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, 75811-75812 [2010-30404]
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Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices
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
emcdonald on DSK2BSOYB1PROD with NOTICES2
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
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
collection of information to OMB for
review and clearance.
Food and Drug Administration
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
[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.
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.
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
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17:33 Dec 03, 2010
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Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices
emcdonald on DSK2BSOYB1PROD with NOTICES2
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
VerDate Mar<15>2010
17:33 Dec 03, 2010
Jkt 223001
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.
PO 00000
Frm 00004
Fmt 4701
Sfmt 9990
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
E:\FR\FM\06DEN2.SGM
06DEN2
]]>Agencies
[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75811-75812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30404]
-----------------------------------------------------------------------
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
[[Page 75812]]
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
