; findings (a) Short title This title may be cited as the Over-the-Counter Monograph User Fee Act of 2018 . (b) Findings The Congress finds that the fees authorized by the amendments made in this title will be dedicated toward the regulation of monograph drugs under section 505G of the Federal, Food, Drug, and Cosmetic Act, as set forth in the goals identified for purposes of such section, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 202. Authority to access and use fees Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379f et seq.) is amended by adding at the end the following: 10 Fees Relating to monograph drugs 744L. Definitions For purposes of this part: (1) The term affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly— (A) one business entity controls, or has the power to control, the other business entity; or (B) a third party controls, or has power to control, both of the business entities. (2) the term contract manufacturing organization facility means a monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells such monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States. (3) The term costs of resources allocated for monograph drug activities means the expenses in connection with monograph drug activities for— (A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors; (B) management of information, and the acquisition, maintenance, and repair of computer resources