Institutional Review Board (IRB) Services

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. Responses from organizations that are not considered a small business under NAICS code 541690 (size standard: $15,000,000) will not be accepted or reviewed as part of this market research. The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified small business companies technically capable of meeting the Government's potential requirement. All small business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Capabilities Sought The purpose of the Institutional Review Board (IRB) is to ensure ethical research practices when conducting research involving human participants. The proper approval, review, and monitoring of clinical studies is essential to ensure both patient safety and the quality of research. The National Institutes of Health (NIH) has issued a policy on the use of a single Institutional Review Board (IRB) for multi-site research. The NIH Office of Logistics and Acquisition Operations (OLAO) Category Management, Strategic Sourcing, and Data Analysis (CMSSDA) branch's mission is to encourage the utilization of government-wide contract solutions and advocate for smarter leveraged buying. As part of its mission CMSSDA establishes and manages an array of NIH-wide strategic sourcing vehicles for commodities and services not managed on a Government-wide level. CMSSDA is partnering with NIH stakeholders to establish a suite of multiple award Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts that, together, will provide a vehicle for NIH program officials to acquire IRB services in support of this pending policy change. OLAO is seeking to identify companies that provide commercial IRB services. See the associated Statement of Work for a complete description of the contract expectations. Anticipated Period of Performance The anticipated ordering period includes a base year and four option years. Government Property Upon receipt, all responses become government property and will not be returned. 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). Response Capability statements should not exceed 10 pages and should include the following information: - Company name and address - Clear and convincing documentation of the ability to provide the services specified in this notice - Examples of prior completed Government contracts, references, and other related information - Respondents' DUNS number, organization name, address, point of contact, size and type of business (e.g., 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) - Point of contact, including telephone number and email address for representative from interested business - Government contract vehicles covering the effort described, if applicable. - Based on the task areas specified in the Statement of Work (SOW), provide information on the spectrum of services that your firm has supported over the last three years. List the information for each task area separately. Respondents need not support all task areas in the Statement of Work; however, covered task areas shall be clearly identified. 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 solicitation may be published on FedBizOpps, e-buy, or other portal. However, responses to this notice will not be considered adequate responses to a solicitation. Interested parties may identify their interest and capability to respond to the requirement. The Government shall consider all responses received within fourteen (14) days of this posting at the email address below. Written responses to this synopsis shall contain sufficient documentation to establish their capability to fulfill this requirement.