This year National Pet Week will be celebrated May 4-10, 1997. Now in its 17th year, this annual event is cosponsored by the American Veterinary Medical Association (AVMA), the American Animal Hospital Association, the Auxiliary to the AVMA, and the North American Veterinary Technician Association. This year's theme is "Every day, animals touch our lives," an appropriate reference to the relationship between animals and human beings. The partnership between veterinarians and pet owners is the central focus of the celebration stressing the importance of preventive health care for our four-legged friends, and urging responsible pet ownership.
Many educational events are planned by local veterinarians and civic groups, such as open houses, seminars, contests, etc., to increase awareness of the human-animal bond, which begins in the home and extends to our communities. Pets draw people together, and provide escape from stress and loneliness through their unconditional love and loyalty.
The FDA Veterinarian is proud to support the National Pet Week campaign and its goals. The Center for Veterinary Medicine continues to cooperate with our customers, i.e., consumers, veterinarians, and the animal health industry to protect the health of humans and animals alike.
by Karen A. Kandra
Rabbits make excellent pets, and offer a wonderful alternative where it may be impossible to keep dogs or cats. Rabbits are clean, docile, and intelligent. However, they still require responsible care and daily attention. Basic needs are a warm, dry hutch, clean, wholesome food, and fresh water to drink. Rabbits may live 10 to 15 years. Since there are over 40 recognized breeds of rabbits, check with a reliable breeder to determine what type would fit in with your lifestyle. The most popular are the smaller breeds, such as the Dutch, Holland Lop, Mini Lop, Netherland Dwarf, and Polish. Rabbits may be taught to use a litter box, and may be leash trained for trips outside the house.
Housing
Rabbits may be safely housed indoors or outdoors, as long as they have protection from rain, wind, and direct sunlight. Extremes in temperature should be avoided. High temperatures may cause overheating and death in rabbits of all ages. Good ventilation is essential, and cages should be easily accessible for daily care. Since rabbits are natural gnawers, cage material must be tough enough to withstand constant chewing. Wire pens or wooden hutches are acceptable, and should be large enough to allow the rabbit to move around freely for exercise. Ideally, cages should be cleaned daily, or at least three times a week. To avoid boredom, toys and chewing materials should be provided. Fruit tree branches make good chew sticks. In addition, rabbits should be protected from predators (dogs, foxes), and avoid contact with wild rodents and insects which can transmit disease.
Cages should be checked for broken wires or splintered boards, and prompt repairs made to avoid injury to the rabbit. If rabbits are allowed to run loose in the house, make sure electric cords are out of reach, as well as any pesticides, or poisons. Also, don't leave rabbits alone with other pets! As with any animal, prevention is the best medicine.
Feeding
Rabbits are monogastric herbivores. Young rabbits may be fed free-choice quality rabbit pellets, but adults should be limited to 4-6 ounces per day. After three months of age, pellets may be supplemented with grass hay, garden vegetables, e.g., romaine lettuce (not iceberg lettuce), cabbage, chicory, cauliflower, spinach, carrots, alfalfa, bread, tender tree growth, and some fruits, such as apples. Commercially produced rabbit pellets are the most important part of the diet, since they contain all the nutrients for proper maintenance. It is best to feed half the daily amount twice a day to prevent boredom and obesity. Avoid overfeeding since an overweight rabbit will be prone to health problems. Experts believe the best overall pet rabbit diet is a measured daily alfalfa meal-based pellet with a hay supplement provided daily and a treat of "greens," or a free-choice hay diet with vegetable supplement. Clean, mold-free hay is a major source of nutrients and provides fiber which promotes normal digestion, and helps prevent hairballs. Of course, fresh water must be provided at all times. Water and feed bowls should be cleaned daily to avoid dirt build-up.
Health
Rabbits should be examined daily for any signs of illness. Make sure they are drinking water daily and eating their food. Watch for signs of fleas, or mites, check for diarrhea, or any unusual lumps. Eyes should appear bright. Rabbits should be handled regularly so they are accustomed to human hands. Then if they do require medical attention, it will not be a traumatic experience for them to be handled.
Rabbits are generally hardy animals, however they can catch colds, termed "snuffles." Respiratory disease is a major cause of morbidity and mortality in rabbits. If your rabbit is sneezing excessively, and appears to have a very wet nose, and signs of nasal discharge on the inside of the front feet from rubbing its nose and eyes, consult a rabbit breeder or veterinarian for advice. If overlooked, this infection can progress from the upper respiratory tract to the lungs and cause pneumonia and death in a relatively short time.
Ear mites may appear at any time, manifested by inflammation and crusting in the external ear canal, causing rabbits to scratch the ears and shake their heads. You should not attempt to clean out the crusts, since this is painful and will bleed. Therapies can be recommended by your veterinarian, and may include topical application of mineral oil, liquid acaricides, or flea powder. Thorough cleaning of the environment is essential to prevent reinfection.
Sore hocks may occur from constant pressure from a wire bottom cage. Avoid this by providing a board for the rabbit to sit on. Infections may result from a severe case of sore hocks.
Since rabbits continually lick their fur, they may have hair balls in their stomach. In some cases, these accumulations may cause clinical problems, e.g., off feed, constipation, lethargy, and death. Good quality hay fed occasionally to increase fiber content of the diet is a good means of prevention.
The teeth of rabbits grow throughout their lives, so overgrowth of upper and lower incisors is quite common. Some rabbits have improper alignment which prevents the teeth from wearing on each other, causing overgrowth. If this occurs, the teeth must be trimmed regularly to enable the animal to eat normally, and to prevent lip, cheek, or gum punctures.
It is normal practice for rabbits to eat "night droppings." These cecal pellets are an essential part of the rabbit's nutrition, rich in vitamins and nutrients necessary to maintain good health.
Owners should NEVER attempt to use antibiotics without veterinary supervision. The rabbit's gastrointestinal tract is extremely delicate, and actually depends on large populations of healthy bacteria to digest food. Indiscriminate use of antibiotics may kill the normal bacteria in the gut and lead to overgrowth of deadly bacteria, resulting in death of the animal.
Currently there are only two FDA-approved drugs for use in rabbits--sulfaquinoxaline and lasalocid. Both drugs are for treatment or prevention of coccidiosis, a common parasitic condition which affects the gastrointestinal tract causing debilitation. Prevention depends on maintaining hygienic conditions and avoidance of infected feces. Other drugs are available for extra-label use by veterinarians under the Animal Medicinal Drug Use Clarification Act (AMDUCA).
The leading cause of death in the female rabbit is uterine cancer. Unfortunately, this disease has often spread to other organs by the time it is diagnosed. Young females may be spayed between 6 months and 2 years of age to prevent this disease. Unless the animal is to be used for breeding, it is recommended that she be spayed.
Male rabbits, especially dwarf varieties, may become extremely aggressive as they reach sexual maturity. They may bite excessively and spray urine outside the litter box area. To avoid this unpleasant behavior, castration may be done any time after 5 months of age.
Handling and Grooming
Always hold rabbits with two hands to support the hind legs and prevent struggling. Fractures of the lumbar spine are commonly encountered from improper handling. Rabbits have a low ratio of skeletal mass to muscle mass, and their strong hind legs can exert enough pressure on the spine to cause fractures, if mishandled.
Rabbits experience a molting process once a year, where they shed their coats and grow a new one. Usually this is a trouble-free process which begins over the back and progresses towards the rump and down the sides. At the same time the hair on the feet, face and ears is shed. The molt continues down to the underside and tail, finishing on the chest. Regular grooming is essential to free the coat of dead hairs and expedite the molting process. A soft brush or bare hands may be used. The rabbit's coat may be kept clean with a little talcum powder or corn flour rubbed into the coat well and then vigorously brushed out.
With proper care and management, your pet rabbit will live a long and healthy life, providing years of companionship to you. For further information about rabbits, contact the American Rabbit Breeders Association, Inc., P.O. Box 426, Bloomington, IL 61702. They are also on the Internet at http://www.ice.net/~arba.
UPDATED POLICY ON THE USE OF ANIMAL ELECTRONIC IDENTIFICATION PRODUCTS IN SWINE
In the March/April 1996 FDA Veterinarian, CVM announced its regulatory policy regarding implantable electronic identification products (EIDs) for use in animal identification. CVM supports the development and use of animal identification products to benefit livestock producers, the agricultural industry, regulatory agencies, and consumers.
After further consideration, the Center has revised its policy that there is no acceptable implantation site for swine. This decision is based on discussions with USDA's Food Safety and Inspection Service (FSIS). CVM agrees that appropriate systems and controls administered at slaughter will prevent EIDs from becoming a part of human food, and concludes that implantation in edible tissue under these conditions is acceptable. For implantation in pigs, FDA accepts the FSIS plan to assure that the EID implantation site is completely trimmed from the tissue that will be processed for human food. EIDs implanted in edible swine tissue will still be regulated as animal food additives, because the trimmed area containing the EID may be rendered and used in animal feed. In some specific cases, CVM may exercise regulatory discretion and not take action against the use of a food additive that is not covered by a food additive regulation. The conditions for regulatory discretion were outlined in the March/April 1996 article.
In the event of a system failure resulting in a meat product containing an EID or parts of one, it is likely that the EID would be considered a deleterious substance that causes the food to be adulterated under the Federal Food, Drug, and Cosmetic Act. Thus, the food would normally be subject to FDA regulatory action. CVM would ordinarily not, however, consider such regulatory action unless asked to do so by USDA/FSIS if FSIS decides not to take action under its applicable laws and regulations.
TIME EXTENDED FOR RELABELING OF CTC/OTC FEEDS
In a January 30, 1997 CVM UPDATE, the Center for Veterinary Medicine announced that the approved conditions of use for some Type A medicated articles containing chlortetracycline (CTC) and oxytetracycline (OTC) were changed as a result of the approval of several supplemental new animal drug applications (NADAs) in accordance with findings of the National Academy of Sciences/National Research Council (NAS/NRC), Drug Efficacy Study Group's (DESI) effectiveness evaluations and the approval of "me-too" NADAs that were dependent upon the DESI-finalization. These changes in labeling no longer allow CTC or OTC in the rations of lactating dairy cows.
In that CVM UPDATE, the Agency stated that manufacturers of these Type A articles would have until April 1, 1997, to revise labeling to comply with the new conditions of use and to cease marketing any of these products bearing unrevised labeling. Similarly, mills manufacturing feed incorporating these Type A articles would have until April 1, 1997, to use up existing stocks of labeling, and to print and begin using revised labeling.
CVM is now extending the time for relabeling of feeds made from CTC and OTC to provide for an orderly transition in the marketplace. CVM is not changing the date the Type A medicated article manufacturer/sponsor needs to have its labeling changed. That date remains April 1, 1997.
CVM is granting an extension of time for distributors in the drug and feed industry to allow for depletion of existing stocks of the previously labeled product. They will have until October 1, 1997, to cease distribution of the old Type A product, and to begin distributing the revised labeled Type A product. After that date, distributors may not sell Type A medicated articles that are not labeled in compliance with the DESI changes.
CVM is granting an extension of time to the feed manufacturers using these Type A products to allow for development and printing of new labels and depletion of existing labeling for products made from the Type A articles. They will have until April 1, 1998, to make this change. After this date, feed manufacturers may not use Type A medicated articles that are not labeled in compliance with the DESI changes and they may not distribute feeds that are not labeled in conformance with the DESI changes.
by Isabel W. Pocurull and Patsy W. Gardner
The President's Reinventing Government Initiative (REGO) and the President's and Vice President's National Performance Review (NPR) "Reinventing Food Regulations" recommended elimination of Medicated Feed Applications. The passage of the Animal Drug Availability Act (ADAA) of 1996 is the vehicle that carried out that mandate by creating a one-step feed mill licensing process, replacing the costlier and more paperwork intensive Medicated Feed Application (MFA) process. ADAA amends Sections 512(m) of the Federal Food, Drug, and Cosmetic Act to require a single facility license rather than multiple MFAs for each feed mill as previously required. CVM is presently updating the procedural regulations in the Code of Federal Regulations regarding the medicated feed regulations to clarify that a license will be required for the manufacture of medicated feeds as reflected in the ADAA.
A feed manufacturing facility that currently holds one or more approved MFAs automatically holds a transitional license, valid through April 9, 1998. The transitional license will be converted by CVM to a permanent license upon receipt of a Medicated Feed Mill License Application (Form FDA 3448) accompanied by a copy of an approved MFA (Form FDA 1900).
As part of the transition to feed mill licenses the Center will collect license information in a fully automated database system. A list, generated by this database, of firms issued licenses will be available on the CVM Home Page on the Internet. The Home Page will also have instructions on how and where to apply for a license.
The Form FDA 3448 has emergency Office of Management and Budget (OMB) clearance until June 30, 1997. CVM expects to gain an OMB three-year extension with the anticipated Federal Register publication of the Medicated Feed Mill Licensing procedural regulations. The form is included on page _____ of this issue of the FDA Veterinarian. It is also available on the CVM Home Page in two formats, pdf or Microsoft Word.
The following is a comparison of the major MFA requirements and the new licensing requirements:
|
Medicated Feed |
Medicated Feed Mill License |
|
multiple MFAs for each Feed Mill |
single facility license |
|
cGMPs compliance |
still required |
|
labeling requirements |
still applicable |
|
registration |
still required |
|
biennial inspections |
still required |
|
statutory 90 days to review |
same |
In addition to the CVM Home Page, any of the information and documents noted above may be obtained through the CVM's Division of Animal Feeds, 7500 Standish Place, Rockville, MD 20855, phone: 301-594-1724, fax: 301-594-1812.
CVM approved the first Medicated Feed Mill License on March 19, 1997. The license was granted to St. Ansgar Mills, Inc., St. Ansgar, Iowa.
ANTIDOTE FOR ETHYLENE GLYCOL POISONING APPROVED
by Monica Brown-Reid, D.V.M.
(A glossary of the medical terms used is included at the end of this article)
For the first time, there is an approved new animal drug for use as an antidote for ethylene glycol (EG) poisoning in dogs. Antizol-Vet™ (fomepizole) injectable was approved by FDA on November 25, 1996. The drug sponsor is Orphan Medical, Inc., Minnetonka, Minnesota. The active ingredient of this product is also known as 4-methylpyrazole (4-MP). The antidote is supplied in a 1.5 ml vial and is accompanied by a 30 ml vial of sodium chloride for reconstitution. This product may only be used by or on the order of a licensed veterinarian. In the past, veterinarians had difficulty in obtaining antidotes for animals in their care. Veterinarians often found that distributors were unwilling to supply them with antidotes that were not approved by the Food and Drug Administration (FDA). FDA's Center for Veterinary Medicine (CVM) has encouraged drug sponsors to submit New Animal Drug Applications (NADAs) for antidotes so that veterinarians will have the tools they need to treat acute poisoning. Antizol-Vet™ is one of the first antidote products that has been found to meet the criteria for an approved NADA. Since there is now an approved antidote, CVM will no longer provide letters facilitating the sale to veterinarians of unapproved 4-methylpyrazole for ethylene glycol poisoning in dogs.
General
Antifreeze poisoning is common in dogs and cats in the fall, winter, and early spring. EG is a chemical component of antifreeze and coolants and is also used as an industrial solvent for manufacturing detergents, paints, and lacquers. Dogs will drink antifreeze if the opportunity arises due to its sweet-tasting nature. It is highly toxic, and the minimal lethal dose of EG in dogs is 4.4 to 6.6 ml/kg of body weight. The clinical syndrome of EG poisoning may present in three distinct stages and at varying time intervals. Stage 1 (30 minutes-12 hours) is generally characterized by central nervous system signs (vomiting, ataxia, depression). Stage 2 (12-24 hours) is evident by cardiopulmonary signs (tachycardia, tachypnea, pulmonary edema). Stage 3 (24-72 hours) is the most commonly seen clinical stage. It consists of renal systemic signs (oliguria, azotemia, vomiting, anorexia).
Metabolism
EG is rapidly absorbed from the gastrointestinal tract and distributed to all body tissues. Metabolism occurs primarily in the liver and to some extent in the kidney. The metabolites of ethylene glycol (glycoaldehyde, glycolic, glyoxalic, and oxalic acids) are the substances responsible for the severe metabolic acidosis and renal tubular epithelial damage present in poisoned animals. The oxidation of ethylene glycol to glycoaldehyde by alcohol dehydrogenase is a critical step in the metabolism of this compound. Antizol-Vet™, a synthetic alcohol dehydrogenase inhibitor, acts as a competitive inhibitor of the liver enzyme alcohol dehydrogenase. Once inhibition of alcohol dehydrogenase has been achieved by treatment with Antizol-Vet™, the remaining unchanged ethylene glycol and its metabolites are excreted in the urine. Glycoaldehyde causes central nervous system (CNS) dysfunction by inhibition of respiration, glucose metabolism, serotonin metabolism, and alteration of amine concentrations. The other metabolites are directly toxic to the renal tubular epithelium. Oxalate combines with calcium in the blood to form a soluble calcium oxalate complex that is filtered by the glomerulus and then crystallizes within the lumina of the tubules. Calcium oxalate crystalluria (monohydrate or dihydrate) is a consistent finding in animals ingesting EG. Crystals may be arranged in rosettes, prisms, and sheaves. Microscopically, renal tubular epithelium in contact with the crystals may appear disrupted, however, crystal deposition is thought to have a relatively minor role in the pathogenesis of renal tubular damage.
Diagnosis
History, clinical signs, laboratory findings, and radiography are of diagnostic usefulness. Diagnosis of EG toxicosis is often difficult as the signs can mimic other disease entities (renal failure, pancreatitis, diabetic ketoacidosis). A commercial test kit is available for accurately measuring blood EG concentrations greater than 50 mg/dl and is useful in determining toxicosis one to twelve hours after ingestion (EGT Test Kit, PRN Pharmacal, Inc.) Measurement of serum concentrations of EG is dose and time dependent and should only be used to document exposure to EG, not to determine if a lethal dose has been ingested. EG is usually not detected in the serum or urine by 72 hours following ingestion.
Clinically, one should be suspicious if an animal presents with 1) acute onset of signs, e.g., ataxia, vomiting, depression, polyuria, 2) azotemia or uremia and 3) low or fixed urine specific gravity. Several laboratory tests are helpful in diagnosing EG poisoning. Test results which may indicate EG toxicity include high blood urea nitrogen (BUN) and/or creatinine, low urine specific gravity, hyperphosphatemia, calcium oxalate crystalluria, metabolic acidosis, decreased urine pH, and hypocalcemia. Due to the renal damage and subsequent decreased glomerular filtration, serum creatinine, phosphorus and urea nitrogen concentrations increase. A decrease in serum calcium concentration is observed in some animals due to the chelation of calcium by oxalic acid. Dogs are isosthenuric (urine specific gravity of 1.012 - 1.014) by 3 hours following ingestion due to the osmotic diuresis and serum hyperosmolality. Animals remain isosthenuric in the later stages of toxicosis as a result of renal dysfunction and impaired ability to concentrate urine. Other inconsistent urinalysis findings include hematuria, proteinuria, and glucosuria. Granular and cellular casts, white or red blood cells, and renal epithelial cells may also be observed. Hyperkalemia develops with the onset of oliguria and anuria. Hyperglycemia may also be observed due to the inhibition of glucose metabolism by aldehydes, increased epinephrine, endogenous corticosteroids, uremia, and possibly inhibition of insulin release due to hypocalcemia. Packed cell volume and total protein are increased due to dehydration. Radiographically the kidneys may appear large due to swelling and edema.
Prognosis and Treatment
Early diagnosis and rapid treatment are key to a positive clinical outcome. Antizol-Vet™ is only effective if injected into the bloodstream prior to complete metabolism of ethylene glycol. To evaluate whether ethylene glycol has been completely metabolized, it is advisable to measure serum BUN and creatinine, and to monitor urine output. Correction of dehydration (fluid therapy) is essential to obtain accurate serum BUN and creatinine values and is also recommended to correct the metabolic acidosis. Serum concentrations of blood urea nitrogen >40 mg/dl and creatinine >1.8 mg/dl that do not resolve after dehydration is corrected indicate that ethylene glycol has been fully metabolized and significant renal damage may exist. Treatment with 4-MP will not prevent renal tubular damage. However, if urine flow is maintained, benefit to risk considerations suggest that treatment with Antizol-Vet™ is warranted. If ingestion of antifreeze is witnessed, vomiting should be induced unless the animal is severely depressed and there is no danger of aspiration (see reference below).
Reference
Kirk, R., Current Veterinary Therapy, IX, W.B. Saunders Company, 211, 1986.
Glossary of terms
FDA VETERINARY MEDICINE ADVISORY COMMITTEE TO MEET
The Food and Drug Administration's Veterinary Medicine Advisory Committee will convene on May 13-14, 1997, in the Goshen Room of the Holiday Inn-Gaithersburg, Two Montgomery Village Avenue, Gaithersburg, Maryland. The meeting will be open to the public. Public participation will be invited at certain times each afternoon as noted in the proposed agenda.
On May 13, 1997, the Committee will discuss veterinary medical issues related to the quality standards for the manufacture of animal drugs, such as current good manufacturing practices (CGMPs). On May 14, 1997, the Committee will discuss topics concerned with the Animal Medicinal Drug Use Clarification Act (AMDUCA), specifically the part of the regulation that permits extralabel use when a drug is clinically ineffective.
The proposed agenda follows:
|
Tuesday, May 13, 1997 |
|
|
8:30 a.m. - 2:30 p.m. |
Open Committee Discussion |
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2:30 p.m. - 3:30 p.m. |
Open Public Hearing |
|
|
(public participation invited) |
|
3:30 p.m. - 4:30 p.m. |
Open Committee Discussion |
|
|
|
|
Wednesday, May 14, 1997 |
|
|
8:30 a.m. - 1:00 p.m. |
Open Committee Discussion |
|
1:00 p.m. - 2:00 p.m. |
Open Public Hearing |
|
|
(public participation invited) |
|
2:00 p.m. - 4:30 p.m. |
Open Committee Discussion |
Any interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. For further information, contact:
Ms. Jacquelyn Pace
FDA/Center for Veterinary Medicine (HFV-200)
7500 Standish Place
Rockville, MD 20855
Telephone: 301-594-5920
FAX: 301-594-4512
The deadline for requesting time to speak during the Open Public Hearing session is May 7, 1997.
An FDA Advisory Committee Information Hotline is available on 1-800-741-8138 (301-443-0572 in the Washington, DC area), Veterinary Medicine Advisory Committee, code 12546. Please call the Hotline for information concerning any possible changes.
During the past two years, CVM has been engaged in a major effort to re-engineer the way they conduct business. The final organizational structure is now in place and the following are some of the highlights. With the retirement of Dr. Teske, Associate Director for Policy, a void emerged. Previous to this event, the Animal Drug Availability Act (ADAA) was signed into law which mandates the development of implementing regulations for the new legislative authority.
To coordinate the implementation of ADAA in the face of shrinking resources, Dr. G.A. (Bert) Mitchell will take on the responsibility for coordination and oversight of all the regulations developed in CVM, including those required for ADAA. Dr. Mitchell's new title is Associate Director for Policy and Regulations. He has a staff assigned to him formerly known as the Petitions and Regulations Branch, now named the Policy and Regulations Team. Dr. Mitchell will also serve as liaison to CVM's external customers.
Dr. Linda Tollefson has been appointed Director of the Office of Surveillance and Compliance, a post formerly held by Dr. Mitchell. Prior to CVM's recent reorganization, Dr. Tollefson was Director of the Division of Voluntary Compliance and Hearings Development. This Division has been abolished and personnel have been dispersed to the Offices of Management and Communications (formerly named Office of Management) and Surveillance and Compliance. The Tissue Residue Branch has been reassigned to the Division of Compliance and renamed the Compliance Information Management Team. The former Case Guidance Branch has been divided into the Food and Feeds Team and Drug and Device Team. An Epidemiology Team and a Marketed Product Information Team have been established under the Division of Epidemiology and Surveillance (formerly the Division of Surveillance). Other Teams in that Division are the Marketed Product Scientific and Regulatory Review Teams I and II, replacing the Medical Review and Drug Listing Branch and the Post-Approval Review Branches, respectively. A Nutrition and Labeling Team has been established within the Division of Animal Feeds, joining the Medicated Feeds Team and the Feed Safety Team. In keeping with the current trend in the Federal Government, former CVM units formerly known as "Branches" are now renamed as "Teams."
Within the Office of New Animal Drug Evaluation, several name changes have occurred. The Generic Animal Drug and Quality Control Staff is retitled as the Quality Assurance Support Team. The Division of Chemistry is renamed the Division of Human Food Safety, and will include the Residue Chemistry Team and a new Toxicology Team. A Division of Manufacturing Technologies has been established, and will include the Antimicrobial Team and the Chemotherapeutics Team, as well as the Environmental Assessment Team.
The Office of Science which resides in Laurel, Maryland at CVM's new animal research center has been retitled as the Office of Research. An Animal Care and Use Staff will be established within the Division of Animal Research.
CVM continues to develop and recommend the veterinary medical policy of the Food and Drug Administration with respect to the safety and effectiveness of animal drugs, feeds, feed additives, veterinary medical devices, and other veterinary medical products. The restructuring of the Center will strengthen the delivery of services to our constituents and customer groups by streamlining the organization through delayering lines of authority and responsibility, and improving channels of communications at all levels within the Center.
The new organizational chart for CVM is shown below:
Click here for a pdf file of the new CVM organizational chart
FOOD SAFETY EDUCATION CONFERENCE SCHEDULED
Changing Strategies, Changing Behavior, What Food Safety Communicators Need to Know is the title of an upcoming conference jointly sponsored by the U.S. Department of Agriculture, the Food and Drug Administration, and the Centers for Disease Control and Prevention. This national conference will be held June 12-13, 1997, at the Hotel Washington, 15th St. and Pennsylvania Ave., NW, Washington, DC. Nationally recognized experts will provide the latest information on the epidemiology of foodborne bacteria, consumers' food handling knowledge, attitudes and behaviors, theories of social marketing and food safety education, as well as other relevant topics. The registration fee of $100 includes all sessions, two continental breakfasts, one lunch and reception. Industry, trade and consumer organization communicators, state and local health educators, and academicians who develop food safety education materials or who follow trends in health education will benefit from this conference. For further information, or registration forms, contact Isabelle Howes at 202-401-9138.
In the March 14, 1997 Federal Register, FDA published a notice stating that the Agency is withdrawing approval of a new animal drug application (NADA 6-776) which provided for the use of 10 percent sulfaquinoxaline powder for making animal feed and 20 percent sulfaquinoxaline liquid. This NADA was held by I.D. Russell Co. Laboratories. The sponsor requested the withdrawal of approval because the products are no longer being marketed.
In the March 26, 1997 Federal Register, FDA published a notice stating that the Agency is withdrawing approval of two new animal drug applications (NADAs) held by Land O'Lakes, Inc. (NADAs 42-489 and 98-156), and three NADAs held by ADM Animal Health and Nutrition Division (NADAs 118-874, 127-825, and 127-826). NADA 42-489 was for tylosin Type A medicated articles, and NADA 98-156 was for tylosin/sulfamethazine Type A medicated articles. NADA 118-874 was for pyrantel tartrate Type A medicated articles, NADA 127-825 was for hygromycin B Type A medicated articles, and NADA 127-826 was for tylosin/sulfamethazine Type A medicated articles. The sponsors requested withdrawal of approval of these NADAs.
In the March 26, 1997 Federal Register, FDA published a technical amendment to a document published in the July 9, 1996 Federal Register reflecting approval of the National Academy of Sciences/National Research Council review of NADAs for chlortetracycline. These NADAs were held by Hoffmann LaRoche, Inc. (NADA 48-761), Pfizer, Inc. (NADAs 92-286 and 92-287), AL Pharma, Inc. (NADA 46-699), ADM Animal Health and Nutrition (NADA 48-480), and Pennfield Oil Co. (NADA 138-935). The July 9, 1996 document failed to include a warning against the use of certain medicated articles in duck eggs for human food.
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:
Bottasso Dairy, Fresno, CA
C.G. Van Vliet Dairy , Escalon, CA
Claren Bosman, Bosman Dairy, Visalia, CA
Crumland Farm, Frederick, MD
D.C. Leal & Sons Dairy, Lemoore, CA
Daniel Griffin, Visalia, CA
Gomes Dairy, Escalon, CA
Joe Pereira, Escalon, CA
John Couto, Riverdale, CA
Marcelino Amaral and Sons Dairy, Stevenson, CA
Orlando Toste, Galt, CA
Peter Vander Werff, Escalon, CA
Rock Creek Dairy, Farmington, CA
Rothdale Farm, Ancramdale, NY
Tom Kroes, Tipton, CA
Varner and Varner, Bristow, OK
Webb Livestock Co., St. George, UT
These violations involved illegal residues of tetracycline in calves, sulfamethazine in cows, sulfadimethoxine in cows, sulfadimethoxine in cull dairy cows, oxytetracycline in a bull calf, streptomycin in a cow, streptomycin in a calf, gentamicin in a cull dairy cow, oxytetracycline in a cow, sulfamethazine and penicillin in a cull dairy cow, violative levels of antibiotics in a cow and calf, and penicillin in a cow.
A warning letter was sent to MFA, Inc., Columbia, MO, for violations from GMPs in a feed mill.
In the "Regulatory Activities" section of the March/April 1997 FDA Veterinarian, it was stated that a warning letter was sent to Anthony Products Co., Irwindale, CA, for deviations from the Good Manufacturing Practice (GMP) regulations. While FDA did correspond with the firm, no warning letter was issued. We regret this error and apologize for any confusion it may have caused.
| Company | Generic and (Brand) Names | Indications | Routes/Remarks |
|---|---|---|---|
| Fermenta Animal Health Co. (NADA 141-011) | Chlortetracycline and Tiamulin | Swine. For treatment of bacterial enteritis and bacterial pneumonia and for control of swine dysentery. | MEDICATED FEED: Provides for separately approved Type A medicated articles containing chlortetracycline and tiamulin in making combination drug Type C medicated feed. The regulations are also amended to increase the tolerance for tiamulin residue in swine tissues. Federal Register 3/14/97. |
| Alpharma, Inc. (NADA 141-059) | Bacitracin Methylene Disalicylate and Chlortetracycline | Swine. For increased rate of weight gain and improved feed efficiency. For treatment of bacterial enteritis and bacterial pneumonia. | MEDICATED FEED: Provides for combining separately approved Type A medicated articles containing bacitracin methylene disalicylate and chlortetracycline in making combination drug Type C medicated feed. Federal Register 3/19/97. |
| Elanco Animal Health (NADA 95-735) | Monensin | Pasture Cattle. For increased rate of weight gain. | MEDICATED FEED: Provides for use of monensin Type A medicated articles to make a revised formulation of a free-choice Type C medicated feed. Federal Register 3/26/97. |
| Ciba-Geigy Animal Health (NADA 141-062) | Lufenuron (Program ®) | Cats and Kittens 6 weeks of age. For control of fleas. | ORAL: Given once a month at a minimum of 13.6 milligrams (mg) of lufenuron per pound of body weight (30 mg/kilogram) in tablets containing 135 or 270 mg lufenuron each. Federal Register 3/26/97. |
ABBREVIATED NEW ANIMAL DRUG APPROVALS
| Company | Generic and (Brand) Names | Indications | Routes/Remarks |
|---|---|---|---|
| Fermenta Animal Health Co. (ANADA 200-165) | Sulfadimethoxine | Broiler and Replacement Chickens, Meat-Producing Turkeys, Dairy Calves, Dairy Heifers, and Beef Cattle. For treatment of bacterial diseases susceptible to sulfadimethoxine. | ORAL: ANADA 200-165 is a generic copy of Hoffmann-LaRoche¹s NADA 31-205 for Albon/Agribon. Federal Register 2/25/97. |
| Med-Pharmex, Inc. (ANADA 200-188) | Gentamicin (Gentaspray ®) Topical Spray | Dogs. For treatment of infected superficial lesions caused by bacteria susceptible to gentamicin. | TOPICAL: ANADA 200-188 is a generic copy of Schering Plough¹s Gentocin®Topical Spray, NADA 132-338. Federal Register 3/6/97. |
SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS
|
Company |
Generic and (Brand) Names |
Indications |
Routes/Remarks |
| Hoffmann-LaRoche, Inc. (NADA 128-686) | Salinomycin | Roaster and Replacement Chickens. For prevention of certain forms of coccidiosis. | MEDICATED FEED: Provides for 30 grams per pound salinomycin Type A article (as salinomycin sodium) to make Type C roaster and replacement (breeder and layer) chicken feeds containing 40 to 60 grams per ton salinomycin sodium. Federal Register 3/26/97. |
| Merck Research Labs (NADA 140-833) | Ivermectin and Clorsulon (Ivomec®Plus) | Cattle. For treatment and control of gastro-intestinal, roundworm, lungworm, grub, lice, and mange mite infections. | INJECTABLE: Provides for Ivomec®Plus Injection (1 percent ivermectin and 10 percent clorsulon). Federal Register 3/26/97. |
| Boehringer Ingelheim Animal Health (formerly sponsored by Fermenta Animal Health Co.) (NADA 97-452) | Oxytetracycline hydrochloride | Cattle. For treatment of diseases caused by oxytetracycline susceptible organisms, for a 2-day withdrawal period following subcutaneous use, and for a 13-day withdrawal period following the intramuscular and intravenous use. | INJECTABLE: Provides for subcutaneous use of 100 mg/mL of oxytetracyline hydrochloride injection in addition to the approved intravenous and intramuscular use in beef and non-lactating dairy cattle for treatment of pneumonia and shipping fever. Federal Register 3/26/97. |
| Merck Research Labs (NADA 128-409) | Ivermectin (Ivomec ®) | Cattle. For treatment and control of certain gastro-intestinal roundworm, lungworm, grub, lice, and mange infections. | INJECTABLE: The supplement provides for control of infections for 21 days after treatment. Federal Register 3/27/97. |
| Pharmacia and Upjohn Co. (NADA 34-254 and 39-402) | Melengestrol Acetate | Heifers Intended for Breeding. For suppression of estrus. | MEDICATED FEED: Provides for dry and liquid MGA Type A medicated articles to manufacture certain Type B and Type C medicated feeds. Federal Register 3/26/97. |
| Elanco Animal Health (NADA 95-735) | Monensin | Cattle and Goats. | MEDICATED FEED: Provides for 90.7 g/lb (200 g/kg) monensin Type A medicated article for making Type B and Type C medicated feeds. The supplement is for a higher concentration of Type A article to make currently approved Type B and Type C medicated feeds. Federal Register 3/26/97. |
| Ciba-Geigy Animal Health (NADA 141-035) | Lufenuron (Program ®) | Cats. For control of fleas. | ORAL: Provides for administration of lufenuron tablets at a minimum dose of 13.6 per pound of body weight (30 milligrams per kilogram.) Supplemental NADA provides for use in cats 6 weeks of age or older. Federal Register 3/14/97. |
| Abbott Labs. (NADA 141-018) | Sarafloxacin Hydrochloride (SaraFlox®Injection) | Broiler Eggs (18-day embryonated). For control of early chick mortality associated with E. coli organisms susceptible to sarafloxacin. | INJECTABLE: Provides for use in 18-day embryonated broiler eggs in addition to approved use in day-old broiler chickens. Federal Register 3/6/97. |
| Ciba-Geigy Animal Health (NADAs 141-026 and 141-035) | Lufenuron (Program ®) | Cats and kittens. For control of flea populations. (NADA 141-026). Dogs and puppies (NADA 141-035) for prevention and control of flea populations. | ORAL: The supplements provide that veterinary prescriptions are no longer required for use of lufenuron tablets for dogs and oral suspension for cats. Federal Register 2/25/97. |
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