81 FR 13798 - Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 50 (March 15, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.'' The draft guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion through the implementation of pathogen reduction technology (PRT) or bacterial testing. The draft guidance also provides recommendations for the use of secondary testing of platelets as the basis to extend the dating period of platelets, when appropriately labeled bacterial detection devices and storage containers are used. The draft guidance replaces the draft guidance entitled ``Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for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 The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled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.

[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13798-13801]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1814]


Bacterial Risk Control Strategies for 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Availability of Platelets for Transfusion; Draft Guidance for Industry; 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 of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Bacterial Risk Control 
Strategies for Blood Collection Establishments and Transfusion Services 
to Enhance the Safety and Availability of Platelets for Transfusion; 
Draft Guidance for Industry.'' The draft guidance document provides 
blood collection establishments and transfusion services with 
recommendations to control the risk of bacterial contamination of room 
temperature stored platelets intended for transfusion through the 
implementation of pathogen reduction technology (PRT) or bacterial 
testing. The draft guidance also provides recommendations for the use 
of secondary testing of platelets as the basis to extend the dating 
period of platelets, when appropriately labeled bacterial detection 
devices and storage containers are used. The draft guidance replaces 
the draft guidance 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, 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.

[[Page 13799]]


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 June 13, 2016. Submit either electronic or written comments 
on the collection of information by May 16, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-1814 for ``Bacterial Risk Control Strategies for Blood 
Collection Establishments and Transfusion Services to Enhance the 
Safety and Availability of Platelets for Transfusion; Draft Guidance 
for Industry.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 240-402-8010. See 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Information Collection Requirements: 
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, 
[email protected].
    Guidance Document: 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 Risk Control Strategies for Blood Collection Establishments 
and Transfusion Services to Enhance the Safety and Availability of 
Platelets for Transfusion; Draft Guidance for Industry.'' 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 is 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 provides blood collection establishments and 
transfusion services with recommendations to control the risk of 
bacterial contamination of room temperature stored platelets intended 
for transfusion through the implementation of PRT or bacterial testing. 
PRT is performed shortly after platelet collection by blood collection 
establishments. Bacterial testing encompasses primary testing of 
platelets by blood collection establishments and subsequent secondary 
testing prior to transfusion primarily by transfusion services. The 
draft guidance also provides recommendations for the use of secondary 
testing of platelets as the basis to extend the dating period of 
platelets, when appropriately labeled bacterial detection devices and 
storage containers are used. Additionally, the draft guidance provides 
recommendations to licensed blood establishments for submitting 
biologics license application supplements to

[[Page 13800]]

include bacterial testing of platelet components. 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, they must register with FDA 
and list the blood products they manufacture.
    The draft guidance applies to 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 draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on bacterial risk 
control strategies for blood collection establishments and transfusion 
services to enhance the safety and availability of platelets for 
transfusion. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative if it 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes Agency requests 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 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.
    Title: Bacterial Risk Control Strategies for Blood Collection 
Establishments and Transfusion Services to Enhance the Safety and 
Availability of Platelets for Transfusion.
    Description: We have identified the following recommendations in 
the draft guidance document as collections of information. In section 
VI, 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 X.A.2, 
the draft guidance recommends that following secondary testing, 
labeling on the container label or a tie-tag, should relay the 
following information: (1) Type of bacterial detection test performed 
(rapid or culture) and (2) the date and time the bacterial detection 
test was performed.
    Description of Respondents: The third-party disclosure 
recommendations described in the draft guidance affect blood collection 
establishments and transfusion services that collect and manufacture 
platelet products for transfusion, including WBD platelets, apheresis 
platelets, pooled platelets, and platelets stored in additive 
solutions.
    Burden Estimate: The Agency believes the information collection 
provision for blood collection establishments in section VI 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 X.A.2, the draft guidance recommends that following 
secondary testing, establishments should maintain a labeling process 
that relays certain information and is integral to the container (e.g., 
on the container label or an attached tie-tag) and label accordingly. 
FDA estimates the burden of this collection of information as follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
                    Activity                         Number of     disclosures per    Total annual     Average burden  per disclosure      Total hours
                                                    respondents       respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section X.A.2: Following secondary testing,                 2480              403        1,000,000   .05 (3 minutes)...................          50,000
 maintain a labeling process that relays certain
 information and is integral to the container
 (e.g., on the container label or an attached
 tie-tag) and label accordingly.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 1 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. The recommendation for labeling following secondary testing 
applies to approximately 4,960 transfusion services in the Unites 
States. We estimate that about 50 percent of all platelets will be 
pathogen-reduced and 50 percent will be cultured. Therefore, to 
estimate the annual third-party disclosure burden in table 1, we assume 
that approximately one-half of the transfusion services will label one-
half of the total platelets intended for transfusion in the United 
States following secondary testing. The average burden disclosure for 
transfusion services to implement the recommendation in table 1 is 
based on FDA's experience and industry information.
    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

[[Page 13801]]

0910-0338; the collections of information in 21 CFR 606.65, 606.100, 
606.120, 606.121, 606.122, and have been approved under OMB control 
number 0910-0116; and the collections of information in 21 CFR part 607 
have been approved under OMB control number 0910-0052.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB (see ADDRESSES). All comments should be 
identified with the title of the information collection.
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has 
submitted the information collection provisions of this document to OMB 
for review. These requirements will not be effective until FDA obtains 
OMB approval. FDA will publish a notice concerning OMB approval of 
these requirements in the Federal Register.

III. 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: March 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05718 Filed 3-14-16; 8:45 am]
 BILLING CODE 4164-01-P