Document ID: FDA-2023-D-0559-0002
Agency: fda
Document Type: Notice
Title: 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Determining Good Cause for Noncompliance With Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Posted Date: 2023-07-14T04:00Z

[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45225-45226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14905]

-----------------------------------------------------------------------

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Drug, and Cosmetic Act; Draft Guidance for Industry; Availability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.

-----------------------------------------------------------------------

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the availability of a draft guidance for industry entitled 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 This draft guidance 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 This draft guidance also provides information on 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DATES: Submit either electronic or written comments on the draft 
guidance by September 12, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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 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.
---------------------------------------------------------------------------

    \1\ See section 505(o)(2)(B) of the FD&C Act.
---------------------------------------------------------------------------

    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 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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