; (iii) the cost to the Federal Government of manufacturing the applicable drug; (iv) the administrative costs of operating the Office; (v) the cost to acquire or manufacture applicable drugs under this section; and (vi) the impact of price on market competition for the applicable drug. (C) Acquiring right to manufacture and market The Office may acquire the rights to manufacture and market applicable drugs as authorized under this section. (D) Active pharmaceutical ingredients (i) In general The Office shall manufacture, or enter into contracts with entities to manufacture, an active pharmaceutical ingredient if— (I) the Office determines that such ingredient is not readily available from existing suppliers; (II) the manufacture of such ingredient would improve the ability of other entities to enter the market for the manufacture of generic drugs or otherwise expand the manufacture of generic drugs; or (III) the manufacture of such ingredient is necessary for the Office to carry out its duties under this section. (ii) Price determinations In determining what price at which to sell an active pharmaceutical ingredient under clause (i), the Office shall consider the cost to manufacture the ingredient, the administrative costs of the Office with respect to the ingredient, and the impact of such price on market competition for the ingredient. (5) Reports to congress The Director shall prepare and submit to the President, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, an annual report that includes— (A) an assessment of the major problems faced by patients in accessing affordable generic medications