Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma Cruzi Infection in Whole Blood and Blood Components for Transfusion, 12506 [2014-04776]
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Federal Register / Vol. 79, No. 43 / Wednesday, March 5, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0868]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for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.
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.
DATES: Fax written comments on the
collection of information by April 4,
2014.
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0681. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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
Trypanosoma cruzi (T. cruzi). The use
of the donor screening tests are to
reduce the risk of transmission of T.
cruzi infection by detecting antibodies
VerDate Mar<15>2010
17:13 Mar 04, 2014
Jkt 232001
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 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 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.
In the Federal Register of August 2,
2013 (78 FR 46954), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
The guidance also refers to previously
approved collections of information
found in FDA regulations. The
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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: February 27, 2014.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–04776 Filed 3–4–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0225]
Announcement of Center for Biologics
Evaluation and Research’s Move to the
Food and Drug Administration’s White
Oak Campus
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that the Center for Biologics Evaluation
and Research (CBER) will be moving its
offices and laboratories from various
Rockville and Bethesda, MD, locations
to the FDA White Oak campus in Silver
Spring, MD. The move will commence
on or about May 1, 2014, and will end
approximately 8 weeks later, on or
about July 1, 2014. During this time
persons may continue to send
applications and other submissions
electronically via the FDA Electronic
Submissions Gateway to CBER for
review, evaluation, or other handling.
However, persons should send
submissions on paper or on electronic
media (CD, DVD), as well as lot release
samples to CBER’s new mailing
addresses once they take effect. CBER’s
new mailing addresses, including the
dates they take effect, as well as other
information concerning CBER’s move to
the FDA White Oak campus in Silver
Spring, MD, will be provided on the
FDA Web site at https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CBER/ucm385240.htm, as they become
available. During the period required for
relocation of files, equipment, and
Agency personnel, CBER will make
every effort to meet its review time
frames and minimize any potential
SUMMARY:
E:\FR\FM\05MRN1.SGM
05MRN1
]]>Agencies
[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Page 12506]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04776]
[[Page 12506]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0868]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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.
-----------------------------------------------------------------------
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.
DATES: Fax written comments on the collection of information by April
4, 2014.
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 emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0681.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@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 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 Trypanosoma cruzi (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 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 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.
In the Federal Register of August 2, 2013 (78 FR 46954), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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: February 27, 2014.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2014-04776 Filed 3-4-14; 8:45 am]
BILLING CODE 4160-01-P
