Document ID: FDA-2018-N-0001-0015
Agency: fda
Document Type: Notice
Title: Pathogen Reduction Technologies for Blood Safety; Public Workshop
Posted Date: 2018-09-17T04:00Z

[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Pages 46959-46960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20090]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]

Pathogen Reduction Technologies for Blood Safety; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Pathogen Reduction Technologies 
for

[[Page 46960]]

Blood Safety.'' The purpose of the public workshop is to foster the 
development and implementation of pathogen reduction technologies for 
blood components intended for transfusion. The workshop will include 
presentations and panel discussions by experts from academic 
institutions, industry, and government agencies.

DATES: The public workshop will be held on November 29, 2018, from 8 
a.m. to 5 p.m., and on November 30, 2018, from 9 a.m. to 1 p.m. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503, sections B and C), Silver Spring, MD 20993. Entrance 
for the public workshop participants (non-FDA employees) is through 
Building 1, where routine security check procedures will be performed. 
For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Loni Warren Henderson or Sherri 
Revell, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-
402-8010, email: [email protected] (subject line: Pathogen 
Reduction Technology and Blood Safety).

SUPPLEMENTARY INFORMATION:

I. Background

    Pathogen reduction technology has the potential to improve blood 
safety by reducing or eliminating infectious organisms, including 
bacteria, viruses, and parasites, from blood components intended for 
transfusion. FDA granted approvals for use of a pathogen reduction 
technology platform in manufacturing plasma and apheresis platelets for 
transfusion. Ideally, pathogen reduction technology should also be 
available for whole blood and red blood cells. Implementation of safe 
and effective pathogen reduction technology may also permit alternative 
donor screening or donation testing strategies in the future. The 
purpose of the public workshop is to foster the development and 
implementation of pathogen reduction technologies for all blood 
components intended for transfusion.

II. Topics for Discussion at the Public Workshop

    The first day of the workshop will include presentations and panel 
discussions on the following topics: (1) Transfusion-transmitted 
infectious agents and their impact on blood safety; (2) status of 
pathogen reduction technology for blood components intended for 
transfusion, including challenges to implementation in the United 
States; and (3) the development of pathogen reduction technology for 
whole blood and red blood cells.
    The second day of the workshop will include presentations and panel 
discussions on the following topics: (1) Emerging pathogen reduction 
technologies and alternative approaches to controlling risk; (2) 
potential funding opportunities for research; and (3) a summary of all 
workshop sessions, panel discussions, and future directions.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://www.eventbrite.com/e/pathogen-reduction-technologies-for-blood-safety-public-workshop-tickets-4464956605. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by November 8, 2018, midnight Eastern Time. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. If time and space permit, onsite registration on the day 
of the public workshop will be provided, beginning at 7 a.m.
    If you need special accommodations, due to a disability, please 
contact Loni Warren Henderson or Sherri Revell no later than November 
19, 2018 (see FOR FURTHER INFORMATION CONTACT). Request for sign 
language interpretation or Computer Aided Realtime Translation (CART)/
captioning should be made 2 weeks in advance of the event, no later 
than November 15, 2018. A request for either interpreting or captioning 
should be sent directly to the FDA Interpreting Services Staff email 
account: [email protected].
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. Individuals who wish to view the webcast should 
register for the workshop at https://www.eventbrite.com/e/pathogen-reduction-technologies-for-blood-safety-public-workshop-tickets-4464956605. A link to the live webcast will be provided upon 
registration.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. A link to the transcript will also be available on 
the internet at https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/default.htm.

    Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20090 Filed 9-14-18; 8:45 am]
 BILLING CODE 4164-01-P