[Congressional Record Volume 148, Number 83 (Thursday, June 20, 2002)]
[Senate]
[Pages S5859-S5866]
From the Congressional Record Online through the 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
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.
[[Page S5860]]
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.
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
[[Page S5861]]
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 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
[[Page S5862]]
``(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--
``(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,
[[Page S5863]]
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;
(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:
[[Page S5864]]
``(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.
``(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
[[Page S5865]]
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 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
[[Page S5866]]
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.
____________________