[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Notices]
[Pages 83886-83887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-2732]


Recommendations for the Development of Blood Collection, 
Processing, and Storage Systems for the Manufacture of Blood Components 
Using the Buffy Coat Method; Draft Guidance for Industry; Availability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 or Agency) is announcing 
the availability of a draft document entitled ``Recommendations for the 
Development of Blood Collection, Processing, and Storage Systems for 
the Manufacture of Blood Components Using the Buffy Coat Method.'' The 
draft guidance document provides recommendations on the development of 
blood collection, processing, and storage systems (e.g., blood bags 
with anticoagulant and additive solutions, empty bags for platelet 
pooling) used for the manufacture of blood and blood components 
intended for transfusion using the buffy coat (BC) method. This 
guidance is intended for manufacturers of blood collection, processing, 
and storage systems.

DATES: Submit either electronic or written comments on the draft 
guidance by December 17, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

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: 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.
    <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-2732 for ``Recommendations for the Development of Blood 
Collection, Processing, and Storage Systems for the Manufacture of 
Blood Components Using the Buffy Coat

[[Page 83887]]

Method.'' 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.
    <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 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 draft 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 draft 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 draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Segal, 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 draft document entitled 
``Recommendations for the Development of Blood Collection, Processing, 
and Storage Systems for the Manufacture of Blood Components Using the 
Buffy Coat Method.'' This guidance provides recommendations on the 
development of blood collection, processing, and storage systems (e.g., 
blood bags with anticoagulant and additive solutions, empty bags for 
platelet pooling) used for the manufacture of blood and blood 
components intended for transfusion using the BC method. This guidance 
is intended for manufacturers of blood collection, processing, and 
storage systems.
    Blood and blood components must be prepared in a manner consistent 
with the instructions provided by the manufacturer (21 CFR 606.65(e)), 
including the directions provided in the instructions for use of the 
approved or cleared collection, processing, and storage system. To 
prepare blood components using the BC method, blood establishments must 
use blood collection, processing and storage systems approved or 
cleared for such use. However, blood collection, processing, and 
storage systems currently marketed in the United States are only 
approved or cleared for the preparation of blood components from Whole 
Blood (WB) using the platelet rich plasma method, and none are yet 
approved or cleared for the preparation of blood components using the 
BC method.
    This guidance provides recommendations to manufacturers who wish to 
obtain FDA approval or clearance to market blood collection, 
processing, and storage systems intended for the manufacture of blood 
components using the BC method. With the availability of such systems, 
blood establishments in the United States would have the option of 
manufacturing WB-derived blood components using the BC method.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 
``Recommendations for the Development of Blood Collection, Processing, 
and Storage Systems for the Manufacture of Blood Components Using the 
Buffy Coat Method.'' 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

    FDA tentatively concludes that this draft guidance contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

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: October 11, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24098 Filed 10-17-24; 8:45 am]
BILLING CODE 4164-01-P