Notice2023-14905
Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance With Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
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Published
July 14, 2023
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act." The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to require certain postmarketing studies and clinical trials for prescription drugs at the time of approval or after approval if FDA becomes aware of new safety information. This draft guidance describes the factors FDA considers when determining whether an applicant has demonstrated good cause for failure to comply with the timetable for completion of studies or clinical trials required under the provisions. This draft guidance also provides information on relevant procedures, including how an applicant should communicate with FDA regarding compliance with these required studies and trials and describes actions FDA may take for noncompliance with the requirements.
Full Text
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<title>Federal Register, Volume 88 Issue 134 (Friday, July 14, 2023)</title>
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[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45225-45226]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14905]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-0559]
Postmarketing Studies and Clinical Trials: Determining Good Cause
for Noncompliance With Section 505(o)(3)(E)(ii) of the Federal Food,
Drug, and Cosmetic Act; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled
``Postmarketing Studies and Clinical Trials: Determining Good Cause for
Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug,
and Cosmetic Act.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to require certain postmarketing studies and clinical
trials for prescription drugs at the time of approval or after approval
if FDA becomes aware of new safety information. This draft guidance
describes the factors FDA considers when determining whether an
applicant has demonstrated good cause for failure to comply with the
timetable for completion of studies or clinical trials required under
the provisions. This draft guidance also provides information on
relevant procedures, including how an applicant should communicate with
FDA regarding compliance with these required studies and trials and
describes actions FDA may take for noncompliance with the requirements.
DATES: Submit either electronic or written comments on the draft
guidance by September 12, 2023 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: <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-2023-D-0559 for ``Postmarketing Studies and Clinical Trials:
Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii)
of the Federal Food, Drug, and Cosmetic Act.'' 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; or 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. 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: Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5367, Silver Spring, MD 20993, 301-796-6054, or Diane
Maloney, 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.
[[Page 45226]]
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Postmarketing Studies and Clinical Trials: Determining Good
Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal
Food, Drug, and Cosmetic Act.'' This draft guidance provides
information for holders of applications for human prescription drugs
that are required to conduct postmarketing studies or clinical trials
under section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3). Section
505(o), added by the Food and Drug Administration Amendments Act of
2007 (FDAAA), authorizes FDA to require certain postmarketing studies
for prescription drugs at the time of approval or after approval if FDA
becomes aware of new safety information. These postmarketing studies
and clinical trials are also referred to as postmarketing requirements
(PMRs) or FDAAA PMRs.
An applicant required to conduct a PMR must provide certain
information to FDA, including a timetable for study or clinical trial
completion and periodic reports on the status of the study or clinical
trial. If an applicant fails to comply with the timetable or fails to
submit periodic status reports, FDA considers the applicant to be in
violation of section 505(o)(3) of the FD&C Act, unless the applicant
has demonstrated good cause for its PMR noncompliance. Under section
505(o)(3)(E)(ii) of the FD&C Act, FDA is responsible for determining
what constitutes good cause for PMR noncompliance. Violations of
requirements under this section are subject to enforcement action,
including pursuant to sections 505(o)(1) (charges under section 505 of
the FD&C Act), 502(z) (21 U.S.C. 332(z)) (misbranding charges), and
303(f)(4)(A) (21 U.S.C. 333(f)(4)(A)) (civil monetary penalties).
This draft guidance describes the factors FDA considers when
determining whether an applicant has demonstrated good cause for its
noncompliance with the timetable for PMR completion. This draft
guidance also provides information on relevant procedures including how
to communicate with FDA regarding PMR compliance, submission of an
explanation of the circumstances that led to noncompliance, and how FDA
notifies an applicant of a determination of noncompliance, and
describes the enforcement actions FDA can take for PMR noncompliance.
Although this draft guidance primarily addresses noncompliance with the
timetable for completion of PMR milestones, any violation of a
requirement under section 505(o)(3)(E)(ii) of the FD&C Act is subject
to enforcement action, in the absence of a demonstration of good cause.
Section 505(o) of the FD&C Act applies only to prescription drugs
approved under section 505(b) of the FD&C Act and biological drug
products approved under section 351 of the Public Health Service
Act.\1\ This draft guidance does not apply to nonprescription drugs,
including nonprescription drugs that are approved under a new drug
application, or to generic drugs approved under section 505(j) of the
FD&C Act.
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\1\ See section 505(o)(2)(B) of the FD&C Act.
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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
``Postmarketing Studies and Clinical Trials: Determining Good Cause for
Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug,
and Cosmetic Act.'' 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314, including the submission of status
reports of postmarketing study commitments under Sec.
314.81(b)(2)(vii), 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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</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>.
Dated: July 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14905 Filed 7-13-23; 8:45 am]
BILLING CODE 4164-01-P
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