written comments on the collection 
of information by February 21, 2025.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find the particular information 
collections by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control numbers 
that FDA is seeking to revise are 0910-0686 and 0910-0485. Also include 
the FDA docket number found in brackets in the heading of this 
document. 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-2008-D-0053 for ``Communications From Firms to Health Care 
Providers Regarding Scientific Information on Unapproved Uses of 
Approved/Cleared Medical Products: Questions and Answers.'' 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, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; the 
Office of Policy, Center for Devices

[[Page 1147]]

and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or 
the Policy and Regulations Staff, Center for Veterinary Medicine, Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 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: 
    Regarding the guidance: Kathleen David, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Room 3203, Silver Spring, MD 20993-0002, 301-796-1200; 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; Stephanie Philbin, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 
301-837-7151; Kathryn Dennehy, Office of Surveillance and Compliance, 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-7002; or Julie Finegan, 
Office of Policy, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver 
Spring, MD 20993-0002, 301-827-4830.
    Regarding the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Communications From Firms to Health Care Providers Regarding 
Scientific Information on Unapproved Uses of Approved/Cleared Medical 
Products: Questions and Answers.'' This guidance describes FDA's 
enforcement policy regarding certain firm-initiated communications of 
scientific information on unapproved use(s) of the firm's approved/
cleared medical products to HCPs engaged in prescribing or 
administering medical products to individual patients. FDA is issuing 
this guidance to provide reassurance to firms that, if they choose to 
provide communications consistent with the recommendations in this 
guidance, FDA does not intend to use the firm's dissemination of such 
communication standing alone as evidence of a new intended use. 
Additionally, FDA does not expect a firm to submit such a communication 
to the Agency at the time the communication is initially shared with 
HCPs. We acknowledge that firms communicate in other ways and with 
other audiences, and this guidance neither speaks to nor intends to 
convey any views on communications that are not within the scope of the 
enforcement policy outlined in this guidance.
    The fact that a communication by a firm does not share all the 
characteristics of communications that are within the scope of this 
enforcement policy does not alone mean that FDA intends to rely on it 
to establish a new intended use. A key tenet underlying this 
enforcement approach is that, to promote the public health, any 
individual firm-initiated communication of scientific information about 
unapproved use(s) of that firm's approved/cleared medical product(s) 
should be truthful and non-misleading, and provide and appropriately 
present all information necessary for HCPs to understand and evaluate 
the strengths and weaknesses, validity, and clinical utility of the 
scientific information on unapproved use(s) in that specific 
communication. Accordingly, the guidance provides recommendations 
consistent with those principles. The guidance also describes the 
characteristics of the specific source publications contained in firm-
initiated communications that fall within the enforcement policy 
outlined in this guidance.
    Specifically, this guidance provides recommendations for firms 
initiating the sharing with HCPs of:

 Source publications that are:

--Published scientific or medical journal articles (reprints)
--Published clinical reference resources, as follows:
[ssquf] Clinical practice guidelines (CPGs)
[ssquf] Scientific or medical reference texts (reference texts)
[ssquf] Materials from digital clinical practice resources
 Firm-generated presentations of scientific information on 
unapproved use(s) provided with a source publication

    For the purposes of this guidance, these specific types of firm-
initiated communications to HCPs, in combination with the disclosures 
recommended in this guidance, are referred to as scientific information 
on unapproved use(s) of approved/cleared medical product communications 
(hereafter referred to as ``SIUU communications'').
    This guidance finalizes the revised draft guidance of the same 
title issued in October 2023 (88 FR 73031). FDA considered comments 
received on the draft guidance as the guidance was finalized. Changes 
from the draft to the final guidance include (1) reorganizing the 
guidance to include dedicated glossary and policy sections; (2) 
revising the recommendations for source publications to provide 
additional specificity and examples to illustrate the recommendations; 
(3) refining language around presentational considerations to provide 
additional clarity and an additional example; and (4) updating the 
section on firm-generated presentations to specify that the 
recommendations apply to firm-generated presentations of scientific 
information from any of the source publications addressed in the 
guidance. In addition, editorial changes were made for 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 ``Communications From Firms to Health Care 
Providers Regarding Scientific Information on Unapproved Uses of 
Approved/Cleared Medical Products: Questions and Answers.'' 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

    In compliance with 44 U.S.C. 3507, FDA has submitted the following 
proposed collection of information for OMB review and clearance. This 
guidance is not for current implementation, pending OMB's decision on 
the collection of information.

Manufacturer Communications on Approved and Unapproved Uses of Drugs 
OMB Control Number 0910-0686--Revision; and Medical Device Labeling

OMB Control No. 0910-0485--Revision
    The guidance document entitled ``Communications From Firms to 
Health Care Providers Regarding Scientific Information on Unapproved 
Uses of Approved/Cleared Medical Products: Questions and Answers'' 
discusses third-party disclosure recommendations regarding information 
that we recommend firms include in SIUU

[[Page 1148]]

communications if the firms choose to publicly share such 
communications.
    In the Federal Register of October 24, 2023 (88 FR 73031), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received in response to the 
four information collection topics solicited in the notice.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Third-Party Disclosure Burden--OMB Control No. 0910-0686 \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
   Information collection activity; guidance       Number of     disclosures per   Total annual        Average burden per disclosure        Total hours
                    section                       respondents      respondent       disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
A statement that the unapproved use(s) of the              747                30          22,410  0.1 (6 minutes).......................           2,241
 medical product has not been approved by FDA
 and that the safety and effectiveness of the
 medical product for the unapproved use(s) has
 not been established; section V. Q2.
A statement disclosing the FDA-approved use(s)             747                27          20,169  0.1 (6 minutes).......................         2,016.9
 of the medical product, including any
 limitations of use specified in the FDA-
 required labeling; section V. Q2.
A statement disclosing any limitations,                    747                 5           3,735  0.2 (12 minutes)......................             747
 restrictions, cautions, warnings, or
 precautions described in the FDA-required
 labeling about the unapproved use(s); section
 V. Q2.
A copy of the most current FDA-required                    747                27          20,169  0.1 (6 minutes).......................         2,016.9
 labeling (or a mechanism for obtaining this
 labeling, as appropriate); section V. Q2.
A statement describing any contraindication(s)             747                 3           2,241  0.1 (6 minutes).......................           224.1
 in the FDA-required labeling for the medical
 product; section V. Q2.
A statement describing any serious, life-                  747                25          18,675  0.2 (12 minutes)......................           3,735
 threatening, or fatal risks posed by the
 medical product that are in the FDA-required
 labeling for the medical product or known by
 the firm and that are relevant to the
 unapproved use(s). If a risk evaluation and
 mitigation strategy (REMS) has been
 established under 21 U.S.C. 355-1, the
 statement should disclose that fact and
 should describe the goal(s) of the REMS;
 section V. Q2.
A statement identifying any authors, editors,              747                20          14,940  0.2 (12 minutes)......................           2,988
 or other contributors to publication(s)
 included in the SIUU communication who were
 employees of or consultants to or who
 received compensation from the firm at the
 time of writing, editing, or contributing to
 the publication, to the extent a firm acting
 reasonably would know of such relationship;
 section V. Q2.
In the case of an SIUU communication that                  747                20          14,940  2.75..................................          41,085
 includes one or more source publications
 primarily focused on a particular scientific
 study or studies, for each such study where
 the following information is not included in
 the source publication, provide a description
 of:.
    --All material aspects of study design,
     methodology, and results;
    --All material limitations related to the
     study design, methodology, and results;
    --Any conclusions--from other
     scientifically sound studies that
     evaluated the same or similar hypotheses
     or research questions--that are in
     conflict with the conclusions from the
     studies or analyses described in the
     source publication(s). The citations for
     any such studies should also be included;
     section V. Q2.
The publication date of any referenced or                  747                 3           2,241  0.1 (6 minutes).......................           224.1
 included source publication (if not specified
 in the source publication or citation);
 section V. Q2.
When a firm shares an SIUU communication that              747                 3           2,241  0.1 (6 minutes).......................           224.1
 does not include a firm-generated
 presentation, but does include an unabridged
 CPG or reference text in its entirety that
 discusses a wide range of medical products
 and that discussion is not primarily focused
 on one or more of a firm's medical products,
 the firm should include, in lieu of some of
 the specific disclosures listed above, a more
 general statement in the SIUU communication,
 such as ``This [CPG/reference text] describes
 some uses of medical products that are not
 approved by FDA, and the safety and
 effectiveness of any unapproved use(s) have
 not been established.''; section V. Q4.
When a firm shares an SIUU communication that              747                10           7,470  0.1 (6 minutes).......................             747
 includes a firm-generated presentation of
 scientific information on unapproved use(s)
 provided with a source publication, that SIUU
 communication should clearly disclose what
 portions of the SIUU communication are firm-
 generated; section V. Q5.
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ................         129,231  ......................................        56,249.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a current listing of firms promoting human and animal drug 
products in calendar year (CY) 2022, we assume 747 firms (``number of 
respondents'' in table 1) may each choose to publicly share 30 SIUU 
communications annually. Our estimate of the burden per disclosure (2.5 
hours) reflects what we believe is the average burden based on the 
number and content and complexity of disclosures as recommended in the 
guidance.

[[Page 1149]]

                                 Table 2--Estimated Annual Third-Party Disclosure Burden--OMB Control No. 0910-0485 \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
   Information collection activity; guidance       Number of     disclosures per   Total annual        Average burden per disclosure        Total hours
                    section                       respondents      respondent       disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
A statement that the unapproved use(s) of the              261                30           7,830  0.1 (6 minutes).......................             783
 medical product has not been approved by FDA
 and that the safety and effectiveness of the
 medical product for the unapproved use(s) has
 not been established; section V. Q2.
A statement disclosing the FDA-approved use(s)             261                27           7,047  0.1 (6 minutes).......................           704.7
 of the medical product, including any
 limitations of use specified in the FDA-
 required labeling; section V. Q2.
A statement disclosing any limitations,                    261                 5           1,305  0.2 (12 minutes)......................             261
 restrictions, cautions, warnings, or
 precautions described in the FDA-required
 labeling about the unapproved use(s); section
 V. Q2.
A copy of the most current FDA-required                    261                27           7,047  0.1 (6 minutes).......................           704.7
 labeling (or a mechanism for obtaining this
 labeling, as appropriate); section V. Q2.
A statement describing any contraindication(s)             261                 3             783  0.1 (6 minutes).......................            78.3
 in the FDA-required labeling for the medical
 product; section V. Q2.
A statement describing any serious, life-                  261                25           6,525  0.2 (12 minutes)......................           1,305
 threatening, or fatal risks posed by the
 medical product that are in the FDA-required
 labeling for the medical product or known by
 the firm and that are relevant to the
 unapproved use(s). If a risk evaluation and
 mitigation strategy (REMS) has been
 established under 21 U.S.C. 355-1, the
 statement should disclose that fact and
 should describe the goal(s) of the REMS;
 section V. Q2.
A statement identifying any authors, editors,              261                20           5,220  0.2 (12 minutes)......................           1,044
 or other contributors to publication(s)
 included in the SIUU communication who were
 employees of or consultants to or who
 received compensation from the firm at the
 time of writing, editing, or contributing to
 the publication, to the extent a firm acting
 reasonably would know of such relationship;
 section V. Q2.
In the case of an SIUU communication that                  261                20           5,220  2.75..................................          14,355
 includes one or more source publications
 primarily focused on a particular scientific
 study or studies, for each such study where
 the following information is not included in
 the source publication, provide a description
 of:.
    --All material aspects of study design,
     methodology, and results
    --All material limitations related to the
     study design, methodology, and results
    --Any conclusions--from other
     scientifically sound studies that
     evaluated the same or similar hypotheses
     or research questions--that are in
     conflict with the conclusions from the
     studies or analyses described in the
     source publication(s). The citations for
     any such studies should also be included;
     section V. Q2
The publication date of any referenced or                  261                 3             783  0.1 (6 minutes).......................            78.3
 included source publication (if not specified
 in the source publication or citation);
 section V. Q2.
When a firm shares an SIUU communication that              261                 3             783  0.1 (6 minutes).......................            78.3
 does not include a firm-generated
 presentation, but does include an unabridged
 CPG or reference text in its entirety that
 discusses a wide range of medical products
 and that discussion is not primarily focused
 on one or more of a firm's medical products,
 the firm should include, in lieu of some of
 the specific disclosures listed above, a more
 general statement in the SIUU communication,
 such as ``This [CPG/reference text] describes
 some uses of medical products that are not
 approved by FDA and the safety and
 effectiveness of any unapproved use(s) have
 not been established.''; section V. Q4.
When a firm shares an SIUU communication that              261                10           2,610  0.1 (6 minutes).......................             261
 includes a firm-generated presentation of
 scientific information on unapproved use(s)
 provided with a source publication, that SIUU
 communication should clearly disclose what
 portions of the SIUU communication are firm-
 generated; section V. Q5.
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ................          45,153  ......................................        19,653.3
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on an estimated number of device firms marketing products in 
calendar year (CY) 2022, we assume 261 firms (``number of respondents'' 
in table 1) may each choose to publicly share 30 SIUU communications 
annually. Our estimate of the burden per disclosure (2.5 hours) 
reflects what we believe is the average burden based on the number and 
content and complexity of disclosures as recommended in the guidance.
    FDA is issuing this final guidance subject to OMB approval of the 
collection of information. Before implementing the guidance, FDA will 
publish a notice in the Federal Register announcing OMB's decision to 
approve, modify, or disapprove the collection of information.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

[[Page 1150]]

    Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31539 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
```