RFP_Attachment_8_Amendment_4.pdf

Attachment 8 NICEATM Support Contract

Additional Technical Proposal Instructions

Additional Technical Proposal Instructions

These additional Technical Proposal instructions reflect the requirement of the RFP and provide additional instructions for the Technical Proposal. While Section L of the RFP provides a generic set of Technical Proposal instructions, these additional instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used, along with Section L to prepare the Technical Proposal. Offerors are advised to give careful consideration to the Statement of Work (SOW), the Technical Evaluation Criteria, and the RFP as a whole in the development of their proposals. Offerors should submit a proposal that addresses all task areas in the SOW.

The Offeror is referred to the following references as guidance for the content and format of validation reports as well as specific examples of the types of documents produced as part of this contract:

ICCVAM. 1997. Validation and Regulatory Acceptance of Toxicological Test Methods, A Report of the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods, NIH Publication No. 97-3981, Research Triangle Park, NC, National Institute of Environmental Health Sciences. Available at:

http://ntp.niehs.nih.gov/iccvam/docs/about_docs/validate.pdf. Last accessed 05/05/2014.

ICCVAM. 2003. ICCVAM Guidelines for the Nomination and Submission of New, Revised and Alternative Test Methods, NIH Publication No. 03-4508, Research Triangle Park, NC, National Institute of Environmental Health Sciences. Available at: http://ntp.niehs.nih.gov/go/41062. Last accessed 05/05/2014.

ICCVAM. 2011. ICCVAM Test Method Evaluation Report: The LUMI-CELL ER (BG1Luc ER TA) Test Method: An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals. Appendix C: Final background Review Document. NIH Publication No. 11-7850, Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available: http://ntp.niehs.nih.gov/go/40419. Last accessed 05/05/2014.

ICCVAM. 2011. ICCVAM Test Method Evaluation Report: The LUMI-CELL ER (BG1Luc ER TA) Test Method: An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals. NIH Publication No. 11-7850, Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available:

http://ntp.niehs.nih.gov/go/40419. Last accessed 05/05/2014.

Independent Scientific Peer Review Panel Report: Evaluation of the LUMI-CELL ER® (BG1Luc ER TA) Test Method, May 2011. Available at: http://ntp.niehs.nih.gov/iccvam/docs/endo_docs/edprprept2011.pdf. Last accessed 05/05/2014.

Stokes WS, Brown K, Kulpa-Eddy J, Srinivas G, Halder M, Draayer H, Galvin J, Claassen I, Gifford G, Woodland R, Doelling V, Jones B. 2011. Improving animal welfare and reducing animal use for veterinary vaccine potency testing:

state-of-the-science and future directions. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 84-105. Available at:

http://iccvam.niehs.nih.gov/articles/publications.htm. Last accessed 05/05/2014.

ICCVAM. 2012. ICCVAM 2010-2011 Biennial Report, NIH Publication No. 10-7612, Research Triangle Park, NC, National Institute of Environmental Health Sciences. Available at: http://ntp.niehs.nih.gov/go/iccvam-bien. Last accessed 05/05/2014.

http://ntp.niehs.nih.gov/iccvam/docs/about_docs/validate.pdf http://ntp.niehs.nih.gov/go/41062 http://ntp.niehs.nih.gov/go/40419 http://ntp.niehs.nih.gov/go/40419 http://ntp.niehs.nih.gov/go/40419 http://ntp.niehs.nih.gov/iccvam/docs/endo_docs/edprprept2011.pdf http://iccvam.niehs.nih.gov/articles/publications.htm http://ntp.niehs.nih.gov/go/iccvam-bien

Additional Technical Proposal Instructions

The NICEATM-ICCVAM Five-Year Plan (2008-2012), NIH Publication No. 08-6410, January 2008, Research Triangle Park, NC, National Institute of Environmental Health Sciences. Available at:

http://ntp.niehs.nih.gov/iccvam/docs/5yrplan/niceatm5yr-final.pdf. Last accessed 05/05/2014.

Submission Instructions

The proposal, including any necessary appendices, shall be formatted by sections, cross-referenced, and include a detailed Table of Contents. In addition electronic copies of the Technical Proposal shall be password protected (use password NICEATM2014). The text portion of the Technical proposal only (without any appendices) should be submitted using a .pdf searchable format. Proposals should NOT include links to Internet website addresses or otherwise direct readers/reviewers to alternate sources of information.

Technical Proposal

Each Offeror shall submit the following items as part of the technical proposal. These items are cross-referenced to the appropriate technical evaluation criteria and should be used as guidance as to how proposals will be evaluated.

The Offeror shall include all information which documents and/or supports the mandatory qualification criteria in one clearly marked section of the Technical Proposal.

Technical Evaluation Criteria 1: Technical Approach (300)

Proposals will be evaluated on how well the Offeror demonstrates the ability to accomplish a complex project as outlined in the Statement of Work. For the purposes of this proposal only, the Offeror should provide details describing their approach to accomplishing the following

I. (200) Provide an overall technical approach for meeting the needs of the Government as described within the Statement of Work, including a general plan of work, with proposed schedule, and methodologies anticipated to accomplish the described plan. Proposed approach should demonstrate an understanding of, and approach for, accessing toxicology databases to obtain relevant information and history; understanding of, and approach for, accomplishing the technical and administrative support activities including coordination and communication with the COR, contract staff, NICEATM government staff, and members of the various committees and expert groups; description of activities necessary to support peer review meetings, workshops, and advisory committee meetings to meet the objectives of the contract; and explanation of financial and organizational monitoring.

II. (100) Sample Project: Provide a validation plan for an endpoint relevant to endocrine disruption that would reduce or replace animals using all publicly available ToxCast and Tox21 data. (It is suggested that the document should not exceed 12 pages).

a) Specify the endocrine disruption endpoint of interest.

b) Provide your comprehensive search strategy to identify existing test methods for the identified endpoint. (~1/2 page)

c) Provide your plan for evaluating the extant literature for knowledge gaps. (~1/2 page) http://ntp.niehs.nih.gov/iccvam/docs/5yrplan/niceatm5yr-final.pdf

Additional Technical Proposal Instructions

d) Identify up to 3 knowledge gaps for the selected endpoint. Design a validation study, including positive and negative controls and your rationale for their selection, to address ONE of the identified knowledge gaps. (~3 pages)

e) Provide a timeline for completing the study, evaluating the results, and submitting the report. Indicate what additional ad hoc expertise outside of the Offeror’s organization is needed to complete the validation process and estimate their level of effort. How would you ensure that the consultants were free from Conflict of Interests? No whole animal work shall be conducted during a validation study. For the purposes of the proposal, assume that the Offeror’s organization does not have the capability to conduct the validation study(ies) in house. Provide a process and criteria for identifying potentially qualified subcontractors, including the Offeror’s mechanism for filtering out subcontractors with Conflicts of Interest. Using the proposed plan, identify 3 qualified subcontractors to complete the validation study of the endpoint of interest. (~3 pages)

f) Provide an outline of the information that would be included in the Background Review Document for submission to the COR. (~2 pages)

g) Provide a list of references used to complete this task. (~2 pages)

Technical Evaluation Criteria 2: Personnel (250)

III. (80) Principal Investigator (Key Personnel): Provide a CV for the Principal Investigator (limited to 10 pages). Include all information relevant to document training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements and provide selected references for publications relevant to the scope of the RFP. Describe experience with projects of similar scope, size and complexity. Describe the overall approach for the active management of the NICEATM Support Team.

The PI shall have demonstrated knowledge of toxicology, including classical toxicology, validation of alternate toxicological test methods, and the use of in vitro and in silico testing methods as they relate to the assessment of hazard and safety of chemicals and other agents to human health as well as the development of adverse outcome pathways and integrated approaches to testing and assessment. The PI shall have demonstrated organizational and communication skills.

The PI shall have a PhD or equivalent in a Life Sciences or Chem/Bio-informatics, with demonstrated experience in Chem/Bio-informatics and/or Toxicology.

IV. (70) Senior Toxicologist (Key Personnel): Provide a CV for the Senior Toxicologist (limited to 10 pages).

Include all information relevant to document training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements and provide selected references for publications relevant to the scope of the RFP. Describe experience with projects of similar scope, size and complexity.

The Senior Toxicologist shall have demonstrated knowledge in toxicology, including classical toxicology, development, validation, evaluation and regulatory acceptance of new toxicological testing methodologies and demonstrated experience in at least one of the following areas: acute/chronic systemic toxicity testing;

ocular and dermal toxicity testing; reproductive toxicology, to include assessment of endocrine active

Additional Technical Proposal Instructions substances; and/or development and validation of alternative toxicological methods and shall be certified by the American Board of Toxicology.

V. (60) Additional Professional Technical Staff: Provide CVs for additional professional technical staff (limit to 10 pages each). Include all information relevant to document individual training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements and provide selected references for publications relevant to the scope of the RFP.

The staff shall have demonstrated experience in the evaluation and validation of alternative toxicological test methods including, but not limited to, sub-discipline(s) of acute systemic toxicity testing, ocular and dermal toxicity testing, reproductive toxicology; understanding of mechanisms of toxicity; assessment of endocrine active substances, and/or vaccines and other biologics; development of integrated approaches to testing and assessment and adverse outcome pathways; and development of computational models and prioritization tools to predict potential human toxicity of chemicals using data from HTS bioassay data, problem evaluation and critical assessment of new test method performance characteristics; practical experience in the creation/utilization of databases, algorithms, computational and statistical techniques, and theory to solve practical problems arising from the management and analysis of large biological data sets; computational screening of in silico compound libraries to identify members likely to possess desired properties such as biological activity against a given target. Describe experience with projects of similar scope, size and complexity.

VI. (40) Project Management, Technical, and Administrative Staff: Provide CVs for additional staff (limit to 5 pages each). Include all information relevant to document individual training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements and provide selected references, as appropriate, for publications relevant to the scope of the RFP.

Project Management, Technical, and Administrative staff shall have demonstrated experience in organization, management, and coordination of scientific review and evaluation activities, preferably related to new testing methods; analysis of in vivo, in vitro, and/or in silico data sets; communications, including expertise in current MS Office products (Word, PowerPoint, Excel), HTML, and Web page design; writing for the web; writing for lay audiences; meeting planning. Describe experience with projects of similar scope, size and complexity.

Technical Evaluation Criteria 3: Project Management and Coordination (250)

I. Quality Management Plan: The Contractor shall have in place a comprehensive quality management plan that clearly and concisely describes how the organization will plan, implement, and assess the effectiveness of its quality assurance and quality control operations. This plan should describe the internal review procedures which facilitate high quality standards in the organization; state whether or not subcontractors are used and, if so, describe the quality control measures your organization uses to ensure acceptable subcontractor performance; describe the procedures for ensuring quality performance while meeting urgent requirements; identify strategies used by your firm to manage and complete multiple projects for multiple agencies simultaneously. Provide you formal Conflict of Interest Plan and strategies employed for mitigating potential and real conflicts of interest. For additional information on quality management plans see http://www.epa.gov/quality/qmps.html.

http://www.epa.gov/quality/qmps.html

Additional Technical Proposal Instructions

II. Functional Organizational Chart: Provide a functional organization chart for the project and a list of proposed personnel including Key Personnel, Professional Technical staff, and Technical and Administrative Support staff, etc.). Include a table of proposed staff, years of experience, skill sets appropriate for the contract, proposed role on the project, and proposed level of effort on and availability to the project.

III. Summary of Corporate information on ability to conduct and manage multidisciplinary projects similar in scope to those outlined in the Statement of Work. Include organization’s size, experience in the field, and resources available to enable the Offeror to fulfill the requirements of the SOW; a brief history of the organization’s activities contributing to the development of expertise and capabilities related to this requirement; information demonstrating the Offeror’s organizational and accounting controls and manpower presently in house or the ability to acquire the type and kinds of personnel proposed.

IV. Statement of ability to avoid real and perceived conflicts of interest relative to NICEATM, ICCVAM, and NTP.

Technical Evaluation Criteria 4: Facilities (200)

V. Provide a description of available facilities, computer equipment, and computational software packages available to perform the duties as described in the SOW.