SOURCES SOUGHT
R -- Biostatistics Consulting Services for the NINDS
- Notice Date
- 6/16/2016
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-16-417
- Archive Date
- 7/12/2016
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Information/Sources Sought HHS-NIH-NIDA-SSSA-SBSS-16-417 Biostatistics Consulting Services for the NINDS Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, MD 20892, UNITED STATES. 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. Background: The National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trials Unit (CTU) staff work with investigators at the NINDS Division of Intramural Research (DIR) in specific neurological and clinical research areas, including protocol development of interventional and non-interventional clinical research studies for neurological disorders and stroke. In addition to advising intramural investigators in the conception, development, implementation, and execution of clinical research studies and clinical trials, CTU interacts with the extramural Offices of Translational Research (OTR) and Clinical Research (OCR) to support the mission of NINDS. The CTU provides expertise to NINDS and investigators in the conception, design, implementation, execution, analysis, and reporting of clinical research. CTU staff advises the investigators and the Institute on clinical research methodology, research ethics, safety monitoring, clinical research data sharing, clinical trial reporting, and gender and minority tracking. For extramural research, NINDS awards grants and cooperative agreements to outside academic institutions, small business concerns and other organizations all over the U.S. and world to fund promising basic, translational, and clinical research projects. The NINDS Office of Translational Research (OTR) is committed to facilitate the translation of basic discoveries into the development of new therapeutic interventions through nonclinical development and early clinical investigation. NINDS seeks statistical advice given the institute's high priority in increasing the predictive value of non-clinical research, in order to ensure therapy projects are moving ahead to the clinic for the right reasons. For more information on the Office of Translational Research, Extramural program visit the website: http://www.ninds.nih.gov/funding/areas/translational_research/index.htm Purpose and Objectives for the Procurement: The purpose of this acquisition is to procure biostatistics consulting services for the NINDS CTU and extramural research community. Project Requirements: The Contractor shall provide the following Biostatistics Consulting Services: •Provide expert and strategic biostatistical technical support, guidance, education, and advice on advancing Government projects through nonclinical and clinical development. •Prepare and review statistical analysis plans, provide detailed specifications for analysis files, consistency checks, tables and figures; communicate with Government staff and investigators regarding statistical protocol design and data analysis issues. •Evaluate the design of Government proposed studies and milestones for sound statistical analysis methodology to ensure studies are sufficiently powered and controlled with experimental and statistical rigor to lend a high degree of confidence in the results. •Interpret and, as needed, perform analyses and assist in the writing of statistical sections of study reports. •Explain statistics in plain language and participates in educational activities when requested. •Provide feedback and recommendations of a biostatistics nature on projects through written documents, conference calls, and by email. Provide technical review and feedback of a biostatistics nature regarding project milestones, progress reports, development plans, study design, and data interpretation. •Interact with Federal staff and clinical trial investigators to facilitate discussions in support of Government research strategy with regards to statistical methods for clinical trials as the Government prepares protocol or grant applications. Level of Effort: The NIH estimates that the level of effort for this requirement shall be one (1) contractor employee on a part time basis for up to forty-five (45) hours per year. Key Personnel Requirements: The Contractor employee working under this award shall be considered key personnel. Key Personnel requirements are as follows: •A PhD in a biostatistical discipline •At least 10 years biostatistical experience in the biotechnology or academic sector •At least 5 years demonstrated experience in: oDesign and review of nonclinical animal research plans and/or analysis of nonclinical animal research results for IND-enabling studies or clinical studies oDesign of clinical trial protocols, innovative and adaptive designs, review of statistical analysis plans, and validations plans. oStatistical interpretation of published results or critique of scientific proposals oStatistical support to non-clinical and/or clinical development efforts The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel. Anticipated Contract Type: A firm fixed price purchase order within the Simplified Acquisition threshold is anticipated. Period of Performance: The period of performance shall be a one year base period plus four (4) one-year option periods as follows: Base Period: September 30, 2016 through September 29, 2017 Option Period 1: September 30, 2017 through September 29, 2018 Option Period 2: September 30, 2018 through September 29, 2019 Option Period 3: September 30, 2019 through September 29, 2020 Option Period 4: September 30, 2020 through September 29, 2021 Place of Performance: The contractor shall provide services remotely from its own site. Capability Statement: Contractors that believe they possess the ability to provide the required consulting support services should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The capability statement should include 1) the total number of employees, 2) documentation of ability to provide the required consulting support services, 3) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Contractors must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested organizations are required to identify their type of business, applicable North American Industry Classification System 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. All capability statements sent in response to this Sources Sought Notice must be submitted to Lauren Phelps, Contract Specialist, via email at lauren.phelps@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government anticipates negotiation of a firm fixed price purchase order.
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