I 
110TH CONGRESS 
1ST SESSION H. R. 2273 
To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
deposit in the general fund of the Treasury of fees that are collected 
from manufacturers of drugs and devices under chapter VII of such 
Act, to terminate the authority of the Food and Drug Administration 
to negotiate with the manufacturers on particular uses of the fees, 
to establish a Center for Postmarket Drug Safety and Effectiveness, 
to establish additional authorities to ensure the safe and effective use 
of drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 10, 2007 
Mr. HINCHEY (for himself, Mr. STUPAK, and Mr. GRIJALVA) 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 
provide for the deposit in the general fund of the Treas-
ury of fees that are collected from manufacturers of 
drugs and devices under chapter VII of such Act, to 
terminate the authority of the Food and Drug Adminis-
tration to negotiate with the manufacturers on particular 
uses of the fees, to establish a Center for Postmarket 
Drug Safety and Effectiveness, to establish additional 
authorities to ensure the safe and effective use of drugs, 
and for other purposes. 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6652
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food and Drug Ad-
ministration Improvement Act of 2007’’. 
SEC. 2. FEES PAID BY MANUFACTURERS TO FOOD AND 
DRUG ADMINISTRATION; DEPOSIT IN GEN-
ERAL FUND OF TREASURY; DIRECT SPEND-
ING. 
(a) IN GENERAL.—Subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379f et seq.) is amended by adding at the end the fol-
lowing part: 
‘‘PART 5—MODIFICATIONS REGARDING USER-FEE 
PROGRAMS 
‘‘SEC. 740A. DEPOSIT OF FEES IN GENERAL FUND OF 
TREASURY; DIRECT SPENDING. 
‘‘(a) DEPOSIT IN GENERAL FUND.—Notwithstanding 
any other provision of this Act related to the collection 
of fees related to drugs, devices, or animal drugs, all such 
fees collected under this Act shall be deposited in the gen-
eral fund of the Treasury. 
‘‘(b) DIRECT SPENDING.— 
‘‘(1) IN GENERAL.—Notwithstanding any other 
provision of this Act related to the collection of such 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
fees, amounts are available to the Secretary for obli-
gation in accordance with the following: 
‘‘(A) The amount authorized to be appro-
priated under this Act for fees related to drugs 
is, 
to 
the 
extent 
described 
in 
section 
736(g)(2)(A)(ii) (as in effect on September 30, 
2007), available to the Secretary for obligation 
solely for the process for the review of human 
drug applications (within the meaning given to 
such term in section 735, as in effect on Sep-
tember 30, 2007). 
‘‘(B) The amount authorized to be appro-
priated under this Act for fees related to de-
vices is, to the extent described in section 
738(h)(2)(A)(ii) (as in effect on September 30, 
2007), available to the Secretary for obligation 
solely for the process for the review of device 
applications (within the meaning given to such 
terms in section 737, as in effect on September 
30, 2007). 
‘‘(C) The amount authorized to be appro-
priated under this Act for fees related to animal 
drugs is, to the extent described in section 
740(g)(2)(A)(ii) (as in effect on September 30, 
2007), available to the Secretary for obligation 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
solely for the process for the review of animal 
drug applications (within the meaning given to 
such terms in section 739, as in effect on Sep-
tember 30, 2007). 
‘‘(2) LIST OF MANDATORY APPROPRIATIONS.— 
The program of spending established in paragraph 
(1) shall be considered entitlement authority within 
the meaning of section 250(17) of the Balanced 
Budget and Emergency Deficit Control Act of 1985. 
‘‘SEC. 740B. TERMINATION OF AUTHORITY FOR NEGOTIA-
TIONS WITH MANUFACTURERS ON USE OF 
FEES. 
‘‘(a) IN GENERAL.—With respect to persons from 
whom fees related to drugs, devices, or animal drugs are 
collected under this Act and notwithstanding any other 
provision of this Act related to the collection of such fees: 
‘‘(1) On and after the date of the enactment of 
the Food and Drug Administration Improvement 
Act of 2007: 
‘‘(A) The Secretary may not enter into 
agreements with such persons on particular 
uses of the fees, including agreements on prior-
ities, performance goals, or other commitments 
relating to— 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
‘‘(i) review times for human drug ap-
plications or supplements (within the 
meaning given to such terms in section 
735, as in effect on September 30, 2007); 
‘‘(ii) review times for premarket appli-
cations, premarket reports, premarket noti-
fication submissions, or supplements (with-
in the meaning given to such terms in sec-
tion 737, as in effect on September 30, 
2007); or 
‘‘(iii) review times for animal drug ap-
plications or supplements (within the 
meaning given to such terms in section 
739, as in effect on September 30, 2007). 
‘‘(B) The Secretary may not otherwise ne-
gotiate understandings with such persons on 
particular uses of the fees. 
‘‘(2) On and after October 1, 2007: 
‘‘(A) Any such agreement or under-
standing that was in effect on the day before 
the date of the Food and Drug Administration 
Improvement Act of 2007 is terminated, includ-
ing agreements or understandings pursuant to 
letters referred to in section 502(4) of Public 
Law 107–188 (116 Stat. 688), section 101(3) 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS
of Public Law 107–250 (116 Stat. 1589), and 
section 2(3) of Public Law 108–130 (117 Stat. 
1361). 
‘‘(B) The Secretary is relieved of responsi-
bility for meeting any particular goals con-
cerning such review times that were established 
in such letters. 
‘‘(b) RULES
OF CONSTRUCTION.—Subsection (a) 
may not be construed— 
‘‘(1) as affecting the responsibility of the Sec-
retary to work toward the general goal of admin-
istering this Act efficiently, including the review of 
applications, reports, supplements and other submis-
sions referred to in subsection (a)(1)(A); or 
‘‘(2) as terminating requirements for the collec-
tion of fees under any other provision of this Act.’’. 
(b) APPLICABILITY.—Section 740A of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a) of this section, applies with respect to fiscal year 2008 
and subsequent fiscal years. 
SEC. 3. ESTABLISHMENT OF CENTER FOR POSTMARKET 
DRUG SAFETY AND EFFECTIVENESS. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 505B the following sections: 
VerDate Aug 31 2005 
22:10 May 11, 2007
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2273.IH
H2273
ycherry on PROD1PC64 with BILLS