[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Platelets for Transfusion; Draft Guidance for Industry; Availability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 The draft guidance document provides blood collection 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 The draft guidance, when finalized, is intended to supersede 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 9, 2015.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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development, 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