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 corresponding fees made available for obligation and expenditure for the process for the review of device applications, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Innovation 

5 Never Stops Act of 2019’’. 


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1 SEC. 2. AUTHORITY DURING A LAPSE IN APPROPRIATIONS. 

2 Chapter VII of the Federal Food, Drug, and Cos3 metic Act is amended by inserting after section 738A (21 

4 U.S.C. 379j–1) the following: 

5 ‘‘SEC. 738B. AUTHORITY DURING A LAPSE IN APPROPRIA6 TIONS. 

7 ‘‘(a) ACCEPTANCE OF SUBMISSIONS AND REGISTRA8 TIONS; APPLICATION OF FEES.—During any period in 

9 which appropriations are not in effect for the Food and 

10 Drug Administration, the Secretary shall— 

11 ‘‘(1) accept a submission described in section 

12 738(a)(2) and a registration described in section 

13 738(a)(3) if an applicable fee has been submitted for 

14 such submission or registration; 

15 ‘‘(2) collect such fees in accordance with this 

16 part, notwithstanding any limitation with respect to 

17 the availability of appropriations in section 738; and 

18 ‘‘(3) obligate and expend such fees as may be 

19 so collected for the process for the review of device 

20 applications. 

21 ‘‘(b) APPLICATION OF PREVIOUSLY PAID FEES.— 

22 ‘‘(1) IN GENERAL.—During any period in which 

23 appropriations are not in effect for the Food and 

24 Drug Administration, the Secretary may obligate 

25 and expend for the process for the review of device 

26 applications any fees— 


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1 ‘‘(A) that were paid before such period 

2 began for submissions described in section 

3 738(a)(2), but with respect to which a submis4 sion has not been received; and 

5 ‘‘(B) that were paid before such period 

6 began for registrations described in section 

7 738(a)(3), but with respect to which a remitter 

8 has not been identified. 

9 ‘‘(2) SUBSEQUENTLY RECEIVED SUBMISSION OR

10 REGISTRATION.—Notwithstanding the obligation or 

11 expenditure of a fee for the process for the review 

12 of device applications pursuant to paragraph (1), 

13 such fee shall be deemed to have been paid for pur14 poses of section 738(f)(1) if the Secretary subse15 quently receives a submission or registration for 

16 such fee. 

17 ‘‘(c) EFFECT OF ENACTMENT OF SUBSEQUENT AP18 PROPRIATIONS.—Upon the enactment of an appropriation 

19 for fees under section 738 for a fiscal year, or a general 

20 appropriation bill providing appropriations for the Food 

21 and Drug Administration for a fiscal year without provi22 sion for such device fees, following a period during which 

23 a collection, obligation, or expenditure of fees occurs pur24 suant to subsection (a) or (b) for such fiscal year— 


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1 ‘‘(1) such collection, obligation, and expenditure 

2 shall be charged to such appropriation (if any); and 

3 ‘‘(2) amounts made available pursuant to such 

4 subsection shall not be available after the date of the 

5 enactment of such appropriation or general appro6 priation bill.’’. 

Æ 


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