SOLICITATION NOTICE
R -- Clinical Pharmacology Consulting Services
- Notice Date
- 12/16/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- #541990
— All Other Professional, Scientific, and Technical 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-17-090
- Archive Date
- 1/13/2017
- Point of Contact
- Lauren M. Phelps, Phone: 3014802453
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Clinical Pharmacology Consulting Services Competitive Combined Synopsis/Solicitation HHS-NIH-NIDA-SSSA-CSS-17-090 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-17-090 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 541990 with a Size Standard of $15 Million. SET-ASIDE STATUS This acquisition is unrestricted and business of all size classifications, large and small, are encouraged to submit offers. 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 2005-92, dated November 18, 2016. 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 late 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 clinical pharmacology consulting services in support of NIH Blueprint Neurotherapeutics Network drug discovery and development programs and the associated BPN External Oversight Committee. Project Requirements The Contractor shall provide consulting support services to the BPN EOC and NIH Leadership in relation to drug discovery and development programs as follows: •Review operations and processes of BPN programs and provide recommendations regarding designing, implementing, conducting, and overseeing clinical trials. •Advise regarding suitability and relevance of proposed BPN program clinical pharmacology milestones, recommend revised clinical pharmacology milestones for BPN programs as needed, and evaluate project progress relative to established milestones. •Analyze potential clinical pharmacology opportunities and concerns for future BPN program projects under consideration. •Recommend 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. •Mentor BPN executive team and project leaders in scientific entrepreneurship, including but not limited to proof-of-concept, first-in-human studies, 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 sixty (70) hours per year. Government Furnished Information/Property: 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 medical doctor degree •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. 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. 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: Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. Confidential Information or records shall not be disclosed by the Contractor without written authorization from the Contracting Officer. Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication. Period of Performance The required period of performance is a one-year base period from January 9, 2017 through January 8, 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. 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 and 2) a separate price quotation. The technical response 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 quotation must include an hourly rate as well as extended pricing for the full level of effort. 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: Technical Approach 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. The proposed technical approach shall include information regarding computer systems security plans, collaboration capabilities, and teleconference and email communication skills. Factor 2: Key Personnel 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 qualifications, as well as for the extent and depth of skills related to managing clinical stage central nervous system 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 trail 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 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.Description of Contractor's Responsibilities c.Contact Name, Title, and Telephone Number Past Performance shall be evaluated for relevance to the current requirement, as well as customer satisfaction in reference to the following: 1)Interpersonal skills 2)Attention to detail 3)Computer and software literacy 4)Writing, Communication, and Presentation Skills 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 2016), applies to this acquisition. 3.FAR clause 52.212-2, Evaluation - Commercial Items (October 2014) applies to this acquisition. 4.A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (October 2016), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 5.FAR clause 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) is applicable to this acquisition. 6.FAR clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (November 2016) applies to this acquisition as detailed below: a.FAR 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards b.FAR 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment c.FAR 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns d.FAR 52.219-28 Post Award Small Business Program Re-representation e.FAR 52.222-3, Convict Labor f.FAR 52.222-19, Child Labor-Cooperation with Authorities and Remedies g.FAR 52.222-21, Prohibition of Segregated Facilities h.FAR 52.222-26, Equal Opportunity i.FAR 52.222-36, Equal Opportunity for Workers with Disabilities j.FAR 52.222-50, Combating Trafficking in Persons k.FAR 52.225-13, Restrictions on Certain Foreign Purchases l.FAR 52.232-33, Payment by Electronic Funds Transfer-System for Award Management 7. FAR Clause 52.237-2 -- Protection of Government Buildings, Equipment, and Vegetation (April 1984) applies to this acquisition. 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. 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-17-090. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-CSS-17-090/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04354351-W 20161218/161216234539-006dc8c3305efaad5c986dc9c83472ef (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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