[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46954-46955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18573]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0868]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Draft Guidance for Industry: Use of Serological Tests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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments concerning establishment
notification of a consignee and consignee notification of a recipient's
physician of record regarding a possible increased risk of Trypanosoma
cruzi (T. cruzi) infection.
DATES: Submit either electronic or written comments on the collection
of information by October 1, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(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
[[Page 46955]]
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, including each proposed extension
of an existing 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 comments 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 of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 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 three 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.
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: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18573 Filed 8-1-13; 8:45 am]
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