82 FR 19062 - 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 for Transfusion

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

The Food and Drug Administration (FDA or we) 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 (the PRA).

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19062-19063]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08306]


-----------------------------------------------------------------------

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; 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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) 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 (the PRA).

DATES: Fax written comments on the collection of information by May 25, 
2017.

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 [email protected]. 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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

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 0910-0681--Extension

    The guidance document implements the donor screening 
recommendations for the FDA-approved serological test systems for the 
detection of antibodies to 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 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 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 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

[[Page 19063]]

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 numbers 0910-0116 and 0910-0795; the collections of 
information in 21 CFR 606.171 have been approved under OMB control 
number 0910-0458.
    In the Federal Register of November 7, 2016 (81 FR 78170), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received 
in response to the notice.

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08306 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P