program
(7) Vector expedited review vouchers (A) Set-aside In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund to establish and carry out the Vector Expedited Review Voucher program in accordance with subparagraph (B). (B) Vector Expedited Review Voucher program (i) Definitions In this subparagraph: (I) Program The term “program” means the Vector Expedited Review Voucher program established under clause (ii). (II) Voucher The term “voucher” means a voucher— (aa) issued under the program by the Administrator to a pesticide registration applicant that entitles the holder to an expedited review described under clause (vi) of a single different pesticide registration action; and (bb) the entitlement to which may be transferred (including by sale) by the holder of the voucher, without limitation on the number of times the voucher may be transferred, before the voucher is redeemed. (ii) Establishment Not later than one year after December 29, 2022 , the Administrator, acting though the Office of Pesticide Programs, shall establish a program to be known as the Vector Expedited Review Voucher program. (iii) Purpose The purpose of the program is to incentivize the development of new insecticides to control and prevent the spread of vector borne disease by expediting reviews by decreasing decision review times provided in section 136w–8(b)(3)(B) of this title . (iv) Issuance of vouchers (I) In general For each of fiscal years 2023 through 2027, the Administrator shall issue a voucher to a pesticide registration applicant for a new active ingredient if the applicant submits and has successfully registered a mosquito-control product that— (aa) demonstrates a proven efficacy against pyrethroid or other insecticide-resistant mosquitoes; (bb) prevents, mitigates, destroys, or repels pyrethroid or other insecticide-resistant mosquitoes, with a novel or unique mechanism or mode of action, different from other insecticides already registered by the Administrator for mosquito control; (cc) targets mosquitoes capable of spreading such diseases as Malaria, Dengue, Zika, Chikungunya, St. Louis encephalitis, Eastern encephalitis, Western encephalitis, West Nile encephalitis, Cache Valley encephalitis, LaCrosse encephalitis, and Yellow Fever; (dd) the registrant has submitted a global access plan that will be made publicly available for the active ingredient and that includes— (AA) manufacturing locations, including any licensed third-party manufacturers; (BB) distribution and procurement processes for malaria vector control programs in selected countries; and (CC) the prices for common quantities of the product; (ee) meets the appropriate guidelines as being effective in the primary vector control intervention areas, including insecticide-treated nets and indoor residual spray; (ff) is made accessible for use in— (AA) the United States, including territories or possessions of the United States; and (BB) countries where mosquito-borne diseases, such as malaria, are prevalent; (gg) meets registration requirements for human health and environmental effects, labeling, and presents no unreasonable adverse effects to the environment; (hh) broadens the adoption of integrated pest management strategies, such as insecticide resistance management, or makes those strategies more effective; (ii) is not contained in any pesticide product registered by the Administrator as of December 29, 2022 ; or (jj) does not contain as attested to by the registrant, an active ingredient approved in the 2-year period preceding the date of registration by any global stringent regulatory authority for the same uses, vectors, and applications. (II) Mosquito vector priority For each of fiscal years 2023 through 2027, the focus of the program shall be to incentivize the development of insecticides to control and prevent the spread of mosquitoes bearing diseases described in subclause (I)(cc). (III) Exception If the Administrator determines that there is a significant public health benefit, an active ingredient that is registered for agricultural use that is repurposed and submitted for control of mosquitoes and that otherwise meets the requirements of subclause (I) (excluding items (bb) and (jj)) as determined necessary by the Administrator, shall be considered a mosquito control product meeting the criteria specified in such subclause. (IV) Eligibility criteria modifications (aa) In general Beginning in fiscal year 2028, the Administrator shall review the program and recommend— (AA) modifications to the requirements described in subclause (I); and (BB) additional vectors to be included in the program, prioritizing vectors that pose the most significant population health risks. (bb) Public involvement In carrying out item (aa), the Administrator shall solicit the involvement of registrants, nongovernmental organizations, and governmental agencies engaged in vector-borne disease mitigation and treatment. (v) Redemption of vouchers To redeem a voucher, the holder shall— (I) notify the Administrator of the intent of the holder to submit a pesticide application with a voucher for expedited review not less than 90 days before the submission of the application; and (II) pay the applicable registration service fee under section 136w–8(b) of this title . (vi) Expedited review On redemption of a voucher, in furtherance of the purpose described in clause (iii), the Administrator shall expedite decision review times as follows: (I) 6 months less than the decision review time for Category R010, New Active Ingredient, Food use. (II) 6 months less than the decision review time for Category R020, New Active Ingredient, Food use; reduced risk. (III) 6 months less than the decision review time for Category R060, New Active Ingredient, Non-food use; outdoor. (IV) 6 months less than the decision review time for Category R110, New Active Ingredient, Non-food use; indoor. (V) 4 months less than the decision review time for Category R070, New Active Ingredient, Non-food use; outdoor; reduced risk. (VI) 2 months less than the decision review time for Category R120, New Active Ingredient, Non-food use; indoor; reduced risk. (vii) Reports Not later than September 30, 2025 , and not later than September 30 of each year thereafter, the Administrator shall issue a report on the program, including— (I) the number of submissions seeking a voucher; (II) the total time in review for each such submission; (III) the number of such vouchers awarded; (IV) the number of such vouchers redeemed; and (V) with respect to each such redeemed voucher— (aa) the decision review time for the pesticide application for which the voucher was redeemed; and (bb) the average standard decision review time for the applicable pesticide category. (C) Unused amounts Any unused amounts made available under this paragraph at the end of each fiscal year shall be made available to the Administrator to carry out other activities for which amounts in the Reregistration and Expedited Processing Fund are authorized to be used.