[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

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     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.''.

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