Additional_Technical_Instructions.pdf

Additional Technical Proposal Instructions

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ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

Each area of the Statement of Work shall be addressed in sufficient detail to permit evaluation of the technical proposal in terms of adequacy of the proposed approach for each aspect of work and adequacy of the personnel proposed to accomplish the work as outlined in the Statement of Work.

MANDATORY QUALIFICATION CRITERIA

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

SAMPLE STUDY PROTOCOLS

A set of sample protocols have been included as an attachment at Section J—List of Attachments, Solicitation Attachments, to serve as an example of a typical NTP study for immunosuppression and hypersensitivity. For purposes of the Technical Proposal, the offeror shall use these sample protocols for INFORMATION PURPOSES ONLY to assist them as they: (1) describe the overall objectives of the project as envisioned by the offeror; (2) demonstrate an understanding of the project requirements; and

(3) outline the overall technical approach used to achieve the objectives outlined in the Statement of Work (SOW). A recapitulation of the sample protocols will not be acceptable to demonstrate overall objectives, an understanding of the project requirements or the overall technical approach.

FORMAT

The proposal, including appendices, shall be formatted by sections, cross referenced, and include a detailed Table of Contents. Proposals should NOT include links to the Internet website addresses or otherwise direct readers/reviewers to alternate sources of information.

The technical proposal shall include a discussion of the items set forth in Section L of the solicitation, as well as the items below. For additional guidance on how each of the items will be will be evaluated in the technical proposal, refer to Section M—Technical Evaluation Criteria of this RFP.

Each offeror shall include the following information as part of the technical proposal:

A. Historical Data

The offeror shall document their capability and experience in conducting GLP immunotoxicology studies by providing data from the assessment of known positive controls or unknown chemicals for immunotoxicity obtained in their laboratory.

The offeror shall include a table that documents the substances the laboratory and principal investigator have evaluated for their potential to induce immunosuppression (adult or developmental studies), hypersensitivity and autoimmunity within the last ten (10) years, along with the date the evaluation was conducted. Specific details regarding proprietary compounds need not be provided, but the offeror should document the number and types of GLP studies completed in the evaluation of these materials.

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B. Study Management Plan

The offeror shall provide a specific plan with regard to study management and detailed information as to how the workflow of the studies will be managed. This shall include but is not limited to:

(1) The proposed approach to overall project management, including: a functional organizational chart with details of organizational experience relative to working together as a project team;

details of project scheduling; and, details of the steps used to encourage communication amongst project staff.

(2) A discussion of the specific duties and responsibilities of involved personnel and all subcontractors, and their availability to the project.

(3) The proposed procedures for day-to-day data management including, data collection, coordination, review for completeness and accuracy, archiving and submission to the NTP. The offeror’s proposal shall include procedures for the electronic submission of data. A contact person shall be named in offer so that NTP personnel will have someone to resolve any problems that may arise in getting the data from electronic databases.

(4) The proposed method for financial monitoring and oversight.

At a minimum, the Study Management Plan should include information on the use of SOPs, study protocols, data integrity and laboratory management.

C. Quality Management Plan

This plan shall include a description of the offeror’s quality control procedures that will be used for all aspects of study conduct. The offeror shall describe the approach and procedures for quality assurance, including details of the operating procedures of the Quality Assurance Unit. Offerors should refer to the U.S. Environmental Protection Agency (EPA) "Requirements for Quality Management Plans (EPA QA/R-2) available from http://www.epa,gov/quality/qs-docs/r2-final.pdf.

D. Health & Safety Plan

The proposal shall include a Health and Safety Plan that addresses the approach and procedures for assurance of the health and safety of project participants, including test article handling, storage and disposal, personal protection procedures/equipment, monitoring methods and strategy, training and institutional review. The Health and Safety Plan shall demonstrate how the offeror will comply with the Occupation Safety and Health Act and applicable state and local safety and health codes, standards, and regulations, and also meets the requirements set forth in the NTP Specifications” (Appendix A).

E. Facilities and Equipment

The offeror shall provide:

(1) A detailed floor plan of the facility, including air flow and traffic patterns, that clearly describes areas in which the work shall be performed, location of equipment, and storage space.

http://www.epa,gov/quality/qs-docs/r2-final.pdf

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(2) Information on equipment used in data management, transfer and storage and appropriate procedures for ensuring data accuracy and integrity shall be provided in the proposal.

(3) A detailed description of all animal facilities (including a detailed floor plan which shows air flows and traffic patterns) that documents the layout of the facility and equipment to be used for treatment and holding of laboratory animals. The floor plan should specifically display the barriers for the transmission of infectious agents as well as any other protective devices used to assure the health and safety of contract staff and laboratory animals.

F. Personnel

Offerors shall provide a list of and a curriculum vitae for all of the personnel, including technicians, proposed for assignment to the project. The vitae should clearly state education, experience, publications, duties and responsibilities by year. Experience specifically related to elements of the project should be clearly identified.

Subcontracting: If subcontractors/consultants are proposed, the offeror must clearly define how any proposed subcontract/consultant arrangements would meet program needs. A letter of commitment from the subcontractor/consultant must be provided with the technical proposal. If subcontracting is suggested, details must be given as to how this would be structured, organized, managed and monitored. Information similar to items above must be provided for the subcontractor (including qualifications, historical control, proficiency data, and other information).

“Subcontract” means any agreement (other than one involving an employer-employee relationship) entered into by a Government prime contractor or subcontractor calling for supplies and/or services required for performance of the contract, contract modification, or subcontract.

(Additional Considerations)

The following labor classifications represent the Government’s assessment of the personnel requirements for this project. These are provided for information only and are not to be considered restrictive for proposal purposes.

Offerors are advised that the Principal Investigator, Deputy-Principal Investigator and other critical staff involved in toxicologic research (as applicable to this contract and defined in Appendix A of the Statement of Work) must be in place by the date of contract award. The Principal Investigator, Deputy-Principal Investigator and technical staff shall be employees of the offeror.

Senior Research Professional:

Typical Titles: Project Leader or Principal Investigator Normal Qualifications: Ph.D. degree or equivalent Experience: 10 years or more Preferences: a Ph.D. in Toxicology, Immunology, Pharmacology or a related discipline and a minimum of 10 years of post-graduate experience in conducting Immunotoxicology studies, with

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(1) demonstrated abilities and experience in planning, conducting and reporting functional studies that evaluate the immune system following chemical or drug insult, (2) demonstrated abilities and experience in pharmacological, toxicological and immunological studies (3) experience in hypersensitivity studies and (4) sufficient supervisory experience to direct this project.

The proposal shall include information regarding the training and experience of the Principal Investigator in the management of laboratory animal studies and in the coordination of multiple ongoing projects.

The Deputy Principal investigator and other professional staff shall possess a Ph.D. in Toxicology, Immunology, Pharmacology or a related discipline and have demonstrated abilities and experience in toxicological testing and statistical analysis and evaluation.

Veterinarian

Qualifications: D.V.M. degree and experience in Laboratory Animal Management

Professional

Typical Titles: Scientist, Senior Technical Staff, Study Director, Analyst or Engineer Normal Qualifications: B.S. degree in Biological Science or related field Experience: 5 years or more Preferences: experience in toxicology research and testing or related laboratory techniques;

sufficient training, planning and supervisory experience in conducting immunotoxicological studies to perform this project

Quality Assurance Staff

Typical Titles: QA Officer or QA Staff Normal Qualifications: Training and education relevant to the position Preferences: appropriate experience and training in managing data for a project of this size and scope

Health and Safety Officer

Normal Qualifications: B.A. or B.S. in industrial hygiene, chemistry, safety engineering, etc.

Junior Technical Staff

Typical Titles: Technician Normal Qualifications: A.A. Degree or equivalent; certification or eligibility for certification as a Laboratory Animal Technologist or Laboratory Animal Technician Experience: at least 3 years preferred Preferences: (1) demonstrated abilities and experience in conducting studies of immune system evaluation following chemical insult, (2) experience in toxicology and immunology techniques, and (3) experience in handling toxic and radiolabeled chemical and infectious agents.

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Support Staff

Typical Titles: Secretary or Data Coordinator Normal Qualifications: Technical Training relevant to the position Experience: at least 1 year preferred