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FDA-NIEHS Interagency Agreement

Comprehensive Toxicological Assessments of FDA Selected Nominations to the National Toxicology Program; Selected NTP/NIEHS Nominations of FDA Importance. FDA-NIEHS Interagency Agreement. Assistant Secretary for Health DHHS. NTP Executive Committee: Heads, DHHS Agencies, EPA, OSHA, NCI

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FDA-NIEHS Interagency Agreement

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

  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 Chemical Evaluation Committee Working Group Report on Carcinogens Technical Reports Subcommittee Reports on Carcinogens Subcommittee

  3. FDA’s 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 FDA’s Mission = LEVERAGING • Using intellect, time, money and resources in a manner that Maximizes their value in enhancing FDA’s role of protecting and promoting public health

  4. NCTR’s 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 NCTR’s 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. 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 FDA-NIEHS IAG FDA Nominations FDA/NIEHS Nominations

  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 & TG:AC 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. Scientific Oversight - Peer Review FDA-NIEHS IAG • 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 Laboratory&NTP Center for Phototoxicology

  20. 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.

  21. IAG (FDA/NIEHS) Post Doc Positions

  22. 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) Animal Room Occupation

  23. IAG (FDA/NIEHS) CostsPriority Chemicals Costs are through the life of the project.

  24. IAG (FDA/NIEHS) CostsEndocrine Disrupting Chemicals Costs are through the life of the project.

  25. IAG (FDA/NIEHS) Pathology Resources Project Hours • Pathology hours through August 2000

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

  27. IAG (FDA/NIEHS) Animal Care/Diet Prep Resources Cage Weeks .Cage weeks reported through August 2000

  28. IAG (FDA/NIEHS) Animal Care/Diet Prep Resources by Chemical Cage Weeks .Cage weeks reported through August 2000

  29. 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

  30. 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 NCTR’s unique facilities and expert scientific staff

  31. 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)

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

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

  34. 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.

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

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