datamatters24/research-document-archive huggingface dataset:
128 
Act or section 552 of title 5 or section 1905 of title 
18, United States Code. 
‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For 
the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) 
of 
subsection 
(a) 
and 
paragraphs 
(1)(B) 
and 
(2)(B)(iii)(I)(aa) of subsection (b), a drug or biological 
product shall be considered to represent a meaningful 
therapeutic benefit over existing therapies if the Secretary 
determines that— 
‘‘(1) if approved, the drug or biological product 
could represent an improvement in the treatment, 
diagnosis, or prevention of a disease, compared with 
marketed products adequately labeled for that use in 
the relevant pediatric population; or 
‘‘(2) the drug or biological product is in a class 
of products or for an indication for which there is 
a need for additional options. 
‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person 
fails to submit an assessment described in subsection 
(a)(2), or a request for approval of a pediatric formulation 
described in subsection (a) or (b), in accordance with ap-
plicable provisions of subsections (a) and (b)— 
‘‘(1) the drug or biological product that is the 
subject of the assessment or request may be consid-
ered misbranded solely because of that failure and
(A) IN GENERAL.—Section 51A is hereby 
repealed. 
(B) CLERICAL AMENDMENT.—The table of 
sections for subpart F of part IV of subchapter 
A of chapter 1 is amended by striking the item 
relating to section 51A. 
(f) EFFECTIVE DATES.— 
(1) IN GENERAL.—Except as provided in para-
graph (2), the amendments made by this section 
shall apply to individuals who begin work for the 
employer after December 31, 2005. 
(2) CONSOLIDATION.—The amendments made 
by subsections (b), (c), (d), and (e) shall apply to in-
dividuals who begin work for the employer after De-
cember 31, 2006. 
SEC. 206. ELECTION TO INCLUDE COMBAT PAY AS EARNED 
INCOME FOR PURPOSES OF EARNED INCOME 
CREDIT. 
(a) IN GENERAL.—Section 32(c)(2)(B)(vi)(II) is 
amended by striking ‘‘2007’’ and inserting ‘‘2008’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall apply to taxable years beginning after 
December 31, 2006. 
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SEC. 207. EXTENSION AND MODIFICATION OF QUALIFIED 
ZONE ACADEMY BONDS. 
(a) 
IN
GENERAL.—Paragraph 
(1) 
of 
section 
1397E(e) is amended by striking ‘‘and 2005’’ and insert-
ing ‘‘2005, 2006, and 2007’’. 
(b) SPECIAL RULES RELATING TO EXPENDITURES, 
ARBITRAGE, AND REPORTING.— 
(1) IN
GENERAL.—Section 1397E is amend-
ed— 
(A) in subsection (d)(1), by striking ‘‘and’’ 
at the end of subparagraph (C)(iii), by striking 
the period at the end of subparagraph (D) and 
inserting ‘‘, and’’, and by adding at the end the 
following new subparagraph: 
‘‘(E) the issue meets the requirements of 
subsections (f), (g), and (h).’’, and 
(B) by redesignating subsections (f), (g), 
(h), and (i) as subsection (i), (j), (k), and (l), 
respectively, and by inserting after subsection 
(e) the following new subsections: 
‘‘(f) SPECIAL
RULES
RELATING
TO
EXPENDI-
TURES.— 
‘‘(1) IN GENERAL.—An issue shall be treated as 
meeting the requirements of this subsection if, as of 
the date of issuance, the issuer reasonably expects— 
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129 
subject to relevant enforcement action (except that 
the drug or biological product shall not be subject to 
action under section 303); but 
‘‘(2) the failure to submit the assessment or re-
quest shall not be the basis for a proceeding— 
‘‘(A) to withdraw approval for a drug 
under section 505(e); or 
‘‘(B) to revoke the license for a biological 
product under section 351 of the Public Health 
Service Act. 
‘‘(e) MEETINGS.—Before and during the investiga-
tional process for a new drug or biological product, the 
Secretary shall meet at appropriate times with the sponsor 
of the new drug or biological product to discuss— 
‘‘(1) information that the sponsor submits on 
plans and timelines for pediatric studies; or 
‘‘(2) any planned request by the sponsor for 
waiver or deferral of pediatric studies. 
‘‘(f) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, 
DEFERRALS, AND WAIVERS.— 
‘‘(1) REVIEW.—Beginning not later than 30 
days after the date of the enactment of the Pediatric 
Research Equity Act of 2007, the Secretary shall 
utilize the internal committee established under sec-
tion 505C to provide consultation to reviewing divi-
‘‘(A) at least 95 percent of the proceeds 
from the sale of the issue are to be spent for 
1 or more qualified purposes with respect to 
qualified zone academies within the 5-year pe-
riod beginning on the date of issuance of the 
qualified zone academy bond, 
‘‘(B) a binding commitment with a third 
party to spend at least 10 percent of the pro-
ceeds from the sale of the issue will be incurred 
within the 6-month period beginning on the 
date of issuance of the qualified zone academy 
bond, and 
‘‘(C) such purposes will be completed with 
due diligence and the proceeds from the sale of 
the issue will be spent with due diligence. 
‘‘(2) EXTENSION
OF
PERIOD.—Upon submis-
sion of a request prior to the expiration of the period 
described in paragraph (1)(A), the Secretary may 
extend such period if the issuer establishes that the 
failure to satisfy the 5-year requirement is due to 
reasonable cause and the related purposes will con-
tinue to proceed with due diligence. 
‘‘(3) FAILURE TO SPEND REQUIRED AMOUNT 
OF BOND PROCEEDS WITHIN 5 YEARS.—To the ex-
tent that less than 95 percent of the proceeds of 
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SECTION 1. SHORT TITLE AND TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘United States Manufacturing Enhancement Act of 
2010’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title and table of contents. 
Sec. 2. Reference. 
TITLE I—NEW DUTY SUSPENSIONS AND REDUCTIONS 
Sec. 1004. Certain reusable grocery bags. 
Sec. 1009. Epilink 701. 
Sec. 1011. Certain synthetic staple fibers that are not carded, combed, or oth-
erwise processed for spinning. 
Sec. 1012. Acrylic or modacrylic synthetic staple fibers, not carded, combed, or 
otherwise processed for spinning. 
Sec. 1013. Acrylic or modacrylic synthetic staple fibers, not carded, combed, or 
otherwise processed for spinning, containing at least 85 percent 
by weight of acrylonitrile units. 
Sec. 1014. Certain synthetic staple fibers that are not carded, combed, or oth-
erwise processed for spinning, not dyed or pigmented. 
Sec. 1015. Certain synthetic staple fibers that are not carded, combed, or oth-
erwise processed for spinning, raw white (undyed). 
Sec. 1016. Certain synthetic staple fibers that are not carded, combed, or oth-
erwise processed for spinning, containing at least 85 percent by 
weight of acrylonitrile units. 
Sec. 1017. Certain synthetic staple fibers that are not carded, combed, or oth-
erwise processed for spinning, not pigmented. 
Sec. 1020. Acrylic or modacrylic synthetic staple fibers, not carded, combed, or 
otherwise processed for spinning, containing 2 percent or more 
but not over 3 percent of water. 
Sec. 1021. Acrylic or modacrylic synthetic staple fibers, not carded, combed, or 
otherwise processed for spinning, not pigmented. 
Sec. 1022. Acrylic or modacrylic synthetic filament tow. 
Sec. 1023. Acrylic or modacrylic synthetic filament tow, containing 2 percent 
or more but not over 3 percent of water. 
Sec. 1024. Acrylic or modacrylic synthetic filament tow containing 85 percent 
or more by weight of acrylonitrile units. 
Sec. 1025. Acrylic or modacrylic synthetic staple fibers, not carded, combed, or 
otherwise processed for spinning, raw white (undyed). 
Sec. 1026. Certain synthetic staple fibers that are not carded, combed, or oth-
erwise processed for spinning, containing 85 percent or more 
of acrylonitrile units. 
Sec. 1027. Certain synthetic staple fibers that are not carded, combed, or oth-
erwise processed for spinning containing 2 percent or more but 
not over 3 percent of water. 
Sec. 1028. MDA50. 
Sec. 1029. Nourybond 276 Modifier.
135 
30 days after receiving the recommendation, 
make a request to the sponsor of the applica-
tion or supplement to make any labeling 
changes that the Commissioner determines to 
be appropriate. 
‘‘(D) MISBRANDING.—If the sponsor of the 
application or supplement, within 30 days after 
receiving a request under subparagraph (C), 
does not agree to make a labeling change re-
quested by the Commissioner, the Commis-
sioner may deem the drug that is the subject of 
the application or supplement to be misbranded. 
‘‘(E) NO EFFECT ON AUTHORITY.—Noth-
ing in this subsection limits the authority of the 
United States to bring an enforcement action 
under this Act when a drug lacks appropriate 
pediatric labeling. Neither course of action (the 
Pediatric Advisory Committee process or an en-
forcement action referred to in the preceding 
sentence) shall preclude, delay, or serve as the 
basis to stay the other course of action. 
‘‘(2) OTHER
LABELING
CHANGES.—If, on or 
after the date of the enactment of the Pediatric Re-
search Equity Act of 2007, the Secretary makes a 
determination that a pediatric assessment conducted
126
SEC. 503. None of the funds made available in this 
Act may be used to plan, design, study, or construct, for 
the purpose of harvesting timber by private entities or in-
dividuals, a forest development road in the Tongass Na-
tional Forest. 
SEC. 504. None of the funds made available in this 
Act may be used to send or otherwise pay for the attend-
ance of more than 50 employees from a Federal depart-
ment or agency at any single conference occurring outside 
the United States. 
SEC. 505. No funds made available by this Act may 
be obligated or expended to conduct the San Gabriel Wa-
tershed and Mountains Special Resource Study (author-
ized by the San Gabriel River Watershed Study Act (Pub-
lic Law 108–42)) in the cities of Diamond Bar, La Habra, 
Industry, Chino Hills, and the community of Rowland 
Heights in Los Angeles County, California (as defined by 
the following boundaries: the City of Industry on the 
north, Orange County on the south, the City of Diamond 
Bar and California State Route 57 on the east, and the 
City of La Habra Heights and Schabarum Regional Park 
on the west.). 
SEC. 506. None of the funds made available in this 
Act may be used to eliminate or restrict programs that 
are for the reforestation of urban areas.
127
SEC. 507. None of the funds made available in this 
Act may be used to limit outreach programs administered 
by the Smithsonian Institution. 
SEC. 508. None of the funds in this Act may be used 
by the Administrator of the Environmental Protection 
Agency to implement or enforce the Joint Memorandum 
published in the Federal Register on January 15, 2003 
(68 Fed. Reg. 1995). 
SEC. 509. No funds provided in title I may be ex-
pended by the Department of the Interior—
(1) for the conduct of offshore natural gas 
preleasing, leasing, and related activities placed 
under restriction in the President’s moratorium 
statement of June 12, 1998, in the areas of north-
ern, central, and southern California; the North At-
lantic; Washington and Oregon; and the eastern 
Gulf of Mexico south of 26 degrees north latitude 
and east of 86 degrees west longitude; 
(2) to conduct offshore natural gas preleasing, 
leasing, and related activities in the eastern Gulf of 
Mexico planning area for any lands located outside 
Sale 181, as identified in the final Outer Continental 
Shelf 5-Year Oil and Gas Leasing Program, 1997–
2002; or
128
(3) to conduct natural gas preleasing, leasing, 
and related activities in the Mid-Atlantic and South 
Atlantic planning areas. 
This Act may be cited as the ‘‘Department of the In-
terior, Environment, and Related Agencies Appropriations 
Act, 2007’’.
Passed the House of Representatives May 18, 2006. 
Attest:
Clerk.
109TH CONGRESS 
2D SESSION 
H. R. 5386
AN ACT 
Making appropriations for the Department of the 
Interior, environment, and related agencies for 
the fiscal year ending September 30, 2007, and 
for other purposes.
(A) Section 1400B(e)(2) is amended— 
(i) by striking ‘‘2010’’ and inserting 
‘‘2012’’, and 
(ii) by striking ‘‘2010’’ in the heading 
thereof and inserting ‘‘2012’’. 
(B) Section 1400B(g)(2) is amended by 
striking ‘‘2010’’ and inserting ‘‘2012’’. 
(C) Section 1400F(d) is amended by strik-
ing ‘‘2010’’ and inserting ‘‘2012’’. 
(3) EFFECTIVE DATES.— 
(A) EXTENSION.—The amendments made 
by paragraph (1) shall apply to acquisitions 
after December 31, 2005. 
(B) 
CONFORMING
AMENDMENTS.—The 
amendments made by paragraph (2) shall take 
effect on the date of the enactment of this Act. 
(d) FIRST-TIME HOMEBUYER CREDIT.— 
(1) IN
GENERAL.—Subsection (i) of section 
1400C is amended by striking ‘‘2006’’ and inserting 
‘‘2008’’. 
(2) EFFECTIVE DATE.—The amendment made 
by this subsection shall apply to property purchased 
after December 31, 2005. 
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SEC. 211. INDIAN EMPLOYMENT TAX CREDIT. 
(a) IN GENERAL.—Section 45A(f) is amended by 
striking ‘‘2005’’ and inserting ‘‘2007’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall apply to taxable years beginning after 
December 31, 2005. 
SEC. 212. ACCELERATED DEPRECIATION FOR BUSINESS 
PROPERTY ON INDIAN RESERVATIONS. 
(a) IN GENERAL.—Section 168(j)(8) is amended by 
striking ‘‘2005’’ and inserting ‘‘2007’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall apply to property placed in service after 
December 31, 2005. 
SEC. 213. FIFTEEN-YEAR STRAIGHT-LINE COST RECOVERY 
FOR QUALIFIED LEASEHOLD IMPROVEMENTS 
AND QUALIFIED RESTAURANT PROPERTY. 
(a) IN GENERAL.—Clauses (iv) and (v) of section 
168(e)(3)(E) are each amended by striking ‘‘2006’’ and 
inserting ‘‘2008’’. 
(b) TREATMENT OF RESTAURANT PROPERTY TO IN-
CLUDE NEW CONSTRUCTION.—Paragraph (7) of section 
168(e) (relating to classification of property) is amended 
to read as follows: 
‘‘(7) QUALIFIED RESTAURANT PROPERTY.—The 
term ‘qualified restaurant property’ means any sec-
tion 1250 property which is a building or an im-
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provement to a building if more than 50 percent of 
the building’s square footage is devoted to prepara-
tion of, and seating for on-premises consumption of, 
prepared meals.’’. 
(c) EFFECTIVE DATES.— 
(1) SUBSECTION (a).—The amendments made 
by subsection (a) shall apply to property placed in 
service after December 31, 2005. 
(2) SUBSECTION (b).—The amendment made 
by subsection (b) shall apply to property placed in 
service after the date of the enactment of this Act. 
SEC. 214. COVER OVER OF TAX ON DISTILLED SPIRITS. 
(a) IN GENERAL.—Section 7652(f)(1) is amended by 
striking ‘‘2006’’ and inserting ‘‘2008’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to articles brought into the 
United States after December 31, 2005. 
SEC. 215. PARITY IN APPLICATION OF CERTAIN LIMITS TO 
MENTAL HEALTH BENEFITS. 
(a) AMENDMENT TO THE INTERNAL REVENUE CODE 
OF 1986.—Section 9812(f)(3) is amended by striking 
‘‘2006’’ and inserting ‘‘2007’’. 
(b) AMENDMENT TO THE EMPLOYEE RETIREMENT 
INCOME SECURITY ACT OF 1974.—Section 712(f) of the 
Employee Retirement Income Security Act of 1974 (29 
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I 
110TH CONGRESS 
2D SESSION 
H. R. 6836 
To designate the facility of the United States Postal Service located at 
140 Merriman Road in Garden City, Michigan, as the ‘‘John J. Shivnen 
Post Office Building’’. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 8, 2008 
Mr. MCCOTTER introduced the following bill; which was referred to the 
Committee on Oversight and Government Reform 
A BILL 
To designate the facility of the United States Postal Service 
located at 140 Merriman Road in Garden City, Michigan, 
as the ‘‘John J. Shivnen Post Office Building’’. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. JOHN J. SHIVNEN POST OFFICE BUILDING. 
(a) DESIGNATION.—The facility of the United States 
Postal Service located at 140 Merriman Road in Garden 
City, Michigan, shall be known and designated as the 
‘‘John J. Shivnen Post Office Building’’. 
(b) REFERENCES.—Any reference in a law, map, reg-
ulation, document, paper, or other record of the United 
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136 
under this section does or does not demonstrate that 
the drug that is the subject of such assessment is 
safe and effective in pediatric populations or sub-
populations, including whether such assessment re-
sults are inconclusive, the Secretary shall order the 
label of such product to include information about 
the results of the assessment and a statement of the 
Secretary’s determination. 
‘‘(h) DISSEMINATION
OF
PEDIATRIC
INFORMA-
TION.— 
‘‘(1) IN GENERAL.—Not later than 210 days 
after the date of submission of a pediatric assess-
ment under this section, the Secretary shall make 
available to the public in an easily accessible manner 
the medical, statistical, and clinical pharmacology re-
views of such pediatric assessments, and shall post 
such assessments on the Web site of the Food and 
Drug Administration. 
‘‘(2) DISSEMINATION
OF
INFORMATION
RE-
GARDING
LABELING
CHANGES.—Beginning on the 
date of the enactment of the Pediatric Research Eq-
uity Act of 2007, the Secretary shall require that 
the sponsors of the assessments that result in label-
ing changes that are reflected in the annual sum-
mary developed pursuant to subsection (f)(6)(H) dis-
143 
retary determines to be appropriate, including a de-
tailed rationale for each recommendation; and 
(5)(A) the efforts made by the Secretary to in-
crease the number of studies conducted in the 
neonate population; and 
(B) the results of those efforts, including efforts 
made to encourage the conduct of appropriate stud-
ies in neonates by companies with products that 
have sufficient safety and other information to make 
the conduct of the studies ethical and safe. 
TITLE 
V—BEST 
PHARMA-
CEUTICALS 
FOR 
CHILDREN 
ACT OF 2007 
SEC. 501. SHORT TITLE. 
This title may be cited as the ‘‘Best Pharmaceuticals 
for Children Act of 2007’’. 
SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS 
FOR CHILDREN ACT. 
(a) PEDIATRIC STUDIES OF DRUGS.— 
(1) IN GENERAL.—Section 505A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
amended to read as follows: 
‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS. 
‘‘(a) DEFINITIONS.—As used in this section, the term 
‘pediatric studies’ or ‘studies’ means at least one clinical
I 
110TH CONGRESS 
2D SESSION 
H. R. 6684 
To amend part D of title XVIII of the Social Security Act to apply the 
exceptions process for tiered formulary drugs to specialty tier drugs 
and to limit to 25 percent the Medicare cost-sharing for specialty tier 
drugs. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 31, 2008 
Mr. ELLSWORTH introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
Ways and Means, 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 amend part D of title XVIII of the Social Security 
Act to apply the exceptions process for tiered formulary 
drugs to specialty tier drugs and to limit to 25 percent 
the Medicare cost-sharing for specialty tier drugs. 
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 ‘‘Medicare Prescription 
Drug Cost Equalization Act’’. 
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144 
investigation (that, at the Secretary’s discretion, may in-
clude pharmacokinetic studies) in pediatric age groups (in-
cluding neonates in appropriate cases) in which a drug 
is anticipated to be used, and, at the discretion of the Sec-
retary, may include preclinical studies. 
‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), if, prior to approval of an application that 
is submitted under section 505(b)(1), the Secretary 
determines that information relating to the use of a 
new drug in the pediatric population may produce 
health benefits in that population, the Secretary 
makes a written request for pediatric studies (which 
shall include a timeframe for completing such stud-
ies), the applicant agrees to the request, such stud-
ies are completed using appropriate formulations for 
each age group for which the study is requested 
within any such timeframe, and the reports thereof 
are submitted and accepted in accordance with sub-
section (d)(3)— 
‘‘(A)(i)(I) the period referred to in sub-
section (c)(3)(E)(ii) of section 505, and in sub-
section (j)(5)(F)(ii) of such section, is deemed 
to be five years and six months rather than five 
years, and the references in subsections
110TH CONGRESS 
2D SESSION 
H. R. 6685 
AN ACT 
To authorize the Secretary of the Interior to provide an 
annual grant to facilitate an iron working training pro-
gram for Native Americans. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
sive businesses that generally will be subject to ex-
emption. 
(b) SEASONED
CUSTOMER
EXEMPTION.—Section 
5313(e) of title 31, United States Code, is amended to 
read as follows: 
‘‘(e) QUALIFIED CUSTOMER EXEMPTION.—
‘‘(1) IN GENERAL.—Before the end of the 270-
day period beginning on the date of the enactment 
of the Seasoned Customer CTR Exemption Act of 
2007, the Secretary of the Treasury shall prescribe 
regulations that exempt any depository institution 
from filing a report pursuant to this section in a 
transaction for the payment, receipt, or transfer of 
United States coins or currency (or other monetary 
instruments the Secretary of the Treasury pre-
scribes) with a qualified customer of the depository 
institution. 
‘‘(2) QUALIFIED
CUSTOMER
DEFINED.—For 
purposes of this section, the term ‘qualified cus-
tomer’, with respect to a depository institution, has 
such meaning as the Secretary of the Treasury shall 
prescribe, which shall include any person that—
‘‘(A) is incorporated or organized under 
the laws of the United States or any State, in-
cluding a sole proprietorship (as defined in 31
111TH CONGRESS 
2D SESSION 
H. R. 4387 
AN ACT 
To designate the Federal building located at 100 North 
Palafox Street in Pensacola, Florida, as the ‘‘Winston 
E. Arnow Federal Building’’. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
106TH CONGRESS
2D SESSION
H. R. 5164
AN ACT
To amend title 49, United States Code, to require reports
concerning defects in motor vehicles or tires or other
motor vehicle equipment in foreign countries, and for
other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,