Document ID: FDA-2009-D-0137-0045
Agency: fda
Document Type: Notice
Title: Use of Serological Tests to Reduce the Risk of Transmission of  Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry; Availability
Posted Date: 2017-12-06T05:00Z

[Federal Register Volume 82, Number 233 (Wednesday, December 6, 2017)]
[Notices]
[Pages 57601-57603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26226]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0137]

Use of Serological Tests to Reduce the Risk of Transmission of 
Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a document entitled ``Use of Serological Tests to 
Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood 
and Blood Components; Guidance for Industry.'' The guidance document 
provides recommendations to blood collection establishments regarding 
the use of serological tests to reduce the risk of transmission of 
Trypanosoma cruzi (T. cruzi) infection in blood and blood components. 
The recommendations apply to the collection of blood and blood 
components, except Source Plasma, for transfusion or for use in 
manufacturing a product, including donations intended as a component 
of, or used to manufacture, a medical device. The guidance announced in 
this notice supersedes the guidance entitled ``Guidance for Industry: 
Use of Serological Tests to Reduce the Risk of Transmission of 
Trypanosoma cruzi Infection in Whole Blood and Blood Components 
Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance) 
and finalizes the draft guidance entitled ``Amendment to `Guidance for 
Industry: Use of Serological Tests to Reduce the Risk of Transmission 
of Trypanosoma cruzi Infection in Whole Blood and Blood Components 
Intended for Transfusion'; Draft Guidance for Industry'' dated November 
2016 (2016 Draft Chagas Guidance). The guidance incorporates 
recommendations for blood donor testing, deferral, and donor reentry 
from the 2016 Draft Chagas Guidance.

DATES: The announcement of the guidance is published in the Federal 
Register on December 6, 2017.

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

[[Page 57602]]

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-2009-D-0137 for ``Use of Serological Tests to Reduce the Risk of 
Transmission of Trypanosoma cruzi Infection in Blood and Blood 
Components; 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.
     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.gpo.gov/fdsys/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.
    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: Tami Belouin, 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 ``Use of 
Serological Tests to Reduce the Risk of Transmission of Trypanosoma 
cruzi Infection in Blood and Blood Components; Guidance for Industry.'' 
The guidance document addresses the use of serological tests to reduce 
the risk of transmission of T. cruzi infection in blood and blood 
components. The recommendations apply to the collection of blood and 
blood components, except Source Plasma, for transfusion or for use in 
manufacturing a product, including donations intended as a component 
of, or used to manufacture, a medical device. The guidance incorporates 
recommendations for blood donor testing, deferral, notification, and 
donor reentry from the 2016 Draft Chagas Guidance. The 2016 Draft 
Chagas Guidance amended the 2010 Chagas Guidance by (1) expanding the 
scope of the guidance to include the collection of blood and blood 
components for use in manufacturing a product, including donations 
intended as a component of, or used to manufacture, a medical device; 
(2) removing the recommendation to ask donors about a history of Chagas 
disease; and (3) providing a recommendation for a reentry algorithm for 
certain donors deferred on the basis of screening test results for 
antibodies to T. cruzi or on the basis of answering ``yes'' to the 
Chagas screening question. The 2016 Draft Chagas Guidance also provided 
notice that FDA had licensed a supplemental test for antibodies to T. 
cruzi. and further testing of donations found repeatedly reactive to a 
screening test for T. cruzi is therefore required under 21 CFR 
610.40(e).
    In the Federal Register of December 6, 2010 (75 FR 75810), FDA 
announced the availability of the guidance entitled ``Guidance for 
Industry: Use of Serological Tests to Reduce the Risk of Transmission 
of Trypanosoma cruzi Infection in Whole Blood and Blood Components 
Intended for Transfusion'' dated December 2010. In the Federal Register 
of November, 10, 2016 (81 FR 79034), FDA announced the availability of 
the draft guidance entitled ``Amendment to 'Guidance for Industry: Use 
of Serological Tests to Reduce the Risk of Transmission of Trypanosoma 
cruzi Infection in Whole Blood and Blood Components Intended for 
Transfusion'; Draft Guidance for Industry'' dated November 2016. FDA 
received two comments on the 2016 Draft Chagas Guidance and those 
comments were considered as the guidance was finalized. The guidance 
announced in this notice supersedes the 2010 Chagas Guidance and 
finalizes the 2016 Draft Chagas Guidance.
    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 ``Use of Serological Tests to Reduce the 
Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood 
Components.'' 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. This guidance is not subject to Executive Order 12866.

[[Page 57603]]

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The 
guidance refers to the following collections of information: (1) 
Establishments notify consignees of all previously collected in-date 
blood and blood components from a donor that tests repeatedly reactive 
by a licensed test for T. cruzi antibody to quarantine and return the 
blood and blood components to the establishments or to destroy them; 
(2) establishments notify consignees of all previously distributed 
blood and blood components collected from such a donor during the 
lookback period; and (3) if such blood components were transfused, 
consignees notify the recipient's physician of record of a possible 
increased risk of T. cruzi infection. These collections of information 
have been approved under OMB control number 0910-0681.
    This guidance also refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by OMB under the PRA. The collections of 
information in 21 CFR part 601 have been approved under OMB control 
number 0910-0338; and the collections of information in 21 CFR parts 
606, 610, and 630 have been approved under OMB control numbers 0910-
0116 and 0910-0795.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: November 30, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26226 Filed 12-5-17; 8:45 am]
 BILLING CODE 4164-01-P