Food and Drug Administration
FY 2004 Justification of Estimates for Appropriations Committees
National Center for Toxicological
Research
| |
FY 2002
Actual Obligations
|
FY
2003 Current Estimate 2/
|
FY
2004 Request 3/
|
Increase or Decrease
|
| Total
Program Level
|
Center
|
$39,259,000 |
$40,688,000 |
$40,151,000 |
- $537,000 |
FTE
|
221 |
233 |
233 |
0 |
|
Budget Authority
|
$39,259,000
|
$40,688,000
|
$40,151,000
|
- $537,000
|
| Cost of Living 1/ |
|
$588,000
|
+ $588,000 |
Homeland Security
|
- $21,000
|
- $21,000
|
|
President’s Management
Agenda
|
|
Management
Savings
|
- $652,000
|
- $652,000
|
FTE
|
- 5 |
- 5 |
IT Consolidation
|
- $385,000
|
- $385,000
|
Restructuring
|
- $67,000
|
- $67,000
|
Budget Authority FTE
|
221
|
233
|
233
|
0
|
1/ Pay increases
shown on separate line and not reflected in individual
initiative areas.
2/ Includes
technical FTE adjustment to reflect current estimates for FY 2003 burn
rate.
3/ Reflects
an adjustment to the FY 2003 base for the transfer of $21,000 to the
Department of Homeland Security.
Historical Funding and FTE Levels
|
Fiscal Year
|
Program Level
|
Budget Authority
|
User Fee
|
Program Level FTE
|
|
2000 Actual
|
$36,522,000
|
$36,522,000
|
0
|
217
|
|
2001 Actual
|
$36,248,000
|
$36,248,000
|
0
|
206
|
|
2002 Actual4/
|
$39,259,000
|
$39,259,000
|
0
|
221
|
|
2003 Estimate
|
$40,688,000
|
$40,688,000
|
0
|
233
|
|
2004 Estimate
|
$40,151,000
|
$40,151,000
|
0
|
233
|
4/ Includes
FDA’s FY 2002 appropriation and the Counterterrorism Supplemental.
MISSION
-
Conduct
peer-reviewed scientific research that provides the basis for
FDA to make sound, science-based regulatory decisions, and to promote
the health
of
the American people through the Agency’s core activities of pre-market
review and post-market surveillance;
-
Conduct
fundamental and applied research aimed at understanding critical
biological events, such as adverse drug reactions and/or antibiotic resistance,
to
determine how people are adversely affected by exposure to products
regulated by FDA;
-
Develop
methods to measure human exposure to products that have been adulterated
or to assess effectiveness and/or the safety of a product; and,
-
Provide
the scientific findings used by the FDA product centers for pre-market
application review and product safety assurance to the scientific
community for the betterment of public health.
PROGRAM RESOURCE CHANGES
Cost of Living: + $588,000
FDA's request for funds to cover pay cost increases is essential to accomplishing
its mission. Without a specially trained national cadre of scientific staff,
FDA’s ability to adequately carry out the mission of protecting public
health and providing consumer safety will be compromised. FDA must maintain
staffing
levels and scientific capabilities that meet the demands of an increasing
workload and new challenges, while facing the reality of a competing tight
labor market. Payroll costs significantly impact all FDA activities as
it accounts for over 60 percent of the Agency’s total budget.
With the pay increases, the Agency can support its ability to fulfill
its mission of protecting the public health. The NCTR portion of this increase is $588,000. Without
the pay increase, the significant inroads that were made with the
counterterrorism supplemental will significantly reduce the FDA’s ability
to fulfill its mission
to protect the public health by helping safe and effective products
reach the market in a timely way, and monitoring products for continued
safety after
they are in use.
Homeland Security: - $21,000
Reflects an adjustment of
$583,000 to the FY 2003 base in support of the Department of Homeland Security
(DHS). DHS will distribute these
funds to States and major cities to support counterterrorism activities such
as increased preparedness by hospitals and public health systems. The objective
is to improve local preparedness, with national resources ready to be deployed
immediately whenever and wherever needed. The
NCTR portion of this is $21,000.
President's Management Agenda
The President's
Management Agenda, announced in the summer of 2001, is an aggressive strategy
for improving the management of the Federal government. It focuses on five
areas of management weakness across the government where improvements and
the most progress can be made to deliver results to the American people. It
reflects the Administration’s commitment to achieve immediate, concrete,
and measurable results in the near term, while focusing on remedies to
serious problems, and commits to implement them fully. The following areas
are FDA’s contribution in FY 2004 towards meeting this aggressive strategy.
Management Savings: - $652,000 and - 5 FTE
FDA has taken
FTE reductions across the board, in the centers, field, and administrative
areas. The FTE in FDA's counterterrorism program were not affected by
the management savings. The current freeze
on administrative hiring will be helpful in reaching our FTE reduction,
by not filling current vacant positions. Both administrative and scientific
positions will be reduced through retirement and attrition.
While it is critical that FDA have the staffing levels to address
added responsibility as a result of recent Congressional action,
including the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002, FDA believes the FTE reductions have
been equitably taken across all areas, except for counterterrorism. The NCTR portion
of this is $652,000 and 5 FTE.
Information Technology Consolidation: - $385,000
FDA's FY 2004 President's Budget includes funding to support Departmental
efforts to improve the HHS Information Technology Enterprise Infrastructure. The
request includes funds to support an enterprise approach to investing
in key information technology infrastructure such as security and network
modernization. These investments will enable DHHS programs to carryout
their missions more securely and at a lower cost. Agency funds will be
combined with resources in the Information Technology Security and Innovation
Fund to promote collaboration in planning and project management and
to achieve common goals such as secure and reliable communication and
lower costs for the purchase and maintenance of hardware and software.
FDA's budget request to Congress includes savings totaling $29,587,000
million in the IT budget from both ongoing IT infrastructure consolidation
efforts ($15,000,000) as well as reduced developmental costs through
the consolidation, streamlining, postponement or elimination of specific
lower priority projects ($14,587,000). Of the total IT budget reduction,
NCTR accounts for $226,000 in IT infrastructure consolidation costs and
$159,000 from reductions in developmental costs to Center and Field systems.
The Agency will
fully implement its IT infrastructure consolidation by October 2003,
therefore reducing infrastructure expenditure in FY 2004. The CIO's
office will look for opportunities that, based on a sound business approach
using a rigorous cost benefit analysis, would benefit from the integration
of new technology. FDA seeks to reduce spending on specific systems
across the entire Agency by identifying savings through one of three
rationales: consolidation or the combining of similar systems either
within FDA/DHHS that will provide savings and reduce potential unnecessary
duplication; streamlining or improved work processes and better project
management; and, postponement or elimination of lower priority projects. These
improved processes will ensure that the Agency commits to the
right projects for the right cost.
Restructuring: -
$67,000
As part of the Administration's
goals to improve management operations of the Department of Health and Human
Services, FDA has been actively implementing the initiatives as included
in our restructuring plan submitted to the Department of Health and Human
Services on November 30, 2001. To reflect these restructuring efforts the
FY 2004 budget request was adjusted for NCTR for the following restructurings:
- Establish
the Office of Crisis Management to serve as the Agency’s focal
point for coordinating emergency and crisis response activities, counterterrorism
activities, intra-agency and interagency coordination of emergency
and
crisis planning and management, internal and external security
and other related activities on both a domestic and international level;
and,
- Improve
tracking of women's health resources, by realigning the funds for
women's health projects to the Office of Women's Heath, in the Office of
the Commissioner.
JUSTIFICATION OF BASE
Activities Related
to High Priority Areas
Counterterrorism
Rapid
response to a terrorist attack is often times the means by which we protect
millions of Americans from further exposure to biowarfare agents. It
is always the goal of FDA to maintain homeland security by actively seeking
new technologies to detect and prevent deliberate contamination of FDA-regulated
products. As a part of FDA’s goal to protect the American public, NCTR
continues to conduct fundamental applied research aimed at understanding
critical biological events to determine how people are adversely affected
by exposure to FDA-regulated products and to develop a means by which
biowarfare agents can be rapidly detected.
- Continue
BioSafety Level 3 (BL-3) staff training to conduct studies at the
Jefferson Laboratories to support animal and microbial bioterrorism research
and
analytical studies of importance to the field’s mission to respond
rapidly to various types of emergencies by supporting the rapid detection and
identification
of biological warfare agents or foodborne contaminants through
methods developed at the BL-3 laboratory;
- Conduct
research studies to allow rapid detection, identification
and assignment of bacterial strains as bioterrorist agents;
- Devise
methods to assess human risk associated with exposure to microbial
agents that may be used by bioterrorists; and,
- Apply
state-of-the-art technologies to identify emerging bacterial
and chemical contaminants in the nation's food supply. Additional benefit
can be gained by using these techniques to assess the risk associated
with the threat
of biochemical terrorism.
Food
Safety
Since
foods continue to be susceptible to an ever‑growing variety of
potentially hazardous substances including microbial pathogens, chemical
residues, natural toxins, and illegal food additives, FDA has an enormous
responsibility that has a direct impact on the health of every man, woman
and child in the nation. NCTR devotes considerable staff and resources
to the discovery and development of new technologies aimed at detecting
and eliminating the hazards of foodborne contaminants.
- Use
chemical analysis and computer assisted data interpretation to
identify a specific protein that may be a contaminant in foods, such as
E. coli 0157 in undercooked meats;
- Collaborate
with FDA Centers, other Agencies and academia to develop a
viable nutrition program to improve human health. This program will promote
research dealing with: chronic obesity in children, nutritional requirements
in pregnant
women, nutrition and its linkage to diabetes and the development
of methods to predict the risk of poor nutrition on sub-populations
at risk, such
as the African-American community in the Mississippi Delta;
- Incorporate
updated mathematical models into risk prediction schemes to
more fully understand and predict the risk associated with foodborne bacterial
exposure;
- Collaborate
with CFSAN and the University of Mississippi to evaluate the
toxicity of botanical ingredients in dietary supplements;
- Use
chemical probes to determine if bacteria in food, food producing
animals or their environment have developed resistance to commonly used
antibiotics; and,
- Test
new technologies, such as competitive exclusion (a bacterial
suspension used to treat poultry), to prevent animals from developing antibiotic
resistance.
New Technologies
FDA must maintain
its ability to protect the public health in a time of rapidly changing technology. To
meet this need, NCTR’s highly qualified staff of scientists works to develop
innovative new technologies to assist FDA product centers to make sound,
science-based regulatory decisions, and to promote the health of the American
people through FDA’s core activities of premarket review and postmarket surveillance.
- Use
state-of-the-art, consumer friendly technologies for determining
the freshness of seafood, to monitor food decomposition. On a national
level, products using similar technologies, would allow consumers to make
informed decisions
on food quality and decrease the need for some food inspections
by allowing the consumer to determine if the product is still
fresh
and possibly reducing
the risk of foodborne illness;
- Develop
methods to measure human exposure to adulterated products and
enhance the understanding of acute and chronic liver disease. This research
is used by FDA’s product centers for premarket application review
and product safety
assurance to improve product quality and better predict the toxicity
of new drugs; thereby, managing public health risk;
- Apply
new scientific discoveries in genomics and proteomics, new technologies
that show promise in the mechanistic understanding of toxicological
responses in the human as well as in test rodents, to regulatory decision-making;
and,
- Use
microchip arrays -- small quantities of genetic material bound
to computer chips -- to do a large number of chemical reactions very quickly. This
technique would allow doctors to screen their patients for genes
that may cause adverse drug reactions, predict cancer susceptibility
or determine
drug efficacy.
Medical Product Safety
NCTR provides the scientific findings used by FDA product centers for premarket
application review and product safety assurance to the scientific community
for the betterment of public health. NCTR develops methods to manage or assess
risk associated with products that have been adulterated, intentionally contaminated,
or found to be detrimental to human health.
SELECTED FY 2002 ACCOMPLISHMENTS
Counterterrorism
- Initiated
the Mass Spectometry Counterterrorism program at NCTR with
the purchase and installation of a state-of-the-art MALDI-time-of-flight
and a
pyrolysis
MABTOF Mass Spectrometer. These instruments will be used
to produce unique mass spectra of microorganisms, and in conjunction
with
pattern recognition,
rapidly characterize biological agents or bio-terror hoax materials;
- Acquired
the skills of an architecture and engineering firm experienced
in BioSafety Level-3 (BL-3) laboratory architecture and requirements to assess
the NCTR
facility and develop a draft design for a BL-3 laboratory with
a projected timeline for completion of December 2003. This upgraded facility
will allow NCTR and Arkansas Regional Laboratory colleagues to
conduct assessments
on suspected biohazards requiring BL-3 containment;
- Recruited
one computational scientist, three chemists and two microbiologists
to support counterterrorism efforts;
- Continued
the development of Freshtag, a bacterial detection system, for
use on meat as well as seafood; and,
- Established
an Interagency Agreement (IAG) with the Federal Aviation Administration
(FAA) to expand the Freshtag methodology to detect explosives
in airline cargo.
Food Safety
- Developed
a DNA-based method to specifically identify Vibrio parahaemolyticus
03:K6 isolates. This method will now be used to fingerprint V. parahaemolyticus
isolates from seafood and environmental samples;
- Developed
molecular methods, such as ribotyping, pulsed field gel electrophoresis
and polymerase chain reaction, to screen for fluoroquinolone
(antibiotics, including ciprofloaxicin), resistance genes in Salmonella ssp.,
Campylobacter spp. and E. coli isolates from chicken and turkey farms. Molecular
characterization of the antibiotic-resistant strains were conducted
to help respond to raising
concerns that antimicrobial use in food-producing animals may
play a role in selecting antibiotic resistance;
- Modified
and refined the in vitro continuous culture system for the analysis
of low levels of antimicrobials on the human intestinal microflora. Intestinal
microflora play significant roles in human health because they
aid in the
digestion of food, metabolize drugs and foreign compounds, and
help prevent pathogens from colonizing the gastrointestinal tract;
- Standardized
a quick and accurate in vitro test for determining the efficacy
of potential competitive exclusion products (a bacterial suspension used
in poultry)
to protect against Salmonella. Also characterized vancomycin-resistant
isolates from a competitive exclusion products, providing FDA
with methods that will help to standardize techniques used to
characterize
the components
of competitive exclusion products;
- Investigated
the environmental fate of veterinary drugs and the factors that
influence the persistence and biodegradation of antibiotics used in farm animals
and aquaculture. Fundamental and applied studies on the biodegradation
pathways of erythromycin and the fluoroquinolines (ciprofloxacin,
norfloxacin, and sarafloxacin) were conducted. Studies indicate
that microorganisms may play an important role in the removal of
antimicrobials from
animal wastes and aquaculture sites;
- Developed
methods to isolate and quantify dietary carcinogens and their
metabolites in human urine from populations determined to be at elevated
risk
of cancer development;
- Reported
at approximately 20 scientific meetings and published approximately
50 publications on the development of new methodologies to identify genetically
modified foods, drug residues in food and antibiotic resistant
strains
of bacteria;
New Technologies
- Collaborated
with Environmental Protection Agency (EPA) scientists and successfully
used microarray gene expression analysis to identify a number
of genes altered in rodents given dichloroacetic acid, a known rodent carcinogen. Identified
specific genes that are involved in cell growth, tissue remodeling,
normal cell death, cancer progression, and foreign chemical metabolism. This
study demonstrates the potential utility of DNA microarray technology
in evaluating the mechanisms by which chemicals exert their toxicity;
- Established
a fully automated microarray printing process to screen known
rodent and human genes. This technology will aid in understanding mechanisms
of toxicity and in predicting toxicity;
- Developed
a quantitative structure-activity relationship (QSAR) approach
that can be used to screen thousands of chemicals and determine the likelihood
that
they would be estrogenic (estrogen like). A series of QSAR models
was developed and validated against experimental data, then applied
to three
environmental data sets identified by the EPA and to a list of
chemicals of concern identified by the Center for Food Safety and
Applied Nutrition
(CFSAN) and the Center for Drug Evaluation and Research (CDER). This
technology can be used to develop a list of priority chemicals
for further experimental
evaluation and/or regulatory decision-making;
- Collaborated
with CDER to establish a database for genomics data and to relate
the changes in gene expression in vitro genotoxicity measures that are utilized
in
hazard assessment. The data generated from this project will
be entered into the International Life Sciences Institute (ILSI)
database
for further
analysis;
- Developed
a knowledge base to collect data generated by microarrays for
genomic and proteomic assessment. Also developed a comprehensive set of
qualitative and quantitative analyses to assist researchers and reviewers
in
better understanding the significance of these data points for
risk decision-making;
and,
- Established
four new Centers for Excellence: Structural Genomics, Functional
Genomics, Toxicoinformatics, and Phototoxicology to assist in the development
of
new regulatory standards arising from new technologies in toxicoinformatics,
genomics, proteomics, and metabonomics. In collaboration with
CFSAN and CDER researchers will continue to expand solicitations
across FDA in order
to share data derived from the new technologies.
Medical Product Safety
- Conducted
a series of investigations to examine the genotoxic consequences
of AIDS drugs in neonatal mice. Initial experiments indicated that zidovudine,
but not lamivudine, is mutagenic, and that lamivudine does not
alter the responses induced by zidovudine. These studies were also expanded
to include other AIDS drugs (stavudine, didanosine, zalcitabine,
and nevirapine);
- Focused
studies at the Center for Phototoxicity on the cancer causing
effects of simulated solar light and topically applied alpha and beta-hydroxy
acids. These
studies were expanded to include similarly designed studies with
topically applied Aloe vera and retinyl palmitate;
- Initiated
experiments to examine the chemicals used for tattooing, including
permanent make-up;
- Established
a fifth Center of Excellence in Hepatotoxicology which has initiated
its research program using metabonomics to assess chemicals and drugs that
may influence metabolism and homeostasis. Acetaminophen, a well-known
hepatotoxin, will be the first drug NCTR scientists investigate
in collaboration with the CDER and the University of Arkansas
for Medical Sciences; and,
- Conducted
experiments to elucidate the mechanisms for tumor induction, with
emphasis on characterizing the DNA adducts formed from Tamoxifen, a drug used
for
the treatment of breast cancer which is known to increase the risk
of endometrial cancer in women. Also developed methods with sufficient sensitivity
to detect and quantify tamoxifen DNA adducts in women receiving the drug. Similar
methods were also developed for DNA adducts arising from 4-aminobiphenyl
and urethane, as well as oxidative DNA damage.
Improving Management
- Implemented
the FAIR Act as a basis for competitively sourcing selected commercial
activities; and,
- Provided
licenses for all federal employees in E-learning, an electronic
program that provides a choice of NetG or Skillsoft courses.
National Center for Toxicological
Research
Performance Goals
|
Initiative
|
FY 2004 Increase Request
|
Goal*
|
Goal Citation
|
|
Counterterrorism
|
NA
|
Develop new strategies and methods
to test/predict toxicity and assess/detect risk for FDA-regulated
products (new and on the market).
Catalogue biomarkers and develop standards to establish risk in a
bioterrorism environment.
|
Strategic Goal #1
Performance Goal #16012 |
|
Food Safety
|
NA
|
Develop risk assessment methods and build biological
dose-response models in support of the Food Safety Initiative.
|
Performance Goal #16007
|
|
New Technologies
|
NA
|
Develop computer-based models and infrastructure
to predict the health risk of biologically active products.
|
Performance Goal #16003
|
|
Medical Product Safety
|
NA
|
Develop new strategies and methods
to test/predict toxicity and assess/detect risk for FDA-regulated
products (new and on the market).
Study the risk associated with how a FDA regulated
compound or product interacts with the human body.
|
Strategic Goal # l
Performance Goal #16004 |
* Goal is expected to be accomplished with base funding.
National Center for Toxicological Research
Program Activity
Data
| Program Output |
FY 2002 Actuals |
FY 2003 Estimate |
FY 2004 Estimate |
|
Research “Accepted” Publications
|
185
|
200
|
200
|
|
Scientific Presentations
|
412
|
430
|
430
|
|
Patents (Industry)
|
5
|
5
|
5
|
|
Interagency Agreements (IAG)*
|
8
|
4
|
3
|
|
Cooperative Research & Development
Agreements
|
6
|
3
|
2
|
|
Total Ongoing Research Projects
|
210
|
217
|
246
|
|
*One IAG includes 28 separate projects
|
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Web page edited by sml
02/25/2003