A test method nomination consists of a proposal to ICCVAM for
review and evaluation for which a complete test method submission is not available. Four examples are:
- Test methods for which adequate validation studies presumably have been completed but lack
a complete submission package
- Test methods that appear promising based on limited prevalidation or validation data and
are proposed for additional validation studies
- Test methods that have been developed and are proposed for prevalidation or validation
studies
- Test methods that are recommended for a workshop or other activity
Test method nominations and submissions may be made via the
NTP Online Nomination Form or by
contacting NICEATM.
Proposed test method nominations or submissions received by ICCVAM are initially assessed by
NICEATM as to the relevance of the nomination or the adequacy and completeness of the submission.
ICCVAM then determines the priority the proposed test method will have for technical evaluation.
Once a proposed test method has been accepted for evaluation, ICCVAM assembles an interagency
working group of government scientists with scientific and regulatory expertise in the appropriate
scientific disciplines to collaborate with NICEATM on the evaluation process. Depending on the
validation status of the proposed test method, ICCVAM, in conjunction with NICEATM, develops
recommendations and priorities for further efforts. Such efforts might include an expert workshop,
an expert panel meeting, a peer review meeting, an expedited peer review process, or a validation
study.
Test method sponsors are encouraged to consult with NICEATM and ICCVAM throughout the test method
development, prevalidation, and validation process, as well as during preparation of submissions.
The objective of these interactions is to maximize the likelihood that validation studies and
submissions will adequately characterize the usefulness and limitations of the proposed test
method. Complete submissions are essential and serve as a basis for assessing the validation
status of a proposed test method through an independent ICCVAM peer review process. This interactive
process enhances the likelihood that agencies will have sufficient data and information to determine
the extent that a test method can generate information that will meet their regulatory needs.
Criteria for the validation and regulatory acceptance for new and alternative test methods are outlined
in the report Validation and Regulatory Acceptance of Toxicological Test Methods (ICCVAM 1997)
[PDF]
|
![ICCVAM Brochure ICCVAM Brochure](https://webarchive.library.unt.edu/web/20130214215806im_/http://iccvam.niehs.nih.gov/images/NomSubBrochure-front-Feb12.gif)
View ICCVAM brochure with guidance for test method developers and sponsors (February 2012)
[PDF]
|
Nominator |
Nominated Test Method Activity |
Activity
Status |
Additional
Materials |
MB Research Labs |
Nomination of the In Vitro Sensitivity Assay for Detection of Substances
That Cause Dermal Sensitization
View Nomination Letter
[PDF] |
Under Consideration |
- |
NIOSH/CDC |
Nomination of the Electrophilic Allergic Screening Assay for the Detection of Substances Causing Allergic Contact Dermatitis
View Nomination Cover Letter
[PDF] |
Under Consideration |
NICEATM Preliminary Evaluation (July 2012)
[PDF] |
BioSentinel Pharmaceuticals |
Submission of the BoTest™, BoTest™ Matrix, and BoCell™
Botulinum Neurotoxin Activity assays for interlaboratory validation studies by ICCVAM and NICEATM.
View Nomination Cover Letter
[PDF] |
Final ICCVAM priority: high
In conjunction with a review of other botulinum toxin test methods |
- |
Biotest AG |
Nomination of an in vitro test method for assessing pyrogenicity
of pharmaceuticals and other products for further evaluation in order to expand its applicability
domain to non-endotoxin pyrogens [PDF]
View Nomination Cover Letter
[PDF] |
Final ICCVAM priority: high,
for further consideration and evaluation |
FDA Document: "Guidance for Industry —
Pyrogen and Endotoxins Testing: Questions and Answers"
[PDF
] |
CPSC |
CPSC Nomination: Request for Assessment of the Validation of the
Local Lymph Node Assay for Classification of Sensitizers [PDF] |
Evaluation Completed -
View Summaries of Evaluations |
List of References |
HSUS |
Alternative Methods to Replace the Mouse LD50 Assay for
Botulinum Toxin Potency Testing [PDF]
View HSUS Letter to Allergan, Inc. (Dec. 15, 2005) [PDF] |
Workshop Completed |
List of References |
CertiChem, Inc |
MCF-7 Estrogenic Activity Cell Proliferation Assay
View Nomination Cover Letter
[PDF]
View Documentation Provided with Nomination
[PDF] |
Validation Study Complete - Evaluation in Progress |
- |
Xenobiotic Detection Systems |
LUMI-CELLTM Estrogen Receptor High-Throughput System
for Screening Estrogen-Like Chemicals for Validation Studies
View Nomination Cover Letter
[PDF]
View Documentation Provided with Nomination
[PDF] |
Validation Study and Evaluation Completed |
-
|
(Redacted at nominator's request)
| NTP Two-Year Toxicology and Carcinogenesis Rodent Studies (received Oct. 24, 2007)
[PDF]
Additional nominating material (received May 13, 2008) [PDF] |
Under Consideration |
Draft ICCVAM Recommended Priority [PDF] |
Sponsor |
Test Method |
Evaluation
Status |
Additional
Materials |
Alternatives Testing Steering Committee:
Johnson Diversey
S.C. Johnson & Son, Inc.
The Procter & Gamble Company
The Accord Group |
In Vitro Test Method for Assessment of the Eye Irritation Potential of
Antimicrobial Cleaning Products
View Submission Cover Letter from IIVS, Inc. [PDF] |
Evaluation Completed |
ICCVAM Test Method Evaluation Report |
ECVAM |
In Vitro Pyrogenicity Test Methods [PDF] |
Peer Review Complete |
Pyrogenicity Test Methods |