[Federal Register Volume 88, Number 204 (Tuesday, October 24, 2023)]
[Notices]
[Pages 73031-73034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23372]



[[Page 73031]]

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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Products: Questions and Answers; Revised Draft Guidance for Industry; 
Availability; Agency Information Collection Activities; Proposed 
Collection; Comment Request

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the availability of a revised draft guidance for industry entitled 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 This revised draft guidance, when 
finalized, will provide FDA's current thinking on common questions 
regarding certain communications by firms to health care providers 
(HCPs) of scientific information on unapproved use(s) of approved/
cleared medical products (the scope of the italicized terms is further 
explained in the revised draft guidance). This revised guidance 
supersedes the revised draft guidance entitled ``Distributing 
Scientific and Medical Publications on Unapproved New Uses--Recommended 
Practices'' issued in 2014 (2014 revised draft guidance).

DATES: Submit either electronic or written comments on the draft 
guidance by December 26, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance. Submit electronic or written comments on the 
proposed collection of information in the draft guidance by December 
26, 2023.

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-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 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; 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 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, 
(HFV-6), 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 request. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: With regard to the draft 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; Anne Taylor, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903

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New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911; Ana Loloei, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5504, Silver Spring, MD 20993-0002, 301-796-8774; Office of 
Surveillance and Compliance, Center for Veterinary Medicine, Food and 
Drug Administration, 7500 Standish Pl. (HFV-6), Rockville, MD 20855, 
240-402-7082; 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.
    With regard to the proposed collection of information: Domini Bean, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10 a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 
301-796-5733, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft 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.'' Specifically, this revised 
draft guidance relates to firms sharing the following types of 
communications with HCPs:
     published scientific or medical journal articles 
(reprints),
     published clinical reference resources, as follows:
    [cir] clinical practice guidelines (CPGs),
    [cir] scientific or medical reference texts (reference texts),
    [cir] materials from independent clinical practice resources, and
     firm-generated presentations of scientific information 
from an accompanying published reprint.
    For the purposes of this revised draft guidance, these specific 
types of communications from firms to HCPs of scientific information on 
unapproved uses (SIUU) of approved/cleared medical products in 
combination with the disclosures recommended in the guidance are 
referred to as ``SIUU communications.'' We acknowledge that firms share 
SIUU communications through different media (e.g., paper, digital), and 
the recommendations in this guidance apply regardless of the medium of 
the communication. Other communications by firms are not specifically 
addressed by this revised draft guidance, and we do not intend to 
convey any views on such communications in issuing this revised draft 
guidance.
    This revised draft guidance represents a continuation of FDA's 
ongoing efforts to consider, develop, and refine its policies and 
recommendations relating to communications by firms about unapproved 
uses of their approved/cleared medical products. In 2009, FDA issued a 
final guidance for industry 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'' (74 FR 1694) to provide guidance 
to firms on distributing ``journal articles'' and ``scientific or 
medical reference publications.'' Then, FDA issued the 2014 revised 
draft guidance (79 FR 11793) to clarify the Agency's position on firms 
disseminating scientific or medical reference texts and CPGs that 
include information on unapproved uses of the firm's medical products 
and to provide additional explanation on these topics.
    In developing this revised draft guidance, FDA considered 
stakeholder feedback, including comments received on the 2014 revised 
draft guidance. This revised draft guidance will supersede the 2014 
revised draft guidance. Changes include a revised title, a question-
and-answer format, and certain changes in scope.
    The Federal Food, Drug, and Cosmetic Act, the Public Health Service 
Act, and their implementing regulations prohibit, among other things, 
the introduction (or causing the introduction) into interstate commerce 
of a medical product that fails to comply with applicable premarket 
requirements or is otherwise misbranded or adulterated. This 
prohibition includes introducing (or causing the introduction) into 
interstate commerce a medical product that is intended for a use that 
has not been approved or cleared by FDA, even if that same product is 
approved or cleared for a different use. These premarket requirements 
further multiple important government interests and distributing 
approved/cleared medical products for unapproved uses can undermine 
these interests. In certain circumstances, however, HCPs may be 
interested in scientific information about unapproved uses of approved/
cleared medical products to inform clinical practice decisions for the 
care of an individual patient. In developing this draft guidance, FDA 
has sought to strike a careful balance between supporting HCP interest 
in scientific information about unapproved uses of approved/cleared 
medical products to inform clinical practice decisions for the care of 
an individual patient, and mitigating the potential that the government 
interests advanced by these statutory requirements will be undermined.
    In light of those goals, FDA believes it is critical that SIUU 
communications be truthful, non-misleading, factual and unbiased and 
provide all information necessary for HCPs to interpret the strengths 
and weaknesses and validity and utility of the information in the SIUU 
communication. In addition, any study or analysis described in a source 
publication that serves as the basis for an SIUU communication should 
be scientifically sound. The studies or analyses should also provide 
information that is relevant to HCPs engaged in making clinical 
practice decisions for the care of an individual patient (as used in 
this revised draft guidance, ``clinically relevant''). The manner of 
presentation of SIUU communications is also critical to consider. This 
revised draft guidance provides recommendations addressing all of these 
considerations.
    If a firm shares an SIUU communication with HCPs in a manner that 
is consistent with the recommendations in this revised draft guidance, 
FDA does not intend to use such communication standing alone as 
evidence of a new intended use.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The revised draft 
guidance, when finalized, will represent 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

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in

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the Federal Register concerning each proposed collection of information 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Recommendations for Drug and Device Manufacturer Communications With 
Payors, Formulary Committees, and Similar Entities; and Communications 
From Firms to Health Care Providers Regarding Scientific Information on 
Unapproved Uses of Approved/Cleared Medical Products

Questions and Answers
OMB Control Number 0910-0857--Revision
    The revised draft guidance document, ``Communications From Firms to 
Health Care Providers Regarding Scientific Information on Unapproved 
Uses of Approved/Cleared Medical Products: Questions and Answers,'' 
discusses information disclosures that we recommend firms include in 
SIUU communications if the firms choose to publicly share such 
communications.
    We estimate the burden of the information collection as follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                   Number of
    Recommended disclosure         Number of      disclosures    Total annual    Average burden     Total hours
  activity; guidance section      respondents   per respondent    disclosures    per disclosure
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A statement that the                     1,008              30          30,240  0.1 (6 minutes).           3,024
 unapproved use(s) of the
 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; Q2.
A statement disclosing the FDA-          1,008              27          27,216  0.1 (6 minutes).         2,721.6
 approved use(s) of the
 medical product, including
 any limitations of use
 specified in the FDA-required
 labeling; Q2.
A statement disclosing any               1,008               5           5,040  0.2 (12 minutes)           1,008
 limitations, restrictions,
 cautions, or warnings
 described in the FDA-required
 labeling about the unapproved
 use(s); Q2.
A copy of the most current FDA-          1,008              27          27,216  0.1 (6 minutes).         2,721.6
 required labeling (or a
 mechanism for obtaining this
 labeling, as appropriate); Q2.
A statement describing any               1,008               3           3,024  0.1 (6 minutes).           302.4
 contraindication(s) in the
 FDA-required labeling for the
 medical product; Q2.
A statement describing any               1,008              25          25,200  0.2 (12 minutes)           5,040
 serious, life-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; Q2.
A statement identifying any              1,008              20          20,160  0.2 (12 minutes)           4,032
 authors, editors, 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
 that a firm acting reasonably
 would know of such
 relationship; Q2.
In the case of an SIUU                   1,008              20          20,160  2.75............          55,440
 communication that is based
 on a source publication that
 is primarily focused on a
 particular scientific study
 or studies, for each such
 study where the following
 information is not included
 in the 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; and
    --When applicable,
     conclusions from other
     relevant studies that are
     contrary to, or cast
     doubt on, the results
     shared, including
     citations for any such
     studies; Q2.

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The publication date of any              1,008               3           3,024  0.1 (6 minutes).           302.4
 referenced or included
 publication(s) (if not
 specified in the publication
 or citation); Q2.
When firms share an SIUU                 1,008               3           3,024  0.1 (6 minutes).           302.4
 communication in the form of
 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 the FDA and the
 safety and effectiveness of
 any unapproved use(s) have
 not been established.''; Q4.
When firms share an SIUU                 1,008              10          10,080  0.1 (6 minutes).           1,008
 communication in the form of
 a firm-generated presentation
 of scientific information
 from an accompanying reprint
 that SIUU communication
 should clearly disclose what
 portions of the communication
 are firm-generated; Q4.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............         174,384  ................        75,902.4
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\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 approved/cleared 
human and animal drug products (747), combined with an estimated number 
of device firms marketing products (261), we assume 1,008 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.

III. Request for Comment on Other Issues for Consideration

    FDA is interested in additional matters related to communications 
by firms about scientific information on unapproved use(s) of approved/
cleared medical products. This revised draft guidance pertains to these 
communications by firms to HCPs engaged in making clinical practice 
decisions for the care of an individual patient. FDA is specifically 
seeking input on the following:
    1. What considerations, if any, exist that are unique to 
communications of scientific information about unapproved use(s) of 
approved/cleared medical products by firms to researchers (including 
HCPs working in their capacity as researchers)?
    2. What other factors should firms consider when sharing firm-
generated presentations (as described in the draft guidance) to ensure 
that presentations are truthful, non-misleading, factual and unbiased 
and provide all information necessary for HCPs to interpret the 
strengths and weaknesses and validity and utility of the presented 
information?

IV. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the draft 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.

    Dated: October 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23372 Filed 10-23-23; 8:45 am]
BILLING CODE 4164-01-P