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
ICR 201403-0910-008
OMB: 0910-0681
Federal Form Document
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0681 can be found here:
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
Extension without change of a currently approved collection
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 and 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, FDA recommends 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, to encourage consignees to notify the recipient's
physician of record of a possible increased risk of T. cruzi
infection. The notification of consignees and of the recipient's
physician of record is intended to provide the necessary
information regarding possible increased risk of T. cruzi
infection. All donors who test repeatedly reactive should be
counseled to seek a physician's advice. It also may be helpful to
refer them to their state and local health departments or to other
appropriate community resources.
US Code:
42
USC 262 Name of Law: PHS Act
US Code: 21
USC 301 Name of Law: Federal Food Drug and Cosmetic Act
ILa Mizrachi 301 796-7726
ila.mizrachi@fda.hhs.gov
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
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