OIE Collaborating Centre Reports
Activities in 2012
Title of Collaborating Centre:
Address of Collaborating Centre:
OIE Collaborating Centre for
Veterinary Drug Regulatory
Programmes
Center for Veterinary Medicine (CVM),
Food and Drug Administration,
Department of Health and Human
Services, United States of America, 7519
Standish Place, HFV-1, Room 177,
Rockville, Maryland, 20855, USA
Tel.:
240-276-9300
Fax:
240-276-9030
e-mail address:
website:
Name of Director of Institute
(Responsible Official):
CVMIPT@FDA.HHS.GOV
http:www.fda.gov/AnimalVeterinary/default.htm
Dr. Bernadette M. Dunham
Name (including Title and
Position) of Head of the
Collaborating Centre (formally
OIE Contact Point):
Dr. Merton V. Smith
Name (including Title and
Position) of writer of this report
(if different from above)
Jon F. Scheid,
Annual reports of OIE Reference Centres, 2012
International Communications Manager
1
Veterinary Drug Regulatory Programmes
Summary of activities specifically related to the mandate of
OIE Collaborating Centres
1.
Activities as a centre of research, expertise, standardisation and dissemination of
techniques within the remit of the mandate given by the OIE
Dr. Kathleen Jones of CVM’s Animal Biotechnology Interdisciplinary Group (ABIG) chaired the Organization
of Economic Cooperation and Development (OECD) Task Force for the Safety of Novel Foods and Feeds in
Paris in March 2012.1 Ms. Jeanette Murphy, an expert in the area of feed safety of genetically engineered plant
material and representing ABIG, also attended the meeting. The Task Force works toward the harmonization of
approaches to the safety assessments of novel foods and feeds, including those derived from GE organisms and
other new technologies.
Members of CVM’s ABIG participated in the OECD Working Group for the Harmonization of Regulatory
Oversight in Biotechnology. Dr. Larisa Rudenko co-chaired the drafting group for the Biology of Atlantic
Salmon Consensus Document, and Dr. Eric Silberhorn was the lead author for the consensus document. The
document is expected to progress to OECD review in 2013.
As part of a joint delegation comprised of representatives from the U.S. Department of Agriculture’s Foreign
Agricultural Service and CVM, Dr. Larisa Rudenko and Dr. Harlan Howard of ABIG visited the People’s
Republic of China for an exchange of information on the state of research and development of genetically
engineered livestock and fish. These CVM experts led discussions with the Chinese delegations on the agency’s
risk-based approaches to the regulation of genetically engineered animals. Members of the Chinese delegations
discussed their research on genetically engineered animals, and gave an overview of the regulatory processes
applicable to genetically engineered animals in China. The U.S. delegation also met with members of the
Chinese Academy of Sciences from four institutions who are involved with genetically engineered animal
research.
In March, CVM announced the availability on its website of its National Antimicrobial Resistance Monitoring
System (NARMS) Retail Meat Annual Report with data collected in 2010. The main purpose of the NARMS
retail meat surveillance program is to monitor antimicrobial resistance among foodborne Salmonella,
Campylobacter, Enterococcus, and Escherichia coli in raw, unprocessed retail meats. The development of
antimicrobial resistance in these organisms may be influenced by the use of antimicrobial agents in food animals.
These data can be combined with data from slaughter plants and on-farm studies for insights into the emergence
and spread of antimicrobial resistance in foodborne bacteria originating from food animals.
In June, Dr. Marilyn Martinez, Senior Scientist in the Office of New Animal Evaluation, served as the chair of the
VICH Expert Working Group on Bioequivalence, which met in Brussels. She was accompanied by Dr. Katherine
Weld of the Office of New Animal Drug Evaluation. The Working Group is developing international guidelines
to describe the protocol development and data analysis of blood level bioequivalence trials conducted in support
of certain veterinary drug approvals.
In June, Dr. David White, Director of the Office of Research, attended the OIE ad hoc Group on Antimicrobial
Resistance in Paris to assist in OIE’s global efforts to harmonize efforts to address the issue of antimicrobial
resistance.
In July, CVM announced the availability of the NARMS Enteric Bacteria 2010 Executive Report, which
summarizes in an integrated format NARMS data on non-typhoidal Salmonella and Campylobacter isolates
recovered in 2010 from human clinical cases, retail meats, and food animals at Federally inspected slaughter and
processing plants. In addition, the report includes data on E. coli isolates recovered from retail meats and
chickens.
In July, Dr. Shaohua Zhao of the Office of Research attended a meeting of the WHO Expert Consultation in
collaboration with FAO and OIE to develop an international approach to address the issue of campylobacteriosis,
1 FDA and CVM review and approve genetically engineered animals under a regulatory framework that is based on the U.S. legal authority to review and
approve new animal drugs. While in many other countries these products are not considered as new animal drugs, activities in this area are being
reported here as part of the activities of the CVM OIE Collaborating Centre for Veterinary Drug Regulatory Programmes.
2
Annual reports of OIE Reference Centres, 2012
Veterinary Drug Regulatory Programmes
The consultation was held in Utrecht, the Netherlands. The purpose of the consultation was to review progress
concerning the development of techniques to control of Campylobacter in the food chain and to develop a
pathway to reduce the burden of disease and health impact, including consideration of antimicrobial resistance.
In August, Dr. Michael Oehlsen of CVM’s International Programs Team, Dr. Steve Yan of CVM’s Office of
New Animal Drug Evaluation, and Dr. Don Prater of FDA’s Office of International Programs organized and
presented a workshop in San Jose, Costa Rica, for a number of Latin American countries covering the recently
developed Codex antimicrobial resistance guidelines. The Codex Task Force on Antimicrobial Resistance
completed in 2011 the development of recommendations that provide guidance on assessing and managing the
risk of antimicrobial resistance as a result of the use of antimicrobial drugs in veterinary medicine. The three-day
workshop was attended by representatives from 16 Latin American countries. The Antimicrobial Resistance
Commission established by the Government of Costa Rica had invited the CVM/FDA team to participate and
make presentations.
2.
Proposal or development of any procedure that will facilitate harmonisation of international
regulations applicable to the surveillance and control of animal diseases, food safety or
animal welfare
None
3.
Networking
a)
Maintenance of a network with other OIE Collaborating Centres designated for the same
specialty, and
CVM hosted an extended visit and training session of several weeks for Dr. Nao Nakajima, Section Chief,
Planning and Coordination Division, National Veterinary Assay Laboratory (NVAL), Ministry of
Agriculture, Forestry and Fisheries, Japan. The training included an in depth review of the process CVM
uses in its review of animal drugs. This activity supports the on-going cooperation between CVM and
NVAL in their roles as OIE Collaborating Centres in the area of veterinary drug regulation.
b)
Should the need arise, maintenance of a network with Collaborating Centres in other
disciplines
Dr. Bettye Walters of CVM’s International Programs Team and Dr. Cindy Burnsteel of CVM’s Office of
New Animal Drug Evaluation accompanied Dr. Rick Hill of the U.S. Department of Agriculture’s Animal
and Plant Health Inspection Service (APHIS), Veterinary Services, Center for Veterinary Biologics at a
CAMEVET Meeting in Sao Palo, Brazil, during October. The APHIS Center for Veterinary Biologics
participates as part of the OIE Collaborating Centre for Diagnosis of Animal Diseases and
Vaccine Evaluation for the Americas.
4.
Placement of expert consultants at the disposal of the OIE
Dr. Pat McDermott of CVM’s Office of Research served on the OIE Ad Hoc Group on Antimicrobial
Resistance and participated in the meeting of this group held in Paris in July. The Ad Hoc Group was able
to finalize two chapters of the OIE Terrestrial Animal Health Code during the meeting that focused on the
prudent use of veterinary antimicrobials guideline and risk assessment.
5.
Provision of scientific and technical training, within the remit of the mandate given by the
OIE, to personnel from OIE Member Countries
CVM hosted an extended visit and training session of several weeks for Dr. Nao Nakajima, Section Chief,
Planning and Coordination Division, National Veterinary Assay Laboratory, Ministry of Agriculture,
Forestry and Fisheries, Japan. The training included an in depth review of the process CVM uses in its
review of animal drugs.
Annual reports of OIE Reference Centres, 2012
3
Veterinary Drug Regulatory Programmes
6.
Organisation of scientific meetings on behalf of the OIE
Dr. Bettye Walters of the International Programs Team was a presenter at the Regional Seminar for OIE
National Focal Points for Veterinary Products in Vienna, Austria, in November. The seminar was organized for
representatives from Eastern European countries. Dr. Walters made presentations on VICH, the
establishment of Maximum Residue Limits, the animal drug residue monitoring plans, and animal drug
withdrawal periods. In addition, she led workshops on the establishment of residue monitoring plans and
on monitoring of antimicrobial resistance and quantities of antimicrobials used in animals.
In May, Dr. Walters and Dr. Margarita Brown of the Division of Veterinary Product Safety in the Office
of Surveillance and Compliance participated in OIE’s National Focal Points for Veterinary Products
Seminar in Bangkok, Thailand.
Both experts gave presentations on several topics including
pharmacovigilance and the establishment of Maximum Residue Limits.
Dr. Bettye Walters organized a Regional Seminar for OIE National Focal Points for Veterinary Products in
Mombasa, Kenya, in March 2012. Dr. Walters and Dr. Merton Smith of CVM’s International Programs
Team, Dr. Steve Vaughn, Director of CVM’s Office of New Animal Drug Evaluation, Dr. Margarita
Brown of the Division of Veterinary Product Safety in the Office of Surveillance and Compliance, and Dr.
Rick Hill, of the U.S. Department of Agriculture’s Center for Veterinary Biologics, presented an overview
of governance of veterinary medicinal products. Dr. Smith also made a presentation about the structure
and organization of the VICH. He described the elaboration of VICH guidelines and the VICH’s program
of global outreach. Dr. Vaughn and Dr. Hill presented information about the control of drugs and vaccines,
including information about inspection systems, monitoring plans, distribution of vaccines, and
counterfeiting. Dr. Margarita Brown of CVM’s Division of Veterinary Drug Safety led a workshop about
pharmacovigiliance of veterinary drugs. Dr. Walters made a presentation about the responsible use of
veterinary products, and led a workshop that featured a practical exercise in the establishment of a drug
residue monitoring plan.
7.
Coordination of scientific and technical studies in collaboration with other laboratories,
organisations or collaborating centres
Dr. Pat McDermott of CVM’s Office of Research led a subcommittee of the WHO Advisory Group on
Integrated Surveillance of Antimicrobial Resistance that during 2012 completed a document on
harmonized approaches to integrated surveillance systems using elements of mature monitoring programs
such as FDA’s NARMS. The document provides guidance to countries as they build laboratory capacity
and implement integrated monitoring programs.
8.
Publication and dissemination of any information within the remit of the mandate given by
the OIE that may be useful to Member Countries of the OIE
Tissue/fluid correlation study for
the depletion of sulfadimethoxine
in bovine kidney, liver, plasma,
urine, and oral fluid.
Chiesa OA, Li H, Kijak P, et al.
June 2012, Issue 3, Vol.
35, pages 249-258
J Vet Pharmacol
Therap
The scientific basis for
establishing solubility criteria for
veterinary species
Martinez MN and Fahmy R.
March 2012, Vol. 35,
pages 81-86
J Vet Pharmacol
Therap
Study of physicomechanical
properties of aqueous
ethylcellulose dispersion films
during the curing process
Lin Z, Qu H, Kothari B, Chokshi October 2012
R, Carlin B, Fahmy R, and Hoag
SW
AAPS Annual
Meeting,
Chicago, IL
Should licking behavior be
considered in the bioavailabilty
evaluation of transdermal
products?
Toutain PL, Modric S, Bousquet- April 2012, Vol. 35,
Mélou A, Sallovitz JM, Lanusse pages 39-43
C
J Vet Pharmacol
Therap
Quality by Design and the
Fahmy R, Danielson D, and
4
October
2012,
book Animal Health
Annual reports of OIE Reference Centres, 2012
Veterinary Drug Regulatory Programmes
Development of Solid Oral
Dosage Forms
Martinez M.
chapter
Drug Delivery
Quality-by-Design I: Application Fahmy R, Kona R, Dandu R, Xie 2012
of Failure Mode Effect Analysis
W, Claycamp G, and Hoag SW
(FMEA) and Plackett-Burman
design of experiments in the
identification of _main factors_ in
the formulation and process
design space for roller compacted
ciprofloxacin hydrochloride
immediate release tablets.
AAPS
PharmSciTech
Probability concepts in quality
risk management
Jan-Feb 2012, Vol. 66,
pages 78-89
PDA J Pharm
Sci Technol
Oxytetracycline pharmacokinetics Miller RA, Pelsor FR, Kane AS,
in rainbow trout during and after and Reimschuessel R
an orally administered medicated
feed regimen
June 2012, Issue 2, Vol.
24, pages 121-128
J Aquat Anim
Health
Neurotoxic effects of ivermectin
administration in genetically
engineered mice with targeted
insertion of the mutated canine
ABCB1 gene
September 2012, Issue 9, Am J Vet Res
Vol. 73, pages 14771484
Claycamp HG
Orzechowski KL, Swain MD,
Robl MG, Tinaza CA, Swaim
HL, Jones YL, Myers MJ, and
Yancy HF
Marker Residue Determination of Shaikh B, Rummel N, Yu D,
Tritium-Labeled Ivermectin in the Gieseker C, Evans E, Hasbrouck
Muscle of Aquacultured
N, Reimschuessel R.
Largemouth Bass, Hybrid Striped
Bass and Yellow Perch following
Oral Treatment
In vivo characterization of
inflammatory biomarkers in swine
and the impact of flunixin
meglumine administration
March 2012, website
Peters SM, Yancy HF, Deaver C, August 2012, Issue
Jones YL, Kenyon E, Chiesa OA, 40972, Vol. 148, pages
Esparza J, Screven R, Lancaster 236-242
V, Stubbs III, JT, Yancy M,
Wiesenfeld PL, and Myers MJ
J Agric Food
Chem
Vet Immunol
Immunopatho
In vitro binding of enrofloxacin in Ahn Y, Linder SW, Veach BT,
human fecal slurries
Steve Yan S, Haydée Fernández
A, Pineiro SA, Cerniglia CE
February 2012, Issue 1,
Vol. 62, pages 74-84
Regul Toxicol
Pharmacol
Introduction to the bioequivalence Martinez MN and Hunter RP
theme issue
March 2012, Vol. 35,
pages 1-2
J Vet Pharmacol
Therap
Eudragit® RS PO/RL PO as rate- Dave VS, Fahmy R, Bensley D,
controlling matrix-formers via
and Hoag SW
roller compaction: Influence of
formulation and process variables
on functional attributes of
granules and tablets
January 2012, book
Drug
Development
and Industrial
Pharmacy
Estimating product
Claxton R, Cook J, Endrenyi L,
bioequivalence for highly variable Lucas A, Martinez MN, and
veterinary drugs
Sutton SC.
March 2012, Vol. 35, J Vet Pharmacol
pages 11-16
Therap
Effects of Preprocessing Methods Ashour A, Fahmy R, and Hoag
In Near Infrared Spectral Data for SW
PLS Modeling of Chemical and
Physical Properties of Intact
Pharmaceutical Tablets
October 2012
AAPS Annual
Meeting,
Chicago, IL
Effect of Humidity on the Coating Kothari BH, Jancsik B, Fahmy R, October 2012
AAPS Annual
Annual reports of OIE Reference Centres, 2012
5
Veterinary Drug Regulatory Programmes
Efficiency of Ciprofloxacin HCl
Controlled Release
Multiparticulate Beads
and Hoag SW
Meeting,
Chicago, IL
Effect of Coating Processing
Parameters on the Dissolution
Profiles of Ciprofloxacin HCl
Controlled Release
Multiparticulate Beads
Kothari BH, Ashour A, Fahmy R, October 2012
Moore C, and Hoag SW
AAPS Annual
Meeting,
Chicago, IL
Drug solubility classification in
the dog
Martinez MN and Papich MG
March 2012, Vol. 35, J Vet Pharmacol
pages 87-91
Therap
Drug solubility classification in
the bovine
Martinez MN and Apley MD
March 2012, Vol. 35, J Vet Pharmacol
pages 93-97
Therap
Development and Validation of a
Stability-indicating HPLC
Method for the Estimation of Ltetrahydropalmatine in a Capsule
Dosage Form
Hepburn S, Lin Z , Wang JB ,
Fahmy R , and Hoag SW
October 2012
Demonstrating bioequivalence
using clinical endpoint studies
Bermingham E, DelCastillo JRE, March 2012, Vol. 35, J Vet Pharmacol
Lainesse C, Paloske K, and
pages 31-37
Therap
Radecki S
Considerations for extrapolating
Modric S, Bermingham E, Heit
in vivo bioequivalence data across M, Lainesse C, Thompson C
species and routes
A systematic review of the safety
of potassium bromide in dogs.
April 2012,
pages 45-52
AAPS Annual
Meeting,
Chicago, IL
Vol.
35, J Vet Pharmacol
Therap
Hope E. Baird-Heinz, A'ndrea L. March 2012, Issue 6, JAVMA
Van Schoick, Francis R. Pelsor, Vol. 240, pages 705-715
Lauren Ranivand, Laura L.
Hungerford
Assessing product bioequivalence Gehring R and Martinez MN
for extended-release formulations
and drugs with long half-lives
March 2012, Vol. 35, J Vet Pharmacol
pages 3-9
Therap
Antimicrobial Drug Resistance in
Escherichia coli from Humans
and Food Animals, United States,
1950_2002
Tadesse DA, Zhao S, Tong E,
Ayers S, Singh A, Bartholomew
MJ, McDermott PF.
May 2012, Issue 5, Vol. Emerging
18, pages 741-749
Infectious
Diseases
Animal Drugs: Factors
Influencing their Development
and Use
Martinez MN, Antonovic L,
Dunham B, Fahmy R, Gilbert J,
Hungerford L, Modric S, Papich
M, Smith M, Yan SS
2012, book chapter 345
A Determinative and
Confirmatory Method for
Ceftiofur Metabolite
Desfuroylceftiofur Cysteine
Disulfide in Bovine Kidney by
LC-MS/MS
Feng S, Chattopadhaya C, Kijak
P, Chiesa O, and Tall EA
June 2012, Vol. 898, Journal of
pages 62-68
Chromatography
B
6
Encyclopedia of
Pharmaceutical
Science and
Technology,
Editor:Swarbrick
Annual reports of OIE Reference Centres, 2012