Notice2026-04291
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 4, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers." This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or NDA supplement. The guidance discusses the statutory and regulatory criteria for eligibility for 3-year exclusivity and provides recommendations on the content and format of requests for 3-year exclusivity in the form of questions and answers (Q&As). FDA intends to update this draft guidance document to include additional Q&As as appropriate.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 42 (Wednesday, March 4, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 42 (Wednesday, March 4, 2026)]
[Notices]
[Pages 10617-10619]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04291]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-4388]
New Clinical Investigation Exclusivity (3-Year Exclusivity) for
Drug Products: Questions and Answers; Draft Guidance for Industry;
Availability; Agency Information Collection Activities; Proposed
Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug
Products: Questions and Answers.'' This draft guidance is intended to
assist applicants requesting New Clinical Investigation exclusivity
(also referred to as 3-year exclusivity) for a new drug application
(NDA) or NDA supplement. The guidance discusses the statutory and
regulatory criteria for eligibility for 3-year exclusivity and provides
recommendations on the content and format of requests for 3-year
exclusivity in the form of questions and answers (Q&As). FDA intends to
update this draft guidance document to include additional Q&As as
appropriate.
DATES: Submit either electronic or written comments on the draft
guidance by May 4, 2026 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 May 4,
2026.
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: <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-2024-D-4388 for ``New Clinical Investigation Exclusivity (3-Year
Exclusivity) for Drug Products: 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
[[Page 10618]]
``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:
With regard to the draft guidance: Susan Levine, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-7936.
With regard to the proposed collection of information: Anne Taylor,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-402-
5683, <a href="/cdn-cgi/l/email-protection#227270637156434444624446430c4a4a510c454d54"><span class="__cf_email__" data-cfemail="acfcfeedffd8cdcacaeccac8cd82c4c4df82cbc3da">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``New Clinical Investigation Exclusivity (3-Year Exclusivity)
for Drug Products: Questions and Answers.'' This guidance is intended
to assist applicants requesting New Clinical Investigation exclusivity,
also referred to as 3-year exclusivity, for an NDA or NDA supplement
under section 505(c)(3)(E)(iii)-(iv) and 505(j)(5)(F)(iii)-(iv) of the
FD&C Act (21 U.S.C. 355(c)(3)(E)(iii)-(iv) and 355(j)(5)(iii)-(iv)).
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) (Hatch-Waxman Amendments), which added section
505(b)(2) and (j) to the FD&C Act, reflect Congress's efforts to
balance the need to ``make available more low cost generic drugs by
establishing a generic drug approval procedure'' with new incentives
for drug development in the form of exclusivities and patent term
extensions. These incentives include a 3-year period of exclusivity for
drugs approved in certain NDAs or supplements to NDAs during which
applications submitted pursuant to section 505(b)(2) of the FD&C Act
(505(b)(2) applications) and abbreviated new drug applications
submitted under section 505(j) of the FD&C Act (ANDAs or 505(j)
applications) may not be approved for exclusivity-protected conditions
of approval of such drugs.
Pursuant to section 505(c)(3)(E)(iii)-(iv) and 505(j)(5)(F)(iii)-
(iv) of the FD&C Act, an application may qualify for 3-year exclusivity
if it is a 505(b) application or supplement to a 505(b) application:
(1) for a drug, which includes an active moiety (or active moieties)
that has been approved in another 505(b) application, and (2) that
contains reports of new clinical investigations that are: (i) not
bioavailability studies, (ii) essential to the approval of the
application (or supplement), and (iii) conducted or sponsored by the
applicant. FDA defined many of the terms in the exclusivity provisions
of the FD&C Act at 21 CFR 314.108(a), and FDA established the framework
for the timing of approval for a 505(b)(2) application or ANDA impacted
by New Clinical Investigation exclusivity at 21 CFR 314.108(b). Using a
Q&A format, this guidance discusses each of the statutory and
regulatory criteria for eligibility for 3-year exclusivity and
clarifies the processes for applicants to request 3-year exclusivity,
for FDA to make 3-year exclusivity eligibility determinations, and for
providing notice of those determinations in FDA's Approved Drug
Products with Therapeutic Equivalence Evaluations (``the Orange
Book''). FDA intends to update this draft guidance document to include
additional Q&As as appropriate.
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 ``New Clinical
Investigation Exclusivity (3-Year Exclusivity) for Drug 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.
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
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 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, we invite
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.
Template for Requesting New Clinical Trial Exclusivity
OMB Control Number 0910-0001--Revision
This information collection helps support implementation of
regulatory requirements that govern an NDA or NDA supplement. We have
issued regulations in 21 CFR part 314, Applications for FDA Approval to
Market a New Drug, setting forth applicable standards and procedures
that include associated reporting and recordkeeping requirements.
We are revising the information collection to support the use of a
[[Page 10619]]
template for requesting New Clinical Investigation exclusivity, also
referred to as 3-year exclusivity. We recommend that the applicant use
the model language we provide to request 3-year exclusivity. The draft
guidance for industry entitled ``New Clinical Investigation Exclusivity
(3-Year Exclusivity) for Drug Products: Questions and Answers''
includes the model language in its Appendix.
All Agency guidance documents are issued in accordance with our
good guidance practice regulations in 21 CFR 10.115, which provide for
public comment at any time. We maintain a searchable guidance database
on our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> that utilizes topic-specific search terms. We
intend to finalize the guidance document upon OMB approval of the
attendant information collection.
The use of a template can assist applicants in more efficiently
communicating requests for 3-year exclusivity and providing the
information required in our regulations. Under 21 CFR 314.50(j)(4), an
applicant claiming eligibility for 3-year exclusivity must provide
certain information to show that the NDA contains ``new clinical
investigations'' that are ``essential to approval of the NDA or
supplement'' and were ``conducted or sponsored by the applicant,''
including a certification required by 21 CFR 314.50(j)(4)(i) that ``to
the best of the applicant's knowledge each of the clinical
investigations included in the NDA meets the definition of `new
clinical investigation' set forth in Sec. 314.108(a).'' The elements
listed in that section are included in the template. The draft guidance
describes FDA's policies for implementing this regulation. The
submission of a claim for 3-year exclusivity is explained in section
QV.1. of the draft guidance. We will use the information provided in
the templated request as we process requests for exclusivity. The
information is needed to support FDA's efforts to protect the health of
users of drugs approved under 21 CFR part 314 and to efficiently
determine eligibility of an NDA or supplement for 3-year exclusivity.
Description of Respondents: Respondents to this information
collection are pharmaceutical industry entities who contribute to the
preparation and marketing of pharmaceutical products regulated by the
FDA.
Burden Estimate: We reviewed our statutory authority at section
505(c)(3)(E)(iii)-(iv) and 505(j)(5)(F)(iii)-(iv) of the FD&C Act, and
implementing regulations in 21 CFR part 314, which provide for the
submission of requests for 3-year exclusivity.
We tentatively conclude that providing the template proposed in the
draft guidance adds no further information collection requirements and
imposes no further burden beyond what is already required in our
statutes and regulations and included in the approved ICR under OMB
control number 0910-0001.
This draft guidance also refers to previously approved FDA
collections of information. The collections of information in 21 CFR
part 314, which relate to the submission of new drug applications and
include requirements for the content and format of new drug
applications in 21 CFR 314.50(j) and 21 CFR 314.108, have been approved
under OMB control number 0910-0001. The collections of information in
21 CFR part 312, which relate to the submission of investigational new
drug applications, and Form FDA 1571 have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR part
11 relating to electronic records and signatures have been approved
under OMB control number 0910-0303.
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. 2026-04291 Filed 3-3-26; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 4, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.