View all text of Part D [§ 379k - § 379l]
§ 379k–1. Electronic format for submissions
(a) Drugs and biologics
(1) In general
(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
(b) Devices
(1) In general
(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
(B) Draft guidance
The Secretary shall, not later than October 1, 2019, issue draft guidance providing for—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) Final guidance
(June 25, 1938, ch. 675, § 745A, as added Pub. L. 112–144, title XI, § 1136, July 9, 2012, 126 Stat. 1123; amended Pub. L. 115–52, title II, § 207, Aug. 18, 2017, 131 Stat. 1019.)