Collapse to view only § 379k-1. Electronic format for submissions
§ 379k. Information system
The Secretary shall establish and maintain an information system to track the status and progress of each application or submission (including a petition, notification, or other similar form of request) submitted to the Food and Drug Administration requesting agency action.
(June 25, 1938, ch. 675, § 745, formerly § 741, as added Pub. L. 105–115, title IV, § 407(a), Nov. 21, 1997, 111 Stat. 2370; renumbered § 745, Pub. L. 110–316, title II, § 202(a), Aug. 14, 2008, 122 Stat. 3515.)
§ 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(B) Draft guidance
The Secretary shall, not later than October 1, 2019, issue draft guidance providing for—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.)
§ 379l. Education
(a) In general
The Secretary shall conduct training and education programs for the employees of the Food and Drug Administration relating to the regulatory responsibilities and policies established by this chapter, including programs for—
(1) scientific training;
(2) training to improve the skill of officers and employees authorized to conduct inspections under section 374 of this title;
(3) training to achieve product specialization in such inspections; and
(4) training in administrative process and procedure and integrity issues.
(b) Intramural fellowships and other training programs
(June 25, 1938, ch. 675, § 746, formerly § 742, as added Pub. L. 105–115, title IV, § 408(a), Nov. 21, 1997, 111 Stat. 2371; amended Pub. L. 110–85, title VI, § 601(c), Sept. 27, 2007, 121 Stat. 897; renumbered § 746, Pub. L. 110–316, title II, § 202(a), Aug. 14, 2008, 122 Stat. 3515.)