SOLICITATION NOTICE
66 -- Statistical Consulting for VRC Clinical Trial Assay Qualifications
- Notice Date
- 7/18/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 5601 Fishers Lane, 3rd Floor MSC 9822, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- RFQ1916092
- Archive Date
- 7/28/2018
- Point of Contact
- Jesse Weidow, , Barbara Horrell,
- E-Mail Address
-
weidowjd@niaid.nih.gov, horrellb@niaid.nih.gov
(weidowjd@niaid.nih.gov, horrellb@niaid.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- FedBizOps Synopsis Title: Statistical Consulting for VRC Clinical Trial Assay Qualifications Solicitation Number: RFQ1916092 Description: This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and solicitation for commercial Items," as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested. The Solicitation number is RFQ1916092 and the solicitation is issued as a Request for Quotes (RFQ). This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-99 as of 06/22/2018 The North American Industry Classification System (NAICS) code for this procurement is 541690, Other Scientific and Technical Consulting Services, with a small business size standard of $15 Million. This is a total small business set aside. The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for the following item. These supplies will be used in the NIAID, Vaccine Research Center (VRC). Place of Performance: NIH, 40 Convent Drive, Bethesda, MD 208920, United States. Requirements: Successful offerors must have the knowledge, skill, ability, and resources to reliably fulfill the following requirements: Description of Research Program The Vaccine Immunology Testing Laboratory (VITL) is responsible for the method development, validation, and testing of all samples from VRC clinical trials. B-Purpose and Objective of the Service VRC-VITL is a Good Clinical Laboratory Practices (GCLP) accredited laboratory and is responsible for the method development, validation and testing of all samples from the VRC Clinical trials. Project and Brand name or equal requirements: Successful offerors must have the knowledge, skill, ability, and resources to reliably fulfill the following requirements: Consulting services requirements: Quote must be submitted in hours. 100 hours of consulting services for 7 different analytical methods to include: Protocol review, data analysis, and report generation. The role of VRC-VITL is to perform immunogenicity testing on samples from VRC clinical trials. Given that the results generated are to be potentially used to support the licensure of vaccine products with the FDA, the analytical methods are qualified. A critical component of the method qualification is the statistical analysis performed on the data. The FDA requirements for assay qualification call upon a very specialized set of statistical analysis and presentation of the data. As such, the awardee must have a documented history of statistical analysis of assay qualifications to include the following analytical methods: •Neutralization assays •Competitive neutralization assays •ELISA assays. The studies and details included in this SOW are detailed in Table 1. The scope of the work for the awardee for each analytical method will include: •Protocol review oAssure that all experiments are statistically sound oDetermine the appropriate analysis of the data oAdvise on general assay validation guidelines •Data Analysis oPerform the appropriate statistical analysis of data provided by client. oAssist in data reduction if needed. •Statistical report. oPresent the statistical methods used for data analysis oProvide appropriate conclusions. oMake recommendations for suitable acceptance criteria and system suitability criteria. Table 1: Details of studies included in this scope of work: Study No. Study TypeStudy Name 1 ELISA AssayPGT121 TMAB ELISA Qualification 2 ELISA AssayCAP256 TMAB ELISA Qualification 3 MSD ADA AssayN6LS ADA Qualification 4 MSD ADA Assay10E8VLS ADA Qualification 5 MSD ADA AssayMB114 ADA Qualification 6 MSD ADA AssayPGT121 ADA Qualification 7 MSD ADA AssayCAP256 ADA Qualification Protocol Review •Assure that all experiments are statistically sound •Determine the appropriate analysis of the data •Advise on general assay guideline Data Analysis •Perform the appropriate statistical analysis of data provided by the Government official •Assist in data reduction Write Statistical Report •Present the statistical methods used for data analysis •Provide appropriate conclusions •Make recommendations for suitable acceptance and system suitability criteria All work must be overseen by a PhD in biological sciences CONTRACTOR SUPPLIED MATERIALS: Protocol review, data analysis, and statistical reports for the 7 studies as detailed in Table 1. Must be capable of working remotely and have your own work space. Government Furnished Materials Government equipment and office space will not be provided. For the 7 studies detailed in Table 1 the Government will provide: •Draft qualification protocol for review •Data for analysis. REPORTING REQUIREMENT AND DELIVERABLES Protocol review, data analysis, and statistical reports for the 7 studies as detailed in Table 1. Timelines will be mutually agreed upon with VRC-VITL and the contractor but will not exceed the period of performance which will begin upon award and go through December 31, 2018. Quotes should also include documentation indicating that offerors business size as determined by the Small Business Administration's Table of Size Standards located at: (https://www.sba.gov/content/small-business-size-standards) for NAICS 541690. This SBA size standard is currently $15 Million but is subject to change. Prospective offerors may also note whether they meet any other socio-economic business categories such as 8(a), Hub-Zone, or Service Disabled Veteran when submitting their quote. Submissions must include the following: The government intends to a firm fixed price purchase order to the responsible contractor as a result of this RFQ that will include the terms and conditions set forth herein. The award will be based on the following; capability to meet the requirements, delivery time, warrant, and price and the best value to the government. The following FAR provisions apply to this acquisition: FAR 52.212-1 Instructions to Offerors Commercial Items (Oct 2014) FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (Nov 2017) Offerors must complete annual representations and certifications on-line at http://www.sam.gov/ in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Please ensure 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Dec 2014) is updated in your SAM record) FAR 52.204-7 System for Award Management (July 2013) FAR 52.203-19 - Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements. The following FAR contract clauses apply to this acquisition: FAR 52-212-4 Contract Terms and Conditions Commercial Items (Jan 2017) FAR 52-212.5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (Jan 2017) *The applicable subparagraphs of FAR52.212-5 are included in the attachment to this posting. FAR 52.204-18 Commercial and Government Entity Code Maintenance (Nov 2014) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 52.204-13 System for Award Management Maintenance (July 2013) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (January 2010) By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov). Copies of the above-referenced provisions and clauses are available from https://www.acquisition.gov/browsefar & https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html or, upon request, either by telephone or fax. Submission shall be received not later than July 27th, 2018 by 5:00 P.M. Eastern time. Offers may be mailed, e-mailed to Jesse.weidow@nih.gov Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f) All responsible sources may submit an offer that will be considered by this Agency. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Jesse Weidow @ Jesse.weidow@nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/RFQ1916092/listing.html)
- Place of Performance
- Address: 40 Convent Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04996805-W 20180720/180718230928-45c65b004c09bdee997a8cc2ef797d31 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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