Notice2026-11966
Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
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Published
June 15, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.
Full Text
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<title>Federal Register, Volume 91 Issue 114 (Monday, June 15, 2026)</title>
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[Federal Register Volume 91, Number 114 (Monday, June 15, 2026)]
[Notices]
[Pages 35985-35987]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11966]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-D-2698]
Forms FDA 3542a and FDA 3542: Questions and Answers; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry titled ``Forms FDA
3542a and FDA 3542: Questions and Answers.'' This draft guidance is
intended to answer commonly asked questions regarding Forms FDA 3542a
and FDA 3542, and to assist applicants in preparing and submitting
these forms to FDA.
DATES: Submit either electronic or written comments on the draft
guidance by August 14, 2026 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
[[Page 35986]]
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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-2026-D-2698 for ``Forms FDA 3542a and FDA 3542: Questions and
Answers.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Rachel Erdman, Office of Generic
Drugs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Rm. 1715, Silver Spring, MD
20993-0002, 301-651-8301.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Forms FDA 3542a and FDA 3542: Questions and Answers.'' This
guidance is intended to assist New Drug Application (NDA) applicants
and NDA holders in submitting patent information to their NDA using the
appropriate forms, Form FDA 3542a or Form FDA 3542, under 21 CFR
314.53(d). This guidance provides answers to commonly asked questions
regarding Forms FDA 3542a and FDA 3542.
Section 505(b)(1)(A)(viii) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355(b)(1)(A)(viii)) requires an NDA applicant
to submit, as part of its NDA, certain information for ``each patent
for which a claim of patent infringement could reasonably be asserted
if a person not licensed by the owner of the patent engaged in the
manufacture, use, or sale of the drug, and that--(I) claims the drug
for which the applicant submitted the application and is a drug
substance (active ingredient) patent or a drug product (formulation or
composition) patent; or (II) claims a method of using such drug for
which approval is sought . . . in the application.''
Section 505(c)(2) of the FD&C Act (21 U.S.C. 355(c)(2)) requires an
NDA holder to submit, no later than 30 days after the date of approval,
certain information for ``each patent for which a claim of patent
infringement could reasonably be asserted if a person not licensed by
the owner of the patent engaged in the manufacture, use, or sale of the
drug, and that--(I) claims the drug for which the applicant submitted
the application and is a drug substance (active ingredient) patent or a
drug product (formulation or composition) patent; or (II) claims a
method of using such drug for which approval . . . has been granted in
the application.'' Section 505(c)(2) further requires that ``a patent
that is identified as claiming a method of using such drug shall be
filed only if the patent claims a method of use approved in the
application.''
Form FDA 3542a must be used when an NDA applicant submits
information on a patent that claims a drug substance (active
ingredient), drug product (formulation or composition), or method of
using the drug that is the subject of an unapproved original NDA,
amendment to an NDA, or supplement to an NDA. Form FDA 3542 must be
used when an NDA holder submits information on a patent that claims a
drug substance (active ingredient), drug product (formulation or
composition), or method of using the drug to that is the subject of an
approved NDA or approved supplement to an NDA. (see 21 CFR 314.53(c)).
This draft guidance provides answers to questions that have been
received regarding Forms FDA 3542a and FDA
[[Page 35987]]
3542. The questions and answers are divided into three topics: (1)
Obtaining and Filling out Forms FDA 3542a and FDA 3542, (2) Section 6
of Forms FDA 3542a and FDA 3542 (``Declaration Certification''), and
(3) Submitting Patent Information to FDA.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Forms FDA
3542a and FDA 3542: 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.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
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
relating to the submission of NDAs under 21 CFR 314 have been approved
under OMB control number 0910-0001. The collections of information from
Form FDA 356h have been approved under OMB control number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11966 Filed 6-12-26; 8:45 am]
BILLING CODE 4164-01-P
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