[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37232-37234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-5365]


Consideration of Enforcement Policies for Tests During a Section 
564 Declared Emergency; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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[[Page 37233]]

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Consideration of 
Enforcement Policies for Tests During a Section 564 Declared 
Emergency.'' This draft guidance, when finalized, will describe the 
factors FDA intends to assess when deciding to issue an enforcement 
policy regarding test manufacturers' offering of certain unapproved 
tests and unapproved uses of approved tests during a declared 
emergency. This draft guidance is not final nor is it for 
implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by July 5, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-5365 for ``Consideration of Enforcement Policies for Tests 
During a Section 564 Declared Emergency.'' 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)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Consideration of Enforcement Policies for Tests During a Section 564 
Declared Emergency'' to the Office of Policy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Toby Lowe, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002, 301-796-6512.

SUPPLEMENTARY INFORMATION:

I. Background

    During an emergency, appropriately safe and effective diagnostic 
tests are critical to the diagnosis, treatment, tracking, and 
interruption of transmission of infectious diseases during outbreaks, 
as well as for diagnosing and treating diseases or conditions caused by 
chemical, biological, radiological, and nuclear threat agents. FDA is 
issuing this draft guidance that, when finalized, will describe the 
factors FDA plans to assess in deciding whether to issue an enforcement 
policy regarding test manufacturers' offering of certain unapproved 
tests and unapproved uses of approved tests for the diagnosis of a 
disease or other condition to help quickly increase test availability 
when appropriate during a declared emergency under section 564 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    This draft guidance describes the factors FDA intends to assess 
when issuing an enforcement policy including: (1) the need for 
accelerated availability of tests; (2) the known or potential risks of 
such tests; (3) the availability of appropriate alternative tests that 
are authorized or approved; and (4) the availability of sufficient 
mitigations to address risks of false results. When issuing an 
enforcement policy, FDA generally intends to describe the circumstances 
in which the Agency intends to exercise enforcement discretion, 
including, for example, when the test has been validated. FDA may also 
identify the initial duration in which an enforcement policy is 
intended to be in effect.
    This draft guidance is being issued consistent with FDA's good 
guidance

[[Page 37234]]

practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 
``Consideration of Enforcement Policies for Tests During a Section 564 
Declared Emergency.'' 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. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Consideration of Enforcement Policies 
for Tests During a Section 564 Declared Emergency'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number GUI00007009 and complete 
title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
OMB under the PRA (44 U.S.C. 3501-3521). The collections of information 
in the following table have been approved by OMB:

------------------------------------------------------------------------
    21 CFR part or guidance             Topic           OMB control No.
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807, subpart E................  Premarket                      0910-0120
                                 notification.
814, subparts A through E.....  Premarket approval...          0910-0231
814, subpart H................  Humanitarian Use               0910-0332
                                 Devices;
                                 Humanitarian Device
                                 Exemption.
812...........................  Investigational                0910-0078
                                 Device Exemption.
860, subpart D................  De Novo                        0910-0844
                                 classification
                                 process.
800, 801, 809, and 830........  Medical Device                 0910-0485
                                 Labeling
                                 Regulations; Unique
                                 Device
                                 Identification.
``Emergency Use Authorization   Emergency Use                  0910-0595
 of Medical Products and         Authorization.
 Related Authorities''.
803...........................  Medical Device                 0910-0437
                                 Reporting.
``Administrative Procedures     CLIA Administrative            0910-0607
 for CLIA Categorization'' and   Procedures; CLIA
 ``Recommendations: Clinical     Waivers.
 Laboratory Improvement
 Amendments of 1988'' (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices''.
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    Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08933 Filed 4-29-24; 8:45 am]
BILLING CODE 4164-01-P