Document ID: FDA-2009-D-0137-0025
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry; Use of Serological Tests to Reduce Risk of Transmission of Trypanosoma cruzi Infection, etc.
Posted Date: 2010-12-06T05:00Z

[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75811-75812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30404]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995. Elsewhere in this issue of the Federal 
Register, FDA is publishing a notice announcing the availability of 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.

DATES: Fax written comments on the collection of information by January 
5, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``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.'' Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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--(OMB Control Number 0910-NEW)

    The guidance document, announced elsewhere in this issue of the 
Federal Register, would implement the donor screening recommendations 
for the FDA-approved serological test systems for the detection of 
antibodies to Trypanosoma cruzi. The use of the donor screening tests 
are 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, including donors of whole blood and blood 
components intended for transfusion. The guidance recommends that 
establishments that manufacture whole blood and blood components 
intended for transfusion should notify consignees of all previously 
collected in-date blood and blood components to quarantine and return 
the blood components to the establishments or to destroy them within 3 
calendar days after a donor tests repeatedly reactive by a licensed 
test for T. cruzi antibody. When establishments identify a donor who is 
repeatedly reactive by a licensed test for T. cruzi antibodies and for 
whom there is additional information indicating risk of T. cruzi 
infection, such as testing positive on a licensed supplemental test 
(when such test is available) or until such test is available, 
information that the donor or donor's mother resided in an area endemic 
for Chagas disease (Mexico, Central and South America) or as a result 
of other medical diagnostic testing of the donor indicating T. cruzi 
infection, we recommend that the establishment notify consignees of all 
previously distributed blood and blood components collected during the 
lookback period and, if blood or blood components were transfused, 
encourage consignees to notify the recipient's physician of record of a 
possible increased risk of T. cruzi infection.
    Respondents to this information collection are establishments that 
manufacture whole blood and blood components intended for transfusion. 
We believe that the information collection provisions for consignee 
notification and for consignees to notify the recipient's physician of 
record in the guidance do not create a new burden for respondents and 
are part of usual and customary business practices. Since the end of 
January 2007, a number of blood

[[Page 75812]]

centers representing a large proportion of U.S. blood collections have 
been testing donors using a licensed assay. We believe these 
establishments have already developed standard operating procedures for 
notifying consignees and the consignees to notify the recipient's 
physician of record.
    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.
    In the Federal Register of March 26, 2009 (74 FR 13211), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.

    Dated: November 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30404 Filed 12-3-10; 8:45 am]
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