21 U.S.C. § 379k–1: Electronic format for…

Summary

Certain drug and biological product filings must be given in an electronic format the Secretary sets out. That change can begin no earlier than 24 months after the Secretary issues final guidance following public notice and comment. The guidance can give a schedule for more detailed electronic rules and explain when waivers or exemptions are allowed. This rule does not apply to filings covered by section 360bbb. For medical devices, after the Secretary issues final guidance, pre‑submissions, submissions, and any supplements for certain device laws must include an electronic copy. The guidance can set the standards for that copy and rules for waivers. Later, on a date the Secretary names in final guidance, those device filings (and related appeals) must be submitted only in the specified electronic format. The Secretary was to issue draft guidance by October 1, 2019, and final guidance within 1 year after the public comment period on that draft closed.

Title 21, §379k–1

Food and Drugs, Source: USLM XML via OLRC

(a)Drugs and biologics

(1)In general

Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall be submitted in such electronic format as specified by the Secretary in such guidance.

(2)Guidance contents

In the guidance under paragraph (1), the Secretary may—

(A)provide a timetable for establishment by the Secretary of further standards for electronic submission as required by such paragraph; and

(B)set forth criteria for waivers of and exemptions from the requirements of this subsection.

(3)Exception

This subsection shall not apply to submissions described in section 360bbb of this title.

(b)Devices

(1)In general

Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb–3 of this title or section 262 of title 42, and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions.

(2)Guidance contents

In the guidance under paragraph (1), the Secretary may—

(A)provide standards for the electronic copy required under such paragraph; and

(B)set forth criteria for waivers of and exemptions from the requirements of this subsection.

(3)Presubmissions and submissions solely in electronic format

(A)In general

Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance.

(B)Draft guidance

The Secretary shall, not later than October 1, 2019, issue draft guidance providing for— (i)

(ii)a timetable for the establishment by the Secretary of such further standards; and

(iii)criteria for waivers of and exemptions from the requirements of this subsection.

(C)Final guidance

The Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2017—Subsec. (b)(3). Pub. L. 115–52 added par. (3).

Statutory Notes and Related Subsidiaries

Effective Date

of 2017 AmendmentAmendment by title II of Pub. L. 115–52, effective Oct. 1, 2017, except that fees under subpart 3 of part C of this subchapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

§379k–1 Electronic Format for Submissions