[Federal Register Volume 85, Number 183 (Monday, September 21, 2020)]
[Notices]
[Pages 59319-59320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1825]


Investigational COVID-19 Convalescent Plasma; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (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 ``Investigational COVID-
19 Convalescent Plasma.'' The guidance document provides 
recommendations to healthcare providers and investigators on the use of 
investigational convalescent plasma for the treatment of the 
Coronavirus Disease 2019 (COVID-19) during the public health emergency. 
The guidance announced in this notice supersedes the guidance of the 
same title dated April 2020 and updated in May 2020. The guidance 
includes a discussion to facilitate the availability of investigational 
convalescent plasma when blood establishments, hospitals, and 
healthcare providers collect plasma that does not meet the Conditions 
of Authorization of the Emergency Use Authorization (EUA). The guidance 
also provides recommendations for healthcare providers who wish to 
administer and study convalescent plasma under an investigational new 
drug (IND) application.

DATES: The announcement of the guidance is published in the Federal 
Register on September 21, 2020.

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-2020-D-1825 for ``Investigational COVID-19 Convalescent Plasma.'' 
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 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 label to assist the 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: Shruti Modi, 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

    FDA is announcing the availability of a guidance entitled 
``Investigational COVID-19 Convalescent Plasma.'' The guidance provides 
recommendations to healthcare providers and investigators on the use of 
investigational convalescent plasma for the treatment of COVID-19 
during the public health

[[Page 59320]]

emergency. The guidance announced in this notice supersedes the 
guidance of the same title dated April 2020 and updated in May 2020, 
and provides recommendations and additional information related to the 
August 23, 2020, EUA for COVID-19 convalescent plasma for the treatment 
of hospitalized patients with COVID-19.\1\ Accordingly, FDA is 
replacing the May 2020 guidance to provide recommendations to 
healthcare providers for administering COVID-19 convalescent plasma 
under the EUA. The new guidance also provides recommendations to blood 
establishments on collection of COVID-19 convalescent plasma under the 
EUA, including on donor eligibility and qualification, testing plasma 
for anti-SARS-CoV2 antibodies, and labeling.
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    \1\ Emergency Use Authorization for COVID-19 Convalescent Plasma 
available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.
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    In addition, the guidance describes FDA's interim compliance and 
enforcement policy regarding the IND requirements for the use of 
investigational convalescent plasma. Following issuance of the EUA for 
COVID-19 convalescent plasma on August 23, 2020, FDA has received 
numerous inquiries from blood establishments and healthcare providers 
regarding investigational convalescent plasma that was collected prior 
to the EUA and that remains in inventory. FDA understands that 
investigational convalescent plasma collected prior to the EUA may not 
meet the Conditions of Authorization set forth in the EUA. FDA also 
understands that it will take time for blood establishments to develop 
the necessary operating procedures to manufacture COVID-19 convalescent 
plasma pursuant to the Conditions of Authorization in the EUA. In 
addition, the Agency is aware that enrollment into the National 
Expanded Access Treatment Protocol sponsored by the Mayo Clinical was 
discontinued as of August 28, 2020.
    Considering these issues and recognizing the immediate need for 
convalescent plasma to treat hospitalized patients with COVID-19, the 
guidance explains that FDA intends to exercise enforcement discretion 
with respect to the IND requirements for the collection, shipment, and 
administration of investigational convalescent plasma for a period of 
90 days following the issuance of the guidance document provided 
certain circumstances are present. The guidance outlines these 
circumstances and explains that during this period of enforcement 
discretion and beyond, FDA will continue to work with any investigators 
who wish to submit INDs for the study of investigational convalescent 
plasma and that ongoing clinical trials of investigational convalescent 
plasma should not be amended because of this enforcement discretion 
policy. The guidance also provides recommendations for healthcare 
providers who wish to administer and study convalescent plasma under an 
IND.
    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 Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371(h)(1)(C)(i)) and Sec.  10.115(g)(2)). Although this 
guidance is immediately in effect, FDA will consider all comments 
received and revise the guidance document as appropriate.
    In the Federal Register of May 26, 2020 (85 FR 31513), FDA 
announced the availability of a guidance of the same title. Elsewhere 
in this issue of the Federal Register, FDA is announcing the withdrawal 
of the guidance of the same title that was announced on May 26, 2020.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on investigational 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.

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 have been approved under OMB control 
number 0910-0014; the collections of information in 21 CFR 606.121 and 
21 CFR part 630 have been approved under OMB control number 0910-0116; 
and the collections of information in Form FDA 3926 have been approved 
under OMB control number 0910-0814.

III. Electronic Access

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

    Dated: September 16, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20800 Filed 9-18-20; 8:45 am]
BILLING CODE 4164-01-P