0681 SS for 2017 Extension

FOOD AND DRUG ADMINISTRATION
Guidance for Industry (GFI): Use of Serological Tests to
Reduce the Risk of Transmission of Trypanosoma cruzi (T. cruzi) Infection in
Whole Blood and Blood Components Intended for Transfusion
OMB Control No. 0910-0681
SUPPORTING STATEMENT
Terms of Clearance: None
A. Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) guidance entitled,
“Guidance for Industry (GFI): Use of Serological Tests to Reduce the Risk of Transmission of
Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion.”
The guidance establishes donor screening recommendations for the FDA approved serological
test systems for the detection of antibodies to T. cruzi. The purpose of the donor screening tests
is 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 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 and
positive on a licensed supplemental test, 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.
Thus, the information collection provisions found in the guidance include recommendations that
establishments notify consignees of all previously distributed blood and blood components that
tested repeatedly reactive for the Trypanosoma cruzi (T. Cruzi) antibody; and recommendations
that consignees to notify the recipient’s physician of record of a possible increased risk of
Trypanosoma cruzi infection, if the recipient was transfused with a blood or blood components
from a donor who tested repeatedly reactive for Trypanosoma cruzi antibody.
Accordingly, we are requesting OMB approval for the information collection provisions found in
the agency guidance entitled, ““Guidance for Industry (GFI): Use of Serological Tests to
Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood
Components Intended for Transfusion.”

2. Purpose and Use of the Information Collection
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.
3. Use of Improved Information Technology and Burden Reduction
Notification of consignees or the recipient’s physician of record can be accomplished by email,
phone, fax, or mail. FDA is not aware of any improved technology to reduce the burden.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
The information collection applies to all respondents without exemption. At the same time, the
agency provides industry assistance through agency guidance and by contacting agency
personnel. Information in this regard may be found on the agency’s website at: www.fda.gov.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with recommendations found in agency
guidance. We believe this presents minimal burden on respondents while ensuring the safety of
the nation’s blood supply.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of November 7, 2016 (81 FR 78170). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift was provided to respondents.

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10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information received by FDA would be consistent with the Freedom of
Information Act (FOIA) and FDA’s published regulations of “Public Information” under 21 CFR
Part 20. Inspectors may copy records as part of an inspection of a blood establishment. This
information is for internal use and may be subject to, in whole or in part, FOIA and applicable
FDA regulations.
11. Justification for Sensitive Questions
Questions of a sensitive nature are not applicable to this information collection.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Respondents to this collection of information are establishments that manufacture Whole
Blood and blood components intended for transfusion. FDA believes that the information
collection provisions mentioned in the guidance document for establishments to notify
consignees and for the consignees to notify the blood and blood component recipient’s physician
of record do not create a new burden for the respondents. FDA believes that the provisions
recommended in the guidance are part of the usual and customary business practice. 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. FDA believes these establishments
have already developed standard operating procedures for notifying consignees and for 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 630.40 have been approved under OMB
control number. 0910-0116 and 0910-0795; the collections of information in 21 CFR 606.171
have been approved under OMB control number. 0910-0458.
There is no annual hour burden estimate associated with this collection of information;
however, we retain our estimate of one annual response and one burden hour to maintain the
information collection provisions.
12b. Annualized Cost Burden Estimate
We estimate no annual cost burden to respondents for this collection of information.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital costs or operating or maintenance costs associated with this collection of
information.

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14. Annualized Cost to the Federal Government
There are no estimated annual costs to the Federal Government associated with this collection of
information.
15. Explanation for Program Changes or Adjustments
There are no program changes or adjustments from the previous burden estimate. The
collections of information in the guidance document are part of usual and customary business
practices.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB Expiration Date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exemptions to the certification.

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