Document ID: FDA-2009-D-0137-0028
Agency: fda
Document Type: Notice
Title: 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the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry; Availability
Posted Date: 2016-11-10T05:00Z

[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Notices]
[Pages 79034-79035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27107]

[[Page 79034]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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Blood and Blood Components Intended for Transfusion; Draft Guidance for 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; 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 draft document 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Components Intended for Transfusion; Draft Guidance for Industry.'' The 
draft guidance document, when finalized, is intended to amend the 
document 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) by 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; removing the 
recommendation to ask donors about a history of Chagas disease; and 
providing a recommendation for a reentry algorithm for donors deferred 
on the basis of screening test results for antibodies to Trypanosoma 
cruzi (T. cruzi) or on the basis of answering ``yes'' to the Chagas 
screening question. Further, the guidance is intended to notify blood 
establishments that collect blood and blood components that FDA has 
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. The draft guidance does not apply to 
the collection of Source Plasma.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 8, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``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.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft 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 draft 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 draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New

[[Page 79035]]

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 draft document 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.'' The draft guidance, when finalized, is intended to amend 
the 2010 Chagas Guidance (75 FR 75810, December 6, 2010) by 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; 
removing the recommendation to ask donors about a history of Chagas 
disease; and providing a recommendation for a reentry algorithm for 
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.
    In the Federal Register of May 22, 2015 (80 FR 29842), FDA 
published the final rule entitled ``Requirements for Blood and Blood 
Components Intended for Transfusion or for Further Manufacturing Use.'' 
The final rule became effective May 23, 2016. The draft guidance is 
intended to notify blood establishments that collect blood and blood 
components that T. cruzi is defined as a relevant transfusion-
transmitted infection in 21 CFR 630.3(h)(1), subject to the testing 
requirements in 21 CFR 610.40, the donor deferral practices in 21 CFR 
610.41, and the donor notification requirements in 21 CFR 630.40 under 
the final rule. In addition, the draft guidance is intended to notify 
blood establishments that collect blood and blood components that FDA 
has 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). The draft 
guidance does not apply to the collection of Source Plasma. All other 
recommendations in the 2010 Chagas Guidance would remain unchanged.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``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.'' 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 draft 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. 3501-3520). The 
collections of information in 21 CFR 601.12 have been approved under 
OMB control number 0910-0338; and the collections of information in 21 
CFR 610.40 and 630.40 have been approved under OMB control numbers 
0910-0116 and 0910-0795.

III. Electronic Access

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

    Dated: November 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27107 Filed 11-9-16; 8:45 am]
BILLING CODE 4164-01-P