Posted: June 1, 2022, 11:49 a.m. EDT
The purpose and of the proposed contract will be to continue to provide a Clinical Pharmacology Quality Assurance Program resource to provide comprehensive quality assessment programs to clinical pharmacology laboratories (Labs) that test samples from subjects enrolled in NIAID-supported clinical studies. The Contractor shall: (1) monitor and evaluate the ability of Labs to accurately and reliably perform study-specified pharmacology assays through an International Organization for Standardization (ISO)-certified proficiency testing program; (2) support the development, validation and implementation of pharmacology assays; (3) acquire, characterize, store, and distribute to Labs, quality control materials and reagents; (4) provide guidance, assistance, and training to laboratory and clinical site staff, in proficiency testing, assay validation, and in the conduct of clinical pharmacology studies; (5) prepare Labs for FDA and other regulatory inspections and study audits; (6) maintain data management systems for tracking and managing CPQA activities; (7) publish and disseminate results, to improve the quality of pharmacology measurements made in NIAID supported clinical trials; and (8) provide for initial and final transition of the contract. Options to provide increased level of effort to support additional labs (domestic and international) and to support unanticipated increases in demand for the activities supported by the base requirements of the contract, are also within the scope of the contract.
It is anticipated that a cost reimbursement, term/level of effort type contact will be awarded. The period of performance will be for one year (Base Period) plus six (6) one-year options to extend the term of the contract, that may be exercised by the Government unilaterally, for a total possible period of performance of seven (7) years, beginning approximately February 28, 2022. The requirement will be the delivery of 8.85 full time equivalents (FTEs) per year for the Base Period (Year 1) and 8.85 FTEs per year for Options 1-6 (Years 2-7). The percentage of effort includes the effort of subcontracts, but does not include the effort of consultants.
In addition, the Government may exercise options for an increased level of effort that may result from the need to support additional labs (domestic and international) and to support unanticipated increases in demand for the activities supported by the base requirements of the contract. Options for increased services may include the following:
Options 1 through 6, to Extend the Term of the Contract: The Government may exercise options to extend the period of the contract beyond the Base Period (Year 1), annually, for a total contract period of up to 7 years. The scope and types of activities, as outlined for Year 1 of the contract, would be continued for each succeeding annual contract period, up to 7 total years. The percentage of effort includes the effort of subcontracts, but does not include the effort of consultants.
Options 7 through 12, to Increase the Level of Effort for Additional Domestic Labs: During the course of the contract, it may be necessary to incorporate additional US-based pharmacology laboratories. Such an increase would require an increase in the Contractor's activities, to be activated, at the discretion of the Government, as an Option, which may be exercised unilaterally. Each Option of this type will implement work commensurate with the addition of one (1) domestic Lab. Up to one Option per year may be exercised during Years 2 through 7 of contract performance. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.60 Full Time Equivalent (FTE) per option. The period of performance of an Option for Increased Level of Effort will not exceed the term of the Option year in which the Option is exercised. The percentage of effort includes the effort of subcontracts, but does not include the effort of consultants.
Options 13 through 18, to Increase the Level of Effort for Additional International Labs: During the course of the contract, it may be necessary to incorporate additional international pharmacology laboratories. Such an increase would require an increase in the Contractor's activities, to be activated, at the discretion of the Government, as an Option, which may be exercised unilaterally. Each Option of this type will implement work commensurate with the addition of one (1) international Lab. Up to one Option per year may be exercised during Years 2 through 7 of contract performance. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.60 FTE per option. The period of performance of an Option for Increased Level of Effort will not exceed the term of the Option year in which the Option is exercised. The percentage of effort includes the effort of subcontracts, but does not include the effort of consultants.
Increased Level of Effort for Unanticipated Increases in Demand (Options 19-32): The Government may exercise options for increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of the contract. Such an increase would require an increase in the Contractor's activities, to be activated, at the discretion of the Government, as an Option, which may be exercised unilaterally. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 FTE for each option exercised. These options may be exercised twice per year, during Years 1 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base year or Option year in which the Option is exercised. The percentage of effort includes the effort of subcontracts, but does not include the effort of consultants.
Any responsible offeror may submit a proposal, which will be considered by the Agency. This RFP will be available electronically, on/about December 28, 2020, and may be accessed through SAM http://beta.sam.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
For this solicitation, the NIAID requires proposals to be submitted online via the NIH's electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website (https://ecps.nih.gov) and then click on "How to Submit."
Amendment No. 1 - March 2, 2021
The purpose of this Amendment is to:
(1) provide responses to questions from potential offerors, regarding the solicitation; (2) amend ARTICLE C.2. REPORTING REQUIREMENTS to address concerns raised by potential offerors; (3) amend PART I THE SCHEDULE, SECTION D PACKAGING, MARKING AND SHIPPING, to address concerns raised by potential offerors; (4) amend Attachment 1 Packaging and Delivery of Proposal, to address concerns raised by potential offerors; (5) amend Attachment 3 Statement of Work, to address concerns raised by potential offerors; and (6) amend Attachment 5 Additional Business Proposal Instructions and Uniform Cost Assumptions, to address concerns raised by potential offerors.
