datamatters24/research-document-archive huggingface dataset:
I
107TH CONGRESS
2D SESSION
H. R. 3858
To modify the boundaries of the New River Gorge National River, West
Virginia.
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. RAHALL introduced the following bill; which was referred to the
Committee on Resources
A BILL
To modify the boundaries of the New River Gorge National
River, West Virginia.
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 ‘‘New River Gorge
Boundary Act of 2002’’.
SEC. 2. NEW RIVER GORGE NATIONAL RIVER BOUNDARY
MODIFICATIONS.
(a) BOUNDARY MODIFICATION.—Section 1101 of the
National Parks and Recreation Act of 1978 (16 U.S.C.
460m–15) is amended by striking ‘‘NERI–80,028A, dated
March 1996’’ and inserting ‘‘NERI 80,034, dated May
2001’’.
(b) LAND EXCHANGE.—
(1) IN GENERAL.—The Secretary of the Inte-
rior shall complete a fee simple land exchange in the
vicinity of Beauty Mountain, Fayette County, West
Virginia, to acquire a tract of land identified as
NERI Tract Number 150–07 that lies adjacent to
the boundary of the New River Gorge National
River in exchange for a tract of land identified as
NERI Tract Number 150–08 located within such
boundary.
(2) TREATMENT
OF
EXCHANGED
LANDS.—
Upon the completion of such land exchange—
(A) the land acquired by the United States
in the exchange shall be included in the bound-
aries, and administered as part, of the New
River Gorge National River; and
(B) the land conveyed by the United
States in the exchange shall be excluded from
the boundaries, and shall not be administered
as part, of the New River Gorge National
River.
Æ
II
107TH CONGRESS
2D SESSION
H. R. 3858
IN THE SENATE OF THE UNITED STATES
JUNE 25, 2002
Received; read twice and referred to the Committee on Energy and Natural
Resources
AN ACT
To modify the boundaries of the New River Gorge National
River, West Virginia.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
HR 3858 RFS
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘New River Gorge
Boundary Act of 2002’’.
SEC. 2. NEW RIVER GORGE NATIONAL RIVER BOUNDARY
MODIFICATIONS.
(a) BOUNDARY MODIFICATION.—Section 1101 of the
National Parks and Recreation Act of 1978 (16 U.S.C.
460m–15) is amended by striking ‘‘NERI–80,028A, dated
March 1996’’ and inserting ‘‘NERI 80,034, dated May
2001’’.
(b) LAND EXCHANGE.—
(1) IN GENERAL.—The Secretary of the Inte-
rior shall complete a fee simple land exchange in the
vicinity of Beauty Mountain, Fayette County, West
Virginia, to acquire a tract of land identified as
NERI Tract Number 150–07 that lies adjacent to
the boundary of the New River Gorge National
River in exchange for a tract of land identified as
NERI Tract Number 150–08 located within such
boundary.
(2) TREATMENT
OF
EXCHANGED
LANDS.—
Upon the completion of such land exchange—
(A) the land acquired by the United States
in the exchange shall be included in the bound-
aries, and administered as part, of the New
River Gorge National River; and
HR 3858 RFS
(B) the land conveyed by the United
States in the exchange shall be excluded from
the boundaries, and shall not be administered
as part, of the New River Gorge National
River.
Passed the House of Representatives June 24, 2002.
Attest:
JEFF TRANDAHL,
Clerk.
‘‘
9902.30.78
Methyl
Cinnamate
(methyl-3-
phenylpropeno-
ate) (CAS No.
103–26–4) (pro-
vided for in sub-
heading
2916.39.20) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
IB
Union Calendar No. 305
107TH CONGRESS
2D SESSION
H. R. 3858
[Report No. 107–509]
To modify the boundaries of the New River Gorge National River, West
Virginia.
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. RAHALL introduced the following bill; which was referred to the
Committee on Resources
JUNE 17, 2002
Committed to the Committee of the Whole House on the State of the Union
and ordered to be printed
A BILL
To modify the boundaries of the New River Gorge National
River, West Virginia.
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 ‘‘New River Gorge
Boundary Act of 2002’’.
SEC. 2. NEW RIVER GORGE NATIONAL RIVER BOUNDARY
MODIFICATIONS.
(a) BOUNDARY MODIFICATION.—Section 1101 of the
National Parks and Recreation Act of 1978 (16 U.S.C.
460m–15) is amended by striking ‘‘NERI–80,028A, dated
March 1996’’ and inserting ‘‘NERI 80,034, dated May
2001’’.
(b) LAND EXCHANGE.—
(1) IN GENERAL.—The Secretary of the Inte-
rior shall complete a fee simple land exchange in the
vicinity of Beauty Mountain, Fayette County, West
Virginia, to acquire a tract of land identified as
NERI Tract Number 150–07 that lies adjacent to
the boundary of the New River Gorge National
River in exchange for a tract of land identified as
NERI Tract Number 150–08 located within such
boundary.
(2) TREATMENT
OF
EXCHANGED
LANDS.—
Upon the completion of such land exchange—
(A) the land acquired by the United States
in the exchange shall be included in the bound-
aries, and administered as part, of the New
River Gorge National River; and
(B) the land conveyed by the United
States in the exchange shall be excluded from
the boundaries, and shall not be administered
as part, of the New River Gorge National
River.
Union Calendar No. 305
107TH CONGRESS
2D SESSION
H. R. 3858
[Report No. 107–509]
A BILL
To modify the boundaries of the New River Gorge
National River, West Virginia.
JUNE 17, 2002
Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
II 
Calendar No. 681
107TH CONGRESS 
2D SESSION 
H. R. 3858
IN THE SENATE OF THE UNITED STATES 
JUNE 25, 2002
Received; read twice and referred to the Committee on Energy and Natural 
Resources 
OCTOBER 8, 2002
Reported by Mr. BINGAMAN, without amendment 
AN ACT 
To modify the boundaries of the New River Gorge National 
River, West Virginia.
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 ‘‘New River Gorge 
Boundary Act of 2002’’. 
SEC. 2. NEW RIVER GORGE NATIONAL RIVER BOUNDARY 
MODIFICATIONS. 
(a) BOUNDARY MODIFICATION.—Section 1101 of the 
National Parks and Recreation Act of 1978 (16 U.S.C.
‘‘
9902.30.73
Benzyl Acetone
(Methyl-
phenylethyl ke-
tone) (CAS No.
2550–26–7)
(provided for in
subheading
2914.39.90) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
HR 3858 RS 
460m–15) is amended by striking ‘‘NERI–80,028A, dated 
March 1996’’ and inserting ‘‘NERI 80,034, dated May 
2001’’. 
(b) LAND EXCHANGE.—
(1) IN GENERAL.—The Secretary of the Inte-
rior shall complete a fee simple land exchange in the 
vicinity of Beauty Mountain, Fayette County, West 
Virginia, to acquire a tract of land identified as 
NERI Tract Number 150–07 that lies adjacent to 
the boundary of the New River Gorge National 
River in exchange for a tract of land identified as 
NERI Tract Number 150–08 located within such 
boundary. 
(2) TREATMENT
OF
EXCHANGED
LANDS.—
Upon the completion of such land exchange—
(A) the land acquired by the United States 
in the exchange shall be included in the bound-
aries, and administered as part, of the New 
River Gorge National River; and 
(B) the land conveyed by the United 
States in the exchange shall be excluded from 
the boundaries, and shall not be administered
HR 3858 RS 
as part, of the New River Gorge National 
River.
Passed the House of Representatives June 24, 2002. 
Attest: 
JEFF TRANDAHL, 
Clerk.
Calendar No. 681
107TH CONGRESS 
2D SESSION 
H. R. 3858
AN ACT 
To modify the boundaries of the New River Gorge 
National River, West Virginia. 
OCTOBER 8, 2002
Reported without amendment
I
107TH CONGRESS
2D SESSION
H. R. 3859
To suspend temporarily the duty on Allyl Cyclo Hexyl Propionate (Allyl
hexahydro phenylpropionate).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on Allyl Cyclo Hexyl
Propionate (Allyl hexahydro phenylpropionate).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SUSPENSION OF DUTY ON ALLYL CYCLO HEXYL
PROPIONATE 
(ALLYL 
HEXAHYDRO
PHENYLPROPIONATE).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
‘‘
9902.30.77
Allyl Cyclo Hexyl
Propionate (Allyl
hexahydro
phenylpropion-
ate) (CAS No.
2705–87–5)
(provided for in
subheading
2916.20.50) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
I
107TH CONGRESS
2D SESSION
H. R. 3860
To suspend temporarily the duty on Methyl Cinnamate (methyl-3-
phenylpropenoate).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on Methyl Cinnamate
(methyl-3-phenylpropenoate).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SUSPENSION OF DUTY ON METHYL CINNAMATE
(METHYL-3-PHENYLPROPENOATE).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
‘‘
9902.30.74
Acetanisole
(Anisyl Methyl
Ketone) (CAS
No. 100–06–1)
(provided for in
subheading
2914.50.30) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
I
107TH CONGRESS
2D SESSION
H. R. 3861
To suspend temporarily the duty on NeoHeliopan Hydro (2-
Phenylbenzimidazole-5-sulfonic acid).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on NeoHeliopan Hydro
(2-Phenylbenzimidazole-5-sulfonic acid).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SUSPENSION OF DUTY ON NEOHELIOPAN
HYDRO 
(2-PHENYLBENZIMIDAZOLE-5-SUL-
FONIC ACID).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
‘‘
9902.30.82
NeoHeliopan
Hydro (2-
Phenylbenzimida-
zole-5-sulfonic
acid) (CAS No.
27503–81–7)
(provided for in
subheading
2933.90.75) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
I
107TH CONGRESS
2D SESSION
H. R. 3862
To suspend temporarily the duty on Sodium Methylate Powder (Na Methylate
Powder).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on Sodium Methylate
Powder (Na Methylate Powder).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SUSPENSION OF DUTY ON SODIUM METHYLATE
POWDER (NA METHYLATE POWDER).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
‘‘
9902.30.66
Sodium Meth-
ylate Powder (Na
Methylate Pow-
der) (CAS No.
124–41–4) (pro-
vided for in sub-
heading
2905.19.00) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
I
107TH CONGRESS
2D SESSION
H. R. 3863
To suspend temporarily the duty on Benzyl Acetone (Methyl-phenylethyl
ketone).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on Benzyl Acetone (Methyl-
phenylethyl ketone).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SUSPENSION OF DUTY ON BENZYL ACETONE
(METHYL-PHENYLETHYL KETONE).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
I
107TH CONGRESS
2D SESSION
H. R. 3864
To suspend temporarily the duty on Globanone (Cyclohexadec-8-en-1-one)
(CHD).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on Globanone
(Cyclohexadec-8-en-1-one) (CHD).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 
1. 
SUSPENSION 
OF 
DUTY 
ON 
GLOBANONE
(CYCLOHEXADEC-8-EN-1-ONE) (CHD).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
‘‘
9902.30.71
Globanone
(Cyclohexadec-8-
en-1-one) (CHD)
(CAS No. 3100–
36–5) (provided
for in subheading
2914.29.50) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
I
107TH CONGRESS
2D SESSION
H. R. 3865
To suspend temporarily the duty on Agrumex (o-t-Butyl cyclohexanol).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on Agrumex (o-t-Butyl
cyclohexanol).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SUSPENSION OF DUTY ON AGRUMEX (O-T-
BUTYL CYCLOHEXANOL).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
‘‘
9902.30.75
Agrumex (o-t-
Butyl
cyclohexanol)
(CAS Nos.
20298–69–5 and
88–41–5) (pro-
vided for in sub-
heading
2915.39.45) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
I
107TH CONGRESS
2D SESSION
H. R. 3866
To suspend temporarily the duty on Acetanisole (Anisyl Methyl Ketone).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on Acetanisole (Anisyl
Methyl Ketone).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SUSPENSION OF DUTY ON ACETANISOLE
(ANISYL METHYL KETONE).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
125 
quire the UV decreed water rights appurtenant 
to 1,000 acres of land (other than special hot 
lands). 
(B) REQUIRED
PHASE
II
ACQUISITION.— 
Not later than December 31 of the sixth calendar 
year that begins after the enforceability date (or 
December 31 of the first calendar year that be-
gins after the payment provided by subpara-
graph (D)(iii), if later), the Districts shall ac-
quire the UV decreed water rights appurtenant 
to 1,000 acres of land (other than special hot 
lands). The reduction of TBI eligible acres under 
this subparagraph shall be in addition to that 
accomplished under subparagraph (A). 
(C) ADDITIONAL ACQUISITION IN CASE OF 
SETTLEMENT.—If the San Carlos Apache Tribe 
reaches a comprehensive settlement that is ap-
proved by Congress and finally approved by all 
courts the approval of which is required, the Sec-
retary shall offer to acquire for fair market value 
the UV decreed water rights associated with not 
less than 500 nor more than 3,000 TBI eligible 
acres of land (other than special hot lands).
I
107TH CONGRESS
2D SESSION
H. R. 3867
To suspend temporarily the duty on Methyl Acetophenone-para (Melilot).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on Methyl Acetophenone-
para (Melilot).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SUSPENSION OF DUTY ON METHYL ACETOPHE-
NONE-PARA (MELILOT).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
‘‘
9902.30.72
Methyl Acetophe-
none-para
(Melilot) (CAS
No. 122–00–9)
(provided for in
subheading
2914.39.90) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
I
107TH CONGRESS
2D SESSION
H. R. 3868
To suspend temporarily the duty on Majantol (2,2-Dimethyl-3-(3-
methylphenyl)proponal).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on Majantol (2,2-Dimethyl-
3-(3-methylphenyl)proponal).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SUSPENSION OF DUTY ON MAJANTOL (2,2-DI-
METHYL-3-(3-METHYLPHENYL)PROPONAL).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
‘‘
9902.30.68
Majantol (2,2-Di-
methyl-3-(3-
methylphenyl)-
proponal) (CAS
No. 103694–68–
4) (provided for
in subheading
2906.29.20) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
I
107TH CONGRESS
2D SESSION
H. R. 3869
To suspend temporarily the duty on NeoHeliopan MA (Menthyl Anthranilate).
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. BROWN of South Carolina introduced the following bill; which was
referred to the Committee on Ways and Means
A BILL
To suspend temporarily the duty on NeoHeliopan MA
(Menthyl Anthranilate).
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SUSPENSION OF DUTY ON NEOHELIOPAN MA
(MENTHYL ANTHRANILATE).
(a) IN GENERAL.—Subchapter II of chapter 99 of
the Harmonized Tariff Schedule of the United States is
amended by inserting in numerical sequence the following
new heading:
‘‘
9902.30.80
NeoHeliopan MA
(Menthyl An-
thranilate) (CAS
No. 134–09–8)
(provided for in
subheading
2922.49.26) .......
Free
No change
No change
On or before
12/31/2005
’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) applies to articles entered, or withdrawn
from warehouse for consumption, on or after the 15th day
after the date of the enactment of this Act.
Æ
I
107TH CONGRESS
1ST SESSION
H. R. 386
To amend the Federal Food, Drug, and Cosmetic Act with respect to orphan
drugs.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 31, 2001
Mr. THORNBERRY 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 with
respect to orphan 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 ‘‘Orphan Drug Program
Improvement Act of 2001’’.
SEC. 2. FEDERAL FOOD, DRUG, AND COSMETIC ACT;
AMENDMENTS TO PROGRAM FOR ORPHAN
DRUGS.
(a) CONFORMING ORPHAN-DRUG DESIGNATION TO
REFLECT
LABELING
OF
APPROVED
DRUG.—Section
526(a) of the Federal Food, Drug and Cosmetic Act (21
U.S.C. 360bb(a)) is amended—
(1) by redesignating paragraph (2) as para-
graph (3); and
(2) by inserting after paragraph (1) the fol-
lowing paragraph:
‘‘(2) In approving an application filed pursuant to
section 505 for a drug designated under paragraph (1),
or approving the issuance of a license under section 351
of the Public Health Service Act for a drug so designated,
the Secretary shall, with respect to the intended use of
the drug, conform the designation of the drug under para-
graph (1) to reflect the labeling that is approved for the
drug.’’.
(b) 
CLINICAL
SUPERIORITY
OF
SUBSEQUENT
DRUG.—Section 527 of the Federal Food, Drug and Cos-
metic Act (21 U.S.C. 360cc) is amended—
(1) in subsection (a), by striking ‘‘subsection
(b)’’ and inserting ‘‘subsections (b) and (c)’’; and
(2) by adding at the end the following:
‘‘(c)(1) In a case in which the Secretary approves an
application filed pursuant to section 505, or issues a li-
cense under section 351 of the Public Health Service Act,
for a drug designated under section 526 for a rare disease
or condition, and such drug is approved or licensed be-
cause it is considered to be clinically superior to a pre-
viously approved or licensed drug designated under section
526, the seven-year period of prohibition against approval
described in subsection (a) shall apply only to prohibit ap-
proval of drugs that exhibit the same clinically superior
features.
‘‘(2) In paragraph (1), the term ‘clinically superior’
means a drug (that is otherwise the same drug) that is
shown to provide better safety or better efficacy, or to pro-
vide a major contribution to patient care.
‘‘(3) In making a determination of whether a drug
is clinically superior for purposes of this subsection, the
Secretary, upon request of the applicant involved, shall
refer a determination as to whether the drug provides a
major contribution to patient care to an advisory com-
mittee.’’.
Æ