; notification The Secretary shall— (aa) not later than 180 calendar days after receiving the request of a manufacturer under subclause (II), make a determination under such subclause with respect to the request; and (bb) not later than 30 calendar days after making such determination, notify the manufacturer of the determination. (IV) Monitoring utilization and outcomes A HCPCS code assigned under this clause shall allow for the reliable monitoring of utilization and outcomes of the novel medical product as described in clause (vi). (V) Effective date of code assignment If the Secretary makes a determination to assign a HCPCS code to a product under subclause (II), such code— (aa) may be assigned within the first quarter after the manufacturer files, with respect to such product, a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ), a biological product license application under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ), a premarket application under section 515(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e(c) ), a report under section 510(k) of such Act ( 21 U.S.C. 360k ), or a request for classification under section 513(f)(2) of such Act ( 21 U.S.C. 360c(f)(2) ); and (bb) may not take effect before the date the product is approved, cleared, or licensed by the Food and Drug Administration. (VI) Trade secrets and confidential information No information submitted under subclause (II) shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code. (iv) Novel medical product defined For purposes of this subparagraph, the term novel medical product means a drug, biological product, or medical device— (I) that has not been assigned a HCPCS code