[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36598-36600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13066]


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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)]


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

AGENCY: Food and Drug Administration, HHS.

[[Page 36599]]


ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Revised Recommendations 
to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for 
Industry.'' The revised guidance provides blood establishments that 
collect blood and blood components with FDA's recommendations to reduce 
the risk of transfusion-transmitted malaria. The recommendations 
contained in this 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. The guidance 
announced in this notice supersedes the guidance entitled 
``Recommendations for Donor Questioning, Deferral, Reentry, and Product 
Management to Reduce the Risk of Transfusion-Transmitted Malaria; 
Guidance for Industry'' dated August 2013 and updated August 2014.

DATES: The announcement of the guidance is published in the Federal 
Register on June 17, 2020. The Agency is soliciting public comment, but 
is implementing this guidance immediately, because the Agency has 
determined that prior public participation is not feasible or 
appropriate. Submit either electronic or written comments on Agency 
guidances at any time.

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 ``Revised 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: Stephen Ripley, 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 
``Revised Recommendations to Reduce the Risk of Transfusion-Transmitted 
Malaria; Guidance for Industry.'' This document was posted on FDA's 
website on April 2, 2020 (see section III for electronic access to the 
guidance). The revised guidance document provides blood establishments 
that collect blood and blood components with FDA's recommendations to 
reduce the risk of transfusion-transmitted malaria. The recommendations 
contained in this guidance apply to the collection of Whole Blood and 
all 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)).
    The guidance revises the recommendations in the August 2013 
guidance, updated August 2014, by reducing from 1 year to 3 months the 
recommended deferral period for certain

[[Page 36600]]

blood donors who are residents of a non-endemic country and who travel 
to malaria-endemic areas. In addition, the guidance provides notice of 
an alternative procedure to permit the collection of blood and blood 
components from such donors without a deferral period, provided the 
blood components are pathogen-reduced using an FDA-approved pathogen 
reduction device, effective against Plasmodium falciparum, according to 
manufacturer's instructions for use. The revised recommendations are 
based on the current epidemiological data on malaria, the risk of 
transfusion-transmitted malaria and the availability of FDA-approved 
devices. FDA expects implementation of these revised recommendations 
will not be associated with any adverse effect on the safety of the 
blood supply. Furthermore, early implementation of the recommendations 
in this guidance may help to address significant blood shortages that 
are occurring as a result of a current and ongoing Coronavirus Disease 
2019 (COVID-19) public health emergency.
    The guidance announced in this notice supersedes the guidance 
entitled ``Recommendations for Donor Questioning, Deferral, Reentry, 
and Product Management to Reduce the Risk of Transfusion-Transmitted 
Malaria; Guidance for Industry'' dated August 2013 and updated August 
2014.
    In light of the COVID-19 public health emergency, FDA is issuing 
this guidance for immediate implementation in accordance with Sec.  
10.115(g)(3) without initially seeking prior comment because the Agency 
has determined that prior public participation is not feasible or 
appropriate (see Sec.  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))). FDA 
expects that the revised recommendations will increase the availability 
of blood and blood components while maintaining the safety of blood and 
blood components.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115(g)(2)). The guidance represents the 
current thinking of FDA on ''Revised 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

    This guidance refers to previously approved collections of 
information found in FDA regulations. These 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 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 
either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or https://www.regulations.gov.

    Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13066 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P


