Document ID: FDA-2009-D-0137-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products
Posted Date: 2009-03-26T04:00Z

[Federal Register: March 26, 2009 (Volume 74, Number 57)]
[Notices]               
[Page 13211-13213]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr09-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0137]

 
Draft Guidance for Industry: Use of Serological Tests to Reduce 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 and Human Cells, Tissues, and 
Cellular and Tissue-Based Products; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``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 and 
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' 
dated March 2009. The draft guidance document notifies establishments 
that manufacture Whole Blood and blood components intended for use in 
transfusion, and establishments that make eligibility determinations 
for donors of HCT/Ps about FDA approval of a biologics license 
application for an enzyme-linked immunosorbent assay (ELISA) test 
system for the detection of antibodies to Trypanosoma cruzi (T. cruzi). 
The draft guidance also notifies establishments that make donor 
eligibility determinations for HCT/P donors that FDA has determined T. 
cruzi to be a relevant communicable disease under current regulations. 
In addition, the guidance provides recommendations for using a licensed 
test for antibodies to T. cruzi to test individual human donors, 
including donors of Whole Blood and blood components for transfusion 
and HCT/P donors (living and cadaveric (non-heart beating)), for 
antibodies to T. cruzi in plasma and serum samples. The guidance 
document does not apply to Source Plasma.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by June 24, 2009. Submit written comments on the information collection 
burden by May 26, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in 
processing your requests. The draft guidance may also be obtained by 
mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for

[[Page 13212]]

Industry: Use of Serological Tests to Reduce the Risk of Transmission 
of Trypanosoma cruzi Infection in Whole Blood and Blood Components for 
Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based 
Products (HCT/Ps)'' dated March 2009. The draft guidance document 
notifies establishments that manufacture Whole Blood and blood 
components intended for use in transfusion, and establishments that 
make eligibility determinations for donors of HCT/Ps about FDA approval 
of a biologics license application for an ELISA test system for the 
detection of antibodies to T. cruzi. The test is intended for use as a 
donor screening test 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, and HCT/P donors.
    In addition, FDA is providing establishments that manufacture Whole 
Blood and blood components intended for use in transfusion with 
recommendations for unit and donor management, labeling of Whole Blood 
and blood components, and procedures for reporting implementation of a 
licensed T. cruzi test at their facilities or contract testing 
laboratories, as required for blood establishments under title 21 of 
the Code of Federal Regulations (CFR) Sec.  601.12 (21 CFR 601.12). FDA 
is notifying establishments that make donor eligibility determinations 
for HCT/P donors, that it has determined T. cruzi to be a relevant 
communicable disease under 21 CFR 1271.3(r)(2), and is providing them 
with recommendations for screening and antibody testing of HCT/P 
donors.
    The guidance document applies to Whole Blood and blood components 
intended for transfusion and donors of HCT/Ps. The guidance document 
does not apply to Source Plasma. The recommendations made in the 
guidance with respect to HCT/Ps are in addition to recommendations made 
in the document entitled ``Guidance for Industry: Eligibility 
Determination for Donors of Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps)'' dated August 2007.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on this topic. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    The draft guidance document contains information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3520). Under the PRA, Federal agencies must obtain approval 
from 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 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 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 comment 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 on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology.
    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 and Human Cells, Tissues, and Cellular 
and Tissue-Based Products (HCT/Ps)
    The draft guidance would implement the FDA approved donor screening 
ELISA test system for the detection of antibodies to T. cruzi. The use 
of the donor screening test 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 use in transfusion. The draft 
guidance recommends establishments that manufacture Whole Blood and 
blood components intended for use in transfusion to 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. The draft guidance 
also recommends that 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 geographical risk for exposure in an endemic area, 
or medical diagnostic testing of the donor, 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, encourage consignees to notify the recipient's 
physician of record of a possible increased risk of T. cruzi infection.
    Description of Respondents: The reporting recommendations described 
in the draft guidance affect establishments that manufacture Whole 
Blood and blood components intended for use in transfusion.
    Burden Estimate: We believe that the information collection 
provisions for consignee notification and consignees to notify the 
recipient's physician in the draft guidance do not create a new burden 
for respondents and are part of 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 this licensed assay. We believe these establishments have already 
developed standard operating procedures for notifying consignees and 
the consignees to notify the recipient's physician.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in Sec.  601.12 have been approved under OMB control no. 0910-0338; the 
collections of information in 21 CFR 606.100, 606.121, 606.122, 
606.160(b)(ix), 606.170(b), and 630.6 have been approved under OMB 
control no. 0910-0116; the collections of information in 21 CFR 606.171 
have been approved under OMB control no. 0910-0458.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. We recognize that 
recent

[[Page 13213]]

scientific information obtained from screening of donors may affect the 
recommendations for implementation in the guidance. In particular, we 
welcome comments on potential strategies for selective donor testing 
for T. cruzi infection. Also, we recognize that lookback studies 
conducted using the licensed ELISA test suggest that the risk of 
transmission of this agent by transfusion of a seropositive unit in the 
United States may be much lower than previously thought, and we welcome 
comments in that regard. Additionally, we encourage you to submit 
comments to the docket regarding the value of performing recipient 
notification on prior collections from a donor who is repeatedly 
reactive on a currently licensed T. cruzi antibody test, and a prior 
collection had a licensed test result with a signal to cutoff ratio 
greater than 0.75 (i.e., a grey zone result), but for whom there may 
not be additional information indicating risk of infection.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the draft 
guidance. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in the brackets in the heading of this document. A copy of the draft 
guidance and received comments are available for public examination in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cber/guidelines.htm or http://
www.regulations.gov.

    Dated: March 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6684 Filed 3-25-09; 8:45 am]

BILLING CODE 4160-01-S