Medical Innovation Never Stops Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 1362 To amend the Federal Food, Drug, and Cosmetic Act to allow, during a lapse in appropriations, acceptance of certain device submissions and registrations with the corresponding fees made available for obligation and expenditure for the process for the review of device applications, and for other purposes. IN THE HOUSE OF REPRESENTATIVES FEBRUARY 26, 2019 Mr. EMMER introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to allow, during a lapse in appropriations, acceptance of certain device submissions and registrations with the cor- responding fees made available for obligation and expend- iture for the process for the review of device applications, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medical Innovation 4 Never Stops Act of 2019’’. 5 VerDate Sep 11 2014 21:36 Mar 05, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1362.IH H1362 kjohnson on DSK79L0C42 with BILLS 2 •HR 1362 IH SEC. 2. AUTHORITY DURING A LAPSE IN APPROPRIATIONS. 1 Chapter VII of the Federal Food, Drug, and Cos- 2 metic Act is amended by inserting after section 738A (21 3 U.S.C. 379j–1) the following: 4 ‘‘SEC. 738B. AUTHORITY DURING A LAPSE IN APPROPRIA- 5 TIONS. 6 ‘‘(a) ACCEPTANCE OF SUBMISSIONS AND REGISTRA- 7 TIONS; APPLICATION OF FEES.—During any period in 8 which appropriations are not in effect for the Food and 9 Drug Administration, the Secretary shall— 10 ‘‘(1) accept a submission described in section 11 738(a)(2) and a registration described in section 12 738(a)(3) if an applicable fee has been submitted for 13 such submission or registration; 14 ‘‘(2) collect such fees in accordance with this 15 part, notwithstanding any limitation with respect to 16 the availability of appropriations in section 738; and 17 ‘‘(3) obligate and expend such fees as may be 18 so collected for the process for the review of device 19 applications. 20 ‘‘(b) APPLICATION OF PREVIOUSLY PAID FEES.— 21 ‘‘(1) IN GENERAL.—During any period in which 22 appropriations are not in effect for the Food and 23 Drug Administration, the Secretary may obligate 24 and expend for the process for the review of device 25 applications any fees— 26 VerDate Sep 11 2014 21:36 Mar 05, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1362.IH H1362 kjohnson on DSK79L0C42 with BILLS 3 •HR 1362 IH ‘‘(A) that were paid before such period 1 began for submissions described in section 2 738(a)(2), but with respect to which a submis- 3 sion has not been received; and 4 ‘‘(B) that were paid before such period 5 began for registrations described in section 6 738(a)(3), but with respect to which a remitter 7 has not been identified. 8 ‘‘(2) SUBSEQUENTLY RECEIVED SUBMISSION OR 9 REGISTRATION.—Notwithstanding the obligation or 10 expenditure of a fee for the process for the review 11 of device applications pursuant to paragraph (1), 12 such fee shall be deemed to have been paid for pur- 13 poses of section 738(f)(1) if the Secretary subse- 14 quently receives a submission or registration for 15 such fee. 16 ‘‘(c) EFFECT OF ENACTMENT OF SUBSEQUENT AP- 17 PROPRIATIONS.—Upon the enactment of an appropriation 18 for fees under section 738 for a fiscal year, or a general 19 appropriation bill providing appropriations for the Food 20 and Drug Administration for a fiscal year without provi- 21 sion for such device fees, following a period during which 22 a collection, obligation, or expenditure of fees occurs pur- 23 suant to subsection (a) or (b) for such fiscal year— 24 VerDate Sep 11 2014 21:36 Mar 05, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1362.IH H1362 kjohnson on DSK79L0C42 with BILLS 4 •HR 1362 IH ‘‘(1) such collection, obligation, and expenditure 1 shall be charged to such appropriation (if any); and 2 ‘‘(2) amounts made available pursuant to such 3 subsection shall not be available after the date of the 4 enactment of such appropriation or general appro- 5 priation bill.’’. 6 Æ VerDate Sep 11 2014 21:36 Mar 05, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H1362.IH H1362 kjohnson on DSK79L0C42 with BILLS