[Federal Register Volume 89, Number 204 (Tuesday, October 22, 2024)]
[Notices]
[Pages 84353-84354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-3903]


Drug Interaction Information in Human Prescription Drug and 
Biological Product Labeling--Content and Format; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Drug 
Interaction Information in Human Prescription Drug and Biological 
Product Labeling.'' The draft guidance is intended to assist applicants 
in developing the DRUG INTERACTIONS section of labeling as described in 
FDA regulations for the content and format of labeling for human 
prescription drug and biological products. The purpose of the draft 
guidance is to provide recommendations on what information to include 
in, and how to present and organize the information within, the DRUG 
INTERACTIONS section of labeling for human prescription drug and 
biological products to enhance communication of clinically significant 
drug interactions and facilitate the safe and effective use of 
prescription drugs by healthcare practitioners.

DATES: Submit either electronic or written comments on the draft 
guidance by January 21, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: 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.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2024-D-3903 for ``Drug Interaction Information in Human 
Prescription Drug and Biological Product Labeling; Draft Guidance for 
Industry.'' 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.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The 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://

[[Page 84354]]

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, or the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. The guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph Grillo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0591; or 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Drug Interactions Section of Labeling for Human Prescription 
Drug and Biological Products--Content and Format.'' The draft guidance 
is intended to assist applicants in developing the DRUG INTERACTIONS 
section of the Prescribing Information labeling as described in FDA 
regulations for the content and format of labeling for human 
prescription drug and biological products.\1\
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    \1\ 21 CFR 201.56(a) and (d) and 201.57(c)(8). This guidance 
applies to drugs, including biological products that are regulated 
as drugs. For the purpose of this guidance, ``drug product'' or 
``drug'' will be used to refer to human prescription drug and 
biological products that are regulated as drugs.
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    Prescription drug labeling must contain a summary of the essential 
information necessary for safe and effective use of the drug and is a 
primary tool for FDA to communicate drug interaction information to 
healthcare practitioners. Effective communication of drug interaction 
information informs the optimal use of the drug and the healthcare 
practitioner's clinical decision-making (e.g., prescribing decisions or 
management instructions).
    The purpose of this guidance is to provide recommendations on what 
information to include in, and how to present and organize the 
information within, the DRUG INTERACTIONS section of prescription drug 
labeling to enhance communication of clinically significant drug 
interactions and facilitate the safe and effective use of prescription 
drugs by healthcare practitioners. This guidance also provides 
illustrative examples of the content and format of drug interaction 
information in prescription drug labeling.
    In addition, the guidance includes an FDA website (https://www.fda.gov/CYPandTransporterInteractingDrugs) as one resource that 
health care practitioners can use to view examples of clinical 
substrates, inhibitors, and inducers of Cytochrome P-450 (CYP) enzymes 
and substrates and inhibitors of transporters. FDA is seeking input 
regarding the utility of this website as a resource that health care 
practitioners can reference to find examples of clinical substrates, 
inhibitors, and inducers of CYP enzymes and substrates and inhibitors 
of transporters. FDA is also seeking input on ways to describe drug 
interactions in labeling, specifically when drugs have numerous, 
clinically relevant drug interactions (e.g., azole antimycotics) that 
require listing many interactions. In addition, FDA is seeking input on 
ways to describe complex drug-interaction scenarios, including but not 
limited to:
    <bullet> Concurrent inhibition of an enzyme and a transporter by a 
drug;
    <bullet> Concurrent inhibition and induction of a drug's metabolic 
pathway by one or more enzymes;
    <bullet> Increased inhibition of drug elimination by use of 
inhibitors of more than one enzyme that metabolizes the drug;
    <bullet> Inhibition of an enzyme other than the genetic polymorphic 
enzyme in poor metabolizers taking a substrate metabolized by both 
enzymes;
    <bullet> Effect of enzyme/transporter inhibitors in subjects with 
organ impairment; and
    <bullet> Two drugs acting as both precipitant and object of a drug 
interaction.
    The draft guidance, when finalized, will represent the current 
thinking of FDA on ``Drug Interaction Information in Human Prescription 
Drug and Biological Product Labeling.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR parts 314 and 601 are approved under OMB control numbers 
0910-0001 and 0910-0338, respectively. The collections of information 
in 21 CFR parts 201.56 and 201.57 have been approved under OMB control 
number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: October 16, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24442 Filed 10-21-24; 8:45 am]
BILLING CODE 4164-01-P