[Federal Register Volume 84, Number 191 (Wednesday, October 2, 2019)]
[Notices]
[Pages 52512-52513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21228]



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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; 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 final guidance entitled ``Bacterial Risk Control 
Strategies for Blood Collection Establishments and Transfusion Services 
to Enhance the Safety and Availability of Platelets for Transfusion; 
Guidance for Industry.'' The 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 recommendations in the 
guidance apply to all platelet products stored at room temperature in 
plasma or additive solutions, including platelets manufactured by 
automated methods (apheresis platelets), and Whole Blood derived (WBD) 
single and pooled (pre-storage and post-storage) platelets. 
Additionally, the guidance provides licensed blood establishments with 
recommendations on how to report implementation of manufacturing and 
labeling changes. The guidance announced in this notice finalizes the 
draft guidance of the same title dated December 2018.

DATES: The announcement of the guidance is published in the Federal 
Register on October 2, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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 establishments and transfusion services to enhance the 
safety and availability of platelets for transfusion.'' 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 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 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, 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 document entitled 
``Bacterial Risk Control Strategies for Blood Collection Establishments 
and Transfusion Services to Enhance the Safety and Availability of 
Platelets for Transfusion; Guidance for Industry.'' The 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 recommendations in the guidance apply to all platelet

[[Page 52513]]

products stored at room temperature in plasma or additive solutions, 
including platelets manufactured by automated methods (apheresis 
platelets), and WBD single and pooled (pre-storage and post-storage) 
platelets. Additionally, the guidance provides licensed blood 
establishments with recommendations on how to report implementation of 
manufacturing and labeling changes.
    Room temperature stored platelets are associated with a higher risk 
of sepsis and related fatality than any other transfusable blood 
component. The risk of bacterial contamination of platelets is a 
leading risk of infection from blood transfusion, and this risk has 
persisted despite the implementation of numerous interventions, 
including a commonly used method of a single culture test after 
collection of the platelets.
    FDA has established regulations to address the control of bacterial 
contamination of platelets. Under 21 CFR 606.145(a), blood 
establishments and transfusion services must assure that the risk of 
bacterial contamination of platelets is adequately controlled using FDA 
approved or cleared devices, or other adequate and appropriate methods 
found acceptable for this purpose by FDA. The guidance provides 
recommendations to control the risk of bacterial contamination of 
platelets with 5-day and 7-day dating, including bacterial testing 
strategies (using culture-based and rapid bacterial detection devices) 
and the implementation of pathogen reduction devices. In the Federal 
Register of December 6, 2018 (83 FR 62872), FDA announced the 
availability of the revised draft guidance of the same title dated 
December 2018. FDA received numerous comments on the draft guidance, 
including comments on the potential impact of the recommendations on 
platelet availability, and those comments were considered as the 
guidance was finalized. In response to comments, the final guidance 
provides recommendations for additional culture-based testing 
strategies for apheresis platelets and pre-storage pools of WBD 
platelets and revised recommendations for testing single unit and post-
storage pools of WBD platelets. In addition, revisions were made to 
clarify recommendations related to labeling, dating periods, inventory 
management, and culture incubation periods. The guidance announced in 
this notice finalizes the draft guidance dated December 2018.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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 parts 601 and 610 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 guidance at 
either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances or 
https://www.regulations.gov.

    Dated: September 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21228 Filed 10-1-19; 8:45 am]
BILLING CODE 4164-01-P


