SOURCES SOUGHT
A -- Humanized Mouse Models for HIV Therapeutics Development
- Notice Date
- 9/27/2012
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- HHS-NIH-NIAID(AI)-SBSS-12-153
- Archive Date
- 10/27/2012
- Point of Contact
- Nancy M Hershey, Phone: 301-496-0193, John Manouelian, Phone: 301-496-0612
- E-Mail Address
-
nhershey@niaid.nih.gov, manouelj@mail.nih.gov
(nhershey@niaid.nih.gov, manouelj@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background The Division of AIDS (DAIDS) 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 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 in 2006 and will expire in December, 2013. The current contract is with the University of California, San Francisco (contract number HHSN272200600002C). The animal model being used is an immunodeficient mouse engrafted with human fetal thymus and liver (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. Purpose and Objectives 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, 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. Project Requirements The offeror must demonstrate the ability to evaluate potential HIV-1 therapeutics, alone and in combination, for efficacy and toxicity in vivo, in a validated animal model consisting of SCID mice engrafted with human fetal thymus (SCID-hu Thy/Liv) and liver tissue and infected with a diverse panel of well characterized primary isolates and molecular clones of HIV-1 and in a second engrafted immunodeficient mouse model as described above. Up to 600 SCID-hu Thy/Liv mice (50 mice per experiment) and 60 unengrafted SCID mice will be needed for evaluations of single and combination therapies per year. The offeror shall be capable of providing up to 50 SCID-hu Thy/Liv mice per month, in a single group engrafted with tissue from a single donor. In the second mouse model, up to 400 engrafted immunodeficient mice (40 mice per experiment) and 50 unengrafted mice shall be needed for evaluations of single and combination therapies per year. The Contractor shall be capable of providing one cohort of up to 40 mice per month, engrafted with tissue from a single donor. The in vivo systems shall be available for efficacy and toxicity testing at the time of award. Furthermore, the offeror should demonstrate appropriate prior personal experience of the PI and/or team members using the mouse models, i.e. performing evaluations of antiviral compounds, immune-based or other therapies; conducting pharmacologic and toxicological studies; modifying models or developing new models; and conducting basic research on the immunopathogenesis of HIV-1. 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 a one (1) year (Base Period) plus six (6) one year options (terms), for a total possible performance period of seven (7) years, beginning on or about December 6, 2013. The requirement will be for the delivery of 6.00 full time equivalents (FTEs) per year for the Base Period (Year 1) and each option period (Years 2 through 7). Capability Statement/Information Sought Capability Statements should clearly convey information regarding the respondent's capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator/co-PI, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: a. DUNS b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought. f. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must be registered in CCR which is located at http://www.ccr.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Responses must be submitted no later than October 12, 2012. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Nancy Hershey, Contracting Officer. She can be emailed at the address provided below. Electronic submissions should be in PDF format. In the subject line, please reference: HHS-NIH-NIAID (AI)-SBSS-12-153. Nancy Hershey Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 6700 B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612 Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a Presolicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contracting Officer: Nancy Hershey Email Address: nhershey@niaid.nih.gov Contracting Officer: John Manouelian Email Address: manouelj@niaid.nih.gov
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