Source: http://uscode.house.gov/view.xhtml?req=(title:21%20section:360n%20edition:prelim)
Timestamp: 2017-08-19 07:34:04
Document Index: 36950224

Matched Legal Cases: ['§ 360', '§360', '§524', '§1102', '§2', '§2', '§3101', '§2', '§2', '§2', '§2', '§2']

[USC04] 21 USC 360n: Priority review to encourage treatments for tropical diseases
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21 USC 360n: Priority review to encourage treatments for tropical diseases Text contains those laws in effect on August 18, 2017
§360n. Priority review to encourage treatments for tropical diseases
The term "priority review", with respect to a human drug application as defined in section 379g(1) of this title, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007.
The term "priority review voucher" means a voucher issued by the Secretary to the sponsor of a tropical disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 262 of title 42 after the date of approval of the tropical disease product application.
(3) Tropical disease
The term "tropical disease" means any of the following:
(A) Tuberculosis.
(C) Blinding trachoma.
(D) Buruli Ulcer.
(E) Cholera.
(F) Dengue/dengue haemorrhagic fever.
(G) Dracunculiasis (guinea-worm disease).
(H) Fascioliasis.
(I) Human African trypanosomiasis.
(J) Leishmaniasis.
(K) Leprosy.
(L) Lymphatic filariasis.
(M) Onchocerciasis.
(N) Schistosomiasis.
(O) Soil transmitted helmithiasis.
(P) Yaws.
(Q) Filovirus Diseases.
(R) Zika Virus Disease.
(S) Any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by order of the Secretary.
(4) Tropical disease product application
The term "tropical disease product application" means an application that-
(A) is a human drug application as defined in section 379g(1) of this title-
(i) for prevention or treatment of a tropical disease; and
(ii) the Secretary deems eligible for priority review;
(B) is approved after September 27, 2007, by the Secretary for use in the prevention, detection, or treatment of a tropical disease; and
(C) is for a human drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under section 355(b)(1) of this title or section 262 of title 42.
(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and
(B) shall not be collected for any fiscal year except to the extent provided in advance in appropriation Acts.
(June 25, 1938, ch. 675, §524, as added Pub. L. 110–85, title XI, §1102, Sept. 27, 2007, 121 Stat. 972 ; amended Pub. L. 113–233, §2, Dec. 16, 2014, 128 Stat. 2127 ; Pub. L. 114–146, §2, Apr. 19, 2016, 130 Stat. 357 ; Pub. L. 114–255, div. A, title III, §3101(a)(2)(M), Dec. 13, 2016, 130 Stat. 1154 .)
2016-Subsec. (a)(3)(Q). Pub. L. 114–146, §2(2), substituted "Filovirus Diseases" for "Filoviruses".
Subsec. (a)(3)(R), (S). Pub. L. 114–146, §2(1), (3), added subpar. (R) and redesignated former subpar. (R) as (S).
Subsec. (c)(4)(A). Pub. L. 114–255 made technical amendment to reference in original act which appears in text as reference to section 262 of title 42.
2014-Subsec. (a)(3)(Q), (R). Pub. L. 113–233, §2(1), added subpar. (Q), redesignated former subpar. (Q) as (R), and in subpar. (R) substituted "order of" for "regulation by".
Subsec. (b)(2). Pub. L. 113–233, §2(2)(A), inserted at end "There is no limit on the number of times a priority review voucher may be transferred before such voucher is used."
Subsec. (b)(4). Pub. L. 113–233, §2(2)(B), substituted "90 days" for "365 days".