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CVM, Director of the Office of Minor Use and Minor Species (OMUMS)

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here:

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

The Center for Veterinary Medicine (CVM) mission is to protect the public health of the nation, as it may be impaired by veterinary drugs, feed additives, and animal devices. CVM’s regulatory functions are geared to ensure that veterinary drugs, feed additives and animal devices are safe and effective, honestly and informatively labeled and packaged. This position is located in the Office of Minor Use and Minor Species Animal Drug Development (OMUMS), Center for Veterinary Medicine.

The Office of Minor Use and Minor Species was established in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The MUMS Animal Health Act creates incentives to help make more animal drugs legally available to veterinarians and animal owners for use in minor animal species or for minor uses (rare diseases) in major species. The Office grants MUMS Designations for new animal drugs and manages the associated grants program. It also handles the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index) to allow legal marketing of products for non-food minor species such as pet birds, zoo animals, and ornamental fish. It also supports the USDA’s Minor Use Animal Drug Program (MUADP) through the efforts of the FDA Liaison to that program.

The Supervisory Veterinary Medical Officer, Office Director ensures the appropriate evaluation of requests for designation of new animal drugs intended for minor use or minor species in accordance with Section 573 of the Federal Food, Drug, and Cosmetic Act (FFDCA) including initial requests, modification, termination, and annual reports.

Specifically, the Supervisory Veterinary Medical Officer will:
• Ensure appropriate handling of applications for grants subsequent to designation.
• Oversee the activities of the FDA Liaison to the USDA’s Minor Use Animal Drug Program (MUADP) in support of new animal drug approval.
• Oversee the assessment of requests for minor use status for the purposes of user fee waivers, eligibility for conditional approval, and designation.
• Ensure appropriate indexing of new animal drugs for use in minor species in accordance with Section 572 of the FFDCA.
• Coordinate the development and implementation of regulations and policies, including development of Guidance for Industry, pertaining to the assessment of minor use status, indexing or designation of new animal drugs intended for minor use or minor species.
• Evaluate Office activities to ensure compliance with the National Environmental Policy Act (NEPA).
• Provide technical support and expert testimony in legal proceedings relative to the indexing or designation of new animal drugs intended for minor use or minor species.
• Participate in international activities intended to harmonize the process of conditionally approving, indexing or designating new animal drugs intended for minor use or minor species.
• Represents the Office at Center Executive Board (CEB) meeting and other working groups in the Center.
• Leads communications with stakeholders – OMUMS Newsletter, answers AskCVM questions about minor use & minor species.
• Works with Management Officer to create and manage budget and to document quarterly accomplishments.
• Clears presentations and articles at Office level for presentation/publication.
Supervisory Responsibilities:
• Performs all supervisory functions for the Office – assigns work, approves leave & timecards, establishes performance plans/goals (PMAPs) for all OMUMS employees, conducts OMUMS employees’ mid-year and end-of-year performance reviews, and works with the Office of Management (OM) to accomplish all hiring.
• Plans and sets long-range plans and schedules for the work of the Office, assures implementation by subordinates of the goals and objectives of the Office, determines goals and objectives that need additional emphasis, determines the best approach and solution for resolving budget problems, and plans for long range staffing needs.