Notice2023-13331
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
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Published
June 23, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act." This draft guidance provides recommendations for industry and review staff on the formal dispute resolution and administrative hearings procedures for resolving scientific and/or medical disputes between the Center for Drug Evaluation and Research (CDER) and requestors and sponsors of drugs that will be subject to a final administrative order (final order) under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Full Text
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<title>Federal Register, Volume 88 Issue 120 (Friday, June 23, 2023)</title>
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[Federal Register Volume 88, Number 120 (Friday, June 23, 2023)]
[Notices]
[Pages 41107-41108]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13331]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-2204]
Formal Dispute Resolution and Administrative Hearings of Final
Administrative Orders Under Section 505G 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Cosmetic Act; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Formal
Dispute Resolution and Administrative Hearings of Final Administrative
Orders Under Section 505G of the Federal Food, Drug, and Cosmetic
Act.'' This draft guidance provides recommendations for industry and
review staff on the formal dispute resolution and administrative
hearings procedures for resolving scientific and/or medical disputes
between the Center for Drug Evaluation and Research (CDER) and
requestors and sponsors of drugs that will be subject to a final
administrative order (final order) under section 505G of the Federal
Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the draft
guidance by August 22, 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-2204 for ``Formal Dispute Resolution and Administrative
Hearings of Final Administrative Orders Under Section 505G 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. 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: Jung Lee, Center for Drug Evaluation
and Research (HFD-600), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5494, Silver Spring, MD 20993, 301-796-
3599.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Formal Dispute Resolution and Administrative Hearings of
Final
[[Page 41108]]
Administrative Orders Under Section 505G of the Federal Food, Drug, and
Cosmetic Act.'' This draft guidance provides recommendations for
industry and review staff on the formal dispute resolution and
administrative hearings procedures for resolving scientific and/or
medical disputes between CDER and requestors \1\ and sponsors \2\ of
drugs that will be subject to a final order under section 505G of the
FD&C Act (21 U.S.C. 355h).
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\1\ Requestor is defined in section 505G(q)(3) of the FD&C Act
as any person or group of persons marketing, manufacturing,
processing, or developing a drug.
\2\ Sponsor is defined in section 505G(q)(2) of the FD&C Act as
any person marketing, manufacturing, or processing a drug that is
listed pursuant to section 510(j) of the FD&C Act and is or will be
subject to an administrative order under section 505G of the FD&C
Act.
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Section 505G of the FD&C Act was added by the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136), which
was enacted on March 27, 2020. After FDA issues a final order in
accordance with section 505G(b)(2) of the FD&C Act, FDA must afford
eligible requestors or sponsors the opportunity for formal dispute
resolution (FDR) and hearings on disputes over the final order. This
draft guidance describes the FDR procedures for eligible requestors or
sponsors that wish to appeal a scientific and/or medical issue related
to a final order. This draft guidance also outlines the procedures for
an administrative hearing related to a final order. Finally, as
required by section 505G(l)(4) of the FD&C Act, this draft guidance
describes the procedures for consolidated proceedings for FDR and
hearings to resolve the scientific and/or medical disputes.
In support of the CARES Act, FDA agreed to specific performance
goals and procedures described in the document ``Over-the-Counter
Monograph User Fee Program Performance Goals and Procedures--Fiscal
Years 2018-2022,'' commonly referred to as the OMUFA commitment letter
(the document can be accessed at <a href="https://www.fda.gov/media/106407/download">https://www.fda.gov/media/106407/download</a>, and the document with updated goal dates for fiscal years
2021-2025 can be accessed at <a href="https://www.fda.gov/media/146283/download">https://www.fda.gov/media/146283/download</a>). The OMUFA commitment letter specifies that FDA will revise
the guidance for industry and review staff entitled ``Formal Dispute
Resolution: Sponsor Appeals Above the Division Level'' (existing FDR
guidance), available at <a href="https://www.fda.gov/media/126910/download">https://www.fda.gov/media/126910/download</a>, to
include circumstances and procedures under which FDR may be used with
respect to final orders under section 505G of the FD&C Act. In
addition, consistent with the statutory requirement under 505G(l)(4),
the OMUFA commitment letter explains that FDA will issue guidance on
its views regarding best practices for consolidated proceedings for
appeals.
For administrative efficiency, rather than amend the existing FDR
guidance to include FDR procedures for final orders and issue a
separate guidance for consolidated proceedings for appeals, FDA is
issuing this single draft guidance. This draft guidance addresses the
process for resolving scientific and/or medical disputes of final
orders, including FDR, administrative hearings, and consolidated
proceedings. FDA has incorporated recommendations from the existing FDR
guidance 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 ``Formal
Dispute Resolution and Administrative Hearings of Final Administrative
Orders Under Section 505G 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
Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act
of 1995 does not apply to collections of information made under section
505G of the FD&C Act. The information collections made in this guidance
implement the provisions of the following subsections of 505G:
(1) Section 505G(l)(4), which requires FDA to issue guidance that
specifies the consolidated proceedings for appeal and the procedures
for such proceedings where appropriate;
(2) Section 505G(b)(2)(A)(iv)(III), which requires that FDA afford
requesters of drugs that will be subject to final administrative orders
the opportunity for formal dispute resolution up to the level of the
Director of CDER;
(3) Section 505G(b)(3) and section 505G(b)(4)(E), which allow
persons who participated in each stage of FDR with respect to a drug to
request a hearing concerning a final administrative order with respect
to such drug. Under Section 505G(b)(3)(C)(ii), a single hearing may be
conducted if more than one request is submitted with respect to the
same administrative order; and
(4) Section 505G(j), which requires that all submissions must be in
electronic format.
Therefore, clearance by the Office of Management and Budget under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not
required for these collections of information.
In addition, this guidance does refer to previously approved FDA
collections of information. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for OTC monograph products, OTC monograph order
requests, and the OTC Monograph User Fee Program have been approved
under OMB control number 0910-0340.
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>.
Dated: June 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13331 Filed 6-22-23; 8:45 am]
BILLING CODE 4164-01-P
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