2018 US Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter VII - General Authority
Part D - Information and Education
Sec. 379k-1 - Electronic format for submissions
| 21 U.S.C. § 379k-1 (2018) |
| §379k–1. Electronic format for submissions |
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(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. 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. This subsection shall not apply to submissions described in section 360bbb of this title. 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. 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. 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. The Secretary shall, not later than October 1, 2019, issue draft guidance providing for— (i) any further standards for the submission by electronic format required under subparagraph (A); (ii) a timetable for the establishment by the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. 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. |
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(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.) |
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AMENDMENTS
2017—Subsec. (b)(3). Pub. L. 115–52 added par. (3). 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. |
| United States Code, 2018 Edition, Title 21 - FOOD AND DRUGS |
| Bills and Statutes |
| United States Code |
| Y 1.2/5: |
| Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER VII - GENERAL AUTHORITY Part D - Information and Education Sec. 379k-1 - Electronic format for submissions |
| section 379k-1 |
| 2018 |
| January 14, 2019 |
| No |
| standard |
| 126 Stat. 1123 131 Stat. 1019 |
| Public Law 112-144, Public Law 115-52 |
