[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60834-60835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Establishments: Questions and Answers; Draft Guidance for Industry,'' 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:
     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-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 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,

[[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 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 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