Document ID: FDA-2013-N-0868-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry:  Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion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: 2013-08-02T04:00Z

[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46954-46955]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18573]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Draft Guidance for Industry: Use of Serological Tests 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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments concerning establishment 
notification of a consignee and consignee notification of a recipient's 
physician of record regarding a possible increased risk of Trypanosoma 
cruzi (T. cruzi) infection.

DATES: Submit either electronic or written comments on the collection 
of information by October 1, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, Ila.mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests

[[Page 46955]]

or requirements that members of the public submit reports, keep 
records, or provide information to a third party. Section 3506(c)(2)(A) 
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to 
provide a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
of an existing collection of information, before submitting the 
collection to OMB for approval. To comply with this requirement, FDA is 
publishing notice of the proposed collection of information set forth 
in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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 three 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.
    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: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18573 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P