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
75812 Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 

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. 

In the Federal Register of March 26, 

2009 (74 FR 13211), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received on the information collection. 

Dated: November 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30404 Filed 12–3–10; 8:45 am] 

BILLING CODE 4160–01–P 


emcdonald on DSK2BSOYB1PROD with NOTICES2