PRIA, Government Policy, Made Personal

Summary

Drug makers or sponsors can ask the Secretary to call a new animal medicine a "designated new animal drug" if it is for a minor use or a minor species. The request must come before the maker files an official approval application under sections 360b(b) or 360ccc. The Secretary can grant the designation only if the drug is for a minor use or species and the same drug, dose form, and use are not already approved or designated when the request is made. If the sponsor stops trying to get approval, they must tell the Secretary, and the designation will end. The Secretary can also end the designation if the sponsor is not working on approval with due effort. If a designated drug is approved but the maker plans to stop making it, the maker must tell the Secretary at least one year before stopping, and the designation will end. The designation also ends when any exclusivity period expires. Notices of designation and any endings will be made public. The Secretary can give grants or sign contracts to help pay for testing and for setting up manufacturing. These payments only cover testing and manufacturing work done after designation and before an approval application is filed. "Qualified safety and effectiveness testing" means testing done after designation and before filing, under the investigational exemption in section 360b(j). "Manufacturing expenses" means costs to develop how the drug is made after designation and before filing. If the Secretary approves a designated drug, no one else can get approval for the same use for seven years from that approval date, except if the approved holder cannot supply enough of the drug (after notice and a chance to respond) or if the holder agrees in writing. For drugs that need new controls under the Controlled Substances Act, the seven-year period starts when the interim final rule controlling the drug is issued under section 201(j) of that Act.

Title 21, §360ccc–2

Food and Drugs, Source: USLM XML via OLRC

(a)Designation

(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)Grants and contracts for development of designated new animal drugs

(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)Exclusivity for designated new animal drugs

(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