SOURCES SOUGHT
B -- Serology Services - Sources Sought 1144614.PDF
- Notice Date
- 4/14/2015
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1144614
- Archive Date
- 5/14/2015
- Point of Contact
- Sondea R Blair, Phone: 8705437469
- E-Mail Address
-
sondea.blair@fda.hhs.gov
(sondea.blair@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought 1144614.PDF MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a sources sought to determine the availability and capability of small businesses in providing Serology Services. The associated North American Industry Classification System (NAICS) Code is 541690- Other Scientific and Technical Consulting Services; Small Business Size Standard is 15 million dollars. Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration (FDA), Offices of Microbiology Surveillance (OMS) and Microbiology Research Animal Diagnostic and Investigative Laboratory (RADIL), within the National Center for Toxicological Research (NCTR) Office of Scientific Coordination, conduct basic and applied research to support regulatory decision-making. This research involves the isolation, identification, and characterization of microorganisms potentially harmful to animals and humans. The microbiological monitoring of test animals helps maintain the integrity of the research program by guarding against primary and opportunistic pathogens that may interfere with research results. NCTR requires Serology Services i.e. diagnostic identification of antibodies, for use in the diagnostic and heath monitoring programs of NCTR animal colonies and anticipates the issuance of a firm-fixed price, indefinite-delivery type contract with up to four option years. Part II: Work Requirements 1. Serology Services At a minimum the contractor shall : • Perform serological testing in accordance with Good Laboratory Practices as defined by the Code of Federal Regulations, Title 21, and highest level of development in serological technology and techniques available. • Furnish all necessary labor, materials, supplies, equipment, and services necessary for performance of the work set forth below. • Perform serological assays by appropriate methods such as Enzyme-Linked Immunosorbent Assay (ELISA), Multiplex Fluorescent Immunoassay (MFI), Immunofluorescent Antibody (IFA), Hemagglutination Inhibition (HAI) and Western Blot. • Perform confirmatory testing by IFA and/or Western Blot methodology, upon request by the government, to confirm initial positive serological. IFA and/or Western Blot methodology to be determined by the contractor premised on test results. • Should new testing technology become available or new pathogenic agents be discovered during the term of the contract, they may be incorporated through contract modification. Screening tests shall include: a) Mouse Serology Panel (all tests shall be performed): • Mouse hepatitis virus (MHV) • Minute Virus for Mice (MVM) • Generic parvovirus (NS1) • Mice pneumonia virus (MPV1-5) • Mouse norovirus (MNV) • Theiler's murine encephalomyelitis virus (TMEV) • Epizootic diarrhea of infant mice virus (EDIM) • Sendai virus • Mycoplasma pulmonis • Pneumonia virus of mice (PVM) • Lymphocytic choriomeningitis virus (LCMV) • Ectromelia virus b) Rat Serology Panel (all tests shall be performed): • Rat coronavirus-sialodacryoadenitis virus (RCV/SDAV) • Generic parvovirus (NS1) • Rat parvovirus (RPV) • Rat minute virus (RMV) • Kilham's rat virus, parvovirus (KRV) • Toolan's H-1, parvovirus (H-1) • Rat theilovirus (RTV) • Sendai virus • Pneumonia virus of mice (PVM) • Mycoplasma pulmonis 2. Deliverables: a) The Government will send, at its expense, serum samples, with contractor-furnished serum submission form, via express overnight delivery service, on Tuesday, Wednesday, or Thursday afternoons at 4:00 p.m. Central Time with an anticipated arrival time at the Contractor's testing facility of 10:30 a.m. Central Time the following day. b) The Contractor shall perform the Mouse Serology Panel or Rat Serology Panel, as specifically requested. Within 3 working days from the date of receipt of the serum samples, the contractor shall provide serological results from the requested tests to the Government's designated Point of Contact (POC) by email, with a final written report via mail within 10 working days from the date of receipt of the serum samples. c) Upon completion of the serological assays the remaining test sample shall be stored for six months at -70°C. During this period, if requested, the stored samples shall be returned to the COR at Government expense. After 6 months, the samples shall be discarded by the contractor. d) The Contractor shall maintain an electronic copy of the serological results report data for the life of the resultant contract for audit and comparison. 3. Additional Requirements: • The Government project officer (PO) may request expedited processing of specimens deemed critical by the PO at no additional cost to the Government. The Contractor shall process and report expedited test results electronically by e-mail within 2 working days of receipt of the specimen from the Government, with a final written report via mail within 5 working days from the date of receipt of the serum samples. • In the event of an outbreak at the NCTR of rodent disease caused by an unknown agent(s), the Contractor shall be able to perform or assist in research to help elucidate the cause, pathogenesis, and epidemiology of the causative agent as requested by the PO and Contracting Officer (CO). In this event or in the event of an outbreak of a known rodent agent the Contractor may be requested to handle a greatly increased number of samples for that particular agent. The Contractor shall process these samples and report the results by email transmission within 2 workdays of receipt of the sera samples from the Government, with a final written report via mail within 5 working days from the date of receipt of the serum samples. • The PO may make an annual visit to the Contractor's place of work to inspect and review the serological testing procedures covered in the resultant contract. The PO shall tour the facility with a representative of the Contractor. The PO has the option to observe all of the procedures addressed in the resultant contract while visiting the Contractor. • Key personnel designated by the Contractor shall include: a) A Project Supervisor, responsible for overseeing all serological and PCR testing related to the contract and personnel. This individual shall have a Ph.D. in microbiology or DVM/VMD from an accredited school of veterinary medicine and be board certified by the American College of Laboratory Animal Medicine, and shall have a minimum of five years in laboratory rodent serology testing and PCR assays. b) A Laboratory Supervisor, who is responsible for supervising the personnel who are actually performing the assays. The individual shall serve as the principal for the Project Officer and/or his/her designee, and shall have a minimum of a Bachelor's degree and one year's experience with rodent serologic testing in a supervisory capacity. Part III: Supporting Information A. Place of Performance U.S. Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079 B. Period of Performance Base Period: June 13, 2015 to June 12, 2016 Option Year One: June 13, 2016 to June 12, 2017 Option Year Two: June 13, 2017 to June 12, 2018 Option Year Three: June 13, 2018 to June 12, 2019 Option Year Four: June 13, 2019 to June 12, 2020 Part IV: Instructions to Prospective Respondents The offeror shall furnish sufficient information necessary for the Government to conclusively determine that the respondent is capable and otherwise qualified to perform the full range of services identified herein. At a minimum, responses shall include the following: ~Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; ~Past performance information for the same or substantially similar services, to include date of services, 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; ~Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the services the responding firm is regularly engaged in providing; ~If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; ~Although this is not a request for quote, informational pricing is encouraged; The Government encourages any comments and/or suggestions from any interested party, regarding these requirements. 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. The Government is not responsible for locating or securing any information, not identified in the response. Interested parties must respond with capability statements, which are due in person, by postal mail or email to the point of contact listed below on or before April 29, 2015 by 9:00 AM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OO|OFBA|OAGS|DAP, Attn: Sondea Blair, 3900 NCTR Road, Bldg 50/Room 421, HFT‐320, Jefferson, AR 72079‐9502 or email sondea.blair@fda.hhs.gov. Reference Number 1144614 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open 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 combined synopsis/solicitation (No. FDA-15-223-SOL-1144614) may be published via 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/DCASC/1144614/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03699647-W 20150416/150415000037-8bcb6027ce2a9cdaaa934aa9dfd9085e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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