Notice2021-24073
Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry; Availability
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Published
November 4, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry." The guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing a pathogen reduction device for the manufacture of pathogen-reduced blood components. The guidance, in a question-and-answer format, addresses the most frequently asked questions concerning implementation of the INTERCEPT[supreg] Blood System for Platelets and Plasma. The guidance also provides recommendations to licensed manufacturers on reporting the manufacturing changes associated with implementation of a pathogen reduction device. The guidance announced in this notice finalizes the draft document entitled "Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry," dated December 2017.
Full Text
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<title>Federal Register, Volume 86 Issue 211 (Thursday, November 4, 2021)</title>
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[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60834-60835]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-24073]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6784]
Manufacture of Blood Components Using a Pathogen Reduction Device
in Blood Establishments: Questions and Answers; 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 final guidance entitled ``Manufacture of Blood
Components Using a Pathogen Reduction Device in Blood Establishments:
Questions and Answers; Guidance for Industry.'' The guidance document
provides blood establishments that collect or process blood and blood
components with recommendations for implementing a pathogen reduction
device for the manufacture of pathogen-reduced blood components. The
guidance, in a question-and-answer format, addresses the most
frequently asked questions concerning implementation of the
INTERCEPT[supreg] Blood System for Platelets and Plasma. The guidance
also provides recommendations to licensed manufacturers on reporting
the manufacturing changes associated with implementation of a pathogen
reduction device. The guidance announced in this notice finalizes the
draft document entitled ``Implementation of Pathogen Reduction
Technology in the Manufacture of Blood Components in Blood
Establishments: Questions and Answers; Draft Guidance for Industry,''
dated December 2017.
DATES: The announcement of the guidance is published in the Federal
Register on November 4, 2021.
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-2017-D-6784 for ``Manufacture of Blood Components using a Pathogen
Reduction Device in Blood Establishments: Questions and Answers;
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 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,
[[Page 60835]]
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: 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
FDA is announcing the availability of a document entitled
``Manufacture of Blood Components Using a Pathogen Reduction Device in
Blood Establishments: Questions and Answers; Guidance for Industry.''
The guidance document provides blood establishments that collect or
process blood and blood components with recommendations for
implementing a pathogen reduction device for the manufacture of
pathogen-reduced blood components. The guidance, in a question-and-
answer format, addresses the most frequently asked questions on this
topic. The guidance also provides recommendations to licensed
manufacturers on reporting the manufacturing changes associated with
implementation of a pathogen reduction device under 21 CFR 601.12.
The recommendations in the guidance apply to blood establishments
that intend to manufacture pathogen-reduced platelet and plasma
products using an FDA approved pathogen reduction device. Currently,
the INTERCEPT[supreg] Blood System has been approved for the
manufacture of certain pathogen-reduced platelet and plasma products.
If the product platforms for this FDA approved device change, or FDA
approves another pathogen reduction device with a similar intended use
in the future, the Agency will consider providing additional
recommendations to blood establishments.
In the Federal Register of December 27, 2017 (82 FR 61304), FDA
announced the availability of the draft document entitled
``Implementation of Pathogen Reduction Technology in the Manufacture of
Blood Components in Blood Establishments: Questions and Answers; Draft
Guidance for Industry.'' FDA received a few comments on the draft
guidance. The comments addressed various issues, including the
indications for use of the INTERCEPT[supreg] Blood System for Platelets
and Plasma; sampling plans for quality control and validation of the
manufacturing process in blood establishments; labeling of pathogen
reduced blood components; submissions to FDA for changes to an approved
application; and requirements for licensure of pathogen reduced blood
components. One comment raised a concern that the guidance addresses a
single product. FDA made changes to the guidance to reflect revised
labeling for the INTERCEPT[supreg] Blood System, and to improve clarity
of the recommendations, including those related to quality control and
submissions to FDA. Additionally, FDA changed the title of the guidance
to clarify that the purpose of the guidance is to provide
recommendations for implementing a pathogen reduction device in blood
establishments, as opposed to providing recommendations regarding the
clinical use of products. However, FDA did not make substantive changes
to the guidance in response to the public comments. The guidance
announced in this notice finalizes the draft guidance dated December
2017.
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 the manufacture of blood components using a
pathogen reduction device in blood establishments. 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
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). 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
parts 606 and 630 have been approved under OMB control number 0910-
0116.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either <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: October 29, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24073 Filed 11-3-21; 8:45 am]
BILLING CODE 4164-01-P
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