Presolicitation_Notice_HMM.pdf

PRESOLICITATION NOTICE

HUMANIZED MOUSE MODELS FOR HIV DRUG DEVELOPMENT

RFP NIAID-DAIDS-NIHAI2012153

Type of Requirement

New Requirement Re-competition of Contract No. HHSN266200700002C Expansion of: (Contract No.:________________)

Place of Performance

Place of performance is unknown at this time Place of performance is known

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B Rockledge Drive, Room 3214, MSC 7612, Bethesda, MD, 20892-7612.

Primary Point of Contact Dena Nannetti Contract Specialist nannettidl@niaid.nih.gov Phone: (301) 496-6424

Secondary Point of Contact John Manouelian Contracting Officer Manouelianj@niaid.nih.gov Phone: (301) 451-3694

Anticipated Period of Performance The period of performance will be for one year with options for continued performance for up to an additional six years, for a total period of performance of up to seven years.

Anticipated award date: December 6, 2013

The NAICS Code is 541712 with a size standard of 500 employees.

Presolicitation Notice Information

The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) supports a comprehensive portfolio of contract resources to discover and develop novel therapeutic agents for the prevention and treatment of infections caused by HIV-1, AIDS-associated opportunistic pathogens, and other infectious agents. Animal model resources constitute one element of this drug discovery and development program. DAIDS initiates the preclinical evaluations of the efficacy and tolerability of novel HIV-1 therapeutics and selects the agents to be tested.

The current contract will expire in December, 2013. The purpose of this solicitation is to re-compete the existing contract for small animal models that can be used to evaluate potential therapeutics for HIV-1 infection. The term of the new award will be seven years.

The current contract was awarded to the University of California, San Francisco (contract number HHSN266200700002C) in December 2006 and will expire in December 2013.

The animal model being used is an immunodeficient mouse engrafted with human fetal thymus and liver severe combined immunodeficiency (SCID)-hu Thy/Liv) and infected with well-characterized isolates of HIV-1. The types of agents tested over the last six years include synthetic and natural compounds as well as biologics. Experience with the SCID-hu Thy/Liv model has demonstrated its suitability for the evaluation of potential HIV-1 therapeutics. It is tissue-based, as is HIV-1 infection, and uses HIV-1 as the viral target. In addition, a second mouse model is being solicited. The second mouse model will consist of immunodeficient mice engrafted with human fetal thymus and liver tissue and other cells and/or tissues, such that the model (or mice) has the following characteristics: reconstitutes gut-associated lymphoid tissue, can be infected by the systemic or mucosal routes, develops viremia and disseminated infection in engrafted human tissue. Such engrafted, infected mice should be capable of supporting longitudinal studies of infection. Therefore, the present solicitation is for the SCID-hu Thy/Liv model and for an additional mouse model.

The scope and intent of the contract for the Humanized Mouse Models for HIV Therapeutics Development is to enable the NIAID to conduct studies in a predictive small-animal model to advance the development of novel therapies for HIV-1 disease.

The model will employ state-of-the-art techniques and technologies in evaluating promising AIDS therapies for HIV/AIDS in a predictive small-animal model and will incorporate new and improved techniques and technologies into the studies conducted throughout the contract period.

It is anticipated that one cost reimbursement, term type contract will be awarded for a 1-year Base period plus six 1-year options to extend the term of the contract, for a possible total period of performance of 7 years beginning on or about December 6, 2013. The performance requirement will be for the delivery of 6.00 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.

For this solicitation, the NIAID requires proposals to be submitted in three methods: (1) Paper, (2) Disc (CD or DVD), and (3) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the paper, 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, 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.”

Any responsible offeror may submit a proposal which will be considered by the Agency.

This RFP will be available electronically on/about January 2, 2013, 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.

https://ecps.niaid.nih.gov/ http://era.nih.gov/applicants/how-to_steps.cfm#register http://www.fedbizopps.gov/

Contracting Office Address