§379k–1 — Title 21 Food and Drugs | U.S. Code

Summary

Send certain drug and device applications in electronic form once the Secretary issues final guidance. For some drug filings listed in the law, the rule takes effect no earlier than 24 months after that final guidance. The Secretary will tell how the electronic files must look and can set a timetable for more rules. The Secretary can also allow waivers or exemptions. The rule does not apply to filings covered by section 360bbb. For many device pre-submissions and submissions (and related appeals), an electronic copy must be included once final guidance is out. Later, the Secretary will set a date when those device filings must be submitted only in the electronic format. The Secretary had to publish draft device guidance by October 1, 2019, and must issue final guidance within one year after public comments close.

Title 21, §379k–1

Food and Drugs — Source: USLM XML via OLRC

(a)(1)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)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)This subsection shall not apply to submissions described in section 360bbb of this title.

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)The Secretary shall, not later than October 1, 2019, issue draft guidance providing for—

(i)any further standards for the submission by electronic format required under subparagraph (A);

(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)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