
[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Rules and Regulations]
[Pages 71736-71737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22957]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 630 and 640

[Docket No. FDA-2022-D-0588]


Compliance Policy Regarding Blood and Blood Component Donation 
Suitability, Donor Eligibility and Source Plasma Quarantine Hold 
Requirements; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Compliance 
Policy Regarding Blood and Blood Component Donation Suitability, Donor 
Eligibility and Source Plasma Quarantine Hold Requirements.'' The 
guidance document addresses certain requirements that apply to blood 
establishments that collect blood and blood components, including 
Source Plasma. Specifically, the guidance explains the conditions under 
which FDA does not intend to take regulatory action for a blood 
establishment's failure to comply with certain requirements in FDA's 
regulations regarding donation suitability, donor eligibility, and 
quarantine hold for Source Plasma. FDA expects that the compliance 
policy described in the guidance will increase the availability of 
blood and blood components, including Source Plasma, while maintaining 
the health of blood donors and the safety of blood and blood 
components. The guidance announced in this document finalizes the draft 
guidance of the same title dated May 2022, and supersedes the guidance 
entitled ``Alternative Procedures for Blood and Blood Components During 
the COVID-19 Public Health Emergency; Guidance for Industry,'' dated 
April 2020.

DATES: The announcement of the guidance is published in the Federal 
Register on October 18, 2023.

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-2022-D-0588 for ``Compliance Policy Regarding Blood and Blood 
Component Donation Suitability, Donor Eligibility and Source Plasma 
Quarantine Hold Requirements; 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, 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: Phillip Kurs, 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 
``Compliance Policy Regarding Blood and Blood Component Donation 
Suitability, Donor Eligibility and Source Plasma

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Quarantine Hold Requirements.'' The guidance document addresses certain 
requirements that apply to blood establishments that collect blood and 
blood components, including Source Plasma. Specifically, the guidance 
explains the conditions under which FDA does not intend to take 
regulatory action for a blood establishment's failure to comply with 
certain requirements in Title 21 of the Code of Federal Regulations (21 
CFR 630.30) regarding donation suitability; 21 CFR 630.10(c)(2) 
regarding donor eligibility; and 21 CFR 640.69(f) regarding quarantine 
hold for Source Plasma.
    In the Federal Register of May 24, 2022 (87 FR 31440), FDA 
announced the availability of the draft guidance of the same title 
dated May 2022. FDA received several comments on the draft guidance and 
those comments were considered as the guidance was finalized. A summary 
of changes includes clarifying the format of the report discussed in 
the guidance and clarifying the scope of the compliance policy. In 
addition, editorial changes were made to improve clarity. The guidance 
announced in this document finalizes the draft guidance dated May 2022, 
and supersedes the guidance entitled ``Alternative Procedures for Blood 
and Blood Components During the COVID-19 Public Health Emergency; 
Guidance for Industry,'' dated April 2020.
    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 ``Compliance Policy Regarding Blood and 
Blood Component Donation Suitability, Donor Eligibility and Source 
Plasma Quarantine Hold Requirements.'' 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 contains information collection provisions that 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 have been approved under OMB control number 
0910-0116. This guidance also refers to previously approved FDA 
collections of information. The collections of information in 21 CFR 
part 601 have been approved under OMB control number 0910-0338 and the 
collections of information in 21 CFR parts 606, 630, and 640 have been 
approved under OMB control number 0910-0116.

III. Electronic Access

    Persons with access to the internet may obtain the 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 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22957 Filed 10-17-23; 8:45 am]
BILLING CODE 4164-01-P


