Inactive Total Small Business Set-Aside (FAR 19.5)

SAM.gov SOURCES SOUGHT NOTICE Amendment 1 is being posted to add the Place of Performance. The primary place of performance shall be the Contractor’s site. Conference calls and emails between the Cont... SAM.gov SOURCES SOUGHT NOTICE Amendment 1 is being posted to add the Place of Performance. The primary place of performance shall be the Contractor’s site. Conference calls and emails between the Contractor and NINDS staff shall be the primary mode of communication. The Contractor shall submit required deliverables electronically. Solicitation Number: 75N95024Q00149_SB Title: Biostatistics Consulting Services Classification Code: R499 – Support-Professional: Other NAICS Code: 541690 – Other Scientific and Technical Consulting Services Size Standard: $19 Million 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; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. 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 notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. 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. Purpose and Objectives: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work. Specific Requirements: The Contractor shall provide biostatistics consulting services to the NINDS CTU as follows: Provide expert and strategic statistical technical support, guidance, education, and advice on advancing NINDS projects through nonclinical and clinical development. Perform complex statistical analyses, prepare and review statistical analysis plans, provide detailed specifications for electronic analysis files, and quality check statistical analyses including tables and figures. Communicate with Government staff and investigators regarding statistical protocol design and data analysis issues. Evaluate the design of NINDS’ proposed studies and milestones using sound statistical analysis methodology to ensure studies are sufficiently powered and controlled with experimental and statistical rigor that will lend a high degree of confidence in study results. Interpret and, as needed, perform biostatistical/statistical analyses of datasets. Assist in the writing of statistical sections of study reports. Explain statistics in plain language, and participate in educational activities upon request. Provide verbal and written feedback and technical recommendations regarding biostatistical data relating to NINDS projects. Provide technical review and feedback on statistical data to inform project milestones, progress reports, development plans, study design, database design, and data interpretation. Communicate with Government staff and clinical trial investigators to facilitate discussions to support the NINDS’ research strategy. Provide written guidance to Government staff and clinical trial investigators on the appropriate statistical methods to employ to accurately interpret clinical trial results. Assist NINDS CTU staff in preparing investigational and research study protocols. Key Personnel Requirements A Ph.D. degree in biostatistics or a closely related discipline. At least ten (10) years of biostatistics experience in the biotechnology or academic sector. At least five (5) years of demonstrated experience in: Designing and reviewing nonclinical animal research plans and/or analysis of nonclinical animal research results for Investigational New Drug (IND)-enabling studies or clinical studies. Designing adaptive clinical trial protocols. Developing and reviewing statistical analysis plans, and data validations plans. Providing statistical interpretation of published results or critique of scientific proposals. Providing statistical support on nonclinical and/or clinical development projects. Anticipated Period of Performance: January 1, 2024 – December 31, 2025, with two (2) one (1) year option periods. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Michele Pastorek, Contract Specialist at e-mail address michele.pastorek@nih.gov. The response must be received on or before February 22, 2024, at 4:00 pm, Eastern Time. “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 presolicitation synopsis and solicitation may be published in www.sam.gov. 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).”