|
 |
ICCVAM Test Method Evaluation Process |
| |
|
|
Test Sponsors (industry or government)
- Request review of proposed test methods by the Center
(methods of multi-agency interest)
- Request comments on pre-validation/validation studies
- Propose workshops ( with appropriate rationale)
NTP Interagency Center for the Evaluation of Alternative Toxicological Methods
- Prescreens test method submissions for completeness, readiness for peer review
- Organizes public peer reviews and workshops with input from ICCVAM, Advisory Committee,
and solicitation of comments in FR notices
- Publishes and distributes peer review and workshop reports
- Serves as an information resource for stakeholders, communication link to appropriate
agencies/staff
- Provides executive secretariat services for ICCVAM/ Adv. Committee
Peer Review Panels and Workshops
Peer Reviews:
- Develop scientific consensus on usefulness of test methods for risk assessment
Workshops:
- Evaluate usefulness of current methods; identify priority research, development,
and validation efforts needed for improved methods;
- Evaluate validation status of methods;
- Evaluate proposed validation studies; and other topics as appropriate
Federal Advisory Committee on Alternative Toxicological Methods
- Provides advice on activities of the Center and ICCVAM
- Priorities and processes
- Input on peer reviews and workshops, participation as appropriate
- Test method development, validation, and review
- Provides advice on fostering public-private partnerships
Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)--15
agencies
- Serves as an interagency forum for the coordination, communication, and information
sharing of test method development, validation, acceptance, national and
international harmonization issues
- Establishes ICCVAM Interagency Expert Working Groups
- Work with Center to organize and coordinate workshops and peer reviews for specific
methods or endpoints
- Ensure adequate information for peer reviews and workshops
- Identify appropriate peer reviewers/workshop panels
- Formulate questions for peer reviewers and workshop panels
- Develop recommendations for agencies on test method usefulness
- Provide comments for sponsors on proposed pre-validation/validation studies
- Forwards recommendations on new methods to agencies
Regulatory Agencies
- Consider ICCVAM recommendations, and approve/disapprove methods, or other action
as appropriate
- Issue appropriate public notices and take steps to implement method, e.g., proposed
changes in regulations, or new/revised guidance documents
- As appropriate, forward methods for international adoption
( e.g., EPA--OECD, FDA--ICH/ISO, DOT--UN)
Research/ Testing Agencies/ Non-Federal Stakeholders
- Consider ICCVAM recommendations, adopt for use as appropriate
- Consider/conduct recommended research, development, and validation efforts
|
|
|
