[Congressional Record (Bound Edition), Volume 148 (2002), Part 8]
[Senate]
[Pages 10964-10971]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     TEACHER TAX RELIEF ACT OF 2002

  Ms. COLLINS. Mr. President, I am pleased today to rise to introduce 
the Teacher Tax Relief Act 2002.
  I am joined with my colleagues, Senator Warner, Senator Landrieu, and 
Senator Allen in introducing this legislation to help our teachers who 
selflessly reach deep into their own pockets to purchase supplies for 
their classrooms or to engage in professional development.
  Senators Warner, Landrieu, and I have long led the effort to 
recognize the invaluable services that teachers provide each and every 
day to our children and to our communities. We were very pleased when 
earlier this year the economic recovery package included our provision 
to create an above-the-line deduction for teachers who purchase 
classroom supplies.
  This tax relief is significant in that it recognizes for the first 
time the extra mile that our dedicated teachers go in order to improve 
the classroom experience for their students.
  Today, we introduce legislation that builds upon the relief enacted 
earlier this year. Our bill would double the amount that a teacher can 
deduct--from $250 to $500--and includes professional development 
expenses in the deduction. Our bill would also make this modest tax 
relief permanent whereas the provision in the economic stimulus package 
is scheduled to sunset in 2 years.
  While our bill provides financial assistance to educators, its 
ultimate beneficiaries will be our students. Other than involved 
parents, a well-qualified teacher is the single most important 
prerequisite for student success. Educational researchers have 
demonstrated, time and again, the strong correlation between qualified

[[Page 10965]]

teachers and successful students. Moreover, educators themselves 
understand just how important professional development is to 
maintaining and expanding their level of confidence.
  When I meet with teachers from Maine, they repeatedly tell me of 
their desire and need for more professional development. But they also 
tell me that, unfortunately, school budgets are so tight that 
frequently the school districts cannot provide that assistance that a 
teacher needs in order to take that additional course or pursue that 
advanced degree. As President Bush aptly put it: ``Teachers sometimes 
lead with their hearts and pay with their wallets.''
  A recent survey by the National Center for Education Statistics 
highlights the benefits of professional development. The survey found 
that most teachers who had participated in more than 8 hours of 
professional development during the previous year felt ``very well 
prepared'' in the area in which the instruction occurred. Obviously, 
teachers who are taking additional course work, and pursuing advanced 
degrees, become even more valuable in the classroom.
  Increasing the deduction for teachers who buy classroom supplies is 
also a critical component of my legislation. So often teachers in 
Maine, and throughout the country, spend their own money to improve the 
classroom experiences of their students. While most of us are familiar 
with the National Education Association's estimate that teachers spend, 
on average, $400 a year on classroom supplies, a new survey 
demonstrates that they are spending even more than that. According to a 
recent report from Quality Education Data, the average teacher spends 
over $520 a year out of pocket on school supplies.
  I have spoken to dozens of teachers in Maine who have told me of the 
books, rewards, supplies, and other materials they routinely purchase 
for their students.
  Idella Harter, president of the Maine Education Association, is one 
such teacher. She told me of spending over $1,000 in 1 year, reaching 
deep into her pocket to buy materials, supplies, and other treats for 
her students. At the end of the year, she started to add up all of the 
receipts that she had saved, and she was startled to discover they 
exceeded $1,000. Idella told me, at that point she decided she better 
stop adding them up.
  Debra Walker is another dedicated teacher in Maine who teaches 
kindergarten and first grade in Milo. She has taught for over 25 years. 
Year after year, she spends hundreds of dollars on books, bulletin 
boards, computer software, crayons, construction paper, tissue paper, 
stamps and ink pads. She even donated her own family computer for use 
by her class. She described it well by saying: ``These are the extras 
that are needed to make learning fun for children and to create a 
stimulating learning environment.''
  Another example is Tyler Nutter, a middle school math and reading 
teacher from North Berwick. He is a new recruit to the teaching 
profession. After teaching for just 2 years, Tyler has incurred 
substantial ``startup'' fees as he builds his own collection of needed 
teaching supplies. In his first years on the job, he has spent well 
over $500 out of pocket each year, purchasing books and other materials 
that are essential to his teaching program.
  Tyler tells me that he is still paying off the loans that he incurred 
at the University of Maine-Farmington. He has car payments and a 
wedding to pay for. He is saving for a house. And he someday hopes to 
get an advanced degree. Nevertheless, despite the relatively low pay he 
is receiving as a new teacher, he says: ``You feel committed to getting 
your students what they need, even if it is coming out of your own 
pocket.''
  That is the kind of dedication that I see time and again in the 
teachers in Maine. I have visited almost 100 schools in Maine, and 
everywhere I go, I find teachers who are spending their own money to 
improve their professional qualifications and to improve the 
educational experiences of their students by supplementing classroom 
supplies.
  The relief we passed overwhelmingly earlier this year was a step in 
the right direction. As Tyler told me, ``It's a nice recognition of the 
contributions that many teachers have made.'' We are committed to 
building on this good work.
  Again, I thank the senior Senator from Virginia, Mr. Warner, for 
being a leader with me on this bill. We invite all of our colleagues to 
join us in recognizing our teachers for a job well done.
  Mr. WARNER. Mr. President, I join my distinguished colleague from 
Maine. We have fought together for this measure for several years now. 
One of the great rewards has been an inducement for this Senator. The 
Senator just spoke of visiting 100 schools. I cannot claim 100, but it 
is growing in number. And what a joy it is.
  For those of us who are privileged to serve in the Senate, and are 
successful in a piece of legislation, what a pleasure it is to go back 
and tell others, and thank them for their support which has enabled us 
to succeed.
  The teachers associations have been instrumental in backing this. 
They even ran a little advertisement in the papers of Virginia thanking 
me, for which I really humbly am very deeply touched and grateful.
  But Senators Collins, Landrieu, Allen, and I have worked closely for 
sometime now in support of legislation to provide our teachers with tax 
relief in recognition of the many out-of-pocket expenses they incur as 
a part of their duties.
  It is not required by law. It is not required by regulation. It is 
not required by the principals or the school districts. They just do it 
out of the generosity of their own hearts and the love and affection 
they have for their students. What a lesson this has been to this 
Senator.
  Earlier this year we were successful in providing much needed tax 
relief for our Nation's teachers with the passage of H.R. 3090, the Job 
Creation and Worker Assistance Act of 2002.
  This legislation, which was signed into law by President Bush early 
this year, included the Collins-Warner Teacher Tax Relief Act of 2001, 
providing a $250--which the Senator mentioned--above-the-line deduction 
for educators who incur out-of-pocket expenses for supplies they bring 
into the classroom to better the education of their students.
  These important provisions will provide almost half a billion 
dollars' worth of tax relief to teachers all across America over the 
next 2 years.
  While these provisions will provide substantial relief to America's 
teachers, our work is not yet complete.
  It is now estimated that the average teacher spends $521 out of their 
own pocket each year on classroom materials--materials such as pens, 
pencils, and books. First year teachers spend even more, averaging $701 
a year on classroom expenses.
  Why do they do this? Simply because school budgets are not adequate 
to meet the costs of education. Our teachers dip into their own pocket 
to better the education of America's youth.
  Moreover, in addition to spending substantial money on classroom 
supplies, many teachers spend even more money out of their own pocket 
on professional development. Such expenses include tuition, fees, 
books, and supplies associated with courses that help our teachers 
become even better instructors.
  The fact is that these out-of-pocket costs place lasting financial 
burdens on our teachers. This is one reason our teachers are leaving 
the profession. Little wonder that our country is in the midst of a 
teacher shortage.
  Without a doubt the Teacher Tax Relief Act of 2001 took a step 
forward in helping to alleviate the nation's teacher shortage by 
providing a $250 above the line deduction for classroom expenses.
  However, it is clear that our teachers are spending much more than 
$250 a year out of their own pocket to better the education of our 
children.
  Accordingly, Senator Collins, Senator Landrieu, Senator Allen, and I 
have joined together to take another step forward by introducing the 
Teacher Tax Relief Act of 2002.

[[Page 10966]]

  This legislation will build upon current law in three ways. The 
legislation will: increase the above-the-line deduction for educators 
from $250 allowed under current law to $500; allow educators to include 
professional development costs within that $500 deduction. Under 
current law, up to $250 is deductible but only for classroom expenses; 
and make the Teacher Tax relief provisions in the law permanent. 
Current law sunsets the Collins-Warner provisions after 2 years.
  Our teachers have made a personal commitment to educate the next 
generation and to strengthen America. And, in my view, the Federal 
Government should recognize the many sacrifices our teachers make in 
their career.
  The Teacher Tax Relief Act of 2002 is another step forward in 
providing our educators with the recognition they deserve.
  I thank my colleague from Maine for her work on this issue.
                                 ______
                                 
      By Mr. BREAUX (for himself, Mr. Grassley, and Mr. McCain):
  S. 2663. A bill to permit the designation of Israeli-Turkish 
qualifying industrial zones; to the Committee on Finance.
  Mr. GRASSLEY. Mr. President, today, Senators Breaux, McCain, and I 
introduce the Turkish-Israeli Economic Enhancement Act of 2002.
  This legislation will allow qualified products from Turkey to be 
eligible for duty-free entry into the United States under the Qualified 
Industrial Zone program. Congress first established the Qualified 
Industrial Zone program in 1996 to facilitate economic cooperation 
between Israel, Egypt and Jordan. The impetus behind this program was 
to help create the economic basis for sustained peace in the region. 
While peace still eludes us today, there is little doubt that the 
program has helped to foster greater economic cooperation in the 
region. Allowing Turkey to participate in the program will foster even 
greater economic growth and stability in the region.
  The Israeli-Turkish Economic Enhancement Act would amend Section 
9(e)(1) of the United States Israel Free Trade Area Implementation Act 
of 1985, as amended, the ``FTA Act, by expanding the definition of 
``qualifying industrial zones'' to include portions of the territory of 
Israel and Turkey. Under the FTA Act, the President may proclaim duty-
free benefits for certain products produced within the qualifying 
industrial zones. The bill would allow the President to proclaim duty-
free benefits for certain products, excluding certain import sensitive 
products, of qualifying industrial zones established jointly by Israel 
and Turkey. The bill would foster cooperation between Israel and Turkey 
and help promote economic growth, opportunity and development in 
Turkey, a vital security partner in NATO and a key ally in the war 
against terrorism.
  I am committed to working with my colleagues and the President to 
enact the legislation as soon as practicable. Enabling Turkey to 
participate in the Qualified Industrial Zone program can help attract 
foreign investment to Turkey and build greater regional stability.
  I understand that there is strong interest in supporting high-
technology investment in Turkey. The investment potential for high 
technology products and services in Turkey has not gone unnoticed by 
major U.S. investors. Microsoft has installed a subsidiary in Istanbul 
responsible for sales and support to all of the Middle East, Central 
Asia and Northern Africa. By creating a qualified industrial zone, 
Turkey may be able to attract even more foreign investment in this 
important sector.
  Turkey has been a staunch, long-time ally of the United States. 
American and Turkish troops fought together in Korea. Today we are 
fighting a different war on a different front in Afghanistan. But our 
friendship and joint commitment to freedom and democracy remains the 
same.
  By enacting this legislation, the U.S. Congress can send a strong 
message to the people of Turkey that we appreciate and value their 
friendship and support and that we will continue to work with them to 
promote freedom and prosperity for all of our people.
  Mr. McCAIN. Mr. President, I am pleased to introduce legislation with 
Senators Breaux and Grassley that would expand the U.S.-Israel Free 
Trade Agreement to recognize Turkey's critical role as a key American 
partner in the Middle East conflict, the war on terrorism, and the NATO 
alliance.
  Turkey has a deepening strategic relationship with Israel, with which 
it has enjoyed military cooperation since 1994. It is a force for 
stability in the Eastern Mediterranean region. Today, it assumed 
command of the International Security Assistance Force, ISAF, in 
Afghanistan. It is one of our best NATO allies. Turkish troops have 
fought alongside U.S. forces from Korea to Kabul. Turkey's support was 
instrumental during the 1991 gulf war; it hosts operation Northern 
Watch, in which American and British aircraft patrol the no-fly zone 
over northern Iraq; and it will be central to any American military 
campaign against Iraq. As a Muslim nation and a secular democracy that 
has embraced modernity, Turkey puts to rest the myth that America's war 
on terror is a war on Islam.
  Turkey's economy shrank by over 8 percent last year. Its ability to 
contribute to the war effort in Afghanistan and elsewhere faces serious 
economic constraints. Turkey has shown a strong commitment to economic 
reform and to working with the International Monetary Fund. A Qualified 
Industrial Zone for Turkey, under the U.S.-Israel Free Trade Agreement, 
would help Turkey attract foreign investment, diversify its exports, 
and boost trade. It would also help Israel and Turkey develop the 
economic dimension of their strong security relationship, which is 
unique in the region.
  I know this issue is important to the administration and to the 
Governments of Turkey and Israel. I am sorry we were unable to pass 
legislation authorizing a QIZ for Turkey as part of the TPA package 
last month. I am confident that the measure we have introduced today 
will enjoy wide bipartisan support and will make a tangible, 
substantive contribution to Israeli-Turkish cooperation and to American 
interests in the region.
                                 ______
                                 

     By Mr. JEFFORDS (for himself and Mr. Smith of New Hampshire):

  S. 2664. A bill to amend the Robert T. Stafford Disaster Relief and 
Emergency Assistance Act to establish a program to provide assistance 
to enhance the ability of first responders to respond to incidents of 
terrorism, including incidents involving weapons of mass destruction, 
and for other purposes; to the Committee on Environmental and Public 
Works.
  Mr. JEFFORDS. 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. 2664

       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 ``First Responder Terrorism 
     Preparedness Act of 2002''.

     SEC. 2. FINDINGS AND PURPOSES.

       (a) Findings.--Congress finds that--
       (1) the Federal Government must enhance the ability of 
     first responders to respond to incidents of terrorism, 
     including incidents involving weapons of mass destruction; 
     and
       (2) as a result of the events of September 11, 2001, it is 
     necessary to clarify and consolidate the authority of the 
     Federal Emergency Management Agency to support first 
     responders.
       (b) Purposes.--The purposes of this Act are--
       (1) to establish within the Federal Emergency Management 
     Agency the Office of National Preparedness;
       (2) to establish a program to provide assistance to enhance 
     the ability of first responders to respond to incidents of 
     terrorism, including incidents involving weapons of mass 
     destruction; and
       (3) to address issues relating to urban search and rescue 
     task forces.

     SEC. 3. DEFINITIONS.

       (a) Major Disaster.--Section 102(2) of the Robert T. 
     Stafford Disaster Relief and Emergency Assistance Act (42 
     U.S.C. 5122(2)) is

[[Page 10967]]

     amended by inserting ``incident of terrorism,'' after 
     ``drought),''.
       (b) Weapon of Mass Destruction.--Section 602(a) of the 
     Robert T. Stafford Disaster Relief and Emergency Assistance 
     Act (42 U.S.C. 5196(a)) is amended by adding at the end the 
     following:
       ``(11) Weapon of mass destruction.--The term `weapon of 
     mass destruction' has the meaning given the term in section 
     2302 of title 50, United States Code.''.

     SEC. 4. ESTABLISHMENT OF OFFICE OF NATIONAL PREPAREDNESS.

       Subtitle A of title VI of the Robert T. Stafford Disaster 
     Relief and Emergency Assistance Act (42 U.S.C. 5196 et seq.) 
     is amended by adding at the end the following:

     ``SEC. 616. OFFICE OF NATIONAL PREPAREDNESS.

       ``(a) In General.--There is established in the Federal 
     Emergency Management Agency an office to be known as the 
     `Office of National Preparedness' (referred to in this 
     section as the `Office').
       ``(b) Appointment of Associate Director.--
       ``(1) In general.--The Office shall be headed by an 
     Associate Director, who shall be appointed by the President, 
     by and with the advice and consent of the Senate.
       ``(2) Compensation.--The Associate Director shall be 
     compensated at the annual rate of basic pay prescribed for 
     level IV of the Executive Schedule under section 5315 of 
     title 5, United States Code.
       ``(c) Duties.--The Office shall--
       ``(1) lead a coordinated and integrated overall effort to 
     build viable terrorism preparedness and response capability 
     at all levels of government;
       ``(2) establish clearly defined standards and guidelines 
     for Federal, State, tribal, and local government terrorism 
     preparedness and response;
       ``(3) establish and coordinate an integrated capability for 
     Federal, State, tribal, and local governments and emergency 
     responders to plan for and address potential consequences of 
     terrorism;
       ``(4) coordinate provision of Federal terrorism 
     preparedness assistance to State, tribal, and local 
     governments;
       ``(5) establish standards for a national, interoperable 
     emergency communications and warning system;
       ``(6) establish standards for training of first responders 
     (as defined in section 630(a)), and for equipment to be used 
     by first responders, to respond to incidents of terrorism, 
     including incidents involving weapons of mass destruction; 
     and
       ``(7) carry out such other related activities as are 
     approved by the Director.
       ``(d) Designation of Regional Contacts.--The Associate 
     Director shall designate an officer or employee of the 
     Federal Emergency Management Agency in each of the 10 regions 
     of the Agency to serve as the Office contact for the States 
     in that region.
       ``(e) Use of Existing Resources.--In carrying out this 
     section, the Associate Director shall--
       ``(1) to the maximum extent practicable, use existing 
     resources, including planning documents, equipment lists, and 
     program inventories; and
       ``(2) consult with and use--
       ``(A) existing Federal interagency boards and committees;
       ``(B) existing government agencies; and
       ``(C) nongovernmental organizations.''.

     SEC. 5. PREPAREDNESS ASSISTANCE FOR FIRST RESPONDERS.

       (a) In General.--Subtitle B of title VI of the Robert T. 
     Stafford Disaster Relief and Emergency Assistance Act (42 
     U.S.C. 5197 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 630. PREPAREDNESS ASSISTANCE FOR FIRST RESPONDERS.

       ``(a) Definitions.--In this section:
       ``(1) Director.--The term `Director' means the Director of 
     the Federal Emergency Management Agency, acting through the 
     Office of National Preparedness established by section 616.
       ``(2) First responder.--The term `first responder' means--
       ``(A) fire, emergency medical service, and law enforcement 
     personnel; and
       ``(B) such other personnel as are identified by the 
     Director.
       ``(3) Local entity.--The term `local entity' has the 
     meaning given the term by regulation promulgated by the 
     Director.
       ``(4) Program.--The term `program' means the program 
     established under subsection (b).
       ``(b) Program To Provide Assistance.--
       ``(1) In general.--The Director shall establish a program 
     to provide assistance to States to enhance the ability of 
     State and local first responders to respond to incidents of 
     terrorism, including incidents involving weapons of mass 
     destruction.
       ``(2) Federal share.--The Federal share of the costs 
     eligible to be paid using assistance provided under the 
     program shall be not less than 75 percent, as determined by 
     the Director.
       ``(3) Forms of assistance.--Assistance provided under 
     paragraph (1) may consist of--
       ``(A) grants; and
       ``(B) such other forms of assistance as the Director 
     determines to be appropriate.
       ``(c) Uses of Assistance.--Assistance provided under 
     subsection (b)--
       ``(1) shall be used--
       ``(A) to purchase, to the maximum extent practicable, 
     interoperable equipment that is necessary to respond to 
     incidents of terrorism, including incidents involving weapons 
     of mass destruction;
       ``(B) to train first responders, consistent with guidelines 
     and standards developed by the Director;
       ``(C) in consultation with the Director, to develop, 
     construct, or upgrade terrorism preparedness training 
     facilities;
       ``(D) to develop, construct, or upgrade emergency operating 
     centers;
       ``(E) to develop preparedness and response plans consistent 
     with Federal, State, and local strategies, as determined by 
     the Director;
       ``(F) to provide systems and equipment to meet 
     communication needs, such as emergency notification systems, 
     interoperable equipment, and secure communication equipment;
       ``(G) to conduct exercises; and
       ``(H) to carry out such other related activities as are 
     approved by the Director; and
       ``(2) shall not be used to provide compensation to first 
     responders (including payment for overtime).
       ``(d) Allocation of Funds.--For each fiscal year, in 
     providing assistance under subsection (b), the Director shall 
     make available--
       ``(1) to each of the District of Columbia, Puerto Rico, the 
     Virgin Islands, Guam, American Samoa, and the Commonwealth of 
     the Northern Mariana Islands, $3,000,000; and
       ``(2) to each State (other than a State specified in 
     paragraph (1))--
       ``(A) a base amount of $15,000,000; and
       ``(B) a percentage of the total remaining funds made 
     available for the fiscal year based on criteria established 
     by the Director, such as--
       ``(i) population;
       ``(ii) location of vital infrastructure, including--

       ``(I) military installations;
       ``(II) public buildings (as defined in section 13 of the 
     Public Buildings Act of 1959 (40 U.S.C. 612));
       ``(III) nuclear power plants;
       ``(IV) chemical plants; and
       ``(V) national landmarks; and

       ``(iii) proximity to international borders.
       ``(e) Provision of Funds to Local Governments and Local 
     Entities.--For each fiscal year, not less than 75 percent of 
     the assistance provided to each State under this section 
     shall be provided to local governments and local entities 
     within the State.
       ``(f) Administrative Expenses.--
       ``(1) Director.--For each fiscal year, the Director may use 
     to pay salaries and other administrative expenses incurred in 
     administering the program not more than the lesser of--
       ``(A) 5 percent of the funds made available to carry out 
     this section for the fiscal year; or
       ``(B)(i) for fiscal year 2003, $75,000,000; and
       ``(ii) for each of fiscal years 2004 through 2006, 
     $50,000,000.
       ``(2) Recipients of assistance.--For each fiscal year, not 
     more than 10 percent of the funds retained by a State after 
     application of subsection (e) may be used to pay salaries and 
     other administrative expenses incurred in administering the 
     program.
       ``(g) Maintenance of Expenditures.--The Director may 
     provide assistance to a State under this section only if the 
     State agrees to maintain, and to ensure that each local 
     government that receives funds from the State in accordance 
     with subsection (e) maintains, for the fiscal year for which 
     the assistance is provided, the aggregate expenditures by the 
     State or the local government, respectively, for the uses 
     described in subsection (c)(1) at a level that is at or above 
     the average annual level of those expenditures by the State 
     or local government, respectively, for the 2 fiscal years 
     preceding the fiscal year for which the assistance is 
     provided.
       ``(h) Reports.--
       ``(1) Annual report to the director.--As a condition of 
     receipt of assistance under this section for a fiscal year, a 
     State shall submit to the Director, not later than 60 days 
     after the end of the fiscal year, a report on the use of the 
     assistance in the fiscal year.
       ``(2) Exercise and report to congress.--As a condition of 
     receipt of assistance under this section, not later than 3 
     years after the date of enactment of this section, a State 
     shall--
       ``(A) conduct an exercise, or participate in a regional 
     exercise, approved by the Director, to measure the progress 
     of the State in enhancing the ability of State and local 
     first responders to respond to incidents of terrorism, 
     including incidents involving weapons of mass destruction; 
     and
       ``(B) submit a report on the results of the exercise to--
       ``(i) the Committee on Environment and Public Works and the 
     Committee on Appropriations of the Senate; and
       ``(ii) the Committee on Transportation and Infrastructure 
     and the Committee on Appropriations of the House of 
     Representatives.
       ``(i) Coordination.--
       ``(1) With federal agencies.--The Director shall, as 
     necessary, coordinate the provision of assistance under this 
     section with activities carried out by--

[[Page 10968]]

       ``(A) the Administrator of the United States Fire 
     Administration in connection with the implementation by the 
     Administrator of the assistance to firefighters grant program 
     established under section 33 of the Federal Fire Prevention 
     and Control Act of 1974 (15 U.S.C. 2229) (as added by section 
     1701(a) of the Floyd D. Spence National Defense Authorization 
     Act for Fiscal Year 2001 (114 Stat. 1654, 1654A-360)); and
       ``(B) other appropriate Federal agencies.
       ``(2) With indian tribes.--In providing and using 
     assistance under this section, the Director and the States 
     shall, as appropriate, coordinate with--
       ``(A) Indian tribes (as defined in section 4 of the Indian 
     Self-Determination and Education Assistance Act (25 U.S.C. 
     450b)) and other tribal organizations; and
       ``(B) Native villages (as defined in section 3 of the 
     Alaska Native Claims Settlement Act (43 U.S.C. 1602)) and 
     other Alaska Native organizations.''.
       (b) Cost Sharing for Emergency Operating Centers.--Section 
     614 of the Robert T. Stafford Disaster Relief and Emergency 
     Assistance Act (42 U.S.C. 5196c) is amended--
       (1) by inserting ``(other than section 630)'' after ``carry 
     out this title''; and
       (2) by inserting ``(other than section 630)'' after ``under 
     this title''.

     SEC. 6. URBAN SEARCH AND RESCUE TASK FORCES.

       Subtitle B of title VI of the Robert T. Stafford Disaster 
     Relief and Emergency Assistance Act (42 U.S.C. 5197 et seq.) 
     (as amended by section 5) is amended by adding at the end the 
     following:

     ``SEC. 631. URBAN SEARCH AND RESCUE TASK FORCES.

       ``(a) Definitions.--In this section:
       ``(1) Urban search and rescue equipment.--The term `urban 
     search and rescue equipment' means any equipment that the 
     Director determines to be necessary to respond to a major 
     disaster or emergency declared by the President under this 
     Act.
       ``(2) Urban search and rescue task force.--The term `urban 
     search and rescue task force' means any of the 28 urban 
     search and rescue task forces designated by the Director as 
     of the date of enactment of this section.
       ``(b) Assistance.--
       ``(1) Mandatory grants for costs of operations.--For each 
     fiscal year, of the amounts made available to carry out this 
     section, the Director shall provide to each urban search and 
     rescue task force a grant of not less than $1,500,000 to pay 
     the costs of operations of the urban search and rescue task 
     force (including costs of basic urban search and rescue 
     equipment).
       ``(2) Discretionary grants.--The Director may provide to 
     any urban search and rescue task force a grant, in such 
     amount as the Director determines to be appropriate, to pay 
     the costs of--
       ``(A) operations in excess of the funds provided under 
     paragraph (1);
       ``(B) urban search and rescue equipment;
       ``(C) equipment necessary for an urban search and rescue 
     task force to operate in an environment contaminated or 
     otherwise affected by a weapon of mass destruction;
       ``(D) training, including training for operating in an 
     environment described in subparagraph (C);
       ``(E) transportation;
       ``(F) expansion of the urban search and rescue task force; 
     and
       ``(G) incident support teams, including costs of conducting 
     appropriate evaluations of the readiness of the urban search 
     and rescue task force.
       ``(3) Priority for funding.--The Director shall distribute 
     funding under this subsection so as to ensure that each urban 
     search and rescue task force has the capacity to deploy 
     simultaneously at least 2 teams with all necessary equipment, 
     training, and transportation.
       ``(c) Grant Requirements.--The Director shall establish 
     such requirements as are necessary to provide grants under 
     this section.
       ``(d) Establishment of Additional Urban Search and Rescue 
     Task Forces.--
       ``(1) In general.--Subject to paragraph (2), the Director 
     may establish urban search and rescue task forces in addition 
     to the 28 urban search and rescue task forces in existence on 
     the date of enactment of this section.
       ``(2) Requirement of full funding of existing urban search 
     and rescue task forces.--Except in the case of an urban 
     search and rescue task force designated to replace any urban 
     search and rescue task force that withdraws or is otherwise 
     no longer considered to be an urban search and rescue task 
     force designated by the Director, no additional urban search 
     and rescue task forces may be designated or funded until the 
     28 urban search and rescue task forces are able to deploy 
     simultaneously at least 2 teams with all necessary equipment, 
     training, and transportation.''.

     SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

       Section 626 of the Robert T. Stafford Disaster Relief and 
     Emergency Assistance Act (42 U.S.C. 5197e) is amended by 
     striking subsection (a) and inserting the following:
       ``(a) Authorization of Appropriations.--
       ``(1) In general.--There are authorized to be appropriated 
     such sums as are necessary to carry out this title (other 
     than sections 630 and 631).
       ``(2) Preparedness assistance for first responders.--There 
     are authorized to be appropriated to carry out section 630--
       ``(A) $3,340,000,000 for fiscal year 2003; and
       ``(B) $3,458,000,000 for each of fiscal years 2004 through 
     2006.
       ``(3) Urban search and rescue task forces.--
       ``(A) In general.--There are authorized to be appropriated 
     to carry out section 631--
       ``(i) $160,000,000 for fiscal year 2003; and
       ``(ii) $42,000,000 for each of fiscal years 2004 through 
     2006.
       ``(B) Availability of amounts.--Amounts made available 
     under subparagraph (A) shall remain available until 
     expended.''.
                                 ______
                                 
      By Mr. HUTCHINSON (for himself, Mr. Harkin, and Mr. Gregg):
  S. 2665. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
establish a program of fees relating to animal drugs; to the Committee 
on Health, Education, Labor, and Pensions.
  MR. HUTCHINSON. Mr. President, I am pleased today to introduce the 
Animal Drug User Fee Act of 2002, along with my distinguished 
colleagues Senator Harkin, who is chairman of the Senate Agriculture 
Committee, and Senator Gregg, who is ranking member of the Senate 
Health, Education, Labor, and Pensions Committee. Modeled after the 
Prescription Drug User Fee Act, which has successfully reduced approval 
and review times by over half, the Animal Drug User Fee Act of 2002 
would authorize the Food and Drug Administration to collect user fees 
from animal pharmaceutical manufacturers to increase the amount of 
resources devoted to reviewing new animal drug applications and 
investigational applications.
  Right now, nearly 90 percent of new animal drug applications are 
overdue, many by over a year. These unprecedented delays in the review 
and approval process are both frustrating and problematic to the 
industry, veterinarians, as well as countless farmers who depend on 
cutting edge tools to combat and prevent animal disease and enhance the 
safety of our food supply.
  Under the Animal Drug User Fee Act of 2002, user fees would be 
contingent upon the Food and Drug Administration's Center for 
Veterinary Medicine reducing its review times to a maximum of 180 days 
over a period of five years. The user fees generated by the Act would 
amount to $5 million in fiscal year 2003, $8 million in fiscal year 
2004, and $10 million for each of the last three years, for a total of 
$43 million over 5 years. The Secretary may determine the user fee 
amount and grant waivers in cases where such fees would inhibit 
innovation or discourage the development of animal drug products for 
minor uses or minor species. Such user fees would be considered an 
addition to, not a replacement for, the annual appropriations amount 
designated for CVM through the annual appropriations process.
  The Animal Drug User Fee Act of 2002 is supported by a broad range of 
pharmaceutical, livestock, and poultry producers, including the 
American Sheep Industry Foundation, the American Veterinary Medical 
Association, the Animal Health Institute, the National Cattlemen's Beef 
Association, the National Milk Producers Federation, the American 
Association of Equine Practitioners, the American Farm Bureau 
Federation, the National Pork Producers Association, and the National 
Turkey Federation.
  This legislation will help address the inefficient review process at 
the Center for Veterinary Medicine and ensure that the veterinary and 
agriculture communities have access to new and innovative drug products 
to keep animals alive and healthy.
  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. 2665

       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 ``Animal Drug User Fee Act of 
     2002.''

     SECTION 2. FINDINGS.

       The Congress finds as follows:
       (1) Prompt approval of safe and effective new animal drugs 
     is critical to the improvement of animal health and the 
     public health;

[[Page 10969]]

       (2) Animal health and the public health will be served by 
     making additional funds available for the purpose of 
     augmenting the resources of the Food and Drug Administration 
     that are devoted to the process for review of new animal drug 
     applications; and
       (3) The fees authorized by this title will be dedicated 
     toward expediting the animal drug development process and the 
     review of new and supplemental animal drug applications and 
     investigational animal drug submissions as set forth in the 
     goals identified, for purposes of part 3 of subchapter C of 
     chapter VII of the Federal Food, Drug, and Cosmetic Act, in 
     the letters from the Secretary of Health and Human Services 
     to the Chairman of the Committee on Energy and Commerce of 
     the House of Representatives and the Chairman of the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate as set forth in the Congressional Record.

     SECTION 3. FEES RELATING TO ANIMAL DRUGS.

       Subchapter C of chapter VII of the Federal Food, Drug and 
     Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at 
     the end the following part:

                ``Part 3--Fees Relating To Animal Drugs

     ``SEC. 738. DEFINITIONS.

       ``For purposes of this subchapter:
       ``(1) The term ``animal drug application'' means an 
     application for approval of any new animal drug submitted 
     under section 512(b)(1). Such term does not include either a 
     new animal drug application submitted under section 512(b)(2) 
     or a supplemental animal drug application.
       ``(2) The term ``supplemental animal drug application'' 
     means--
       ``(A) a request to the Secretary to approve a change in an 
     animal drug application which has been approved; or
       ``(B) a request to the Secretary to approve a change to an 
     application approved under section 512(c)(2) for which data 
     with respect to safety or effectiveness are required.
       ``(3) The term ``animal drug product'' means each specific 
     strength or potency of a particular active ingredient or 
     ingredients in final dosage form marketed by a particular 
     manufacturer or distributor, which is uniquely identified by 
     the labeler code and product code portions of the national 
     drug code, and for which an animal drug application or a 
     supplemental animal drug application has been approved.
       ``(4) The term ``animal drug establishment'' means a 
     foreign or domestic place of business which is at one general 
     physical location consisting of one or more buildings all of 
     which are within 5 miles of each other, at which one or more 
     animal drug products are manufactured in final dosage form.
       ``(5) The term ``investigational animal drug submission'' 
     means--
       ``(A) the filing of a claim for an investigational 
     exemption under.section 512(j) for a new animal drug intended 
     to be the subject of an animal drug application or a 
     supplemental animal drug application, or
       ``(B) the submission of information for the purpose of 
     enabling the Secretary to evaluate the safety or 
     effectiveness of an animal drug application or supplemental 
     animal drug application in the event of their filing.
       ``(6) The term ``animal drug sponsor'' means either an 
     applicant named in an animal drug application, except for an 
     approved application for which all subject products have been 
     removed from listing under Section 510, or a person who has 
     submitted an investigational animal drug submission that has 
     not been terminated or otherwise rendered inactive by the 
     Secretary.
       ``(7) The term ``final dosage form'' means, with respect to 
     an animal drug product, a finished dosage form which is 
     approved for administration to an animal without substantial 
     further manufacturing. Such term includes animal drug 
     products intended for mixing in animal feeds.
       ``(8) The term ``process for the review of animal drug 
     applications'' means the following activities of the 
     Secretary with respect to the review of animal drug 
     applications, supplemental animal drug applications, and 
     investigational animal drug submissions:
       ``(A) The activities necessary for the review of animal 
     drug applications, supplemental animal drug applications, and 
     investigational animal drug submissions.
       ``(B) The issuance of action letters which approve animal 
     drug applications or supplemental animal drug applications or 
     which set forth in detail the specific deficiencies in animal 
     drug applications, supplemental animal drug applications, and 
     investigational animal drug submissions and, where 
     appropriate, the actions necessary to place such 
     applications, supplements or submissions in condition for 
     approval.
       ``(C) The inspection of animal drug establishments and 
     other facilities undertaken as part of the Secretary's review 
     of pending animal drug applications, supplemental animal drug 
     applications, and investigational animal drug submissions.
       ``(D) Monitoring of research conducted in connection with 
     the review of animal drug applications, supplemental animal 
     drug applications, and investigational animal drug 
     submissions.
       ``(E) The development of regulations and policy related to 
     the review of animal drug applications, supplemental animal 
     drug applications, and investigational animal drug 
     submissions.
       ``(F) Development of standards for products subject to 
     review.
       ``(G) Meetings between the agency and the animal drug 
     sponsor.
       ``(H) Review of advertising and labeling prior to approval 
     of an animal drug application or supplemental animal drug 
     application, but not such activities after an animal drug has 
     been approved.
       ``(9) The term ``costs of resources allocated for the 
     process for the review of animal drug applications'' means 
     the expenses incurred in connection with the process for the 
     review of animal drug applications for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees consulted with respect to 
     the review of specific animal drug applications, supplemental 
     animal drug applications, or investigational animal drug 
     submissions, and costs related to such officers, employees, 
     committees, and contractors, including costs for travel, 
     education, and recruitment and other personnel activities,
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources,
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies, and
       ``(D) collecting fees under section 739 and accounting for 
     resources allocated for the review of animal drug 
     applications, supplemental animal drug applications, and 
     investigational animal drug submissions.
       ``(10) The term ``adjustment factor'' applicable to a 
     fiscal year refers to the formula set forth in section 735(8) 
     with the base or comparator year being 2002.
       ``(11) The term ``affiliate'' refers to the definition set 
     forth in section 735(9).

     ``SEC. 739. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.

       ``(a) Types of Fees.--Beginning in fiscal year 2003, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) Animal drug application and supplement fee.--
       ``(A) In general.--Each person that submits, on or after 
     September 1, 2002, an animal drug application or a 
     supplemental animal drug application shall be subject to a 
     fee as follows:
       ``(i) A fee established in subsection (b) for an animal 
     drug application; and
       ``(ii) A fee established in subsection (b) for a 
     supplemental animal drug application for which safety or 
     effectiveness data are required.
       ``(B) Payment.--The fee required by subparagraph (A) shall 
     be due upon submission of the animal drug application or 
     supplemental animal drug application.
       ``(C) Exception for previously filed application or 
     supplement.--If an animal drug application or a supplemental 
     animal drug application was submitted by a person that paid 
     the fee for such application or supplement, was accepted for 
     filing, and was not approved or was withdrawn (without a 
     waiver or refund), the submission of an animal drug 
     application or a supplemental animal drug application for the 
     same product by the same person (or the person's licensee, 
     assignee, or successor) shall not be subject to a fee under 
     subparagraph (A).
       ``(D) Refund of fee if application refused for filing.--The 
     Secretary shall refund 75 percent of the fee paid under 
     subparagraph (B) for any animal drug application or 
     supplemental animal drug application which is refused for 
     filing.
       ``(E) Refund of fee if application withdrawn.--If an animal 
     drug application or a supplemental animal drug application is 
     withdrawn after the application or supplement was filed, the 
     Secretary may refund the fee or portion of the fee paid under 
     subparagraph B if no substantial work was performed on the 
     application or supplement after the application or supplement 
     was filed. The Secretary shall have the sole discretion to 
     refund the fee under this paragraph. A determination by the 
     Secretary concerning a refund under this paragraph shall not 
     be reviewable.
       ``(2) Animal drug product fee.--Each person--
       ``(A) who is named as the applicant in an animal drug 
     application or supplemental animal drug application for an 
     animal drug product which has been submitted for listing 
     under Section 510, and
       ``(B) who, after September 1, 2002, had pending before the 
     Secretary an animal drug application or supplemental animal 
     drug application;

     shall pay for each such animal drug product the annual fee 
     established in subsection (b). Such fee shall be payable for 
     the fiscal year in which the animal drug product is first 
     submitted for listing under Section 510, or is submitted for 
     relisting under section 510 if the animal drug product has 
     been withdrawn from listing and relisted. After such fee is 
     paid for that fiscal year, such fee shall be payable on or 
     before January 31 of each year. Such fee shall be paid only 
     once for each animal drug product for a fiscal year in which 
     the fee is payable.

[[Page 10970]]

       ``(3) Animal drug establishment fee.--Each person--
       ``(A) who owns or operates, directly or through an 
     affiliate, an animal drug establishment, and
       ``(B) who is named as the applicant in an animal drug 
     application or supplemental animal drug application for an 
     animal drug product which has been submitted for listing 
     under Section 510, and
       ``(C) who, after September 1, 2002, had pending before the 
     Secretary an animal drug application or supplemental animal 
     drug application,

     shall be assessed an annual fee established in subsection (b) 
     for each animal drug establishment listed in its approved 
     animal drug application as an establishment that manufactures 
     the animal drug product named in the application. The annual 
     establishment fee shall be assessed in each fiscal year in 
     which the animal drug product named in the application is 
     assessed a fee under paragraph (2) unless the animal drug 
     establishment listed in the application does not engage in 
     the manufacture of the animal drug product during the fiscal 
     year. The fee shall be paid on or before January 31 of each 
     year. The establishment shall be assessed only one fee per 
     fiscal year under this section, provided, however, that where 
     a single establishment manufactures both animal drug products 
     and prescription drug products, as defined in section 735(3), 
     such establishment shall be assessed both the animal drug 
     establishment fee and the prescription drug establishment 
     fee, as set forth in section 736(a)(2), within a single 
     fiscal year.
       ``(4) Animal drug sponsor fee.--Each person--
       ``(A) who meets the definition of an animal drug sponsor 
     within a fiscal year; and
       ``(B) who, after September 1, 2002, had pending before the 
     Secretary an animal drug application, a supplemental animal 
     drug application, or an investigational animal drug 
     submission,

     shall be assessed an annual fee established under subsection 
     (b). The fee shall be paid on or before January 31 of each 
     year. Each animal drug sponsor shall pay only one such fee 
     each fiscal year.
       ``(b) Fee Amounts.--Except as provided in subsection (a)(1) 
     and subsections (c), (d), (f), and (g) below, the fees 
     required under subsection (a) shall be determined and 
     assessed as follows:
       ``(1) Application and supplement fees.--
       ``(A) The animal drug application fee under subsection 
     (a)(1)(A)(i) shall be $35,750 in fiscal year 2003, $57,150 in 
     fiscal year 2004, and $71,500 in fiscal years 2005, 2006, and 
     2007.
       ``(B) The supplemental animal drug application fee under 
     subsection (a)(1)(A)(ii) shall be $17,850 in fiscal year 
     2003, $28,575 in fiscal year 2004, and $35,700 in fiscal 
     years 2005, 2006, and 2007.
       ``(2) Total fee revenues for product fees.--The total fee 
     revenues to be collected in product fees under subsection 
     (a)(2) shall be $1,250,000 in fiscal year 2003, $2,000,000 in 
     fiscal year 2004, and $2,500,000 in fiscal years 2005, 2006, 
     and 2007.
       ``(3) Total fee revenues for establishment fees.--The total 
     fee revenues to be collected in establishment fees under 
     subsection (a)(3) shall be $1,250,000 in fiscal year 2003, 
     $2,000,000 in fiscal year 2004, and $2,500,000 in fiscal 
     years 2005, 2006, and 2007.
       ``(4) Total fee revenues for sponsor fees.--The total fee 
     revenues to be collected in sponsor fees under subsection 
     (a)(4) shall be $1,250,000 in fiscal year 2003, $2,000,000 in 
     fiscal year 2004, and $2,500,000 in fiscal years 2005, 2006, 
     and 2007.
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--The fees and total fee 
     revenues established in subsection (b) shall be adjusted by 
     the Secretary by notice, published in the Federal Register, 
     for a fiscal year according to the formula set forth in 
     section 736(c)(1).
       ``(2) Workload adjustment.--After the fee revenues are 
     adjusted for inflation in accordance with subparagraph (1), 
     the fee revenues shall be further adjusted each fiscal year 
     after fiscal year 2003 to reflect changes in review workload. 
     With respect to such adjustment:
       ``(A) This adjustment shall be determined by the Secretary 
     based on a weighted average of the change in the total number 
     of animal drug applications, supplemental animal drug 
     applications for which data with respect to safety or 
     effectiveness are required, manufacturing supplemental animal 
     drug applications, investigational animal drug study 
     submissions, and investigational animal drug protocol 
     submissions submitted to the Secretary. The Secretary shall 
     publish in the Federal Register the fees resulting from this 
     adjustment and the supporting methodologies.
       ``(B) Under no circumstances shall this workload adjustment 
     result in fee revenues for a fiscal year that are less than 
     the fee revenues for that fiscal year established in 
     subsection (b), as adjusted for inflation under subparagraph 
     (c)(1).
       ``(3) Final year adjustment.--For FY 2007, the Secretary 
     may further increase the fees to provide for up to 3 months 
     of operating reserves of carryover user fees for the process 
     for the review of animal drug applications for the first 
     three months of FY 2008. If the Food and Drug Administration 
     has carryover balances for the process for the review of 
     animal drug applications in excess of three months of such 
     operating reserves, then this adjustment will not be made. If 
     this adjustment is necessary, then the rationale for the 
     amount of the increase shall be contained in the annual 
     notice setting fees for FY 2007.
       ``(4) Annual fee adjustment.--Subject to the amount 
     appropriated for a fiscal year under subsection (g), the 
     Secretary shall, within 60 days after the end of each fiscal 
     year beginning after September 30, 2002, adjust the fees 
     established by the schedule in subsection (b) for the fiscal 
     year in which the adjustment occurs so that the revenues 
     collected from each of the categories of fees described in 
     paragraphs (1), (2), (3), and (4) of subsection (b) shall be 
     set to be equal to 25 percent of the total fees appropriated 
     under subsection (g).
       ``(5) Limit.--The total amount of fees charged, as adjusted 
     under this subsection, for a fiscal year may not exceed the 
     total costs for such fiscal year for the resources allocated 
     for the process for the review of animal drug applications.
       ``(d) Fee Waiver or Reduction.--
       ``(1) In general.--The Secretary shall grant a waiver from 
     fees assessed under subsection (a) where the Secretary finds 
     that--
       ``(A) the assessment of the fee would present a significant 
     barrier to innovation because of limited resources available 
     to such person or other circumstances,
       ``(B) the fees to be paid by such person will exceed the 
     anticipated present and future costs incurred by the 
     Secretary in conducting the process for the review of animal 
     drug applications for such person,
       ``(C) the animal drug application is intended solely to 
     provide for a minor use or minor species indication, or
       ``(D) the sponsor involved is a small business submitting 
     its first animal drug application to the Secretary for 
     review.
       ``(2) Use of standard costs.--In making the finding in 
     paragraph (1)(B), the Secretary may use standard costs.
       ``(3) Rules for small businesses.--
       ``(A) Definition.--In paragraph (1)(D), the term ``small 
     business'' means an entity that has fewer than 500 employees, 
     including employees of affiliates.
       ``(B) Waiver of application fee.--The Secretary shall waive 
     under paragraph (1)(D) the application fee for the first 
     animal drug application that a small business or its 
     affiliate submits to the Secretary for review. After a small 
     business or its affiliate is granted such a waiver, the small 
     business or its affiliate shall pay application fees for all 
     subsequent animal drug applications and supplemental animal 
     drug applications for which safety or effectiveness data are 
     required in the same manner as an entity that does not 
     qualify as a small business.
       ``(C) Certification.--The Secretary shall require any 
     person who applies for a waiver under paragraph (1)(D) to 
     certify their qualification for the waiver. The Secretary 
     shall periodically publish in the Federal Register a list of 
     persons making such certifications.
       ``(e) Effect of Failure To Pay Fees.--An animal drug 
     application or supplemental animal drug application submitted 
     by a person subject to fees under subsection (a) shall be 
     considered incomplete and shall not be accepted for filing by 
     the Secretary until all fees owed by such person have been 
     paid. An investigational animal drug submission under section 
     738(5)(B) that is submitted by a person subject to fees under 
     subsection (a) shall be considered incomplete and shall not 
     be accepted for review by the Secretary until all fees owed 
     by such person have been paid. The Secretary may discontinue 
     review of any animal drug application, supplemental animal 
     drug application or investigational animal drug submission 
     from a person if such person has not submitted for payment 
     all fees owed under this section by 30 days after the date 
     upon which they are due.
       ``(f) Assessment of Fees.--
       ``(1) Limitation.--Fees may not be assessed under 
     subsection (a) for a fiscal year beginning after fiscal year 
     2002 unless appropriations for salaries and expenses of the 
     Food and Drug Administration for such fiscal year (excluding 
     the amount of fees appropriated for such fiscal year) are 
     equal to or greater than the amount of appropriations for the 
     salaries and expenses of the Food and Drug Administration for 
     the fiscal year 2002 (excluding the amount of fees 
     appropriated for such fiscal year) multiplied by the 
     adjustment factor applicable to the fiscal year involved.
       ``(2) Authority.--If the Secretary does not assess fees 
     under subsection (a) during any portion of a fiscal year 
     because of paragraph (1) and if at a later date in such 
     fiscal year the Secretary may assess such fees, the Secretary 
     may assess and collect such fees, without any modification in 
     the rate, for animal drug applications, supplemental animal 
     drug applications, investigational animal drug submissions, 
     sponsors, animal drug establishments and animal drug products 
     at any time in such fiscal year notwithstanding the 
     provisions of subsection (a) relating to the date fees are to 
     be paid.
       ``(g) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in

[[Page 10971]]

     the amount provided in advance in appropriations Acts. Such 
     fees are authorized to be appropriated to remain available 
     until expended. Such sums as may be necessary may be 
     transferred from the Food and Drug Administration salaries 
     and expenses appropriation account without fiscal year 
     limitation to such appropriation account for salary and 
     expenses with such fiscal year limitation. The sums 
     transferred shall be available solely for the process for the 
     review of animal drug applications.
       ``(2) Collections and appropriation acts.--
       ``(A) In general.--The fees authorized by this section--
       (i) shall be retained in each fiscal year in an amount not 
     to exceed the amount specified in appropriation Acts, or 
     otherwise made available for obligation for such fiscal year, 
     and
       (ii) shall only be collected and available to defray 
     increases in the costs of the resources allocated for the 
     process for the review of animal drug applications (including 
     increases in such costs for an additional number of full-time 
     equivalent positions in the Department of Health and Human 
     Services to be engaged in such process) over such costs, 
     excluding costs paid from fees collected under this section, 
     for fiscal year 2002 multiplied by the adjustment factor.
       ``(B) Compliance with requirement.--The Food and Drug 
     Administration will be considered to have met the 
     requirements of subparagraph (A)(ii) in any fiscal year if--
       ``(i) the costs funded by appropriations and allocated for 
     the process for the review of animal drug applications are 
     not more than 3 percent below the level specified in (B)(i); 
     or
       ``(ii) the costs funded by appropriations and allocated for 
     the process for the review of animal drug applications are 
     more than 3 percent below the level specified in (A)(ii), and 
     fees assessed for a subsequent fiscal year are decreased by 
     the amount in excess of 3 percent by which the costs funded 
     by appropriations and allocated for the process for the 
     review of animal drug applications fell below the level 
     specified in (A)(ii), provided that the costs funded by 
     appropriations and allocated for the process for the review 
     of animal drug applications are not more than 5 percent below 
     the level specified in (B)(i).
       ``(3) Authorization of appropriations.--There are 
     authorized to be appropriated for fees under this section--
       ``(A) $5,000,000 for fiscal year 2003,
       ``(B) $8,000,000 for fiscal year 2004,
       ``(C) $10,000,000 for fiscal year 2005,
       ``(D) $10,000,000 for fiscal year 2006, and
       ``(E) $ 10,000,000 for fiscal year 2007, as adjusted to 
     reflect adjustments in the total fee revenues made under this 
     section and changes in the total amounts collected by animal 
     drug application fees, supplemental animal drug application 
     fees, animal drug sponsor fees, animal drug establishment 
     fees, and animal drug product fees.
       ``(4) Offset.--Any amount of fees collected for a fiscal 
     year under this section that exceeds the amount of fees 
     specified in appropriations Acts for such fiscal year shall 
     be credited to the appropriation account of the Food and Drug 
     Administration as provided in paragraph (1), and shall be 
     subtracted from the amount of fees that would otherwise be 
     authorized to be collected under this section pursuant to 
     appropriation Acts for a subsequent fiscal year.
       ``(h) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 days after it is due, such fee shall 
     be treated as a claim of the United States Government subject 
     to subchapter II of chapter 37 of title 31, United States 
     Code.
       ``(i) Written Requests for Waivers, Reductions, and 
     Refunds.--To qualify for consideration for a waiver or 
     reduction under subsection (d), or for a refund of any fee 
     collected in accordance with subsection (a), a person shall 
     submit to the Secretary a written request for such waiver, 
     reduction, or refund not later than 180 days after such fee 
     is due.
       ``(j) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of Health and Human Services, for officers, 
     employees, and advisory committees not engaged in the process 
     of the review of animal drug applications, be reduced to 
     offset the number of officers, employees, and advisory 
     committees so engaged.

     SECTION 4. ANNUAL REPORTS.

       (a) Performance Report.--Beginning with fiscal year 2003, 
     not later than 60 days after the end of each fiscal year 
     during which fees are collected under part 2 of subchapter C 
     of chapter VII of the Federal Food, Drug, and Cosmetic Act, 
     the Secretary of Health and Human Services shall prepare and 
     submit to the Committee on Energy and Commerce of the House 
     of Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report concerning the 
     progress of the Food and Drug Administration in achieving the 
     goals identified in the letters described in section 2(3) of 
     this Act toward expediting the animal drug development 
     process and the review of the new and supplemental animal 
     drug applications and investigational animal drug submissions 
     during such fiscal year and the future plans of the Food and 
     Drug Administration for meeting the goals.
       (b) Fiscal Report.--Beginning with fiscal year 2003, not 
     later than 120 days after the end of each fiscal year during 
     which fees are collected under the part described in 
     subsection (a), the Secretary of Health and Human Services 
     shall prepare and submit to the Committee on Energy and 
     Commerce of the House of Representatives and the Committee on 
     Health, Education, Labor, and Pensions of the Senate a report 
     on the implementation of the authority for such fees during 
     such fiscal year and the use, by the Food and Drug 
     Administration, of the fees collected during such fiscal year 
     for which the report is made.

     SECTION 5. SUNSET.

       The amendments made by section 3 shall not be in effect 
     after October 1, 2007 and section 4 shall not be in effect 
     after 120 days after such date.

  Mr. HARKIN. Mr. President, today I am pleased to join my 
distinguished colleagues, Senators Hutchinson, with whom I am pleased 
to work with on the Agriculture Committee and the Health, Education, 
Labor, and Pensions (HELP) Committee, and Senator Gregg, who is also a 
member of the HELP Committee, in introducing the Animal Drug User Fee 
Act of 2002. The Animal Drug User Fee Act would authorize the Food and 
Drug Administration, FDA, to collect user fees from animal drug 
manufacturers to support new animal drug applications and 
investigational applications. This important legislation is modeled 
after the successful Prescription Drug User Fees Act, which after a few 
years of implementation has reduced approval and review times by half.
  The need for expedited review of animal drug applications is 
substantial. Nine out of ten new animal drug applications are overdue. 
Prompt approval of safe and effective animal drugs is critical to the 
improvement of not only animal health but public health as well. Our 
animal health professionals need the newest and most effective drugs to 
combat dangerous animal diseases.
  Under the Animal Drug User Fee Act, the collection of user fees from 
animal drug manufacturers would be contingent on FDA's Center for 
Veterinary Medicine, CVM, reducing its review times to a maximum of 180 
days over five years. The user fees generated by the Act would amount 
to $5 million in Fiscal Year 2003, $8 million in Fiscal Year 2004, and 
$10 million for each of the last three years, totaling $43 million over 
5 years. The Secretary may determine the user fee amount and grant 
waivers in cases where such fees would inhibit innovation or discourage 
the development of animal drug products for minor uses or minor 
species. Such user fees would be considered an addition to, not a 
replacement for, the annual appropriations amount designated for CVM 
through the annual appropriations process.
  This legislation enjoys broad support from pharmaceutical, livestock 
and poultry producers and from the American Veterinary Medical 
Association, the Animal Health Institute, the National Pork Producers 
Association, the National Turkey Federation, the National Cattlemen's 
Beef Association, the National Milk Producers Federation, and the 
American Farm Bureau Federation.
  I urge my colleagues to support this important legislation.

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