[Federal Register Volume 89, Number 140 (Monday, July 22, 2024)]
[Notices]
[Pages 59116-59117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16046]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-2442]


Recommendations for Investigational and Licensed COVID-19 
Convalescent Plasma; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance for immediate 
implementation entitled ``Recommendations for Investigational and 
Licensed COVID-19 Convalescent Plasma; Guidance for Industry.'' The 
purpose of this guidance is to provide FDA's recommendations to blood 
establishments for the submission of a Biologics License Application 
(BLA) for the manufacture of COVID-19 convalescent plasma intended for 
transfusion in patients with immunosuppressive disease or receiving 
immunosuppressive treatment in either the outpatient or inpatient 
setting. The guidance also provides FDA's recommendations for 
investigational new drug applications (INDs) for investigational COVID-
19 convalescent plasma for transfusion.

DATES: The announcement of the guidance is published in the Federal 
Register on July 22, 2024.

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-2024-D-2442 for ``Recommendations for Licensed COVID-19 
Convalescent Plasma; Guidance for Industry.'' 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

[[Page 59117]]

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 guidance to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive labels to assist that office in processing 
your requests. The guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for blood 
establishments entitled ``Recommendations for Investigational and 
Licensed COVID-19 Convalescent Plasma; Guidance for Industry.'' We are 
issuing this guidance consistent with our good guidance practices (GGP) 
regulation (Sec.  10.115 (21 CFR 10.115)). We are implementing this 
guidance without prior public comment because we have determined that 
prior public participation is not feasible or appropriate (see Sec.  
10.115(g)(2) and section 701(h)(1)(C) of the Federal Food, Drug, and 
Cosmetic Act (FD & C Act) (21 U.S.C. 371(h)(1)(C))). We made this 
determination because the revisions to the guidance reflect the current 
epidemiology of COVID-19 and provide updated recommendations needed by 
blood establishments and sponsors. Specifically, we are issuing this 
guidance to ensure that blood establishments and sponsors are aware of 
our current recommendations to expedite the timely development of 
COVID-19 convalescent plasma. Immediate implementation of the guidance 
is required to facilitate the licensure of COVID-19 convalescent plasma 
to protect the public health. Although this guidance document is being 
implemented immediately, it remains subject to comment in accordance 
with FDA's GGP regulation (Sec.  10.115(g)(3)(D)).
    COVID-19 convalescent plasma is plasma containing antibodies to 
SARS-CoV-2 intended for transfusion that is collected from individuals 
who have recovered from COVID-19. FDA first issued an emergency use 
authorization (EUA) on August 23, 2020, for COVID-19 convalescent 
plasma for the treatment of hospitalized patients with COVID-19, 
pursuant to section 564 of the FD & C Act (21 U.S.C. 360bbb-3). FDA has 
subsequently reissued the EUA with revisions. Most recently, on 
December 28, 2021, FDA revised the EUA to limit authorization to the 
use of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 
antibodies for the treatment of COVID-19 in patients with 
immunosuppressive disease or receiving immunosuppressive treatment in 
either the outpatient or inpatient setting. The purpose of this 
guidance is to provide FDA's recommendations on two regulatory pathways 
for the manufacture of COVID-19 convalescent plasma. Specifically, the 
guidance provides recommendations to blood establishments for the 
submission of a BLA for the manufacture of COVID-19 convalescent plasma 
for transfusion intended to treat patients with immunosuppressive 
disease or receiving immunosuppressive treatment in either the 
outpatient or inpatient setting. The guidance also provides FDA's 
recommendations for INDs for investigational COVID-19 convalescent 
plasma for transfusion.
    The guidance represents the current thinking of FDA on 
investigational and licensed COVID-19 convalescent plasma. 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.
    FDA has also issued a separate guidance entitled ``Investigational 
COVID-19 Convalescent Plasma,'' which was most recently updated in 
October 2023 (88 FR 15417). The ``Investigational COVID-19 Convalescent 
Plasma'' guidance provides recommendations and additional information 
related to the EUA for COVID-19 convalescent plasma, as well as 
recommendations for administering COVID-19 convalescent plasma under 
the IND pathway in accordance with 21 CFR part 312. The recommendations 
in section III.A.2 of the guidance being announced today pertaining to 
investigational new drug applications for COVID-19 convalescent plasma 
supersede the recommendations in section III.C. of the 
``Investigational COVID-19 Convalescent Plasma'' guidance. We intend to 
revise the ``Investigational COVID-19 Convalescent Plasma'' guidance to 
reflect this change.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved 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 21 CFR part 312 have been approved under OMB control number 0910-
0014; the collections of information in 21 CFR part 601 have been 
approved under OMB control number 0910-0338; the collections of 
information in 21 CFR part 606 have been approved under OMB control 
number 0910-0116; and the collections of information in 21 CFR part 630 
have been approved under OMB control number 0910-0795.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    Dated: July 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16046 Filed 7-19-24; 8:45 am]
BILLING CODE 4164-01-P