21 U.S. Code § 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) 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.)

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21 CFR - Food and Drugs

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

 

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