Amendment_2_-_Section_M.pdf

RFP No: NIEHS2013158

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

Selection of an offeror for contract award will be based on an evaluation of proposals against four factors. The factors in order of importance are: technical, cost, past performance and Small Disadvantaged Business (SDB) participation. Although technical factors are of paramount consideration in the award of the contract, past performance, cost/price and SDB participation are also important to the overall contract award decision.

All evaluation factors other than cost or price, when combined, are significantly more important than cost. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government.

The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed factors listed below.

2. LIVE VERTEBRATE ANIMALS EVALUATION

The offerors proposal must include, as a separate section of the Technical Proposal titled "Vertebrate Animal Section," (VAS) a complete, concise (no more than 1-2 pages) description addressing the following five points. (See NIH Guide Notice NOT-OD-10-049 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-049.html):

a) Detailed description of the proposed use of the animals, including species, strains, ages, sex and number to be used.

b) Justification for the use of animals, choice of species, and numbers to be used.

c) Information on the veterinary care of the animals.

d) Description of procedures for minimizing discomfort, distress, pain and injury.

e) Method of euthanasia and the reasons for the selection.

As part of the overall technical evaluation of proposals, the reviewers will consider the acceptability of the offeror's description in the VAS of the technical proposal. The discussion of all five points will be addressed and evaluated. Based on the evaluation of this Section, the VAS may be rated "unacceptable" (i.e., concerns are identified as to the adequacy of the description addressing each of the five points, or no discussion can be found regarding the VAS), or "acceptable." If the reviewers find that this Section of the technical proposal is "unacceptable" they will provide a narrative supporting their findings.

If the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to address the concerns raised by reviewers. You will be able to further discuss and/or clarify your position until submission of your Final Proposal Revision (FPR). Once discussions are closed with the submission of your FPR, if your proposed description under the VAS is still found to be unacceptable, then your proposal may not be considered further for award.

3. MANDATORY QUALIFICATION CRITERIA

Listed below are mandatory qualification criteria. THE OFFEROR SHALL INCLUDE ALL

INFORMATIONWHICH DOCUMENTS AND/OR SUPPORTS THE QUALIFICATION

CRITERIA IN ONE CLEARLY MARKEDSECTION OF ITS TECHNICAL PROPOSAL. /

PROVIDE AN INDEX WITHIN ITS TECHNICAL PROPOSALWHICH DIRECTS THE

REVIEWER(S) TO THE SPECIFIC AREA(S) OF THE TECHNICAL PROPOSAL

THATADDRESS A PARTICULAR MANDATORY QUALIFICATION.

Instructions for Mandatory Criteria 1

The qualification criteria establishes conditions that must be met at the time of receipt of Technical Proposals by the Contracting Officer in order for your proposal to be considered any further for award.

1. GLP COMPLIANCE

The NTP requires that these studies be conducted in compliance with FDA GLP regulations as specified in Part 58 "Good Laboratory Practices for Non-clinical Laboratory Studies". All laboratories (including proposed subcontractors) performing core work as defined in the Statement of Work are required to meet this mandatory qualification criterion.The offeror shall include information and documentation that demonstrates evidence of the testing laboratory's current compliance with the provisions of 21 CFR 58. Such documentation may include (but is not limited to):

a) FDA 482-Notice of Inspection Form, as evidence that general surveillance inspections and/or directed inspections have occurred.

b) Establishment Inspection Report (EIR) forms issued to document the results of any inspections.

c) Any adverse findings or FDA Form 483 - Inspectional Observations reports issued.

d) History (number, time-frame and evidence) of GLP studies conducted if documentation from a regulatory agency such as the above a, b or c cannot be provided.

Instructions for Mandatory Criteria 2

The qualification criteria establishes conditions that must be met for AAALAC accreditation at the time of receipt of Final Proposal Revisions (FPRs) Technical Proposals by the Contracting Officer in order for your proposal to be considered any further for award. The PHS Assurance number shall be provided prior to contract award.

2. ANIMAL WELFARE

The offeror and any proposed subcontractors that conduct work involving the use of live animals must have an AAALAC-accredited animal facility. Offerors shall also have a PHS Assurance from the NIH Office of Laboratory Animal Welfare (OLAW). The Assurance number shall be provided prior to contract award. The offeror must demonstrate their compliance with the NIH Guide for Care and Use of Laboratory Animals. Further information may be obtained from the following source:

Office of Laboratory Animal Welfare Office of Extramural Research National Institutes of Health Rockledge Center I, Suite 360, MSC 79826705 Rockledge Drive Bethesda, MD 20817 Phone: (301) 496-7163, ext. 234 Copies of the PHS policy are available by fax at 301-402-2803 and on the internet at URLhttp;//grants.nih.gov/grants/olaw/olaw.htm

4. EVALUATION OF OPTIONS

It is anticipated that any contract(s) awarded from this solicitation will contain option provision(s) and period(s).In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of options will not obligate the Government to exercise the option(s).

5. EVALUATION OF DATA SHARING PLAN

The offeror's plan for the sharing of final research data shall be assessed for appropriateness and adequacy. If your proposal does not include a plan or if the plan in your proposal is considered "unacceptable," and the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to further discuss, clarify or modify your data sharing plan during discussions and in your Final Proposal Revision(FPR). If your data sharing plan is still considered "unacceptable" by the Government after discussions, your proposal may not be considered further for award.

6. EVALUATION OF PLAN FOR SHARING MODEL ORGANISMS FOR BIOMEDICAL

RESEARCH

The offeror's proposal must address the plans for sharing model organisms, OR state appropriate reasons why such sharing is restricted or not possible. Offerors must also address as part of the sharing plan if, or how, they will exercise their intellectual property rights while making model organisms and research resources available to the broader scientific community. The discussion areas regarding intellectual property outlined in Section L should be addressed. If your proposal does not include a plan, appropriate reasons for restricting sharing, or, if the plan in your proposal is considered "unacceptable," and the Government includes your proposal in the competitive range(for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to further discuss, clarify or modify your plan for sharing model organisms during discussions and in your Final Proposal Revision (FPR). If your plan for sharing model organisms is still considered "unacceptable," or your justification for restricting sharing is still considered inappropriate by the Government after discussions, your proposal may not be considered further for award.

A. Personnel Qualifications 315 points

This factor will be scored on 1) the strength and qualifications of the personnel proposed 2) relevant experience, training, education, and certifications and degree to which the qualifications of proposed personnel successfully fulfill their prescribed roles 3) suitability, training and qualifications of proposed staff and their demonstrated ability to perform the tasks as outlined in the statement of work 4) experience of personnel working together as a team.

a. Principle Investigator - 100 Points

The Principle Investigator is a key position and shall be a Ph.D. in a relevant scientific discipline (e.g., Biology, Toxicology, Genetics, Cell Biology, Molecular Biology).

Demonstrated 5 years of experience in managing an interdisciplinary team in the conduct of a variety of in vitro and in vivo assays for evaluating endpoints of genetic toxicity following exposure to environmental compounds

Demonstrated expertise with all laboratory protocols required to perform the SOW and in data interpretation

Exemplifies adequate and suitable scientific accomplishments, training, and experience as evidenced by his/her bibliography and Curriculum Vitae, relevant publications in peer reviewed journals, and written study reports relevant to the statement of work.

b. Laboratory Director - 75 Points

The Laboratory Director is a key position and shall be a Ph.D. in a relevant scientific discipline (e.g., Biology, Toxicology, Genetics, Cell Biology, Molecular Biology).

Demonstrated 3 years of experience in maintaining a diversified genetic toxicity testing laboratory and successfully organizing and prioritizing competing work assignments, and apportioning workload.

Demonstrated expertise in the assays outlined in the SOW Exemplifies adequate and suitable scientific accomplishments, training, and experience as evidenced by his/her bibliography and Curriculum Vitae, relevant publications in peer reviewed journals, and written study reports relevant to the statement of work.

c. Lead assay personnel, aggregate training, experience, and qualifications to perform the assays described in the SOW (up to four positions) - 60 Points

Demonstrated experience and proficiency in flow cytometric evaluation of rodent blood samples for determination of frequencies of micronucleated reticulocytes and erythrocytes, and for determination of median channel fluorescence

Demonstrated experience and proficiency in performing the pig-a assay, preparing blood samples for pig-a analysis, and evaluating pig-a mutation frequencies in erythrocytes of mice and rats

Demonstrated experience and proficiency in all aspects of the comet assay from preparation of single cell samples, sample freezing and thawing, slide preparation, electrophoresis, and evaluating comet figures using image analysis equipment

Demonstrated experience and proficiency in performing the Ames assay, evaluating assay performance, troubleshooting, and interpreting assay outcome.

d. Additional personnel - 50 Points

Training, experience, and qualifications (e.g., degrees, certifications) of other personnel to perform the assays and other tasks (data entry, report preparation, research and development activities, record keeping, quality control, dose formulation, laboratory animal care) outlined in the Statement of Work and to coordinate multiple tasks and responsibilities.

e. Labor Mix/cohesiveness of staff - 30 Points

The extent that the proposed personnel have previously worked together as a team on projects equivalent to those described in the Statement of Work.

Suitability of the relative mix of expertise proposed to carry out the requirements of the statement of work and availability of all proposed personnel to the project

B. Technical Approach 300 Points

This factor shall be scored on the strength of the approach used to demonstrate a thorough, in-depth understanding of the technical aspects required to accomplish the assays and related activities described in the Statement of Work.

Appropriateness of the proposed scientific and technical approach toward performing the work required in the SOW, including:

Demonstrated understanding of the analytical methods and assay procedures relevant to the SOW.

Demonstrated expertise in collection and analysis of genotoxicity test data in animals and in cells examined in vitro, as evidenced by the examples given in Section L of the proposal.

Demonstrated understanding of the problems likely to be encountered in the conduct of such studies, and their solution, as demonstrated by first-hand experience with diverse types of agents, assays, cell-types, and animal species.

C. Management / Organizational Approach / Health and Safety

225 Points

This factor will be scored based on the strength of approach used to coordinate the work as detailed in the SOW and the understanding of management objectives as they relate to the technical requirements of this procurement.

Workload and Staffing - 75 Points Demonstrated ability to retain talented staff and provide training to refine, update, and expand staff capabilities

Adequacy of approach for workload apportionment and prioritization Strength of the organizational management structure in areas covered by the

SOW.

Statement of Work- 75 Points

Soundness and feasibility of proposed approach to project management, including a functional organizational chart, demonstrated understanding of management objectives as they relate to the SOW, and description of the operating procedures in relation to the Quality Management Plan

Adequacy of approach for quality control management Adequacy of information and documentation that demonstrates evidence of the testing laboratory’s compliance with FDA GLP regulations

Variable Workload - 50 Points Ability of the organization to handle (technically and administratively) varying levels of assigned work, including simultaneous projects

Evidence of the organization's ability to provide appropriate personnel, resources, and capacity to carry out the work and submit deliverables (data and reports) in a timely manner.

Health and Safety - 25 Points Adequacy of the safety and security procedures to be used in conducting the proposed work:

• Health and safety assurance of proposed Contractor staff

• Test article handling, storage, and disposal

• Training of staff, and institutional review of health and safety protocols

D. Facilities/Equipment/IT 75 Points

This factor shall be scored on the proposed facilities and equipment for performance of duties as specified in the Statement of Work.

Facilities - 30 Points

Documented compliance with federal, state, and local regulations and statutes, and possession of appropriate accreditations and licensures, as required, for both wet lab and animal rooms.

Suitability of facilities and floor plan (including a scaling factor) to accomplish each task outlined in the SOW, including multiple study scenarios.

Equipment - 25 Points

Availability and adequacy of proposed major equipment to the contract (e.g., flow cytometers, -80°C freezers, image analysis equipment, automated scoring equipment, etc.)

Information Technology - 20 Points

Adequacy of proposed information management systems (IMS) and practices, including security policies and practices that will be employed to track work performed under the contract, manage data generated by the contract, and to facilitate communication between the offeror and the NTP COR and Contracting Officers.

Adequacy of the proposed IT Security plan to meet the security requirements of the data being generated.

Adequacy and availability of computing hardware and software, appropriate software (e.g., Citrix) for internet connection to NTP databases, and electronic information and/or library resources

E. Animal Welfare and Animal Management 75 Points

Animal welfare - 50 Points

This factor shall be scored on the adequacy and appropriateness of the proposed facility and equipment for laboratory animal management.

Adequacy of policies and procedures the contractor will employ to ensure that laboratory animal care complies with the Animal Welfare Act of 1966 (P.L. 89-

544) as amended in 1970, 1976, and 1985, and other applicable Federal, state, and local laws, regulations, and policies, including requirements set forth in the Statement of Work.

Demonstrated understanding of the humane care and use of laboratory animals and description of procedures for ensuring that animal-related activities are in compliance with Public Health Service policies.

Animal Management - 25 Points

Adequacy of animal facilities (including a detailed floor plan showing air flow and traffic patterns) Suitability of the facility and equipment for treatment and housing of laboratory animals Adequacy of facilities relative to barriers for the transmission of infectious agents and other protective devices used to assure the health and safety of the contract staff and the laboratory animals

Adequacy of disease monitoring plan

F. Conflict of Interest 10 Points

Acceptability of the Conflict of Interest plan that describes how the offeror will manage and control potential and perceived conflicts.

G. Past Performance

Offeror's past performance information will be evaluated prior to establishment of the competitive range. However, this evaluation will not be conducted on any offeror whose proposal is determined to be technically unacceptable.

The evaluation will be based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

The government will assess the relative risks associated with each offeror.

Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance.

The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers relevant information.

When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offeror's record of performing according to specifications, including standards of good workmanship; the offeror's record of controlling and forecasting costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer.

The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance.

The lack of a relevant performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror.