[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Pages 73081-73083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28809]
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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Platelets for Transfusion; Draft Guidance for Industry; Availability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.
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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 The draft guidance document provides blood collection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 The draft guidance, when finalized, is intended to supersede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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 9, 2015.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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development,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 http://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
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Number of
Labeling Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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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..........................................................
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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
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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 http://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 http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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