[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Products: Questions and Answers; Revised Draft Guidance for Industry;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the availability of a revised draft guidance for industry entitled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 This revised draft guidance, when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explained in the revised draft guidance).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supersedes the revised draft guidance entitled ``Distributing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Practices'' issued in 2014 (2014 revised draft guidance).
DATES: Submit either electronic or written comments on the draft
guidance by December 26, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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proposed collection of information in the draft guidance by December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.
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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