SOLICITATION NOTICE
R -- Biostatistician Consulting Support Services - Appendix A: Information Security Clauses - Copy of the Solicitation
- Notice Date
- 8/3/2016
- 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 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-CSS-16-473
- Archive Date
- 8/27/2016
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Copy of the Solicitation Applicable Information Security Clauses Biostatistician Consulting Support Services Competitive Combined Synopsis/Solicitation HHS-NIH-NIDA-SSSA-CSS-16-473 INTRODUCTION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items. The solicitation number is HHS-NIH-NIDA-SSSA-CSS-16-473 and the solicitation is issued as a request for proposal (RFP). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541690 with a Size Standard of $14 Million. SET-ASIDE STATUS This acquisition is 100% set aside for small businesses. ACQUISITION AUTHORIT Y This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures and FAR Part 12-Acquisition of Commercial Items, and IS NOT expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-89 dated July 14, 2016. The resultant contract will include all applicable provisions and clauses in effect through this date. DESCRIPTION OF REQUIREMENT 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 The purpose of this acquisition is to procure biostatistics consulting services for the NINDS CTU and extramural research community. Scope of Work 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 as follows: The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. Collaboration It is required that all contractors involved with the NINDS community work collaboratively with federal staff and other contractors towards the NINDS mission and other affected organizations and follow the direction of the Contracting Officer's Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. 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. Travel Under special circumstances, the consultant may be required to travel within the continuous United States to provide the services described in this statement of work. Travel reimbursement will be provided for such required travel. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer's Representative prior to being finalized or invoiced. Contracting Officer's Representative-authorized travel shall not exceed $1,200.00 annually. Government Furnished Property/Information No Government furnished property shall be provided. Project related data will be provided to the contractor for performance of work efforts. All data provided to consultant must be treated as confidential and not be disclosed to any third party. Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the COR for approval to store data longer. NINDS requires that the consultant's meet certain minimum requirements: All computers that are used by the consultant to perform work under this contract whether contractor furnished or government furnished will have to have: •Virus protection with regular automated scans •Up to date security patching •Two factor authentication •Encryption - FIPS 140-2 compliant encryption solution •Regular vulnerability scans and if the scan produces any high or medium results they need to be corrected - highs within 30 days and mediums within 90 days •Contractors will have to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/ •Consultant will have to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf •Report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a contractor furnished computer. •Contractors must adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx Confidential Treatment of Sensitive Information Consultant(s) must guarantee strict confidentiality of the information/data that is provided by the NINDS or by any other participant on a project to which the consultant is assigned. The NINDS has determined that the information/data that the consultant will be provided during the performance of the consulting contract is of a sensitive nature. Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified when the consultant is assigned to a project. Disclosure of the information/data, in whole or in part, by the consultant to anyone else can only be made after the consultant receives prior written approval from the Contracting Officer. Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information. Data Rights The NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and shall be made a part of any resulting contract/order. Non-Personal Service Statement Contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR). Contract Type The Government intends to issue one or more fixed price requirement contract(s) in reference to this requirement. Each contract shall include fixed hourly rates for each contract period. Only funding for the minimum level of effort is guaranteed, but funding may be obligated for additional hours up to the maximum level of effort specified in this solicitation. RESPONSE FORMAT Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical proposal and 2) a separate price proposal. The technical proposal should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to thirty (30) single-sided pages. The price proposal must include fixed hourly rates for proposed consultant(s) for each contract period. Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." IMPORTANT NOTE TO OFFERORS: PLEASE ENSURE THAT YOUR RESPONSE MEETS THE FORMAT REQUIREMENTS AND SPECIFICALLY ADDRESSES EACH OF THE TECHNICAL EVALUATION CRITERION AND THE EVALUATION FOCUS THAT IS INDICATED FOR EACH CRITERION. PROPOSALS MUST INCLUDE BOTH A TECHNICAL DOCUMENT AND A SEPARATE PRICE PROPOSAL. CONTRACTORS NOT SUBMITTING BOTH A TECHINICAL PROPOSAL ADDRESSING THE EVALUATION CRITERIA AND A SEPARATE PRICE PROPOSAL SHALL NOT BE CONSIDERED. EVALUATION CRITERIA FAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contact resulting from this solicitation on the basis of best value in consideration of trade-off between technical factors and price/cost. Technical factors together shall be considered more important than price. The technical evaluation factors are as follows, in order of importance: Factor 1: Technical Capability (50 Points) The Contractor's proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. Factor 2: Key Personnel Qualifications (25 Points) Offerors proposals shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work. Offeror proposals must contain a resume/CV. Factor 3: Past Performance (25 Points) The Contractor shall provide a list of two (2) past performance references with knowledge of the contractor's relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information: a)Name of Organization b)Description of Contractor's responsibilities as they relate to this SOW c)Contract Period of Performance d)Contact Name and Title e)Telephone Number Past Performance shall be evaluated for relevance to the current requirement. Technical proposals will be evaluated using a summary adjectival rating based on total numerical score in accordance with the above and the following scale: Excellent (90 - 100) Very Good (80 - 89) Good (70 - 79) Fair (60 - 69) Poor (0-59) Award shall be made to the contractor offering the greatest value in consideration of both technical factors and price. Award shall not be considered for proposals evaluated to be "Poor." APPLICABLE CLAUSES AND PROVISIONS The FAR clauses and provisions below shall apply to this solicitation. Please note that any clauses requiring fill-ins shall be completed at time of award. 1.All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2.The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition. 3.A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (March 2015), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4.FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (October 2015) apply to this acquisition. 5.FAR clause 52.217-5 Evaluation of Options (July 1990) applies to this acquisition. 6.FAR clause 52.217-9 Option to Extend the Term of the Contract (March 200) applies to this acquisition. 7.The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 8.FAR clause 52.227-14 Rights in Data-General (May 2014) is applicable to this requirement. 9.HHSAR clause 352.224-70 Privacy Act (December 18, 2015) is applicable to this requirement. 10.HHSAR clause 352.237-75 Key Personnel (December 18, 2015) is applicable to this requirement. 11.The information security clauses included in Appendix A of this solicitation are applicable to this acquisition. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." CONTRACTING OFFICER'S REPRESENTATIVE A Contracting Officer's Representative (COR) shall be assigned to the awarded contract. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract The Government may unilaterally change the COR designation for this contract. CLOSING INFORMATION Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-16-473. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.
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