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)

Page Range		1343-1344
FR Document		2016-32029

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 Issue 3 (Thursday, January 5, 2017)

[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

Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices 1343

requirements. FDA has participated in Drugs in Food-Producing Species: Study Dated: December 30, 2016.
efforts to enhance harmonization and Design Recommendations for Residue Leslie Kux,
has expressed its commitment to seek Studies in Honey for Establishing MRLs Associate Commissioner for Policy.
scientifically based, harmonized and Withdrawal Periods’’ (VICH GL56) [FR Doc. 2016–31998 Filed 1–4–17; 8:45 am]
technical procedures for the should be made available for public BILLING CODE 4164–01–P
development of pharmaceutical comment. This draft VICH guidance
products. One of the goals of document is intended to provide study
harmonization is to identify, and then design recommendations which will DEPARTMENT OF HEALTH AND
reduce, differences in technical facilitate the universal acceptance of the HUMAN SERVICES
requirements for drug development generated residue depletion data to
among regulatory agencies in different fulfill the national/regional Food and Drug Administration
countries. requirements in order to establish [Docket No. FDA–2016–N–4531]
FDA has actively participated in the appropriate MRLs or other safe limits in
International Council for Harmonisation honey following the treatment of Emerging Tick-Borne Diseases and
of Technical Requirements for honeybees with veterinary drug Blood Safety; Public Workshop
Pharmaceuticals for Human Use for products, or to justify withdrawal
several years to develop harmonized periods in honey for registration AGENCY: Food and Drug Administration,
technical requirements for the approval purposes when an MRL already exists. HHS.
of human pharmaceutical and biological Use of veterinary drug products in ACTION: Notice of public workshop.
products among the European Union, honeybee production is considered as a
Japan, and the United States. The VICH minor use in minor species in most SUMMARY: The Food and Drug
is a parallel initiative for veterinary jurisdictions. Administration (FDA) is announcing a
medicinal products. The VICH is public workshop entitled ‘‘Emerging
FDA and the VICH Expert Working
concerned with developing harmonized Tick-Borne Diseases and Blood Safety.’’
Group will consider comments about
technical requirements for the approval The purpose of the public workshop is
the draft guidance document.
of veterinary medicinal products in the to discuss tick-borne pathogens that
European Union, Japan, and the United III. Significance of Guidance continue to emerge as threats to blood
States, and includes input from both safety, the effectiveness of current and
This level 1 draft guidance, developed
regulatory and industry representatives. potential mitigation strategies, and the
under the VICH process, has been
The VICH Steering Committee is general approach to decision making on
revised to conform to FDA’s good
composed of member representatives blood safety interventions. The
guidance practices regulation (21 CFR
from the European Commission and workshop has been planned in
European Medicines Agency, 10.115). For example, the document has
partnership with AABB; America’s
International Federation for Animal been designated ‘‘guidance’’ rather than
Blood Centers; National Heart, Lung,
Health—Europe, FDA, the U.S. ‘‘guideline.’’ In addition, guidance
and Blood Institute, National Institutes
Department of Agriculture, the U.S. documents do not include mandatory
of Health (NIH); the U.S. Department of
Animal Health Institute, the Japanese language such as ‘‘shall,’’ ‘‘must,’’
Defense; and the U.S. Department of
Ministry of Agriculture, Forestry, and ‘‘require,’’ or ‘‘requirement,’’ unless
Health and Human Services. The
Fisheries, and the Japanese Veterinary FDA is using these words to describe a
workshop will include presentations
Products Association. statutory or regulatory requirement.
and panel discussions by experts from
Six observers are eligible to The draft guidance, when finalized, academic institutions, industry, and
participate in the VICH Steering will represent the current thinking of government agencies.
Committee: One representative from the FDA on this topic. It does not establish
DATES: The public workshop will be
government of Australia/New Zealand, any rights for any person and is not
held on April 6, 2017, from 8 a.m. to
one representative from the industry in binding on FDA or the public. You can
5:30 p.m. See the SUPPLEMENTARY
Australia/New Zealand, one use an alternative approach if it satisfies
INFORMATION section for registration date
representative from the government of the requirements of the applicable
and information.
Canada, one representative from the statutes and regulations.
ADDRESSES: The public workshop will
industry of Canada, one representative IV. Paperwork Reduction Act of 1995 be held at the Natcher Auditorium,
from the government of South Africa,
This draft guidance refers to Natcher Conference Center, Bldg. 45,
and one representative from the
previously approved collections of National Institutes of Health Campus,
industry of South Africa. The VICH
information found in FDA regulations. 9000 Rockville Pike, Bethesda, MD
Secretariat, which coordinates the
These collections of information are 20892. Entrance for the public
preparation of documentation, is
subject to review by the Office of workshop participants (non-NIH
provided by the International
Management and Budget (OMB) under employees) is through the NIH Gateway
Federation for Animal Health.
the Paperwork Reduction Action of Center located adjacent to the Medical
II. Draft Guidance on Studies To 1995 (44 U.S.C. 3501–3520). The Center Metro, where routine security
Evaluate the Metabolism and Residue collections of information in 21 CFR check procedures will be performed.
Kinetics of Veterinary Drugs in Food- part 514 have been approved under Please visit the following Web site for
Producing Species: Study Design OMB control number 0910–0032. NIH campus location, parking, security,
Recommendations for Residue Studies and travel information http://
mstockstill on DSK3G9T082PROD with NOTICES

in Honey for Establishing MRLs and V. Electronic Access www.nih.gov/about/visitor/index.htm.
Withdrawal Periods Persons with access to the Internet Please visit the following Web site for
The VICH Steering Committee held a may obtain the draft guidance at either information on the Natcher Conference
meeting in June 2016 and agreed that http://www.fda.gov/AnimalVeterinary/ Center: http://www.genome.gov/
the draft guidance document entitled GuidanceComplianceEnforcement/ 11007522.
‘‘Studies to Evaluate the Metabolism GuidanceforIndustry/default.htm or FOR FURTHER INFORMATION CONTACT:
and Residue Kinetics of Veterinary http://www.regulations.gov. Kimberly Jones or Pauline Cottrell,

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Document Created: 2018-02-01 14:50:55
Document Modified: 2018-02-01 14:50:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop.
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.
Contact		Kimberly Jones or Pauline Cottrell, 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).
FR Citation		82 FR 1343

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration