The FDA Reauthorization Act of 2017, referred to in subsec. (b)(11), (16), is Pub. L. 115–52,
Section 505C–1 of the Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(12), probably means section 505(c) of Pub. L. 115–52, the FDA Reauthorization Act of 2017, which is set out as a note under section 355a of this title. The Federal Food, Drug, and Cosmetic Act does not contain a section 505C–1, and section 505(c) of the FDA Reauthorization Act of 2017 relates to the development and implementation of a plan for earlier submission of pediatric studies under sections 355a and 355c of this title and section 262(m) of Title 42, The Public Health and Welfare.
Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
2017—Subsec. (b)(11) to (16). Pub. L. 115–52 added pars. (11) to (16) and struck out former par. (11) which read as follows: “an assessment of the Secretary’s efforts to address the suggestions and options described in any prior report issued by the Comptroller General, Institute of Medicine, or the Secretary, and any subsequent reports, including recommendations therein, regarding the topics addressed in the reports under this section, including with respect to—
“(A) improving public access to information from pediatric studies conducted under such sections 355a and 355c of this title; and
“(B) improving the timeliness of pediatric studies and pediatric study planning under such sections 355a and 355c of this title.”
Nothing in amendment by Pub. L. 115–52 to limit the authority of the Secretary of Health and Human Services to issue written requests under section 355a of this title or section 262(m) of Title 42, The Public Health and Welfare, or to negotiate or implement amendments to such requests proposed by applicants, see section 504(e) of Pub. L. 115–52, set out as a note under section 355c of this title.
The term “Secretary” as used in this section means the Secretary of Health and Human Services, see section 503 of Pub. L. 112–144, set out as a note under section 355a of this title.