U.S Code last checked for updates: May 26, 2024
§ 360n.
Priority review to encourage treatments for tropical diseases
(a)
Definitions
In this section:
(1)
Priority review
(2)
Priority review voucher
(3)
Tropical disease
The term “tropical disease” means any of the following:
(A)
Tuberculosis.
(B)
Malaria.
(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;
(ii)
the Secretary deems eligible for priority review;
(iii)
that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and
(iv)
that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.1
1
 So in original. The period probably should be a semicolon.
(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—
(i)
a human drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under section 355(b)(1) of this title; or
(ii)
a biological product, no active ingredient of which has been approved in any other application under section 262 of title 42.
(b)
Priority review voucher
(1)
In general
(2)
Transferability
(3)
Limitation
(A)
No award for prior approved application
(B)
One-year waiting period
(4)
Notification
(c)
Priority review user fee
(1)
In general
(2)
Fee amount
(3)
Annual fee setting
(4)
Payment
(A)
In general
(B)
Complete application
(C)
No waivers, exemptions, reductions, or refunds
(5)
Offsetting collections
Fees collected pursuant to this subsection for any fiscal year—
(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; Pub. L. 115–52, title VI, § 611(a), Aug. 18, 2017, 131 Stat. 1054; Pub. L. 117–9, § 1(a)(3), Apr. 23, 2021, 135 Stat. 257.)
cite as: 21 USC 360n