Request for Proposals (RFP): NIAID/Division of AIDS: Clinical Research Support Services (CRSS) NIAID-DAIDS-NIHAI2015050

Notice Number: NOT-AI-16-044

Key Dates
Release Date: April 5, 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), 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. NIAID/Division of AIDS (DAIDS) sponsors more than 150 Phase I, II, III and IV clinical trials, in over 17 countries and at more than 110 clinical site to evaluate the safety and efficacy of therapeutics, vaccines, and other preventive modalities. The current contract for this work is being carried out under contract number HHSN272201200009C, entitled "HIV Clinical Research Support Services" (CRSS) and the incumbent contractor is Westat, Inc. Over the past five years, the incumbent has conducted more than 90 work requests to support this clinical research portfolio in the areas of clinical research, laboratory and training.

The purpose of this proposed contract is to continue to provide a broad range of research support services to the current and evolving DAIDS-supported clinical research portfolio and other infectious diseases that are of relevance to HIV infections and at risk populations, Primary objectives are to provide a responsive and flexible infrastructure/base for both recurring and ad hoc support services and to serve as a gap-filling mechanism to provide urgent or unanticipated services for emerging or evolving needs and provide prompt access to subject matter experts, consultants and subcontractors. The Contractor will provide a wide variety of support services including but not limited to:

  • Clinical site research support activities, to include: capacity assessment, capacity building, audits to assess compliance with Federal regulatory and in-country requirements, and targeted site training
  • Provide clinical trial support including support services for study-specific document preparation, translations, data management, biostatistical design and analysis, and project management
  • Conduct laboratory audits to include good clinical laboratory practices (GCLP), current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) to assess compliance with Federal regulatory requirement and DAIDS policy requirements and perform other related laboratory support work
  • Provide training support to include review and revision of training materials and support and management of DAIDS Learning Portal (DLP), training warehouse, and DLP help desk support
  • Coordinate and collaborate with other DAIDS grantees and clinical research support contractors in the performance of the Performance Work Statement.
  • Project management and quality assurance for individual projects and for the overall contract

The current NIAID/Division of AIDS: Clinical Research Support Services (CRSS) contract was awarded to Westat, Inc., Rockville, Maryland on November 15, 2011, for a total period of seven years.

Anticipated Period of Performance
It is anticipated that one (1) cost-reimbursement, level-of-effort (term) type contract 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 May 15, 2017. The requirement will be for the delivery of 48.10 full time equivalents (FTEs) per year, inclusive of subcontractors and consultants, for the Base Period (Year 1) and 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 (1.0 FTE): The Government may exercise options for incremental increases in the level of effort. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. For each option quantity exercised, the Contractor shall provide an additional 1.0 FTE, inclusive of subcontractor and consultant effort. Up to two (2) Options per year may be exercised during years 1 through 7 of contract performance.

Increased Level of Effort (2.0 FTEs): The Government may exercise quantity options for increased the level of effort. For each option quantity exercised, the Contractor shall provide an additional 2.0 FTEs, inclusive of subcontractor and consultant effort. Up to two (2) Options per year may be exercised during years 1 through 7 of contract performance.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about April 1, 2016, 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.

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.

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. 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/home and then click on "How to Submit."

Inquiries

Please direct all inquiries to:

Rosemary Gomes
Contract Specialist
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5374
Email: rosemary.gomes@nih.gov

Michelle L. Scala
Contracting Officer
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5156
Email: mscala@niaid.nih.gov