21 USC § 379k–1 - Electronic format for submissions | Title 21 - Food and Drugs | U.S. Code

USCPrelim is a preliminary release and may be subject to further revision before it is released again as a final version.

Current through Pub. L. 112-238. (See Public Laws for the current Congress.)

(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.

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This preliminary release may be subject to further revision before it is released again as a final version. As with other online versions of the Code, the U.S. Code Classification Tables should be consulted for the latest laws affecting the Code. Those using the USCPrelim should verify the text against the printed slip laws available from GPO (Government Printing Office), the laws as shown on THOMAS (a legislative service of the Library of Congress), and the final version of the Code when it becomes available.

Current through Pub. L. 112-173. (See Public Laws for the current Congress.)

(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.

This preliminary release may be subject to further revision before it is released again as a final version. As with other online versions of the Code, the U.S. Code Classification Tables should be consulted for the latest laws affecting the Code. Those using the USCPrelim should verify the text against the printed slip laws available from GPO (Government Printing Office), the laws as shown on THOMAS (a legislative service of the Library of Congress), and the final version of the Code when it becomes available.

Current through Pub. L. 112-173. (See Public Laws for the current Congress.)

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 Friday, May 3, 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.

How To Use

Multiple entries for a section are listed most recent first, within the section.

The Session Year indicates which session of Congress was responsible for the changes classified. The Congress number forms the first part of the Public Law number; each Congress has two sessions.

Abbreviations used in the Description of Change column:

An empty field implies a standard amendment.
"new" means a new section or new note, or all new text of an existing section or note.
"nt" means note.
"nt [tbl]" means note [table].
"prec" means preceding.
"fr" means a transfer from another section.
"to" means a transfer to another section.
"omitted" means the section is omitted.
"repealed" means the section is repealed.
"nt ed change" and "ed change" - See the Editorial Classification Change Table [pdf].

The Public Law field is linked to the development of the law in the Thomas system at the Library of Congress.

The Statutes at Large field is linked to the text of the law, in the context of its volume of the Statutes at Large, at the Government Printing Office. Please note that it takes a while for these pages to get posted, so for very recent legislation, you need to look at the "enrolled" version at the Thomas site.

The Statutes at Large references have been rendered in the format used as page numbers in the Public Law web pages to which we link, to facilitate copy-paste into browser "find on this (web) page" tools. We are still working on a more direct link facility.

For serious comparison work, we suggest copying all or a portion of the Public Law text into your favorite text editor, for convenient content traversal and window control.

Sections with change type "new" are a special case, still under development. All are now listed, at the title level only.

You will find that occassionally a specific update you notice in a Public Law listed in a classification table will already have made it into the Code. We assume this is an artifact of the LRC edit process. The LII does not edit the LRC content.

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General Reference

Refer to the LRC (Law Revision Council) for explanations about the US Code from the folks who put it all together.

You can look for information about what it is and is not, which titles are positive law, the schedule of Supplements, etc. Under download you can find the source data we use here (GPO locator files), as well as, PDF files that look just like the paper books (these may be rather large).

Refer to the Thomas site for changes that have not yet made it into the classification tables.

21 USC	Description of Change	Session Year	Public Law	Statutes at Large
§ 379k-1	new	2012	112-144 [Sec.] 1136 "745A"	126 Stat. 1123

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

21 USC § 379k–1 - Electronic format for submissions

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