Page:United States Statutes at Large Volume 121.djvu/994

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[121 STAT. 973]
[121 STAT. 973]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 973

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‘‘(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) Any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by regulation by 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 735(1)— ‘‘(i) for prevention or treatment of a tropical disease; and ‘‘(ii) the Secretary deems eligible for priority review; ‘‘(B) is approved after the date of the enactment of the Food and Drug Administration Amendments Act of 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 505(b)(1) or section 351 of the Public Health Service Act. ‘‘(b) PRIORITY REVIEW VOUCHER.— ‘‘(1) IN GENERAL.—The Secretary shall award a priority review voucher to the sponsor of a tropical disease product application upon approval by the Secretary of such tropical disease product application. ‘‘(2) TRANSFERABILITY.—The sponsor of a tropical disease product that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 505(b)(1) or section 351 of the Public Health Service Act will be submitted after the date of the approval of the tropical disease product application. ‘‘(3) LIMITATION.— ‘‘(A) NO AWARD FOR PRIOR APPROVED APPLICATION.— A sponsor of a tropical disease product may not receive a priority review voucher under this section if the tropical disease product application was submitted to the Secretary prior to the date of the enactment of this section. ‘‘(B) ONE-YEAR WAITING PERIOD.—The Secretary shall issue a priority review voucher to the sponsor of a tropical disease product no earlier than the date that is 1 year

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