In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

Ex Input:
SECTION 1. SHORT TITLE.

This Act may be cited as the ''Preservation of Antibiotics for
Medical Treatment Act of 2011''.

SEC. 2. FINDINGS.

The Congress finds the following:
(1) In January 2001, a Federal interagency task force--
(A) released an action plan to address the
continuing decline in effectiveness of antibiotics
against common bacterial infections, referred to as
antibiotic resistance;
(B) determined that antibiotic resistance is a
growing menace to all people and poses a serious threat
to public health; and
(C) cautioned that if current trends continue,
treatments for common infections will become
increasingly limited and expensive, and, in some cases,
nonexistent.
(2) Antibiotic resistance, resulting in a reduced number of
effective antibiotics, may significantly impair the ability of
the United States to respond to terrorist attacks involving
bacterial infections or a large influx of hospitalized
patients.
(3)(A) Any overuse or misuse of antibiotics contributes to
the spread of antibiotic resistance, whether in human medicine
or in agriculture.
(B) Recognizing the public health threat caused by
antibiotic resistance, Congress took several steps to curb
antibiotic overuse in human medicine through amendments to the
Public Health Service Act (42 U.S.C. 201 et seq.) made by
section 102 of the Public Health Threats and Emergencies Act
(Public Law 106-505, title I; 114 Stat. 2315), but has not yet
addressed antibiotic overuse in agriculture.
(4) In a March 2003 report, the National Academy of
Sciences stated that--
(A) a decrease in antimicrobial use in human
medicine alone will have little effect on the current
situation; and
(B) substantial efforts must be made to decrease
inappropriate overuse in animals and agriculture.
(5) In 2010, the FDA determined that--
(A) 13.1 million kilograms of antibacterial drugs
were sold for use on food animals in the United States
in 2009;
(B) 3.3 million kilograms of antibacterial drugs
were used for human health in 2009; and
(C) therefore, 80 percent of antibacterial drugs
disseminated in the United States in 2009 were sold for
use on food animals, rather than being used for human
health.
(6)(A) Large-scale, voluntary surveys by the Department of
Agriculture's Animal and Plant Health Inspection Service in
1999, 2001, and 2006 revealed that--
(i) 84 percent of grower-finisher swine farms, 83
percent of cattle feedlots, and 84 percent of sheep
farms administer antimicrobials in the feed or water
for health or growth promotion reasons; and
(ii) many of the antimicrobials identified are
identical or closely related to drugs used in human
medicine, including tetracyclines, macrolides,
Bacitracin, penicillins, and sulfonamides; and
(B) these drugs are used in people to treat serious
diseases such as pneumonia, scarlet fever, rheumatic fever,
venereal disease, skin infections, and even pandemics like
malaria and plague, as well as bioterrorism agents like
smallpox and anthrax.
(7) Many scientific studies confirm that the nontherapeutic
use of antibiotics in agricultural animals contributes to the
development of antibiotic-resistant bacterial infections in
people.
(8) The periodical entitled ''Clinical Infectious
Diseases'' published a report in June 2002, that--
(A) was based on a 2-year review by experts in
human and veterinary medicine, public health,
microbiology, biostatistics, and risk analysis, of more
than 500 scientific studies on the human health impacts
of antimicrobial use in agriculture; and
(B) recommended that antimicrobial agents should no
longer be used in agriculture in the absence of
disease, but should be limited to therapy for diseased
individual animals and prophylaxis when disease is
documented in a herd or flock.
(9) The United States Geological Survey reported in March
2002 that--
(A) antibiotics were present in 48 percent of the
streams tested nationwide; and
(B) almost half of the tested streams were
downstream from agricultural operations.
(10) An April 1999 study by the General Accounting Office
concluded that resistant strains of 3 microorganisms that cause
food-borne illness or disease in humans (Salmonella,
Campylobacter, and E. coli) are linked to the use of
antibiotics in animals.
(11) Epidemiological research has shown that resistant
Salmonella and Campylobacter infections are associated with
increased numbers of ill patients and bloodstream infections,
and increased death.
(12) In 2010, the peer-reviewed journal Molecular Cell
published a study demonstrating that low-dosage use of
antibiotics causes a dramatic increase in genetic mutation,
raising new concerns about the agricultural practice of using
low-dosage antibiotics in order to stimulate growth promotion
and routinely prevent disease in unhealthy conditions.
(13)(A) In January 2003, Consumer Reports published test
results on poultry products bought in grocery stores nationwide
showing disturbingly high levels of Campylobacter and
Salmonella bacteria that were resistant to the antibiotics used
to treat food-borne illnesses.
(B) The Food and Drug Administration's National
Antimicrobial Resistance Monitoring System routinely finds that
retail meat products are contaminated with bacteria (including
the foodborne pathogens Campylobacter and Salmonella) that are
resistant to antibiotics important in human medicine.
(C) In December 2007, the USDA issued a fact sheet on the
recently recognized link between antimicrobial drug use in
animals and Methicillin Resistant Staphylococcus Aureas (MRSA)
infections in humans.
(14) In October 2001, the New England Journal of Medicine
published an editorial urging a ban on nontherapeutic use of
medically important antibiotics in animals.
(15)(A) In 1998, the National Academy of Sciences noted
that antibiotic-resistant bacteria generate a minimum of
$4,000,000,000 to $5,000,000,000 in costs to United States
society and individuals yearly.
(B) In 2009, Cook County Hospital and the Alliance for
Prudent Use of Antibiotics estimated that the total health care
cost of antibiotic resistant infections in the United States
was between $16,600,000,000 and $26,000,000,000 annually.
(16) The American Medical Association, the American Public
Health Association, the National Association of County and City
Health Officials, and the National Campaign for Sustainable
Agriculture are among the more than 300 organizations
representing health, consumer, agricultural, environmental,
humane, and other interests that have supported enactment of
legislation to phase out nontherapeutic use in farm animals of
medically important antibiotics.
(17) In 2010, the Danish Veterinary and Food Administration
testified that the Danish ban of the non-therapeutic use of
antibiotics in food animal production resulted in a marked
reduction in antimicrobial resistance in multiple bacterial
species, including Campylobacter and Enterococci.
(18) In 2009, the Congressional Research Service concluded
that restrictions overseas on the use of antimicrobial drugs in
the production of livestock could impact U.S. export markets
for livestock and poultry.
(19) The Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.)--
(A) requires that all drugs be shown to be safe
before the drugs are approved; and
(B) places the burden on manufacturers to account
for health consequences and prove safety.
(20)(A) The Food and Drug Administration recently modified
the drug approval process for antibiotics to recognize the
development of resistant bacteria as an important aspect of
safety, but most antibiotics currently used in animal
production systems for nontherapeutic purposes were approved
before the Food and Drug Administration began considering
resistance during the drug-approval process.
(B) The Food and Drug Administration has not established a
schedule for reviewing those existing approvals.
(21) Certain non-routine uses of antibiotics in animal
agriculture are legitimate to prevent animal disease.
(22) An April 2004 study by the General Accounting Office--
(A) concluded that Federal agencies do not collect
the critical data on antibiotic use in animals that
they need to support research on human health risks;
and
(B) recommends that the Department of Agriculture
and the Department of Health and Human Services develop
and implement a plan to collect data on antibiotic use
in animals.

SEC. 3. PURPOSE.

The purpose of this Act is to preserve the effectiveness of
medically important antibiotics used in the treatment of human and
animal diseases by reviewing the safety of certain antibiotics for
nontherapeutic purposes in food-producing animals.

SEC. 4. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS.

(a) Definitions.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the
following:
''(ss) Critical Antimicrobial Animal Drug.--The term 'critical
antimicrobial animal drug' means a drug that--
''(1) is intended for use in food-producing animals; and
''(2) is composed wholly or partly of--
''(A) any kind of penicillin, tetracycline,
macrolide, lincosamide, streptogramin, aminoglycoside,
or sulfonamide; or
''(B) any other drug or derivative of a drug that
is used in humans or intended for use in humans to
treat or prevent disease or infection caused by
microorganisms.
''(tt) Nontherapeutic Use.--The term 'nontherapeutic use', with
respect to a critical antimicrobial animal drug, means any use of the
drug as a feed or water additive for an animal in the absence of any
clinical sign of disease in the animal for growth promotion, feed
efficiency, weight gain, routine disease prevention, or other routine
purpose.''.
(b) Applications Pending or Submitted After Enactment.--Section
512(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360b(d)(1)) is amended--
(1) in the first sentence--
(A) in subparagraph (H), by striking ''or'' at the
end;
(B) in subparagraph (I), by inserting ''or'' at the
end; and
(C) by inserting after subparagraph (I) the
following:
''(J) with respect to a critical antimicrobial
animal drug or a drug of the same chemical class as a
critical antimicrobial animal drug, the applicant has
failed to demonstrate that there is a reasonable
certainty of no harm to human health due to the
development of antimicrobial resistance that is
attributable, in whole or in part, to the
nontherapeutic use of the drug; or''; and
(2) in the second sentence, by striking ''(A) through (I)''
and inserting ''(A) through (J)''.
(c) Phased Elimination of Nontherapeutic Use in Animals of Critical
Antimicrobial Animal Drugs Important for Human Health.--Section 512 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by
adding at the end the following:
''(q) Phased Elimination of Nontherapeutic Use in Animals of
Critical Antimicrobial Animal Drugs Important for Human Health.--
''(1) Applicability.--This subsection applies to the
nontherapeutic use in a food-producing animal of a drug--
''(A)(i) that is a critical antimicrobial animal
drug; or
''(ii) that is of the same chemical class as a
critical antimicrobial animal drug; and
''(B)(i) for which there is in effect an approval
of an application or an exemption under subsection (b),
(i), or (j) of section 505; or
''(ii) that is otherwise marketed for use.
''(2) Withdrawal.--The Secretary shall withdraw the
approval of a nontherapeutic use in food-producing animals
described in paragraph (1) on the date that is 2 years after
the date of enactment of this subsection unless--
''(A) before the date that is 2 years after the
date of the enactment of this subsection, the Secretary
makes a final written determination that the holder of
the approved application has demonstrated that there is
a reasonable certainty of no harm to human health due
to the development of antimicrobial resistance that is
attributable in whole or in part to the nontherapeutic
use of the drug; or
''(B) before the date specified in subparagraph
(A), the Secretary makes a final written determination
under this subsection, with respect to a risk analysis
of the drug conducted by the Secretary and other
relevant information, that there is a reasonable
certainty of no harm to human health due to the
development of antimicrobial resistance that is
attributable in whole or in part to the nontherapeutic
use of the drug.
''(3) Exemptions.--Except as provided in paragraph (5), if
the Secretary grants an exemption under section 505(i) for a
drug that is a critical antimicrobial animal drug, the
Secretary shall rescind each approval of a nontherapeutic use
in a food-producing animal of the critical antimicrobial animal
drug, or of a drug in the same chemical class as the critical
antimicrobial animal drug, as of the date that is 2 years after
the date on which the Secretary grants the exemption.
''(4) Approvals.--Except as provided in paragraph (5), if
an application for a drug that is a critical antimicrobial
animal drug is submitted to the Secretary under section 505(b),
the Secretary shall rescind each approval of a nontherapeutic
use in a food-producing animal of the critical antimicrobial
animal drug, or of a drug in the same chemical class as the
critical antimicrobial animal drug, as of the date that is 2
years after the date on which the application is submitted to
the Secretary.
''(5) Exception.--Paragraph (3) or (4), as the case may be,
shall not apply if--
''(A) before the date on which approval would be
rescinded under that paragraph, the Secretary makes a
final written determination that the holder of the
application for the approved nontherapeutic use has
demonstrated that there is a reasonable certainty of no
harm to human health due to the development of
antimicrobial resistance that is attributable in whole
or in part to the nontherapeutic use in the food-
producing animal of the critical antimicrobial animal
drug; or
''(B) before the date specified in subparagraph
(A), the Secretary makes a final written determination
under this subsection, with respect to a risk analysis
of the critical antimicrobial animal drug conducted by
the Secretary and any other relevant information, that
there is a reasonable certainty of no harm to human
health due to the development of antimicrobial
resistance that is attributable in whole or in part to
the nontherapeutic use of the drug.''.

SEC. 5. COMMITTEE HEARINGS ON IMPLEMENTATION.

(a) In General.--The Committee on Energy and Commerce of the House
of Representatives and the Committee on Energy of the Senate shall each
hold a hearing on the implementation by the Commissioner of Food and
Drugs of section 512(q) of the Federal Food, Drug, and Cosmetic Act, as
added by section 4 of this Act.
(b) Exercise of Rulemaking Authority.--Subsection (a) is enacted--
(1) as an exercise of the rulemaking power of the House of
Representatives and Senate, and, as such, they shall be
considered as part of the rules of the House or Senate (as the
case may be), and such rules shall supersede any other rule of
the House or Senate only to the extent that rule is
inconsistent therewith; and
(2) with full recognition of the constitutional right of
either House to change such rules (so far as relating to the
procedure in such House) at any time, in the same manner, and
to the same extent as in the case of any other rule of the
House or Senate.

Ex Output:
Preservation of Antibiotics for Medical Treatment Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms.

Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met. Directs specified congressional committees to hold hearings on the implementation of such a withdrawal of approval.

Ex Input:
SECTION 1. SHORT TITLE.

This Act may be cited as the ''Next Generation Internet Research
Act of 1998''.

SEC. 2. DEFINITIONS.

(a) Terms Used in This Act.--For purposes of this Act--
(1) Internet.--The term ''Internet'' has the meaning given
such term by section 230(e)(1) of the Communications Act of
1934 (47 U.S.C. 230(e)(1)).
(2) Geographic penalty.--The term ''geographic penalty''
means the imposition of costs on users of the Internet in rural
or other locations attributable to the distance of the user
from network facilities, the low population density of the area
in which the user is located, or other factors, that are
disproportionately greater than the costs imposed on users in
locations closer to such facilities or on users in locations
with significantly greater population density.
(b) Definition of Network in High-Performance Computing Act of
1991.--Paragraph (4) of section 4 of the High-Performance Computing Act
of 1991 (15 U.S.C. 5503) is amended by striking ''network referred to
as the National Research and Education Network established under
section 102; and'' and inserting ''network, including advanced computer
networks of Federal agencies and departments; and''.

SEC. 3. FINDINGS.

(a) In General.--The Congress finds that--
(1) United States leadership in science and technology has
been vital to the Nation's prosperity, national and economic
security, and international competitiveness, and there is every
reason to believe that maintaining this tradition will lead to
long-term continuation of United States strategic advantages in
information technology;
(2) the United States' investment in science and technology
has yielded a scientific and engineering enterprise without
peer, and that Federal investment in research is critical to
the maintenance of United States leadership;
(3) previous Federal investment in computer networking
technology and related fields has resulted in the creation of
new industries and new jobs in the United States;
(4) the Internet is playing an increasingly important role
in keeping citizens informed of the actions of their
government; and
(5) continued inter-agency cooperation is necessary to
avoid wasteful duplication in Federal networking research and
development programs.
(b) Additional Findings for the 1991 Act.--Section 2 of the High-
Performance Computing Act of 1991 (15 U.S.C. 5501) is amended by--
(1) striking paragraph (4) and inserting the following:
''(4) A high-capacity, flexible, high-speed national
research and education computer network is needed to provide
researchers and educators with access to computational and
information resources, act as a test bed for further research
and development for high-capacity and high-speed computer
networks, and provide researchers the necessary vehicle for
continued network technology improvement through research.'';
and
(2) adding at the end thereof the following:
''(7) Additional research must be undertaken to lay the
foundation for the development of new applications that can
result in economic growth, improved health care, and improved
educational opportunities.
''(8) Research in new networking technologies holds the
promise of easing the economic burdens of information access
disproportionately borne by rural users of the Internet.
''(9) Information security is an important part of
computing, information, and communications systems and
applications, and research into security architectures is a
critical aspect of computing, information, and communications
research programs.''.

SEC. 4. PURPOSES.

(a) In General.--The purposes of this Act are--
(1) to serve as the first authorization in a series of
computing, information, and communication technology
initiatives outlines in the High-Performance Computing Act of
1991 (15 U.S.C. 5501 et seq.) that will include research
programs related to--
(A) high-end computing and computation;
(B) human-centered systems;
(C) high confidence systems; and
(D) education, training, and human resources; and
(2) to provide for the development and coordination of a
comprehensive and integrated United States research program
which will--
(A) focus on the research and development of a
coordinated set of technologies that seeks to create a
network infrastructure that can support greater speed,
robustness, and flexibility than is currently available
and promote connectivity and interoperability among
advanced computer networks of Federal agencies and
departments;
(B) focus on research in technology that may result
in high-speed data access for users that is both
economically viable and does not impose a geographic
penalty; and
(C) encourage researchers to pursue approaches to
networking technology that lead to maximally flexible
and extensible solutions wherever feasible.
(b) Modification of Purposes of the 1991 Act.--Section 3 of the
High-Performance Computing Act of 1991 (15 U.S.C. 5502) is amended by--
(1) striking the section caption and inserting the
following:

''SEC. 3. PURPOSES.'';

(2) striking ''purpose of this Act is'' and inserting
''purposes of this Act are'';
(3) striking ''universities; and'' in paragraph (1)(I) and
inserting ''universities;'';
(4) striking ''efforts.'' in paragraph (2) and inserting
''network research and development programs;''; and
(5) adding at the end thereof the following:
''(3) promoting the further development of an information
infrastructure of information stores, services, access
mechanisms, and research facilities available for use through
the Internet;
''(4) promoting the more rapid development and wider
distribution of networking management and development tools;
and
''(5) promoting the rapid adoption of open network
standards.''.

SEC. 5. DUTIES OF ADVISORY COMMITTEE.

Title I of the High-Performance Computing Act of 1991 (15 U.S.C
5511 et seq.) is amended by adding at the end thereof the following:

''SEC. 103. ADVISORY COMMITTEE.

''(a) In General.--In addition to its functions under Executive
Order 13035 (62 F.R. 7231), the Advisory Committee on High-Performance
Computing and Communications, Information Technology, and the Next
Generation Internet, established by Executive Order No. 13035 of
February 11, 1997 (62 F.R. 7231) shall--
''(1) assess the extent to which the Next Generation
Internet program--
''(A) carries out the purposes of this Act;
''(B) addresses concerns relating to, among other
matters--
''(i) geographic penalties (as defined in
section 2(2) of the Next Generation Internet
Research Act of 1998); and
''(ii) technology transfer to and from the
private sector; and
''(2) assess the extent to which--
''(A) the role of each Federal agency and
department involved in implementing the Next Generation
Internet program is clear, complementary to and non-
duplicative of the roles of other participating
agencies and departments; and
''(B) each such agency and department concurs with
the rule of each other participating agency or
department.
''(b) Reports.--The Advisory Committee shall assess implementation
of the Next Generation Internet initiative and report, not less
frequently than annually, to the President, the United States Senate
Committee on Commerce, Science, and Transportation, and the United
States House of Representatives Committee on Science on its findings
for the preceding fiscal year. The first such report shall be submitted
6 months after the date of enactment of the Next Generation Internet
Research Act of 1998 the last report shall be submitted by September
30, 2000.''.

SEC. 6. AUTHORIZATION OF APPROPRIATIONS.

Title I of the High-Performance Computing Act of 1991 (15 U.S.C
5511 et seq.), as amended by section 5 of this Act, is amended by
adding at the end thereof the following:

''SEC. 104. AUTHORIZATION OF APPROPRIATIONS.

''There are authorized to be appropriated for the purpose of
carrying out the Next Generation Internet program the following
amounts:

------------------------------------------------------------------------
''Agency FY 1999 FY 2000
------------------------------------------------------------------------
''Department of Defense.................... $40,000,000 $42,500,000
''Department of Energy..................... $20,000,000 $25,000,000
''National Science Foundation.............. $25,000,000 $25,000,000
''National Institutes of Health............ $5,000,000 $7,500,000
''National Aeronautics and Space
Administration............................ $10,000,000 $10,000,000
''National Institute of Standards and
Technology................................ $5,000,000 $7,500,000.
------------------------------------------------------------------------

The amount authorized for the Department of Defense for fiscal year
1999 under this section shall be the amount authorized pursuant to the
National Defense Authorization Act for Fiscal Year 1999.''.

SEC. 7. STUDY OF EFFECTS ON TRADEMARKS AND INTELLECTUAL PROPERTY RIGHTS
OF ADDING GENERIC TOP-LEVEL DOMAINS.

(a) Study by National Research Council.--Not later than 60 days
after the date of enactment of this Act, the Secretary of Commerce
shall request the National Research Council of the National Academy of
Sciences to conduct a comprehensive study, taking into account the
diverse needs of domestic and international Internet users, of the
short-term and long-term effects on trademark and intellectual property
rights holders of adding new generic top-level domains and related
dispute resolution procedures.
(b) Matters To Be Assessed In Study.--The study shall assess and,
as appropriate, make recommendations for policy, practice, or
legislative changes relating to--
(1) the short-term and long-term effects on the protection
of trademark and intellectual property rights and consumer
interests of increasing or decreasing the number of generic
top-level domains;
(2) trademark and intellectual property rights clearance
processes for domain names, including--
(A) whether domain name databases should be readily
searchable through a common interface to facilitate the
clearing of trademarks and intellectual property rights
and proposed domain names across a range of generic
top-level domains;
(B) the identification of what information from
domain name databases should be accessible for the
clearing of trademarks and intellectual property
rights; and
(C) whether generic top-level domain registrants
should be required to provide certain information;
(3) domain name trademark and intellectual property rights
dispute resolution mechanisms, including how to--
(A) reduce trademark and intellectual property
rights conflicts associated with the addition of any
new generic top-level domains; and
(B) reduce trademark and intellectual property
rights conflicts through new technical approaches to
Internet addressing;
(4) choice of law or jurisdiction for resolution of
trademark and intellectual property rights disputes relating to
domain names, including which jurisdictions should be available
for trademark and intellectual property rights owners to file
suit to protect such trademarks and intellectual property
rights;
(5) trademark and intellectual property rights infringement
liability for registrars, registries, or technical management
bodies; and
(6) short-term and long-term technical and policy options
for Internet addressing schemes and the impact of such options
on current trademark and intellectual property rights issues.
(c) Cooperation With Study.--
(1) Interagency cooperation.--The Secretary of Commerce
shall--
(A) direct the Patent and Trademark Office, the
National Telecommunications and Information
Administration, and other Department of Commerce
entities to cooperate fully with the National Research
Council in its activities in carrying out the study
under this section; and
(B) request all other appropriate Federal
departments, Federal agencies, Government contractors,
and similar entities to provide similar cooperation to
the National Research Council.
(2) Private corporation cooperation.--The Secretary of
Commerce shall request that any private, not-for-profit
corporation established to manage the Internet root server
system and the top-level domain names provide similar
cooperation to the National Research Council.
(d) Report.--
(1) In general.--Not later than 12 months after the date of
enactment of this Act, the National Research Council shall
complete the study under this section and submit a report on
the study to the Secretary of Commerce. The report shall set
forth the findings, conclusions, and recommendations of the
Council concerning the effects of adding new generic top-level
domains and related dispute resolution procedures on trademark
and intellectual property rights holders.
(2) Submission to congressional committees.--Not later than
30 days after the date on which the report is submitted to the
Secretary of Commerce, the Secretary shall submit the report to
the Committees on Commerce and the Committees on the Judiciary
of the Senate and House of Representatives.
(e) Authorization of Appropriations.--There is authorized to be
appropriated $800,000 for the study conducted under this Act.

Passed the Senate June 26, 1998.

Attest:

GARY SISCO,

Secretary.

Ex Output:
Next Generation Internet Research Act of 1998 - Declares the purposes of this Act to be to: (1) serve as the first authorization in a series of computing, information, and communication technology initiatives outlined in the High-Performance Computing Act of 1991 (HPCA); and (2) provide for the development and coordination of a comprehensive and integrated U.S. research program on computer network infrastructure, high-speed data access, and networking technology. Directs the Advisory Committee on High-Performance Computing and Communications, Information Technology, and the Next Generation Internet (created under the HPCA) to assess the extent to which: (1) the Next Generation Internet program (program) carries out the purposes of this Act and addresses concerns relating to geographic penalties (costs imposed on Internet users in rural or small population areas that are greater than those imposed on users in large population areas or areas closer to network facilities) and technology transfer to and from the private sector; and (2) the role of each Federal department and agency involved in implementing the program is clear, complementary, and non-duplicative, as well as the extent to which each such department and agency concurs with the role of each other participating department or agency.
Requires the Advisory Committee to assess program implementation and report at least annually to the President and specified congressional committees.
Authorizes appropriations for FY 1999 and 2000 for the program. Requires the amount authorized for the Department of Defense for FY 1999 to be the amount authorized pursuant to the National Defense Authorization Act for FY 1999.
Directs the Secretary of Commerce to request the National Research Council of the National Academy of Sciences to conduct a comprehensive study, taking into account the diverse needs of domestic and international Internet users, of the short-term and long-term effects on trademark and intellectual property rights holders of adding new generic top-level domains and related dispute resolution procedures. Sets forth reporting requirements for the Council and the Secretary. Authorizes appropriations.

Ex Input:
SECTION 1. SHORT TITLE.

This Act may be cited as the ''Medication Equity and Drug Savings
Act''.

SEC. 2. IMPORTATION OF COVERED PRODUCTS FOR PERSONAL USE.

(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.) is amended by adding at the end
the following:

''SEC. 805. IMPORTATION OF COVERED PRODUCTS FOR PERSONAL USE.

''(a) Definitions.--In this section:
''(1) Covered product.--The term 'covered product' means a
prescription drug described in section 503(b)(1).
''(2) Foreign country.--The term 'foreign country' means--
''(A) Australia, Canada, Israel, Japan, New
Zealand, Switzerland, and South Africa; and
''(B) any other country, union, or economic area
that the Secretary designates for the purposes of this
section, subject to such limitations as the Secretary
determines to be appropriate to protect the public
health.
''(3) Market value.--The term 'market value' means--
''(A) the price paid for a covered product in
foreign country; or
''(B) in the case of a gift, the price at which the
covered product is being sold in the foreign country
from which the covered product is imported.
''(b) Importation in Person.--
''(1) Regulations.--Notwithstanding subsections (d) and (t)
of section 301 and section 801(a), the Secretary shall
promulgate regulations permitting individuals to import into
the United States from a foreign country, in personal baggage,
a covered product that meets--
''(A) the conditions specified in paragraph (2);
and
''(B) such additional criteria as the Secretary
specifies to ensure the safety of patients in the
United States.
''(2) Conditions.--A covered product may be imported under
the regulations if--
''(A) the intended use of the covered product is
appropriately identified;
''(B) the covered product is not considered to
represent a significant health risk (as determined by
the Secretary without any consideration given to the
cost or availability of such a product in the United
States); and
''(C) the individual seeking to import the covered
product--
''(i) states in writing that the covered
product is for the personal use of the
individual;
''(ii) seeks to import a quantity of the
covered product appropriate for personal use,
such as a 90-day supply;
''(iii) provides the name and address of a
health professional licensed to prescribe drugs
in the United States that is responsible for
treatment with the covered product or provides
evidence that the covered product is for the
continuation of a treatment begun in a foreign
country;
''(iv) provides a detailed description of
the covered product being imported, including
the name, quantity, and market value of the
covered product;
''(v) provides the time when and the place
where the covered product is purchased;
''(vi) provides the port of entry through
which the covered product is imported;
''(vii) provides the name, address, and
telephone number of the individual who is
importing the covered product; and
''(viii) provides any other information
that the Secretary determines to be necessary,
including such information as the Secretary
determines to be appropriate to identify the
facility in which the covered product was
manufactured.
''(3) Importation by an individual other than the
patient.--The regulations shall permit an individual who seeks
to import a covered product under this subsection to designate
another individual to effectuate the importation if the
individual submits to the Secretary a certification by a health
professional licensed to prescribe drugs in the United States
that travelling to a foreign country to effectuate the
importation would pose a significant risk to the health of the
individual.
''(4) Consultation.--In promulgating regulations under
paragraph (1), the Secretary shall consult with the United
States Trade Representative and the Commissioner of Customs.
''(c) Importation by Mail.--
''(1) Regulations.--Notwithstanding subsections (d) and (t)
of section 301 and section 801(a), the Secretary shall
promulgate regulations permitting individuals to import into
the United States by mail a covered product that meets such
criteria as the Secretary specifies to ensure the safety of
patients in the United States.
''(2) Criteria.--In promulgating regulations under
paragraph (1), the Secretary shall impose the conditions
specified in subsection (b)(2) to the maximum extent
practicable.
''(3) Consultation.--In promulgating regulations under
paragraph (1), the Secretary shall consult with the United
States Trade Representative and the Commissioner of Customs.
''(d) Records.--Any information documenting the importation of a
covered product under subsections (b) and (c) shall be gathered and
maintained by the Secretary for such period as the Secretary determines
to be appropriate.
''(e) Study and Report.--
''(1) Study.--The Secretary shall conduct a study on the
imports permitted under this section, taking into consideration
the information received under subsections (b) and (c).
''(2) Evaluations.--In conducting the study, the Secretary
shall evaluate--
''(A) the safety and purity of the covered products
imported; and
''(B) patent, trade, and other issues that may have
an effect on the safety or availability of the covered
products.
''(3) Report.--Not later than 5 years after the date of
enactment of this section, the Secretary shall submit to
Congress a report describing the results of the study.
''(f) No Effect on Other Authority.--Nothing in this section limits
the statutory, regulatory, or enforcement authority of the Secretary
relating to importation of covered products, other than the importation
described in subsections (b) and (c).
''(g) Limitation.--Information collected under this section shall
be subject to section 522a of title 5, United States Code.''.
(b) Conforming Amendment.--Section 801(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(d)(1)) is amended by striking
''section 804'' and inserting ''sections 804 and 805''.

SEC. 3. CORRECTION OF IMPEDIMENTS IN IMPLEMENTATION OF MEDICINE EQUITY
AND DRUG SAFETY ACT OF 2000.

(a) Access to Labeling to Permit Importation.--Section 804 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) is amended--
(1) in subsection (b)--
(A) in paragraph (2), by striking ''and'' at the
end;
(B) in paragraph (3), by striking the period at the
end and inserting ''; and''; and
(C) by adding at the end the following paragraph:
''(4) specify a fair and reasonable fee that a manufacturer
may charge an importer for printing and shipping labels for a
covered product for use by the importer.'';
(2) in subsection (e)(2), by inserting after ''used only
for purposes of testing'' the following: ''or the labeling of
covered products''; and
(3) in subsection (h)--
(A) by striking ''No manufacturer'' and inserting
the following:
''(1) In general.--No manufacturer''; and
(B) by adding at the end the following:
''(2) No conditions for labeling.--No manufacturer of a
covered product may impose any condition for the privilege of
an importer in using labeling for a covered product, except a
requirement that the importer pay a fee for such use
established by regulation under subsection (b)(4).''.
(b) Prohibition of Pricing Conditions.--Paragraph (1) of section
804(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(h))
(as designated by subsection (a)(3)(A)) is amended by inserting before
the period at the end the following: ''that--
''(A) imposes a condition regarding the price at
which an importer may resell a covered product; or
''(B) discriminates against a person on the basis
of--
''(i) importation by the person of a
covered product imported under subsection (a);
or
''(ii) sale or distribution by the person
of such covered products''.
(c) Conditions for Taking Effect.--Section 804 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384) is amended by striking
subsection (l) and inserting the following:
''(l) Conditions for Taking Effect.--
''(1) In general.--Except as provided in paragraph (2),
this section shall become effective only if the Secretary
certifies to Congress that there is no reasonable likelihood
that the implementation of this section would pose any
appreciable additional risk to the public health or safety.
''(2) Regulations.--Notwithstanding the failure of the
Secretary to make a certification under paragraph (1), the
Secretary, not later than 30 days after the date of enactment
of this paragraph, shall commence a rulemaking for the purpose
of formulating regulations to enable the Secretary to implement
this section immediately upon making such a certification.''.
(d) Repeal of Sunset Provision.--Section 804 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384) is amended by striking
subsection (m).
(e) Authorization of Appropriations.--Section 804 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 384) (as amended by subsection
(d)) is amended by adding at the end the following:
''(m) Authorization of Appropriations.--There are authorized to be
appropriated for fiscal year 2002 and each subsequent fiscal year such
sums as are necessary to carry out this section.''.

Ex Output:
Medication Equity and Drug Savings Act - Amends the Federal Food, Drug, and Cosmetic Act to require regulations permitting the personal-use importation into the United States of covered prescription drugs in personal baggage or by mail.Amends the Medicine Equity and Drug Safety Act of 2000 respecting specified imported pharmaceutical regulations to: (1) eliminate the sunset provision; (2) prohibit manufacturers from imposing importer pricing or labeling conditions, other than label fees; and (3) revise certification and rulemaking conditions.