Drug Metabolism and Pharmacokinetics Consultant Support Services
Added: Dec 16, 2016 11:12 am Drug Metabolism and Pharmacokinetics Consultant Support ServicesCompetitive Combined Synopsis/Solicitation HHS-NIH-NIDA-SSSA-CSS-17-094INTRODUCTIONThis 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-17-094 and the solicitation is issued as a request for quotation (RFQ). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 541990 with a Size Standard of $15 Million. SET-ASIDE STATUSThis 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 expected to exceed the simplified acquisition teshold. The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular 2005-92, dated November 18, 2016. The resultant contract will include all applicable provisions and clauses in effect tough this date. DESCRIPTION OF REQUIREMENT BackgroundThe National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives.The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the 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 development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support tough Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded tough an award to the PI; other research services are provided without cost to the PI tough NIH contracts.PurposeThe purpose of this requirement is to procure consultant services to provide technical recommendations to the NIH Blueprint Neurotherapeutics Network drug discovery and development programs in the area of Drug Metabolism and Pharmacokinetics [DMPK].Project RequirementsIndependently 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 below.The Contractor shall provide this support while serving on NIH BPN Lead Development Teams. Lead Development Teams (LDT) meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between tee and ten hours weekly, inclusive of meeting and preparation time.The Contractor is expected to provide support services in a collaborative way. Lead Development Teams the Contractor is assigned to may work on a number of projects in the exploratory tough preclinical safety stages. Some projects may proceed to investigational new drug and clinical trial stages.The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network as follows:• Evaluate pharmacokinetics study protocols and data to identify potential drug discovery and development challenges. Recommend strategies to address these challenges.• Develop plans to assist NIH BPN staff in strategically managing pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies.• Assist NIH BPN staff to design investigative pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports are needed.• Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.• Analyze and interpret data for pharmacokinetics drug discovery, development, and translational projects.Level of EffortThe estimated level of effort for this requirement is one (1) contractor employee on a part-time basis.The required level of effort varies depending on the quantity and complexity of BPN projects at any given time. Accordingly, a minimum and maximum level of effort is anticipated. A minimum of 200 hours and a maximum of 800 hours of support is required annually. Hours above the annual minimum shall be exercised in increments of 20 hours, if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.Government Furnished Information/PropertyNo 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 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 permission 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 a life or physical science discipline• 15 years of experience in pharmacokinetics and drug metabolism of small molecules• 10 years of experience providing drug metabolism and pharmacokinetics consulting services in support of small molecule drug discovery.• Experience leading drug development teams from discovery tough clinical trials for at least one drug.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.pdf6. 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.aspx8. 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 tee of the following types of characters:a. capital lettersb. lower case lettersc. numeric charactersd. 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 PerformanceThe required period of performance is a one-year base period from June 8, 2017 tough June 7, 2018 and four (4) subsequent one-year option periods.Place of PerformanceThe 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 or facilities of selected principal investigators in the continental United States on an as needed basis.Contract TypeA Firm Fixed Price Contract 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 FORMATResponses 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 of each contract period. Options for increased quantity must also be detailed, as in the example below. A summary of the whole contract price should all options be exercised must also be included. Exampe for Base Period Pricing:Base Period:Hourly Rate - $0.00 Hours - XXX Extended Price - $0.00Base Period Options for Increased Quantity: Hourly Rate -- $0.00 Hours Per Option - XXX Extended Price per Option for Increased Quantity - $0.00Contractors 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 CRITERIAThe 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 Professional Experience in Drug Discovery and Development Key personnel proposed shall be evaluated for length and breadth of demonstrated leadership experience in drug discovery and development projects related to drug metabolism and pharmacokinetics.Leadership experience in executing and managing drug discovery and development tasks, particularly for nervous system conditions, shall be evaluated. Broad experience across the entire drug discovery and development process from discovery to clinical trials shall be considered favorably.Key personnel professional experience shall also be evaluated for preparation of successful investigational new drug applications, as well as publications, patents, and work on drugs brought to market. In addition, experience showing use of expertise to identify or anticipate problems early, overcome technical or regulatory difficulties, distill complex situations, or demonstrate strong risk-assessment ability to make wise use of limited resources shall be considered favorably.Finally, key personnel professional experience shall be evaluated for efforts involving compliance and familiarity with regulatory procedures and guidelines relevant to small molecule drug discovery development, especially for nervous system indications.Factor 2: Key Personnel Education & QualificationsKey personnel proposed shall be evaluated for conformance to the key personnel qualifications identified in the statement of work as well as for additional education and certifications related to the statement of work requirements. Advanced education and board certifications, as well as other evidence of advanced expertise applicable to drug metabolism and pharmacokinetics shall be considered favorably.Factor 3: Key Personnel Collaborative Team ExperienceKey personnel proposed shall be evaluated for length and breadth of experience collaborating with multi-disciplinary teams, especially teams with members from outside organizations and members at various management levels. Experiences such as team leadership, consulting, or service on strategic and advisory boards shall be considered favorably.Factor 4: Past PerformanceThe 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 Organizationb. Brief Description of Contractor's Responsibilitiesc. Point of Contact Name, Title, and Telephone NumberPast Performance shall be evaluated for relevance to the current requirement as well as customer satisfaction in reference to the following:1) Interpersonal skills2) Attention to detail3) Computer and software literacy4) Writing, Communication, and Presentation SkillsAPPLICABLE CLAUSES AND PROVISIONSThe 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. 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006)b. 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015)c. 52.204-14, Service Contract Reporting Requirements (Jan 2014)d. 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015)e. 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013f. 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011)g. 52.219-8, Utilization of Small Business Concerns (Oct 2014)h. 52.219-13, Notice of Set-Aside of Orders (Nov 2011i. 52.219-14, Limitations on Subcontracting (Nov 2011)j. 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013)k. 52.222-3, Convict Labor (June 2003l. 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016)m. 52.222-21, Prohibition of Segregated Facilities (Apr 2015)n. 52.222-26, Equal Opportunity (Apr 2015)o. 52.222-35, Equal Opportunity for Veterans (Oct 2015)p. 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014)q. 52.222-37, Employment Reports on Veterans (FEB 2016)r. 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)s. 52.222-50, Combating Trafficking in Persons (Mar 2015)t. 52.222-54, Employment Eligibility Verification (OCT 2015)u. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011v. 52.225-13, Restrictions on Certain Foreign Purchases (June 2008)w. 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013)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 REPRESENTATIVEA 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 INFORMATIONResponses 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-17-094. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.
HHS-NIH-NIDA-SSSA-CSS-17-094 Department of Health and Human Services National Institutes of Health
12/16/16, 11:12 AM