[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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