[Federal Register Volume 87, Number 235 (Thursday, December 8, 2022)]
[Notices]
[Pages 75275-75276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26711]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-D-0187 [Formerly Docket No. 2000D-1267]]


Recommendations To Reduce the Risk of Transfusion-Transmitted 
Malaria; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance entitled 
``Recommendations to Reduce the Risk of Transfusion-Transmitted 
Malaria.'' The guidance document provides blood establishments that 
collect blood and blood components with FDA's recommendations to reduce 
the risk of transfusion-transmitted malaria (TTM). The recommendations 
contained in the guidance apply to the collection of Whole Blood and 
blood components, except Source Plasma. The guidance announced in this 
notice supersedes the guidance entitled ``Revised Recommendations to 
Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for 
Industry'' dated April 2020.

DATES: The announcement of the guidance is published in the Federal 
Register on December 8, 2022.

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-2000-D-0187 for ``Recommendations to Reduce the Risk of 
Transfusion-Transmitted Malaria; 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: Jessica Gillum, 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 final guidance entitled 
``Recommendations to Reduce the Risk of Transfusion-Transmitted 
Malaria;

[[Page 75276]]

Guidance for Industry.'' The guidance document provides blood 
establishments that collect blood and blood components with FDA's 
recommendations to reduce the risk of TTM. The recommendations 
contained in the guidance apply to the collection of Whole Blood and 
blood components, except Source Plasma. Blood establishments are not 
required to assess Source Plasma donors for malaria risk (see 21 CFR 
630.15(b)(8)).
    To address the urgent and immediate need for blood and blood 
components during the Coronavirus Disease 2019 (COVID-19) public health 
emergency, in April 2020 FDA issued revised recommendations to reduce 
the risk of TTM during the public health emergency. The recommendations 
in the April 2020 guidance were based on the Agency's evaluation of the 
available scientific and epidemiological data on malaria risk, and data 
on FDA-approved pathogen reduction devices. FDA stated in the April 
2020 guidance that we expected implementation of the revised 
recommendations would not be associated with any adverse effect on the 
safety of the blood supply and that early implementation of the 
recommendations may help to address significant blood shortages that 
occurred as result of the COVID-19 public health emergency. Further, 
the guidance explained that we expected that the recommendations set 
forth in the revised guidance would continue to apply outside the 
context of the COVID-19 public health emergency, and that FDA would 
replace the April 2020 guidance with an updated guidance that 
incorporates any appropriate changes based on public comments and our 
experience with implementation. Although the April 2020 guidance stated 
that we intended to reissue the guidance within 60 days following the 
termination of the public health emergency, we are not delaying this 
issuance because the guidance represents our current thinking on the 
topic.
    FDA is issuing this guidance for immediate implementation in 
accordance with our good guidance practices regulation (10.115(g)(3)) 
without initially seeking prior comment because the Agency has 
determined that prior public participation is not feasible or 
appropriate (see 10.115(g)(2) and section 701(h)(1)(C)(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i))). 
Specifically, we are not seeking prior comment because the 
recommendations present a less burdensome policy for reducing the risk 
of transfusion-transmitted malaria that is consistent with public 
health, and interested parties have had the opportunity to comment on 
the recommendations in the April 2020 guidance. The recommendations, 
which are unchanged from the April 2020 guidance, will remain in effect 
outside of the context of the public health emergency related to COVID-
19.
    In the Federal Register of June 17, 2020 (85 FR 36598), FDA 
announced the availability of the final guidance entitled ``Revised 
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; 
Guidance for Industry'' dated April 2020. FDA received no comments on 
the final guidance.
    The guidance represents the current thinking of FDA on 
``Recommendations to Reduce the Risk of Transfusion-Transmitted 
Malaria.'' 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. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 601 and Form FDA 356h have been approved 
under OMB control number 0910-0338; 21 CFR parts 606 and 630 have been 
approved under OMB control number 0910-0116; and the collections of 
information for consignee and transfusion recipient physician 
notification have been approved under OMB control number 0910-0681.

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: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26711 Filed 12-7-22; 8:45 am]
BILLING CODE 4164-01-P


