datamatters24/research-document-archive huggingface dataset:
SEC. 2. CLARIFICATION OF ORPHAN DRUG EXCEPTION TO 
ANNUAL FEE ON BRANDED PRESCRIPTION 
PHARMACEUTICAL 
MANUFACTURERS 
AND 
IMPORTERS. 
(a) IN GENERAL.—Paragraph (3) of section 9008(e) 
of the Patient Protection and Affordable Care Act (26 
U.S.C. 4001 note prec.; Public Law 111–148) is amended 
to read as follows: 
‘‘(3) EXCLUSION OF ORPHAN DRUG SALES.— 
‘‘(A) IN
GENERAL.—The term ‘branded 
prescription drug sales’ shall not include sales 
of any drug or biological product— 
‘‘(i) with respect to which a credit was 
allowed for any taxable year under section 
45C of the Internal Revenue Code of 1986; 
‘‘(ii) with respect to which a credit 
was allowable for any taxable year begin-
ning before January 1, 2011, under such 
section 45C (without regard to whether 
such credit was claimed or received); or 
‘‘(iii) which was any drug or biological 
product approved or licensed prior to Jan-
uary 1, 2011, by the Food and Drug Ad-
ministration, for marketing solely for 1 or 
more rare diseases or conditions. 
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I 
114TH CONGRESS 
1ST SESSION H. R. 3678 
To clarify the orphan drug exception to the annual fee on branded prescription 
pharmaceutical manufacturers and importers, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 1, 2015 
Mr. KELLY of Pennsylvania (for himself, Mrs. BLACK, Mr. NEAL, Mr. HOLD-
ING, Mr. RANGEL, Ms. JENKINS of Kansas, Mr. TIBERI, Mr. MARCHANT, 
and Mr. NUNES) introduced the following bill; which was referred to the 
Committee on Ways and Means, and in addition to the Committee on En-
ergy and Commerce, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To clarify the orphan drug exception to the annual fee on 
branded prescription pharmaceutical manufacturers and 
importers, 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 ‘‘Preserving Access to 
Orphan Drugs Act of 2015’’. 
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shall deliver ownership and control of such
switch station to the Tribe. Subsequent to the
transfer of the power lines and the right-of-way
and the delivery of ownership and control of the
switch station to the Tribe, Phelps Dodge shall
have no further obligation or liability of any na-
ture with respect to the ownership, operation,
or maintenance of the power lines, the right-of-
way, or the switch station.
‘‘(D) The Tribe and the United States will
enter into an exchange agreement with the Salt
River Project which will deliver CAP water con-
trolled by the Tribe to the Salt River Project in
return for the diversion of water from the Black
River into the Black River facilities. The ex-
change agreement shall be subject to review and
approval by Phelps Dodge, which approval shall
not be unreasonably withheld. Notwithstanding
any other provision of law, the contract referred
to in this subparagraph is ratified and con-
firmed.
‘‘(E) The Tribe, the United States, and
Phelps Dodge will execute a contract covering
the lease and delivery of CAP water from the
Tribe to Phelps Dodge on the following terms:
‘‘(B) 
EXPIRATION.—Subparagraph 
(A) 
shall not apply with respect to any drug or bio-
logical product after the date on which such 
drug or biological product is approved or li-
censed by the Food and Drug Administration 
for marketing for any indication other than the 
treatment of a rare disease or condition. 
‘‘(C) RARE
DISEASE
OR
CONDITION.—In 
this paragraph, the term ‘rare disease or condi-
tion’ has the meaning given such term under 
section 45C(d)(1) of the Internal Revenue Code 
of 1986.’’. 
(b) HOLD HARMLESS FOR COVERED ENTITIES WITH 
NO OR LIMITED ORPHAN DRUG SALES.—Subsection (b) 
of section 9008 of the Patient Protection and Affordable 
Care Act (26 U.S.C. 4001 note prec.; Public Law 111– 
148) is amended by adding at the end the following new 
paragraph: 
‘‘(5) ADJUSTMENT FOR CERTAIN COVERED EN-
TITIES
WITH
NO
OR
LIMITED
ORPHAN
DRUG 
SALES.—If— 
‘‘(A) the fee under this section for a cal-
endar year with respect to a covered entity (de-
termined without regard to this paragraph), ex-
ceeds 
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‘‘(B) the fee that would be determined 
under this section for such year with respect to 
such entity if branded prescription drug sales of 
all covered entities were determined without re-
gard to clauses (ii) and (iii) of subsection 
(e)(3)(A), 
then such entity’s fee under this section for such cal-
endar year shall be determined as described in sub-
paragraph (B).’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply with respect to fees the annual 
payment date for which under section 9008 of the Patient 
Protection and Affordable Care Act (26 U.S.C. 4001 note 
prec.; Public Law 111–148) is after December 31, 2014. 
Æ 
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•HR 4766 EH1S 
ANIMAL AND PLANT HEALTH INSPECTION 
SERVICE 
SALARIES AND EXPENSES 
(INCLUDING TRANSFERS OF FUNDS) 
For expenses, not otherwise provided for, necessary 
to prevent, control, and eradicate pests and plant and ani-
mal diseases; to carry out inspection, quarantine, and reg-
ulatory activities; and to protect the environment, as au-
thorized by law, $808,823,000 (increased by $5,000,000) 
(increased by $18,000,000), of which $4,119,000 shall be 
available for the control of outbreaks of insects, plant dis-
eases, animal diseases and for control of pest animals and 
birds to the extent necessary to meet emergency condi-
tions; of which $47,000,000 shall be used for the boll wee-
vil eradication program for cost share purposes or for debt 
retirement for active eradication zones: Provided, That no 
funds shall be used to formulate or administer a brucel-
losis eradication program for the current fiscal year that 
does not require minimum matching by the States of at 
least 40 percent: Provided further, That this appropriation 
shall be available for the operation and maintenance of 
aircraft and the purchase of not to exceed four, of which 
two shall be for replacement only: Provided further, That, 
in addition, in emergencies which threaten any segment 
of the agricultural production industry of this country, the
HR 5025 PCS 
under the charge and control of the Postal Service, and 
such guards shall have, with respect to such property, the 
powers of special policemen provided by the first section 
of the Act of June 1, 1948, as amended (62 Stat. 281; 
40 U.S.C. 318), and, as to property owned or occupied 
by the Postal Service, the Postmaster General may take 
the same actions as the Administrator of General Serv-
ices may take under the provisions of sections 2 and 3 
of the Act of June 1, 1948, as amended (62 Stat. 281; 
40 U.S.C. 318a and 318b), attaching thereto penal con-
sequences under the authority and within the limits pro-
vided in section 4 of the Act of June 1, 1948, as amend-
ed (62 Stat. 281; 40 U.S.C. 318c). 
SEC. 612. None of the funds made available pursu-
ant to the provisions of this Act shall be used to imple-
ment, administer, or enforce any regulation which has 
been disapproved pursuant to a resolution of disapproval 
duly adopted in accordance with the applicable law of the 
United States. 
SEC. 613. (a) Notwithstanding any other provision 
of law, and except as otherwise provided in this section, 
no part of any of the funds appropriated for fiscal year 
2005, by this or any other Act, may be used to pay any 
prevailing 
rate 
employee 
described 
in 
section 
5342(a)(2)(A) of title 5, United States Code—
IIB 
114TH CONGRESS 
2D SESSION 
H. R. 3680 
IN THE SENATE OF THE UNITED STATES 
MAY 12, 2016 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
To provide for the Secretary of Health and Human Services 
to carry out a grant program for co-prescribing opioid 
overdose reversal drugs. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Co-Prescribing to Re-
duce Overdoses Act of 2016’’. 
SEC. 
2. 
OPIOID 
OVERDOSE 
REVERSAL 
DRUGS 
PRE-
SCRIBING GRANT PROGRAM. 
(a) ESTABLISHMENT.— 
(1) IN
GENERAL.—Not later than 6 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services may establish, 
in accordance with this section, a 5-year opioid over-
dose reversal drugs prescribing grant program (in 
this Act referred to as the ‘‘grant program’’). 
(2) MAXIMUM GRANT AMOUNT.—A grant made 
under this section may not be for more than 
$200,000 per grant year. 
(3) ELIGIBLE ENTITY.—For purposes of this 
section, the term ‘‘eligible entity’’ means a federally 
qualified health center (as defined in section 
1861(aa) of the Social Security Act (42 U.S.C. 
1395x(aa)), an opioid treatment program under part 
8 of title 42, Code of Federal Regulations, any prac-
titioner dispensing narcotic drugs pursuant to sec-
tion 303(g) of the Controlled Substances Act (21 
U.S.C. 823(g)), or any other entity that the Sec-
retary deems appropriate. 
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IB 
Union Calendar No. 427 
114TH CONGRESS 
2D SESSION 
H. R. 3680 
[Report No. 114–553] 
To provide for the Secretary of Health and Human Services to carry out 
a grant program for co-prescribing opioid overdose reversal drugs. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 1, 2015 
Mr. SARBANES introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
MAY 10, 2016 
Additional sponsors: Mr. BUCSHON, Mr. HULTGREN, Mr. BILIRAKIS, Mr. 
SHUSTER, and Ms. MCSALLY 
MAY 10, 2016 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on October 1, 2015] 
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partment of Defense: Provided further, That such amount
is designated by Congress as an emergency requirement
pursuant to section 251(b)(2)(D)(i) of the Balanced
Budget and Emergency Deficit Control Act of 1985, as
amended.
OPLAN 34A/35 P.O.W. PAYMENTS
For payments to individuals under section 657 of
Public Law 104–201, $20,000,000, to remain available
until expended.
REVOLVING AND MANAGEMENT FUNDS
RESERVE MOBILIZATION INCOME INSURANCE FUND
For an additional amount for the ‘‘Reserve Mobiliza-
tion Income Insurance Fund’’, $72,000,000, to remain
available until expended: Provided, That the entire amount
is designated by Congress as an emergency requirement
pursuant to section 251(b)(2)(D)(i) of the Balanced
Budget and Emergency Deficit Control Act of 1985, as
amended.
GENERAL PROVISIONS, CHAPTER 1
(TRANSFER OF FUNDS)
SEC. 101. The Secretary of the Navy shall transfer
up to $23,000,000 to ‘‘Operation and Maintenance, Ma-
rine Corps’’ from the following accounts in the specified
amounts, to be available only for reimbursing costs in-
curred for repairing damage caused by hurricanes, flood-
‘‘(1) Progress with respect to each objective
since the most recent preceding report.
‘‘(2) Views of the Parties with respect to privat-
ization.
‘‘(3) Views of industry and consumers on pri-
vatization.
‘‘SEC. 647. CONSULTATION WITH CONGRESS.
‘‘The President’s designees and the Commission shall
consult with the Committee on Commerce of the House
of Representatives and the Committee on Commerce,
Science, and Transportation of the Senate prior to each
meeting of the INTELSAT or Inmarsat Assembly of Par-
ties, the INTELSAT Board of Governors, the Inmarsat
Council, or appropriate working group meetings.
‘‘SEC. 648. SATELLITE AUCTIONS
‘‘Notwithstanding any other provision of law, the
Commission shall not have the authority to assign by com-
petitive bidding orbital slots or spectrum used for the pro-
vision of international or global satellite communications
services. The President shall oppose in the International
Telecommunication Union and in other bilateral and mul-
tilateral fora any assignment by competitive bidding of or-
bital slots or spectrum used for the provision of such serv-
ices.
‘‘Subtitle D—NEGOTIATIONS TO
PURSUE PRIVATIZATION
‘‘SEC. 661. METHODS TO PURSUE PRIVITIZATIONS.
‘‘The President shall secure the pro-competitive
privatizations required by this title in a manner that meets
the criteria in subtitle B.
‘‘Subtitle E—Definitions
‘‘SEC. 681. DEFINITIONS.
‘‘(a) IN GENERAL.—As used in this title:
‘‘(1) INTELSAT.—The term ‘INTELSAT’
means the International Telecommunications Sat-
ellite Organization established pursuant to the
Agreement Relating to the International Tele-
communications 
Satellite 
Organization
(INTELSAT).
‘‘(2) INMARSAT.—The term ‘Inmarsat’ means
the International Mobile Satellite Organization es-
tablished pursuant to the Convention on the Inter-
national Maritime Organization.
‘‘(3) SIGNATORIES.—The term ‘signatories’—
‘‘(A) in the case of INTELSAT, or
INTELSAT successors or separated entities,
means a Party, or the telecommunications en-
tity designated by a Party, that has signed the
Operating Agreement and for which such
not be included as part of any deposit under this
subsection.
SEC. 4. NOTIFICATION AND OTHER DUTIES OF THE OFFICE
OF PERSONNEL MANAGEMENT.
(a) NOTICE.—The Office of Personnel Management
shall take such action as may be necessary and appro-
priate to inform individuals of any rights they might have
as a result of the enactment of this Act.
(b) ASSISTANCE.—The Office shall, on request, assist
any individual in obtaining from any department, agency,
or other instrumentality of the United States any informa-
tion in the possession of such instrumentality which may
be necessary to verify the entitlement of such individual
to have any service credited under section 8411(b)(5) of
title 5, United States Code, as amended by this Act, or
to have an annuity recomputed under section 3(c).
(c) INFORMATION.—Any department, agency, or
other instrumentality of the United States which possesses
any information with respect to an individual’s perform-
ance of any service described in such section 8411(b)(5)
shall, at the request of the Office, furnish such informa-
tion to the Office.
Æ
(2) RELATION TO CURRENT QUALIFIED HIGH 
RISK POOL PROGRAM.— 
(A) STATES NOT OPERATING A QUALIFIED 
HIGH RISK POOL.—In the case of a State that 
is not operating a current section 2745 quali-
fied high risk pool as of the date of the enact-
ment of this Act— 
(i) the State may only meet the re-
quirement of paragraph (1) through the 
operation of a qualified State reinsurance 
program described in subsection (b); and 
(ii) the State’s operation of such a re-
insurance program shall be treated, for 
purposes of section 2745 of the Public 
Health Service Act, as the operation of a 
qualified high risk pool described in such 
section. 
(B) STATE OPERATING A QUALIFIED HIGH 
RISK POOL.—In the case of a State that is op-
erating a current section 2745 qualified high 
risk pool as of the date of the enactment of this 
Act— 
(i) as of January 1, 2017, such a pool 
shall not be treated as a qualified high risk 
pool under section 2745 of the Public 
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(1) during the period from the date of expira-
tion of the limitation imposed by the comparable sec-
tion for previous fiscal years until the normal effec-
tive date of the applicable wage survey adjustment 
that is to take effect in fiscal year 2005, in an 
amount that exceeds the rate payable for the appli-
cable grade and step of the applicable wage schedule 
in accordance with such section; and 
(2) during the period consisting of the remain-
der of fiscal year 2005, in an amount that exceeds, 
as a result of a wage survey adjustment, the rate 
payable under paragraph (1) by more than the sum 
of—
(A) the percentage adjustment taking ef-
fect in fiscal year 2005 under section 5303 of 
title 5, United States Code, in the rates of pay 
under the General Schedule; and 
(B) the difference between the overall aver-
age percentage of the locality-based com-
parability payments taking effect in fiscal year 
2005 under section 5304 of such title (whether 
by adjustment or otherwise), and the overall av-
erage percentage of such payments which was 
effective in the previous fiscal year under such 
section.
placement satellite to the extent such contracts are
equal to or less than the design life of the satellite.
‘‘(21) GMDSS.—The term ‘global maritime dis-
tress and safety services’ or ‘GMDSS’ means the auto-
mated ship-to-shore distress alerting system which
uses satellite and advanced terrestrial systems for
international distress communications and promoting
maritime safety in general. The GMDSS permits the
worldwide alerting of vessels, coordinated search and
rescue operations, and dissemination of maritime
safety information.
‘‘(b) COMMON TERMINOLOGY.—Except as otherwise
provided in subsection (a), terms used in this title that are
defined in section 3 of the Communications Act of 1934
have the meanings provided in such section.’’.
I
105TH CONGRESS
1ST SESSION
H. R. 1875
To amend the Harmonized Tariff Schedule of the United States to allow
entry of peanut butter and paste manufactured from Mexican peanuts
in foreign trade zones, without being subject to a tariff-rate quota.
IN THE HOUSE OF REPRESENTATIVES
JUNE 12, 1997
Mr. CRANE introduced the following bill; which was referred to the Committee
on Ways and Means
A BILL
To amend the Harmonized Tariff Schedule of the United
States to allow entry of peanut butter and paste manu-
factured from Mexican peanuts in foreign trade zones,
without being subject to a tariff-rate quota.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. PEANUT BUTTER AND PASTE MANUFACTURED
IN A FOREIGN-TRADE ZONE.
General Note 15 of the Harmonized Tariff Schedule
of the United States is amended—
(1) by striking ‘‘and’’ at the end of subdivision
(d);
(2) by striking the period at the end of subdivi-
sion (e) and inserting a semicolon; and
(3) by adding at the end the following:
‘‘(f) peanut butter and paste manufactured in,
and entered from, a foreign-trade zone: Provided,
That—
‘‘(i) any peanuts that are not qualifying
goods under General Note 12, and
‘‘(ii) any peanut butter or paste,
imported for use in such manufacturing are en-
tered for consumption prior to admission to the
foreign-trade zone.
For purposes of subdivision (f), the term ‘foreign-
trade zone’ means a foreign-trade zone established
pursuant to the Act of June 18, 1934, commonly
referred to as the ‘Foreign Trade Zones Act (19
U.S.C. 81a and following).’’.
Æ
I
105TH CONGRESS
1ST SESSION
H. R. 1876
To clarify that certain large components of certain scientific instruments
and apparatus shall be provided the same tariff treatment as those
scientific instruments and apparatus.
IN THE HOUSE OF REPRESENTATIVES
JUNE 12, 1997
Mr. SENSENBRENNER (for himself, Mr. BROWN of California, Mr. SCHIFF,
Mr. BARCIA, Mr. BOEHLERT, Mrs. MORELLA, Mr. WELDON of Penn-
sylvania, Mr. ROHRABACHER, Mr. CRAMER, Mr. BARTON of Texas, Mr.
EHLERS, Mr. GUTKNECHT, and Mr. MCHALE) introduced the following
bill; which was referred to the Committee on Ways and Means
A BILL
To clarify that certain large components of certain scientific
instruments and apparatus shall be provided the same
tariff treatment as those scientific instruments and appa-
ratus.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. TARIFF TREATMENT FOR CERTAIN COMPO-
NENTS OF SCIENTIFIC INSTRUMENTS AND
APPARATUS.
U.S. Note 6 of subchapter X of chapter 98 of the
Harmonized Tariff Schedule of the United States is
amended in subdivision (a) be adding at the end the fol-
lowing new sentence: ‘‘The term ‘instruments and appara-
tus’ under subheading 9810.00.60 includes separable com-
ponents of an instrument or apparatus listed in this sub-
division that are imported for assembly in the United
States in such instrument or apparatus in a case in which
the instrument or apparatus, due to its size and complex-
ity, cannot be imported in its assembled state.’’.
SEC. 2. CONSOLIDATED HEARING PROCESS.
U.S. Note 6 of subchapter X of chapter 98 of the
Harmonized Tariff Schedule of the United States is
amended in subdivision (c) by adding at the end the fol-
lowing: ‘‘In order to provide for expedited consideration
of each component of a scientific instrument or apparatus
for which duty treatment is requested under subheading
9810.00.60, the Secretary of Commerce, upon receipt of
a petition by an affected institution, may hold a single
expedited hearing to determine whether or not to grant
such duty treatment to all of the components of the par-
ticular scientific instrument or apparatus for which the
application is made.’’.
SEC. 3. MODIFICATIONS OF REGULATIONS.
The Secretary of the Treasury and the Secretary of
Commerce shall make such modifications to regulations as
are necessary to carry out the amendments made by this
Act.
Æ