[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Pages 13126-13128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0202]


Potency Assay Considerations for Monoclonal Antibodies and Other 
Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 13127]]


ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Potency 
Assay Considerations for Monoclonal Antibodies and Other Therapeutic 
Proteins Targeting Viral Pathogens.'' The purpose of this draft 
guidance is to provide to sponsors recommendations that assist in the 
development of monoclonal antibodies (mAbs) and other therapeutic 
proteins that directly target viral proteins or host cell proteins 
mediating pathogenic mechanisms of infection. A critical quality 
control measure for these products is the development and 
implementation of a potency assay(s) adequate to ensure that each lot 
is produced consistently with the potency necessary to achieve clinical 
efficacy and that such potency is maintained over the shelf life of the 
product. This draft guidance provides detailed recommendations to drug 
developers with the goal of helping to ensure that drug developers 
provide adequate information to assess potency at each stage of a 
product's life cycle.

DATES: Submit either electronic or written comments on the draft 
guidance by May 1, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-0202 for ``Potency Assay Considerations for Monoclonal 
Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens.'' 
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: Natalia Comella, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993-0002, 301-
796-6226.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Potency Assay Considerations for Monoclonal Antibodies and 
Other Therapeutic Proteins Targeting Viral Pathogens.'' The purpose of 
this draft guidance is to provide to sponsors recommendations that 
assist in the development of mAbs and other therapeutic proteins that 
directly target viral proteins or host cell proteins mediating 
pathogenic mechanisms of infection. A critical quality control measure 
for these products is the development and implementation of a potency 
assay(s) adequate to ensure that each lot is produced consistently with 
the potency necessary to achieve clinical efficacy and that such 
potency is maintained over the shelf life of the product. This draft 
guidance provides detailed recommendations to drug developers with the 
goal of helping to ensure that drug developers provide adequate 
information to assess potency at each stage of a product's life cycle.
    This draft guidance applies only to mAbs and other therapeutic 
proteins regulated by the Center for Drug Evaluation and Research that 
are designed to bind to viral proteins or their receptors on host 
cells, inhibit

[[Page 13128]]

viral entry, and/or elicit Fc-mediated effector function and are 
subject to licensure under section 351(a) or section 351(k) of the 
Public Health Service Act (PHS Act) (42 U.S.C. 262(a) or (k)). This 
draft guidance does not apply to immunomodulatory drugs (e.g., 
cytokines or cytokine antagonists), vaccines, hyperimmune globulins, 
gene therapies, cell therapies, and convalescent plasma.
    The draft guidance describes approaches that sponsors should use to 
develop potency assay methods for release and stability that assess 
comprehensively known or potential mechanism(s) of action of the 
product. The sensitivity of these methods must be established, for 
example, to conduct the appropriate laboratory determination of 
satisfactory conformance to final specifications for the drug product 
(i.e., demonstrate lot-to-lot consistency). In addition to release and 
stability methods, other methods that demonstrate the biological 
function(s) of the product may be needed for characterization and 
comparability studies. The draft guidance describes methods that 
sponsors should use to ensure the potency of mAbs and other therapeutic 
proteins proposed to prevent or treat a viral infection.
    In January 2021, FDA published the guidance for industry entitled 
``COVID-19: Potency Assay Considerations for Monoclonal Antibodies and 
Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity'' 
(available at https://www.fda.gov/media/145128/download) to support 
public health efforts following a declaration, under section 319 of the 
PHS Act (42 U.S.C. 247d), by the Secretary of Health and Human Services 
of a public health emergency related to Coronavirus Disease 2019 (the 
disease caused by SARS-CoV-2) (section 319 public health emergency). 
The 2021 guidance focuses solely on addressing potency assays as they 
relate to mAbs and other therapeutic proteins that directly target 
SARS-CoV-2, and it is intended to remain in effect only for the 
duration of the section 319 public health emergency related to 
Coronavirus Disease 2019. However, FDA believes that many of the 
recommendations set forth in the 2021 guidance are applicable outside 
the context of the section 319 public health emergency and are 
applicable to mAbs and other therapeutic proteins directly targeting 
any viral surface (glyco)proteins mediating pathogenic mechanisms of 
infection, not just those that directly target SARS-CoV-2. FDA is, 
therefore, issuing this draft guidance. In preparing this guidance, FDA 
considered comments received regarding the 2021 guidance as well as the 
Agency's experience with SARS-CoV-2 and other viruses.
    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 ``Potency 
Assay Considerations for Monoclonal Antibodies and Other Therapeutic 
Proteins Targeting Viral Pathogens.'' 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

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 312 for submission of an investigational 
new drug application have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 for new drug 
applications have been approved under OMB control number 0910-0001. The 
collections of information in 21 CFR parts 601 and 610 pertaining to 
biologics license applications have been approved under OMB control 
number 0910-0338. The collections of information in 21 CFR parts 210 
and 211 pertaining to current good manufacturing practices have been 
approved under OMB control number 0910-0139. The collections of 
information in 21 CFR part 11 pertaining to electronic records and 
signatures have been approved under OMB control number 0910-0303.

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: February 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04267 Filed 3-1-23; 8:45 am]
BILLING CODE 4164-01-P