Request for Proposals (RFP): Nonhuman Primate Core Humoral Immunology Laboratory for AIDS Vaccine Research and Development, NIAID-DAIDS-NIHAI2016071

Notice Number: NOT-AI-17-005

Key Dates
Release Date: November 3, 2016
RFP Publication Date: This RFP will be available electronically on/about November 14, 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 (DAIDS), has a requirement for the operation of the Nonhuman Primate Core Humoral immunology Laboratory for AIDS Vaccine Research and Development. The current Nonhuman Primate Core Humoral immunology Laboratory for AIDS Vaccine Research and Development (under Contract No. HHSN27220110016C) is held by Duke University.

The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID) is to ensure an end to the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic by supporting research that can lead to the development of therapies, vaccines, and prevention strategies. Nonhuman primate (NHP) models present the opportunity to test a variety of candidate AIDS vaccines, optimizing their ability to elicit immune responses and testing their ability to prevent infection or to control virus replication after virus challenge. NIAID supports NHP studies through both contract and grant mechanisms.

DAIDS provides immunological and virological support for NHP studies conducted at NIAID’s Simian Vaccine Evaluation Unit (SVEU) contract sites and by AIDS vaccine researchers through three Nonhuman Primate Immunology and Virology Laboratories for AIDS Vaccine Research and Development (NHP Core Labs) contracts. The objective of these Core Laboratories has been to ensure standardization and comparability of the assays conducted for preclinical NHP studies and to provide a common basis for assessment of the immunogenicity and efficacy of candidate HIV and SIV vaccines. The current Nonhuman Primate Core Humoral Immunology Laboratory for AIDS Vaccine Research and Development contract (under Contract No. HHSN272201100016C) is held by Duke University.

The purpose of the proposed contract is to conduct, develop, acquire, improve, and implement assays to evaluate and characterize the humoral immune responses of nonhuman primates (NHP) that have been immunized with candidate HIV or SIV vaccines or infected with SIV, SHIV, or HIV, in studies conducted by the NIAID Simian Vaccine Evaluation Units (SVEUs) or by investigators supported by or collaborating with NIH.

Project Requirements
The Contractor shall conduct, develop, acquire, improve, and implement assays to evaluate and characterize the humoral immune responses of NHP that have been immunized with candidate HIV or SIV vaccines or infected with SIV, SHIV, or HIV in studies conducted by the NIAID Simian Vaccine Evaluation Units (SVEUs) or by investigators supported by or collaborating with NIH. The Contractor shall use state-of-the-art assays under this contract to detect and evaluate humoral immune responses generated in nonhuman primates by immunization with AIDS vaccines or by infection with SIV or SHIV. This shall include assays to optimize detection of neutralizing antibodies and assays to optimize the detection of non-neutralizing antiviral activities in immunized and infected animals. Assays shall incorporate appropriate positive and negative controls to define background and dynamic range, and shall demonstrate reproducibility and consistency.

The Contractor shall: 1) furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed, to perform the requirements of the contract; (2) perform humoral immunology assays; (3) receive, store, catalog, track, and maintain an inventory of the specimens to be evaluated; (4) manage and report study data; (5) perform project management activities in support of contract activities; (6) conduct initial and final transition activities, as needed; and (6) perform optional work, as described below, if required.

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 up to seven (7) years, beginning on or about December 29, 2017. The performance requirement will be the delivery of 10.53 full time equivalents (FTEs) per year for the Base Period (Year 1) and 10.53 FTEs per year for Options 1-6 (Years 2-7). If Options 1-6 are exercised, the services required will be the same as provided during the Base period.

In addition, the Government may exercise options to accommodate unanticipated increases in demand, as follows:

  • Options 7 - 20: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 Full Time Equivalent (FTE) for each option exercised. These options may be exercised twice per year during Years 1 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base Period or Option year in which the Option is exercised.
  • Options 21 - 27: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 0.5 FTE for each option exercised. It is anticipated that only one option will be exercised per performance year. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base Period or Option year in which the Option is exercised.

Please note that the number of FTEs required, for the Base Period and each option, is inclusive of subcontractor and consultant effort.

Any responsible offeror may submit a proposal, which will be considered by the Agency. This RFP will be available electronically, on/about November 14, 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.

For this solicitation, the NIAID requires proposals to be submitted online via the NIH’s electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website (https://ecps.nih.gov) and then click on "How to Submit".

Inquiries

Please direct all inquiries to:

Primary Point of Contact:
Shane Sarchiapone
Contract Specialist
National Institute of Allergy & Infectious Diseases
Telephone: 301-761-7494
Email: shane.sarchiapone@nih.gov

Secondary Point of Contact:
John R. Manouelian
Contracting Officer
National Institute of Allergy & Infectious Diseases
Telephone: 240-669-5152
Email: manouelj@mail.nih.gov