Notice2022-19709
Policy for Monkeypox Tests To Address the Public Health Emergency; Guidance for Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff; Availability
Primary source
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Published
September 13, 2022
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 final guidance entitled "Policy for Monkeypox Tests To Address the Public Health Emergency." On August 4, 2022, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency related to monkeypox. Monkeypox virus is a zoonotic infection (a virus transmitted to humans from animals), caused by Orthopoxvirus genus of the Poxviridae family similar to variola virus (the causative agent of smallpox), and can spread to humans. Since early May 2022, cases of monkeypox have been reported from countries where the disease is not endemic and continue to be reported in several endemic countries. Rapid detection of monkeypox cases in the United States requires wide availability of diagnostic testing to control the emergence of this contagious infection. This guidance describes FDA's review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests, as well as FDA's enforcement policies for various monkeypox tests. The guidance document has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.
Full Text
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<title>Federal Register, Volume 87 Issue 176 (Tuesday, September 13, 2022)</title>
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[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56064-56066]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19709]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1908]
Policy for Monkeypox Tests To Address the Public Health
Emergency; Guidance for Laboratories, Commercial Manufacturers, and
Food and Drug Administration Staff; 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 final guidance entitled ``Policy for Monkeypox
Tests To Address the Public Health Emergency.'' On August 4, 2022, the
Secretary of the Department of Health and Human Services (HHS)
determined that there is a public health emergency related to
monkeypox. Monkeypox virus is a zoonotic infection (a virus transmitted
to humans from animals), caused by Orthopoxvirus genus of the
Poxviridae family similar to variola virus (the causative agent of
smallpox), and can spread to humans. Since early May 2022, cases of
monkeypox have been reported from countries where the disease is not
endemic and continue to be reported in several endemic countries. Rapid
detection of monkeypox cases in the United States requires wide
availability of diagnostic testing to control the emergence of this
contagious infection. This guidance describes FDA's review priorities
of emergency use authorization (EUA) requests for monkeypox diagnostic
tests, as well as FDA's enforcement policies for various monkeypox
tests. The guidance document has been implemented without prior
comment, but it remains subject to comment in accordance with the
Agency's good guidance practices.
DATES: The announcement of the guidance is published in the Federal
Register on September 13, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2022-D-1908 for ``Policy for Monkeypox Tests To Address the Public
Health 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
[[Page 56065]]
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 Sec.
10.115(g)(5) (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 guidance document entitled
``Policy for Monkeypox Tests To Address the Public Health 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: Amy Zale, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3423A, Silver Spring, MD 20993-0002, 301-796-0869.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance entitled ``Policy
for Monkeypox Tests To Address the Public Health Emergency.'' On August
4, 2022, the Secretary of HHS determined that there is a public health
emergency related to monkeypox.\1\ On August 9, 2022, the Secretary of
HHS determined \2\ under section 564 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3) that there is a public
health emergency, or significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad that involves monkeypox virus. On September 7, 2022, the
Secretary of HHS determined that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for detection
and/or diagnosis of infection with the monkeypox virus, including in
vitro diagnostics that detect and/or diagnose infection with non-
variola Orthopoxvirus.<SUP>3</SUP>
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\1\ See HHS Secretary Section 319 Declaration (August 4, 2022),
available at <a href="https://aspr.hhs.gov/legal/PHE/Pages/monkeypox-4Aug22.aspx">https://aspr.hhs.gov/legal/PHE/Pages/monkeypox-4Aug22.aspx</a>.
\2\ See HHS Secretary Section 564 Determination (August 9,
2022), available at <a href="https://aspr.hhs.gov/legal/Section564/Pages/Monkeypox-9Aug22.aspx">https://aspr.hhs.gov/legal/Section564/Pages/Monkeypox-9Aug22.aspx</a>.
\3\ See HHS Secretary Section 564 Determination (September 7,
2022), available at <a href="https://aspr.hhs.gov/legal/Section564/Pages/InVitro-Diagnostics-Monkeypox-7Sept22.aspx">https://aspr.hhs.gov/legal/Section564/Pages/InVitro-Diagnostics-Monkeypox-7Sept22.aspx</a>.
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Rapid detection of monkeypox cases in the United States requires
wide availability of diagnostic testing to help control the emergence
of this contagious infection. This guidance describes FDA's review
priorities of EUA requests for monkeypox diagnostic tests, describes
FDA's enforcement policies for certain diagnostic tests that are
developed by and performed in a laboratory certified under the Clinical
Laboratory Improvement Amendments that meets the requirements to
perform tests of high complexity, describes FDA's enforcement policies
for FDA-cleared or authorized monkeypox diagnostic tests that are
modified, describes FDA's enforcement policies for certain serology
tests, and provides recommendations for diagnostic test validation.
In light of this public health emergency, FDA has determined that
prior public participation for this guidance is not feasible or
appropriate and is issuing this guidance without prior public comment
(see section 701(h)(1)(C)(i) of the FD&C Act (21 U.S.C.
371(h)(1)(C)(i)) and Sec. 10.115(g)(2)). Although this guidance has
been implemented without prior comment, FDA will consider all comments
received and revise the guidance document as appropriate.
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). The guidance represents the
current thinking of FDA on ``Policy for Monkeypox Tests To Address the
Public Health 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 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> or <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 ``Policy for Monkeypox Tests To Address
the Public Health Emergency'' may send an email request to <a href="/cdn-cgi/l/email-protection#bffcfbedf792f8cad6dbded1dcdaffd9dbde91d7d7cc91d8d0c9"><span class="__cf_email__" data-cfemail="95d6d1c7ddb8d2e0fcf1f4fbf6f0d5f3f1f4bbfdfde6bbf2fae3">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document number 22003 and complete title to identify the
guidance you are requesting.
III. Paperwork Reduction Act of 1995
The guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following FDA regulations and guidances have been approved by
OMB as listed in the table below. The guidance also contains a new
collection of information not approved under a current collection.
These new collections of information were granted a public health
emergency (PHE) waiver from the PRA by HHS on August 19, 2022, under
section 319(f) of the Public Health Service Act (42 U.S.C. 247d(f)).
Information concerning the PHE PRA waiver can be found on the HHS
website at <a href="https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers">https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers</a>.
[[Page 56066]]
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Another guidance OMB New collection
Guidance title CFR cite referenced in referenced in control covered by PHE PRA
guidance guidance No(s). waiver
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Policy for Monkeypox Tests to ......................... Emergency Use 0910-0595
Address the Public Health Authorization of
Emergency. Medical Products
and Related
Authorities;
Guidance for
Industry and Other
Stakeholders.
Administrative 0910-0607
Procedures for
Clinical
Laboratory
Improvement
Amendments of 1988
Categorization.
803...................... ................... 0910-0437
806...................... ................... 0910-0359
807, subpart E........... ................... 0910-0120
FDA Notification
of Laboratory
Development and
Validation of
Monkeypox Test
(including
notification
template).
Statements on
patient test
reports.
Commercial
Manufacturer Test
for Monkeypox--
EUA Test Summary
Information.
EUA templates for
monkeypox tests.
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Dated: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19709 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P
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