NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS)

Introduction
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.

 
Description
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:

a. 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
b. Provide clinical trial support including support services for study-specific document preparation, translations, data management, biostatistical design and analysis, and project management
c. 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
d. 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
e. Coordinate and collaborate with other DAIDS grantees and clinical research support contractors in the performance of the Performance Work Statement.
f. Project management and quality assurance for individual projects and for the overall contract

Offerors will be evaluated on their experience and suitability/availability of personnel in those areas of clinical research, laboratory and training support (to include experience in site assessments, clinical site audits, laboratory audits and management of a web-based training site). Other evaluation criteria include experience in project management and past performance.
It is anticipated that one (1) cost-plus-award-fee, level-of-effort (term) type contract will be awarded for a 1-year Base Period plus six 1-year Options, for a possible total period of performance of 7-years beginning on or about May 15, 2017. The Contracting Officer has determined that a performance based contract is suitable for this acquisition. An Award Fee Plan will be included in the solicitation. The performance requirement will be for the delivery of 48.10 Full Time Equivalents (FTEs). A total level of effort of 48.10 full time equivalents (FTEs) per year for the base period (Year 1) and option periods (Years 2 through 7), which may be unilaterally exercised by the Government.
In addition, the Government may exercise options to accommodate significant increases in work to be provided for the base period and option periods. Should the Government elect to exercise an option for increased level of effort, the Contractor shall provide resources for the unanticipated increase in work volume for one, and two additional FTEs for each option exercised. The Government may exercise an option for 1 FTE for up to two times per year and may exercise an option for 2 FTEs up to two times per year in any year of the contract.
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.fbo.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 NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable.

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