Request for Proposals (RFP) Announcement: Immunology Quality Assessment Program NIAID-DAIDS-NIH-AI-2012150

Notice Number: NOT-AI-13-049

Key Dates
Release Date: June 7, 2013

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS has a requirement for reliable laboratory data, important for the meaningful interpretation of therapeutic and prevention clinical trials/studies and for the appropriate management of subjects enrolled in these studies. Immunological tests, as well as frozen peripheral mono-nuclear cells (PBMC) for future or off-site testing, are included in many DAIDS-supported trials. It is, therefore, important to evaluate objectively the ability of laboratories to process PBMC and perform tests reliably, and to enhance laboratory performance by providing assistance and training when deficiencies are identified.

The purpose of the Immunology Quality Assessment Program (IQA) is to continue and provide a resource to (1) evaluate the abilities of U.S. and non-U.S. laboratories to accurately and reliably perform study-specified immunological tests (with focus on CD4 and CD8 T cell lymphocyte counts and percentages) and viable PBMC freezing, (2) advise and train when deficiencies are identified, (3) evaluate immunology-based novel technologies (with focus on novel, simple tests for diagnosis and disease monitoring) for implementation in multi-site NIAID trials, and (4) maintain a computerized data management system and document library that include lab performance data and guidance documents. IQA will continue to support laboratories that are part of current and future NIAID-sponsored clinical trial networks: (http://www.niaid.nih.gov/about/organization/daids/networks/pages/daidsnetworks.aspx).

It is anticipated that one (1) cost-reimbursement, level-of-effort (term) type contact will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about June 30, 2014. The requirement will be for the delivery of 6.50 full time equivalents (FTEs) per year for the Base Period (Year 1) each option period (Years 2 through 7).

In addition, the Government may unilaterally exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include:

Increased Level of Effort for Additional non-U.S. CD4 laboratories: During the course of the contract it may be necessary to incorporate additional laboratories to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. Each Option of this type will implement work commensurate with the addition of 10 Laboratories. If the Government elects to exercise this Option, the Contractor shall provide an additional .30 FTEs per option. The period of performance of an Option for Increased Services will not exceed the term of the Base year or Option year in which the Option is exercised.

Increased Level of Effort for Additional US and non-U.S. PBMC processing laboratories: During the course of the contract it may be necessary to incorporate additional laboratories to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. Each Option of this type will implement work commensurate with the addition of 10 Laboratories. If the Government elects to exercise this Option, the Contractor shall provide an additional .35 FTEs per option. The period of performance of an Option for Increased Services will not exceed the term of the Base year or Option year in which the Option is exercised.

The NAICS Code is 541712 with a size standard of 500 employees.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about June 12, 2013, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This Notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

Inquiries

Please direct all inquiries to:

Robert Corno, Contract Specialist
National Institute of Allergy and Infectious Diseases (NIAID)
6700B Rockledge Drive Room 3214, MSC 7612 (Express mail: Use Zip Code 20817)
Telephone: 301-496-0612
Fax: 301-480-4675
Email: cornorj@niaid.nih.gov

John R. Manouelian, Contracting Officer
National Institute of Allergy and Infectious Diseases (NIAID)
6700B Rockledge Drive Room 3214, MSC 7612 (Express mail: Use Zip Code 20817)
Telephone: 301-496-0612
Fax: 301-480-4675
Email: manouelj@niaid.nih.gov