Rule2023-22957
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry; Availability
Primary source
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Published
October 18, 2023
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 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 The guidance announced in this document finalizes the draft guidance of the same title dated May 2022, and supersedes the guidance entitled "Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health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.
Full Text
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<title>Federal Register, Volume 88 Issue 200 (Wednesday, October 18, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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-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 <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, 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
[[Page 71737]]
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
<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 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
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</html>Indexed from Federal Register on October 18, 2023.
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