datamatters24/research-document-archive huggingface dataset:
705 
(8) $241,044 from ‘‘U.S. Customs and Border 
Protection—Air and Marine Interdiction, Operations, 
Maintenance, and Procurement’’; 
(9) $15,807,298 from ‘‘Coast Guard—Operation 
Expenses’’; 
(10) $746,434 from ‘‘Coast Guard—Reserve 
Training’’; 
(11) $310,872 from ‘‘Coast Guard—Acquisition, 
Construction and Improvements’’; 
(12) $8,340,572 from ‘‘United States Secret 
Service—Salaries and Expenses’’; 
(13) $332,309 from ‘‘Federal Emergency Man-
agement Agency—State and Local Programs’’; 
(14) $48,524 from ‘‘Federal Emergency Manage-
ment Agency—United States Fire Administration’’; 
(15) $1,275,569 from ‘‘Federal Emergency Man-
agement Agency—Management and Administration’’; 
(16) $59,453 from ‘‘Office of Health Affairs’’; 
(17) $625,696 from ‘‘United States Citizenship 
and Immigration Services—Salaries and Expenses’’; 
(18) $372,881 from ‘‘Federal Law Enforcement 
Training Center—Salaries and Expenses’’; 
(19) $1,094,894 from ‘‘Transportation Security 
Agency—Aviation Security’’; and
(i) in the heading of subparagraph 
(B), by inserting after ‘‘EXCEPTION’’ the 
following: ‘‘FOR
CERTAIN
PRESCRIPTION 
DRUG PRODUCTS’’; and 
(ii) by striking ‘‘A prescription drug 
product shall not be assessed a fee’’ and 
inserting ‘‘A prescription drug program fee 
shall not be assessed for a prescription 
drug product’’; and 
(L) by adding at the end of such para-
graph (2) the following: 
‘‘(C) 
LIMITATION.—A 
person 
who 
is 
named as the applicant in an approved human 
drug application shall not be assessed more 
than 5 prescription drug program fees for a fis-
cal year for prescription drug products identi-
fied in such approved human drug applica-
tion.’’. 
(2) CONFORMING AMENDMENT.—Subparagraph 
(C) of section 740(a)(3) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–12(a)(3)) is 
amended to read as follows: 
‘‘(C) LIMITATION.—An establishment shall 
be assessed only one fee per fiscal year under 
this section.’’. 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(b) FEE REVENUE AMOUNTS.—Subsection (b) of sec-
tion 736 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379h) is amended to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.—For each of the fiscal years 
2018 through 2022, 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) the annual base revenue for the fiscal 
year (as determined under paragraph (3)); 
‘‘(B) the dollar amount equal to the infla-
tion adjustment for the fiscal year (as deter-
mined under subsection (c)(1)); 
‘‘(C) the dollar amount equal to the capac-
ity planning adjustment for the fiscal year (as 
determined under subsection (c)(2)); 
‘‘(D) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
applicable (as determined under subsection 
(c)(3)); 
‘‘(E) the dollar amount equal to the addi-
tional direct cost adjustment for the fiscal year 
(as determined under subsection (c)(4)); and 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
I 
115TH CONGRESS 
1ST SESSION H. R. 2430 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
the user-fee programs for prescription drugs, medical devices, generic 
drugs, and biosimilar biological products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 16, 2017 
Mr. WALDEN (for himself, Mr. PALLONE, Mr. BURGESS, and Mr. GENE 
GREEN of Texas) 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 
revise and extend the user-fee programs for prescription 
drugs, medical devices, generic drugs, and biosimilar bio-
logical products, and for other purposes. 
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 ‘‘FDA Reauthorization 
Act of 2017’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6211
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
Sec. 2. Table of contents. 
TITLE I—FEES RELATING TO DRUGS 
Sec. 101. Short title; finding. 
Sec. 102. Authority to assess and use drug fees. 
Sec. 103. Reauthorization; reporting requirements. 
Sec. 104. Sunset dates. 
Sec. 105. Effective date. 
Sec. 106. Savings clause. 
TITLE II—FEES RELATING TO DEVICES 
Sec. 201. Short title; findings. 
Sec. 202. Definitions. 
Sec. 203. Authority to assess and use device fees. 
Sec. 204. Reauthorization; reporting requirements. 
Sec. 205. Conformity assessment pilot program. 
Sec. 206. Reauthorization of review. 
Sec. 207. Electronic format for submissions. 
Sec. 208. Savings clause. 
Sec. 209. Effective date. 
Sec. 210. Sunset clause. 
TITLE III—FEES RELATING TO GENERIC DRUGS 
Sec. 301. Short title; finding. 
Sec. 302. Definitions. 
Sec. 303. Authority to assess and use human generic drug fees. 
Sec. 304. Reauthorization; reporting requirements. 
Sec. 305. Sunset dates. 
Sec. 306. Effective date. 
Sec. 307. Savings clause. 
TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL 
PRODUCTS 
Sec. 401. Short title; finding. 
Sec. 402. Definitions. 
Sec. 403. Authority to assess and use biosimilar fees. 
Sec. 404. Reauthorization; reporting requirements. 
Sec. 405. Sunset dates. 
Sec. 406. Effective date. 
Sec. 407. Savings clause. 
TITLE V—REAUTHORIZATION OF OTHER PROGRAMS 
Sec. 501. Reauthorization of provision relating to exclusivity of certain drugs 
containing single enantiomers. 
Sec. 502. Reauthorization of pediatric humanitarian device exceptions. 
Sec. 503. Reauthorization of the critical path public-private partnerships. 
Sec. 504. Reauthorization of pediatric device consortia. 
Sec. 505. Reauthorization of orphan grants program. 
Sec. 506. Reauthorization of inspection program. 
Sec. 507. Reauthorization of pediatric study of drugs. 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6211
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
TITLE VI—ADDITIONAL PROVISIONS 
Sec. 601. Technical corrections. 
TITLE I—FEES RELATING TO 
DRUGS 
SEC. 101. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Prescription Drug User Fee Amendments of 2017’’. 
(b) FINDING.—The Congress finds that the fees au-
thorized by the amendments made in this title will be dedi-
cated toward expediting the drug development process and 
the process for the review of human drug applications, in-
cluding postmarket drug safety activities, as set forth in 
the goals identified for purposes of part 2 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Con-
gressional Record. 
SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES. 
(a) TYPES OF FEES.— 
(1) IN GENERAL.—Section 736(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(a)) is amended— 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(A) in the matter preceding paragraph (1), 
by striking ‘‘fiscal year 2013’’ and inserting 
‘‘fiscal year 2018’’; 
(B) in the heading of paragraph (1), by 
striking ‘‘AND SUPPLEMENT’’; 
(C) in paragraph (1), by striking ‘‘or a 
supplement’’ and ‘‘or supplement’’ each place 
either appears; 
(D) in paragraph (1)(A)— 
(i) in clause (i), by striking ‘‘(c)(4)’’ 
and inserting ‘‘(c)(5)’’; and 
(ii) in clause (ii), by striking ‘‘A fee 
established’’ and all that follows through 
‘‘are required.’’ and inserting the following: 
‘‘A fee established under subsection (c)(5) 
for a human drug application for which 
clinical data (other than bioavailability or 
bioequivalence studies) with respect to 
safety or effectiveness are not required for 
approval.’’; 
(E) in the heading of paragraph (1)(C), by 
striking ‘‘OR SUPPLEMENT’’; 
(F) in paragraph (1)(F)— 
(i) in the heading, by striking ‘‘OR IN-
DICATION’’; and 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
724 
gered Species Conservation Fund; and of which $30,800,000 
is to be derived from the Land and Water Conservation 
Fund. 
NATIONAL WILDLIFE REFUGE FUND 
For expenses necessary to implement the Act of October 
17, 1978 (16 U.S.C. 715s), $13,228,000. 
NORTH AMERICAN WETLANDS CONSERVATION FUND 
For expenses necessary to carry out the provisions of 
the North American Wetlands Conservation Act (16 U.S.C. 
4401 et seq.), $38,145,000, to remain available until ex-
pended. 
NEOTROPICAL MIGRATORY BIRD CONSERVATION 
For expenses necessary to carry out the Neotropical 
Migratory Bird Conservation Act (16 U.S.C. 6101 et seq.), 
$3,910,000, to remain available until expended. 
MULTINATIONAL SPECIES CONSERVATION FUND 
For expenses necessary to carry out the African Ele-
phant Conservation Act (16 U.S.C. 4201 et seq.), the Asian 
Elephant Conservation Act of 1997 (16 U.S.C. 4261 et seq.), 
the Rhinoceros and Tiger Conservation Act of 1994 (16 
U.S.C. 5301 et seq.), the Great Ape Conservation Act of 
2000 (16 U.S.C. 6301 et seq.), and the Marine Turtle Con-
servation Act of 2004 (16 U.S.C. 6601 et seq.), $11,061,000, 
to remain available until expended.
candy vendor attempted to stab a security guard 
near the Gilboa crossing. 
(216) An attack on October 23, 2015, when an 
Israel Defense Forces soldier was stabbed in Gush 
Etzion. 
(217) An attack on October 23, 2015, when an 
Israeli couple and their three young children were 
wounded when a firebomb was thrown at their car 
near Beit El. 
(218) An attempted attack on October 22, 
2015, when a student was stabbed and moderately 
injured while waiting for the bus in Bet Shemesh. 
(219) An attempted attack on October 22, 
2015, when two Palestinian terrorists attempted to 
board an Israeli school bus to carry out a knife at-
tack in Bet Shemesh. 
(220) An attempted attack on October 21, 
2015, when a 15-year-old Palestinian with a knife 
attempted to attack Israeli security forces in 
Yitzhar. 
(221) An attack on October 21, 2015, when an 
Israeli policeman was injured in a car-ramming at-
tack in Ofra. 
(222) An attack on October 21, 2015, when an 
Israel Defense Forces soldier was critically wounded 
VerDate Sep 11 2014 
04:38 May 23, 2017
Jkt 069200
PO 00000
Frm 00032
Fmt 6652
Sfmt 6201
E:\BILLS\H2497.IH
H2497
rfrederick on DSK30NT082PROD with BILLS
116 
(C) in paragraph (5)— 
(i) by striking ‘‘described in this sec-
tion’’ and inserting ‘‘described in para-
graph (1) or (2)’’; and 
(ii) by striking ‘‘the Attorney General 
may grant in the Attorney General’s dis-
cretion.’’ and inserting ‘‘the Secretary of 
Homeland Security or the Attorney Gen-
eral may grant, in the discretion of the 
Secretary or the Attorney General, in any 
proceeding.’’; 
(D) by redesignating paragraphs (3), (4), 
and (5) as paragraphs (4), (5), and (6) respec-
tively; and 
(E) by inserting after paragraph (2) the 
following: 
‘‘(3) The Secretary of Homeland Security, in 
the exercise of discretion, may determine inadmis-
sibility under section 212(a)(2) and issue an order 
of removal pursuant to the procedures set forth in 
this subsection, in lieu of removal proceedings under 
section 240, with respect to an alien who— 
‘‘(A) has not been admitted or paroled; 
VerDate Sep 11 2014 
04:03 May 18, 2017
Jkt 069200
PO 00000
Frm 00116
Fmt 6652
Sfmt 6201
E:\BILLS\H2431.IH
H2431
rfrederick on DSKBCBPHB2PROD with BILLS
‘‘(iv) pursuing new or expanded indi-
cations for such drug through supple-
mental applications under section 505 of 
the Federal Food, Drug, and Cosmetic 
Act; and 
‘‘(v) carrying out postmarket require-
ments related to such drug, including those 
under section 505(o)(3) of such Act; 
‘‘(I) the total revenue and the net profit 
generated from the qualifying drug for each cal-
endar year since the approval of the application 
for the drug under section 505 of the Federal 
Food, Drug, and Cosmetic Act or the issuance 
of the license for the drug under section 351, 
or since the manufacturer acquired such ap-
proved application or license; and 
‘‘(J) the total costs associated with mar-
keting and advertising for the qualifying drug; 
‘‘(2) with respect to the manufacturer— 
‘‘(A) the total revenue and the net profit 
of the manufacturer for the 12-month period 
described in subsection (b)(1)(A) or the 36- 
month period described in subsection (b)(1)(B), 
as applicable; 
VerDate Sep 11 2014 
01:54 May 18, 2017
Jkt 069200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2439.IH
H2439
SSpencer on DSK7TPTVN1PROD with BILLS
(ix) How the Federal Government can 
leverage existing Community Development 
Financial Institutions programs. 
(x) How various sectors (including but 
not limited to philanthropic, for-profit, and 
nonprofit sectors) and levels of government 
currently interact with social enterprises. 
(xi) Review of the current process 
through which social enterprises—both for- 
profit and nonprofit organizations—can 
obtain Federal loans, grants, and contracts 
and offer recommendations for improving 
these processes in light of the special needs 
and contributions of social enterprises. 
(xii) Review of the current process, 
policies, and procedures through which so-
cial enterprises—both for-profit and non-
profit organizations—can access Federal 
contracting opportunities and offer rec-
ommendations for improving the access of 
social enterprises to Federal procurement 
opportunities. 
(xiii) How the Federal Government 
can play a role in developing a purchasing 
directory of social enterprises within the 
VerDate Sep 11 2014 
20:30 May 19, 2017
Jkt 069200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2448.IH
H2448
sradovich on DSK3GMQ082PROD with BILLS
155 
1301 of the 2000 Act: Provided, That unobligated bal-
ances available for the programs authorized by section 
1301 of the 2000 Act and section 41002 of the 1994 
Act, prior to their amendment by the 2013 Act, shall 
be available for this program; 
(12) $6,000,000 is for education and training to 
end violence against and abuse of women with dis-
abilities, as authorized by section 1402 of the 2000 
Act; 
(13) $500,000 is for the National Resource Cen-
ter on Workplace Responses to assist victims of do-
mestic violence, as authorized by section 41501 of the 
1994 Act; 
(14) $1,000,000 is for analysis and research on 
violence against Indian women, including as author-
ized by section 904 of the 2005 Act: Provided, That 
such funds may be transferred to ‘‘Research, Evalua-
tion and Statistics’’ for administration by the Office 
of Justice Programs; 
(15) $500,000 is for a national clearinghouse 
that provides training and technical assistance on 
issues relating to sexual assault of American Indian 
and Alaska Native women; 
(16) $4,000,000 is for grants to assist tribal gov-
ernments in exercising special domestic violence
in a stabbing attack at the Adam Junction near Je-
rusalem. 
(223) An attempted attack on October 21, 
2015, when two Palestinians were apprehended by 
Israeli security forces who found homemade explo-
sive devices in their vehicle. 
(224) An attack on October 21, 2015, when 
five Israel Defense Forces soldiers were injured after 
their vehicle was attacked with stones, and, after 
exiting the vehicle in order to apprehend the stone- 
throwers, were rammed by a vehicle near Beit 
Ummar. 
(225) An attack on October 20, 2015, when an 
Israeli man was killed after his vehicle was stoned, 
and, after escaping the vehicle, was struck and run 
over in a vehicular attack. 
(226) An attack on October 20, 2015, when an 
Israel Defense Forces soldier was injured in a stab-
bing attack in Hebron. 
(227) An attack on October 20, 2015, when 
two Israelis were wounded in a vehicular attack and 
attempted stabbing at a bus stop at the Gush Etzion 
Junction. 
(228) An attack on October 18, 2015, when an 
Israel Defense Forces soldier was killed and 10 civil-
VerDate Sep 11 2014 
04:38 May 23, 2017
Jkt 069200
PO 00000
Frm 00033
Fmt 6652
Sfmt 6201
E:\BILLS\H2497.IH
H2497
rfrederick on DSK30NT082PROD with BILLS
‘‘(B) the organization itself has expressly 
authorized the specific conduct constituting the 
act or omission. 
‘‘(2) Notwithstanding section 4(c)(1), no volun-
teer nonprofit organization shall be liable for harm 
caused by an act or omission of the organization or 
of a volunteer acting on behalf of the organization 
if— 
‘‘(A) the organization or the volunteer en-
gaged in the act or omission at the request of 
or pursuant to an authorization by a State or 
the United States or any agency or subdivision 
of either; and 
‘‘(B) either— 
‘‘(i) the requesting or authorizing gov-
ernmental entity would have been immune 
either from suit or from liability in dam-
ages if it had engaged in the acts or omis-
sions itself or through employees or inde-
pendent contractors; or 
‘‘(ii) 
the 
governmental 
employee, 
agent, or contractor who engaged in the 
acts would have been immune either from 
suit or from liability in damages by virtue 
VerDate Sep 11 2014 
01:52 May 18, 2017
Jkt 069200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2432.IH
H2432
SSpencer on DSK7TPTVN1PROD with BILLS
1676 
the nonoperational and more common areas of such 
elements. 
(4) A study of whether the classification level of 
‘‘confidential’’ could be eliminated within agency-gen-
erated classification guides from use by elements of 
the intelligence community and any negative impacts 
that elimination could have on mission success. 
(b) REPORTS AND BRIEFINGS TO CONGRESS.— 
(1) PROGRESS REPORT.—Not later than 30 days 
after the date of the enactment of this Act, the Direc-
tor of National Intelligence shall submit a report to 
the congressional intelligence committees and provide 
the congressional intelligence committees a briefing on 
the progress of the elements of the intelligence commu-
nity in producing the covered studies. 
(2) FINAL REPORT.—Not later than the earlier of 
120 days after the date of the enactment of this Act 
or June 30, 2017, the Director of National Intel-
ligence shall submit a report and provide a briefing 
to the congressional intelligence committees on— 
(A) the final versions of the covered studies 
that have been provided to the Director by the 
elements of the intelligence community; and 
(B) a plan for implementation of each ini-
tiative included in each such covered study.
115TH CONGRESS 
1ST SESSION H. R. 2433 
AN ACT 
To direct the Under Secretary of Homeland Security for 
Intelligence and Analysis to develop and disseminate a 
threat assessment regarding terrorist use of virtual cur-
rency. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
I 
115TH CONGRESS 
1ST SESSION H. R. 2441 
To amend the Omnibus Crime Control and Safe Streets Act of 1968 to 
include an additional permissible use of amounts provided as grants 
under the Byrne JAG program, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 16, 2017 
Mrs. HARTZLER introduced the following bill; which was referred to the 
Committee on the Judiciary 
A BILL 
To amend the Omnibus Crime Control and Safe Streets 
Act of 1968 to include an additional permissible use 
of amounts provided as grants under the Byrne JAG 
program, and for other purposes. 
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 ‘‘Sex Trafficking De-
mand Reduction Act of 2017’’. 
VerDate Sep 11 2014 
01:55 May 18, 2017
Jkt 069200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H2441.IH
H2441
SSpencer on DSK7TPTVN1PROD with BILLS
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Homeland Security 
Assessment of Terrorists Use of Virtual Currencies Act’’. 
SEC. 2. THREAT ASSESSMENT ON TERRORIST USE OF VIR-
TUAL CURRENCY. 
(a) IN GENERAL.—Not later than 120 days after the 
date of the enactment of this Act, the Under Secretary 
of Homeland Security for Intelligence and Analysis, as au-
thorized by section 201(b)(1) of the Homeland Security 
Act of 2002 (6 U.S.C. 121), shall, in coordination with 
appropriate Federal partners, develop and disseminate a 
threat assessment regarding the actual and potential 
threat posed by individuals using virtual currency to carry 
out activities in furtherance of an act of terrorism, includ-
ing the provision of material support or resources to a for-
eign terrorist organization. Consistent with the protection 
of classified and confidential unclassified information, the 
Under Secretary shall share the threat assessment devel-
oped under this section with State, local, and tribal law 
enforcement officials, including officials that operate with-
in State, local, and regional fusion centers through the De-
partment of Homeland Security State, Local, and Re-
gional Fusion Center Initiative established in section 210A 
of the Homeland Security Act of 2002 (6 U.S.C. 124h). 
(b) DEFINITIONS.—In this section:
(1) The term ‘‘foreign terrorist organization’’ 
means an organization designated as a foreign ter-
rorist organization under section 219 of the Immi-
gration and Nationality Act (8 U.S.C. 1189). 
(2) The term ‘‘virtual currency’’ means a digital 
representation of value that functions as a medium 
of exchange, a unit of account, or a store of value. 
Passed the House of Representatives September 12, 
2017. 
Attest: 
Clerk.
115TH CONGRESS 
1ST SESSION 
H. R. 2433 
AN ACT 
To direct the Under Secretary of Homeland Secu-
rity for Intelligence and Analysis to develop and 
disseminate a threat assessment regarding ter-
rorist use of virtual currency.