[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 [www.gpo.gov]
[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 This guidance finalizes the draft guidance entitled ``Blood 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Draft Guidance for Industry'' issued on May 24, 2022.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:
     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-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.
     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

[[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 
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: 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