75810 Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0137] 

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; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a 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 Intended for Transfusion’’ 

dated December 2010. The guidance 

document notifies establishments that 

manufacture whole blood and blood 

components intended for transfusion 

about FDA approvals of biologics 

license applications for serological test 

systems for the detection of antibodies 

to Trypanosoma cruzi. These tests are 

intended for use as donor screening 

tests 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. The guidance document does 

not apply to the collection of source 

plasma. Also, the guidance does not 

apply to establishments that make 

eligibility determinations for donors of 

human cells, tissues, and cellular and 

tissue-based products (HCT/Ps). The 

guidance announced in this document 

finalizes the draft guidance entitled 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 recommendations for 

HCT/P donor screening and testing for 

T. cruzi antibodies contained in the 

draft guidance are not being finalized at 

this time because FDA believes 

additional discussion is warranted. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a 30-day 

notice announcing that the proposed 

collection of information for the 

guidance has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit either electronic or 

written comments on agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448. Send one selfaddressed adhesive label to assist the 

office in processing your requests. The 

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 guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

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 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 Intended 

for Transfusion’’ dated December 2010. 

The guidance document notifies 

establishments that manufacture whole 

blood and blood components intended 

for transfusion about FDA license 

approvals for serological test systems for 

the detection of antibodies to T. cruzi. 

These tests are intended for use as 

donor screening tests 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. The guidance 

document provides recommendations 

for one time testing of donations of 

whole blood and blood components for 

evidence of T. cruzi infection, blood 

donor and product management, 

labeling of whole blood and blood 

components, and procedures for 

reporting the implementation of a 

licensed T. cruzi test. The guidance 

document does not apply to the 

collection of source plasma. Also, the 

guidance does not apply to 

establishments that make eligibility 

determinations for donors of HCT/Ps. 

The recommendations for HCT/P donor 

screening and testing for T. cruzi 

antibodies contained in the draft 

guidance are not being finalized at this 

time because FDA believes additional 

consideration of the recommendations 

is warranted. 

At the April 2009 Blood Products 

Advisory Committee (committee) 

meeting, FDA sought advice from the 

committee regarding selective testing 

strategies for T. cruzi infection in repeat 

blood donors. After discussing the 

testing strategies presented, the 

committee voted in favor of a selective 

testing strategy in which one negative 

test would qualify a donor for all future 

donations without further testing or the 

need to ask questions regarding risk of 

a newly acquired T. cruzi infection. 

In the Federal Register of March 26, 

2009 (74 FR 13211), FDA announced the 

availability of the draft guidance 

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 guidance announced 

in this document finalizes only the 

recommendations concerning testing 

donations of whole blood and blood 

components intended for transfusion for 

T. cruzi antibodies. 

At this time, FDA is continuing to 

review public comments on our 

recommendations for testing HCT/P 

donors for T. cruzi. Therefore, we are 

not finalizing our recommendations for 

HCT/Ps in this guidance. We intend to 

issue guidance for testing HCT/P donors 

for T. cruzi infection in the future. 

FDA received numerous comments on 

the draft guidance and those comments 

were considered as the guidance was 

finalized. Editorial changes also were 

made to improve clarity. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents 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 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the OMB under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). Elsewhere in this 

issue of the Federal Register, FDA is 

publishing a 30-day notice entitled 

‘‘Agency Information Collection 


emcdonald on DSK2BSOYB1PROD with NOTICES2
Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 75811 

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 Intended 

for Transfusion,’’ which announces that 

the proposed collection of information 

has been submitted to OMB for review 

and clearance under the Paperwork 

Reduction Act. FDA will publish a 

notice concerning OMB approval of 

these information collection provisions 

in the Federal Register prior to the 

implementation date provided in the 

guidance document. 

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. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

or comments regarding this document. It 

is only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the 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 guidance at either http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or http://

www.regulations.gov. 

Dated: November 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30405 Filed 12–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0137] 

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 

Intended for Transfusion 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice 

announcing the availability of the 

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 Intended 

for Transfusion’’ dated December 2010. 

DATES: Fax written comments on the 

collection of information by January 5, 

2011. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘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.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

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–NEW) 

The guidance document, announced 

elsewhere in this issue of the Federal 

Register, would implement the donor 

screening recommendations for the 

FDA-approved serological test systems 

for the detection of antibodies to 

Trypanosoma 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 the 

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 or 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 for consignee 

notification 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 


emcdonald on DSK2BSOYB1PROD with NOTICES2