Document ID: FDA-2009-D-0137-0026
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Use of Serological Tests to Reduce Riskof Transmission of Trypanosoma cruzi Infection, etc.
Posted Date: 2010-12-06T05:00Z

[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75810-75811]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30405]

[[Page 75809]]

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Part IV

Department of Health and Human Services

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Food and Drug Administration

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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; Availability; Agency Information 
Collection Activities; Submission for Office of Management and Budget 
Review; Comment Request; 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; Notices

  Federal Register / Vol. 75 , No. 233 / Monday, December 6, 2010 / 
Notices  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a 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. The guidance document notifies 
establishments that manufacture whole blood and blood components 
intended for transfusion about FDA approvals of biologics license 
applications for serological test systems for the detection of 
antibodies to Trypanosoma cruzi. These tests are intended for use as 
donor screening tests to reduce the risk of transmission of T. cruzi 
infection by detecting antibodies to T. cruzi in plasma and serum 
samples from individual human donors. The guidance document does not 
apply to the collection of source plasma. Also, the guidance does not 
apply to establishments that make eligibility determinations for donors 
of human cells, tissues, and cellular and tissue-based products (HCT/
Ps). The guidance announced in this document finalizes the draft 
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 for Transfusion and Human Cells, Tissues, 
and Cellular and Tissue-Based Products (HCT/Ps)'' dated March 2009. The 
recommendations for HCT/P donor screening and testing for T. cruzi 
antibodies contained in the draft guidance are not being finalized at 
this time because FDA believes additional discussion is warranted. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
30-day notice announcing that the proposed collection of information 
for the guidance has been submitted to the Office of Management and 
Budget (OMB) for review and clearance under the Paperwork Reduction Act 
of 1995.

DATES: Submit either electronic or written comments on agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. 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 301-827-1800. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a 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. The guidance 
document notifies establishments that manufacture whole blood and blood 
components intended for transfusion about FDA license approvals for 
serological test systems for the detection of antibodies to T. cruzi. 
These tests are intended for use as donor screening tests to reduce the 
risk of transmission of T. cruzi infection by detecting antibodies to 
T. cruzi in plasma and serum samples from individual human donors. The 
guidance document provides recommendations for one time testing of 
donations of whole blood and blood components for evidence of T. cruzi 
infection, blood donor and product management, labeling of whole blood 
and blood components, and procedures for reporting the implementation 
of a licensed T. cruzi test. The guidance document does not apply to 
the collection of source plasma. Also, the guidance does not apply to 
establishments that make eligibility determinations for donors of HCT/
Ps. The recommendations for HCT/P donor screening and testing for T. 
cruzi antibodies contained in the draft guidance are not being 
finalized at this time because FDA believes additional consideration of 
the recommendations is warranted.
    At the April 2009 Blood Products Advisory Committee (committee) 
meeting, FDA sought advice from the committee regarding selective 
testing strategies for T. cruzi infection in repeat blood donors. After 
discussing the testing strategies presented, the committee voted in 
favor of a selective testing strategy in which one negative test would 
qualify a donor for all future donations without further testing or the 
need to ask questions regarding risk of a newly acquired T. cruzi 
infection.
    In the Federal Register of March 26, 2009 (74 FR 13211), FDA 
announced the availability of the draft 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 for Transfusion and Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps)'' dated March 2009. The guidance 
announced in this document finalizes only the recommendations 
concerning testing donations of whole blood and blood components 
intended for transfusion for T. cruzi antibodies.
    At this time, FDA is continuing to review public comments on our 
recommendations for testing HCT/P donors for T. cruzi. Therefore, we 
are not finalizing our recommendations for HCT/Ps in this guidance. We 
intend to issue guidance for testing HCT/P donors for T. cruzi 
infection in the future.
    FDA received numerous comments on the draft guidance and those 
comments were considered as the guidance was finalized. Editorial 
changes also were made to improve clarity.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this topic. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). Elsewhere in this issue of the Federal Register, 
FDA is publishing a 30-day notice entitled ``Agency Information 
Collection

[[Page 75811]]

Activities; Submission for Office of Management and Budget Review; 
Comment Request; 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,'' which announces 
that the proposed collection of information has been submitted to OMB 
for review and clearance under the Paperwork Reduction Act. FDA will 
publish a notice concerning OMB approval of these information 
collection provisions in the Federal Register prior to the 
implementation date provided in the guidance document.
    The guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR 601.12 have been approved under OMB control number 0910-0338; 
the collections of information in 21 CFR 606.100, 606.121, 606.122, 
606.160(b)(ix), 606.170(b), 610.40, and 630.6 have been approved under 
OMB control number 0910-0116; the collections of information in 21 CFR 
606.171 have been approved under OMB control number 0910-0458.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written or comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

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

    Dated: November 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30405 Filed 12-3-10; 8:45 am]
BILLING CODE 4160-01-P