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Center for Veterinary Medicine

2008 Vol. XXIII, No. III

President Bush Signs Bill Reauthorizing

ADUFA, Authorizing AGDUFA

by Shannon Cameron, Assistant Editor, and Jon F. Scheid, Editor

O n August 14, 2008, President Bush

signed a bill reauthorizing the Ani­
mal Drug User Fee Act (ADUFA) and au­
CVM and sponsors will be able to use
a new end-review amendment process
for a drug application. The process
days. The review timeframe is reduced
over the life of the program to 270 days
by fiscal year 2013.
thorizing the Animal Generic Drug User gives the Center the option of allow­
Fee Act (AGDUFA), which will provide ing a sponsor more time to submit Antimicrobial drug distribution
the Food and Drug Administration with additional, non-substantial data or reports
more funding for timely animal drug information that CVM needs to finish Under the ADUFA reauthorization,
reviews. The reauthorized ADUFA also reviewing an animal drug submission. drug sponsors must report annually the
begins a new “end-review amendment Previously, when data were missing, amount of an antimicrobial active in­
process” that gives FDA additional flex­ CVM typically had to issue an “in­ gredient sold or distributed for use in
ibility in dealing with new animal drug complete” letter to the sponsor, which food-producing animals the previous
applications. The plan to implement the meant the entire review process had to calendar year. The new law requires the
reauthorized ADUFA also is designed to start again, once the sponsor submitted reports to specify the amount by “con­
improve communication with industry. the missing information. tainer size, strength, and dosage form”
Congress initially approved ADUFA Among the new provisions in the of the antimicrobial active ingredient.
legislation in 2003. Under that law, ADUFA reauthorization are plans to im­ Domestic as well as export sales must
FDA collected $43 million in user fees prove the timeliness and predictability be reported.
over the 5 years of the first ADUFA of foreign pre-approval inspections and The measure requires drug sponsors
program. Under the reauthorized pro­ conduct 10 public workshops during to submit the information to the Sec­
gram, FDA expects to collect approxi­ the program’s 5-year life. The workshop retary of Health and Human Services.
mately $98 million over the 5-year life topics will be mutually agreed upon by The Secretary is directed to make
of the program. FDA and the regulated industry. CVM summaries of the information avail­
The AGDUFA program calls for user also plans to develop an electronic sub­ able publicly. The public summaries
fees to generate a total of $27 million mission tool for industry submissions will present the information by class
for generic animal drug review over which will have online review capabil­ of antimicrobial, but only if three or
the 5-year life of the measure, begin­ ity. In addition, CVM and sponsors will more sponsors produce that class of
ning in FY 2009. AGDUFA is FDA’s discuss the applicable use of pharma­ antimicrobial.
first user fee program to cover generic cokinetic/pharmacodynamic data. The reports will be due March 31
animal drugs. Currently, the generic FDA has promised to meet specific each year, with the first report due in
animal drug review process is entirely performance goals for generic animal 2010.
funded through appropriations. Under drug review as it begins to col­
both ADUFA and AGDUFA, FDA will lect generic animal drug user IN THIS ISSUE
collect funds through application fees, fees. For example, FDA has
Reptile Dealer Convicted and Sentenced ............. 2
product fees, and sponsor fees. The agreed to review 90 percent
fees will supplement appropriated re­ of non-administrative Abbre­ Team Revises AFSS Framework Document ........... 2
sources for drug review. viated New Animal Drug Ap­ Horse, Cat, Dog Dietary Supplement Safety ......... 4
Under a plan developed by CVM plications in fiscal year 2009, NRSP-7 Minor Use Research Program Holds Semi-
and the animal drug industry for im­ the first year of generic animal Annual Meeting to Reach Out to Stakeholders ...... 6
plementing the reauthorized ADUFA, drug user fees, within 700



Reptile Dealer Convicted, Sentenced

for Illegally Selling Turtles
by Walt D. Osborne, M.S., J.D., Assistant Editor

A fter entering a guilty plea in a Fed­

eral district court on July 14, 2008,
a reptile firm was convicted of violat­
aware of the legal restrictions placed
on the sale or holding for sale of these
reptiles, and to file semi-annual reports
lic Health Service Act, because of the
public health impact of turtle-associated
salmonellosis. FDA enforces the regula­
ing a public health law that prohibits to the court during the 2-year proba­ tion in cooperation with State and local
the sale of turtles with shells less than tion period, as well as to the Food and health jurisdictions. Exceptions to the
4 in. long. Drug Administration and the Fish and regulation are made for sales of turtles
Strictly Reptile, Inc., Hollywood, FL, Wildlife Service. less than 4 in. long for bona fide sci­
forfeited approximately 7,000 turtles Strictly Reptile, Inc., sold approxi­ entific, educational, or exhibition pur­
and tortoises seized by government mately 1,000 undersized turtles in poses, other than the use as pets.
agents on May 2, 2008, in the course March 2008 from its Hollywood loca­ Public health investigators had iden­
of executing a Federal search warrant. tion to a tourist souvenir business in tified undersized turtles as a major
The company was ordered to pay a Panama City, FL. The principal of the source of Salmonella and other infec­
criminal fine of $5,000 and was placed firm had admitted to investigators that tions, especially in small children who
on 2 years’ probation. The court also he intentionally did not ask customers are prone to handling turtles without
ordered the company to implement a the purpose of their purchases so as not washing their hands afterwards, and to
business practice requiring it to secure to lose sales. putting the turtles in their mouths.
a signed notice document from every The limitation on turtle sales was put
buyer of undersized turtles that they are into effect in 1975, pursuant to the Pub­

Team Revises AFSS Framework Document

by Jon F. Scheid, Editor

T he Animal Feed Safety System

(AFSS) Team has revised the AFSS
Framework Document by adding a new
standards, and labeling standards—
including nutritional and ingredient
information—for pet food. It also re­
A. Ingredients and the approval process
(includes a new gap)
B. Limits for animal feed contaminants
component about reporting unsafe feed quires FDA to establish an Early Warn­
and by identifying additional gaps in ing Surveillance and Notification Sys­ C. Process control for the production of
the existing feed safety system. tem to identify adulteration of the pet feed ingredients and mixed feed
The Center for Veterinary Medicine food supply and illness outbreaks and (Continued, next page)
released the revised Framework Docu­ to notify veterinarians and other stake­
ment (the 3rd version) in April 2008 holders of pet food recalls. FDA VETERINARIAN
and posted it on its Web site at http:// In addition, the legislation requires Andrew C. von Eschenbach, M.D. FDA to establish a searchable database Commissioner of Food and Drugs
work.html. of recalled human and pet foods to en­ Bernadette Dunham, D.V.M., Ph.D.
The changes to the Framework sure efficient and effective communica­ Center for Veterinary Medicine
Document came about because of the tions during a recall. And it requires a Jon F. Scheid, Editor
requirements placed on the Food and “Reportable Food Registry” for animal Walt Osborne, M.S., J.D., Assistant Editor
Drug Administration by provisions of as well as human food. Reportable food Richard L. Arkin, J.D., Assistant Editor
the FDA Amendments Act (FDAAA) of is any food that carries a reasonable Shannon Cameron, Assistant Editor
2007. Besides continuing FDA’s user fee probability that its use or exposure to it Published bi-monthly.
programs for human drugs and devices, will cause serious adverse health conse­ Articles are free of copyright and may be reprinted.
FDAAA requires FDA to take steps de­ quences or death to humans or animals. Comments are invited.
signed to improve the safety of pet food Home Page

and ingredients. Revised AFSS Framework Document Phone (240) 276-9300

FAX (240) 276-9115 or write to:
Title 10 of FDAAA requires FDA to The six components of the AFSS pre­ FDA Veterinarian (HFV-3)
establish, “by regulation,” ingredient sented in the revised Framework Docu­ 7519 Standish Place
Rockville, MD 20855
standards and definitions, processing ment now are:
Team Revises AFSS Framework Document (Continued)

they cause widespread in­ it is a non-Federal document and lacks

jury or death would greatly the force and effect of law.
assist FDA. Further, the The revised Framework Document
public needs to be advised says that the AFSS Team has put on hold
about those incidents to its plans to write the Compliance Policy
protect themselves and Guide under Component A, while FDA
their pets. works to implement FDAAA’s require­
In response to this gap, ment to write regulations for feed ingre­
as required by FDAAA, FDA dient standards for pet food.
will implement an early The new gap listed under Compo­
warning and surveillance nent F concerns updating labeling
system to identify adultera­ standards for pet food, as required by
tion incidents affecting pet FDAAA. Through that Act, Congress
food supplies. It would also has required a regulation that includes
alert the public about any standards for nutritional and ingredient
outbreaks of illness con­ information on the label.
nected to pet food.
Component A was also
AFSS, Food Protection Plan fit
CVM Director Dr. Bernadette Dunham addresses the Animal Feed changed in the revised
Safety System public meeting on May 14, 2008 Framework Document. An The AFSS initiative fits well into
D. Reporting of unsafe feed (new com- earlier version of the docu­ FDA’s overarching Food Protection
ponent, added for the 3rd draft of the ment noted that the AFSS Team had be­ Plan, which is designed to integrate all
Framework Document, and includes gun developing a Compliance Policy Federal, State, and local food safety and
a new gap) Guide to explain the relationship be­ food defense (counterterrorism) pro­
tween the Association of American grams in the United States. The Food
E. Regulatory oversight Feed Control Officials (AAFCO) and Protection Plan was developed last year
F. Education and outreach (includes a FDA and to establish a policy by which and announced in November 2007. It
new gap) FDA could recognize the ingredient has specific action items that involve
definitions presented in AAFCO’s Offi­ FDA’s Federal and State counterparts.
The focus of the new component, D
cial Publication. FDA has no complete At an AFSS public meeting held in
(what used to be Component D is now
list of all acceptable animal feed ingre­ May 2008, Dr. George Graber, consul­
Component E, and what was E is now
dients. AAFCO’s Official Publication tant to CVM’s AFSS Team, pointed out
F), is gathering information about feed
contains the most complete list avail­ that the AFSS Initiative and the Food
problems. To help protect the health of
able, and it includes comprehensive in­ Protection Plan have many “cross-cut­
animals and prevent food safety prob­
gredient definitions. FDA relies heavily ting” principles.
lems, FDA should know about the feed
on the Official Publication, even though (Continued, next page)
problems before they become wide­
spread. Also, other feed users and the
public should know about the incidents
so that they can protect themselves.
The new Component D addresses
the FDAAA provisions requiring FDA
to establish a Reportable Food Regis­
try. The component includes the lack of
information about pet food, feed, and
ingredient contaminants as a gap, and
the requirements of the FDAAA as the
fix for that gap.
Another gap noted in Component D
of the revised Framework Document is
that FDA needs to know quickly about
unsafe pet food and feed incidents. Stakeholders listen to presentations at the 5th public meeting of the Animal Feed Safety System, held
Knowing about such incidents before May 14 in Gaithersburg, MD.

NRC Publishes Report on Horse, Cat, Dog

Dietary Supplement Safety

by Jon. F. Scheid, Editor

T he National Research Council

(NRC) has published a report exam­
ining considerations for the safe use of
the less restrictive pathway should not
apply to products for animals. However,
according to the report’s summary, FDA
dietary supplements. The regulations
need to differentiate between an animal
dietary supplement, a food additive,
dietary supplements in companion ani­ and other regulatory bodies are “under and an animal drug, “as well as factors
mals, highlighting needs for consistent pressure” to resolve the gulf between that differentiate regulation of human
data, a good system of adverse event re­ the public’s desire to use the products and animal dietary supplements.”
porting, and clarification of the regula­ and the different regulatory require- To develop the report, the NRC as­
tions covering the supplements. sembled a committee of experts,
The Center for Veterinary including animal nutritionists,
Medicine commissioned the re­ A key finding listed in the report’s veterinarians, clinical pharma­
port, “Safety of Dietary Supple­ summary was that data on safety cologists, and toxicologists. Dr.
ments for Horses, Dogs, and William Price, special assistant
Cats,” to help the Food and Drug
for dietary supplements fell short to the Director of CVM’s Divi­
Administration address the pub­ of what would typically be required sion of Animal Feeds and project
lic’s desire to use dietary supple­ for reviewing the safety of animal officer for the report, described
ments for companion animals. the panel members as “highly
The Dietary Supplement
drugs or animal food additives. qualified scientists” in the areas
Health and Education Act of animal health and nutrition.
(DSHEA), passed in 1994, created ments. The committee was charged On the panel were:
a less restricted pathway for dietary sup­ with developing considerations about • Dr. Jim E. Riviere, (Chair), D.V.M.,
plements for humans to get to market. the safety of the products, but not about Ph.D., North Carolina State
Since then, CVM has maintained that product utility or efficacy. University
According to the summary, “The re­
port was intended to help form the basis • Dr. Dawn M. Boothe, D.V.M., Ph.D.,
Team Revises of a more general framework for evalu­ Auburn University
ating animal dietary supplement safety.” • Dr. Gail L. Czarnecki-Maulden,
AFSS Framework The committee used public data to con­ Ph.D., Nestle Purina PetCare PT
duct safety assessments of three dietary
Document (Cont.) supplements – lutein, evening primrose
• Dr. David A. Dzanis, D.V.M., Ph.D.,
Dzanis Consulting and Collabora­
• For example, FDA’s definition of oil, and garlic. “The knowledge gained tions
food includes food for animals as from conducting these assessments al­
lowed the committee to review and • Dr. Patricia A. Harris, M.R.C.V.S.,
well as humans. Therefore, food Ph.D., Waltham Centre for Pet
safety must mean feed safety, too. begin to define factors that should be
considered when evaluating the safety Nutrition
• Both the AFSS and the Food Protec­ of animal dietary supplements in gen­ • Dr. W outer H. Hendricks, Ph.D.,
tion Plan focus on risks over a food eral,” the summary said. Wageningen Agricultural University
product’s life cycle—from produc­
A key finding listed in the report’s • Dr. Claudia A. Kirk, D.V.M., Ph.D.,
tion to consumption.
summary was that data on safety for The University of Tennessee
• Both initiatives use a risk-based ap­ dietary supplements fell short of what
proach, targeting resources in a way would typically be required for review­ • Dr. Lori K. Warren, Ph.D., University
that will permit the greatest reduc­ ing the safety of animal drugs or ani­ of Florida
tion of risk. mal food additives. In addition, it said, Copies of the report are available
• Both address accidental as well as “There is a clear need for a comprehen­ from the National Academies Press,
deliberate contamination of food. sive adverse event reporting system.” 500 Fifth Street, N.W., Lockbox 285,
Existing systems have limitations for Washignton, DC 20055; (800) 624­
• And both rely on science and mod­
supplements, it said. 6242, or (in the Washington, DC, area)
ern technology, including enhanced
The report also recommended that (202) 334-3313;
“IT” systems, to be most effective.
FDA review the regulation of animal
CVM Begins “Animal Health Literacy

Campaign” Initiative

by Shannon Cameron, Assistant Editor

A s part of the Food and Drug Ad­

ministration’s goal to improve
public health, the Center for Veteri­
matter experts throughout the Center
to produce informative materials on
animal health literacy and participate
nella, CVM clerkships, opportunities
for statisticians, and the ombudsman
nary Medicine has initiated the Animal in outreach activities. As a second phase of the Animal
Health Literacy Campaign to provide In 2007, CVM produced a brochure Health Literacy Campaign, CVM is
timely information to consumers, in­ about non-steroidal anti-inflammatory planning to increase its outreach pro­
dustry, trade, and Federal/State orga­ drugs entitled Treating Pain in Your gram to key stakeholders.
nizations about pressing animal and Dog: Keeping Your Best Friend Active, Strategic communication is vital to
human health issues. Safe and Pain Free (available for free CVM’s relationship with the public
The Animal Health Literacy Cam­ through the Federal Citizen Informa­ and with the industries it regulates.
paign began as a grassroots outreach tion Center in Pueblo, CO, at http:// Through our strategic communication
program through which the Commu­ efforts, CVM can communicate more
nications staff would partner with vet­ html) and the success of that publica­ effectively about policy and regulatory
erinarians and others in various CVM tion led the way for the current cam­ responsibilities. By exchanging ideas
program offices to create and produce paign. More than 50,000 brochures with outside groups and institutions
informational materials for various have been ordered in bulk by veteri­ we can better advise policymakers and
stakeholders, with an emphasis on nary practitioners and another 10,000 educate the public.
educating consumers. by individuals. If you have ideas for possible out­
Through a proactive approach to CVM is currently working on new in­ reach opportunities or suggestions
animal health literacy and with the formational materials such as posters, for topics for our next brochure/fact­
help of Michelle Sharkey, D.V.M., from brochures, handouts, and children’s sheet, please call Shannon Cameron
the Office of New Animal Drug Evalu­ school book covers to offer safety in­ at 240-276-9300, or email us at CVM_
ation, CVM’s Communication Staff is formation about subjects as varied as
working in conjunction with subject aquaculture drugs, turtles and salmo­

Regulatory Activities – July & August 2008

lion (ppm) moxidectin in the liver tis­ Todd Simmons, president and chief
sue and 0.0161 ppm moxidectin in the executive officer of Simmons Pet Food,
muscle tissue. Because no tolerance for Inc., Siloam Springs, AR, has received
residues of this drug in the edible tissues a WARNING LETTER for serious devia­
of goats has been established by FDA, tions from the Low-Acid Canned Food
the animal was found to be adulterated Regulations described in CFR Parts 108
within the meaning of Section 402(a) of (Emergency Permit Control) and 113
Warning Letters the FFDCA. The firm was also found to (Thermally Processed Low-Acid Foods
The Food and Drug Administra­ have adulterated moxidectin (Cydectin) Packaged in Hermetically Sealed Con­
tion has sent a WARNING LETTER to within the meaning of Section 501(a) of tainers). Specific violations included
Wayne R. Mathis, managing partner the FFDCA for failing to use it in confor­ the following: the firm has not estab­
of Mathis Ranch, d/b/a Texas Legend mance with its approved labeling. Also, lished a product traffic control sys­
Ranch, Kendalia, TX, for violations of FDA’s extralabel use requirements set tem to prevent unretorted product
the adulteration provisions of the Fed­ forth in 21 Code of Federal Regulations from bypassing the retort process (21
eral Food, Drug, and Cosmetic Act (CFR) 530 with respect to moxidectin CFR 113.87(b)); the firm’s container
(FFDCA). Specifically, the ranch sold were violated, and use of the drug was cooling water was not chlorinated or
a goat for slaughter as food that was found to be unsafe within the meaning otherwise sanitized as necessary for
found to contain 0.0577 parts per mil­ of Section 512(a) of the FFDCA. (Continued, page 14)

NRSP-7 Minor Use Research Program

Holds Semi-Annual Meeting to Reach
Out to Stakeholders
by Dr. Meg Oeller, Director, Office of Minor Use and Minor Species Animal Drug Development, and
Dr. John Babish, NRSP-7 National Coordinator

T he U.S. Department of Agriculture’s National Re­

search Support Project #7 (NRSP-7) held its Spring
Meeting for 2008 in April at the Food and Drug Ad­
research entities makes it possible for pharmaceutical
sponsors to get their products approved at a much
reduced cost.
ministration’s Center for Veterinary Medicine in Rock­ Despite incentives for companies to increase drug
ville, MD. The committee that runs the NRSP-7 pro­ availability for these minor species, there are few to
gram used the opportunity to invite stakeholders (see no drugs approved for their use. Much work remains
related article, “Importance of Minor Species to Re­ to be done for the benefit of the numerous fish spe­
gional, U.S. Economy”) and legislative affairs profes­ cies in U.S. aquaculture, for sheep and goats, game-
sionals to come to the table to discuss the importance birds, deer, rabbits, honey bees and other even less
of minor species to the U.S. economy and the impor­ common species.
tance of the NRSP-7 program to the various minor
species groups that benefit from its work. What is the mission of the NRSP-7 program?
The purpose of the NRSP-7 Minor Use Animal Drug The committee that runs the NRSP-7 program
Program is to address the shortage of minor species (see “The NRSP-7 Committee”) meets twice yearly
animal drugs by providing funding and overseeing ef­ to assess the status of ongoing projects and to select
fectiveness, target animal new ones.
safety, and human food At the April 2008
safety research and the Minor species and minor uses rep­ meeting, Dr. John Babish
environmental assess­ and Dr. Garry Adams
resent small markets when com­
ment required for the ap­ provided the attendees
proval of a New Animal pared to the value of markets for with a complete history
Drug Application. Phar­ major food-producing animals of the NRSP-7 program
maceutical companies such as poultry, cattle, and swine and described its ongo­
then are able to use these ing problems with inade­
data at no cost in con­
or for companion animals such as
quate funding, increasing
junction with their own dogs, cats, and horses. costs, and more rigorous
manufacturing and label­ regulatory requirements
ing information to sup­ that have evolved over
port an application for approval of a new animal drug the program’s 25-year existence.
for an intended use in the minor species. They described the mission of NRSP-7 as fourfold:
The major species are horses, cattle, swine, dogs, 1) identify animal drug needs for minor species and
cats, chickens, and turkeys. All other species, except minor uses in major species, 2) generate and 3) dis­
humans, are minor species. The scope of the program seminate data for safe and effective therapeutic ap­
includes minor species of agricultural importance plications, and 4) facilitate FDA/CVM approvals for
and generally excludes companion animals. drugs identified as a priority for a minor species or
minor use.
Why is NRSP-7 needed? To accomplish these goals, NRSP-7 functions
Minor species and minor uses represent small through coordinated efforts among animal produc­
markets when compared to the value of markets for ers, pharmaceutical manufacturers, CVM, USDA/
major food-producing animals such as poultry, cattle, Cooperative State Research, Education, and Exten­
and swine or for companion animals such as dogs, sion Service (CSREES), universities, State Agricultural
cats, and horses. The costs of studies to support drug Experiment Stations, and veterinary medical colleges
approval cannot be easily recovered from such small throughout the country.
markets. The work done by NRSP-7 and other public (Continued, next page)
Semi-Annual Meeting (Continued)

Dr. Gary Sherman described the funding methods The attendees discussed possible future lobbying
of the program and the complexities of the budget efforts and stakeholder participation. Action items in­
process. He also described the activities of USDA/ cluded further contacts with stakeholder lobbyists to
CSREES. Its mission is to advance knowledge for agri­ emphasize the need to support funding for NRSP-7
culture, the environment, human health and wellbe­ in the USDA budget and to support inclusion of the
ing, and communities. program in the 2008 Farm Bill. (The lobbying efforts
Dr. Meg Oeller, FDA liaison to NRSP-7, provided were not successful, and the NRSP-7 program was not
additional information about the mission and or­ include in the 2008 Farm Bill.)
ganization of NRSP-7 and the relationship between
NRSP-7 and CVM. Progress of the program
The meeting was also attended by CVM Director Each of the Regional Coordinators described the
Dr. Bernadette Dunham. In a presentation, she de­ accomplishments and ongoing work of NRSP-7 in
scribed new and ongoing programs within CVM that their region.
are intended to facilitate the drug approval process for • NORTHEAST REGION: An outline of aquaculture
minor uses and minor species. She stressed the impor­ “species grouping” research conducted in the
tance of the partnership between all interested parties Northeastern Region was provided by Dr. Paul
as the best way to achieve success. Bowser. His work has fo­
In addition, other mem­ cused on human food
bers of CVM also partici­ safety (tissue residue
pated in the meeting to help In a presentation, Dr. Bernadette
elimination studies) in
increase understanding be- Dunham described new and ongo- tilapia, walleye, hy­
tween the scientific review­ ing programs within CVM that are brid striped bass, and
ers on the regulatory side summer flounder. Re-
and the scientists and pro­ intended to facilitate the drug ap-
sults to date indicate
ducers responsible for the proval process for minor uses and species grouping is a
studies intended to support
approval of these needed
minor species. viable method for the
reduction of animals
products. used in research.
What are the plans for regaining funding? In addition to modeling species grouping, these
studies will be used to extend the label indications
For many years, the program has operated on the for oxytetracycline, sulfadimethoxine/ormetoprim,
same limited funding of approximately $500,000 a and florfenicol.
year. This is a very small budget, given the large num­
ber of needed projects and the high cost of studies • NORTH CENTRAL REGION: Dr. Ronald Griffith de­
to support new animal drug approvals. For the past scribed the North Central Region’s active projects.
few years, the funding has been severely cut, and the These include the CIDR-g, a progesterone implant
future of the program is in peril. used to synchronize estrus cycles in sheep and
Several legislative affairs professionals attended goats. A study at North Dakota State using the CI-
the meeting to discuss their efforts to support the DR-g resulted in 100 percent synchronization, the
NRSP-7. highest in comparison to any other technique. At
Mr. John Hamilton, (ANR Federal Relations Liai­ this time, the project for sheep is nearly complete.
son of UC Davis), Ms. Dianne Miller (Director of the Only the human food safety component remains to
Federal Government Relations for Cornell University), be accepted. The project for goats is earlier in its
and Mr. Dustin Bryant (Meyers and Associates, for progress. The target animal safety study has been
Texas A&M University) gave updates on the lobbying accepted, and a milk residue study is close to sub­
efforts of the institutions participating in NRSP-7 as mission to CVM for review.
well as the status of the 2008 Farm Bill. Dr. Mark T. Tulathromycin for respiratory disease in sheep
Lutschaunig (Director, Governmental Relations Divi­ and goats is also under study. The current status in
sion of the American Veterinary Medical Association) goats is that the target animal safety study is near­
emphasized the importance of NRSP-7 and the sup­ ing completion, protocols for effectiveness have
port that the American Veterinary Medical Association been submitted for review, and the protocol for
has for the program. (Continued, next page)

Semi-Annual Meeting (Continued)

the residue depletion study has been accepted. The A Summary of the successes of the program
Western region is working in partnership on this
The NRSP-7 has published 33 Public Master Files
project and is currently concentrating on the ana­
that have supported 27 new animal drug approvals
lytical method.
during its 25-year history; an average of 1.3 completed
Lasalocid is being studied for treatment of coccidi­
files per year. The approvals have been accomplished
osis in ring-necked pheasants. The effectiveness study
through strategic partnerships and the efficient use of
was completed at the University of Georgia last fall.
resources so that the mean expenditure per approval
The first draft of the study report was submitted this
is approximately $450,000, or 10 percent to 40 per­
spring. The target animal safety protocol has been
cent of the usual cost to industry.
submitted, and the study was planned for the sum­
Work done as part of the NRSP-7 led to five peer-re­
mer at the University of Georgia. The human food
viewed publications in 2007. Publication of research
safety protocol will be submitted in the near future.
is common for the members of the program.
• SOUTHERN REGION: Dr. Alistair Webb presented an NRSP-7 currently supports 14 active projects with
overview of efforts in the Southern Region, focus­ 41 potential projects on the Animal Drug Request List.
ing on project tracking, game bird projects, and If adequate funding is secured, there is an opportunity
the NRSP-7 Web site. This region is also complet­ for a great deal more to be done for the minor species
ing the work for public master files for fenbenda­ that are so important and yet so underserved when it
zole in pheasants and quail and for ivermectin for comes to availability of safe and effective products for
rabbits. their benefit.
began her presentation by re­
viewing the historical NRSP-7

The NRSP-7 Committee
accomplishments of the West-

John Babish ............. The National Coordinator (Cornell University)

ern Region. Work in this region

has led to approval of indica-

Paul Bowser ............. Northeast Regional Coordinator (Cornell

tions for drugs for reindeer, University)

big horn sheep, sheep, finfish,
goats, and honey bees. Ronald Griffith.......... North Central Regional Coordinator (Iowa State

Current projects include University)

erythromycin for treatment of

bacterial kidney disease in sal­ Lisa Tell .................... Western Regional Coordinator (University of

monids, lincomycin for treat­

California, Davis)
ment of American foulbrood

Alistair Webb............ Southern Regional Coordinator (University of

in honey bees, the CIDR-g for

goats, and strontium chloride

for skeletal marking of fish. Garry Adams ............ Chairman of Administrative Advisors (Texas A&M)

Lastly, a detailed description

was presented of the region’s David Thawley ......... Administrative Advisor Western Region

study of the pharmacokinetics (University of Nevada)

of ceftiofur crystalline free acid
John Baker .............. Administrative Advisor North Central Region

(CCFA) in non-lactating do­

(Michigan State University)
mestic goats (Capra aegagrus

hircus) following a single sub-

Kirklyn Kerr .............. Administrative Advisor Northeast Region

cutaneous injection. The study (University of Connecticut) He was unable to

demonstrated that a single sub­ attend this meeting.
cutaneous injection of CCFA

did not result in any adverse Gary Sherman .......... USDA/CSREES Liaison (Washington, DC)

effects, and the serum con-

centration of CCFA remained

Meg Oeller................ FDA Liaison (Rockville, MD)

above therapeutic concentra­

tions for at least 4 days.


Report from NRSP-7 Meeting…
Importance of Minor Species to
Regional, U.S. Economy
by Dr. Meg Oeller, Director, Office of Minor Use and Minor Species Animal Drug Development, and
Dr. John Babish, NRSP-7 National Coordinator

T he members of the committee that runs the Na­

tional Research Support Project #7 (NRSP-7) pro­
gram invited stakeholders to attend their Spring 2008
lodging, sale of birds, meat production, buildings,
and energy sales. In addition, there are 16 million
acres dedicated to habitat preservation.
meeting. This provided an opportunity to discuss the The top game-bird-producing States are Texas,
value of several minor species to national and re­ North Carolina, Pennsylvania, Kansas, Wisconsin,
gional economies and to identify some of the animal New York, Illinois, South Dakota, Florida, Minnesota,
health products these species need. Iowa, Georgia, Missouri, Indiana, and Alabama.
The NRSP-7 Minor Use Animal Drug Program ad­ Gamebird health is threatened by major disease
dresses the shortage of minor species animal drugs challenges from bacterial infections and parasites.
by funding and overseeing research to support the Coccidiosis alone is holding back game bird produc­
approval of New Animal Drug Applications. Data tion by at least 10 percent to 25 percent.
generated by NRSP-7 research are made available Another problem is that few veterinarians are famil­
to the public. Pharmaceutical companies may then iar with diseases in game birds and how to properly
use these data at no cost as a way to encourage the prescribe medications for them. Water treatments
development of drugs for minor species. NRSP-7 are difficult to administer to birds raised outdoors.
research is focused on species of agricultural Medicated feeds cannot be used outside their label­
importance. ing. So, available medications are very limited.
At the Spring Meeting, held April 21-22, 2008, Despite the challenges, the future is very bright for
the stakeholders presented the following informa­ game bird industry growth. Research into safe and
tion demonstrating the regional and national value effective medications will play a huge role in helping
of their industries as well as specific therapeutic and this industry reach its full potential.
other drug needs for their animals.
(See the table on page 11 for a quick reference to Rabbits
demonstrate the importance of minor species indus­ Dr. Chris Hayhow, representing the American
tries to the U.S. economy as well as the importance Rabbit Breeders Association (ARBA), gave a presen­
of NRSP-7 to these industries.) tation on the make-up of the rabbit industry in the
United States and the therapeutic needs of rabbits
Gamebirds and cavies.
The North American Gamebird Association was The American Veterinary Medical Association re­
represented by Dr. Eva Wallner-Pendleton of The ported that, in 2006, approximately 2 million house­
Pennsylvania State University. She provided the fol­ holds owned rabbits. In addition, approximately
lowing information about the economic impact, cur­ 600,000 households owned cavies. ARBA is the larg­
rent research, and medication needs of gamebirds in est organization in the world devoted to rabbits and
the United States. cavies. Its members raise rabbits and cavies as pets
Gamebirds are raised in all 50 States. The birds for show and for commercial use.
raised include pheasants, bobwhite quail, Chukar The rabbit industry includes the raising of lago­
partridges, mallards, wild turkeys, and Hungarian morphs for pets, meat, pelts, wool, animal by-products,
partridges. These birds support an estimated $5.0 bil­ and research. The market is divided into five major
lion in economic activity through production facilities segments with common overlap: meat, fur, exhibition
and sport hunting preserves with an especially sig­ and breeding, pet, and laboratory businesses.
nificant impact in rural areas. There are 14,000 game The rabbit industry employs a large and eclectic
bird producers nationwide, with 25 percent deriv­ group of workers, including farmers growing crops for
ing their full-time income from this business. Several consumption by rabbits and cavies, feed mill workers,
farms produce 250,000 to 1.8 million birds annually. rabbit growers, pet supply personnel, lab personnel,
Associated businesses profit through feed sales, jobs, family members who make a living selling rabbits or
outdoor recreation, tourism, hunting fees, kennels, (Continued, next page)

Importance of Minor Species… (Continued)

rabbit-related products, and end users, such as res­ do tricks. This upward trend in rabbit ownership will
taurant personnel. lead to increased demand by clients for products to
Due to the lack of available drugs, only an ex­ maintain rabbit health and treat disease problems.
tremely small percentage of rabbits and cavies re­ Laboratory use: Laboratory use of rabbits is a well-
ceive preventive or therapeutic medications when developed business. With decreases in research fund­
needed. In some situations, the herd morbidity and ing and development of alternative animal models,
mortality rates are very high. The resulting losses can the use of rabbits in research settings continues to de­
be great, both financially and emotionally. cline. Most estimates put the decline at greater than
The limited availability of drugs to treat rabbits and 50 percent since the mid 1960s.
cavies means that most animals either go untreated Therapeutic needs: It is obvious that the rabbit in­
or treatment is delayed. Both situations lead to de­ dustry is very large. Rabbits face challenges similar
creased treatment success. The result is increased to other animals raised in confinement, including in­
suffering, loss of use, and loss of life for affected ani­ fectious diseases, internal and external parasites, and
mals. The emotional impact of these losses is difficult production problems that require therapeutic agents.
to measure. The human-animal bond is strong and Unfortunately, this minor species has few drugs
the emotional attachment to animals is tremendous. that have been approved by FDA. Only three such
The lack of approved medications also increases products are available for use in rabbits in the United
the risk of transmission of zoonotic diseases. States—sulfaquinoxaline is used as an aid in the
The meat industry: The prevention of coccidiosis,
meat production seg­ lasalocid is used for the
ment is very fragmented, The NRSP-7 Minor Use Animal prevention of Eimeria
and few producers can stiedea, and tetracycline
Drug Program addresses the short-
maintain a continuous is used for increased
supply of rabbits to meet age of minor species animal drugs growth and improved
slaughter demand. This by funding and overseeing re- feed efficiency.
fluctuation in animal The U.S. market needs
numbers leads to pro-
search to support the approval of several products based
ducers contracting with New Animal Drug Applications. on current management
other growers to fill or­ practices. Antibiotics for
ders and meet demand. therapeutic use such as en­
The result is a product that lacks uniformity and qual­ rofloxacin and trimethoprim are broad spectrum, and
ity at the retail level. could be used to treat infections due to Pasteurella
Fur and wool markets: The fur and wool markets multocida and other bacterial agents. Antiparasit­
have declined in recent years for numerous reasons. ics, such as amprolium, salinomycin, fenbendazole,
Whether the problem is consumer dissatisfaction due and ivermectin, could be used to treat susceptible
to price, quality of the product, pressure from foreign internal parasite infestations. Also, ivermectin could
markets, or public perception of fur products, the be used to treat susceptible external parasite infes­
negative impact has contributed to the decline of the tations. Hormones, such as GnRHa for induction of
rabbit fur industry. ovulation for postpartum insemination, are needed.
Exhibition and breeding: Exhibition and breeding are And an antifungal medication, such as griseofulvin,
fast growing segments of the rabbit industry. The ARBA is also needed.
has more than 28,000 members. At the 2007 Annual With very few approved products, and legal re­
Convention and Show, more than 24,000 rabbits and strictions that limit the owners ability to treat animals
cavies were exhibited. The number of rabbits exhib­ with therapeutics not approved for over-the-counter
ited at ARBA-sanctioned shows has increased from use in rabbits, there are few alternatives. The Animal
595,960 in 1990 to 885,895 in 2006. These numbers Medicinal Drug Use Clarification Act made it easier
do not include shows not sanctioned by the ARBA, to obtain therapeutics through a veterinarian. Unfor­
such as 4-H and local fairs. tunately, the economics of the rabbit industry do not
Pets: Rabbits represent one of the fastest growing allow for the widespread use of veterinarians. Own­
types of pet ownership. Acceptance of rabbits as ers tend to treat their own animals using mass medi­
household pets is expected to continue to increase. cation via the feed or water.
Some rabbits are actually housebroken and trained to (Continued, page 12)
Importance of Minor Species . . . (Continued)

Overview of Minor Species Industries, Leading States, Farm Gate Value and Economic Impact in the United States

U.S. farm gate U.S. economic NRSP-7 Activity
Industry Leading States value1 (in impact 2(in
millions) millions) Approvals Active
GAME BIRD TX, NC, PA, KS, WI, NY, IL, $830.0 $5,000 Chukar partridges Pheasants
SD, FL, MN, IA, GA, MS, IN Sulfadimethoxine/Ormetoprim Lasalocid
& AL Lasalocid Sulfadimethoxine/Ormetoprim
Pheasants Fenbendazole
Amprolium, Thiabendazole
Salinomycin, Bacitracin, Monensin

RABBITS CA, GA, OH, PA, & TX $20.0 $831 Lasalocid Ivermectin
HONEY BEES ND, CA, SD, FL, MT, MN, TX, $153.0 $16,000 Tylosin Lincomycin
& WI
CERVID TX, PA, OH, FL, LA, IA, & KS $894.0 (farming) $3,000 Bison Deer
$757.0 (hunting) Ivermectin Lasalocid
Reindeer Fallow Deer
Ivermectin Fenbendazole

MEAT GOATS TX, TN, CA, GA, OK, NC, KY, $173.2 $1,039 Fenbendazole, Monensin, Lasalocid
MO, FL, & AL $189.0 (breeding) Decoquinate, Morantel tartrate CIDR (progesterone), Tulathromycin
DAIRY GOATS TX, OH, NY, PA, WI, WA, IN, $58.3 $439 Fenbendazole, Monensin, Lasalocid, CIDR (progesterone),
CA, MD, MN, MI, FL, & KS $14.8 (export) Decoquinate, Morantel tartrate Ceftiofur HCl (intramammary),
SHEEP TX, CA, WY, & CO $750.0 $4,500 Bighorn Sheep Sheep
Fenbendazole CIDR (progesterone), Tulathromycin
Decoquinate, Ceftiofur, Tilmicosin
(Article continues on next page)

CATFISH/AQUACULTURE Catfish Catfish: $480.0 $2,880 Catfish Fish
MS, AK, AL, & LA Trout: $87.5 $159 Sulfadimethoxine/Ormetoprim Sulfadimethoxine/Ormetoprim,
Trout Finfish Florfenicol, Erythromycin, Carp,
WA, WI, PA, ID, NC, OR, NY, Formalin, Oxytetracycline pituitary, Strontium chloride,
CA, & CO Lobster Oxytetracycline
Total = $4,406.8 Total = $33,848

2008 – NO. III

1 In this table, the term “farm gate value” refers to the net value of an agricultural product when it leaves the farm after marketing costs have been subtracted.
2 The “U.S. Economic Impact” reflects the value of the industry, including associated businesses. For example, the sale of milk and cheese from a goat farm profits the farm directly, but the
economic effect is much broader when feed and equipment sales, worker salaries, and other goods and services are taken into account.


Importance of Minor Species . . . (Continued)

Honey bees approval of tylosin to treat American Foulbrood in

Troy Fore, representing the American Beekeeping honey bees. There is also a project in progress to
Association, provided information on the value of support the approval of lincomycin for the same
bees in U.S. agriculture. He also presented informa­ indication.
tion on the issues of Colony Collapse Disorder and
American foulbrood in beekeeping culture.
The economic impact of bees in U.S. agriculture is Shane Donely and Shawn Schafer, representing
considerable. The production of honey is actually only the North American Deer Farmers Association, and
a small part of the importance of bees. By far their Scott Bugai of the Texas Deer Association, provided
greatest role is through pollination of crops. Honey the following information regarding the cervid indus­
bees have their greatest economic impact in Califor­ try in the United States.
nia, Florida, the Dakotas, Montana, Minnesota, Texas, The cervid family includes whitetail deer, elk,
and Wisconsin. The estimated annual economic value fallow deer, reindeer, axis, sika, and red deer. In
of the work of honey bees is $16 billion. general, the production side of the industry is com­
Colony Collapse Disorder is causing enormous posed of breeding stock producers, trophy hunting
losses in commercial colonies around the country. preserves, commercial venison producers, and com­
Efforts are ongoing to identify the cause and find a mercial scent collection. Across the Nation, the to­
treatment for this devastating syndrome. tal number of cervid farms is 7,828, with Texas and
American Foulbrood is a disease that affects the Pennsylvania home to roughly 1,000 farms each.
developing bees in the hive. NRSP-7, in partner­ Deer farming and hunting provide approximately
ship with the U.S. Department of Agriculture Bee $3 billion to the U.S. economy each year.
Lab, was able to complete a project that led to the (Continued, next page)

Honey bees have their greatest economic impact in California, Florida, the Dakotas, Montana, Minnesota, Texas, and Wisconsin. The
estimated annual economic value of the work of honey bees is $16 billion.
Importance of Minor Species . . . (Continued)

Therapeutic and produc­

tion needs of the dairy goat
industry include products
for estrus induction/syn­
chronization, milk quality/
mastitis treatments, anthel­
mintics, and products to
promote animal welfare,
such as those for pain man­

Paul Rodgers of the
American Sheep Industry
joined the meeting via tele­
phone and noted that sheep
are most populous in Texas,
California, Wyoming, and
Colorado. The sheep in­
The most recent census shows that there are 3,015,000 goats in the United States. These are divided as dustry contributes approxi­
follows: Angora goat – 210,000; dairy goat – 305,000; meat and other goats – 2,500,000.
mately $4.5 billion to the
Goats U.S. economy each year.
Since 2006, U.S. meat goat numbers have in­
creased by 9 percent with no projected drop in future
growth. U.S. dairy goats show a 5 percent increase,
and U.S. Angora goats show a 19 percent decline in
population for the same period (USDA/National Ag­
ricultural Statistics Service numbers used).
The most recent census shows that there are
3,015,000 goats in the United States. These are di­
vided as follows: Angora goat – 210,000; dairy goat
– 305,000; meat and other goats – 2,500,000.

Meat goats
Marvin Shurley of the American Meat Goat As­
sociation presented information on meat goat pro­
duction in the United States. He stated that 75 per­
cent of the U.S. meat goat herd resides in 10 States:
Texas, Tennessee, California, Georgia, Oklahoma,
North Carolina, Kentucky, Missouri, Florida, and

Dairy goats
A characterization of the American dairy goat in­
dustry was presented by Linda S. Campbell, presi­
dent of the American Dairy Goat Association.
Dairy goat products include milk, cheese, meat,
fiber, seed stock, browsing, and companionship. The
breeding stock export market was $14.8 million in
2003, and dairy goat sales are valued at $250 million The sheep industry contributes approximately $4.5 billion to the
annually (2007). U.S. economy each year.

Regulatory Activities . . . (Continued)

cooling canals and recirculated water Recalls unacceptable levels. The products were
supplies (21 CFR 113.60(b)); the firm distributed in North Carolina, South
failed to record all process deviations A Class II firm-initiated recall is on­ Carolina, Virginia, and West Virginia.
involving a failure to satisfy the mini­ going by Pfizer Inc. of Canada, Kirk­ A total of 154,313 units of Dr. Turtle
mum requirements of the scheduled land, Canada, for 1,441 50-blus bottles Medication Block Card and Medica­
process, as well as the actions taken of Neo-Sulfalyte neomycin/sulfamet­ tion Bulk are the subject of an ongoing,
by the firm to either fully re-process or hazine/electrolyte bolus. The products, firm-initiated Class III recall by Aqua­
set aside and evaluate that portion of which were distributed only within trol, Inc., Anaheim, CA. The recall is
the production involved in the process Canada, were recalled due to low po­ being conducted because the products
deviations (21 CFR 113.89); and the tency for neomycin. may not contain the specified level of
firm’s recording thermometer charts Land O’Lakes Purina Feed LLC, sulfathiazole ingredient indicated on
and container closure records were Statesville, NC, is conducting a firm- the labeling. Distribution took place
not adequately reviewed by represen­ initiated Class III recall of 13,522 nationwide and in Guam.
tatives of plant management (21 CFR 50-lb. bags of horse feed because of
113.100(b) and (c)). the presence of aflatoxin in the feed at

Comings and Goings

New Hires • David Cooper, Staff Fellow Departures

• Laura Bradbard, Health Communi­ • Vashti Klein, Management Analyst
cations Program Manager • York Lu, Office Automation Clerk
• Debbie Brooks, Management
• Shannon Cameron, Public Affairs • Barbara Hamilton, Consumer Safety Analyst
Assistant Officer
• Liju Fan, Biologist OFFICE OF MANAGEMENT
• Kathie Foley, Management Officer
• Rachel Bowman, Program Analyst
• Kelly Covington, Program Support • Heather Gennagios, Chemist
Specialist • Kathie Foley, Management Officer
• William Yowell, Program Support
OFFICE OF MANAGEMENT Assistant • Schuyler Winstead, Staff Fellow
• Bryan Walsh, Program Support • Sujaya Dessai, Consumer Safety • Sujaya Dessai, Consumer Safety
Assistant Officer Officer
• Scott Strunk, Program Support • Sonya Barbee, Program Support • David Petullo, Mathematical
Assistant Assistant Statistician
• Heather Weiser, Program Analyst • Stacey Wilford, Veterinary Medical • Beverly Cook, Management
Officer Specialist
• Shannon Bradbury, Program Analyst
EVALUATION • Kristin Cameron, Microbiologist
• Philip Whitney, Consumer Safety
• Sarah Bates, Staff Fellow • Jonathan Sabo, Microbiologist Officer
• Warren Nesbit, Staff Fellow • Sampa Mukherjee, Microbiologist • George Prager, Consumer Safety
• A’ndrea VanSchoick, Veterinary • Gina Weems, Program Support Officer
Medical Officer Assistant
• Tami Cloyd, Veterinary Medical • Karen Taylor, Program Support
Officer Assistant • Jurgen VonBredow, Pharmacologist
Approvals for June – August 2008

CVM has published in the Federal Register notice of the approval of these
New Animal Drug Applications (NADA)

EXCENEL RTU EZ (ceftiofur hydrochloride) Sterile Suspension (NADA 141-288), filed by

Pharmacia & Upjohn Co., a Division of Pfizer, Inc., New York, NY. The approved NADA
provides for the veterinary prescription use of EXCENEL RTU EZ (ceftiofur hydrochlo­
ride) Sterile Suspension for the treatment of various bacterial infections in swine and
cattle. Notice of approval was published August 6, 2008.

CVM has published in the Federal Register notice of the approval of these
Supplemental New Animal Drug Applications (NADA)

TERRAMYCIN 200 for Fish (oxytetracycline dihydrate) Type A medicated article (supple­
ment to NADA 38-439), filed by Phibro Animal Health, Ridgefield Park, NJ. The NADA
provides for the use of TERRAMYCIN 200 for Fish Type A medicated article for the
control of certain bacterial diseases in several species of fish and for skeletal marking of
Pacific salmon. The supplement provides for use of oxytetracycline dihydrate in Type C
medicated feeds for the control of mortality in freshwater-reared salmonids due to cold-
water disease associated with Flavobacterium psychrophilum and for the control of mor­
tality in freshwater-reared Oncorhynchus mykiss due to columnaris disease associated
with Flavobacterium columnare. Notice of approval was published August 7, 2008.

COCCIPROL (amprolium) 9.6% Oral Solution (supplement to NADA 13-633), filed by Phi­
bro Animal Health, Ridgefield Park, NJ. The NADA provides for the use of COCCIPROL
9.6% Oral Solution to make medicated drinking water for chickens and turkeys for the
treatment of coccidiosis; the approved supplemental NADA provides for label revisions
associated with a previous change of sponsoring and other minor changes. Notice of ap­
proval was published August 6, 2008.

SYNANTHIC (oxfendazole) Bovine Dewormer Suspension (supplement to NADA 140­

854), filed by Fort Dodge Animal Health, Division of Wyeth, Fort Dodge, IA. The NADA
provides for the oral use of SYNANTHIC Bovine Dewormer Suspension in cattle for the
removal of various internal parasites; the supplemental NADA provides for a revised
warning statement, label formatting changes, and revised scientific nomenclature for
parasite species. Notice of approval was published August 6, 2008.

VETISULID (sulfachloropyridazine sodium) Powder (NADA 33-373), filed by Fort Dodge

Animal Health, a Division of Wyeth Holdings Corp., Fort Dodge, IA. The NADA is ap­
proved for the oral use of VETISULID Powder in calves and swine for the treatment of
diarrhea caused or complicated by Escherichia coli (colibacillosis). The supplemental
NADA provides for a revised warning statements and label formatting changes for oral
use of sulfachloropyridazine in the milk replacer of ruminating calves. Notice of ap­
proval was published June 24, 2008.



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