21 USC 355 - Report

1 See References in Text note below.

regarding earlier submission of pediatric studies under sections 355a and 355c of this title and

Editorial Notes

References in Text

The FDA Reauthorization Act of 2017, referred to in subsec. (span)(11), (16), is Puspan. L. 115–52, Aug. 18, 2017, 131 Stat. 1005. Section 504 of the Act amended this section and section 355c of this title. For complete classification of this Act to the Code, see Short Title of 2017 Amendment note set out under section 301 of this title and Tables.

Section 505C–1 of the Federal Food, Drug, and Cosmetic Act, referred to in subsec. (span)(12), probably means section 505(c) of Puspan. 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.

Codification

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.

Amendments

2017—Subsec. (span)(11) to (16). Puspan. 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.”

Statutory Notes and Related Subsidiaries

Rule of Construction

Nothing in amendment by Puspan. 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 Puspan. L. 115–52, set out as a note under section 355c of this title.

Definition of “Secretary”

The term “Secretary” as used in this section means the Secretary of Health and Human Services, see section 503 of Puspan. L. 112–144, set out as a note under section 355a of this title.