Notice2023-13513
Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding When Conventional Platelets Are Not Available or Their Use Is Not Practical; Guidance for Industry; Availability
Primary source
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Published
June 26, 2023
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 an immediate in effect guidance entitled "Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical." FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in the biologics regulations regarding blood and blood components. This notice is being issued to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical. In addition, the guidance document provides recommendations to blood establishments for the manufacture and labeling of cold-stored platelets (CSP).
Full Text
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<title>Federal Register, Volume 88 Issue 121 (Monday, June 26, 2023)</title>
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[Federal Register Volume 88, Number 121 (Monday, June 26, 2023)]
[Notices]
[Pages 41405-41407]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13513]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-2034]
Alternative Procedures for the Manufacture of Cold-Stored
Platelets Intended for the Treatment of Active Bleeding When
Conventional Platelets Are Not Available or Their Use Is Not Practical;
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 an immediate in effect guidance entitled
``Alternative Procedures for the Manufacture of Cold-Stored Platelets
Intended for the Treatment of Active Bleeding when Conventional
Platelets Are Not Available or Their Use Is Not Practical.'' FDA is
issuing this guidance to provide a notice of exceptions and
alternatives to certain requirements in the biologics regulations
regarding blood and blood components. This notice is being issued to
respond to a public health need and address the urgent and immediate
need for platelets for the treatment of active bleeding when
conventional platelets are not available, or their use is not
practical. In addition, the guidance document provides recommendations
to blood establishments for the manufacture and labeling of cold-stored
platelets (CSP).
[[Page 41406]]
DATES: The announcement of the guidance is published in the Federal
Register on June 26, 2023.
ADDRESSES: You may submit comments on any guidance 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-2023-D-2034 for ``Alternative Procedures for the Manufacture of
Cold-Stored Platelets Intended for the Treatment of Active Bleeding
when Conventional Platelets Are Not Available or Their Use Is Not
Practical; Guidance for Industry; Availability.'' 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 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: Jessica Gillum, 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 an immediate in effect
guidance entitled ``Alternative Procedures for the Manufacture of Cold-
Stored Platelets Intended for the Treatment of Active Bleeding when
Conventional Platelets Are Not Available or Their Use Is Not
Practical.'' FDA is issuing this guidance to provide a notice of
exceptions and alternatives to certain requirements in subchapter F of
chapter I of title 21 of the CFR (21 CFR parts 600-680) regarding blood
and blood components. This notice is being issued under 21 CFR
640.120(b) to respond to a public health need and address the urgent
and immediate need for platelets for the treatment of active bleeding
when conventional platelets are not available, or their use is not
practical. Maintaining platelet availability in the face of logistical
challenges (e.g., in military, prehospital, or austere settings) or
other threats to blood availability (e.g., mass casualty events or
public health emergencies) is critical to assure that platelets are
available to patients with active bleeding.
In addition, this guidance document provides recommendations to
blood establishments for the manufacture and labeling of CSP. The
guidance also discusses the need for additional data on the efficacy of
CSP, in particular, to address whether their use is supported when
conventional platelets are available, and their use is practical.
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115 (21 CFR 10.115)). FDA is issuing
this guidance for immediate implementation in accordance with Sec.
10.115(g)(3) without initially seeking prior comment because the Agency
has determined that prior public participation is not feasible or
appropriate (see Sec. 10.115(g)(2)). Specifically, we are not seeking
comments before implementing this guidance because of the urgent and
immediate need for platelets for the treatment of active bleeding when
conventional platelets are not available, or their use is not
practical.
The guidance represents the current thinking of FDA on alternative
procedures for the manufacture of cold-stored platelets intended for
the treatment of active bleeding when
[[Page 41407]]
conventional platelets are not available, or their use is not
practical. 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 211.100 and 211.160(b) have been approved
under OMB control number 0910-0139; the collections of information in
21 CFR 601.12 and Form FDA 356h have been approved under OMB control
number 0910-0338; and the collections of information in 21 CFR 606.121
and 21 CFR 606.122 have been approved under OMB control number 0910-
0116.
III. Electronic Access
Persons with access to the internet may obtain the draft 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: June 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13513 Filed 6-23-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on June 26, 2023.
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