4164-01-P
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.
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 This guidance finalizes the draft guidance
entitled “Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft
Guidance for Industry” issued on May 24, 2022.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 [INSERT
DATE OF PUBLICATION IN THE FEDERAL REGISTER].
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:

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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.

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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 https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

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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-2015-0918/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 1800-835-4709 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 components1. 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

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).
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.
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
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-informationbiologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidancedocuments, or https://www.regulations.gov.
Dated: July 5, 2024.

Lauren K. Roth,
Associate Commissioner for Policy.

[FR Doc. 2024-15228 Filed: 7/17/2024 8:45 am; Publication Date: 7/18/2024]