Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability, 13211-13213 [E9-6684]
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Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices
DATES: Submit a written or electronic
request for participation in this program
by April 27, 2009. You should include
the following information in your
request: contact name, contact phone
number, e-mail address, name of the
establishment, address, and license
number (if applicable).
ADDRESSES: If you are interested in
participating in this program, you
should submit a request to participate in
the program to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic requests to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Lore
Fields, Center for Biologics Evaluation
and Research (HFM–375), Food and
Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852–
1448, 301–827–6143, Fax: 301–827–
3534, or e-mail: lore.fields@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CBER regulates certain biological
products, including blood and blood
products, and is committed to
advancing the public health through
innovative activities that help ensure
the safety, effectiveness and timely
delivery of these products to patients.
Further, CBER seeks to continuously
enhance and update review efficiency
and quality, and the quality of its
regulatory efforts and interactions, by
providing CBER staff and industry with
improved processes. In support of this
goal, CBER has participated in the FDA
development of a computer-assisted
automated BLA/BLS submission
program called eSubmitter to improve
the process for providing certain
regulatory submissions to FDA. The
eSubmitter will include programs to
submit applications for licensure,
supplements to an approved license,
and amendments to pending
applications or supplements.
II. The eSubmitter Pilot Evaluation
Program Expectations
The eSubmitter pilot evaluation
program is expected to last
approximately 6 months. During this
period of time, participants will
complete BLA/BLS regulatory
submissions using the eSubmitter
template developed at CBER for use by
Source Plasma establishments. The
eSubmitter was developed using the
same review criteria for applications for
these products as currently used in the
BLA/BLS review process at CBER.
During the BLA/BLS submission
process, the participants will enter the
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requested information into the
eSubmitter tool and attach requested
documents as an Adobe document (pdf
format). This information will be saved
onto a CD–ROM and mailed to CBER for
review. Paper copies of submissions
will not be required. CBER will review
the information provided on the CD–
ROM and the attachments according to
current managed review procedures.
During the BLA/BLS submission
process, CBER staff will be available to
answer any questions or concerns that
may arise. As each submission is
completed, the users will be asked to
comment on the eSubmitter program.
These discussions will assist CBER in
the final development and release of
this electronic tool for use by industry.
III. Requests for Participation
Requests to participate in the
eSubmitter pilot are to be identified
with the docket number found in
brackets in the heading of this
document. Once requests for
participation are received, FDA will
contact interested establishments to
discuss the pilot program.
Dated: March 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–6687 Filed 3–25–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0137]
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 and
Human Cells, Tissues, and Cellular and
Tissue-Based Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft 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 for Transfusion and
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)’’ dated
March 2009. The draft guidance
document notifies establishments that
manufacture Whole Blood and blood
components intended for use in
PO 00000
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Fmt 4703
Sfmt 4703
13211
transfusion, and establishments that
make eligibility determinations for
donors of HCT/Ps about FDA approval
of a biologics license application for an
enzyme-linked immunosorbent assay
(ELISA) test system for the detection of
antibodies to Trypanosoma cruzi (T.
cruzi). The draft guidance also notifies
establishments that make donor
eligibility determinations for HCT/P
donors that FDA has determined T.
cruzi to be a relevant communicable
disease under current regulations. In
addition, the guidance provides
recommendations for using a licensed
test for antibodies to T. cruzi to test
individual human donors, including
donors of Whole Blood and blood
components for transfusion and HCT/P
donors (living and cadaveric (non-heart
beating)), for antibodies to T. cruzi in
plasma and serum samples. The
guidance document does not apply to
Source Plasma.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by June 24, 2009. Submit
written comments on the information
collection burden by May 26, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The draft 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 draft guidance
document.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
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 draft document entitled ‘‘Guidance for
E:\FR\FM\26MRN1.SGM
26MRN1
13212
Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices
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 draft
guidance document notifies
establishments that manufacture Whole
Blood and blood components intended
for use in transfusion, and
establishments that make eligibility
determinations for donors of HCT/Ps
about FDA approval of a biologics
license application for an ELISA test
system for the detection of antibodies to
T. cruzi. The test is intended for use as
a donor screening test 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,
and HCT/P donors.
In addition, FDA is providing
establishments that manufacture Whole
Blood and blood components intended
for use in transfusion with
recommendations for unit and donor
management, labeling of Whole Blood
and blood components, and procedures
for reporting implementation of a
licensed T. cruzi test at their facilities or
contract testing laboratories, as required
for blood establishments under title 21
of the Code of Federal Regulations (CFR)
§ 601.12 (21 CFR 601.12). FDA is
notifying establishments that make
donor eligibility determinations for
HCT/P donors, that it has determined T.
cruzi to be a relevant communicable
disease under 21 CFR 1271.3(r)(2), and
is providing them with
recommendations for screening and
antibody testing of HCT/P donors.
The guidance document applies to
Whole Blood and blood components
intended for transfusion and donors of
HCT/Ps. The guidance document does
not apply to Source Plasma. The
recommendations made in the guidance
with respect to HCT/Ps are in addition
to recommendations made in the
document entitled ‘‘Guidance for
Industry: Eligibility Determination for
Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products
(HCT/Ps)’’ dated August 2007.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent 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 requirement
VerDate Nov<24>2008
20:28 Mar 25, 2009
Jkt 217001
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
The draft guidance document
contains information collection
provisions that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (the PRA) (44 U.S.C. 3501–
3520). Under the PRA, Federal agencies
must obtain approval from 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 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
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
comment 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 on respondents, including
through the use of automated collection
techniques, when appropriate, and other
forms of information technology.
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 and
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)
The draft guidance would implement
the FDA approved donor screening
ELISA test system for the detection of
antibodies to T. cruzi. The use of the
donor screening test is 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 use in
transfusion. The draft guidance
recommends establishments that
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
manufacture Whole Blood and blood
components intended for use in
transfusion to 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. The draft
guidance also recommends that 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
geographical risk for exposure in an
endemic area, or medical diagnostic
testing of the donor, 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.
Description of Respondents: The
reporting recommendations described in
the draft guidance affect establishments
that manufacture Whole Blood and
blood components intended for use in
transfusion.
Burden Estimate: We believe that the
information collection provisions for
consignee notification and consignees to
notify the recipient’s physician in the
draft guidance do not create a new
burden for respondents and are part of
usual and customary business practice.
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 this
licensed assay. We believe these
establishments have already developed
standard operating procedures for
notifying consignees and the consignees
to notify the recipient’s physician.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in
§ 601.12 have been approved under
OMB control no. 0910–0338; the
collections of information in 21 CFR
606.100, 606.121, 606.122,
606.160(b)(ix), 606.170(b), and 630.6
have been approved under OMB control
no. 0910–0116; the collections of
information in 21 CFR 606.171 have
been approved under OMB control no.
0910–0458.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. We recognize that recent
E:\FR\FM\26MRN1.SGM
26MRN1
Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices
scientific information obtained from
screening of donors may affect the
recommendations for implementation in
the guidance. In particular, we welcome
comments on potential strategies for
selective donor testing for T. cruzi
infection. Also, we recognize that
lookback studies conducted using the
licensed ELISA test suggest that the risk
of transmission of this agent by
transfusion of a seropositive unit in the
United States may be much lower than
previously thought, and we welcome
comments in that regard. Additionally,
we encourage you to submit comments
to the docket regarding the value of
performing recipient notification on
prior collections from a donor who is
repeatedly reactive on a currently
licensed T. cruzi antibody test, and a
prior collection had a licensed test
result with a signal to cutoff ratio greater
than 0.75 (i.e., a grey zone result), but
for whom there may not be additional
information indicating risk of infection.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding the draft guidance.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in the brackets in
the heading of this document. A copy of
the draft guidance and received
comments are available for public
examination 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 draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.regulations.gov.
Dated: March 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–6684 Filed 3–25–09; 8:45 am]
BILLING CODE 4160–01–S
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20:28 Mar 25, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0149]
Agency Emergency Processing Under
Office of Management and Budget
Review; Guidance for Industry: Animal
Generic Drug User Fees and Fee
Waivers and Reductions
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 emergency processing under
the Paperwork Reduction Act of 1995
(the PRA). The proposed collection of
information concerns the burden hours
required to implement the new statutory
requirements for the user fees and fee
waivers reductions provisions of the
Animal Generic Drug User Fee Act of
2008 (AGDUFA) (Federal Food, Drug,
and Cosmetic Act (the act)).
DATES: Fax written comments on the
collection of information provisions by
March 31, 2009.
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:
202–395–6974, 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: Animal
Generic Drug Fees and Fee Waivers
Reduction; Emergency Request.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710); Food and Drug
Administration 5600 Fishers Lane
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: FDA is
requesting emergency processing of this
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j) and 5 CFR 1320.13).
Section 741(d) of the act (21 U.S.C.
379k(d)), as amended by AGDUFA,
authorizes FDA to collect user fees for
certain: (1) Abbreviated applications for
generic new animal drugs, (2) new
animal drug products, and (3) sponsors
of such abbreviated applications for
PO 00000
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Fmt 4703
Sfmt 4703
13213
generic new animal drugs and/or
investigational submissions of new
animal drugs. However, AGDUFA also
provides FDA with the authorization to
grant a waiver from or a reduction of
those fees in certain circumstances. To
provide guidance, FDA has developed
the guidance entitled ‘‘Animal Generic
Drug User Fees and Fee Waivers and
Reductions,’’ which is crucial to firms
understanding whether they might
qualify for the waiver or reduction, and
if so, how to apply for it.
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: Animal Generic
Drug User Fees and Fee Waivers and
Reductions (Section 741(d) of the
Federal Food, Drug, and Cosmetic Act);
Emergency Request
AGDUFA requires FDA to collect user
fees for certain: (1) Abbreviated
applications for a generic new animal
drug, (2) generic new animal drug
products, and (3) sponsors of such
abbreviated applications for generic new
animal drugs and/or investigational
submissions for generic new animal
drugs. AGDUFA also contains a specific
provision under which a fee waiver or
reduction may be requested for any or
all of these fees. The type of fee waiver
and reduction requests to be submitted
is: Minor Use or Minor Species. FDA
seeks OMB approval for this summary
of information required for a fee waiver
or reduction request.
Respondents to the proposed
collection of information will likely be
private industry. Requests for a waiver
or reduction may be submitted by a
person paying any of the generic new
animal drug user fees assessed—
application fees, product fees, or
sponsor fees.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\26MRN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 57 (Thursday, March 26, 2009)]
[Notices]
[Pages 13211-13213]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-6684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0137]
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 and Human Cells, Tissues, and
Cellular and Tissue-Based Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft 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 for Transfusion and
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)''
dated March 2009. The draft guidance document notifies establishments
that manufacture Whole Blood and blood components intended for use in
transfusion, and establishments that make eligibility determinations
for donors of HCT/Ps about FDA approval of a biologics license
application for an enzyme-linked immunosorbent assay (ELISA) test
system for the detection of antibodies to Trypanosoma cruzi (T. cruzi).
The draft guidance also notifies establishments that make donor
eligibility determinations for HCT/P donors that FDA has determined T.
cruzi to be a relevant communicable disease under current regulations.
In addition, the guidance provides recommendations for using a licensed
test for antibodies to T. cruzi to test individual human donors,
including donors of Whole Blood and blood components for transfusion
and HCT/P donors (living and cadaveric (non-heart beating)), for
antibodies to T. cruzi in plasma and serum samples. The guidance
document does not apply to Source Plasma.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by June 24, 2009. Submit written comments on the information collection
burden by May 26, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft 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 draft
guidance document.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov.
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 draft document entitled
``Guidance for
[[Page 13212]]
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 draft guidance document
notifies establishments that manufacture Whole Blood and blood
components intended for use in transfusion, and establishments that
make eligibility determinations for donors of HCT/Ps about FDA approval
of a biologics license application for an ELISA test system for the
detection of antibodies to T. cruzi. The test is intended for use as a
donor screening test 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, and HCT/P donors.
In addition, FDA is providing establishments that manufacture Whole
Blood and blood components intended for use in transfusion with
recommendations for unit and donor management, labeling of Whole Blood
and blood components, and procedures for reporting implementation of a
licensed T. cruzi test at their facilities or contract testing
laboratories, as required for blood establishments under title 21 of
the Code of Federal Regulations (CFR) Sec. 601.12 (21 CFR 601.12). FDA
is notifying establishments that make donor eligibility determinations
for HCT/P donors, that it has determined T. cruzi to be a relevant
communicable disease under 21 CFR 1271.3(r)(2), and is providing them
with recommendations for screening and antibody testing of HCT/P
donors.
The guidance document applies to Whole Blood and blood components
intended for transfusion and donors of HCT/Ps. The guidance document
does not apply to Source Plasma. The recommendations made in the
guidance with respect to HCT/Ps are in addition to recommendations made
in the document entitled ``Guidance for Industry: Eligibility
Determination for Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)'' dated August 2007.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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 requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
The draft guidance document contains information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520). Under the PRA, Federal agencies must obtain approval
from 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 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 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 comment 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 on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
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 and Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps)
The draft guidance would implement the FDA approved donor screening
ELISA test system for the detection of antibodies to T. cruzi. The use
of the donor screening test is 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 use in transfusion. The draft
guidance recommends establishments that manufacture Whole Blood and
blood components intended for use in transfusion to 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. The draft guidance
also recommends that 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 geographical risk for exposure in an endemic area,
or medical diagnostic testing of the donor, 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.
Description of Respondents: The reporting recommendations described
in the draft guidance affect establishments that manufacture Whole
Blood and blood components intended for use in transfusion.
Burden Estimate: We believe that the information collection
provisions for consignee notification and consignees to notify the
recipient's physician in the draft guidance do not create a new burden
for respondents and are part of usual and customary business practice.
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 this licensed assay. We believe these establishments have already
developed standard operating procedures for notifying consignees and
the consignees to notify the recipient's physician.
The draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in Sec. 601.12 have been approved under OMB control no. 0910-0338; the
collections of information in 21 CFR 606.100, 606.121, 606.122,
606.160(b)(ix), 606.170(b), and 630.6 have been approved under OMB
control no. 0910-0116; the collections of information in 21 CFR 606.171
have been approved under OMB control no. 0910-0458.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. We recognize that
recent
[[Page 13213]]
scientific information obtained from screening of donors may affect the
recommendations for implementation in the guidance. In particular, we
welcome comments on potential strategies for selective donor testing
for T. cruzi infection. Also, we recognize that lookback studies
conducted using the licensed ELISA test suggest that the risk of
transmission of this agent by transfusion of a seropositive unit in the
United States may be much lower than previously thought, and we welcome
comments in that regard. Additionally, we encourage you to submit
comments to the docket regarding the value of performing recipient
notification on prior collections from a donor who is repeatedly
reactive on a currently licensed T. cruzi antibody test, and a prior
collection had a licensed test result with a signal to cutoff ratio
greater than 0.75 (i.e., a grey zone result), but for whom there may
not be additional information indicating risk of infection.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft
guidance. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in the brackets in the heading of this document. A copy of the draft
guidance and received comments are available for public examination 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 draft guidance
at either https://www.fda.gov/cber/guidelines.htm or https://www.regulations.gov.
Dated: March 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6684 Filed 3-25-09; 8:45 am]
BILLING CODE 4160-01-S
