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Electronic Code of Federal Regulations

e-CFR data is current as of February 20, 2020

Title 21Chapter ISubchapter EPart 516Subpart B → §516.29


Title 21: Food and Drugs
PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Subpart B—Designation of a Minor Use or Minor Species New Animal Drug


§516.29   Termination of MUMS-drug designation.

(a) The sponsor of a MUMS-designated drug must notify FDA of any decision to discontinue active pursuit of conditional approval or approval of such MUMS drug. FDA must terminate the designation upon such notification.

(b) A conditionally-approved or approved MUMS-designated drug sponsor must notify FDA at least 1 year before it intends to discontinue the manufacture of such MUMS drug. FDA must terminate designation upon such notification.

(c) MUMS designation shall terminate upon the expiration of any applicable period of exclusive marketing rights under this subpart.

(d) FDA may terminate designation if it independently determines that the sponsor is not actively pursuing conditional approval or approval with due diligence. At a minimum, due diligence must be demonstrated by:

(1) Submission of annual progress reports in a timely manner in accordance with §516.30 that demonstrate that the sponsor is progressing in accordance with the drug development plan submitted to the agency under §516.20 and

(2) Compliance with all applicable requirements of part 511 of this chapter.

(e) Designation of a conditionally approved or approved MUMS-designated drug and the associated exclusive marketing rights may be terminated if the sponsor is unable to provide sufficient quantities of the drug to meet the needs for which it is designated.

(f) FDA may also terminate MUMS-drug designation for any drug if the agency finds that:

(1) The request for designation contained an untrue statement of material fact; or

(2) The request for designation omitted material information required by this subpart; or

(3) FDA subsequently finds that the drug in fact had not been eligible for MUMS-drug designation at the time of submission of the request;

(4) The same drug, in the same dosage form, for the same intended use becomes conditionally approved or approved for another sponsor; or

(5) FDA withdraws the conditional approval or approval of the application for the new animal drug.

(g) For a conditionally approved or approved drug, termination of MUMS-drug designation also terminates the sponsor's exclusive marketing rights for the drug but does not withdraw the conditional approval or approval of the drug's application.

(h) Where a drug has been MUMS-designated for a minor use in a major species, its designation will not be terminated on the grounds that the number of animals to which the drug could potentially be administered on an annual basis for the treatment, control, or prevention of the disease or condition for which the drug is being developed, including animals administered the drug as part of herd or flock treatment, subsequently increases.

(i) When a MUMS-drug designation is terminated, FDA will notify the sponsor in writing and will give public notice of the termination of the MUMS-drug designation.

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