; (B) the standards used to grant such approval, marketing authorization, or licensure; and (3) specifies the benefit-risk considerations that the Secretary uses to determine whether to approve, authorize for marketing, or license oral contraceptive drugs; and (4) details the Secretary’s efforts to facilitate the development of oral contraceptive drugs to be marketed without being subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(b)(1) ). (b) Labeling comprehension study (1) In general The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall complete a study on consumer comprehension of the labeling of oral contraceptive drugs. (2) Issues to be studied The study required by paragraph (1) shall address how the labeling of oral contraceptive drugs could be improved to increase consumer comprehension of the information conveyed in such labeling, including the proper use of such drugs and for whom such drugs are indicated. (3) Completion; publication The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— (A) not later than 1 year after the date of the enactment of this Act, complete the study required by paragraph (1); and (B) publish the results of such study in conjunction with the issuance of the guidance required by subsection (a). (c) Oral contraceptive drug defined In this section, the term oral contraceptive drug means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) ) that— (1) is used to prevent fertilization; (2) is administered orally; (3) is solely intended for routine use and not as an emergency contraceptive; (4) does not include any drug, substance, or combination of drugs or substances used after fertilization; and (5) does not include any drug or other method used to terminate a pregnancy.