Rule2024-15228
Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 18, 2024
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 "Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry." The guidance document addresses certain regulatory requirements for determining donor eligibility that apply to blood establishments that collect blood and blood components for transfusion or for further manufacturing use, including Source Plasma. In a final rule dated May 22, 2015, FDA amended the regulations applicable to blood establishments for determining donor eligibility and testing blood and blood components. The revised requirements were implemented in order to assure the safety of the blood supply and to protect donor health. This guidance finalizes the draft guidance entitled "Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry" issued on May 24, 2022.
Full Text
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<title>Federal Register, Volume 89 Issue 138 (Thursday, July 18, 2024)</title>
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[Federal Register Volume 89, Number 138 (Thursday, July 18, 2024)]
[Rules and Regulations]
[Pages 58274-58275]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15228]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 630
[Docket No. FDA-2022-D-0362]
Blood Pressure and Pulse Donor Eligibility Requirements:
Compliance Policy; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Blood Pressure and
Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for
Industry.'' The guidance document addresses certain regulatory
requirements for determining donor eligibility that apply to blood
establishments that collect blood and blood components for transfusion
or for further manufacturing use, including Source Plasma. In a final
rule dated May 22, 2015, FDA amended the regulations applicable to
blood establishments for determining donor eligibility and testing
blood and blood components. The revised requirements were implemented
in order to assure the safety of the blood supply and to protect donor
health. This guidance finalizes the draft guidance entitled ``Blood
Pressure and Pulse Donor Eligibility Requirements: Compliance Policy;
Draft Guidance for Industry'' issued on May 24, 2022.
DATES: The announcement of the guidance is published in the Federal
Register on July 18, 2024.
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-0362 for ``Blood Pressure and Pulse Donor Eligibility
Requirements: Compliance Policy; 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
[[Page 58275]]
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: Myrna Hanna, 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 ``Blood
Pressure and Pulse Donor Eligibility Requirements: Compliance Policy.''
The document addresses certain regulatory requirements for determining
donor eligibility that apply to blood establishments that collect blood
components for transfusion or for further manufacturing use, including
Source Plasma. In the final rule dated May 22, 2015 (80 FR 29841)
entitled ``Requirements for Blood and Blood Components Intended for
Transfusion or for Further Manufacturing Use,'' FDA amended the
regulations applicable to blood establishments for determining donor
eligibility and testing blood and blood components.\1\ The revised
requirements were implemented in order to assure the safety of the
blood supply and to protect donor health. The final rule became
effective on May 23, 2016. FDA has developed the document in response
to feedback from blood establishments regarding the donor eligibility
requirements for blood pressure and pulse in 21 CFR 630.10 and the
corresponding requirements for medical supervision in 21 CFR 630.5. The
guidance describes the circumstances in which FDA does not intend to
take regulatory action for a blood establishment's failure to comply
with certain regulations for determining the eligibility of blood
donors with blood pressure or pulse measurements outside of the
specified limits.
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\1\ The Office of the Federal Register has published this
document under the category ``Rules and Regulations'' pursuant to 1
CFR 5.9(b). The categorization is solely for purposes of publication
in the Federal Register and does not change the nature of the
document and is not intended to affect its validity, content, or
intent. See 1 CFR 5.1(c).
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This guidance finalizes the draft guidance entitled ``Blood
Pressure and Pulse Donor Eligibility Requirements: Compliance Policy;
Draft Guidance for Industry'' issued on May 24, 2022 (87 FR 31567).
Changes made from the draft to the final guidance took into
consideration comments received. After considering the comments, we
made a few clarifying edits to the guidance and other editorial
changes.
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 blood pressure and pulse donor eligibility
requirements and explains our compliance policy with respect to these
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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved 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
<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: July 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15228 Filed 7-17-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on July 18, 2024.
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