Operation of a Facility Testing Malaria Vaccines in Adult Human Subjects

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; woman-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 National Institutes of Health (NIH)'s National Institute of Allergy and Infectious Diseases (NIAID) Division of Intramural Research (DIR) founded the Laboratory of Malaria Immunology and Vaccinology (LMIV) in 2009 to conduct basic and applied research relevant to malaria immunology and vaccine development, to pursue novel vaccine concepts, to produce prototype malaria vaccines, and to conduct early-phase clinical trials of promising vaccine candidates. The overarching goal is to develop malaria vaccines that will reduce severe disease and death among African children and pregnant women and will eliminate malaria from low-transmission areas of the world. Malaria is the most prevalent and deadly human parasitic disease, with 220 million cases reported annually resulting in at least 625,000 deaths each year; most cases and deaths are in children under the age of five and pregnant women. Globally, young people constitute a large proportion of new infections and deaths. LMIV fully complies with the regulations of 45 CFR Part 46 Subpart D in the conduct of malaria vaccine trials when considering the inclusion of children. Research studies that involve children will be permitted only if the local IRB finds that the level of risk is no greater than minimal regardless of whether the research offers to prospect of direct benefit to the child. Given the nature of malaria challenge trials and the fact that the risk is more than minimal, evaluation of malaria vaccine candidates in infants and children under 18 is considered too risky in children without first conducting trials on adults. It is therefore the intent of LMIV to perform clinical trials on adults, with the goal of introducing clinical trials in children once the vaccine is proven safe and effective for adults. LMIV requires clinical trials to investigate initial safety, immunogenicity, and biologic impact of promising vaccine candidates. Clinical studies may also be conducted as part of pathogenesis research to facilitate vaccine development. These may include a Phase 1 Malaria Vaccine Trial, Challenge Studies, and Experimental Infection Studies. NIAID expects to issue task orders for clinical trials of LMIV's promising vaccine candidates under Indefinite Delivery Indefinite Quantity (IDIQ) Contracts. Purpose and Objectives LMIV requires clinical trials to investigate initial safety, immunogenicity, and biologic impact of promising vaccine candidates. Clinical studies may also be conducted as part of pathogenesis research to facilitate vaccine development. These may include a Phase 1 Malaria Vaccine Trial, Challenge Studies, and Experimental Infection Studies. Project requirements The purpose of this requirement is to conduct clinical trials on a task order basis under the guidance of LMIV. This IDIQ will be administered and used primarily to support NIAID Intramural initiatives. However, other NIAID programs may initiate Task Orders under this IDIQ as necessary to help accomplish their mission. NIAID intends to solicit proposals to perform clinical trials in the following areas: Phase 1 Malaria Vaccine Trial, Challenge Studies, and Experimental Infection Studies. Anticipated period of performance The anticipated period of performance will begin around June, 2015 and continue for five years. Other important considerations Please note that the contractor shall be responsible for initial processing, temporary storage, and shipment of samples to the LMIV per protocols provided by LMIV for evaluation of immunological outcomes (to include at a minimum serum or plasma for assessment of antibody levels, and peripheral blood mononuclear cells [PBMCs] for the assessment of cellular responses). Fresh PBMCs may also need to be transported to LMIV, depending on the assays to be conducted in each protocol. The Contractor is required to deliver specimens as described below to LMIV at 5640 Fishers Lane, Rockville, MD 20852: a. PBMCs - delivered within two hours of initial processing and before 2 P.M. Eastern Time (ET) on the day of collection. Certain assays require a fresh sample to maintain validity. Initial processing includes a period that is not to exceed a maximum of four (4) hours for sample collection and shipping preparation, and must occur on the same day of the Contracting Officer Representative (COR) requested delivery date or; b. Cryopreserved PBMCs - delivered between 8 A.M and 4 P.M. ET on the next business day after the COR request date. Capability statement / information sought Potential sources must demonstrate and document the following in their capability statements: - Ability to perform Phase 1 Malaria Vaccine Trials, Phase 1-2 Challenge Trials, and Experimental Infection Trials. - Ability to provide facilities for conducting clinical trials. - Ability to provide facilities for temperature controlled storage of investigational vaccines. - Ability to provide personnel with adequate, appropriate, and relevant expertise, experience, qualifications, and availability by demonstrating key personnel and technical staff with a project of similar size, scope, and complexity. - Ability to ship specimens as follows: o PBMCs - delivered within two hours of initial processing and before 2 P.M. Eastern Time (ET) on the day of collection. Certain assays require a fresh sample to maintain validity. Initial processing includes a period that is not to exceed a maximum of four (4) hours for sample collection and shipping preparation, and must occur on the same day of the Contracting Officer Representative (COR) requested delivery date or; o Cryopreserved PBMCs - delivered between 8 A.M and 4 P.M. ET on the next business day after the COR request date. - Past Performance: Identify at least three other projects of similar size and complexity. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 10 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: - DUNS. - Company Name. - Company Address. - Company Point of Contact, Phone and Email address - Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. - Do you have a Government approved accounting system? If so, please identify the agency that approved the system. - Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System of Award Management (SAM) located at https://www.sam.gov/index.html/##11 This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Alice Sobsey, Contract Specialist, at contact@example.gov with a cc: to Dixie Harper, Contracting Officer, at contact@example.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID(AO)-SBSS-15-023. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00pm Eastern Time Thursday, October 30. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award an IDIQ contract or Task Order 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 pre-solicitation synopsis and solicitation may be published in 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(s).