Request for Proposal (RFP) Announcement: Mycobacterium tuberculosis (Mtb) Quality Assessment Program (TBQA), NIAID-DAIDS-NIHAI2015048

Notice Number: NOT-AI-16-021

Key Dates
Release Date: January 6, 2016

Related Announcements
None    

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 participants enrolled in these studies.  It is important to evaluate objectively the ability of laboratories to perform tests reliably, and to enhance laboratory performance by providing assistance and training if deficiencies are identified.

The purpose of the Mycobacterium Tuberculosis (Mtb) Quality Assessment Program (TBQA) is to provide a new resource to assess the ability of 25-30 laboratories located both in the United States (U.S.) and outside (non-U.S.) to accurately and reliably perform Mtb testing to diagnose active and latent Mtb infection, monitor disease progression, and assess treatment response and vaccine efficacy in direct support of clinical trials.  As new tests/methodologies are developed, the TBQA program will facilitate their adaptation, standardization and quality assessment prior to inclusion in NIAID-supported clinical investigations.  The TBQA program will serve NIAID-sponsored and collaborating clinical trials networks and cohorts as well as individual grantees conducting research in and outside the U.S. 

The TBQA contract will be responsible for monitoring Labs’ ability to perform accurately and reliably study-specified Mtb tests (e.g. next-generation bacterial DNA and RNA sequencing, serial sputum colony count on solid media, time to positivity in liquid culture, minimal inhibitory concentration assessment, and host-based assays). This will include preparation of proficiency testing panels (or acquisition from commercial and non-commercial sources), distribution to participating laboratories, capture and statistical analysis of test results obtained from Labs, determination of performance acceptability, and generation of Lab-specific performance reports.  The TBQA will provide assistance, guidance and training in corrective action when Labs’ test performance is unacceptable.

The TBQA contract will evaluate and compare sample preparation parameters (e.g., specimen collection, storage and shipping) and assay procedures of existing and novel Mtb methodologies (e.g., point-of-care tests for active Mtb and tests to diagnose extra-pulmonary Mtb) by conducting in-house preliminary studies as well as facilitating multi-Lab studies for ultimate inclusion in studies.  This will require statistical support for designing the evaluations and for determining within-lab and between-lab magnitude and sources of variability. The TBQA contract will obtain, characterize, store and distribute materials and reagents needed for the preparation of quality control materials (QCMs) used to prepare proficiency testing panels and for method evaluation studies. Examples of QCMs include a collection of distinct clinical Mtb isolates from geographically diverse Mtb-endemic regions obtained from adult and pediatric individuals with and without HIV infection. Isolates shall represent drug-sensitive and -resistant strains from various lineages and genetic diversity. Other QCMs may include extra-pulmonary samples, such as urine, blood and saliva.

It is anticipated that a level of effort type contact will be awarded.  The period of performance will be for one year beginning approximately December 15, 2016 through December 14, 2017.  The requirement will be the delivery of 5.4 full time equivalents (FTEs) per year for the base period (Year 1) and 5.4 FTEs per year for Options 1-6 (Years 2-7).

In addition, the Government may 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 Labs (Options 7-27):  During the course of the contract, it may be necessary to incorporate additional U.S. and non-U.S. Labs to support NIAID-supported clinical trial. Such an increase would require an increase in the Contractor’s effort 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 five (5) Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.50 FTE per option. During the life of the contract, there are a total of twenty one (21) Options of this type available to be exercised (there are no options of this type available to be exercised during the Base Period) as follows:
  • One (1) Option may be exercised in Year 2;
  • Up to Two (2) Options may be exercised in Year 3;
  • Up to Three (3) Options may be exercised in Year 4;
  • Up to Four (4) Options may be exercised in Year 5;
  • Up to Five (5) Options may be exercised in Year 6;
  • and up to six (6) Options may be exercised in Year 7.
  • The period of performance of an Option for Increased Level of Effort for Additional Labs will not exceed the term of the Option year in which the Option is exercised.
  • Increased Level of Effort for Additional Evaluation of Mtb Assay and Specimen Processing Methodologies (Options 28-33). During the course of the contract, it may be necessary to conduct in-house and/or facilitate multi-Lab studies to evaluate/compare Mtb assay and specimen processing methodologies. 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 one (1) multi-Lab assay evaluation study. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.55 FTE per option. One (1) Option per year may be exercised during years 2 through 7 of contract performance, for a total of six (6) Options during the life of the contract. The period of performance of an Option for Increased Level of Effort for Additional Evaluation of Mtb Assay and Specimen Processing Methodologies will not exceed the term of the Option year in which the Option is exercised.

Any responsible offeror may submit a proposal which will be considered by the Agency.  This RFP was released electronically on December 8, 2015, 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.

For this solicitation, the NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.nih.gov/NIAID and then click on "How to Submit."

To submit online using eCPS, offerors must have a valid NIH electronic Research Administration (eRA) Commons account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NIAID. The eRA Commons registration process may take up to 4 weeks. For more information, please see http://era.nih.gov/applicants/how-to_steps.cfm#register.”

Inquiries

Please direct all inquiries to:

Patrick Finn
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5401
Email: patrick.finn@nih.gov 

John R. Manouelian
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5152
Email: manouelj@niaid.nih.gov

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