Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability, 73081-73083 [2014-28809]
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Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices
Dated: December 2, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–28713 Filed 12–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1814]
Bacterial Detection Testing by Blood
Collection Establishments and
Transfusion Services To Enhance the
Safety and Availability of Platelets for
Transfusion; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Bacterial Detection Testing by Blood
Collection Establishments and
Transfusion Services to Enhance the
Safety and Availability of Platelets for
Transfusion’’ dated December 2014. The
draft guidance document provides blood
collection establishments and
transfusion services with
recommendations for initial testing
(primary testing) for bacterial
contamination of platelets intended for
transfusion, and provides additional
considerations for blood collection
establishments and transfusion services
for subsequent retesting (secondary
testing) of platelets prior to transfusion.
The recommendations for primary
testing of platelets and the additional
considerations for secondary testing of
platelets described in this guidance are
expected to enhance the detection of
bacteria in platelet products and thus
enhance transfusion safety. The draft
guidance, when finalized, is intended to
supersede the recommendation in
section VII.A.2, in regard to bacterial
contamination testing in the document
entitled ‘‘Guidance for Industry and
FDA Review Staff: Collection of
Platelets by Automated Methods’’ dated
December 2007.
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considers your comment on this draft
guidance before it begins work on the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
either electronic or written comments
on the draft guidance by March 9, 2015.
Submit either electronic or written
comments on the collection of
information by February 9, 2015.
rljohnson on DSK3VPTVN1PROD with NOTICES
SUMMARY:
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Jkt 235001
Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. 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 240–402–7800. See
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit electronic comments on the
draft guidance and information
collection to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jonathan McKnight, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Bacterial
Detection Testing by Blood Collection
Establishments and Transfusion
Services to Enhance the Safety and
Availability of Platelets for Transfusion’’
dated December 2014. The draft
guidance document provides blood
collection establishments and
transfusion services with
recommendations for primary testing for
bacterial contamination of platelets
intended for transfusion and additional
considerations for blood collection
establishments and transfusion services
for secondary testing of platelets prior to
transfusion. FDA also provides
recommendations to licensed blood
establishments for submitting Biologics
License Application supplements to
include bacterial testing of platelet
components. Furthermore, the guidance
informs transfusion services that are
currently exempt from registration and
blood product listing that if they choose
to perform secondary testing of platelets
to extend the dating period, should this
option become available, they must
register with FDA and list the blood
products they manufacture.
The draft guidance addresses all
platelet products, including platelets
manufactured from Whole Blood
(Whole Blood Derived (WBD) platelets),
PO 00000
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73081
platelets collected by automated
methods from a single donor (apheresis
platelets), pooled platelets, and platelets
stored in additive solutions. The
recommendations for primary testing of
platelets and the additional
considerations for secondary testing of
platelets described in this guidance are
expected to enhance the detection of
bacteria in platelet products and thus
enhance transfusion safety. The draft
guidance, when finalized, is intended to
supersede the recommendation in
section VII.A.2, in regard to bacterial
contamination testing in the document
entitled ‘‘Guidance for Industry and
FDA Review Staff: Collection of
Platelets by Automated Methods’’ dated
December 2007.
Platelets are associated with a higher
risk of sepsis and are related to more
fatalities than any other transfusable
blood component. The risk of bacterial
contamination of platelets stands out as
a leading risk of infection from blood
transfusion. This risk has persisted
despite numerous interventions
including the introduction, in the last
decade, of analytically sensitive culturebased bacterial detection methods,
which are widely used to test platelets
prior to their release from blood
collection establishments to transfusion
services.
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
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (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
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
E:\FR\FM\09DEN1.SGM
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Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices
of the proposed collections of
information set forth in this document.
With respect to the following
collections 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.
Bacterial Detection Testing by Blood
Collection Establishments and
Transfusion Services To Enhance the
Safety and Availability of Platelets for
Transfusion
We have identified the following
recommendations in the draft guidance
document as collections of information.
In section V, the draft guidance
recommends that blood collection
establishments have in place measures
to promptly alert the transfusion
services in the event that a distributed
platelet product is subsequently
identified as positive for bacterial
contamination. In section IX.A.2, the
draft guidance recommends that
following secondary testing, a tie-tag
should be attached to the platelet
products to relay the following
information: Type of bacterial detection
test performed (rapid or culture); date
and time the bacterial detection test was
performed; and, the results of the
bacterial detection testing. The draft
guidance also recommends that a single
tie-tag may be attached to a pooled
platelet product.
Description of Respondents: The
third-party disclosure and one-time
recordkeeping recommendations
described in the draft guidance affect
blood collection establishments and
transfusion services that collect and
manufacture platelet products for
transfusion, including WBD platelets,
platelets collected by automated
methods from a single donor (apheresis
platelets), pooled platelets, and platelets
stored in additive solutions.
Burden Estimate: The Agency believes
the information collection provision for
licensed blood collection establishments
in section V does not create a new
burden for respondents and is part of
usual and customary business practice.
Blood collection establishments
currently have in place standard
operating procedures for notifying
consignees (transfusion services) if a
distributed platelet product has
subsequently tested positive for
bacterial contamination.
In section IX.A.2, the draft guidance
recommends that following secondary
testing, a tie-tag should be attached to
the platelet products to relay certain
information related to the bacterial
detection test. FDA estimates the burden
of this collection of information as
follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Labeling
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Under section IX.A.2, a tie-tag to the platelet product relaying specific information following secondary testing
should be attached ...........................................................
150
1,250
187,500
.05
9,375
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 of this document provides an
estimate of the annual third-party
disclosure burden for the information to
be submitted in accordance with the
draft guidance. Based on FDA data and
information submitted by industry, FDA
believes that there are approximately 2
million platelet transfusions per year
and that 75 percent or 1.5 million
transfusions occur at large volume
transfusion services. FDA also believes
that on average, the large volume
transfusion services perform about 5,000
platelet transfusions annually.
Furthermore, FDA approximates that
150 transfusion services, most of which
will be large volume transfusion
services, may elect to perform secondary
testing. We expect that secondary
testing will be used primarily for the
extension of dating up to 7 days at large
volume transfusion services. However,
while each of the 150 transfusion
services may issue, on average, 5,000
platelets a year, secondary testing will
be performed on only a portion of these
platelets. Based on FDA experience, we
estimate that secondary testing will be
performed on approximately 25 percent
or 1,250 platelets to permit transfusion
beyond day 5. Thus, the total estimated
annual burden of 9,375 hours for
transfusion services to implement the
recommendation in Table 1 is based on
FDA’s experience and industry
information.
TABLE 2—ESTIMATED ONE-TIME RECORDKEEPING BURDEN 1
rljohnson on DSK3VPTVN1PROD with NOTICES
Creation of SOPs
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Under section IX.A.2, a tie-tag to the platelet product relaying specific information following secondary testing
should be attached. ..........................................................
150
1
150
16
2,400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices
Table 2 of this document provides a
one-time recordkeeping burden estimate
for the information to be submitted in
accordance with the draft guidance. As
described in the proceeding paragraphs,
based on FDA’s experience and industry
information, FDA anticipates that 150
respondents, mainly from large volume
transfusion services, will implement the
recommendations set forth in section
IX.A.2. Thus, based on FDA data and
industry recordkeeping information,
FDA estimates that the total estimated
one-time recordkeeping burden is 2,400
hours.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR 601.12 and 610.60 have been
approved under OMB control number
0910–0338; the collections of
information in 21 CFR 606.65, 606.100,
606.120, 606.121, 606.122, and 606.140
have been approved under OMB control
number 0910–0116; and the collections
of information in 21 CFR 607.3, 607.7
and 607.65 have been approved under
OMB control number 0910–0052.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit either electronic comments
regarding this document to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (see ADDRESSES). It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
rljohnson on DSK3VPTVN1PROD with NOTICES
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–28809 Filed 12–8–14; 8:45 am]
BILLING CODE 4164–01–P
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Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2083]
Draft Guidance for Industry on Drug
Supply Chain Security Act
Implementation: Annual Reporting by
Prescription Drug Wholesale
Distributors and Third-Party Logistics
Providers; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Drug Supply Chain
Security Act Implementation: Annual
Reporting by Prescription Drug
Wholesale Distributors and Third-Party
Logistics Providers.’’ This draft
guidance addresses new provisions in
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Drug Supply Chain Security Act
(DSCSA). The draft guidance describes
FDA’s expectations for prescription
drug wholesale distributors (wholesale
distributors) and third-party logistics
providers (3PLs) about reporting to FDA
under the DSCSA.
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
either electronic or written comments
on the draft guidance by February 9,
2015. Submit either electronic or
written comments concerning the
collection of information proposed in
the draft guidance by February 9, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, 4147, Silver Spring, MD
20993; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
73083
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Suzanne Barone, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3130, wdd3plrequirements@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Drug Supply Chain Security Act
Implementation: Annual Reporting by
Prescription Drug Wholesale
Distributors and Third-Party Logistics
Providers.’’ This guidance is being
issued to facilitate implementation of
new reporting provisions under the
DSCSA. On November 27, 2013, the
DSCSA (Title II of Pub. L. 113–54) was
signed into law. The DSCSA outlines
new requirements for the licensing of
prescription drug wholesale distributors
and 3PLs.
Section 204 of the DSCSA amends
section 503(e) of the FD&C Act (21
U.S.C. 353(e)) and outlines requirements
for reporting by wholesale distributors.
Section 503(e)(2)(A) of the FD&C Act (as
amended) requires wholesale
distributors to report annually,
beginning on January 1, 2015.
Information to be reported includes
State licensure information and contact
information for each facility. Wholesale
distributors are also to report to FDA
any significant disciplinary actions
taken by the State or Federal
Government, such as revocation or
suspension of a license. Section 204 of
the DSCSA also amends section
503(e)(2)(B) of the FD&C Act and
requires FDA to make information about
wholesale distributors’ licensure
available to the public on FDA’s Web
site. Updates to the public information
are to be made on a schedule to be
determined by FDA.
Section 205 of the DSCSA adds
section 584 to the FD&C Act. Section
584 sets forth requirements for licensure
and reporting by 3PLs. Under section
584 of the FD&C Act (as amended) (21
U.S.C. 360eee–3), 3PLs are required to
report annually to FDA, beginning on
November 27, 2014 (1 year after the date
of enactment of the DSCSA). Thirdparty logistic providers are required to
report State licensure information, name
and address for each facility, and all
trade names under which each facility
conducts business.
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Pages 73081-73083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28809]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1814]
Bacterial Detection Testing by Blood Collection Establishments
and Transfusion Services To Enhance the Safety and Availability of
Platelets for Transfusion; Draft Guidance for Industry; 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 ``Bacterial Detection Testing
by Blood Collection Establishments and Transfusion Services to Enhance
the Safety and Availability of Platelets for Transfusion'' dated
December 2014. The draft guidance document provides blood collection
establishments and transfusion services with recommendations for
initial testing (primary testing) for bacterial contamination of
platelets intended for transfusion, and provides additional
considerations for blood collection establishments and transfusion
services for subsequent retesting (secondary testing) of platelets
prior to transfusion. The recommendations for primary testing of
platelets and the additional considerations for secondary testing of
platelets described in this guidance are expected to enhance the
detection of bacteria in platelet products and thus enhance transfusion
safety. The draft guidance, when finalized, is intended to supersede
the recommendation in section VII.A.2, in regard to bacterial
contamination testing in the document entitled ``Guidance for Industry
and FDA Review Staff: Collection of Platelets by Automated Methods''
dated December 2007.
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 either electronic or written comments on the draft
guidance by March 9, 2015. Submit either electronic or written comments
on the collection of information by February 9, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development,
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. 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 240-402-7800. See
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
Submit electronic comments on the draft guidance and information
collection to https://www.regulations.gov. Submit written comments to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Bacterial Detection Testing by Blood Collection Establishments and
Transfusion Services to Enhance the Safety and Availability of
Platelets for Transfusion'' dated December 2014. The draft guidance
document provides blood collection establishments and transfusion
services with recommendations for primary testing for bacterial
contamination of platelets intended for transfusion and additional
considerations for blood collection establishments and transfusion
services for secondary testing of platelets prior to transfusion. FDA
also provides recommendations to licensed blood establishments for
submitting Biologics License Application supplements to include
bacterial testing of platelet components. Furthermore, the guidance
informs transfusion services that are currently exempt from
registration and blood product listing that if they choose to perform
secondary testing of platelets to extend the dating period, should this
option become available, they must register with FDA and list the blood
products they manufacture.
The draft guidance addresses all platelet products, including
platelets manufactured from Whole Blood (Whole Blood Derived (WBD)
platelets), platelets collected by automated methods from a single
donor (apheresis platelets), pooled platelets, and platelets stored in
additive solutions. The recommendations for primary testing of
platelets and the additional considerations for secondary testing of
platelets described in this guidance are expected to enhance the
detection of bacteria in platelet products and thus enhance transfusion
safety. The draft guidance, when finalized, is intended to supersede
the recommendation in section VII.A.2, in regard to bacterial
contamination testing in the document entitled ``Guidance for Industry
and FDA Review Staff: Collection of Platelets by Automated Methods''
dated December 2007.
Platelets are associated with a higher risk of sepsis and are
related to more fatalities than any other transfusable blood component.
The risk of bacterial contamination of platelets stands out as a
leading risk of infection from blood transfusion. This risk has
persisted despite numerous interventions including the introduction, in
the last decade, of analytically sensitive culture-based bacterial
detection methods, which are widely used to test platelets prior to
their release from blood collection establishments to transfusion
services.
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 requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 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
[[Page 73082]]
of the proposed collections of information set forth in this document.
With respect to the following collections 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.
Bacterial Detection Testing by Blood Collection Establishments and
Transfusion Services To Enhance the Safety and Availability of
Platelets for Transfusion
We have identified the following recommendations in the draft
guidance document as collections of information. In section V, the
draft guidance recommends that blood collection establishments have in
place measures to promptly alert the transfusion services in the event
that a distributed platelet product is subsequently identified as
positive for bacterial contamination. In section IX.A.2, the draft
guidance recommends that following secondary testing, a tie-tag should
be attached to the platelet products to relay the following
information: Type of bacterial detection test performed (rapid or
culture); date and time the bacterial detection test was performed;
and, the results of the bacterial detection testing. The draft guidance
also recommends that a single tie-tag may be attached to a pooled
platelet product.
Description of Respondents: The third-party disclosure and one-time
recordkeeping recommendations described in the draft guidance affect
blood collection establishments and transfusion services that collect
and manufacture platelet products for transfusion, including WBD
platelets, platelets collected by automated methods from a single donor
(apheresis platelets), pooled platelets, and platelets stored in
additive solutions.
Burden Estimate: The Agency believes the information collection
provision for licensed blood collection establishments in section V
does not create a new burden for respondents and is part of usual and
customary business practice. Blood collection establishments currently
have in place standard operating procedures for notifying consignees
(transfusion services) if a distributed platelet product has
subsequently tested positive for bacterial contamination.
In section IX.A.2, the draft guidance recommends that following
secondary testing, a tie-tag should be attached to the platelet
products to relay certain information related to the bacterial
detection test. FDA estimates the burden of this collection of
information as follows:
Table 1--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Labeling Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Under section IX.A.2, a tie-tag to the platelet product relaying 150 1,250 187,500 .05 9,375
specific information following secondary testing should be
attached..........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 of this document provides an estimate of the annual third-
party disclosure burden for the information to be submitted in
accordance with the draft guidance. Based on FDA data and information
submitted by industry, FDA believes that there are approximately 2
million platelet transfusions per year and that 75 percent or 1.5
million transfusions occur at large volume transfusion services. FDA
also believes that on average, the large volume transfusion services
perform about 5,000 platelet transfusions annually. Furthermore, FDA
approximates that 150 transfusion services, most of which will be large
volume transfusion services, may elect to perform secondary testing. We
expect that secondary testing will be used primarily for the extension
of dating up to 7 days at large volume transfusion services. However,
while each of the 150 transfusion services may issue, on average, 5,000
platelets a year, secondary testing will be performed on only a portion
of these platelets. Based on FDA experience, we estimate that secondary
testing will be performed on approximately 25 percent or 1,250
platelets to permit transfusion beyond day 5. Thus, the total estimated
annual burden of 9,375 hours for transfusion services to implement the
recommendation in Table 1 is based on FDA's experience and industry
information.
Table 2--Estimated One-Time Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Creation of SOPs Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Under section IX.A.2, a tie-tag to the platelet product relaying 150 1 150 16 2,400
specific information following secondary testing should be
attached..........................................................
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 73083]]
Table 2 of this document provides a one-time recordkeeping burden
estimate for the information to be submitted in accordance with the
draft guidance. As described in the proceeding paragraphs, based on
FDA's experience and industry information, FDA anticipates that 150
respondents, mainly from large volume transfusion services, will
implement the recommendations set forth in section IX.A.2. Thus, based
on FDA data and industry recordkeeping information, FDA estimates that
the total estimated one-time recordkeeping burden is 2,400 hours.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR 601.12 and 610.60 have been approved under OMB control number
0910-0338; the collections of information in 21 CFR 606.65, 606.100,
606.120, 606.121, 606.122, and 606.140 have been approved under OMB
control number 0910-0116; and the collections of information in 21 CFR
607.3, 607.7 and 607.65 have been approved under OMB control number
0910-0052.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28809 Filed 12-8-14; 8:45 am]
BILLING CODE 4164-01-P
