[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]
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