datamatters24/research-document-archive huggingface dataset:
HR 3580 RDS
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 Amendments Act of 2007’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 
Sec. 101. Short title; references in title; finding. 
Sec. 102. Definitions. 
Sec. 103. Authority to assess and use drug fees. 
Sec. 104. Fees relating to advisory review of prescription-drug television adver-
tising. 
Sec. 105. Reauthorization; reporting requirements. 
Sec. 106. Sunset dates. 
Sec. 107. Effective date. 
Sec. 108. Savings clause. 
Sec. 109. Technical amendment; conforming amendment. 
TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007 
Sec. 201. Short title; references in title; finding. 
Subtitle A—Fees Related to Medical Devices 
Sec. 211. Definitions. 
Sec. 212. Authority to assess and use device fees. 
Sec. 213. Reauthorization; reporting requirements. 
Sec. 214. Savings clause. 
Sec. 215. Additional authorization of appropriations for postmarket safety in-
formation. 
Sec. 216. Effective date. 
Sec. 217. Sunset clause. 
Subtitle B—Amendments Regarding Regulation of Medical Devices 
Sec. 221. Extension of authority for third party review of premarket notifica-
tion. 
Sec. 222. Registration. 
Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propa-
gated, and compounded by registrants; statements; accom-
panying disclosures. 
Sec. 224. Electronic registration and listing. 
Sec. 225. Report by Government Accountability Office. 
Sec. 226. Unique device identification system. 
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(ii) by inserting before the period at 
the end the following: ‘‘or withdrawn with-
out a waiver before filing’’; 
(B) by redesignating subparagraphs (E) 
and (F) as subparagraphs (F) and (G), respec-
tively; and 
(C) by inserting after subparagraph (D) 
the following: 
‘‘(E) 
FEES
FOR
APPLICATIONS
PRE-
VIOUSLY REFUSED FOR FILING OR WITHDRAWN 
BEFORE FILING.—A human drug application or 
supplement that was submitted but was refused 
for filing, or was withdrawn before being ac-
cepted or refused for filing, shall be subject to 
the full fee under subparagraph (A) upon being 
resubmitted or filed over protest, unless the fee 
is waived or reduced under subsection (d).’’; 
and 
(3) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘sub-
paragraph (B)’’ and inserting ‘‘subparagraphs 
(B) and (C)’’; and 
(B) by adding at the end the following: 
‘‘(C) SPECIAL RULES FOR POSITRON EMIS-
SION TOMOGRAPHY DRUGS.— 
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‘‘(i) IN
GENERAL.—Except as pro-
vided in clause (ii), each person who is 
named as the applicant in an approved 
human drug application for a positron 
emission tomography drug shall be subject 
under subparagraph (A) to one-sixth of an 
annual establishment fee with respect to 
each such establishment identified in the 
application as producing positron emission 
tomography drugs under the approved ap-
plication. 
‘‘(ii) EXCEPTION FROM ANNUAL ES-
TABLISHMENT FEE.—Each person who is 
named as the applicant in an application 
described in clause (i) shall not be assessed 
an annual establishment fee for a fiscal 
year if the person certifies to the Sec-
retary, at a time specified by the Secretary 
and using procedures specified by the Sec-
retary, that— 
‘‘(I) the person is a not-for-profit 
medical center that has only 1 estab-
lishment 
for 
the 
production 
of 
positron emission tomography drugs; 
and 
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‘‘(II) at least 95 percent of the 
total number of doses of each positron 
emission tomography drug produced 
by such establishment during such fis-
cal year will be used within the med-
ical center. 
‘‘(iii) DEFINITION.—For purposes of 
this subparagraph, the term ‘positron 
emission tomography drug’ has the mean-
ing given to the term ‘compounded 
positron emission tomography drug’ in sec-
tion 201(ii), except that paragraph (1)(B) 
of such section shall not apply.’’. 
(b) FEE REVENUE AMOUNTS.—Section 736(b) (21 
U.S.C. 379h(b)) is amended to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.—For each of the fiscal years 
2008 through 2012, fees under subsection (a) shall, 
except as provided in subsections (c), (d), (f), and 
(g), be established to generate a total revenue 
amount under such subsection that is equal to the 
sum of— 
‘‘(A) $392,783,000; and 
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‘‘(B) an amount equal to the modified 
workload adjustment factor for fiscal year 2007 
(as determined under paragraph (3)). 
‘‘(2) TYPES
OF
FEES.—Of the total revenue 
amount determined for a fiscal year under para-
graph (1)— 
‘‘(A) one-third shall be derived from fees 
under subsection (a)(1) (relating to human 
drug applications and supplements); 
‘‘(B) one-third shall be derived from fees 
under subsection (a)(2) (relating to prescription 
drug establishments); and 
‘‘(C) one-third shall be derived from fees 
under subsection (a)(3) (relating to prescription 
drug products). 
‘‘(3) MODIFIED WORKLOAD ADJUSTMENT FAC-
TOR
FOR
FISCAL
YEAR 2007.—For purposes of 
paragraph (1)(B), the Secretary shall determine the 
modified workload adjustment factor by determining 
the dollar amount that results from applying the 
methodology that was in effect under subsection 
(c)(2) for fiscal year 2007 to the amount 
$354,893,000, except that, with respect to the por-
tion of such determination that is based on the 
change in the total number of commercial investiga-
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tional new drug applications, the Secretary shall 
count the number of such applications that were ac-
tive during the most recent 12-month period for 
which data on such submissions is available. 
‘‘(4) ADDITIONAL FEE REVENUES FOR DRUG 
SAFETY.— 
‘‘(A) IN GENERAL.—For each of the fiscal 
years 2008 through 2012, paragraph (1)(A) 
shall be applied by substituting the amount de-
termined 
under 
subparagraph 
(B) 
for 
‘$392,783,000’. 
‘‘(B) AMOUNT DETERMINED.—For each of 
the fiscal years 2008 through 2012, the amount 
determined under this subparagraph is the sum 
of— 
‘‘(i) $392,783,000; plus 
‘‘(ii)(I) 
for 
fiscal 
year 
2008, 
$25,000,000; 
‘‘(II) 
for 
fiscal 
year 
2009, 
$35,000,000; 
‘‘(III) 
for 
fiscal 
year 
2010, 
$45,000,000; 
‘‘(IV) 
for 
fiscal 
year 
2011, 
$55,000,000; and 
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‘‘(V) 
for 
fiscal 
year 
2012, 
$65,000,000.’’. 
(c) ADJUSTMENTS TO FEES.— 
(1) 
INFLATION
ADJUSTMENT.—Section 
736(c)(1) (21 U.S.C. 379h(c)(1)) is amended— 
(A) in the matter preceding subparagraph 
(A), by striking ‘‘The revenues established in 
subsection (b)’’ and inserting ‘‘For fiscal year 
2009 and subsequent fiscal years, the revenues 
established in subsection (b)’’; 
(B) in subparagraph (A), by striking ‘‘or’’ 
at the end; 
(C) in subparagraph (B), by striking the 
period at the end and inserting ‘‘, or’’; 
(D) by inserting after subparagraph (B) 
the following: 
‘‘(C) the average annual change in the 
cost, per full-time equivalent position of the 
Food and Drug Administration, of all personnel 
compensation and benefits paid with respect to 
such positions for the first 5 years of the pre-
ceding 6 fiscal years.’’; and 
(E) in the matter following subparagraph 
(C) (as added by subparagraph (D)), by strik-
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ing ‘‘fiscal year 2003’’ and inserting ‘‘fiscal 
year 2008’’. 
(2) 
WORKLOAD
ADJUSTMENT.—Section 
736(c)(2) (21 U.S.C. 379h(c)(2)) is amended— 
(A) in the matter preceding subparagraph 
(A), by striking ‘‘Beginning with fiscal year 
2004,’’ and inserting ‘‘For fiscal year 2009 and 
subsequent fiscal years,’’; 
(B) in subparagraph (A), in the first sen-
tence— 
(i) by striking ‘‘human drug applica-
tions,’’ and inserting ‘‘human drug applica-
tions (adjusted for changes in review ac-
tivities, as described in the notice that the 
Secretary is required to publish in the 
Federal Register under this subpara-
graph),’’; 
(ii) by striking ‘‘commercial investiga-
tional new drug applications,’’; and 
(iii) by inserting before the period the 
following: ‘‘, and the change in the total 
number of active commercial investiga-
tional new drug applications (adjusted for 
changes in review activities, as so de-
scribed) during the most recent 12-month 
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period for which data on such submissions 
is available’’; 
(C) in subparagraph (B), by adding at the 
end the following: ‘‘Any adjustment for changes 
in review activities made in setting fees and rev-
enue amounts for fiscal year 2009 may not re-
sult in the total workload adjustment being 
more than 2 percentage points higher than it 
would have been in the absence of the adjust-
ment for changes in review activities.’’; and 
(D) by adding at the end the following: 
‘‘(C) The Secretary shall contract with an 
independent accounting firm to study the ad-
justment for changes in review activities applied 
in setting fees and revenue amounts for fiscal 
year 2009 and to make recommendations, if 
warranted, for future changes in the method-
ology for calculating the adjustment. After re-
view of the recommendations, the Secretary 
shall, if warranted, make appropriate changes 
to the methodology, and the changes shall be ef-
fective for each of the fiscal years 2010 through 
2012. The Secretary shall not make any adjust-
ment for changes in review activities for any 
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fiscal year after 2009 unless such study has 
been completed.’’. 
(3) RENT AND RENT-RELATED COST ADJUST-
MENT.—Section 736(c) (21 U.S.C. 379h(c)) is 
amended— 
(A) by redesignating paragraphs (3), (4), 
and (5) as paragraphs (4), (5), and (6), respec-
tively; and 
(B) by inserting after paragraph (2) the 
following: 
‘‘(3) RENT AND RENT-RELATED COST ADJUST-
MENT.—For fiscal year 2010 and each subsequent 
fiscal year, the Secretary shall, before making ad-
justments under paragraphs (1) and (2), decrease 
the fee revenue amount established in subsection (b) 
if actual costs paid for rent and rent-related ex-
penses for the preceding fiscal year are less than es-
timates made for such year in fiscal year 2006. Any 
reduction made under this paragraph shall not ex-
ceed the amount by which such costs fall below the 
estimates made in fiscal year 2006 for such fiscal 
year, and shall not exceed $11,721,000 for any fiscal 
year.’’. 
(4) FINAL YEAR ADJUSTMENT.—Paragraph (4) 
of section 736(c) (21 U.S.C. 379h(c)), as redesig-
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nated by paragraph (3)(A), is amended to read as 
follows: 
‘‘(4) FINAL YEAR ADJUSTMENT.— 
‘‘(A) INCREASE IN FEES.—For fiscal year 
2012, the Secretary may, in addition to adjust-
ments under this paragraph and paragraphs 
(1), (2), and (3), further increase the fee reve-
nues and fees established in subsection (b) if 
such an adjustment is necessary to provide for 
not more than 3 months of operating reserves 
of carryover user fees for the process for the re-
view of human drug applications for the first 3 
months of fiscal year 2013. If such an adjust-
ment is necessary, the rationale for the amount 
of the increase shall be contained in the annual 
notice establishing fee revenues and fees for fis-
cal year 2012. If the Secretary has carryover 
balances for such process in excess of 3 months 
of such operating reserves, the adjustment 
under this subparagraph shall not be made. 
‘‘(B) DECREASE IN FEES.— 
‘‘(i) IN
GENERAL.—For fiscal year 
2012, the Secretary may, in addition to 
adjustments under this paragraph and 
paragraphs (1), (2), and (3), decrease the 
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‘‘(A) The drug meets the public health re-
quirements contained in this Act as such re-
quirements are applied to requests for waivers 
for product and establishment fees. 
‘‘(B) The drug is owned or licensed and is 
marketed by a company that had less than 
$50,000,000 in gross worldwide revenue during 
the previous year. 
‘‘(2) EVIDENCE
OF
QUALIFICATION.—An ex-
emption under paragraph (1) applies with respect to 
a drug only if the applicant involved submits a cer-
tification that its gross annual revenues did not ex-
ceed $50,000,000 for the preceding 12 months be-
fore the exemption was requested.’’. 
(g) CONFORMING AMENDMENT.—Section 736(a) (21 
U.S.C. 379h(a)) is amended in paragraphs (1)(A)(i), 
(1)(A)(ii), (2)(A), and (3)(A) by striking ‘‘(c)(4)’’ each 
place such term appears and inserting ‘‘(c)(5)’’. 
(h) TECHNICAL AMENDMENT.— 
(1) 
AMENDMENT.—Section 
736(g)(1) 
(21 
U.S.C. 379h(g)(1)) is amended by striking the first 
sentence and inserting the following: ‘‘Fees author-
ized under subsection (a) shall be collected and 
available for obligation only to the extent and in the 
amount provided in advance in appropriations Acts. 
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‘‘(v) Data collected under subpara-
graph (C)(v). 
‘‘(vi) All other information that is re-
quired to be reported under this title by in-
stitutions receiving financial assistance or 
procurement contracts under this title. 
‘‘(C) ADMINISTRATION AND USE OF DATA-
BASE.—The Secretary shall— 
‘‘(i) ensure that the database uses ac-
curate data structures and taxonomies to 
allow for easy cross-referencing, compiling, 
and reporting of numerous data elements; 
‘‘(ii) ensure that the database pro-
vides for filtering of data content to allow 
users to screen for the events most rel-
evant to identifying waste, fraud, and 
abuse, such as management changes and 
material corporate events; 
‘‘(iii) ensure that the database pro-
vides geospatial analysis capabilities; 
‘‘(iv) make the database available to 
the Comptroller General of the United 
States and to the Special Inspector Gen-
eral and the Congressional Oversight Panel 
established under sections 121 and 125,
respectively, to provide them with access to 
current information on the status of the 
funds distributed under this title, including 
funds distributed through procurement 
contracts; 
‘‘(v) collect from each Federal agency 
on at least a daily basis all data that is rel-
evant to determining the effectiveness of 
the Troubled Asset Relief Program in 
stimulating prudent lending and strength-
ening bank capital, including regulatory fil-
ings and data generated by the use of in-
ternal models, financial models, and ana-
lytics; and 
‘‘(vi) compare the data in the data-
base with other appropriate data to iden-
tify activities inconsistent with the goals of 
this title. 
‘‘(2) MEETING TARP GOALS.— 
‘‘(A) DETERMINATION
BY
SECRETARY; 
RECOMMENDATIONS.—If the Secretary deter-
mines that a recipient’s use of funds distributed 
under this title is not meeting the goals of this 
title, the Secretary shall, in coordination with 
the appropriate Federal agencies, develop rec-
‘‘(A) the date on which the applicable regular 
appropriation bill for such fiscal year becomes law 
(whether or not such law provides for such project 
or activity) or a continuing resolution making appro-
priations becomes law, as the case may be; or 
‘‘(B) the last day of such fiscal year. 
‘‘(b) An appropriation or funds made available, or au-
thority granted, for a project or activity for any fiscal year 
pursuant to this section shall be subject to the terms and 
conditions imposed with respect to the appropriation made 
or funds made available for the preceding fiscal year, or 
authority granted for such project or activity under cur-
rent law. 
‘‘(c) Appropriations and funds made available, and 
authority granted, for any project or activity for any fiscal 
year pursuant to this section shall cover all obligations or 
expenditures incurred for such project or activity during 
the portion of such fiscal year for which this section ap-
plies to such project or activity. 
‘‘(d) Expenditures made for a project or activity for 
any fiscal year pursuant to this section shall be charged 
to the applicable appropriation, fund, or authorization 
whenever a regular appropriation bill or a joint resolution 
making continuing appropriations until the end of a fiscal 
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and maintain an integrated technology and training pro-
gram that provides— 
(1) a secure system enabling online communica-
tion and collaboration by ICAC task forces, Federal 
law enforcement agencies, and other State and local 
law enforcement agencies regarding ongoing inves-
tigations; 
(2) a secure, online system for resolving case 
conflicts, for use by ICAC task forces, Federal law 
enforcement agencies, and other State and local law 
enforcement agencies; 
(3) a secure data storage and analysis system 
for use by ICAC task forces, Federal law enforce-
ment agencies, and other State and local law en-
forcement agencies; 
(4) guidelines for the use of such Data Network 
by Federal, State, and local law enforcement agen-
cies; and 
(5) training and technical assistance on the use 
of such Data Network by Federal, State, and local 
law enforcement agencies. 
(d) ICAC DATA NETWORK STEERING COMMITTEE.— 
The Attorney General shall establish an ICAC Data Net-
work Center Steering Committee to provide guidance to 
the Center relating to the program under subsection (c),
‘‘(B) a certification for such country under 
paragraph (2)(B). 
‘‘(2) CERTIFICATION.— 
‘‘(A) FOREIGN
FACILITY.—Each foreign 
facility seeking to import food into the United 
States may obtain a certification by the Sec-
retary stating that the facility maintains a pro-
gram using reliable analytical methods to en-
sure compliance with all the standards referred 
to in subsection (a). 
‘‘(B) FOREIGN COUNTRY.—A foreign coun-
try may obtain a certification by the Secretary 
stating that— 
‘‘(i) the country has in effect and is 
enforcing food safety standards at least as 
protective of food safety as the standards 
applicable to food in the United States; 
and 
‘‘(ii) the country has a program in ef-
fect to monitor and enforce its food safety 
standards with respect to food being ex-
ported from such country to the United 
States. 
‘‘(3) PERIODIC REVIEW.—The Secretary shall 
periodically review certifications under paragraph (2) 
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$42,356,145 (2004 dollars) for projects referred to in 
paragraphs (20) through (38) of subsection (a)’’. 
Passed the House of Representatives June 5, 2007. 
Attest: 
Clerk.
110TH CONGRESS 
1ST SESSION 
H. R. 361 
AN ACT 
To amend the Lower Rio Grande Valley Water Re-
sources Conservation and Improvement Act of 
2000 to authorize additional projects and activi-
ties under that Act, and for other purposes.
138 
(B) by striking ‘‘(P)’’ and inserting ‘‘(R)’’; 
(2) in paragraph (2)— 
(A) by striking ‘‘$26,600,000, but not in 
excess 
of 
$28,600,000’’ 
and 
inserting 
‘‘$54,500,000, 
but 
not 
in 
excess 
of 
$58,500,000’’; and 
(B) by striking ‘‘subparagraphs (Q) and 
(R)’’ and inserting ‘‘subparagraphs (S) through 
(Y)’’; and 
(3) in paragraph (3)— 
(A) by striking ‘‘$28,600,000’’ and insert-
ing ‘‘$58,500,000’’; and 
(B) by striking ‘‘(R)’’ and inserting ‘‘(Y)’’. 
(f) HOLD HARMLESS.—Section 326(g) (20 U.S.C. 
1063b(g)) is amended by striking ‘‘1998’’ each place it 
appears and inserting ‘‘2006’’. 
SEC. 304. TECHNICAL AMENDMENTS. 
(a) AMENDMENTS.—Title III is further amended— 
(1) in section 311(c) (20 U.S.C. 1057(c))— 
(A) 
by 
redesignating 
paragraphs 
(7) 
through (12) as paragraphs (8) through (13), 
respectively; and 
(B) by inserting after paragraph (6) the 
following: 
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the Secretary determines that the person has 
provided incorrect information to support any 
claim for preferential tariff treatment that has 
been made with respect to any such good; or 
(B) the textile or apparel good for which a 
claim of preferential tariff treatment has been 
made that is the subject of a verification under 
subsection (a)(1) regarding a claim described in 
subsection (a)(2)(B), if the Secretary deter-
mines that a person has provided incorrect in-
formation to support that claim; 
(3) detention of any textile or apparel good ex-
ported or produced by the person that is the subject 
of a verification under subsection (a)(1) regarding 
compliance described in subsection (a)(2)(A) or a 
claim described in subsection (a)(2)(B), if the Sec-
retary determines that there is insufficient informa-
tion to determine the country of origin of any such 
good; and 
(4) denial of entry into the United States of 
any textile or apparel good exported or produced by 
the person that is the subject of a verification under 
subsection (a)(1) regarding compliance described in 
subsection (a)(2)(A) or a claim described in sub-
section (a)(2)(B), if the Secretary determines that 
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140 
(B) by inserting after subparagraph (F) 
the following: 
‘‘(G) education or counseling services de-
signed to improve the financial literacy and eco-
nomic literacy of students and, as appropriate, 
their parents;’’; and 
(C) in subparagraph (N), as redesignated 
by subparagraph (A), by striking ‘‘subpara-
graphs (A) through (K)’’ and inserting ‘‘sub-
paragraphs (A) through (M)’’; 
(6) 
in 
section 
317(c)(2) 
(20 
U.S.C. 
1059d(c)(2)), by inserting after subparagraph (I) 
(as added by section 302(a)(6) of this Act) the fol-
lowing: 
‘‘(J) education or counseling services de-
signed to improve the financial literacy and eco-
nomic literacy of students and, as appropriate, 
their parents.’’; 
(7) in section 323(a) (20 U.S.C. 1062(a))— 
(A) by striking ‘‘section 360(a)(2)’’ and in-
serting ‘‘section 399(a)(2)(A)’’; 
(B) 
by 
redesignating 
paragraphs 
(7) 
through (12) as paragraphs (8) through (13), 
respectively; and 
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