[Congressional Record Volume 146, Number 123 (Thursday, October 5, 2000)]
[Senate]
[Pages S9949-S9963]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PHYSICIAN RECRUITMENT AND RETENTION ACT OF 2000
Mr. DOMENICI. Mr. President, I rise today with my friend Senator
Bingaman to introduce the ``Physician Recruitment and Retention Act of
2000.''
Almost like clockwork one can pick up an Albuquerque newspaper and
read about the shortage of physicians in New Mexico and the resulting
problems. When individuals have difficulty receiving adequate medical
treatment, action must be taken.
For example, in Albuquerque an urban area of almost 700,000 there are
only two neurosurgeons besides the five practicing at the University of
New Mexico. Such a ratio can only cause one thing, severe difficulties
for patients. Thus, a patient recently waited eighteen hours in an
Albuquerque emergency room before seeing a neurosurgeon.
I would ask my colleagues the following: what good are hospitals
filled with the latest technology if there are not enough doctors? And
what good are modern medical offices if there are not enough doctors to
treat the patients in a timely manner?
The problem I have just described is not just occurring in New
Mexico, rather other states are experiencing similar problems because
of a common set of problems. I would submit the combination of high
levels of poverty and low Medicare reimbursement rates causes a twofold
problem.
First, patients often have difficulty obtaining timely care and
second, states cannot effectively recruit and retain their physicians.
Our Bill builds upon the simple proposition that if Medicare Physician
reimbursement rates are raised, patients will be the ultimate
beneficiaries.
The Bill we are introducing creates a two state demonstration program
to address these problems by increasing Medicare Physician
reimbursements by 5 percent for a period of three years if certain
criteria are met.
The Bill also authorizes a GAO study to determine whether: (1)
patient access to care and the ability of states to recruit and retain
physicians is adversely impacted when the enumerated factors in the
previous section are present; and (2) increased Medicare Physician
reimbursements improve patient access to care and the ability of states
to recruit and retain physicians.
Thank you and I look forward to working with my colleague, Senator
Bingaman, on this very important issue.
Mr. President, I ask unanimous consent that a copy of the bill be
printed in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 3167
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Physician Recruitment and
Retention Act of 2000''.
SEC. 2. MEDICARE PHYSICIAN RECRUITMENT AND RETENTION
DEMONSTRATION PROJECT.
(a) Establishment.--The Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall establish a demonstration project for the purpose of
improving--
(1) access to health care for beneficiaries under part B of
the medicare program under title XVIII of the Social Security
Act (42 U.S.C. 1395j et seq.); and
(2) the ability of States to recruit and retain physicians.
(b) Conduct of Demonstration Project.--
(1) Demonstration sites.--The demonstration project under
this section shall be conducted in 2 sites, which shall be
statewide.
(2) Recruitment and retention of physicians.--Under the
demonstration project, the Secretary shall increase by 5
percent payments for physicians' services (as defined in
section 1861(q) of the Social Security Act (42 U.S.C.
1395x(q)) under section 1848 of such Act (42 U.S.C. 1395w-4)
to physicians furnishing such services in any State that
submits an application under paragraph (3) that is approved
by the Secretary under paragraph (4).
(3) Application.--Any State wishing to participate in the
demonstration program shall submit an application to the
Secretary at such time, in such manner, and in such form as
the Secretary may reasonably require.
(4) Approval.--The Secretary shall approve the applications
of 2 States that, based upon 1998 data, have--
(A) an uninsured population above 20 percent (as determined
by the Bureau of the Census);
(B) a population eligible for medical assistance under the
medicaid program under title XIX of the Social Security Act
(42 U.S.C. 1396 et seq.) above 17 percent (as determined by
the Health Care Financing Administration);
(C) an unemployment rate above 4.8 percent (as determined
by the Bureau of Labor Statistics);
(D) an average per capita income below $21,200 (as
determined by the Bureau of Economic Analysis); and
(E) a geographic practice cost indices component of the
reimbursement rate for physicians under the medicare program
that is below the national average (as determined by the
Health Care Financing Administration).
(5) Duration.--The demonstration project under this section
shall be conducted for a period of 3 years.
(c) Waiver Authority.--The Secretary may waive such
requirements of the medicare program under title XVIII of the
Social Security Act (42 U.S.C. 1395 et seq.) to the extent
and for the period that the Secretary determines is necessary
for carrying out the demonstration project under this
section.
(d) GAO Study and Report.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on the demonstration project conducted
under this section to determine whether the access of
beneficiaries under the medicare program to health care and
the ability of States to recruit and retain physicians is--
(A) adversely impacted by the factors described in
subparagraphs (A) through (E) of subsection (b)(4); and
(B) improved by increased payments to physicians under
subsection (b)(2).
(2) Report.--Not later than 1 year after the Secretary
completes the demonstration project under this section, the
Comptroller General of the United States shall submit a
report on the results of the study conducted under paragraph
(1) to the appropriate committees of Congress.
______
By Mr. TORRICELLI:
S. 3168. A bill to eliminate any limitation on indictment for sexual
offenses and make awards to State to reduce their DNA casework
backlogs; to the Committee on the Judiciary.
Sexual assault Prosecution act of 2000
Mr. TORRICELLI. Mr. President, I rise today to introduce the Sexual
Assault Prosecution act of 2000. This legislation will ensure that no
rapist will evade prosecution when there is reliable evidence of their
guilt.
As the law is written today, a rapist can walk away scot-free if they
are not charged within five years of committing their crime. This is
true when if overwhelming evidence of the offender's guilt, such as a
DNA match with evidence taken from the crime scene, is later
discovered. Some states, including my home state of New Jersey, have
recognized the injustice presented by this situation and have already
abolished their statutes of limitations on sexual assault crimes, and
many other states are considering similar measures. Given the power and
precision of DNA evidence, it is now time that the federal government
abolish the current statute of limitations on federal sexual assault
crimes.
The precision with which DNA evidence can identify a criminal
assailant
[[Page S9950]]
has increased dramatically over the past couple decades. Because of its
exactness, DNA evidence is now routinely collected by law enforcement
personnel in the course of investigating many crimes, including sexual
assault crimes. The DNA profile of evidence collected at a sexual
assault crime scene can be compared to the DNA profiles of convicted
criminals, or the profile of a particular suspect, in order to
determine who committed the crime. Moreover, because of the longevity
of DNA evidence, it can be used to positively identify a rapist many
years after the actual sexual assault.
The enormous advancements in DNA science have greatly expanded law
enforcement's ability to investigate and prosecute sexual assault
crimes. Unfortunately, the law has not kept pace with science. Given
the precise accuracy and reliability of DNA testing, however, the legal
and moral justifications for continuing to impose a statute of
limitations on sexual assault crimes are extremely weak. To that end, I
am introducing the ``Sexual Assault Prosecution Act of 2000'' which
will eliminate the statute of limitations for sexual assault crimes.
This legislation will not affect the burdens of proof and the
government will still have to prove guilt beyond a reasonable doubt
before any person could be convicted of a crime.
Currently, the statute of limitations for arson and financial
institution crimes is 10 years and is 20 years for crimes involving the
theft of major artwork. If it made sense to extend the traditional
five-year limitations period for these offenses, surely it makes sense
to do so for sexual assault crimes, particularly when DNA technology
makes it possible to identify an offender many years after the
commission of the crime. By eliminating this ticking clock, we can see
to it that no victim of sexual assault is denied justice simply because
the clock ran out. I look forward to working with each and every one of
you in order to get this legislation enacted into law.
I ask unanimous consent that the full text of the bill be printed in
the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 3168
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Sexual Assault Prosecution
Act of 2000''.
SEC. 2. SEXUAL OFFENSE LIMITATION.
(a) In General.--Chapter 213 of title 18, United States
Code, is amended--
(1) in section 3283, by striking ``sexual or''; and
(2) by adding at the end the following:
``Sec. 3296. Sexual offenses
``An indictment for any offense committed in violation of
chapter 109A of this title may be found at any time without
limitation.''.
(b) Technical and Conforming Amendments.--The table of
sections for chapter 213 of title 18, United States Code, is
amended by adding at the end the following:
``3296. Sexual offenses.''.
SEC. 3. AWARDS TO STATES TO REDUCE DNA CASEWORK BACKLOG.
(a) Development of Plan.--
(1) In general.--Not later than 45 days after the date of
enactment of this Act, the Director of the Federal Bureau of
Investigation, in coordination with the Assistant Attorney
General of the Office of Justice Programs of the Department
of Justice, and after consultation with representatives of
States and private forensic laboratories, shall develop a
plan to grant voluntary awards to States to facilitate DNA
analysis of all casework evidence of unsolved crimes.
(2) Objective.--The objective of the plan developed under
paragraph (1) shall be to effectively expedite the analysis
of all casework evidence of unsolved crimes in an efficient
and effective manner, and to provide for the entry of DNA
profiles into the combined DNA Indexing System (``CODIS'').
(b) Award Criteria.--The Federal Bureau of Investigation,
in coordination with the Assistant Attorney General of the
Office of Justice Programs of the Department of Justice,
shall develop criteria for the granting of awards under this
section including--
(1) the applying State's number of unsolved crimes awaiting
DNA analysis; and
(2) the applying State's development of a comprehensive
plan to collect and analyze DNA evidence.
(c) Granting of Awards.--The Federal Bureau of
Investigation, in coordination with the Assistant Attorney
General of the Office of Justice Programs of the Department
of Justice, shall develop applications for awards to be
granted to States under this section, shall consider all
applications submitted by States, and shall disburse all
awards under this section.
(d) Award Conditions.--States receiving awards under this
section shall--
(1) require that each laboratory performing DNA analysis
satisfies quality assurance standards and utilizes state-of-
the-art DNA testing methods, as set forth by the Federal
Bureau of Investigation in coordination with the Assistant
Attorney General of the Office of Justice Programs of the
Department of Justice;
(2) ensure that each DNA sample collected and analyzed be
made available only--
(A) to criminal justice agencies for law enforcement
purposes;
(B) in judicial proceedings if otherwise admissible;
(C) for criminal defense purposes, to a criminal defendant,
who shall have access to samples and analyses performed in
connection with any case in which such defendant is charged;
or
(D) if personally identifiable information is removed, for
a population statistics database, for identification research
and protocol development purposes, or for quality control
purposes; and
(3) match the award by spending 15 percent of the amount of
the award in State funds to facilitate DNA analysis of all
casework evidence of unsolved crimes.
(e) Authorization of Appropriations.--There are authorized
to be appropriated to the Department of Justice $15,000,000
for each of fiscal years 2001, 2002, 2003, and 2004, for
awards to be granted under this section.
______
Mr. SESSIONS (for himself, Mr. Bingaman, Mr. Allard, Mr. Johnson,
Mr. Crapo, and Mrs. Lincoln):
S. 3169. A bill to amend the Federal Food, Drug, and Cosmetic Act and
the International Revenue Code of 1986 with respect to drugs for minor
animal species, and for other purposes; to the Committee on Finance.
minor animal species health and welfare act of 2000
Mr. SESSIONS. Mr. President, I rise today to bring attention to a
problem that unfortunately goes largely unnoticed except by those who
are directly affected. Livestock and food animal producers, pet owners,
zoo and wildlife biologists, and animals themselves are facing a severe
shortage of approved animal drugs for minor species.
Minor species include thousands of animal species, including all
fish, birds, and sheep. By definition, they are any animals other than
cattle, horses, chickens, swine, turkeys, dogs and cats, the most
common animals. There are millions of those animals. A similar shortage
of drugs and medicines for major animal species exists for diseases
which occur infrequently or which occur in limited geographic areas.
Due to the lack of availability for these minor-use drugs, millions of
animals go untreated or treatment is delayed. Unnecessary animal
physical and human emotional suffering results, and human health may be
threatened as well.
Without access to these necessary minor-use drugs, farmers and
ranchers will also suffer. An unhealthy animal left untreated can
spread disease throughout an entire stock. This causes severe economic
hardship to struggling ranchers and farmers.
For example, sheep ranchers lost nearly $45 million worth of
livestock alone in 1999. The sheep industry estimates that if it had
access to effective and necessary drugs, growers' reproduction costs
for their animals could be cut by up to 15 percent. In addition,
feedlot deaths from disease would be reduced by 1 to 2 percent, adding
approximately $8 million to the revenue of the industry.
The catfish industry is the No. 2 agriculture industry in Alabama.
Though it is not the State's only aquacultural commodity, catfish is by
far its largest. The catfish industry generates enormous economic
opportunity in the State, particularly in west Alabama, one of the
poorest regions of the State and where I grew up.
The catfish industry estimates its losses at $60 million a year,
attributable to diseases for which drugs are not available. Indeed, it
is not uncommon for a catfish producer to lose half his stock in a pond
due to disease. The U.S. aquaculture industry overall, including food
fish and ornamental fish, produces and raises over 800 different
species. Unfortunately, this industry has only five drugs that are
approved for treating these diseases. This results in tremendous
economic hardship and suffering.
Because of limited market opportunity, low profit margins, and the
enormous capital investment required, it is seldom economically
feasible for drug manufacturers to pursue research
[[Page S9951]]
and development and then seek approval of it by FDA for drugs used in
treating these minor species and for infrequent conditions and diseases
in all animals. As a result, a group of people have come together, an
effective professional coalition, to deal with this problem.
I, along with Senator Bingaman from New Mexico, Senator Allard,
Senator Crapo, Senator Lincoln, and Senator Johnson resolve to improve
this situation by introducing the Minor Animal Species Health and
Welfare Act of 2000. This legislation will allow animal drug
manufacturers the opportunity to develop and obtain approval for minor-
use drugs which are vitally needed by a wide variety of animal
industries.
Our legislation incorporates the major proposals of the Food and Drug
Administration's Center for Veterinary Medicine to increase the
availability of drugs for minor animal species and rare diseases in all
animals. It actually creates incentives for animal drug manufacturers
to invest in product development and obtain FDA marketing approvals.
This legislation creates a program very similar to the very
successful human orphan drug program that has dramatically increased
the availability of drugs to treat rare human diseases over the past 20
years. Besides providing benefits to livestock producers and animal
owners, this measure will develop incentives and sanctioning programs
for the pharmaceutical industry, while maintaining and ensuring public
health.
The Minor Animal Species Health and Welfare Act will not alter FDA
drug approval responsibilities that ensure the safety of animal drugs
to the public. The FDA Center for Veterinary Medicine currently
evaluates new animal drug products prior to approval and use. This
rigorous testing and review process provides consumers with the
confidence that animal drugs are safe for animals and consumers of
products derived from treated animals.
Current FDA requirements include guidelines to prevent harmful
residues and evaluations to examine the potential for the selection of
resistant pathogens. Any food animal medicine or drug considered for
approval under this bill would be subject to these same assessments.
The Minor Animal Species Health and Welfare Act is supported by 25
organizations, including the American Farm Bureau Federation, the
American Health Institute, the American Veterinary Medical Association,
and the National Aquaculture Association. It is vital legislation.
This act will reduce the economic risks and hardship which fall upon
ranchers and farmers as a result of diseases. It will benefit pets and
their owners and benefit various endangered species of aquatic animals.
The act will also promote the health of all animal species while
protecting human health and will alleviate unnecessary animal
suffering.
This is commonsense legislation which will benefit millions of
American pet owners, farmers, and ranchers. It is the result of a
tremendous cooperative effort by virtually every entity concerned with
this problem. They have worked with the Food and Drug Administration
and continue to work with the FDA on this bill.
I believe we are on the verge of taking a big step to facilitate the
introduction of more drugs that help treat animals in our country. I
thank the people who have all worked to make this a reality. I
particularly thank Mary Alice Tyson on my staff who has worked so hard
on this project.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 3169
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Minor Animal Species Health
and Welfare Act of 2000''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) There is a severe shortage of approved animal drugs for
use in minor species.
(2) There is a severe shortage of approved drugs for
treating animal diseases and conditions that occur
infrequently or in limited geographic areas.
(3) Because of the small market shares, low-profit margins
involved, and capital investment required, it is generally
not economically feasible for animal drug manufacturers to
pursue approvals for these species, diseases, and conditions.
(4) Because the populations for which such drugs are
intended are small and conditions of animal management may
vary widely, it is often difficult or impossible to design
and conduct studies to establish drug safety and
effectiveness under traditional animal drug approval
processes.
(5) It is in the public interest and in the interest of
animal welfare to provide for special procedures to sanction
the lawful use and marketing of animal drugs for minor
species and minor uses that take into account these special
circumstances and that ensure that such drugs do not endanger
the public health.
(6) Exclusive marketing rights and tax credits for clinical
testing expenses have helped encourage the development of
orphan drugs for human use, and comparable incentives will
help encourage the development and sanctioning for lawful
marketing of animal drugs for minor species and minor uses.
SEC. 3. AMENDMENTS AFFECTING THE FOOD AND DRUG
ADMINISTRATION.
(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:
``(kk) The term `minor species' means animals other than
cattle, horses, swine, chickens, turkeys, dogs, and cats,
except that the Secretary may amend this definition by
regulation.
``(ll) The term `minor use' means the use of a drug--
``(1) in a minor species, or
``(2) in an animal species other than a minor species for a
disease or condition that occurs infrequently or in limited
geographic areas, except that the Secretary may amend this
definition by regulation.
``(mm) The term `species with no human food safety concern'
means an animal species, or life stage of an animal species,
that is not customarily used for food for humans and does not
endanger the public health.''.
(b) Minor Use Animal Drugs.--Chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
adding at the end the following new subchapter:
``SUBCHAPTER F--ANIMAL DRUGS FOR MINOR USES
``designation of drugs for minor uses
``Sec. 571. (a) Prior to the submission of an application
for approval of a new animal drug under section 512(b), a
manufacturer or sponsor of such drug may request that the
Secretary designate such drug as a drug for a minor use. The
Secretary shall designate such drug as a drug for minor use
if the Secretary finds that such drug is or will be
investigated for a minor use and the application for such
drug is approved under section 512. A request for a
designation of a drug under this subsection shall contain the
consent of the applicant to notice being given by the
Secretary under subsection (c) respecting the designation of
the drug.
``(b) The designation of a drug as a drug for a minor use
under subsection (a) shall be subject to the condition that--
``(1) if an application was approved for the drug under
section 512(c), the manufacturer of the drug will notify the
Secretary of any discontinuance of the production of the drug
at least 1 year before discontinuance; and
``(2) if an application has not been approved for the drug
under section 512(c) and if preclinical investigations or
investigations under section 512(j) are being conducted with
the drug, the manufacturer or sponsor of the drug will notify
the Secretary of any decision to discontinue active pursuit
of approval of an application under section 512(b).
``(c) Notice respecting the designation of a drug under
subsection (a) shall be made available to the public.
``protection for drugs for minor uses
``Sec. 572. (a) Except as provided in subsection (b):
``(1) If the Secretary approves an application filed
pursuant to section 512 for a drug designated under section
571 for a minor use, no active ingredient (including any salt
or ester of the active ingredient) of which has been approved
in any other application under section 512, the Secretary may
not approve or conditionally approve another application
submitted under section 512 or section 573 for such drug for
such minor use for a person who is not the holder of such
approved application until the expiration of 10 years from
the date of the approval of the application.
``(2) If the Secretary approves an application filed
pursuant to section 512 for a drug designated under section
571 for a minor use, which includes an active ingredient
(including an ester or salt of the active ingredient) that
has been approved in any other application under section 512,
the Secretary may not approve or conditionally approve
another application submitted under section 512 or section
573 for such drug for such minor use for a person who is not
the holder of such approved application until the expiration
of 7 years from the date of approval of the application.
``(b) If an application filed pursuant to section 512 is
approved for a drug designated under section 571, the
Secretary may, during the 10-year or 7-year period beginning
on the date of the application approval, approve or
[[Page S9952]]
conditionally approve another application under section 512
or section 573 for such drug for such minor use for a person
who is not the holder of such approved application if--
``(1) the Secretary finds, after providing the holder
notice and opportunity for the submission of views, that in
such period the holder of the approved application cannot
assure the availability of sufficient quantities of the drug
to meet the needs for which the drug was designated; or
``(2) such holder provides the Secretary in writing the
consent of such holder for the approval or conditional
approval of other applications before the expiration of such
10-year or 7-year period.
``conditional approval for minor use new animal drugs
``Sec. 573. (a)(1) Except as provided in paragraph (2), any
person may file with the Secretary an application for
conditional approval of a new animal drug for a minor use.
Such person shall submit to the Secretary as part of an
application--
``(A) reports of investigations which have been made to
show whether or not such drug is safe for use;
``(B) information to show that there is a reasonable
expectation that the drug is effective for its intended use,
such as data from a pilot investigation, data from an
investigation in a related species, data from a single
investigation, data from an investigation using surrogate
endpoints, data based on pharmacokinetic extrapolations, data
from a short-term investigation, or data from the
investigation of closely-related diseases;
``(C) the quantity of drug expected to be manufactured and
distributed on an annual basis;
``(D) a commitment that the applicant will conduct
additional investigations to support approval of an
application under section 512 within the time frame set forth
in subsection (d)(1)(A);
``(E) reasonable data for establishing a conditional dose;
and
``(F) the information required by section 512(b)(1)(B)-(H).
``(2) A person may not file an application under paragraph
(1) if the person has filed a previous application under
paragraph (1) for the same drug and conditions for use that
was conditionally approved by the Secretary under subsection
(b).
``(b)(1) Within 180 days after the filing of an application
pursuant to subsection (a), or such additional period as may
be agreed upon by the Secretary and the applicant, the
Secretary shall either (A) issue an order conditionally
approving the application if the Secretary then finds that
none of the grounds for denying conditional approval
specified in subsection (c) applies, or (B) give the
applicant notice of an opportunity for an expedited informal
hearing on the question whether such application is
conditionally approvable.
``(2) A drug manufactured in a pilot or other small
facility may be used to demonstrate the safety and
effectiveness of the drug and to obtain conditional approval
for the drug prior to manufacture of the drug in a larger
facility, unless the Secretary makes a determination that a
full scale production facility is necessary to ensure the
safety or effectiveness of the drug.
``(c)(1) If the Secretary finds, after due notice to the
applicant and giving the applicant an opportunity for an
expedited informal hearing, that--
``(A) the investigations, reports of which are required to
be submitted to the Secretary pursuant to subsection (a), do
not include adequate tests by all methods reasonably
applicable to show whether or not such drug is safe for use
under the conditions prescribed, recommended, or suggested in
the proposed labeling;
``(B) the results of such tests show that such drug is
unsafe for use under such conditions or do not show that such
drug is safe for use under such conditions;
``(C) the methods used in, and the facilities and controls
used for, the manufacture, processing, and packing of such
drug are inadequate to preserve its identity, strength,
quality, and purity;
``(D) upon the basis of the information submitted to the
Secretary as part of the application, or upon the basis of
any other information before the Secretary with respect to
such drug, the Secretary has insufficient information to
determine whether such drug is safe for use under such
conditions;
``(E) evaluated on the basis of the information submitted
to the Secretary as part of the application and any other
information before the Secretary with respect to such drug,
there is insufficient information to show that there is a
reasonable expectation that the drug will have the effect it
purports or is represented to have under the conditions of
use prescribed, recommended, or suggested in the proposed
labeling;
``(F) upon the basis of information submitted to the
Secretary as part of the application or any other information
before the Secretary with respect to such drug, any use
prescribed, recommended, or suggested in labeling proposed
for such drug will result in a residue of such drug in excess
of a tolerance found by the Secretary to be safe for such
drug;
``(G) based on a fair evaluation of all material facts,
such labeling is false or misleading in any particular;
``(H) such drug induces cancer when ingested by humans or
animal or, after tests which are appropriate for the
evaluation of the safety of such drug, induces cancer in
humans or animal, unless the Secretary finds that, under the
conditions for use specified in proposed labeling and
reasonably certain to be followed in practice--
``(i) such drug will not adversely affect the animals for
which it is intended; and
``(ii) no residue of such drug will be found (by methods of
examination prescribed or approved by the Secretary by
regulations, which regulations shall not be subject to
subsections (c)) in any edible portion of such animals after
slaughter or in any food yielded by or derived from the
living animals; or
``(I) another person has received approval under section
512 for a drug with the same active ingredient or ingredients
and the same conditions of use, and that person is able to
assure the availability of sufficient quantities of the drug
to meet the needs for which the drug is intended;
the Secretary shall issue an order refusing to conditionally
approve the application. If, after such notice and
opportunity for hearing, the Secretary finds that
subparagraphs (A) through (I) do not apply, the Secretary
shall issue an order conditionally approving the application.
``(2) In determining whether such drug is safe for use
under the conditions prescribed, recommended, or suggested in
the proposed labeling thereof, the Secretary shall consider,
among other relevant factors, (A) the probable consumption of
such drug and of any substance formed in or on food because
of the use of such drug, (B) the cumulative effect on man or
animal of such drug, taking into account any chemically or
pharmacologically related substance, (C) safety factors which
in the opinion of experts, qualified by scientific training
and experience to evaluate the safety of such drugs, are
appropriate for the use of animal experimentation data, and
(D) whether the conditions of use prescribed, recommended, or
suggested in the proposed labeling are reasonably certain to
be followed in practice. Any order issued under this
subsection refusing to approve an application shall state the
findings upon which it is based.
``(d)(1) A conditional approval granted by the Secretary
under this section shall be effective for a 1-year period.
The Secretary shall, upon request, renew a conditional
approval for up to 4 additional 1-year terms, unless the
Secretary by order makes a finding that--
``(A) the applicant is not making appropriate progress
toward meeting approval requirements under section 512, and
is unlikely to be able to fulfill such requirements and
obtain such approval under such section before the 5 year
maximum term of the conditional approval expires;
``(B) excessive quantities of the drug have been produced,
without adequate explanation; or
``(C) another drug with the same active ingredient or
ingredients for the same conditions of use has received
approval under section 512, and the holder of the approved
application is able to assure the availability of sufficient
quantities of the drug to meet the needs for which the drug
is intended.
``(2) If the Secretary does not renew a conditional
approval, the Secretary shall provide due notice and an
opportunity for an expedited informal hearing to the
applicant.
``(e)(1) The Secretary shall, after due notice and
opportunity for an expedited informal hearing to the
applicant, issue an order withdrawing conditional approval of
an application filed pursuant to subsection (a) if the
Secretary finds--
``(A) that experience or scientific data show that such
drug is unsafe for use under the conditions of use upon the
basis of which the application was conditionally approved;
``(B) that new evidence not contained in such application
or not available to the Secretary until after such
application was conditionally approved, or tests by new
methods, or tests by methods not deemed reasonably applicable
when such application was conditionally approved, evaluated
together with the evidence available to the Secretary when
the application was conditionally approved, shows that such
drug is not shown to be safe for use under the conditions of
use upon the basis of which the application was conditionally
approved;
``(C) on the basis of new information before the Secretary
with respect to such drug, evaluated together with the
evidence available to the Secretary when the application was
conditionally approved, that there is not a reasonable
expectation that such drug will have the effect it purports
or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling;
``(D) that the application contains any untrue statement of
a material fact; or
``(E) that the applicant has made any changes from the
standpoint of safety or effectiveness beyond the variations
provided for in the application unless the applicant has
supplemented the application by filing with the Secretary
adequate information respecting all such changes and unless
there is in effect a conditional approval of the supplemental
application, which supplemental application shall be treated
in the same manner as the original application.
If the Secretary finds that there is an imminent hazard to
the health of man or of the animals for which such drug is
intended, the Secretary may suspend the conditional approval
of such application immediately, and give the applicant
prompt notice of the Secretary's action and afford the
applicant the
[[Page S9953]]
opportunity for an expedited informal hearing. Authority to
suspend the conditional approval of an application shall not
be delegated below the Commissioner of Food and Drugs.
``(2) The Secretary may also, after due notice and
opportunity for an expedited informal hearing to the
applicant, issue an order withdrawing the conditional
approval of an application with respect to any new animal
drug under this section if the Secretary finds--
``(A) that the applicant has failed to establish a system
for maintaining required records, or has repeatedly or
deliberately failed to maintain such records or to make
required reports in accordance with a regulation or order
under subsection (h), or the applicant has refused to permit
access to, or copying or verification of, such records as
required by paragraph (2) of such subsection;
``(B) that on the basis of new information before the
Secretary, evaluated together with the evidence before the
Secretary when the application was conditionally approved,
the methods used in, or the facilities and controls used for,
the manufacture, processing, and packing of such drug are
inadequate to assure and preserve its identity, strength,
quality, and purity and were not made adequate within a
reasonable time after receipt of written notice from the
Secretary specifying the matter complained of; or
``(C) that on the basis of new information before the
Secretary, evaluated together with the evidence before the
Secretary when the application was conditionally approved,
the labeling of such drug, based on a fair evaluation of all
material facts, is false or misleading in any particular and
was not corrected within a reasonable time after receipt of
written notice from the Secretary specifying the matter
complained of.
``(3) Any order under this subsection shall state the
findings upon which it is based.
``(f) The decision of the Secretary under subsections (c),
(d), or (e) shall constitute a final agency decision for
purposes of judicial review.
``(g)(1) When an application filed pursuant to subsection
(a) is conditionally approved, the Secretary shall by notice
publish in the Federal Register the name and address of the
applicant and the conditions and indications of use of the
new animal drug covered by such application, including any
tolerance and withdrawal period or other use restriction and,
if such new animal drug is intended for use in animal feed,
appropriate purposes and conditions of use (including special
labeling requirements and any requirement that an animal feed
bearing or containing the new animal drug be limited to use
under the professional supervision of a licensed
veterinarian) applicable to any animal feed for use in which
such drug is conditionally approved, the expiration date of
the conditional approval, and such other information, upon
the basis of which such application was conditionally
approved, as the Secretary deems necessary to assure the safe
and effective use of such drug.
``(2) Upon withdrawal of conditional approval of such new
animal drug application or upon its suspension, the Secretary
shall publish a notice in the Federal Register.
``(h)(1) In the case of any new animal drug for which a
conditional approval of an application filed pursuant to
subsection (a) is in effect, the applicant shall establish
and maintain such records, and make such reports to the
Secretary, of data relating to experience, and other data or
information, received or otherwise obtained by such applicant
with respect to such drug, or with respect to animal feeds
bearing or containing such drug, as the Secretary may by
general regulation, or by order with respect to such
application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination,
whether there is or may be ground for refusing to renew the
conditional approval under subsection (d) or for invoking
subsection (e). Such regulation or order shall provide, where
the Secretary deems it to be appropriate, for the
examination, upon request, by the persons to whom such
regulation or order is applicable, of similar information
received or otherwise obtained by the Secretary.
``(2) Every person required under this subsection to
maintain records, and every person in charge or custody
thereof, shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee
at all reasonable times to have access to and copy and verify
such records.
``(i)(1) The label and labeling of a drug with a
conditional approval under this section shall state that fact
prominently and conspicuously.
``(2) Conditions of use that are the subject of a
conditional approval under this section shall not be combined
in product labeling with any conditions of use approved under
section 512.
``(j)(1) Safety and effectiveness data and information
which has been submitted in an application filed under
subsection (a) for a drug and which has not previously been
disclosed to the public shall be made available to the
public, upon request, unless extraordinary circumstances are
shown--
``(A) if no work is being or will be undertaken to have the
application conditionally approved,
``(B) if the Secretary has determined that the application
is not conditionally approvable and all legal appeals have
been exhausted,
``(C) if conditional approval of the application under
subsection (c) is withdrawn and all legal appeals have been
exhausted, or
``(D) if the Secretary has determined that such drug is not
a new animal drug.
``(2) Any request for data and information pursuant to
paragraph (1) shall include a verified statement by the
person making the request that any data or information
received under such paragraph shall not be disclosed by such
person to any other person--
``(A) for the purpose of, or as part of a plan, scheme, or
device for, obtaining the right to make, use, or market, or
making, using, or marketing, outside the United States, the
drug identified in the application filed under subsection
(a), and
``(B) without obtaining from any person to whom the data
and information are disclosed an identical verified
statement, a copy of which is to be provided by such person
to the Secretary, which meets the requirements of this
paragraph.
``(k) To the extent consistent with the public health, the
Secretary shall promulgate regulations for exempting from the
operation of this section new animal drugs, and animal feeds
bearing or containing new animal drugs, intended solely for
investigational use by experts qualified by scientific
training and experience to investigate the safety and
effectiveness of animal drugs. Such regulations may, in the
discretion of the Secretary, among other conditions relating
to the protection of the public health, provide for
conditioning such exemption upon the establishment and
maintenance of such records, and the making of such reports
to the Secretary, by the manufacturer or the sponsor of the
investigation of such article, of data (including but not
limited to analytical reports by investigators) obtained as a
result of such investigational use of such article, as the
Secretary finds will enable the Secretary to evaluate the
safety and effectiveness of such article in the event of the
filing of an application pursuant to this section. Such
regulations, among other things, shall set forth the
conditions (if any) upon which animals treated with such
articles, and any products of such animals (before or after
slaughter), may be marketed for food use.
``index of legally marketed unapproved minor use animal drugs for minor
species with no human food safety concern
``Sec. 574. (a)(1) The Secretary shall establish an index
of unapproved minor use new animal drugs that may be lawfully
marketed for use in minor species with no human food safety
concern.
``(2) Such index is intended to benefit primarily zoo and
wildlife species, aquarium and bait fish, reptiles and
amphibians, caged birds, and small pet mammals as well as
some commercially produced species such as cricket,
earthworms and possibly nonfood life stages of some minor
species used for human food such as oysters and shellfish.
``(3) Such index shall conform to the requirements in
subsection (d).
``(b)(1) Any person may submit a request to the Secretary
for a preliminary determination that a drug may be eligible
for inclusion in the index. Such a request shall include--
``(A) information regarding the proposed species,
conditions of use, and anticipated annual production;
``(B) information regarding product formulation and
manufacturing; and
``(C) information sufficient for the Secretary to determine
that there does not appear to be human food safety,
environmental safety, occupational safety, or bioavailability
concerns with the proposed use of the drug.
``(2) Within 90 days after the submission of a request for
a preliminary determination under paragraph (1), the
Secretary shall grant or deny the request, and notify the
submitter of the Secretary's conclusion. The Secretary shall
grant the request if it appears that--
``(A) the request addresses the need for a minor use animal
drug for which there is no approved or conditionally approved
drug, and
``(B) the proposed drug use does not appear to raise human
food safety, environmental safety, occupational safety, or
bioavailability concerns.
``(3) If the Secretary denies the request, the Secretary
shall provide due notice and an opportunity for an expedited
informal hearing.
``(4) If the Secretary does not grant or deny the request
within 90 days, the Secretary shall provide the Committee on
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate with the
reasons action on the request did not occur within such 90
days.
``(5) The decision of the Secretary under this subsection
shall constitute a final agency decision for purposes of
judicial review.
``(c)(1) With respect to a drug for which the Secretary has
made a preliminary determination of eligibility under
subsection (b), the submitter of that request may request
that the Secretary add the drug to the index established by
subsection (a). Such a request shall include--
``(A) a copy of the Secretary's preliminary determination
of eligibility issued under subsection (b);
``(B) a qualified expert panel report that meets the
requirements in paragraph (2);
``(C) a proposed index entry;
``(D) proposed labeling;
``(E) anticipated annual production of the drug; and
[[Page S9954]]
``(F) a commitment to manufacture, label, and distribute
the drug in accordance with the index entry and any
additional requirements that the Secretary may prescribe by
general regulation or specific order.
``(2) For purposes of paragraph (1), a `qualified expert
panel report' is a written report that--
``(A) is authored by a panel of individuals qualified by
scientific training and experience to evaluate the safety and
effectiveness of animal drugs for the intended uses and
species in question and operating external to the Food and
Drug Administration;
``(B) addresses all available target animal safety and
effectiveness information, including anecdotal information
where necessary;
``(C) addresses proposed labeling;
``(D) addresses whether the drug should be limited to use
under the professional supervision of a licensed
veterinarian; and
``(E) addresses whether, in the expert panel's opinion, the
benefits of using the drug outweigh its risks, taking into
account the harm being caused by the absence of an approved
or conditionally approved new animal drug for the minor use
in question.
``(3) Within 180 days after the receipt of a request for
listing a drug in the index, the Secretary shall grant or
deny the request. The Secretary shall grant the request if
the Secretary finds, on the basis of the expert panel report
and other information available to the Secretary, that the
benefits of using the drug outweigh its risks, taking into
account the harm caused by the absence of an approved or
conditionally approved new animal drug for the minor use in
question. If the Secretary denies the request, the Secretary
shall provide due notice and the opportunity for an expedited
informal hearing. If the Secretary does not grant or deny the
request within 180 days, the Secretary shall provide the
Committee on Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate with the reasons action on the request did not occur
within such 180 days. The decision of the Secretary under
this paragraph shall constitute a final agency decision for
purposes of judicial review.
``(d)(1) The index established by subsection (a) shall
include the following information for each listed drug:
``(A) The name and address of the sponsor of the index
listing.
``(B) The name of the drug, its dosage form, and its
strength.
``(C) Labeling.
``(D) Production limits or other conditions the Secretary
deems necessary to prevent misuse of the drug.
``(E) Requirements that the Secretary deems necessary for
the safe and effective use of the drug.
``(2) The Secretary shall publish the index, and revise it
monthly.
``(e)(1) If the Secretary finds, after due notice to the
sponsor and an opportunity for an expedited informal hearing,
that--
``(A) on the basis of new information before the Secretary,
evaluated together with the evidence available to the
Secretary when the drug was listed in the index, the benefits
of using the drug do not outweigh its risks, or
``(B) the conditions and limitations of use in the index
listing have not been followed,
the Secretary shall remove the drug from the index. The
decision of the Secretary shall constitute final agency
decision for purposes of judicial review.
``(2) If the Secretary finds that there is an imminent
hazard to the health of man or of the animals for which such
drug is intended, the Secretary may suspend the listing of
such drug immediately, and give the sponsor prompt notice of
the Secretary's action and afford the sponsor the opportunity
for an expedited informal hearing. Authority to suspend the
listing of a drug shall not be delegated below the
Commissioner of Food and Drugs.
``(f)(1) In the case of any new animal drug for which an
index listing pursuant to subsection (a) is in effect, the
sponsor shall establish and maintain such records, and make
such reports to the Secretary, of data relating to
experience, and other data or information, received or
otherwise obtained by such sponsor with respect to such drug,
or with respect to animal feeds bearing or containing such
drug, as the Secretary may by general regulation, or by order
with respect to such listing, prescribe on the basis of a
finding that such records and reports are necessary in order
to enable the Secretary to determine, or facilitate a
determination, whether there is or may be ground for invoking
subsection (e). Such regulation or order shall provide, where
the Secretary deems it to be appropriate, for the
examination, upon request, by the persons to whom such
regulation or order is applicable, of similar information
received or otherwise obtained by the Secretary.
``(2) Every person required under this subsection to
maintain records, and every person in charge or custody
thereof, shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee
at all reasonable times to have access to and copy and verify
such records.
``(g) The labeling of a drug that is the subject of an
index listing shall state, prominently and conspicuously,
that the drug is legally marketed but not approved.
``(h) The Secretary shall promulgate regulations to
implement this section. Such regulations shall address, among
other subjects, the composition of the expert panel,
sponsorship of the expert panel under the auspices of a
recognized professional organization, conflict of interest
criteria for panel members, and the use of advisory
committees convened by the Food and Drug Administration.
``(i) To the extent consistent with the public health, the
Secretary shall promulgate regulations for exempting from the
operation of this section new animal drugs intended solely
for investigational use by experts qualified by scientific
training and experience to investigate the safety and
effectiveness of animal drugs. Such regulations may, in the
discretion of the Secretary, among other conditions relating
to the protection of the public health, provide for
conditioning such exemption upon the establishment and
maintenance of such records, and the making of such reports
to the Secretary, by the manufacturer or the sponsor of the
investigation of such article, of data (including but not
limited to analytical reports by investigators) obtained as a
result of such investigational use of such article, as the
Secretary finds will enable the Secretary to evaluate the
safety and effectiveness of such article in the event of the
filing of a request for an index listing pursuant to this
section. Such regulations, among other things, shall set
forth the conditions (if any) upon which animals treated with
such articles, and any products of such animals (before or
after slaughter), may be marketed for food use.
``grants and contracts for development of animal drugs for minor uses
``Sec. 575. (a) The Secretary may make grants to and enter
into contracts with public and private entities and
individuals to assist in defraying the costs of qualified
testing expenses and manufacturing expenses incurred in
connection with the development of drugs for minor uses.
``(b) For purposes of subsection (a) of this section:
``(1) The term `qualified testing' means--
``(A) clinical testing--
``(i) which is carried out under an exemption for a drug
for minor uses under section 512(j), 573(k), or 574(i); and
``(ii) which occurs after the date such drug is designated
under section 571 and before the date on which an application
with respect to such drug is submitted under section 512; and
``(B) preclinical testing involving a drug for minor use
which occurs after the date such drug is designated under
section 571 and before the date on which an application with
respect to such drug is submitted under section 512.
``(2) The term `manufacturing expenses' means expenses
incurred in developing processes and procedures intended to
meet current good manufacturing practice requirements which
occur after such drug is designated under section 571 and
before the date on which an application with respect to such
drug is submitted under section 512.
``(c) For grants and contracts under subsection (a), there
are authorized to be appropriated $1,000,000 for fiscal year
2001, $1,500,000 for fiscal year 2002, and $2,000,000 for
fiscal year 2003.''.
(c) Three-Year Exclusivity for Minor Use Approvals.--
Section 512(c)(2)(F)(ii), (iii), and (v) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii), (iii),
and (v)) is amended by striking ``(other than bioequivalence
or residue studies)'' and inserting ``(other than
bioequivalence studies or, except in the case of a new animal
drug for minor uses, residue studies)''.
(d) Scope of Review for Minor Use Applications.--Section
512(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360b(d)) is amended by adding at the end the following:
``(5) In reviewing a supplement to an approved application
that seeks a minor use approval, the Secretary shall not
reconsider information in the approved application to
determine whether it meets current standards for approval.''.
(e) Presumption of New Animal Drug Status.--Section 709 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379a) is
amended by designating the existing text as subsection (a),
and by adding after such new subsection the following:
``(b) In any action to enforce the requirements of this Act
respecting a drug for minor use that is not the subject of an
approval under section 512, a conditional approval under
section 573, or an index listing under section 574, it shall
be presumed that the drug is a new animal drug.''.
(f) Conforming Amendments.--
(1) Section 512(a)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended by striking
subparagraphs (A) and (B) and inserting the following:
``(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such use or
intended use of such drug, and such drug, its labeling, and
such use conform to such approved application;
``(B) there is in effect a conditional approval of an
application filed pursuant to section 573 with respect to
such use or intended use of such drug, and such drug, its
labeling, and such use conform to such conditionally approved
application; or
``(C) there is in effect an index listing pursuant to
section 574 with respect to such use or intended use of such
drug, and such drug, its labeling, and such use conform to
such index listing.''.
(2) Section 512(a)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(a)(4)) is amended by adding
after ``if an approval of an application filed under
subsection (b)'' the following: ``or a conditional approval
of an application filed under section 573''.
[[Page S9955]]
(3) Section 503(f) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 353(f)) is amended as follows:
(A) In paragraph (1)(A)(ii) by striking ``512'' and
inserting the following: ``512, a conditionally approved
application under subsection (b) of section 573, or an index
listing under subsection (a) of section 574.''.
(B) In paragraph (3) by striking ``section 512'' and
inserting the following: ``sections 512, 573, or 574.''.
(4) Section 504(a)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 354(a)(1)) is amended by striking
``512(b)'' and inserting ``512(b), a conditionally approved
application filed pursuant to section 573, or an index
listing pursuant to section 574.''.
(5) Section 504(a)(2)(B) and (b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 354(a)(2)(B), and 354(b)) are
amended by striking ``512(i)'' and inserting ``512(i) or
section 573(g), or the index listing pursuant to section
574.''.
(6) Section 403(a) of the Food and Drug Administration
Modernization Act of 1997 (21 U.S.C. 371(a)) is amended by
adding at the end ``For purposes of this section, an approved
article includes a new animal drug that is the subject of a
conditional approval or an index listing under sections 573
and 574 of the Federal Food, Drug, and Cosmetic Act,
respectively.''.
(g) Regulations.--The Secretary of Health and Human
Services shall promulgate proposed regulations to implement
amendments to the Federal Food, Drug, and Cosmetic Act made
by this Act within 6 months of the date of enactment of this
Act, and final regulations within 24 months of the date of
enactment of this Act.
(h) Office of Minor Use Animal Drug Development.--
(1) The Secretary of Health and Human Services shall
establish within the Center of Veterinary Medicine of the
Food and Drug Administration an Office of Minor Use Animal
Drug Development (referred to in this subsection as the
``Office''). The Secretary of Health and Human Services shall
select an individual to serve as the Director of such Office.
The Director of such Office shall report directly to the
Director of the Center for Veterinary Medicine. The Office
shall be responsible for designating minor use animal drugs
under section 571 of the Federal Food, Drug, and Cosmetic
Act, for administering grants and contracts for the
development of animal drugs for minor uses under section 575
of the Federal Food, Drug, and Cosmetic Act, and for serving
as liaison with any party interested in minor use animal drug
development.
(2) For the Office described under paragraph (1), there are
authorized to be appropriated $1,200,000 for each of the
fiscal years 2001 through 2003.
SEC. 4. CREDIT FOR CLINICAL TESTING EXPENSES FOR CERTAIN
ANIMAL DRUGS FOR MINOR USES.
(a) In General.--Subpart D of part IV of subchapter A of
chapter 1 of the Internal Revenue Code of 1986 is amended by
inserting after section 45C the following new section:
``SEC. 45D. CLINICAL TESTING EXPENSES FOR CERTAIN ANIMAL
DRUGS FOR MINOR USES.
``(a) General Rule.--For purposes of section 38, the minor
use animal drug credit determined under this section for the
taxable year is an amount equal to 50 percent of the
qualified animal clinical testing expenses for the taxable
year.
``(b) Qualified Animal Clinical Testing Expenses.--For
purposes of this section--
``(1) Qualified animal clinical testing expenses.--
``(A) In general.--Except as otherwise provided in this
paragraph, the term `qualified animal clinical testing
expenses' means the amounts which are paid or incurred by the
taxpayer during the taxable year which would be described in
subsection (b) of section 41 if such subsection were applied
with the modifications set forth in subparagraph (B).
``(B) Modifications.--For purposes of subparagraph (A),
subsection (b) of section 41 shall be applied--
``(i) by substituting `animal clinical testing' for
`qualified research' each place it appears in paragraphs (2)
and (3) of such subsection, and
``(ii) by substituting `100 percent' for `65 percent' in
paragraph (3)(A) of such subsection.
``(C) Exclusion for amounts funded by grants, etc.--The
term `qualified animal clinical testing expenses' shall not
include any amount to the extent such amount is funded by any
grant, contract, or otherwise by another person (or any
governmental entity).
``(D) Special rule.--For purposes of this paragraph:
``(i) section 41 shall be deemed to remain in effect for
periods after June 30, 2000; and
``(ii) the trade or business requirement of section
41(b)(1) shall be deemed to be satisfied in the case of a
taxpayer that owns animals and that conducts clinical testing
on such animals.
``(2) Animal clinical testing.--
``(A) In general.--The term `animal clinical testing' means
any clinical testing--
``(i) which is carried out under an exemption for a drug
being tested for minor use under section 512(j), 573(k), or
574(i) of the Federal Food, Drug, and Cosmetic Act (or
regulations issued under such sections),
``(ii) which occurs--
``(I) after the date such drug is designated under section
571 of such Act, and
``(II) before the date on which an application with respect
to such drug is approved under section 512(c) of such Act,
and
``(iii) which is conducted by or on behalf of--
``(I) the taxpayer to whom the designation under such
section 571 applies, or
``(II) the owner of the animals that are the subject of
clinical testing.
``(B) Testing must be for minor use.--Animal clinical
testing shall be taken into account under subparagraph (A)
only to the extent such testing is related to the use of a
drug for the minor use for which it was designated under
section 571 of the Federal Food, Drug, and Cosmetic Act.
``(c) Coordination With Credit for Increasing Research
Expenditures.--
``(1) In general.--Except as provided in paragraph (2), any
qualified animal clinical testing expenses for a taxable year
to which an election under this section applies shall not be
taken into account for purposes of determining the credit
allowable under section 41 for such taxable year.
``(2) Expenses included in determining base period research
expenses.--Any qualified animal clinical testing expenses for
any taxable year which are qualified research expenses
(within the meaning of section 41(b)) shall be taken into
account in determining base period research expenses for
purposes of applying section 41 to subsequent taxable years.
``(d) Definition and Special Rules.--
``(1) Minor use.--For purposes of this section, the term
`minor use' has the meaning given such term by section
201(ll) of the Federal Food, Drug, and Cosmetic Act.
Determinations under the preceding sentence with respect to
any drug shall be made on the basis of the facts and
circumstances as of the date such drug is designated under
section 571 of the Federal Food, Drug, and Cosmetic Act.
``(2) Denial of credit for testing conducted by
corporations to which section 936 applies.--No credit shall
be allowed under this section with respect to any animal
clinical testing conducted by a corporation to which an
election under section 936 applies.
``(3) Certain rules made applicable.--Rules similar to the
rules of paragraphs (1) and (2) of section 41(f) shall apply
for purposes of this section.
``(4) Election.--This section shall apply to any taxpayer
for any taxable year only if such taxpayer elects (at such
time and in such manner as the Secretary may by regulations
prescribe) to have this section apply for such taxable
year.''.
(b) Conforming Amendments.--
(1) Section 38(b) of such Code is amended--
(A) by striking ``plus'' at end of paragraph (11),
(B) by striking the period at the end of paragraph (12) and
inserting ``, plus'', and
(C) by adding at the end the following new paragraph:
``(13) the minor use animal drug credit determined under
section 45D(a).''.
(2) Section 280C(b) of such Code is amended--
(A) in paragraph (1), by striking ``section 45C(b)'' and
inserting ``section 45C(b) or 45D(b)'', and
(B) in paragraphs (1) and (2), by striking ``section 45C''
each place it appears and inserting ``section 45C or 45D''.
(c) Clerical Amendment.--The table of sections for subpart
D of part IV of subchapter A of chapter 1 of such Code is
amended by inserting after the item relating to section 45C
the following new item:
``Sec. 45D. Clinical testing expenses for certain animal drugs for
minor uses.''.
(d) Effective Date.--The amendments made by this section
shall apply to taxable years beginning after the date of the
enactment of this Act.
(e) Regulations.--The Secretary of the Treasury shall
publish proposed regulations to implement amendments to the
Internal Revenue Code of 1986 made by this Act within 6
months after the date of the enactment of this Act, and final
regulations within 24 months after such date.
______
Mr. DODD (for himself, Ms. Collins, and Mr. Kennedy):
S. 3170. A bill to amend the Higher Education Act of 1965 to assist
institutions of higher education to help at-risk students to stay in
school and complete their 4-year postsecondary academic programs by
helping those institutions to provide summer programs and grant aid for
such students, and for other purposes; to the Committee on Health,
Education, Labor, and Pensions.
College Completion Challenge Grants Act of 2000
Mr. DODD. Mr. President, I rise today to join Senator Collins in
offering legislation that will support our youth and promote their
abilities by helping them stay in college and complete their degrees.
There is no question that post-secondary education is a critical
component in individual success in today's economy. Parents understand
this reality from the day their children are born and they start
worrying about how to make college affordable. Students know it as they
work to achieve
[[Page S9956]]
good grades and high test scores. And policymakers know it as we work
to increase Pell grants and support increased saving options for
families.
But colleges achievement is not just about being accepted at a higher
education institution. To fully see the benefits of post-secondary
education, one must complete a degree. And yet, while college
enrollment rates have been rising, 37 percent of students who enter
post-secondary education drop out before they receive a degree or
certificate. This problem is especially acute for minorities. Thirty
percent of African-Americans and Hispanic-Americans drop out of college
before the end of their first year. This is almost double the rate of
white Americans.
For these students and for us as a nation, these statistics represent
a lost opportunity. Clearly, these students aspire to greater things--
to more education and better careers. But instead of fulfilling this
promise, they leave school with their potential unrealized.
Unfortunately, many of them also leave school not just with an academic
set-back, but also with substantial student loan debt, which today is
as much a reality of college attendance as is a course syllabus.
The legislation I am introducing today, the ``College Completion
Challenge Grants Act of 2000'', would provide vital support and
assistance to at-risk students to help them stay in school and complete
their degrees. The College Completion Challenge grant program is based
on the successful work of the Student Support Services (SSS) program,
which is one of the Turning R Into Opportunity programs. While TRIO is
better known for its early intervention programs with talented, at-risk
high school students, SSS follows through on these early efforts by
supporting at-risk, first-generation college students once they are
enrolled. The College Completion Challenge grants would supplement
these student support services by offering additional scholarship aid,
intensive summer programs, and further support services to students at
risk of dropping out. Higher education institutions participating in
SSS as well as those that provide similar support through other sources
would be eligible to apply for these additional dollars.
Mr. President, the House of Representatives has already acted on
similar legislation, which was included in the Higher Education
Technical Amendments that passed the House earlier this year. So, I am
hopeful that we too can find an appropriate vehicle to support these
students as they pursue their dreams. I urge my colleagues to support
this legislation.
______
By Mr. MURKOWSKI (for himself, Mr. Breaux, and Mr. Stevens):
S. 3171. A bill to amend the Internal Revenue Code of 1986 to extend
the section 29 credit for producing fuel from a non-conventional
source; to the Committee on Finance.
Energy Security for American Consumers Act of 2000
Mr. MURKOWSKI. Mr. President, if this country is ever going to
achieve the goal of reducing our dependency on foreign sources of oil
to at least 50 percent, we are going to have to provide incentives that
will encourage our energy industry to recover oil and gas from
nonconventional sources.
In the aftermath of the twin oil shocks of the 1970s, Congress
enacted Section 29 of the tax code which provides a tax credit to
encourage production of oil and gas from unconventional sources such as
Devonian shale, tight rock formations, coalbeds and geopressurized
brine. This credit has helped the industry invest in new technologies
which allow us to recover large oil and gas deposits that are locked in
various formations which are very expensive to develop.
Since the Clinton-Gore Administration came into office, it has sent
up various proposals all designed to eliminate the Section 29 credit.
As a result of their efforts, the Section 29 credit has not applied to
any facilities placed in service since July 1, 1998. That makes
absolutely no sense when we realize that today we are 56 percent
dependent on foreign sources of oil. Doing away with this credit sends
a direct signal to the market--this country will not lift a finger to
encourage energy development at home.
I think it is time to reverse the failed energy policies of the
Clinton-Gore administration. As part of that effort, I am today
introducing legislation that would extend the Section 29 credit until
2013 and allow it to apply to facilities that are placed in service
before 2011. I am pleased that Senators Breaux and Stevens are joining
me in this effort.
Mr. President, if we are to retain the prosperity we have enjoyed
over the last 20 years, we must have a stable and secure supply of oil
and natural gas. Section 29 is an important provision that will allow
our energy development companies to bring technologies on line to
develop new energy deposits.
Moreover, the bill expands the definition of qualifying investments
to include heavy oil. In Alaska, there are several billion barrels of
heavy oil in West Sak Prudhoe Bay that are just too costly to exploit
because of the density of the oil and the fact that it is heavily laden
with sand. Extension of the Section 29 credit could very well mean that
these billions of barrels of heavy oil could be exploited and brought
onto the U.S. energy market.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 3171
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Energy Security for American
Consumers Act of 2000''.
SEC. 2. EXTENSION OF CREDIT FOR PRODUCING FUEL FROM A
NONCONVENTIONAL SOURCE.
(a) Extension of Credit.--Subsection (f) of section 29 of
the Internal Revenue Code of 1986 (relating to credit for
producing fuel from a nonconventional source) is amended--
(1) in paragraph (1)(A), by inserting before ``or'' the
following: ``or from a well drilled after the date of the
enactment of the Energy Security for American Consumers Act
of 2000, and before January 1, 2011,'',
(2) in paragraph (1)(B), by inserting before ``and'' at the
end the following: ``or placed in service after the date of
the enactment of the Energy Security for American Consumers
Act of 2000, and before January 1, 2011,'', and
(3) in paragraph (2), by striking ``2003'' and inserting
``2013''.
(b) Reduction in Amount of Credit by 20 percent per Year
Starting in 2007.-- Subsection (a) of section 29 of such Code
is amended to read as follows:
``(a) Allowance of Credit.--
``(1) In general.--There shall be allowed as a credit
against the tax imposed by this chapter for the taxable year
an amount equal to--
``(A) the applicable amount, multiplied by
``(B) the barrel-of-oil equivalent of qualified fuels--
``(i) sold by the taxpayer to an unrelated person during
the taxable year, and
``(ii) the production of which is attributable to the
taxpayer.
``(2) Applicable amount.--For purposes of paragraph (1),
the applicable amount is the amount determined in accordance
with the following table:
In the case of taxable years beginning in caleThe applicable amount is:
2001 to 2008...............................................$3.00
2009.......................................................$2.60
2010.......................................................$2.00
2011.......................................................$1.40
2012.......................................................$0.80
2013 and thereafter......................................$0.00.''
(c) Credit Allowed Against Both Regular Tax and Alternative
Minimum Tax.--Paragraph (6) of section 29(b) of such Code is
amended to read as follows:
``(6) Application With Other Credits.--The credit allowed
by subsection (a) for any taxable year shall not exceed the
excess of--
``(A) the sum of the regular tax liability (as defined in
section 26(b)) plus the tax imposed by section 55, over
``(B) the sum of the credits allowable under this part
(other than subpart C and this section) and under section
1397E.''
(d) Qualified Fuels To Include Heavy Oil.--Subsection (c)
of section 29 of such Code (defining qualified fuels) is
amended--
(1) in paragraph (1), by striking ``and'' at the end of
subparagraph (B), by striking the period at the end of
subparagraph (C) and inserting ``, and'', and by adding at
the end the following new subparagraph:
``(D) heavy oil, as defined in section 613A(c)(6)(7).'',
and
(2) by adding at the end the following new paragraph:
``(4) Special rule for heavy oil.--Heavy oil shall be
considered to be a qualified fuel only if it is produced from
a well drilled, or in a facility placed in service, after the
date of the enactment of the Energy Security for American
Consumers Act of 2000, and before January 1, 2011.''
(e) Repeal of Superseded Subsection.--Subsection (g) of
section 29 of such Code is repealed.
[[Page S9957]]
(f) Effective Date.--The amendments made by this Act shall
apply to taxable years beginning after December 31, 2000.
______
By Mr. KENNEDY:
S. 3172. A bill to provide access to affordable health care for all
Americans; to the Committee on Finance.
BASIC HEALTH PLAN ACT
Mr. KENNEDY. Mr. President, last week, the Census Bureau released new
figures on the number of the uninsured. Thanks to a prosperous economy
and the Children's Health Insurance Program, the number of the
uninsured declined for the first time in more than a decade. But that
decline was small, and it is no cause for complacency. The number of
uninsured is still far too high--43 million Americans have no insurance
coverage--and any weakening in the economy is likely to send the number
higher again.
It's a national disgrace that so many Americans find the quality of
their health determined by the quantity of their wealth. In this age of
the life sciences, the importance of good medical care in curing
disease and improving and extending life is more significant than ever,
and denying any family the health care they need is unacceptable.
Earlier this year, along with a number of my colleagues in the House
and Senate, I introduced bipartisan legislation to extend the Child
Health Insurance Program to include the parents of participating
children and to increase the enrollment of eligible children in
Medicaid and CHIP. It received a majority vote in the Senate, but it
was defeated on a procedural motion. I hope that we will be able to
pass it promptly next year, as an initial effective step to reduce the
number of the uninsured.
Today, I am introducing an additional measure. The Basic Access to
Secure Insurance Coverage Health plan--or BASIC Health plan.
Congressman John Dingell is introducing a companion measure in the
House. Our proposal uses the model of the Child Health Insurance
Program to make subsidized coverage available--through private
insurance or Medicaid--to all Americans with incomes below 300 percent
of poverty--$25,000 a year for an individual and $42,000 a year for a
family of three.
Almost three-quarters of the uninsured are in this income range. Our
plan also includes innovative steps to encourage current and newly
eligible individuals and families to enroll. It is a major step toward
the day when access to affordable health care will be a reality for all
Americans, and I hope it will be enacted as well next year.
The need for BASIC is clear. One of our highest national priorities
for the new century must be to make good health care a reality for all
our people. Every other industrialized society in the world except
South Africa achieved that goal in the 20th century--and under Nelson
Mandela and Thabo Mbeki, South Africa has taken giant steps toward
universal health care today. But in our country, the law of the jungle
still too often prevails. Forty-three million of our fellow citizens
are left out and left behind when it comes to health insurance.
The dishonor roll of suffering created by this national problem is a
long one.
Children fail to get a healthy start in life because their parents
cannot afford the eyeglasses or hearing aids or doctors visits they
need.
A young family loses its chance to participate in the American dream,
when a breadwinner is crippled or killed because of lack of timely
access to medical care.
A teenager is condemned to go without a college education because the
family's income and energy are sucked away by the high financial and
emotional cost of uninsured illness.
An older couple sees its hope for a dignified retirement dashed when
the savings of a lifetime are washed away by a tidal wave of medical
debt.
Even in this time of unprecedented prosperity, more than 200,000
Americans annually file for bankruptcy because of uninsured medical
costs. And the human costs of being uninsured are often just as
devastating.
In any given year, one-third of the uninsured go without needed
medical care.
Eight million uninsured Americans fail to take the medication that
their doctor prescribes, because they cannot afford to fill the
prescription.
Four hundred thousand children suffer from asthma but never see a
doctor. Five hundred thousand children with recurrent earaches never
see a doctor. Another five hundred thousand children with severe sore
throats never see a doctor.
Thirty-two thousand Americans with heart disease go without life-
saving and life-enhancing bypass surgery or angioplasty--because they
are uninsured.
Twenty-seven thousand uninsured women are diagnosed with breast
cancer each year. They are twice as likely as insured women not to
receive medical treatment before their cancer has already spread to
other parts of their bodies. As a result, they are 50 percent more
likely to die of the disease.
Overall, eighty-three thousand Americans die each year because they
have no insurance. The lack of insurance is the seventh leading cause
of death in America today. Our failure to provide health insurance for
every citizen kills more people than kidney disease, liver disease, and
AIDS combined.
Today our opportunity to finally end these millions of American
tragedies is greater than ever before. Our prosperous economy gives us
large new resources to invest in meeting this critical need. Recently,
some Republicans in Congress have finally joined Democrats in
urging our country to meet the challenge of providing health coverage
to the 43 million Americans who are uninsured.
The BASIC plan can be a bridge for both Republicans and Democrats to
come together. It is based on the model of the Child Health Insurance
Program, which enjoys broad bi-partisan support in every state in the
country. It emphasizes a Federal-State partnership to make care
accessible and affordable. Insurance is provided primarily through the
private sector, but without employer mandates.
The BASIC plan is designed to supplement, not replace, the current
employment-based system of health care. It will also build on Medicaid,
which effectively serves so many of the very poor, the working poor,
the disabled, and people with AIDS.
Federal subsidies under BASIC will be targeted to those without
insurance today. We should not disrupt the health coverage that 161
million Americans now receive through their employers. It makes no
sense to encourage those who already have reliable employer-based
health insurance to turn instead to a new government-subsidized
program. The cost to taxpayers would balloon needlessly, and force us
to reduce benefits in order to cut costs.
The proposal builds on and expands proven programs that are already
in place. States will provide coverage under Medicaid for all very low
income people, consistent with the mandate that already exists in
federal law to provide Medicaid coverage for all children with family
incomes below 100 percent of poverty. Medicaid's broad benefits and
minimal cost-sharing are ideal for very low income people, because they
cannot afford to contribute significantly to the cost of their own
care.
For low and moderate income individuals and families, the plan
follows the CHIP model. States will have the choice of providing
coverage through Medicaid or contracting with private insurance
companies to offer subsidized coverage to those eligible to
participate. The state would pay the insurance company a premium for
each individual enrolled. For higher income enrollees, the individual
would make a premium contribution as well.
One-third of all the uninsured today are poor, and almost three-
quarters of the uninsured have incomes below 300 percent of poverty. A
program of subsidies targeted on these low and moderate income
Americans will put affordable health insurance within reach of the vast
majority of the uninsured.
One of the biggest problems we face in expanding health insurance
coverage through such a program is assuring that those who are eligible
actually participate. We have learned a great deal from the experience
under CHIP on how to achieve this objective. We know that simple, mail-
in forms are important. We know that public information campaigns and
the involvement of community-based organizations can be valuable. We
know that programs with presumptive eligibility are effective--so that
people can be signed up
[[Page S9958]]
right away, without waiting until the eligibility verification process
has been completed. We know that enrolling people for a year at a time
without subjecting them to reapplications or reverification of income
more often than once a year is critical. Through steps like these, we
can see that the uninsured are not only eligible for the program but
actually participate in it, so that they actually have the financial
protection and access to timely medical care they need.
The BASIC Health plan will not require employers to contribute to the
cost of coverage. But it will require them to make the BASIC plan
coverage available through the workplace, and forward the premiums of
workers to the insurance company that the workers choose. This step is
a minimum obligation that responsible employers should be willing to
accept--and it can significantly increase the number of the uninsured
who actually have coverage. Eighty-two percent of uninsured Americans
today are workers or dependents of workers. Our message to all of them
is that help is finally on the way.
The cost of the BASIC place is an estimated $200 billion to $300
billion over the next ten years--approximately the cost of the
prescription drug plans that many of us have proposed under Medicare.
It's a substantial amount of the surplus, but as we know from the
success of Medicare, few if any federal dollars are better spent.
In sum, every child deserves a healthy start and life. Every family
deserves protection against the high cost of illness. All Americans
deserve timely access to quality, affordable health care. The American
people want action. It is time for all of us to make the cause of
health care for all a national priority.
I ask unanimous consent that a summary of the BASIC plan and a fact
sheet on the problem of the uninsured be included in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Need for Legislation and Summary of the ``Basic'' Health Program:
Universal Access to Affordable Quality Health Insurance
America is the only industrial country in the world, except
South Africa, that does not guarantee health care for all its
citizens. The number of uninsured declined last year for the
first time in more than a decade--but 43 million Americans
remain uninsured, and any slowdown in the economy is likely
to send the number up again. The vast majority of the
uninsured are workers or dependents of workers. The
consequences of being uninsured go far beyond vulnerability
to catastrophic medical costs. The uninsured often lack
timely access to quality health care, especially preventive
care. They suffer unnecessary illness and even death because
they have no coverage.
Growth in the Uninsured
The number of the uninsured has grown from 32 million in
1987 to 43 million this year. Except for a brief pause in
1993 and 1994, the number of uninsured has consistently
increased by a million or more each year until this year.
Even these figures understate the number of the uninsured.
During the course of a year, 70 million Americans will be
uninsured for an extended period of time.
Characteristics of the Uninsured
The vast majority of privately insured Americans--161
million citizens under 65--receive coverage on the job as
workers or members of their families. But the uninsured are
also overwhelmingly workers or their dependents. Eighty-two
percent of those without insurance are employees or family
members of employees. Of these uninsured workers, most are
members of families with at least one person working full-
time.
Most uninsured workers are uninsured because their employer
either does not offer coverage, or because they are not
eligible for the coverage offered. Seventy percent of
uninsured workers are in firms where no coverage is offered.
Eighteen percent are in firms that offer coverage, but they
are not eligible for it, usually because they are part-time
workers or have not been employed by the firm long enough to
qualify for coverage. Only 12 percent of uninsured workers
are offered coverage and decline.
The uninsured are predominantly low and moderate income
persons. Almost 25 percent are poor (income of $8,501 or less
for a single individual; $13,290 or less for a family of
three). Twenty-eight percent have incomes between 100 and 200
percent of poverty. Eighteen percent have incomes between 200
and 300 percent of poverty. Almost three-fourths have incomes
below 300 percent of poverty.
Consequences of Being Uninsured
An uninsured family is exposed to financial disaster in the
event of serious illness. Unpaid medical bills account for
200,000 bankruptcies annually. Over 9 million families spend
more than one fifth of their total income on medical costs.
The health consequences of being uninsured are often as
devastating as the economic costs:
In any given year, one-third of the uninsured go without
needed medical care.
Eight million uninsured Americans fail to take medication
their doctors prescribe, because they cannot afford to fill
the prescription.
Thirty-two thousand Americans with heart disease go without
life-saving and life-enhancing bypass surgery or angioplasty,
because they are uninsured.
Twenty-seven thousand uninsured women are diagnosed with
breast cancer each year. They are twice as likely as insured
women not to receive medical treatment until their cancer has
already spread in their bodies. As a result, they are 50
percent more likely to die of the disease.
The tragic bottom line is that eighty-three thousand
Americans die every year because they have no insurance.
Being uninsured is the seventh leading cause of death in
America. Our failure to provide health insurance for every
citizen kills more people than kidney disease, liver disease,
and AIDS combined.
the proposal: summary of basic access to secure insurance coverage
health plan (``basic'' health plan)
Overview
The BASIC program builds on the bi-partisan Child Health
Insurance Program and on Vice-President Gore's proposal to
extend insurance coverage under CHIP and Medicaid to the
parents of eligible children. The Child Health Insurance
Program provides subsidized coverage through Medicaid or
private insurers contracting with state governments for low
and moderate income children. The BASIC plan extends the
availability of subsidized coverage to all uninsured low and
moderate income Americans, regardless of age or family
status. It guarantees the availability of coverage in every
state for every uninsured person, and includes provisions to
encourage enrollment by those who are eligible. The plan also
allows those who have incomes too high to qualify for
subsidies to participate in the program by paying the full
premium.
Key Provisions
Phase 1: Coverage for Children and Parents--Expansion of CHIP
and Medicaid
Eligibility levels are raised to 300 percent of poverty for
all uninsured children.
Coverage is made available to all uninsured parents of
eligible children.
Coverage is made available to legal immigrant children and
their parents.
The required benefit package for children is improved by
adding eye-glasses, hearing aids, and medically necessary
rehabilitative services for disabled or developmentally
delayed children.
Additional steps are established to encourage enrollment of
eligible children and their parents, including presumptive
eligibility, qualification for at least twelve months, and
simplified application forms.
The system of capped state allotments under CHIP is
eliminated and federal matching funds are made available for
all eligible persons enrolled in the program.
Phase II: Coverage for the Remaining Uninsured
Subsidized coverage is made available for all uninsured
single adults with incomes below 300 percent of poverty.
Coverage is phased in by income levels, beginning with those
below 50 percent of poverty in the third year of the program,
rising to 300 percent of poverty in the ninth year.
Unsubsidized coverage is available to all individuals in
families with incomes too high to qualify for subsidized
coverage, by paying the cost through premiums.
Responsibility of Employers
Eighty-two percent of the uninsured are workers or
dependents of workers. Employers will not be required to
provide coverage or contribute to the cost of coverage--but
they will be required to offer their uninsured employees an
opportunity to enroll in the program and agree to facilitate
the coverage by withholding any required premium
contributions from the employee's periodic pay.
Cost
Preliminary estimates of similar proposals indicate that
the federal cost will be $200-$300 billion over the next ten
years, beyond the amount already budgeted for expansions of
coverage under the current CHIP program.
______
By Mr. SMITH of New Hampshire (for himself, Mr. Warner, Mr.
Inhofe, Mr. Thomas, Mr. Bond, Mr. Voinovich, Mr. Crapo, Mr. L.
Chafee, Mr. Baucus, Mr. Moynihan, and Mr. Graham):
S. 3173. A bill to improve the implementation of the environmental
streamling provisions of the Transportation Equity Act for the 21st
Century; read the first time.
Environmental Streamlining Improvement Act
Today I am introducing legislation that requires the US Department of
Transportation to make substantial revisions to the recently proposed
regulations on transportation planning and environmental streamlining.
This action is necessary because the proposed
[[Page S9959]]
regulations fail to fully comply with the direction that Congress gave
to the U.S. Department of Transportation (US DOT) in the Transportation
Equity Act for the 21st Century--the so-called TEA--21--that we passed
in 1998.
The proposed regulations cover the inter-related disciplines of
transportation planning and environmental protection. It is my view
that transportation system development and the environment can exist in
harmony if there is proper planning and foresight. All too often,
though, there is a lack of coordination that results in unnecessary
delays to transportation projects, or leads to wasted time and funds on
projects that never get built.
This is the problem that I, along with my colleagues, Senators Graham
and Wyden, attempted to address when we authored TEA-21's environmental
streamlining provision. Our provision, which is section 1309 of TEA-21,
required a more systematic approach to avoid conflicts, expedite
approvals, and eliminate duplicated efforts in developing
transportation projects.
Section 1309 does not weaken environmental standards or avoid
existing requirements for environmental analysis. Instead, section 1309
requires better coordination between the transportation and
environmental agencies.
Specifically, section 1309 requires that US DOT to establish a
coordinated review process among the various state and federal
agencies, to ensure concurrent rather than sequential reviews by these
agencies, and to establish a dispute resolution process so that delays
are not created by lingering, unresolved problems. We also included
other changes in TEA-21 that were intended to put greater order and
efficiency into the planning and approval of transportation projects.
Unfortunately, the proposed regulations fail to meet the requirements
of TEA-21 in two important respects: First, the regulations do not
incorporate the specific requirements of environmental streamlining
with regard to time periods for review or a dispute resolution process.
Second, the regulations create new data collection, consultation and
analysis requirements that will further complicate and delay
transportation projects.
The full Committee on Environment and Public Works held a hearing
two weeks ago to take testimony from the administration and the states
on the intent and effect of these regulations. the states unanimously
objected to the increased burden that would result from these proposed
regulations. Where we intended to reduce delay, state transportation
departments testified that these regulations would add years to project
development, putting us even further behind in meeting our
transportation needs.
A few weeks ago, eleven bipartisan members of my committee joined in
a letter to the Secretary of Transportation recommending that the
proposed regulations be revised and reissued. That is precisely the
subject of the legislation I am introducing today.
This bill requires the Secretary of Transportation to revise the
rules, taking into consideration the hundreds of comments received on
the current proposal, and to comply with the clear directives that US
DOT received from Congress in section 1309 of TEA-21. I hope that with
a second chance, the US DOT will craft rules that clearly meet
Congressional intent.
Mr. BAUCUS. Mr. President, today Senator Smith, on behalf of Senator
Voinovich, myself and others is introducing the Environmental
Streamlining Improvement Act.
This bill ensures that the United States Department of Transportation
will issue a revised rule on TEA-21 environmental streamlining
regulations. This bill will give the USDOT another chance to follow the
statute when issuing proposed rules on planning and the environment.
The Environment and Public Works Committee has held three hearings on
the subject of environmental streamlining since the passage of TEA-21
in 1998. I am sorry to say that in the 2 years it has taken the USDOT
to issue this NPRM, they fall far short of what Congress has intended.
TEA-21 is very specific about what the regulations should do. The
proposed regulations follow neither the word nor the intent of TEA-21.
I remember working with Senators Warner, Graham, Wyden and Chafee and
with the House members to develop an agreement on environmental
streamlining. Those provisions are now Sections 1308 and 1309 of TEA-
21.
I had heard from the Montana Department of Transportation and from
others about how cumbersome a process it is to complete a highway
project. Everyone who worked on TEA-21, in both the House and Senate,
wanted to include a direction to the USDOT to streamline the planning
and project development processes for the states.
We were very clear--the environment and the environmental reviews
should not get short shrift! But, we need to find a way to make it
easier to get a final decision, eliminate unnecessary delays, move
faster and with as little paperwork as possible.
I cannot over-emphasize that the planning and environmental
provisions of TEA-21 need to be implemented in a way that will
streamline the expedite, not complicate, the process of delivering
transportation projects.
That is why Congress directed the USDOT to include certain elements
in their regulations on environmental streamlining.
We included concepts to be incorporated in future regulations--like
concurrent environmental reviews by agencies and reasonable deadlines
for the agencies to follow when completing their reviews.
Certainly we did not legislate an easy task to the USDOT. Trying to
coordinate so many separate agencies is like trying to herd cats. The
whole concept of environmental streamlining--that is, to make the
permit and approval process work more smoothly and effectively, while
still ensuring protection of the environment--is one of the more
difficult challenges of TEA-21.
So I waited for the rules to come out. And waited. And two years
after the passage of TEA-21 I look at the proposed rules and I am very
disappointed.
I have identified several problems with these regulations and I would
like to mention just a few things that I see as real problems.
First, elevating the planning process participants to the roles of
decision makers. These regulations were supposed to help the States get
their jobs done better and more efficiently. Its one thing to add more
participants to the process. More involvement is a good thing.
But its another thing to give them the authority to make decisions
about how the planning process will work. This decision maker role is
currently held by State DOTs and Metropolitan Planning Organizations
for a reason.
Second, what happened to ``streamlining?'' The basic elements of real
streamlining are the only things not in the regs.
Third, these regulations are supposed to answer questions--but what
is contained in the proposed regulations raises even more questions
because they are vague there they need to be precise.
Fourth, this proposal makes it even harder, if not impossible to come
to a decision. These regulations include initiatives not outlined in
sections 1308 and 1309 and in many areas would strip states of their
authority.
I would also like to mention that the Montana Department of
Transportation filed comments or wrote letters at every possible
opportunity for the public record. As I read these proposed
regulations, I see that MDT's comments were either never read by the
USDOT or ignored.
Let me close by saying that I believe the proposed rules would add
significant requirements and uncertainty to planning and environmental
review for transportation projects. In practical terms, they would
increase overhead and delay--and delay usually means increased project
costs. These proposed rules could make it difficult for States to
deliver their programs. Contracts won't get let and jobs will be lost.
I know this is a tough task. To streamline a process while ensuring
that we maintain a thorough planning and environmental review process.
But, adding requirements to the process is contrary to the course
charted by Congress.
At our last hearing, the administration testified that their intent
was to streamline the process. The bill we are introducing today would
allow them to make good on their intent.
Our bill requires the USDOT go back to the drawing board and
incorporate
[[Page S9960]]
comments received from States and others and issue another NPRM. I am
confident the USDOT will do the right thing this time.
Mr. VOINOVICH. Mr. President, I rise today to thank Senator Bob Smith
of introducing the Environmental Streamlining Improvement Act today.
Last month several of my colleagues on the Environmental and Public
Works Committee, following a full committee hearing on the issue,
requested that the Administration revise its proposed rules on
environmental streamlining and transportation planning, taking into
consideration comments already submitted on the proposed rules, and
publish them in the Federal Register for an additional 120-day comment
period. This legislation is being introduced today because the
Administration has not responded to our request.
In addition to requiring the Administration to consider public
comments and to revise and re-propose rules on environmental
streamlining and transportation planning, this legislation would
prevent the Secretary of Transportation from finalizing the rules until
May 1, 2001, and require a report on changes that were made to the
revised rules.
When I was Governor of Ohio, I witnessed first-hand the frustration
of many of the various state agencies because they were required to
complete a myriad of federally-required tasks on whatever project they
initiated.
With my background as a local and state official, I bring a unique
perspective to this issue. While environmental review is good public
policy, I believe that there are more efficient ways to ensure adequate
and timely delivery of construction projects, while still carefully
assessing environmental concerns.
Congress recognized the frustration of the states and enacted
planning and environmental provisions to initiate environmental
streamlining and expedite project delivery. These programs are embodied
in Sections 1308 and 1309 of TEA-21. Section 1308 calls for the
integration of the Major Investment Study, which had been a separate
requirement for major metropolitan projects, with the National
Environmental Policy Act (NEPA) process. Section 1309 of TEA-21 calls
for the establishment of a coordinated review process for the
Department of Transportation to work with other federal agencies to
ensure that transportation projects are advanced according to
cooperatively determined time-frames. This is accomplished by using
concurrent rather than sequential reviews, and allows states to include
state-specific environmental reviews in the coordinated process.
Last year, I conducted two hearings as Chairman of the Subcommittee
on Transportation and Infrastructure on streamlining and project
delivery. During those hearings I stressed how important it is that the
planning and environmental streamlining provisions of TEA-21 be
implemented in a way that will streamline and expedite, not complicate,
the process of delivering transportation projects. A year after these
hearings and nearly two years after the passage of TEA-21, the
Department of Transportation finally published its proposed planning
and NEPA regulations on May 25, 2000. Frankly, I am very disappointed
with how long it took to propose these rules, and I believe many of my
colleagues feel the same way. More importantly, there is a lot of
disappointment with the proposed rules in general.
I strongly believe these proposed regulations are inconsistent with
TEA-21 and Congressional intent and do little, if anything, to
streamline and expedite the ability of states to commence
transportation projects. The proposed rules create new mandates and
requirements, add new decision-makers to the process, and provide
endless fodder for all kinds of lawsuits, especially with regard to
environmental justice.
In Ohio, the process of highway construction has been dubbed: ``So
you Want a Highway? Here's the Eight Year Hitch.'' My hope has been
that in the future we could say ``So you Want a Highway? Here's the
Five Year Hitch.'' I don't see that happening with the proposal we have
before us. For that reason, I am very pleased Senator Smith has
introduced this legislation today.
______
Mr. CRAIG (for himself, Mr. Conrad, Mr. Baucus, Mr. Bingaman, Mr.
Breaux, Mr. Burns, Mr. Crapo, Mr. Daschle, Mr. Enzi, Mr.
Gorton, Mr. Gramm, Mr. Grams, Mr. Gregg, Mr. Harkin, Mrs.
Hutchison, Mr. Jeffords, Mr. Johnson, Mr. Kennedy, Mr. Kerrey,
Mr. Leahy, Mr. Lugar, Ms. Mikulski, Mrs. Murray, Mr. Reed, Mr.
Sarbanes, Mr. Smith of New Hampshire, Mr. Thomas, and Mr.
Wellstone):
S. 3175. A bill to amend the Consolidated Farm and Rural Development
Act to authorize the National Rural Development Partnership, and for
other purposes; to the Committee on Agriculture, Nutrition, and
Forestry.
national rural development partnership act of 2000
Mr. CRAIG. Mr. President, I rise today with Senator Conrad to
introduce the ``National Rural Development Partnership Act of 2000''--a
bill to codify the National Rural Development Partnership (NRDP or the
Partnership) and provide a funding source for the program. I am pleased
that Senators Baucus, Bingaman, Breaux, Burns, Crapo, Daschle, Enzi,
Gorton, Gramm, Grams, Gregg, Harkin, Hutchison, Jeffords, Johnson,
Kennedy, Kerrey, Leahy, Lugar, Mikulski, Murray, Reed, Sarbanes, Bob
Smith, Thomas, and Wellstone are joining us as original cosponsors.
The Partnership was established under the Bush Administration in
1990, by Executive Order 12720. Although the Partnership has existed
for ten years, it has never been formally authorized by Congress. The
current basis for the existence of the Partnership is found in the
Consolidated Farm and Rural Development Act of 1972 and the Rural
Development Policy Act of 1980. In addition, the Conference Committee
Report on the 1996 federal Farm Bill created specific responsibilities
and expectations for the Partnership and state rural development
councils (SRDCs).
The Partnership is a nonpartisan interagency working group whose
mission is to ``contribute to the vitality of the Nation by
strengthening the ability of all rural Americans to participate in
determining their futures.'' The NRDP and SRDCs do something no other
entities do: facilitate collaboration among federal agencies and
between federal agencies and state, local, and tribal governments and
the private and non-profit sectors to increase coordination of programs
and services to rural areas. When successful, these efforts result in
more efficient use of limited rural development resources and actually
add value to the efforts and dollars of others.
On March 8, 2000, the Subcommittee on Forestry, Conservation, and
Rural Revitalization, which I chair, held an oversight hearing on the
operation and accomplishments of the NRDP and SRDCs. The Subcommittee
heard from a number of witnesses, including officials of the US
Departments of Agriculture, Transportation and Health & Human Services,
state agencies, and private sector representatives. The hearing
established the need for some legislative foundation and consistent
funding. The legislation we are introducing accomplishes this.
This legislation formally recognizes the existence and operations of
the Partnership, the National Rural Development Council (NRDC), and
SRDCs. In addition, the legislation gives specific responsibilities to
each component of the Partnership and authorizes it to receive
Congressional appropriations.
Specifically, the bill formally establishes the NRDP and indicates it
is composed of the NRDC and SRDCs. NRDP is established for empowering
and building the capacity of rural communities, encouraging
participation in flexible and innovative methods of addressing the
challenges of rural areas, and encouraging all those involved in the
Partnership to be fully engaged and to share equally in decision
making. This legislation also identifies the role of the federal
government in the Partnership as being that of partner, coach, and
facilitator. Federal agencies are called upon to designate senior-level
officials to participate in the NRDC and to encourage field staff to
participate in SRDCs. Federal agencies are also authorized to enter
into cooperative agreements with, and to provide grants and other
assistance to, state rural development councils, regardless of the form
of legal organization of a state rural development council.
[[Page S9961]]
The composition of the NRDC is specified as being one representative
from each federal agency with rural responsibilities, and governmental
and non-governmental for-profit and non-profit organizations that elect
to participate in the NRDC. The legislation outlines the duties of the
Council as being to provide support to SRDCs; facilitate coordination
among federal agencies and between the federal, state, local and tribal
governments and private organizations; enhance the effectiveness,
responsiveness, and delivery of federal government programs; gather and
provide to federal agencies information about the impact of government
programs on rural areas; review and comment on policies, regulations,
and proposed legislation; provide technical assistance to SRDCs; and
develop strategies for eliminating administrative and regulatory
impediments. Federal agencies do have the ability to opt out of
participation in the Council, but only if they can show how they can
more effectively serve rural areas without participating in the
Partnership and Council.
This legislation provides that states may participate in the
Partnership by entering into a memorandum of understanding with USDA to
establish an SRDC. SRDCs are required to operate in a nonpartisan and
nondiscriminatory manner and to reflect the diversity of the states
within which they are organized. The duties of the SRDCs are to
facilitate collaboration among government agencies at all levels and
the private and non-profit sectors; to enhance the effectiveness,
responsiveness, and delivery of federal and state government programs;
to gather information about rural areas in its state and share it with
the NRDC and other entities; to monitor and report on policies and
programs that address, or fail to address, the needs of rural areas; to
facilitate the formulation of needs assessments for rural areas and
participate in the development of the criteria for the distribution of
federal funds to rural areas; to provide comments to the NRDC and
others on policies, regulations, and proposed legislation; assist the
NRDC in developing strategies for reducing or eliminating impediments;
to hire an executive director and support staff; and to fundraise.
As I have stated before, this legislation authorizes the Partnership
to receive appropriations as well as authorizing and encouraging
federal agencies to make grants and provide other forms of assistance
to the Partnership and authorizing the Partnership to accept private
contributions. The SRDCs are required to provide at least a 25 percent
match for funds it receives as a result of its cooperative agreement
with the federal government.
As you know, too many parts of rural America have not shared in the
boom that has brought great prosperity to urban America. We need to do
more to ensure that rural citizens will have opportunities similar to
those enjoyed by urban areas. To do so, we do not necessarily need new
government programs. Instead, we must do a better job of coordinating
the many programs available for USDA and other federal agencies that
can benefit rural communities. With the passage of this legislation,
the NRDP and SRDCs will be better situated to provide that much needed
coordination.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 3175
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National Rural Development
Partnership Act of 2000''.
SEC. 2. FINDINGS.
Congress finds that--
(1) rural development has been given high priority
throughout most of this century as a means of achieving a
sound balance between rural and urban areas in the United
States, a balance that Congress considers essential to the
peace, prosperity, and welfare of all citizens of the United
States;
(2)(A) during the last half century, Congress has enacted
many laws and established many programs to provide resources
to rural communities;
(B) in addition, numerous efforts have been made to
coordinate Federal rural development programs; and
(C) during the last decade, the National Rural Development
Partnership and its principal components, the National Rural
Development Council and State rural development councils,
have successfully provided opportunities for collaboration
and coordination among Federal agencies and between Federal
agencies and States, nonprofit organizations, the private
sector, tribal governments, and other entities committed to
rural advancement;
(3) Congress enacted the Rural Development Act of 1972 (86
Stat. 657) and the Rural Development Policy Act of 1980 (94
Stat. 1171) as a manifestation of this commitment to rural
development;
(4) section 2(b)(3) of the Rural Development Policy Act of
1972 (7 U.S.C. 2204b(b)(3)) directs the Secretary of
Agriculture to develop a process through which multi-state,
State, substate, and local rural development needs, goals
objectives, plans and recommendations can be received and
assessed on a continuing basis;
(5) the National Rural Development Partnership and State
Rural Development Councils were established as vehicles to
help coordinate development of rural programs in 1990;
(6) in 1991, the Secretary began to execute those statutory
responsibilities, in part through the innovative mechanism of
national, State, and local rural development partnerships
administered by the Under Secretary of Agriculture for Small
Community and Rural Development;
(7) that mechanism, now known as the ``National Rural
Development Partnership'', has been recognized as a model of
new governance and as an example of the effectiveness of
collaboration between the Federal, State, local, tribal,
private, and nonprofit sectors in addressing the needs of the
rural communities of the United States;
(8) partnerships by agencies and entities in the
Partnership would extend scarce but valuable funding through
collaboration and cooperation; and
(9) the continued success and efficacy of the Partnership
could be enhanced through specific Congressional
authorization removing any statutory barriers that could
detract from the benefits potentially achieved through the
Partnership's unique structure.
SEC. 3. NATIONAL RURAL DEVELOPMENT PARTNERSHIP.
The Consolidated Farm and Rural Development Act (7 U.S.C.
1921 et seq.) is amended by adding at the end the following:
``SEC. 381P. NATIONAL RURAL DEVELOPMENT PARTNERSHIP.
``(a) Definitions.--In this section:
``(1) Agency with rural responsibilities.--The term `agency
with rural responsibilities' means any executive agency (as
defined in section 105 of title 5, United States Code) that--
``(A) implements Federal law targeted at rural areas,
including--
``(i) the Act of April 24, 1950 (commonly known as the
Granger-Thye Act) (64 Stat. 82, chapter 9);
``(ii) the Intergovernmental Cooperation Act of 1968 (82
Stat. 1098);
``(iii) section 41742 of title 49, United States Code;
``(iv) the Rural Development Act of 1972 (86 Stat. 657);
``(v) the Rural Development Policy Act of 1980 (94 Stat.
1171);
``(vi) the Rural Electrification Act of 1936 (2 U.S.C. 901
et seq.);
``(vii) amendments made to section 334 of the Public Health
Service Act (42 U.S.C. 254g) by the Rural Health Clinics Act
of 1983 (97 Stat. 1345); and
``(viii) the Rural Housing Amendments of 1983 (97 Stat.
1240) and the amendments made by the Rural Housing Amendments
of 1983 to title V of the Housing Act of 1949 (42 U.S.C. 1471
et seq.); or
``(B) administers programs that have a significant impact
on rural areas, including--
``(i) the Appalachian Regional Commission;
``(ii) the Department of Agriculture;
``(iii) the Department of Commerce;
``(iv) the Department of Defense;
``(v) the Department of Education;
``(vi) the Department of Energy;
``(vii) the Department of Health and Human Services;
``(viii) the Department of Housing and Urban Development;
``(ix) the Department of the Interior;
``(x) the Department of Justice;
``(xi) the Department of Labor;
``(xii) the Department of Transportation;
``(xiii) the Department of the Treasury.
``(xiv) the Department of Veterans Affairs;
``(xv) the Environmental Protection Agency;
``(xvi) the Federal Emergency Management Administration;
``(xvii) the Small Business Administration;
``(xviii) the Social Security Administration;
``(xix) the Federal Reserve System;
``(xx) the United States Postal Service;
``(xxi) the Corporation for National Service;
``(xxii) the National Endowment for the Arts and the
National Endowment for the Humanities; and
``(xxiii) other agencies, commissions, and corporations.
``(2) Council.--The term ``Council'' means the National
Rural Development Council established by subsection (c).
``(3) Partnership.--The term ``Partnership'' means the
National Rural Development Partnership established by
subsection (b).
``(4) Rural area.--The term ``rural area'' means--
[[Page S9962]]
``(A) all the territory of a State that is not within the
boundary of any standard metropolitan statistical area, as
designated by the Director of the Office of Management and
Budget;
``(B) all territory within any standard metropolitan
statistical area described in subparagraph (A) within a
census tract having a population density of less than 20
persons per square mile, as determined by the Secretary
according to the most recent census of the United States as
of any date; and
``(C) such areas as a State Rural Development Council may
identify as rural.
``(5) State rural development council.--The term ``State
rural development council'' means a State rural development
council that meets the requirements of subsection (d).
``(b) Establishment.--
``(1) In general.--There is established a National Rural
Development Partnership composed of--
``(A) the National Rural Development Council established
under subsection (a); and
``(B) State rural development councils established under
subsection (d).
``(2) Purposes.--The purposes of the Partnership are--
``(A) to empower and build the capacity of States and rural
communities within States to design unique responses to their
own special rural development needs, with local
determinations of progress and selection of projects and
activities;
``(B) to encourage participants to be flexible and
innovative in establishing new partnerships and trying fresh,
new approaches to rural development issues, with responses to
rural development that use different approaches to fit
different situations; and
``(C) to encourage all 5 partners of the Partnership
(Federal, State, local, and tribal governments, the private
sector, and nonprofit organizations) to be fully engaged and
share equally in decisions.
``(3) Role of federal government.--The role of the Federal
Government in the Partnership should be that of a partner,
coach, and facilitator, with Federal agencies authorized--
``(A) to cooperate closely with States to implement the
Partnership;
``(B) to provide States with the technical and
administrative support necessary to plan and implement
tailored rural development strategies to meet local needs;
``(C) to delegate decisionmaking to other levels;
``(D) to ensure that the head of each department and agency
specified in subsection (a)(1)(B) designates a senior-level
agency official to represent the department or agency,
respectively, on the Council and directs appropriate field
staff to participate fully with the State rural development
council within their jurisdiction; and
``(E) to enter into cooperative agreements with, and to
provide grants and other assistance to, State rural
development councils, regardless of the form of legal
organization of a State rural development council and
notwithstanding any other provision of law.
``(4) Role of private and nonprofit sector organizations.--
Private and nonprofit sector organizations are encouraged--
``(A) to act as full partners in the Partnership and State
rural development councils; and
``(B) to cooperate with participating government
organizations in developing innovative problem approaches to
rural development.
``(c) National Rural Development Council.--
``(1) Establishment.--There is established a National Rural
Development Council.
``(2) Composition.--The Council shall be composed of--
``(A) 1 representative of each agency with rural
responsibilities that elects to participate in the Council;
and
``(B) representatives of local, regional, State, tribal,
and nongovernmental profit and nonprofit organizations that
elect to participate in the activities of the Council.
``(3) Duties.--The Council shall--
``(A) provide support for the work of the State rural
development councils;
``(B) facilitate coordination among Federal programs and
activities, and with State, local, tribal, and private
programs and activities, affecting rural development;
``(C) enhance the effectiveness, responsiveness, and
delivery of Federal programs in rural areas;
``(D) gather and provide to Federal authorities information
and input for the development and implementation of Federal
programs impacting rural economic and community development;
``(E) review and comment on policies, regulations, and
proposed legislation that affect or would affect rural areas;
``(F) provide technical assistance to State rural
development councils for the implementation of Federal
programs; and
``(G) develop and facilitate strategies to reduce or
eliminate administrative and regulatory impediments.
``(4) Election not to participate.--An agency with rural
responsibilities that elects not to participate in the
Partnership shall submit to Congress a report that
describes--
``(A) how the programmatic responsibilities of the Federal
agency that target or have an impact on rural areas are
better achieved without participation by the agency in the
Partnership; and
``(B) a more effective means of partnership-building and
collaboration to achieve the programmatic responsibilities of
the agency.
``(5) Performance evaluations.--In conducting a performance
evaluation of an employee of an agency with rural
responsibilities, the agency shall consider any comments
submitted by a State rural development council.
``(d) State Rural Development Councils.--
``(1) Establishment.--Each State may elect to participate
in the Partnership by entering into a memorandum of agreement
with the Secretary to establish a State rural development
council.
``(2) State diversity.--Each State rural development
council shall--
``(A) have a nonpartisan and nondiscriminatory membership
that is broad and representative of the economic, social, and
political diversity of the State; and
``(B) carry out programs and activities in a manner that
reflects the diversity of the State.
``(3) Duties.--Each State rural development council shall--
``(A) facilitate collaboration among Federal, State, local,
and tribal governments and the private and nonprofit sectors
in the planning and implementation of programs and policies
that target or have an impact on rural areas of the State;
``(B) enhance the effectiveness, responsiveness, and
delivery of Federal and State programs in rural areas of the
State;
``(C) gather and provide to the Council and other
appropriate organizations information on the condition of
rural areas in the State;
``(D) monitor and report on policies and programs that
address, or fail to address, the needs of the rural areas of
the State;
``(E) facilitate the formulation of local needs assessments
for the rural areas of the State and participate in the
development of criteria for the distribution of Federal funds
to the rural areas of the State;
``(F) provide comments to the Council and other appropriate
organizations on policies, regulations, and proposed
legislation that affect or would affect the rural areas of
the State;
``(G) in conjunction with the Council, facilitate the
development of strategies to reduce or eliminate conflicting
or duplicative administrative or regulatory requirements of
Federal, State, local, and tribal governments;
``(H) use grant or cooperative agreement funds available to
the Partnership to--
``(i) retain an Executive Director and such support staff
as are necessary to facilitate and implement the directives
of the State rural development council; and
``(ii) defray expenses associated with carrying out
subparagraphs (A) through (G) and subparagraph (J);
``(I) be authorized to solicit funds to supplement and
match funds granted under subparagraph (H); and
``(J) be authorized to engage in all other appropriate
activities.
``(4) Comments or recommendations.--
``(A) In general.--A State rural development council may
provide comments and recommendations to an agency with rural
responsibilities related to the activities of the State rural
development council within the State.
``(B) Agency.--The agency with rural responsibilities shall
provide to the State rural development council a written
response to the comments or recommendations.
``(5) Actions of state rural development council members.--
When carrying out a program or activity authorized by a State
rural development council, a member of the Council shall be
regarded as an employee of the Federal Government for
purposes of chapter 171 of title 28, United States Code.
``(6) Federal participation in state rural development
councils.--
``(A) In general.--Subject to subparagraph (B), Federal
employees may participate in a State rural development
council.
``(B) Conflicts.--A Federal employee who participates in a
State rural development council shall not participate in the
making of any council decision if the agency represented by
the Federal employee has any financial or other interest in
the outcome of the decision.
``(C) Federal guidance.--The Attorney General shall issue
guidance to all Federal employees that participate in State
rural development councils that describes specific decisions
that--
``(i) would constitute a conflict of interest for the
Federal employee; and
``(ii) from which the Federal employee must recuse himself
or herself.
``(e) Administration of the Partnership.--
``(1) Detail of employees.--In order to provide experience
in intergovernmental collaboration, with the approval of the
head of an agency with rural responsibilities that elects to
participate in the Partnership, an employee of the agency
with rural responsibilities is encouraged to be detailed to
the Partnership without reimbursement, and such detail shall
be without interruption or loss of civil service status or
privilege.
``(2) Additional support.--The Secretary shall provide for
any additional support staff to the Partnership as the
Secretary determines to be necessary to carry out the duties
of the Partnership.
``(3) Panel.--
``(A) In general.--A panel consisting of representatives of
the Council and State rural development councils shall be
established to lead and coordinate the strategic
[[Page S9963]]
operation, policies, and practices of the Partnership.
``(B) Annual reports.--In conjunction with the Council and
State rural development councils, the panel shall prepare and
submit to Congress an annual report on the activities of the
Partnership.
``(f) Funding.--
``(1) Authorization of appropriations.--There are
authorized to be appropriated such sums as are necessary to
carry out this section.
``(2) Federal agencies.--
``(A) In general.--Notwithstanding any other provision of
law, in order to carry out the purposes described in
subsection (b)(2), the Partnership shall be eligible to
receive grants, gifts, contributions, or technical assistance
from, or enter into contracts with, any Federal department or
agency, to the extent otherwise permitted by law.
``(B) Assistance.--Federal departments and agencies are
encouraged to use funds made available for programs that
target or impact rural areas to provide assistance to, and
enter into contracts with, the Partnership, as described in
subparagraph (A).
``(3) Contributions.--The Partnership may accept private
contributions.
``(g) Matching Requirements for State Rural Development
Councils.--A State rural development council shall provide
matching funds, or in-kind goods or services, to support the
activities of the State rural development council in an
amount that is not less than 25 percent of the amount of
Federal funds received under the agreement described in
subsection (d)(1).
``(h) Termination.--The authority provided under this
section shall terminate 5 years after the date of enactment
of this section.''.
____________________