2016 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 (2016) |
| §379k–1. Electronic format for submissions |
|
(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. |
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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.) |
| United States Code, 2012 Edition, Supplement 4, 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 |
| 2016 |
| January 6, 2017 |
| No |
| standard |
| 126 Stat. 1123 |
| Public Law 112-144 |
