datamatters24/research-document-archive huggingface dataset:
H. R. 400
One Hundred Seventh Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Wednesday,
the twenty-third day of January, two thousand and two
An Act
To authorize the Secretary of the Interior to establish the Ronald Reagan Boyhood
Home National Historic Site, and for other purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. RONALD REAGAN BOYHOOD HOME NATIONAL HISTORIC
SITE.
(a) ACQUISITION OF PROPERTY.—As soon as practicable after
the date of the enactment of this Act, the Secretary shall purchase
with donated or appropriated funds, at fair market value and from
a willing owner only, fee simple, unencumbered title to the Property
and to any personal property related to the Property which the
Secretary determines to be appropriate for the purposes of this
Act.
(b) ESTABLISHMENT OF HISTORIC SITE.—After the Property is
acquired by the Secretary, the Secretary shall designate the Prop-
erty as the Ronald Reagan Boyhood Home National Historic Site.
(c) LAND DESCRIPTION.—The Secretary shall ensure that a copy
of the land description referred to in section 2(2) is on file and
available for public inspection in the appropriate offices of the
National Park Service.
(d) MANAGEMENT OF HISTORIC SITE.—
(1) COOPERATIVE AGREEMENT.—The Secretary shall enter
into a cooperative agreement with the Ronald Reagan Boyhood
Home Foundation for the management, operation, and use of
the Historic Site. The cooperative agreement shall provide for
the preservation of the Property in a manner that preserves
the historical significance thereof and upon such terms and
conditions as the Secretary considers necessary to protect the
interests of the United States.
(2) GENERAL MANAGEMENT PLAN.—Not later than 2 years
after the date of the enactment of this Act, the Secretary,
in consultation with the Ronald Reagan Boyhood Home Founda-
tion, shall complete a general management plan for the Historic
Site that defines the role and responsibility of the Secretary
with regard to the interpretation and the preservation of the
Historic Site.
(e) APPLICABILITY OF OTHER LAWS.—The Secretary shall admin-
ister the Historic Site in accordance with the provisions of this
Act and the provisions of laws generally applicable to national
historic sites, including the Act entitled ‘‘An Act to establish a
National Park Service, and for other purposes’’, approved August
25, 1916 (16 U.S.C. 1–4), and the Act entitled ‘‘An Act to provide
for the preservation of historic American sites, buildings, objects
H. R. 400—3
(3) The term ‘‘Secretary’’ means the Secretary of the
Interior.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.
hardship to the alien’s spouse, parent, or child, who
is a citizen of the United States or an alien lawfully
admitted for permanent residence.
(2) RESTRICTIONS.—
(A) The waiver authority of the Attorney
General under this subsection may be delegated
only to the Commissioner of the Immigration
and Naturalization Service.
(B) The waiver authority under this sub-
section may be exercised with respect to the ad-
mission of not more than 100 aliens from each
country under subsection (a)(2) for each fiscal
year.
SEC. 4. EXPANSION OF TERRORIST ACTIVITIES FOR PUR-
POSES OF DEPORTATION.
(a) AMENDMENT TO INA.—Section 237(a)(4)(B) of
the 
Immigration 
and 
Nationality 
Act 
(8 
U.S.C.
1227(a)(4)(B)) is amended by striking ‘‘as defined in sec-
tion 212(a)(3)(B)(iii))’’ and inserting ‘‘as described under
section 212(a)(3)(B))’’.
(b) RETROACTIVE APPLICATION OF AMENDMENT.—
The amendments made by this section shall take effect
on the date of the enactment of this Act and shall apply
to—
II
107TH CONGRESS
2D SESSION
H. R. 4013
IN THE SENATE OF THE UNITED STATES
OCTOBER 2, 2002
Received
AN ACT
To amend the Public Health Service Act to establish an
Office of Rare Diseases at the National Institutes of
Health, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SEC. 4. RARE DISEASE REGIONAL CENTERS OF EXCEL-
LENCE.
Title IV of the Public Health Service Act (42 U.S.C.
281 et seq.), as amended by section 3, is further amended
by inserting after section 404F the following:
‘‘RARE DISEASE REGIONAL CENTERS OF EXCELLENCE
‘‘SEC. 404G. (a) COOPERATIVE AGREEMENTS AND
GRANTS.—
‘‘(1) IN GENERAL.—The Director of the Office
of Rare Diseases (in this section referred to as the
‘Director’), in collaboration with the directors of the
other relevant institutes and centers of the National
Institutes of Health, may enter into cooperative
agreements with and make grants to public or pri-
vate nonprofit entities to pay all or part of the cost
of planning, establishing, or strengthening, and pro-
viding basic operating support for regional centers of
excellence for clinical research into, training in, and
demonstration of diagnostic, prevention, control, and
treatment methods for rare diseases.
‘‘(2) POLICIES.—A cooperative agreement or
grant under paragraph (1) shall be entered into in
accordance with policies established by the Director
of NIH.
‘‘(b) COORDINATION WITH OTHER INSTITUTES.—
The Director shall coordinate the activities under this sec-
tion with similar activities conducted by other national re-
search institutes, centers and agencies of the National In-
stitutes of Health and by the Food and Drug Administra-
tion to the extent that such institutes, centers and agen-
cies have responsibilities that are related to rare diseases.
‘‘(c) USES FOR FEDERAL PAYMENTS UNDER COOP-
ERATIVE AGREEMENTS OR GRANTS.—Federal payments
made under a cooperative agreement or grant under sub-
section (a) may be used for—
‘‘(1) staffing, administrative, and other basic
operating costs, including such patient care costs as
are required for research;
‘‘(2) clinical training, including training for al-
lied health professionals, continuing education for
health professionals and allied health professions
personnel, and information programs for the public
with respect to rare diseases; and
‘‘(3) clinical research and demonstration pro-
grams.
‘‘(d) PERIOD OF SUPPORT; ADDITIONAL PERIODS.—
Support of a center under subsection (a) may be for a
period of not to exceed 5 years. Such period may be ex-
tended by the Director for additional periods of not more
than 5 years if the operations of such center have been
reviewed by an appropriate technical and scientific peer
review group established by the Director and if such group
has recommended to the Director that such period should
be extended.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated such sums as already have been appro-
priated for fiscal year 2002, and $20,000,000 for each of
the fiscal years 2003 through 2006.’’.
Passed the House of Representatives October 1,
2002.
Attest:
Clerk.
Union Calendar No. 324
107TH CONGRESS
2D SESSION
H. R. 4013
[Report No. 107–543]
A BILL
To amend the Public Health Service Act to estab-
lish an Office of Rare Diseases at the National
Institutes of Health, and for other purposes.
JUNE 26, 2002
Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
I
107TH CONGRESS
2D SESSION
H. R. 4013
To amend the Public Health Service Act to establish an Office of Rare
Diseases at the National Institutes of Health, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 20, 2002
Mr. SHIMKUS (for himself, Mr. WAXMAN, Mr. FOLEY, Mr. BROWN of Ohio,
Mrs. ROUKEMA, Mr. RUSH, Mr. KING, Mr. GREENWOOD, and Mr. DIN-
GELL) introduced the following bill; which was referred to the Committee
on Energy and Commerce
A BILL
To amend the Public Health Service Act to establish an
Office of Rare Diseases at the National Institutes of
Health, 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 ‘‘Rare Diseases Act of
2002’’.
SEC. 2. FINDINGS AND PURPOSES.
(a) FINDINGS.—Congress makes the following find-
ings:
(1) Rare diseases and disorders are those which
affect small patient populations, typically popu-
lations smaller than 200,000 individuals in the
United States. Such diseases and conditions include
Huntington’s disease, amyotrophic lateral sclerosis
(Lou Gehrig’s disease), Tourette syndrome, Crohn’s
disease, cystic fibrosis, cystinosis, and Duchenne
muscular dystrophy.
(2) For many years, the 25,000,000 Americans
suffering from the over 6,000 rare diseases and dis-
orders were denied access to effective medicines be-
cause prescription drug manufacturers could rarely
make a profit from marketing drugs for such small
groups of patients. The prescription drug industry
did not adequately fund research into such treat-
ments. Despite the urgent health need for these
medicines, they came to be known as ‘‘orphan
drugs’’ because no companies would commercialize
them.
(3) During the 1970s, an organization called
the National Organization for Rare Disorders
(NORD) was founded to provide services and to
lobby on behalf of patients with rare diseases and
disorders. NORD was instrumental in pressing Con-
gress for legislation to encourage the development of
orphan drugs.
(4) The Orphan Drug Act created financial in-
centives for the research and production of such or-
phan drugs. New Federal programs at the National
Institutes of Health and the Food and Drug Admin-
istration encouraged clinical research and commer-
cial product development for products that target
rare diseases. An Orphan Products Board was estab-
lished to promote the development of drugs and de-
vices for rare diseases or disorders.
(5) Before 1983, some 38 orphan drugs had
been developed. Since the enactment of the Orphan
Drug Act, more than 220 new orphan drugs have
been approved and marketed in the United States
and more than 800 additional drugs are in the re-
search pipeline.
(6) Despite the tremendous success of the Or-
phan Drug Act, rare diseases and disorders deserve
greater emphasis in the national biomedical research
HR 4013 RDS
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Rare Diseases Act of
2002’’.
SEC. 2. FINDINGS AND PURPOSES.
(a) FINDINGS.—Congress makes the following find-
ings:
(1) Rare diseases and disorders are those which
affect small patient populations, typically popu-
lations smaller than 200,000 individuals in the
United States. Such diseases and conditions include
Huntington’s disease, amyotrophic lateral sclerosis
(Lou Gehrig’s disease), Tourette syndrome, Crohn’s
disease, cystic fibrosis, cystinosis, and Duchenne
muscular dystrophy.
(2) For many years, the 25,000,000 Americans
suffering from the over 6,000 rare diseases and dis-
orders were denied access to effective medicines be-
cause prescription drug manufacturers could rarely
make a profit from marketing drugs for such small
groups of patients. The prescription drug industry
did not adequately fund research into such treat-
ments. Despite the urgent health need for these
medicines, they came to be known as ‘‘orphan
drugs’’ because no companies would commercialize
them.
HR 4628 EAS
‘‘(12) The annual audit of the Central Intel-
ligence Agency central services program required by
section 21(g) of the Central Intelligence Agency Act of
1949 (50 U.S.C. 403u(g)).
‘‘(13) The annual report on the use of National
Security Agency personnel as special policemen re-
quired by section 11(a)(5) of the National Security
Agency Act of 1959 (50 U.S.C. 402 note).
‘‘(14) The annual report of the Inspectors Gen-
erals of the intelligence community on proposed re-
sources and activities of their offices required by sec-
tion 8H(g) of the Inspector General Act of 1978.
‘‘(15) The annual report on commercial activi-
ties as security for intelligence collection required by
section 437(c) of title 10, United States Code.
‘‘(16) The annual report on expenditures for
postemployment assistance for terminated intelligence
employees required by section 1611(e)(2) of title 10,
United States Code.
‘‘(17) The annual report on activities of per-
sonnel of the Federal Bureau of Investigation outside
the United States required by section 540C(c)(2) of
title 28, United States Code.
‘‘(18) The annual update on foreign industrial
espionage required by section 809(b) of the Counter-
(c) DISAPPROVAL OF RULES ISSUED NEAR END OF
SESSION.—(1) In addition to the opportunity for review
otherwise provided under this Act, in the case of any mili-
tary tribunal rule for which a report was submitted in ac-
cordance with subsection (a)(1) during the period begin-
ning on the date occurring—
(A) in the case of the Senate, 60 session days,
or
(B) in the case of the House of Representatives,
60 legislative days,
before the date the Congress adjourns a session of Con-
gress and ending on the date on which the same or suc-
ceeding Congress first convenes its next session, section
3 shall apply to such military tribunal rule in the suc-
ceeding session of Congress.
(2)(A) In applying section 3 for purposes of the op-
portunity for additional review provided under paragraph
(1), a military tribunal rule described under such para-
graph shall be treated as though a report on such military
tribunal rule were submitted to Congress under subsection
(a)(1) on—
(i) in the case of the Senate, the 15th session
day, or
(ii) in the case of the House of Representatives,
the 15th legislative day,
I
107TH CONGRESS
2D SESSION
H. R. 4014
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
development of products for rare diseases.
IN THE HOUSE OF REPRESENTATIVES
MARCH 20, 2002
Mr. FOLEY (for himself, Mr. WAXMAN, Mr. SHIMKUS, Mr. BROWN of Ohio,
Mrs. ROUKEMA, Mr. RUSH, Mr. KING, Mr. GREENWOOD, and Mr. DIN-
GELL) 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 the development of products for rare diseases.
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 ‘‘Rare Diseases Orphan
Product Development Act of 2002’’.
SEC. 2. FINDINGS AND PURPOSES.
(a) FINDINGS.—Congress makes the following find-
ings:
(1) Rare diseases and disorders are those which
affect small patient populations, typically popu-
lations smaller than 200,000 individuals in the
United States. Such diseases and conditions include
Huntington’s disease, amyotrophic lateral sclerosis
(Lou Gehrig’s disease), Tourette syndrome, Crohn’s
disease, cystic fibrosis, cystinosis, and Duchenne
muscular dystrophy.
(2) For many years, the 25,000,000 Americans
suffering from the over 6,000 rare diseases and dis-
orders were denied access to effective medicines be-
cause prescription drug manufacturers could rarely
make a profit from marketing drugs for such small
groups of patients. The prescription drug industry
did not adequately fund research into such treat-
ments. Despite the urgent health need for these
medicines, they came to be known as ‘‘orphan
drugs’’ because no companies would commercialize
them.
(3) During the 1970s, an organization called
the National Organization for Rare Disorders
(NORD) was founded to provide services and to
lobby on behalf of patients with rare diseases and
disorders. NORD was instrumental in pressing Con-
gress for legislation to encourage the development of
orphan drugs.
(4) The Orphan Drug Act created financial in-
centives for the research and production of such or-
phan drugs. New Federal programs at the National
Institutes of Health and the Food and Drug Admin-
istration encouraged clinical research and commer-
cial product development for products that target
rare diseases. An Orphan Products Board was estab-
lished to promote the development of drugs and de-
vices for rare diseases or disorders.
(5) Before 1983, some 38 orphan drugs had
been developed. Since the enactment of the Orphan
Drug Act, more than 220 new orphan drugs have
been approved and marketed in the United States
and more than 800 additional drugs are in the re-
search pipeline.
(6) Despite the tremendous success of the Or-
phan Drug Act, rare diseases and disorders deserve
greater emphasis in the national biomedical research
enterprise.
(7) The Food and Drug Administration sup-
ports small clinical trials through Orphan Products
Research Grants. Such grants embody successful
partnerships of government and industry, and have
out the employment, training, and placement services re-
quired under this chapter, including Assistant Directors
for Veterans’ Employment and Training.’’.
(2) CLERICAL AMENDMENTS.—The items relat-
ing to sections 4102A and 4103, respectively, in the
table of sections at the beginning of chapter 41 are
amended to read as follows:
‘‘4102A. Assistant Secretary of Labor for Veterans’ Employment and Training;
program functions; Regional Administrators.
‘‘4103. Directors and Assistant Directors for Veterans’ Employment and Train-
ing; additional Federal personnel.’’.
(3) CONFORMING
AMENDMENT
RELATING
TO
PERFORMANCE STANDARDS.—(A)(i) Section 4104A
is repealed.
(ii) The table of sections at the beginning of
chapter 41 is amended by striking the item relating
to section 4104A.
(B) Section 4107(b) is amended by striking
‘‘The Secretary shall establish definitive performance
standards’’ and inserting ‘‘The Secretary shall apply
performance standards established under section
4102A(f) of this title’’.
(4) EFFECTIVE DATE.—The amendments made
by this subsection shall take effect on December 1,
2002, and shall apply to appointments made on or
after that date.
led to the development of at least 23 drugs and four
medical devices for rare diseases and disorders. Yet
the appropriations in fiscal year 2001 for such
grants were less than in fiscal year 1995.
(b) PURPOSES.—The purpose of this Act is to in-
crease the national investment in the development of
diagnostics and treatments for patients with rare diseases
and disorders.
SEC. 3. FOOD AND DRUG ADMINISTRATION; GRANTS AND
CONTRACTS FOR THE DEVELOPMENT OF OR-
PHAN DRUGS.
Subsection (c) of section 5 of the Orphan Drug Act
(21 U.S.C. 360ee(c)) is amended to read as follows:
‘‘(c) For grants and contracts under subsection (a),
there are authorized to be appropriated such sums as al-
ready have been appropriated for fiscal year 2002, and
$25,000,000 for each of the fiscal years 2003 through
2006.’’.
SEC. 4. TECHNICAL AMENDMENT.
Section 527(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360cc(a)) is amended in the matter
following paragraph (2)—
(1) by striking ‘‘, of such certification,’’; and
(2) by striking ‘‘, the issuance of the certifi-
cation,’’.
Æ
suant to Executive Order 12985 (61 Fed. Reg.
1209).
‘‘(iv) Recently separated veterans.
‘‘(B) The term ‘qualified’, with respect to an
employment position, means having the ability to
perform the essential functions of the position with
or without reasonable accommodation for an indi-
vidual with a disability.’’.
(2) CONFORMING
AND
TECHNICAL
AMEND-
MENTS.—(A) Section 4212(c) is amended—
(i) by striking ‘‘suitable’’; and
(ii) by striking ‘‘subsection (a)(2) of this
section’’ and inserting ‘‘subsection (a)(2)(B)’’.
(B) Section 4212(d)(1) is amended—
(i) in the matter preceding subparagraph
(A), by striking ‘‘of this section’’ after ‘‘sub-
section (a)’’; and
(ii) by amending subparagraphs (A) and
(B) to read as follows:
‘‘(A) the number of employees in the workforce
of such contractor, by job category and hiring loca-
tion, and the number of such employees, by job cat-
egory and hiring location, who are qualified covered
veterans;
HR 4628 EAS
intelligence and Security Enhancements Act of 1994
(title VIII of Public Law 103–359; 50 U.S.C. App.
2170b(b)).
‘‘(19) The annual report on coordination of
counterintelligence matters with the Federal Bureau
of Investigation required by section 811(c)(6) of the
Counterintelligence and Security Enhancements Act
of 1994 (50 U.S.C. 402a(c)(6)).
‘‘(20) The annual report on intelligence activities
of the People’s Republic of China required by section
308(c) of the Intelligence Authorization Act for Fiscal
Year 1998 (Public Law 105–107; 50 U.S.C. 402a
note).
‘‘(21) The annual report on enhancing protection
of national security at the Department of Justice re-
quired by section 606(b)(2)(B) of the Counterintel-
ligence Reform Act of 2000 (title VI of Public Law
106–567).
‘‘(22) The annual report on foreign companies
involved in the proliferation of weapons of mass de-
struction that raise funds in the United States capital
markets required by section 314 of the Intelligence
Authorization Act for Fiscal Year 2003.
into account the needs of disabled veterans and special dis-
abled veterans, and such other factors as the Secretary
determines appropriate.
‘‘(b) ADMINISTRATION OF PROGRAMS AT STATE AND
LOCAL LEVELS.—An entity of a State or a political sub-
division of the State that administers or delivers services
under a qualified job training program shall—
‘‘(1) provide information and priority of service
to covered persons regarding benefits and services
that may be obtained through other entities or serv-
ice providers; and
‘‘(2) ensure that each covered person who ap-
plies to or who is assisted by such a program is in-
formed of the employment-related rights and bene-
fits to which the person is entitled under this sec-
tion.
‘‘(c) ANNUAL REPORT.—By not later than December
31, 2003, and each December 31 thereafter, the Secretary
of Labor, following review and comment by the Advisory
Committee on Veterans Employment and Training, shall
submit to the Committees on Veterans’ Affairs of the
House of Representatives and Senate a report. The report
shall evaluate whether covered persons are receiving pri-
ority of service and are being fully served by qualified job
training programs, and whether the levels of service of
such programs are in proportion to the incidence of rep-
resentation of veterans in the labor market, including
within groups that the Secretary may designate for pri-
ority under such programs, if any.
‘‘(d) DEFINITIONS.—In this section:
‘‘(1) The term ‘covered person’ means any of
the following individuals:
‘‘(A) A veteran.
‘‘(B) The spouse of any of the following in-
dividuals:
‘‘(i) Any veteran who died of a serv-
ice-connected disability.
‘‘(ii) Any member of the Armed
Forces serving on active duty who, at the
time of application for assistance under
this section, is listed, pursuant to section
556 of title 37 and regulations issued
thereunder, by the Secretary concerned in
one or more of the following categories and
has been so listed for a total of more than
90 days: (I) missing in action, (II) cap-
tured in line of duty by a hostile force, or
(III) forcibly detained or interned in line of
duty by a foreign government or power.
‘‘(iii) Any veteran who has a total dis-
ability permanent in nature resulting from
a service-connected disability.
‘‘(iv) Any veteran who died while a
disability so evaluated was in existence.
‘‘(2) The term ‘qualified job training program’
means any workforce preparation, development, or
delivery program or service that is funded, in whole
or in part, by the Department of Labor and includes
the following:
‘‘(A) Any such program or service that
uses technology to assist individuals to access
workforce development programs (such as job
and training opportunities, labor market infor-
mation, career assessment tools, and related
support services).
‘‘(B) Any such program or service under
the public employment service system, one-stop
career centers, the Workforce Investment Act of
1998, a demonstration or other temporary pro-
gram, and those programs implemented by
States or local service providers based on Fed-
eral block grants.