§360ccc–2 — Title 21 Food and Drugs | U.S. Code

Summary

Manufacturers can ask the Secretary to call a new animal drug a "designated new animal drug" for a minor use or a minor species. The request must come before they file a regular approval application. The Secretary may grant the label if the drug is for a minor use or minor species and the same drug in the same form and use is not already approved or already designated. The sponsor must tell the Secretary if they stop trying to get approval, and the Secretary will end the designation when told. The Secretary can also end the designation if the sponsor is not working on approval with due effort. If a designated drug that is approved stops being made, the sponsor must give at least one year’s notice and the Secretary will then end the designation. The Secretary must make public any decisions to give or end the designation. The Secretary can give grants or make contracts to help pay for testing and for making manufacturing processes that happen after designation and before an approval application is filed. “Qualified safety and effectiveness testing” means safety and effectiveness tests done after designation and before filing, under an investigational exemption. “Manufacturing expenses” means costs to develop how the drug will be made after designation and before filing. If the Secretary approves a designated drug, no one else may get approval for the same drug and use for seven years, unless the approved sponsor cannot supply enough product (after notice and chance to respond) or agrees in writing. For drugs that need control under the Controlled Substances Act, the seven-year period starts when the interim control rule is issued.

Title 21, §360ccc–2

Food and Drugs — Source: USLM XML via OLRC

(a)(1)The manufacturer or the sponsor of a new animal drug for a minor use or use in a minor species may request that the Secretary declare that drug a “designated new animal drug”. A request for designation of a new animal drug shall be made before the submission of an application under section 360b(b) of this title or section 360ccc of this title for the new animal drug.

(2)The Secretary may declare a new animal drug a “designated new animal drug” if—

(A)it is intended for a minor use or use in a minor species; and

(B)the same drug in the same dosage form for the same intended use is not approved under section 360b or 360ccc of this title or designated under this section at the time the request is made.

(3)Regarding the termination of a designation—

(A)the sponsor of a new animal drug shall notify the Secretary of any decision to discontinue active pursuit of approval under section 360b or 360ccc of this title of an application for a designated new animal drug. The Secretary shall terminate the designation upon such notification;

(B)the Secretary may also terminate designation if the Secretary independently determines that the sponsor is not actively pursuing approval under section 360b or 360ccc of this title with due diligence;

(C)the sponsor of an approved designated new animal drug shall notify the Secretary of any discontinuance of the manufacture of such new animal drug at least one year before discontinuance. The Secretary shall terminate the designation upon such notification; and

(D)the designation shall terminate upon the expiration of any applicable exclusivity period under subsection (c).

(4)Notice respecting the designation or termination of designation of a new animal drug shall be made available to the public.

(b)(1)The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in defraying the costs of qualified safety and effectiveness testing expenses and manufacturing expenses incurred in connection with the development of designated new animal drugs.

(2)For purposes of paragraph (1) of this section—

(A)The term “qualified safety and effectiveness testing” means testing—

(i)which occurs after the date such new animal drug is designated under this section and before the date on which an application with respect to such drug is submitted under section 360b of this title; and

(ii)which is carried out under an investigational exemption under section 360b(j) of this title.

(B)The term “manufacturing expenses” means expenses incurred in developing processes and procedures associated with manufacture of the designated new animal drug which occur after the new animal drug is designated under this section and before the date on which an application with respect to such new animal drug is submitted under section 360b or 360ccc of this title.

(c)(1)Except as provided in subsection (c)(2), if the Secretary approves or conditionally approves an application for a designated new animal drug, the Secretary may not approve or conditionally approve another application submitted for such new animal drug with the same intended use as the designated new animal drug for another applicant before the expiration of seven years from the date of approval or conditional approval of the application.

(2)If an application filed pursuant to section 360b of this title or section 360ccc of this title is approved for a designated new animal drug, the Secretary may, during the 7-year exclusivity period beginning on the date of the application approval or conditional approval, approve or conditionally approve another application under section 360b of this title or section 360ccc of this title for such drug for such minor use or minor species for another applicant if—

(A)the Secretary finds, after providing the holder of such an approved application notice and opportunity for the submission of views, that in the granted exclusivity period the holder of the approved application cannot assure the availability of sufficient quantities of the drug to meet the needs for which the drug was designated; or

(B)such holder provides written consent to the Secretary for the approval or conditional approval of other applications before the expiration of such exclusivity period.

(3)For purposes of determining the 7-year period of exclusivity under paragraph (1) for a drug for which the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], the drug shall not be considered approved or conditionally approved until the date that the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (c)(3), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see

Short Title

note set out under section 801 of this title and Tables.

Amendments

2015—Subsec. (c)(3). Pub. L. 114–89 added par. (3).

§360ccc–2 Designated new animal drugs for minor use or minor species