B.1 SOW - Cannabinoid Consultant.pdf

Draft Statement of Work (SOW)

A. GENERAL INFORMATION:

1. Title of Project: Part-Time Consultant for the NCCIH Cannabinoid Working

Group

2. Background Information:

The National Center for Complementary and Integrative Health (NCCIH) is the Federal Government’s lead agency for scientific research on complementary and integrative health approaches. The mission of NCCIH is to determine, through rigorous scientific investigation, the fundamental science, usefulness, and safety of complementary and integrative health approaches and their roles in improving health and health care.

The NCCIH supports rigorous scientific investigation of natural products such as the cannabis plant and its components and is looking to hire a contractor to provide consultation services to our Cannabinoid Working Group to assist with promoting the research, assisting outreach to the extramural research community and setting up a trans-National Institutes of Health (NIH) Cannabinoid Working Group. These activities will be advanced through multi-, inter-, and trans-disciplinary research efforts. To this end, NCCIH wishes to engage the activities of an individual with broad expertise in the cannabis and cannabinoid research field, with established contacts in that field, and with experience with NIH extramural program and procedures.

3. Purpose or Objective of the Requirement: The contractor will assist NCCIH in developing initiatives leading to expansion of the extramural cannabinoid/cannabis research portfolio.

4. Type of Contract Contemplated: Fixed-Firm Price with travel reimbursement in accordance with FAR 52.212-4 Alternate I

5. Period of Performance: 6 months from date of award with three option periods to extend for an additional 6 months each

B. CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

Support initiatives to expand NCCIH and trans- NIH supported extramural cannabinoid/cannabis research focused on potential therapeutic use, in the form of funding opportunity announcements, internal and external meetings and workshops, or other vehicles, which will require the following activities by the Contractor:

1. Contribution to the development of meeting agendas content, synthesizing relevant concepts and gaps and directions from internal meetings;

a. NCCIH internal cannabinoid working group meetings are held monthly. Planned trans NIH workgroup meetings will be quarterly, with an additional quarterly interim meeting on follow-up activities, for a total of 10 trans-NIH workgroup meetings. The contractor will be responsible for proposing and assisting with agenda items for these meetings, for making presentations on areas of expertise as required, and participating in NCCIH activities to address follow-up items and coordinating trans NIH topic specific meetings in follow-up to the quarterly workgroup meetings. Summaries of topics discussed, actions taken, needed follow-up items and recommendations to achieve proposed activities to address follow-up items will be provided for each meeting.

2. Assist in the organization and coordination of stakeholder meetings;

a. The contractor shall, at the direction of the COR, organize, plan, and coordinate approximately three meetings with outside experts and stakeholders, each six months on topics to be identified by the NCCIH cannabinoid working group and/or the trans NIH working group. Such meetings will address outstanding issues related to developing research initiatives on the potential medical benefits of cannabis derived compounds (e.g., cannabinoids and terpenes). Potential topics include but are not limited to: manufacture and supply of cannabinoids for research. Issues related to human use of new chemical agents, regulatory concerns regarding patient use and possession of such compounds, identification of areas of research appropriate for NCCIH or trans NIH support, coordination of NIH activities with non-government organizations, establishing communication with key government and non-government organizations relevant to the NCCIH mission, such as the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), the Department of Veterans Affairs (VA), the Centers for Disease Control and Prevention (CDC), state research programs, etc.

3. Assist in the writing of funding initiatives that arise from such meetings and from related efforts;

a. The contractor shall be responsible for assisting in the drafting of funding initiatives such as requests for applications (RFAs), program announcements (Pas), and notices of special interest (NOSIs) that will be supported by multiple NIH Institutes and Centers. Initially it is expected that there will be at least two such trans NIH activities in the first six-month period. Work shall include drafting of language, soliciting comments from other Institutes and Centers (ICs), incorporating comments as appropriate, recommending funding mechanisms to achieve goals of collaborations, and leading discussions and negotiations to achieve consensus.

4. Serve as a liaison to the NIH Institutes and key external stakeholder to support interest and action as needed in the development of grant -funding initiatives.

a. The contractor shall be a point of contact (POC) during the development of NIH initiatives and will be involved in establishing contacts in relevant ICs on each initiative, maintaining clear, frequent, and goal-oriented communications, and obtaining consensus among the ICs on specific initiatives. For activities involving external stakeholders, the contractor will identify key personnel, engaging with them on topics of relevance, and as appropriate, bringing their input to the NCCIH and trans-NIH working groups.

C. GOVERNMENT RESPONSIBILITIES:

NCCIH will provide the contractor with a laptop computer, NIH ID, email, and phone number to conduct the work. Work may be performed remotely with possible occasional in-person meetings. All work under this professional service contract shall be monitored by an NCCIH Project Officer.

D. DELIVERY OR DELIVERABLES:

1. Description of Tasks and Associated Deliverables:

The contractor will provide written documents consisting of agendas for meetings and assemble and deliver PowerPoint presentations at meetings and workshops.

The contractor shall provide written recommendations for initiatives and contribute to written reports, meeting summaries and funding opportunity announcements and other related documents. The timeline and date of deliverables will be specified by NCCIH.

2. Reporting Requirements

The contractor is required to provide written progress reports every 30 business days for the duration of the project period. The progress report shall cover all work completed during the specified period and shall present the work to be accomplished during the subsequent period. This report shall also identify any problems that arose and a statement explaining how the problem was resolved.

This report shall also identify any problems that have arisen but have not been completely resolved and provide an explanation.

E. TRAVEL:

Local travel expenses for travel to and from NIH for in person meetings will be reimbursed to the contractor. Travel and per diem expenses for the contractor to attend up to two meetings on cannabinoid/cannabis research, subject to NCCIH approval, will be an option available for NCCIH to exercise should the need arise.

F. CONTRACTOR EXPERIENCE REQUIREMENTS – KEY PERSONNEL:

1. The contractor must have NIH 15 years program experience and an understanding of the NIH Institutes and Centers and their extramural programs.

The contractor must have at least 15 years of NIH program experience with the cannabis/cannabinoids research field. The experience requirements would be minimums to provide the depth of knowledge and experience needed to successfully and effectively accomplish the tasks described. There have been significant changes in cannabis policy and research over the last 15 years and experiential knowledge of these changes is deemed essential for this project. In addition, the 15-year experience requirement for NIH programs is deemed essential in order to assure that an adequate knowledge base exists in order to effectively advise and consult with external stakeholders on the complex NIH research grant policy for developing and NIH pragma initiatives

G. CONTRACTING OFFICER'S REPRESENTATIVE (COR):

1. The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

Name: Katie Howes Address: National Center for Complementary and Integrative Health 6707 Democracy Blvd, Suite 401 Bethesda, MD 20871 Telephone Number: (301) 922-6787 E-mail address: katie.howes@nih.gov

2. 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.

3. 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

4. The Government may unilaterally change the COR designation for this contract mailto:katie.howes@nih.gov