Document ID: FDA-2014-D-1814-0125
Agency: fda
Document Type: Notice
Title: 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Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability
Posted Date: 2018-12-06T05:00Z

[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62872-62873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26477]

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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Availability of Platelets for Transfusion; Draft Guidance for Industry; 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Draft Guidance for Industry.'' The draft guidance document provides 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. The guidance 
provides recommendations for all platelet products, including platelets 
manufactured by automated methods (apheresis platelets), whole blood 
derived (WBD) platelets, pooled platelets (pre-storage and post-
storage) and platelets stored in additive solutions. The draft guidance 
replaces the draft guidance of the same title dated March 2016.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 4, 2019. Submit either electronic or written 
comments on the draft guidance by February 4, 2019 to ensure that the 
Agency considers your comment on this draft guidance before it begins 
work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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

[[Page 62873]]

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 https://www.regulations.gov or at the Dockets Management Staff 
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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 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.'' 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. The draft guidance provides recommendations for all 
platelet products, including platelets manufactured by automated 
methods (apheresis platelets), WBD platelets, pooled platelets (pre-
storage and post-storage) and platelets stored in additive solutions. 
Additionally, this guidance provides licensed blood establishments with 
recommendations on how to report implementation of manufacturing and 
labeling changes under 21 CFR 601.12.
    The draft guidance replaces the draft guidance of the same title 
dated March 2016 (81 FR 13798; March 15, 2016).
    Most recently, FDA convened a Blood Products Advisory Committee 
(BPAC) meeting in July 2018 to discuss bacterial contamination of 
platelets and strategies to control the risk. At this meeting, BPAC 
considered the scientific evidence and operational considerations of 
all available strategies to control the risk of bacterial contamination 
of platelets with 5-day and 7-day dating, including bacterial testing 
strategies using culture-based devices, rapid bacterial detection 
devices, and the implementation of pathogen reduction technology. The 
data presented and BPAC's discussion at the July 2018 meeting provided 
the foundation for the recommendations in this guidance.
    This 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 approach if it 
satisfies the requirements of the applicable statutes and regulations. 
This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338; the collections of information in 21 CFR 
part 606 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.

III. 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: November 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26477 Filed 12-4-18; 8:45 am]
 BILLING CODE 4164-01-P