[Federal Register Volume 88, Number 120 (Friday, June 23, 2023)]
[Notices]
[Pages 41107-41108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13331]


=======================================================================
-----------------------------------------------------------------------

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Cosmetic Act; Draft Guidance for Industry; Availability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.

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

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the availability of a draft guidance for industry entitled ``Formal 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 This draft guidance provides recommendations for industry and 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DATES: Submit either electronic or written comments on the draft 
guidance by August 22, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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. 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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 https://www.fda.gov/media/106407/download, and the document with updated goal dates for fiscal years 
2021-2025 can be accessed at https://www.fda.gov/media/146283/download). 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 https://www.fda.gov/media/126910/download, 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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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