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Increasing Drug Availability for Minor Use and Minor Species (MUMS)

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2011 Annual Report

CVM has authority to approve new animal drugs for minor uses and minor species under the Minor Use and Minor Species Animal Health Act of 2004. Special provisions of that Act accommodate therapeutic needs for a variety of species and uses that may not support conventional approvals because of a lack of economic incentive. The provisions include designations, indexing, and conditional approvals.

 

Challenges and Accomplishments 

 

Designations

Designation of a MUMS drug makes it eligible for incentives to help bring the product to market, including an exclusive marketing period and grants to defray the cost of effectiveness and safety studies required to support approval. The Office of Minor Use and Minor Species Animal Drug Development granted 10 new drug designations during FY 2011. The following is a brief description of each of these designations:

  1. Tulathromycin (DRAXXIN Injectable Solution) is an injectable product for the treatment of respiratory disease associated with Mannheimia haemolytica in sheep.
  2. Lincomycin hydrochloride (LINCOMIX Soluble Powder) is an oral therapy for the control of American Foulbrood (Paenibacillus larvae) in honey bees.
  3. Replication competent amphotropic murine leukemia virus with a cytosine deaminase gene (TOCA 511) and oral flucytosine (5-FC) is an intracranial injection (TOCA 511) followed by the oral product (5-FC) for the treatment of primary malignant brain tumors in dogs.
  4. Fenbendazole (SAFE-GUARD) is an oral Type A medicated article for the removal and control of adult Syngamus trachea (gapeworm) in pheasants.
  5. Hydrogen peroxide 50% (INTEROX PARAMOVE 50) is an immersion product for the treatment of Lepeophtherius salmonis sea lice on saltwater-reared Atlantic salmon (Salmo salar).
  6. Paclitaxel (PACCAL VET) is an injectable product for the treatment of resectable and non-resectable squamous cell carcinoma in dogs.
  7. Ivermectin is a Type C medicated free-choice feed for the control of cattle fever ticks (Rhipicephalus microplus and R. annulatus) in beef cattle as part of the U.S. Cattle Fever Tick Eradication Program.
  8. Alpha-neurotoxoid (PANAVIRA) is an injectable product for the treatment of local disease in stage II and III oral malignant melanoma in dogs.
  9. Florfenicol (AQUAFLOR) is an oral 50% Type A medicated article for the control of mortality in freshwater-reared salmonids due to bacterial kidney disease associated with Renibacterium salmoninarum.
  10. Azamethiphos (SALMOSAN) is an immersion product for the treatment and control of adult and pre-adult Lepeophtheirus salmonis sea lice on saltwater-reared Atlantic salmon (Salmo salar).
 
The following grants were awarded for designated indications:
  1. The efficacy of BENZOAK (20% benzocaine) to sedate a variety of freshwater-reared finfish to handleable: Coolwater Species #1
  2. The efficacy of BENZOAK (20% benzocaine) to sedate a variety of freshwater-reared finfish to handleable: Coldwater Species #1
  3. The efficacy of BENZOAK (20% benzocaine) to sedate a variety of freshwater-reared finfish to handleable: Coldwater Species #2
  4. The efficacy of AQUI-S E (50% eugenol) to sedate a variety of freshwater-reared finfish to handleable: Coldwater Species #1
  5. The efficacy of AQUI-S E (50% eugenol) to sedate a variety of freshwater-reared finfish to handleable: Coolwater Species #1
  6. Field effectiveness of 35% PEROX-AID (hydrogen peroxide) to reduce Gyrodactylus sp. infestation density on coolwater and warmwater finfish – Trial 2
  7. Field effectiveness of 35% PEROX-AID (hydrogen peroxide) to reduce Gyrodactylus sp. infestation density on coolwater and warmwater finfish – Trial 1
  8. Depletion of florfenicol amine from the fillet tissue of rainbow trout (Oncorhynchus mykiss) maintained in recirculating and flow-through aquaculture systems and treated with Aquaflor medicated feed
  9. The target animal safety of SLICE (emamectin benzoate) for rainbow trout (Oncorhynchus mykiss)
  10. Human food safety (tissue residue) study for fenbendazole in pheasants

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 Photo by Evgenji Miko

Indexing

Indexing allows a sponsor to legally market a product that is unlikely to be approved because the numbers of animals in the species group are too few or too precious to use in field trials. The Office of Minor Uses and Minor Species has no new index listings to report for FY 2011. However, at the end of the fiscal year, the Office of Minor Uses and Minor Species was actively reviewing requests that cover a wide range of species and indications.

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Conditional Approvals

Conditional approval allows drug sponsors to bring a product to market after showing safety in the target animal and, if appropriate, safety of any food derived from the animals, but before gathering all the effectiveness data for a full approval. Sponsors can use the revenue they obtain from the marketing to fund the continuing effectiveness studies.
The CVM Office of New Animal Drug Evaluation processes the applications for conditional approval. During FY 2011, the Office of New Animal Drug Evaluation granted the first conditional approval for a companion animal under the Minor Use and Minor Species Animal Health Act. Kinavet-CA1 was conditionally approved for the treatment of recurrent (post-surgery) or nonresectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids. 
 

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 Liaison to the U.S. Department of Agriculture’s (USDA’s) Minor Use Animal Drug Program  

The Office of Minor Use and Minor Species performs a liaison function for the USDA’s Minor Use Animal Drug Program, formerly known as the National Research Support Project # 7 or NRSP-7.
The Minor Use Animal Drug Program conducts the studies, and CVM’s Office of Minor Use and Minor Species liaison performs a regulatory affairs function to assist in the compilation and submission of data and information required for approval.

During this fiscal year, the program completed the following important milestones: 

Fenbendazole for gapeworm in pheasants – Protocols were accepted for a tissue residue depletion study and for a target animal safety study. These studies have been conducted and the reports were to be submitted for review early in FY 2012.
Erythromycin for bacterial kidney disease in salmonid fish – A supportive study for the environmental assessment was accepted. The final draft of the environmental assessment was to be submitted for review early in FY 2012.
Progesterone for estrus synchronization in goats – The human food safety technical section was completed.
Florfenicol for respiratory disease in sheep – The tissue residue depletion study was accepted.
Lasalocid for coccidiosis in pheasants – The effectiveness technical section was completed.
Tulathromycin for respiratory disease in goats – The target animal safety technical section was completed.
A Public Master File was published containing data (effectiveness, target animal safety, human food safety, and environmental data) to support a new animal drug application for the use of lincomycin for American Foulbrood in honey bees.
Minor Use Animal Drug Program is working in cooperation with the USDA’s Agricultural Research Service and the Tick Eradication Program to investigate the use of mineral blocks containing ivermectin to control cattle fever ticks in the quarantine zone in Texas.
 

The Office of Minor Use and Minor Species has the lead for the update of Guidance for Industry #61, “FDA Approval of New Animal Drugs for Minor Uses and Minor Species.” The scope of this guidance is being expanded to provide an introduction to the process for all new sponsors and a discussion of special considerations for minor use and minor species projects. This Level 1 guidance will first be published as a draft for public comment. 
 

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Guidance for Industry

The Office of Minor Use and Minor Species has the lead for the update of Guidance for Industry #61, “FDA Approval of New Animal Drugs for Minor Uses and Minor Species.” The scope of this guidance is being expanded to provide an introduction to the process for all new sponsors and a discussion of special considerations for minor use and minor species projects. This Level 1 guidance will first be published as a draft for public comment.

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