Notice2024-16046
Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 22, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 140 (Monday, July 22, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 140 (Monday, July 22, 2024)]
[Notices]
[Pages 59116-59117]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16046]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
<a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
</pre></body>
</html>Indexed from Federal Register on July 22, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.