[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Availability of Platelets for Transfusion; Draft Guidance for Industry;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Draft Guidance for Industry.'' The draft guidance document provides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 The draft guidance
replaces the draft guidance of the same title dated March 2016.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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 4, 2019.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comments on the draft guidance by February 4, 2019 to ensure that the
Agency considers your comment on this draft guidance before it begins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]
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