SOLICITATION NOTICE
R -- Executive Clinical Pharmacology Consulting Services - Copy of the Solicitation
- Notice Date
- 3/17/2017
- 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-2017-256
- Archive Date
- 4/12/2017
- Point of Contact
- Lauren M. Phelps, Phone: 3014802453
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Copy of the Solicitation with the quotation format included. Executive Clinical Pharmacology Consulting Services Competitive Combined Synopsis/Solicitation HHS-NIH-NIDA-SSSA-CSS-2017-256 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-2017-256 and the solicitation is issued as a request for quotation (RFQ). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541690 with a Size Standard of $15 Million. SET-ASIDE STATUS This acquisition is 100% set aside for small businesses. ACQUISITION AUTHORITY 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 2005-95, dated January 19, 2017. The resultant contract will include all applicable provisions and clauses in effect through this date. DESCRIPTION OF REQUIREMENT Background The NIH Blueprint for Neuroscience Research, a consortium of 15 NIH Institutes and Centers that support neuroscience research, established the NIH Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug discovery and development services and expertise. The BPN program is intended for projects requiring medicinal chemistry optimization and CRO support through phase I clinical testing. Each project is directed by a Lead Development Team composed of the principal investigator, industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by contract research providers. Bioactivity and efficacy studies are funded through an award to the principal investigator; other research services are provided without cost to the PI through NIH contracts. The BPN External Oversight Committee (EOC) was instituted in 2011 and will continue through 2027 or until all of the projects in the Network are completed. The NIH National Institute of Neurological Disorders and Stroke (NINDS) oversees the EOC. The EOC typically convenes monthly via web-enabled virtual meetings and teleconference calls. Additionally, the EOC meets once per year at NIH for a day long face to face meeting and on an ad hoc basis to evaluate BPN project specific issues. These additional meetings of the EOC are scheduled around EOC member availability and full participation in such scheduled events is expected. Purpose The purpose of this requirement is to procure executive level small molecule drug discovery and development consultant services and expertise in clinical pharmacology to support the NIH Blueprint Neurotherapeutics Network and associated BPN External Oversight Committee. Project Requirements The Contractor shall provide clinical pharmacology consulting support services to the BPN EOC and NIH Leadership in relation to drug discovery and development programs as follows: •Apply executive level experience in small molecule drug discovery to provide recommendations regarding suitability and relevance of proposed BPN program milestones, recommend revised clinical pharmacology milestones for BPN programs as needed, and evaluate project progress relative to established milestones. •Analyze opportunities and concerns for future BPN program and projects under consideration and provide expert insight into clinical pharmacology. •Make executive level recommendations on potential solutions and assist in implementation of selected strategies to resolve programmatic challenges related to clinical pharmacology for drug discovery and development as they arise. •Assist NIH BPN executive team and project leaders in scientific entrepreneurship, including but not limited to providing expert input on preclinical enablement of clinical first-in-human studies, and proof-of-concept, identifying and addressing recruitment challenges, and global regulatory regulations and guidelines, for continued development and improvement of the BPN programs •Provide feedback to assist in successful work towards scientific and business goals and aspirations of program projects •Participate in web-enabled virtual meetings and teleconference calls with BPN staff on both a monthly and an ad-hoc-as-required basis. Level of Effort The estimated level of effort for this requirement is one (1) contractor employee on a part-time basis for seventy (70) hours per year. Government Responsibilities 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 the Contractor must be treated as confidential and not be disclosed to any third party. Project data will be collected and stored by BPN. BPN will provide data as needed to the Contractor each time it requests service. The Contractor may store data up to 12 months after initially receiving it, after that time the Contractor 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. Key Personnel: The Contractor employee providing services for this effort shall be considered key personnel. Key Personnel requirements are as follows: •A PhD in Pharmacology •At least 10 years of experience providing guidance at the executive level in small molecule drug discovery and development. •At least 15 years of experience providing clinical pharmacology guidance related to biopharmaceutical endeavors to government agencies, academic institutions, and/or start-up companies at the executive level. Experience must include efforts in the clinical stage. 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. Travel: The consultant may be required to travel within the contiguous 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 and authorized by the Contracting Officer's Representative prior to being finalized or invoiced. Contracting Officer approved and Contracting Officer's Representative-authorized travel shall not exceed $1,500.00 annually. Approximately eight hours of travel time are anticipated for this requirement. Please note that time spent travelling may not be billed to the Government. Please see the Federal Travel Regulation for allowable travel expenses, such as fares, rental fees, mileage payments, and other expenses related to transportation per FTR §301-10.2. Information Security: The Contractor must ensure that any computer system used in the course of this contract shall include the following features: 1.Any computer used in relation to this contract must be patched with most updated IT Security Patches. 2.Any Contractor computer used in relation this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis. 3.Hard drives and portable media used for this contract must be encrypted using the FIPS 140-2 standard. 4.Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/ 5.Contractor are required to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf 6.Contractors are required to 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. 7.Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx 8.Any computers used in reference to this contract must be assessed for vulnerabilities. 9.Any computers used in reference to this contract must be backed up on an external hard drive which is password protected. 10.Any computers used in reference to this contract must have auditing enabled such that if an incident occurred then that event could be reconstructed. 11.Any computers that are used in reference to this contract must employ at a minimum user name and password authentication or if possible two factor authentication. 12.Any computer used in relation to this contract must be password protected. All Password must meet the NIH standard such that users must choose passwords that have at least eight characters and at least three of the following types of characters: a.capital letters b.lower case letters c.numeric characters d.special characters (!@#$%^&*()_+|~-=\`{}[]:";'<>?,./) Data Rights: The National Institute of Neurological Disorders and Stroke shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations 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," shall be incorporated into any resulting award by reference. Consultants who contribute to the creation of new intellectual property may, however, be named as co-inventors according to US or prevailing patent law. Accordingly, consultants must complete negotiations with the principal investigator's institution regarding assignment of rights and royalties distribution prior to advising on any activities. The consultant shall provide copies of all intellectual property agreements to the NINDS Contracting Officer's Representative, for documentation purposes. Section 508 Compliance: Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies' electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board's Web site at https://www.access-board.gov/508.htm. The contractor must state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception. Non-Personal Service Statement: The 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). Collaboration Requirements: It is required that all contractors involved with the NIH community work collaboratively with federal staff and other contractors towards the NIH 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. Confidentiality of Information: Consultant(s) must guarantee strict confidentiality of the information/data that it is provided by the NIH or by any other participant on a drug development project to which the consultant is assigned by the NIH. The NIH 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 by the Contracting Officer's Representative when the consultant is assigned to a project. Disclosure of the information/data, in whole or in part, by the consultant to anyone else may 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. Period of Performance The required period of performance is a one-year base period from April 17, 2017 through April 16, 2018 and four (4) subsequent one-year optional periods. Place of Performance The primary place of performance shall be Contractor site. Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities in the continental United States, primarily Bethesda, MD, on an as needed basis. Contract Type A Firm Fixed Price Purchase Order with Options to Extend the Term of the Contract is contemplated. The order shall be sourced via the Open Market on a single-source basis and is not expected to exceed $150,000. Invoicing shall be on a NET30 basis and payment shall be made via Electronic Funds Transfer (EFT). 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 response, 2) a copy of the proposed contractor employee's Curriculum Vitae or Resume and 3) a separate price quotation. The technical response should address each individual evaluation criteria identified in this solicitation and may be up to fifteen (15) single-sided pages. This limit does not include key personnel curriculum vitae/ resumes. Price quotations submitted must include a fully burdened hourly rate for each contract period. This hourly rate must cover all associated labor, materials, etc. Please see the attached PDF version of the solicitation for a quotation format. 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." EVALUATION CRITERIA The Government will award a contract resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below: Factor 1: Key Personnel Education and Experience The Contractor's proposal shall include a resume or curriculum vitae for proposed key personnel. This document shall be evaluated for conformance to the key personnel education and qualifications, as well as for the extent and depth of skills related to managing on an executive level clinical pharmacology related drug development projects; designing, implementing, conducting, and overseeing clinical trials for neurological disorders with emphasis on proof-of-concept and first-in-human studies; identifying and preparing for trial design and recruitment challenges, knowledge of global regulatory regulations and guidelines, advising scientific boards regarding clinical pharmacology, and working with multi-disciplinary drug development teams. Factor 2: Technical Approach and Executive-Level Professional Experience The key personnel proposed shall address each area of the statement of work specific requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. Leadership experience in executing and managing drug discovery and development tasks, particularly for nervous system conditions, shall be evaluated. Executive level experience across the entire drug discovery and development process from discovery to clinical trials shall be considered favorably. Key personnel professional experience shall be evaluated for expert insight pertaining to small molecules drug discovery as it pertains to clinical pharmacology Factor 3: Past Performance The Contractor shall provide at least 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.Brief Description of Contractor's Responsibilities c.Point of Contact Name, Title, and Telephone Number Past Performance shall be evaluated for relevance to the current requirement. EVALUATION METHOD Technical proposals will be evaluated using a summary adjectival rating in accordance with the following scale: Excellent The following factors shall be considered for assignment of an "excellent" rating: •A PhD in Pharmacology •10 years' experience providing guidance and portfolio decisions at the executive level in small molecule drug discovery and development as demonstrated by holding a senior level executive position. •15 years' providing clinical pharmacology guidance related to biopharmaceutical endeavors to government agencies, academic institutions, and/or start-up companies at the executive level. Experience must include efforts in the clinical stage. •Engaging the offeror is anticipated to represent a benefit to the BPN program. Risk level: Very low Good The following factors shall be considered for assignment of a "good" rating: •A PhD in Pharmacology •10 years' experience providing guidance and portfolio decisions at the executive level in small molecule drug discovery and development as demonstrated by holding a senior level executive position. •12 years' providing clinical pharmacology guidance related to biopharmaceutical endeavors to government agencies, academic institutions, and/or start-up companies at the executive level. Experience must include efforts in the clinical stage. •Engaging the offeror is anticipated to represent neutral risk to the BPN program. Risk Level: Low Acceptable The following factors shall be considered for assignment of an "acceptable" rating: •A PhD in Pharmacology •8 years' experience providing guidance and portfolio decisions at the executive level in small molecule drug discovery and development as demonstrated by holding a senior level executive position. •10 years' providing clinical pharmacology guidance related to biopharmaceutical endeavors to government agencies, academic institutions, and/or start-up companies at the executive level. Experience must include efforts in the clinical stage. •Engaging the offeror is anticipated to represent limited risk to the BPN program. Risk Level: Neutral Marginal The following factors shall be considered for assignment of a "marginal" rating: •A PhD in pharmaceutical sciences •Limited experience providing guidance and portfolio decisions at the executive level in small molecule drug discovery and development as demonstrated by holding a senior level executive position. •Limited experience providing clinical pharmacology guidance related to biopharmaceutical endeavors to government agencies, academic institutions, and/or start-up companies at the executive level. Experience must include efforts in the clinical stage. •Engaging the offeror is anticipated to represent risk to the BPN program. Risk Level: High Unacceptable The following factors shall be considered for assignment of an "unacceptable" rating: •Lack of graduate degree in Pharmacology or pharmaceutical sciences. •Lack of or limited executive level experience in clinical pharmacology as in pertains to drug discovery and development processes. •Lack of or limited experience providing executive level recommendations, analyzing opportunities leading small molecule drug development •Engaging the offeror represents a high degree of risk to the BPN program. Risk Level: Very High APPLICABLE CLAUSES AND PROVISIONS The following FAR clauses and provisions shall apply to this solicitation: 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 (October 2017), applies to this acquisition. 3.A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (January 2017), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4.FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items (January 2017) is applicable to this acquisition. 5.FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (January 2017) apply to this acquisition. The following clauses shall be checked/included in this clause: a.52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) b.52.204-14, Service Contract Reporting Requirements (Jan 2014) c.52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) d.52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) e.52.219-8, Utilization of Small Business Concerns (Oct 2014) f.52.219-13, Notice of Set-Aside of Orders (Nov 2011 g.52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) h.52.222-3, Convict Labor (June 2003 i.52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016) j.52.222-21, Prohibition of Segregated Facilities (Apr 2015) k.52.222-26, Equal Opportunity (Apr 2015) l.52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) m.52.222-37, Employment Reports on Veterans (FEB 2016) n.52.222-50, Combating Trafficking in Persons (Mar 2015) o.52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011 p.52.225-13, Restrictions on Certain Foreign Purchases (June 2008) q.52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) 6.FAR Clause 52.217-5: Evaluation of Options (July 1990) applies to this acquisition. 7.FAR Clause 52.217-9: Option to Extend the Term of the Contract (March 2000) applies to this acquisition as follows: (a) The Government may extend the term of this contract by written notice to the Contractor within the contract period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least thirty (30) days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years. 8.The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 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. All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-2017-256. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.
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- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04439857-W 20170319/170317235026-2f9f057936920e88b37a86a791246256 (fbodaily.com)
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