; and (B) is or will be subject to an administrative order under this section of the Food and Drug Administration. (3) The term requestor refers to any person or group of persons marketing, manufacturing, processing, or developing a drug. . (b) GAO study Not later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall submit a study to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate addressing the effectiveness and overall impact of exclusivity under section 505G of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), and section 586C of such Act ( 21 U.S.C. 360fff–3 ), including the impact of such exclusivity on consumer access. Such study shall include— (1) an analysis of the impact of exclusivity under such section 505G for nonprescription drug products, including— (A) the number of nonprescription drug products that were granted exclusivity and the indication for which the nonprescription drug products were determined to be generally recognized as safe and effective; (B) whether the exclusivity for such drug products was granted for— (i) a new active ingredient (including any ester or salt of the active ingredient); or (ii) changes in the conditions of use of a drug, for which new human data studies conducted or sponsored by the requestor were essential; (C) whether, and to what extent, the exclusivity impacted the requestor’s or sponsor’s decision to develop the drug product; (D) an analysis of the implementation of the exclusivity provision in such section 505G, including— (i) the resources used by the Food and Drug Administration; (ii) the impact of such provision on innovation, as well as research and development in the nonprescription drug market; (iii) the impact of such provision on competition in the nonprescription drug market; (iv) the impact of such provision on consumer access to nonprescription drug products