Comprehensive Toxicological Assessments of FDA Selected Nominations to the National Toxicology Program; Selected NTP/NIEHS Nominations of FDA Importance - PowerPoint PPT Presentation

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Comprehensive Toxicological Assessments of FDA Selected Nominations to the National Toxicology Program; Selected NTP/NIEHS Nominations of FDA Importance

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Title: Comprehensive Toxicological Assessments of FDA Selected Nominations to the National Toxicology Program; Selected NTP/NIEHS Nominations of FDA Importance


1
FDA-NIEHSInteragency Agreement
  • Comprehensive Toxicological Assessments of FDA
    Selected Nominations to the National Toxicology
    Program Selected NTP/NIEHS Nominations of FDA
    Importance

2
Assistant Secretary for Health DHHS
NTP Executive Committee Heads, DHHS Agencies,
EPA, OSHA, NCI Asnt. Sec. Labor
National Toxicology Program (Dr. Ken Olden)
NTP Board of Scientific Counselors
NCTR/FDA NIEHS/NIH NIOSH/CDC
Steering Committee
Technical Reports Subcommittee
Reports on Carcinogens Subcommittee
Chemical Evaluation Committee
Working Group Report on Carcinogens
3
FDAs Mission
  • To Protect and Promote Public Health
  • FADAMA directs FDA to draw on the resources from
    organizations outside FDA with shared interest to
    help accomplish FDAs Mission LEVERAGING
  • Using intellect, time, money and resources in a
    manner that Maximizes their value in enhancing
    FDAs role of protecting and promoting public
    health

4
NCTRs LEVERAGING EFFORTS
  • An example of an ongoing successful partnership
    is the one FDA enjoys with the NIEHS/NTP, which
    funds research and bioassays on FDA-regulated
    products, at NCTR.
  • Jane Henney - 10/04/00 FDA Leveraging Handbook

5
FDA-NIEHS InterAgency Agreement Signed December
6, 1992
Dr. J.E. Henney, FDA Deputy Commissioner for
Operations
Dr. K.L. Olden, Director, NIEHS
6
IAG Concept/Genesis
  • Innovative Applied Toxicology Studies
  • FDA Scientists Involved in Protocol Design
  • Mechanistic/Mode of Action Studies Support
    Chronic Study Interpretation/Risk Assessments
  • Reports in Timely Manner
  • Utilize NCTRs Expert Scientific Staff / Unique
    Facilities

7
IAG Supports FDA Research
  • High Quality/Science-Based Safety Assessments
    Support Risk Management Decisions
  • Reduce Uncertainty in Risk Assessments and
    Risk-Benefit Analysis
  • Measurable - Real Time Regulatory Impact

8
IAG History (Fiscal Years)
  • 1993 - IAG Signed
  • 1995 - IAG Open-Ended
  • 1996 - Expanded to Include Putative Endocrine
    Disruptor Chemicals
  • 1998 - Resources to Develop a FDA-NIEHS
    Phototoxicity Research and Testing
    Center
  • 1999 - Resources Set Aside to Renovate 5A Animal
    Rooms (pending)
  • 2000 - Additional FDA High Priority Compounds
    Including Dietary Supplements
  • 2001 - AIDS Therapeutic Mixtures

9
Compounds/Agents Nominated - IAG
  • Chloral Hydrate (CDER)
  • Fumonisin B1 (CFSAN)
  • Malachite Green (CVM)
  • Urethane/Ethanol (CFSAN)
  • Riddelliine (CFSAN/NIEHS)
  • Glycolic Salicylic Acids (CFSAN)
  • Endocrine Disrupting Chemicals (FDA / NIEHS)
  • Phototoxicology Nominations (CFSAN/NTP)
  • Dietary Supplements (CFSAN/NTP)
  • AIDS Therapeutic Mixtures (NTP/CDER)
  • Thimerosal (CBER)

10
FDA-NIEHS IAG
FDA Nominations
FDA/NIEHS Nominations
  • Chloral Hydrate
  • Fumonisin B1
  • Malachite Green
  • Urethane/Ethanol
  • ? ? Hydroxy Acids
  • Glycolic Acid
  • Salicylic Acid
  • Retinyl Palmitate
  • Thimerosal
  • Riddelliine
  • Endocrine Disruptors
  • Methoxychlor
  • Genistein
  • Nonylphenol
  • Vinclozolin
  • Ethinyl Estradiol
  • Aloe Vera
  • AIDS Therapeutics

11
FY 1999 NTP Nominations
  • Radio Frequency Radiation Emissions (CDRH)
  • DNA-Based Safety Assessment of Selected
    Vaccines/Therapeutics (CBER)
  • Cefuroxime and Clarithromycin (CDER)
  • p53 Study with Senna (CDER)
  • p53 TGAC Studies with Pilocarpine (OOPD)

12
FY 2000 FDA Nominations
  • trans-Retinyl Palmitate (PT) CFSAN
  • D C Red No. 27 (PT) CFSAN
  • D C Red No. 28 (PT) CFSAN
  • Lemon Oil (PT) CFSAN
  • Lime Oil (PT) CFSAN
  • Thimerosal (Ethyl Mercury) CBER

13
IAG Chemical/Agent Starts FY 2001
  • Aloe vera (Dr. Boudreau)
  • Phototoxicology Studies
  • Orally Administered Studies
  • trans-Retinyl Palmitate (Dr. Culp)
  • Phototoxicology Studies
  • AIDS Mixtures (Dr. Beland)

14
FDA-NIEHS IAG
Scientific Oversight - Peer Review
  • Toxicology Study Selection and Review Committee
    (TSSRC)
  • FDA Product Center(s) Protocol Review
  • NCTR Protocol Review
  • NCTR Support Group Review
  • NTP/NIEHS Protocol Review
  • IAG Executive Team Funding Approval
  • NIEHS/NTP BSC Technical Report Subcommittee

15
FDA-NIEHS IAG
Toxicology Study Selection and Review Committee
(TSSRC)
  • Reviews research concepts and plans
  • Reviews PI designed protocols
  • Recommends protocol modifications (e.g. dose
    level selection, design changes, additional
    studies) and protocol implementation
  • Monitors the progress of each study

16
IAG Principle Investigators
  • Chloral Hydrate - Dr. Frederick Beland
  • Fumonisin B1 - Dr. Paul Howard
  • Malachite Green - Dr. Sandra Culp
  • Urethane/Urethane-Ethanol - Dr. Fred Beland
  • Glycolic Acid/Salicylic Acid - Dr. Paul Howard
  • Endocrine Disruptors - Dr. Barry Delclos, Dr.
    Andy Scallet, Dr. Sherry Ferguson, Dr. Dan
    Doerge, Dr. Suzanne Morris
  • Riddelliine - Dr.'s Peter Fu Ming Chou
  • Aloe Vera - Dr. Mary Boudreau
  • Retinyl Palmitate - Dr. Sandra Culp
  • AIDS Therapeutics - Dr. Frederick Beland
  • Thimerosal - Dr. William Slikker

17
IAG Benefits
  • Enhance Regulatory Decision Process
  • Support Quantitative Risk Assessments
  • New/Innovative Research Approaches
  • Speed Research/Testing Process
  • Utilize NCTR Scientific/Contract Staff
  • FTE/Post-Doc Support
  • Facilities Renovation (Phototoxicology)
  • Equipment Purchase
  • Travel for Scientific Meetings

18
Funding Source Comparison
19
FDA-NIEHS Phototoxicology Research and Testing
LaboratoryNTP Center for Phototoxicology
20
(No Transcript)
21
IAG (FDA/NIEHS) Overhead to NCTR through FY 2000
Overhead generated from the IAG (FDA/NIEHS)
covers the cost of doing business for NIEHS.
Resources from "overhead" support facilities
maintenance, equipment maintenance,
contracts/procurement administration, security,
utilities, laundry services, library services,
janitorial services, supply management. These
indirect costs are determined by usage and vary
in rate according to the usage in each area.
22
IAG (FDA/NIEHS) Post Doc Positions
23
Animal Room Occupation
  • 53 A and B used for IAG (Endocrine Disruptors,
    Priority Chemicals
  • A 7 ten-rack rooms (70)
  • 2 seven-rack rooms (14)
  • 4 five-rack rooms (20)
  • B 11 five-rack rooms (55)
  • 53 C and D New born mouse and other Center
    studies
  • C 10 five-rack rooms (50)
  • 17 two-rack rooms (34)
  • D 4 five-rack rooms (20)
  • 60 of Bldg 53 is used for IAG
  • 100 of Bldg. 5 is used for IAG
  • Building 5 Phototoxicology
  • 1 Control Room
  • 1 Dose Room (2 Lights)
  • 6 Animal Rooms
  • Building 14 Neurotoxicology others (No IAG
    studies)

24
IAG (FDA/NIEHS) CostsPriority Chemicals
Costs are through the life of the project.
25
IAG (FDA/NIEHS) CostsEndocrine Disrupting
Chemicals
Costs are through the life of the project.
26
IAG (FDA/NIEHS) Pathology Resources
Project Hours
  • Pathology hours through August 2000

27
IAG (FDA/NIEHS) ADP Resources
Project Hours
  • ADP hours through August 2000

28
IAG (FDA/NIEHS) Animal Care/Diet Prep Resources
Cage Weeks
.Cage weeks reported through August 2000
29
IAG (FDA/NIEHS) Animal Care/Diet Prep Resources
by Chemical
Cage Weeks
.Cage weeks reported through August 2000
30
FDA/NIEHS IAG Billed Estimated Costs through FY
2005
Some out year projects not yet submitted to
Planning for costing are estimated based on
similar animal studies.
Billed to NIEHS
31
FDA-NIEHS IAG
IAG Concept Genesis
  • Innovative applied toxicology studies
  • Involve FDA scientists in protocol design
  • Conduct specific mechanistic/mode of action
    studies in support of sound science-based
    safety/risk assessments
  • Reports in a timely manner
  • Utilize NCTRs unique facilities and expert
    scientific staff

32
FDA-NIEHS IAG
Chemical/Agent Selection, Nomination Approval
  • FDA Chemical Selection Working Group
  • NTP Interagency Chemical Coordination and
    Evaluation Committee
  • NTP Executive Committee
  • FDA Study director assigned to chemical
  • Study director develops research plan
  • Study director/PI develops protocol(s)

33
FDA-NIEHS IAG
TSSRC
  • Core Members
  • NCTR Deputy Director for Research (chair)
  • FDAs NTP Liaison (vice-chair/Executive Sec)
  • NIEHS Project Officer

34
FDA-NIEHS IAG
TSSRC
  • Ad Hoc Members
  • NCTR Study Director/PIs
  • FDA NIEHS scientists
  • Other federal agencies (USDA, NCI, NIOSH)
  • Academia
  • International (Agriculture Canada, U.K.)
  • Industry

35
FDA-NIEHS IAG
Public Health Benefit
  • The FDA-NIEHS IAG has leveraged resources -
    public funds and scientific expertise - in a most
    effective and efficient manner which enables both
    FDA and NTP to better identify chemical/agent
    hazards, assess safety and human health risk, to
    the benefit of the American public.

36
IAG Cost Include
  • Labor
  • Government
  • ORISE
  • PAI
  • ROW
  • Bionetics
  • Travel
  • Supplies
  • Equipment
  • Overhead
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