US Senate introduced the revised user fee bill (S 3187) and is expected to take up the bill early next week.
Page 294-95, "Drugs and Biologics . . . 24 months after issuance of a final guidance. . . submissions under subsection (b), (i) or (j) of section 505 . . . or subsection (a) or (k) of section 351 of the Public Health Service Act shall be submitted in such electronic format as specified . . . Exception . . . submissions described in section 561."
Page 295, "Devices . . . after the issuance of final guidance . . . pre-submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of this Act or section 351 of the Public Health Service Act, and any supplements to such pre-submissions or submissions, shall include an electronic copy of such pre-submissions or submissions."
Please see link below for a copy of the bill. See Subtitle C - Miscellaneous Provisions, Section 1123 Electronic submission of applications.
https://www.box.net/s/d4fd62225a6b4bb2cc28 -------------------------------------------
Antoinette Azevedo
President & CEO
e-SubmissionsSolutions.com
San Diego CA
United States
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