82 FR 1343 - Emerging Tick-Borne Diseases and Blood Safety; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 3 (January 5, 2017)

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Emerging Tick-Borne Diseases and Blood Safety.'' The purpose of the public workshop is to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions. The workshop has been planned in partnership with AABB; America's Blood Centers; National Heart, Lung, and Blood Institute, National Institutes of Health (NIH); the U.S. Department of Defense; and the U.S. Department of Health and Human Services. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies.

[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1343-1344]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-32029]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4531]


Emerging Tick-Borne Diseases and 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 a public 
workshop entitled ``Emerging Tick-Borne Diseases and Blood Safety.'' 
The purpose of the public workshop is to discuss tick-borne pathogens 
that continue to emerge as threats to blood safety, the effectiveness 
of current and potential mitigation strategies, and the general 
approach to decision making on blood safety interventions. The workshop 
has been planned in partnership with AABB; America's Blood Centers; 
National Heart, Lung, and Blood Institute, National Institutes of 
Health (NIH); the U.S. Department of Defense; and the U.S. Department 
of Health and Human Services. 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 April 6, 2017, from 8 a.m. 
to 5:30 p.m. See the SUPPLEMENTARY INFORMATION section for registration 
date and information.

ADDRESSES: The public workshop will be held at the Natcher Auditorium, 
Natcher Conference Center, Bldg. 45, National Institutes of Health 
Campus, 9000 Rockville Pike, Bethesda, MD 20892. Entrance for the 
public workshop participants (non-NIH employees) is through the NIH 
Gateway Center located adjacent to the Medical Center Metro, where 
routine security check procedures will be performed. Please visit the 
following Web site for NIH campus location, parking, security, and 
travel information http://www.nih.gov/about/visitor/index.htm. Please 
visit the following Web site for information on the Natcher Conference 
Center: http://www.genome.gov/11007522.

FOR FURTHER INFORMATION CONTACT: Kimberly Jones or Pauline Cottrell,

[[Page 1344]]

Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993, [email protected]. For questions email: 
[email protected] (Subject line: Tick-Borne Diseases and 
Blood Safety Workshop).

SUPPLEMENTARY INFORMATION: 

I. Background

    The purpose of the public workshop is to discuss tick-borne 
pathogens that continue to emerge as threats to blood safety, the 
effectiveness of current and potential mitigation strategies, and the 
general approach to decision making on blood safety interventions.

II. Topics for Discussion at the Public Workshop

    The workshop will include presentations and panel discussions on 
the following topics: (1) Biology, epidemiology, and clinical burden of 
Anaplasma phagocytophilum (the etiologic agent of human granulocytic 
anaplasmosis) and other emerging tick-borne agents; (2) the performance 
characteristics of currently available diagnostic assays for agents of 
concern; (3) known and potential risks of transfusion transmission 
posed by emergent tick-borne agents; (4) current and potential 
mitigation strategies; and (5) considerations in decision making for 
safety interventions. The day will conclude with a roundtable 
discussion.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following Web site at: https://www.eventbrite.com/e/emerging-tick-borne-diseases-and-blood-safety-public-workshop-tickets-28654127266. 
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 March 23, 2017. Early registration is 
recommended because seating is limited. If time and space permit, 
onsite registration on the day of the public workshop will be provided 
beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Kimberly Jones or Pauline Cottrell by email sent to 
[email protected] at least 7 days in advance. Requests for 
sign language interpretation or Computer Aided Realtime Translation 
(CART)/captioning should be made 2 weeks in advance of the event, no 
later than March 23, 2017. A request for either interpreting or 
captioning is to be sent directly to the FDA Interpreting Services 
Staff email account: [email protected].
    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 Division of Dockets 
Management (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 http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm525485.htm.

    Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-32029 Filed 1-4-17; 8:45 am]
 BILLING CODE 4164-01-P