[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]
[[Page 52512]]
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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draft guidance of the same title dated December 2018.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