SOURCES SOUGHT
R -- Support for Research on Retroviral Pathogenesis, Treatment, and Prevention
- Notice Date
- 6/29/2017
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- HHS-NIH-NCI-SBSS-ETSB-71023-75
- Point of Contact
- Catherine Kennedy,
- E-Mail Address
-
catherine.kennedy3@nih.gov
(catherine.kennedy3@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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. This requirement is assigned a code of 541380 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $15 M per annum. Statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible business concern's name, point of contact, address, and DUNS number. Support for Research on Retroviral Pathogenesis, treatment and prevention, a project within the Vaccine Branch, Center for Cancer Research (CRC), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses as stated above. Background Historically, three sequential contracts have provided essential research support to investigators of the previous Basic Research Laboratory, now the Vaccine Branch. Initially, support was provided to the Section on Animal Models and Retroviral Vaccines (AMRV) and the Section on Immune Biology of Retroviral Infection (IBRI) within the Basic Research Laboratory (BRL). When the Vaccine Branch (VB) was created within the Center for Cancer Research (CCR) and incorporated some BRL Principal Investigators, contract support was available not only to the AMRV and IBRI sections, but also to the Molecular Immunogenetics and Vaccine Research Section. A key area of research in the VB involves retroviruses, particularly human immunodeficiency virus (HIV), the causative agent of acquired immune deficiency syndrome (AIDS), and Simian Immunodeficiency Virus (SIV), the related monkey virus which provides a model for detailed experimental investigations. Other viruses are studied as well, including Human T cell leukemia ‘lymphoma virus (HTLV-1/2) and viruses used as vaccine vectors. Vaccine approaches are a major area of research; however studies on viral pathogenesis and treatment are also on-going. Previous contracts have provided critical support to these research endeavors. Contract activities have included provision of retroviruses, purified retroviral and cellular proteins, polyclonal and monoclonal antibodies and cell culture support; and performance of assays to assess the immunological status of research subjects and the virological status of cells and tissues in vivo and in vitro. The proposed project will continue to provide research support for major research programs of the VB, and will include support activities related to development of vaccines for prevention of retroviral infection, development of treatment strategies for AIDS, and elucidation of mechanisms of retroviral pathogenesis. Four previous contracts awarded competitively and entitled "Support for Research on Retroviral Pathogenesis, Treatment and Prevention", have provided support. These included contracts N02RC91017 (1999-2004); N02RC47703 (2004-2010); NO2RC201000003 (2010-2014) and the current contract NO1RC2015-00001 (2014-2017). The Contractor in all cases has been Advanced BioScience Laboratories, Inc., Rockville, MD. Purpose and Objectives: The scope of this contract is to provide ongoing research support activities in areas including cell culture and virology, immunology, protein biochemistry, molecular biology, storage of biological material and delivery of specimens for the Vaccine Branch, Center for Cancer Research, of the National Cancer Institute, Bethesda, Maryland Project Requirements Organizations must be able to complete the following: Part I - Transition In: Ensure a smooth transition between the incumbent contract and the new award, if required. Transfer relevant files, records, materials, and data; use an appropriately bonded moving agent experienced in secure transfer of biological material; ensure adequate computer service and data storage is available and ensure that equipment is in place for receipt and storage of biological samples at appropriate temperatures. Part II - Core work: Accomplish the following: A.Pickup and delivery of Biological specimens: The Contractor shall arrange for pick-up and delivery of specimens, Monday through Friday, except Government holidays, between the Contractor's site and laboratories on the NIH campus. The Contractor shall also arrange shipment of specimens or reagents to outside investigators as requested by the COR. The Contractor shall package biological specimens according to U.S. Department of Transportation regulations. B.Immunological assays and reagent preparation: 1.Conduct serological assays of human or animal samples supplied by NIH. Serum or plasma samples provided by the Government shall be tested for the presence of antibodies to human and other mammalian viral proteins or peptides (HIV, SIV, HTLV-1/2) using such techniques as ELISA, Western blot, and antigen capture assays. Pepscan assays shall be conducted to determine specific antibody epitopes recognized and ELISAs shall be conducted to determine antibody titers and isotypes. 2.Provide purified, biochemically characterized and biologically active (where appropriate) native viral proteins from infected cells or conditioned media and from bacterial or mammalian expression systems. 3.Provide between three (3) and six (6) sets of overlapping peptides, representing proteins from the HIV, SIV, or adenovirus genomes. 4.Provide purified monoclonal antibodies by expressing antibody genes provided by the government in 293 T-cells by transfection or by producing stable CHO cell lines and purifying the antibody in quantities up to 2 grams. 5.Carry out assays measuring the ability of sera or purified antibody to inhibit virus propagation by virus reduction assay. 6.Provide CD4/CD8 and B cell counts (percentages and absolute numbers) from 500 to 1500 blood samples per year from non-human primates. C.Viral stock preparation and virological assays: 1.Provide between one (1) and four (4) purified and titered stocks of attenuated recombinant poxviruses or recombinant TK- vaccinia with titers of 10^9 to 10^10 TCID 50/ml as requested by the COR. The TK- vaccinia recombinants must be expanded under BL2 conditions. Quality control for the expression of heterologous HIV/SIV genes should be provided by Western Blot. 2.Provide between two (2) and ten (10) titered stocks of aliquots of field isolates for in vitro use from virus-infected humans and non-human primates at low passage number on human or non-human primate PBMC. The stocks shall be of sufficient titer for in vitro experimentation (10^4 to 10^5 TCID50/ml). Determine titer by plaque assay and provide aliquots of high-titered T-cell-line-adapted (TCLA) stocks of HIV or SIV for in vitro use. 3.Expand and purify replication-competent Adenovirus stocks provided by the Government, to 2 to 3 ml with a titer of 10^10 - 10^11 plaque forming units/ml. Titers shall be determined by OD and by plaque assay. For the purified Adenovirus stock, the ratio of the OD titer to the titer by plaque assay shall be no more than 30. 4.Conduct real time PCR assays for SIV gag in plasma and SIV gag in tissues. Purify and quantitate mRNA in plasma or tissue samples of animals or humans by real time PCR. 5.Conduct assays to quantitate viral DNA levels by real time PCR for SIV from cells of non-human primates. D.General molecular assays and regent preparation: 1.Synthesize and purify codon-optimized genes encoding cellular or viral proteins designed by the Government for eukaryotic or prokaryotic expression. For the individual genes produced, the Contractor shall provide up to 2-50 mg of DNA. 2.Provide pre-clinical grade plasmid DNA (up to 50 mg per preparation) containing minimal levels of endotoxin and encoding HIV or SIV genes. E.Storage of biological materials: Provide storage and electronic inventory for viable cell lines, titered field isolates, viral challenge stocks and viable cell specimens from inoculated and immunized animals as requested by the COR. The Contractor shall maintain a backup system capable of maintaining materials stored at the required temperatures. The storage capacities and temperature requirements are: 1) 25 cubic feet of minus 180 degrees Celsius storage maintained by liquid nitrogen, 2) 185 cubic feet of minus 80 degrees Celsius storage, and 3) 75 cubic feet of minus 20 degrees Celsius storage. F.Transition out Plan and coordinate an orderly, secure, and efficient transition of all activities, materials, data, and other documents to the successor Contractor or the Government. A description of transition activities and timelines shall be provided in a Draft and Final Transition Plan, which shall be reviewed and approved by the COR and Contracting Officer. Anticipated Period of Performance: It is anticipated the services will be acquired through full and open competitive procedures. It is anticipated that a cost reimbursement type contract will be awarded with base plus options of performance beginning on or about June 1, 2018. Other Important Information Mandatory Criteria: This criterion establishes conditions that must be met at the time of receipt of proposal. Companies that fail to meet these requirements will not be considered further for award. Capability Statements must clearly document your ability in the following areas: •Must have biocontainment facilities with Biosafety level (BSL) 2 with Biosafety level (BSL3) practices to conduct work with human retroviruses and non-human primate retroviruses (HIV, SIV, SHIV, HTLV-1/2), adenovirus, and poxviruses. The offeror is required to provide a certification of BSL 2 with a BSL 3 at the time of proposal submission. •Must be able to supply fresh, viable cells and biologically active purified proteins to the Government within one hour after harvest or preparation. The offeror is required to provide their address and distance from the NIH Campus located at 9000 Rockville Pike, Bethesda, MD 20892-1360 and NCI Fort Detrick Campus located at 810 Schredier Street #1, Frederick, MD 21702. The offeror must be within one hour from both NIH campus locations. Demonstrate past performance and expertise in (1) Personnel, (2) Technical Approach, (3) Facilities, and (4) Organizational Experience. Capability Statement/Information Sought: Page Limitations: Interested qualified small business organizations should submit a capability statement, not to exceed 10 total single-spaced pages using a 12-point font size at a minimum, that clearly details the ability to perform and that addresses the specific requirements described above. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Delivery Point and Common Cut-Off Date and Time: All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Catherine Kennedy, Contracting Officer at catherine.kennedy3@nih.gov either in MS Word or Adobe Portable Document Format (PDF) no later than July 14, 2017 5:00PM EST. The subject line must specify HHS-NIH-NCI-SBSS-ETSB-71023-75. Facsimile responses will not be accepted. All responses must be received by the specified due date and time in order to be considered. ANY RESPONSES RECEIVED AFTER THAT DATE AND TIME WILL NOT BE CONSIDERED. 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 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 responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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