; and (2) codifies and expands regulations issued by the Food and Drug Administration under which the Food and Drug Administration may impose restrictions on distribution necessary to ensure a drug is safely used. (b) Contents of study In conducting the review under subsection (a), the Comptroller General shall examine each relevant element described in subsection (c) with respect to each of the following categories: (1) New drug applications under subsection (b) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ). (2) Abbreviated new drug applications under subsection (j) of such section. (3) Applications for the license of a biological product under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). (4) Single, shared system REMS, as described in section 505–1(i) of the Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(i) ). (5) Controlled substances as defined in section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ). (6) RISKMAPs or other risk management processes employed by the Food and Drug Administration. (c) Elements under review In conducting the review under subsection (a), the Comptroller General shall examine each of the following elements with respect to each relevant category described in subsection (b). (1) For each type of application, and by year, the number of REMS required, submitted, voluntarily submitted, modified, added, approved, or removed, and whether those REMS included elements to assure safe use, such as restricted distribution. (2) For each type of application, the number of REMS in effect at the time of the review and the number of years that each such REMS has been in effect at such time. (3) If and how the REMS program has improved drug safety, as compared to the time before the REMS program became effective, and how the Food and Drug Administration tracks such improvements. (4) The burdens associated with REMS, including burdens on patients, health care providers, generic drug manufacturers, brand drug manufacturers, pharmacies, and