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, 1146-1150 [2024-31539]
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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; 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.
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This guidance finalizes the revised draft
guidance of the same title issued in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draft guidance revised and replaced the
draft guidance entitled ‘‘Distributing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.
SUMMARY:
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
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DATES:
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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
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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-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 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
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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 selfaddressed 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, PRAStaff@
fda.hhs.gov.
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
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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:
D Clinical practice guidelines (CPGs)
D Scientific or medical reference texts
(reference texts)
D 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
PO 00000
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1147
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 firmgenerated 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
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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
respondents
Information collection activity; guidance section
Total annual
disclosures
Average
burden per
disclosure
Total hours
A statement that the 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;
section V. Q2.
A statement disclosing the FDA-approved use(s) of the medical product,
including any limitations of use specified in the FDA-required labeling;
section V. Q2.
A statement disclosing any limitations, 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 labeling (or a mechanism for
obtaining this labeling, as appropriate); section V. Q2.
A statement describing any contraindication(s) in the FDA-required labeling for the medical product; section V. Q2.
A statement describing any 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; section V. Q2.
A statement identifying any 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
a firm acting reasonably would know of such relationship; section V.
Q2.
In the case of an SIUU communication that 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 included source publication (if
not specified in the source publication or citation); section V. Q2.
When a firm shares an SIUU communication that 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 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 firmgenerated; section V. Q5.
747
30
22,410
0.1 (6 minutes) .....
2,241
747
27
20,169
0.1 (6 minutes) .....
2,016.9
747
5
3,735
0.2 (12 minutes) ...
747
747
27
20,169
0.1 (6 minutes) .....
2,016.9
747
3
2,241
0.1 (6 minutes) .....
224.1
747
25
18,675
0.2 (12 minutes) ...
3,735
747
20
14,940
0.2 (12 minutes) ...
2,988
747
20
14,940
2.75 ......................
41,085
747
3
2,241
0.1 (6 minutes) .....
224.1
747
3
2,241
0.1 (6 minutes) .....
224.1
747
10
7,470
0.1 (6 minutes) .....
747
Total ....................................................................................................
........................
............................
129,231
...............................
56,249.1
1 There
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Number of
disclosures per
respondent
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
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respondents’’ in table 1) may each
choose to publicly share 30 SIUU
communications annually. Our estimate
of the burden per disclosure (2.5 hours)
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Fmt 4703
Sfmt 4703
reflects what we believe is the average
burden based on the number and
content and complexity of disclosures
as recommended in the guidance.
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TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN—OMB CONTROL NO. 0910–0485 1
Number of
respondents
Information collection activity; guidance section
Total annual
disclosures
Average
burden per
disclosure
Total hours
A statement that the 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;
section V. Q2.
A statement disclosing the FDA-approved use(s) of the medical product,
including any limitations of use specified in the FDA-required labeling;
section V. Q2.
A statement disclosing any limitations, 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 labeling (or a mechanism for
obtaining this labeling, as appropriate); section V. Q2.
A statement describing any contraindication(s) in the FDA-required labeling for the medical product; section V. Q2.
A statement describing any 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; section V. Q2.
A statement identifying any 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
a firm acting reasonably would know of such relationship; section V.
Q2.
In the case of an SIUU communication that 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 included source publication (if
not specified in the source publication or citation); section V. Q2.
When a firm shares an SIUU communication that 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 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 firmgenerated; section V. Q5.
261
30
7,830
0.1 (6 minutes) .....
783
261
27
7,047
0.1 (6 minutes) .....
704.7
261
5
1,305
0.2 (12 minutes) ...
261
261
27
7,047
0.1 (6 minutes) .....
704.7
261
3
783
0.1 (6 minutes) .....
78.3
261
25
6,525
0.2 (12 minutes) ...
1,305
261
20
5,220
0.2 (12 minutes) ...
1,044
261
20
5,220
2.75 ......................
14,355
261
3
783
0.1 (6 minutes) .....
78.3
261
3
783
0.1 (6 minutes) .....
78.3
261
10
2,610
0.1 (6 minutes) .....
261
Total ....................................................................................................
........................
............................
45,153
...............................
19,653.3
1 There
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Number of
disclosures per
respondent
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
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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/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm,
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4976]
Pulse Oximeters for Medical
Purposes—Non-Clinical and Clinical
Performance Testing, Labeling, and
Premarket Submission
Recommendations; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Pulse Oximeters for
Medical Purposes—Non-Clinical and
Clinical Performance Testing, Labeling,
and Premarket Submission
Recommendations.’’ This draft guidance
document, when finalized, will provide
recommendations regarding non-clinical
and clinical performance testing of
certain pulse oximeters for medical
purposes, including devices with a
pulse oximeter function that estimates
the amount of oxygen in arterial blood
and pulse rate. These recommendations
are being proposed based in part on
concerns that the accuracy of pulse
oximeters can be affected by, among
other factors, a person’s skin
pigmentation. The recommendations are
being proposed to inform the
performance evaluation for these
devices, to support premarket
submissions, regardless of submission
type, and to promote consistency and
facilitate efficient review of these
submissions. Among other topics, the
draft guidance also proposes
recommendations for labeling, which
are intended to promote the safe and
effective use of pulse oximeters and
help users understand the benefits and
risks associated with the use of the
device. This draft guidance is not final
nor is it for implementation at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by March 10, 2025 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
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SUMMARY:
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You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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–N–4976 for ‘‘Pulse Oximeters for
Medical Purposes—Non-Clinical and
Clinical Performance Testing, Labeling,
and Premarket Submission
Recommendations.’’ 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
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
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-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)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Pulse Oximeters for
Medical Purposes—Non-Clinical and
Clinical Performance Testing, Labeling,
and Premarket Submission
Recommendations’’ to the Office of
Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5441, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Kumudhini Hendrix, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[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
