Notice Number: NOT-AI-15-047

Key Dates
Release Date: July 2, 2015

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

Purpose

The development of highly effective HIV prevention strategies, including a preventive vaccine and other non-vaccine biomedical prevention (nBP) products, remains one of the highest priorities for the Division of AIDS (DAIDS) and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). With current global HIV infection estimates exceeding 33 million people, the development of safe, effective, and acceptable nBP products to prevent the sexual transmission of HIV could play a major role in the worldwide reduction of the estimated 5000 new HIV infections per day.

These services are currently provided by two NIAID contracts entitled. This is a recompetition of two existing contracts, Non-human Primate Models to Evaluate Therapeutic Strategies and Topical Microbicides for HIV (under Contract with Advanced BioScience Laboratories, Inc. under contract number No. HHSN272200800020C with Advanced BioScience Laboratories) and, Comprehensive Resources for HIV Microbicides and Biomedical Prevention (with Advanced BioScience Laboratories, Inc. under Contract number No. HHSN272201000001C with Advanced Bioscience Laboratories). However, the Government intends to consolidate these services into one requirement under one contract.

The Government intends to award multiple-award Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts in order to continue these support services. Task Orders will be issued in the following areas:

• Preclinical gap-filling services (Task Area A)
• HIV animal models supporting product development (Task Area B)
• Bioanalytical support services (Task Area C)
• Product manufacturing (Task Area D)
• Scientific and quality/regulatory support services (Task Area E)

It is anticipated that NIAID will award base contract awards to multiple contractors for Task Areas A, B, C, and D; however, NIAID anticipates awarding a base contract to a single contractor for Task Area E. In order to ensure the independence and objectivity required for the functions carried out under Task Area E, the contractor who is selected for the award of Task Area E will not be awarded a base contract for Task Areas A, B, C, and/or D. This includes both the Prime Contractor as well as any potential Subcontractor(s).
The purpose of the proposed contract is to provide NIAID with preclinical product development services for candidate products that emerge from investigator-initiated research studies or from collaborations with outside companies or organizations. The scope of work encompasses preclinical activities that range from initial product discovery to those required to support clinical trials and/or product licensure. More specifically, these development services may be used to support a product at any point along the product development pathway, from discovery to IND, Investigational Device Exemption (IDE), and/or New Drug Application (NDA) filings with the Food and Drug Administration (FDA). NIAID will primarily use this contract to more rapidly and efficiently fill critical development gaps and advance promising nBP products and MPTs into clinical testing. Although the focus of this contract will be development of nBP products, contract resources, at the discretion of NIAID, may be used to advance HIV vaccines, antivirals, or other HIV preventive or therapeutic strategies. Throughout this contract, these candidate products and/or strategies will collectively be referenced as products.

Offerors should have the qualifications, experience and capability to perform this requirement. The Contractor will carry out tasks in the following five areas:

• Preclinical Gap-Filling Services: Under this task area, the Contractor shall conduct the following types of activities: 1) In vitro/ex vivo assays or methods; 2) Small and large animal safety models; and 3) Other specific activities in support of this task area as required by NIAID to advance products into clinical testing.
• HIV Animal Models Supporting Product Development: Under this task area, the Contractor shall conduct pharmacokinetic (PK), safety, and efficacy studies in animal models of mucosal HIV/SIV/SHIV transmission in order to characterize promising products, inform dose selection, optimize formulations, and/or obtain other information necessary to advance or support product testing in subsequent animal or human studies. These models may include nonhuman primates (NHP), humanized mice, or other animal models of HIV infection or pathogenesis as they become available. When applicable, other activities (e.g., immunology, histopathology, etc.) as specified in the Task Order SOW shall be performed.
• Bioanalytical Support Services: Under this task area, the Contractor shall conduct the following types of activities to support product development and fulfill regulatory requirements: 1) Analytical method development, method transfer and validation, and/or performance of the method; and 2) Other specific activities in support of this task area as required by FDA to advance products into clinical testing.
• Product Manufacturing: Under this task area, the Contractor shall conduct the following types of activities: 1) Product manufacturing and/or characterization to support both preclinical and clinical product indications.; and 2) Other specific activities in support of this task area as required by FDA to advance products into clinical testing.
• Scientific and Quality/Regulatory Support Services: Under this task area, the Contractor shall perform the following types of activities to advise and support the COR, other NIAID staff, and/or product sponsors, or support the general development of products through provision of resources to the HIV prevention field: 1) Provide additional expertise; 2) Develop and support programmatic meetings in specific regulatory requirements or other topics; 3) Provide Quality Assurance/Quality Control (QA/QC) support; 4) Conduct audits; 5) Prepare regulatory documentation; 6) Convene scientific groups related to non-vaccine biomedical prevention (nBP) products in support of this contract; and 7) Provide centralized storage for contract materials.
• It is anticipated that multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contracts will be awarded on or about June 15, 2016 for a period of 7 years through June 14, 2023. Task Orders to be issued against the base contract will primarily be cost-reimbursement type, both term and completion form. The Government reserves the right, however, to issue fixed price type Task Orders, when appropriate.

Upon award of the base contract, the Government anticipates awarding a Task Order as follows:

Task Order #E-001, Quality Assurance/Quality Control Support. The period of performance will be for a one (1) year (Base Period), plus six 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 15, 2016. The requirement will be for the delivery of 2.05 full time equivalents (FTEs) per year for the base period (Year 1) and 2.05 FTEs per year for Options 1-6 (Years2-7).

All responsible sources may submit a proposal which shall be considered by the Agency. This RFP will be available electronically on or about 7/10/2015 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:

• Disc (CD or DVD) and
• 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.niaid.nih.gov and then click on "How to Submit."

To submit online using eCPS, offeror 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:

Robert Corno
Contract Specialist
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5151
Email: robert.corno@.nih.gov

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