Document ID: FDA-2013-N-0868-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Draft Guidance for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
Posted Date: 2014-03-05T05:00Z

[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Page 12506]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04776]

[[Page 12506]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0868]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 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

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.

DATES: Fax written comments on the collection of information by April 
4, 2014.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0681. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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 for Transfusion--(OMB Control Number 0910-0681)--Extension

    The guidance implements the donor screening recommendations for the 
FDA-approved serological test systems for the detection of antibodies 
to Trypanosoma cruzi (T. 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 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 and 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 in the guidance 
for establishments to notify consignees and for consignees to notify 
the recipient's physician of record 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 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.
    In the Federal Register of August 2, 2013 (78 FR 46954), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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.

    Dated: February 27, 2014.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2014-04776 Filed 3-4-14; 8:45 am]
BILLING CODE 4160-01-P