SOURCES SOUGHT
R -- Clinical Pharmacology Consulting Services Consulting Services
- Notice Date
- 11/17/2016
- Notice Type
- Sources Sought
- 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-SBSS-17-047
- Archive Date
- 12/13/2016
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Information/Sources Sought HHS-NIH-NIDA-SSSA-SBSS-17-047 Clinical Pharmacology Consulting Services Consulting Services Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, MD 20892, UNITED STATES. Introduction: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources, (2) whether they are small businesses; HUBZone small businesses, service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Background: The 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 and Objectives for the Procurement: 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. Key Personnel Requirements: 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 contractor employee working under this contract will be required to attend at least one in-person meeting at the NIH to discuss BPN project issues. Under this and other circumstances as needed, the consultant will 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. Anticipated Contract Type: A firm fixed price purchase order within the Simplified Acquisition threshold is anticipated. 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. Capability Statement: Contractors that believe they possess the ability to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The capability statement should include 1) the total number of employees, 2) documentation of ability to provide the required services, 3) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Contractors must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted to Lauren Phelps, Contract Specialist, via email at lauren.phelps@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government anticipates negotiation of a firm fixed price purchase order.
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