21 U.S. Code § 379k–1 - Electronic format for submissions

Status message

There is 1 Update Pending. Select the tab below to view.
(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) ofsection 355 of this title or subsection (a) or (k) ofsection 262 of title 42 shall be submitted in such electronic format as specified by the Secretary in such guidance.
(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
This subsection shall not apply to submissions described in section 360bbb of this title.
(b) Devices
(1) In general
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) 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.

Source

(June 25, 1938, ch. 675, § 745A, as added Pub. L. 112–144, title XI, § 1136,July 9, 2012, 126 Stat. 1123.)

The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013

An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.

21 USCDescription of ChangeSession YearPublic LawStatutes at Large
§ 379k-1new2012112-144 [Sec.] 1136 "745A"126 Stat. 1123

 

LII has no control over and does not endorse any external Internet site that contains links to or references LII.