[Federal Register Volume 88, Number 121 (Monday, June 26, 2023)]
[Notices]
[Pages 41405-41407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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-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 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: 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 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: 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