Document ID: FDA-2022-D-1908-0001
Agency: fda
Document Type: Notice
Title: Policy for Monkeypox Tests To Address the Public Health Emergency; Guidance for Laboratories,
Commercial Manufacturers, and Food and Drug Administration Staff; Availability
Posted Date: 2022-09-13T04:00Z

[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56064-56066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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-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 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

[[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: 
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 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.3
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    \1\ See HHS Secretary Section 319 Declaration (August 4, 2022), 
available at https://aspr.hhs.gov/legal/PHE/Pages/monkeypox-4Aug22.aspx.
    \2\ See HHS Secretary Section 564 Determination (August 9, 
2022), available at https://aspr.hhs.gov/legal/Section564/Pages/Monkeypox-9Aug22.aspx.
    \3\ See HHS Secretary Section 564 Determination (September 7, 
2022), available at https://aspr.hhs.gov/legal/Section564/Pages/InVitro-Diagnostics-Monkeypox-7Sept22.aspx.
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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 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 or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Policy for Monkeypox Tests To Address 
the Public Health Emergency'' may send an email request to [email protected] 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 https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

[[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
----------------------------------------------------------------------------------------------------------------
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