SOURCES SOUGHT
65 -- HIV Plasma Samples, Viruses and Paired Cells
- Notice Date
- 1/20/2016
- Notice Type
- Sources Sought
- NAICS
- 621991
— Blood and Organ Banks
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1160571
- Archive Date
- 2/18/2016
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement HIV positive plasma samples, viruses and paired cells from Cameroon. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required services. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-621991- Blood and Organ Banks; Small Business Size Standard is $32.5 million. A. Background The Lab of Molecular Virology (LMV) within CBER has the responsibility for regulating all retroviral (.HIV and HTLV) diagnostic kits. In an effort towards maintaining blood safety, LMV has been procuring samples from Cameroon through this contractor (NYU) for the past 10 years. This is a follow-on contract for PO: HHSF223200730762P, HHSF223200910181P, HHSF223201300822P and HHSF223201510643P. Some of these viruses and plasma are represented in the CBER lot release panel testing. This is a dynamic panel and when a new HIV-1 variant is identified and increases in prevalence worldwide it will be added to the CBER panel. This effort is to ensure safety of HIV blood screening kits by assessing the ability of the FDA licensed tests to detect the emerging viruses. The contractor has access to the samples needed for this work and we have procured viruses and plasma from this institution for the past ten years. We are unable to identify another person in Cameroon to perform the task of providing the deliverables needed. In order to continue this long term effort we request using the existing mechanism for sample acquisition from Cameroon. It would not be cost effective to the government to delay this ongoing project while another facility/physician are cleared to collect samples in Cameroon. Additionally, use of another source for sample collection and processing could potentially introduce variables to the data which are currently otherwise controlled by continuity of all processes, staff and equipment. B. SCOPE Genetic characterization of HIV-1 is important for several reasons. First, it implies that studies are needed to monitor the occurrence of infection with diverse subtypes. Second, the emergence and transmission of different subtypes to regions where specific subtypes predominate will confound efforts to protect against infection with subtype-specific vaccines. Third, subtypes might differ in pathogenicity, and forth, virus variability is a problem for diagnosis and treatment. Therefore, there is need for continuous surveillance for emerging viruses. Several projects are ongoing at LMV related to HIV-1 subtypes mentioned above. In addition, LMV is involved in regulatory work related to HIV diagnostics, all research activities supportive of regulatory task. It has been previously reported that some HIV strains were not detected by US licensed assays. Specifically some HIV group O viruses were not detected by FDA licensed assays. It is therefore important to monitor emergence of new strains and to understand their significance for diagnostics and blood safety. LMV will test plasma samples using the approved HIV blood donor screenings assays, rapid and viral load assays and evaluate whether samples are detected and quantitated by all assays. C. DESCRIPTION OF ACTIVITIES TO BE UNDERTAKEN BY: CONTRACTOR: Incumbent: (NYU) New York University School of Medicine, New York Organize Sample Collection from Cameroon in coordination with the Health Science Foundation (HSF) in Cameroon: • 500 blood samples per year will be screened in the local health centers in the rural villages of the West and South Provinces, Buea and Limbe in the South West Province and the blood bank at the Bamenda Hospital blood bank using the Abbott Determine HIV-1/2 rapid assay (Abbott, Wiesbaden, Germany). • Patients referred to the Medical Diagnostic Center in Yaounde will also be screened for antibodies to HIV-1. • Out of these 500 samples, 15 samples from HIV positive patients will be shipped to the Contractor. These blood samples will be separated to obtain plasma and 10 Peripheral Blood Mononuclear Cell PBMCs. • High titer virus (~9 log copies/ml) will be isolated from 10 patients' PBMCs and stored in liquid Nitrogen until shipped to the FDA Lab. • Cost for all shipping to the FDA lab is included in the price. Health Science Foundation (HSF), Cameroon: The administrative and logistic aspects of the work in Cameroon will be coordinated by the Health Science foundation, a nongovernmental organization involved in HIV prevention programs in Cameroon. The work coordinated by HSF will include management of personnel including reimbursements; patient reimbursements; shipping of specimens to the Contractor; and receiving and distributing reagents from Contractor to the collection sites in Cameroon where patients are seen. D. Deliverables to government. 1. 45 HIV positive plasma (25-50ml) specimens from patients newly infected identified through HIV screening tests at Cameroon and 10 negative plasma. 2. 15 viruses isolated from paired PBMC of the above plasma specimens shipped to the government lab. 3. 30 paired PBMCs isolated and shipped to government lab Period of performance: Base Year: March 1, 2016 through February 28, 2017 Option Year 1: March 1, 2017 through February 28, 2018 Option Year 2: March 1, 2018 through February 28, 2019 Option Year 3: March 1, 2019 through February 28, 2020 Option Year 4: March 1, 2020 through February 28, 2021 FOB Point Destination. All items/services shall include shipping and handling to the destination identified herein. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small businesses all interested parties may respond. At a minimum, responses shall include the following: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. • Three (3) years of past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar service solutions. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; and • Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before February 3, 2016 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1160571. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. 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 FedBizOpps. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1160571/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03996227-W 20160122/160120234522-c0b6387e17fbb035b57e677ecb955c88 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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