Notice2024-08933
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency." This draft guidance, when finalized, will describe the factors FDA intends to assess when deciding to issue an enforcement policy regarding test manufacturers' offering of certain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 This draft guidance is not final nor is it for implementation at this time.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 88 (Monday, May 6, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37232-37234]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-08933]
-----------------------------------------------------------------------
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564 Declared Emergency; Draft Guidance for Industry and Food and Drug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.
-----------------------------------------------------------------------
[[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the availability of the draft guidance entitled ``Consideration of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 This draft guidance, when finalized, will describe the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 This draft guidance is not final nor is it for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:
<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-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 <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)).
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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#41020513096c06342825202f2224012725206f2929326f262e37"><span class="__cf_email__" data-cfemail="dc9f988e94f19ba9b5b8bdb2bfb99cbab8bdf2b4b4aff2bbb3aa">[email protected]</span></a> 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.
------------------------------------------------------------------------
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''.
------------------------------------------------------------------------
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 6, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.