Sole Source Justification_Redacted.pdf

extramural research activities and establish a trans-NIH Cannabinoid Working Group.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Part-Time Consultant for the NCCIH Cannabinoid Working Group

b. Project description. See attached SOW

Requirement type.

Support services (non-R&D)

Type of action.

New requirement

Proposed contract/order type. Check all that apply:

Other (specify): Fixed price with a cost reimbursement line for travel

Acquisition identification number. RFQ HHS-NIH-NCI-TSB-

0504HHS

c. Total estimated dollar value and performance/delivery period.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under FAR 13.106-1 (b)(1)(i)

(b) Soliciting from a single source.

(1) For purchases not exceeding the simplified acquisition threshold.

(i) Contracting officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s). Dr. Steven Gust, 8615 Lochaven Drive, Gaithersburg, MD 20882

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). As the work expands and the workgroup works with other NIH Institutes, Centers and Offices, the group needs someone with extensive experience in managing and promoting cannabinoid research.

Someone who has a broad perspective on cannabinoid research from regulatory requirements to available resources to a broad appreciation of the research gaps, particularly with regard to studying the therapeutic potential of cannabinoids. Dr. Gust brings a unique set of skills regarding knowledge of cannabis pharmacodynamics pharmacokinetics and therapeutics in addition to the federal and state regulatory requirements affecting cannabis research gained over his 35+ years in government service at the National Institutes of Health. He has served as a subject matter expert on cannabis, its pharmacological and behavioral effects, for 30 years while at the National Institute on Drug Abuse (NIDA). In addition, he has similar experience working with the DEA and FDA on the various regulatory requirements for cannabis research on behalf of the Institute and its researchers. This combination of scientific and regulatory knowledge and experience make him uniquely qualified to assist with NCCIH in its efforts to expand research on the potential therapeutic benefits of cannabinoids and cannabis constituents. To our knowledge, there are no other candidates with the combined experience and knowledge.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. A SAM.gov Contracting Opportunities notice was published on 04 May 2022 as required by FAR Subpart

5.2. The notice was a combined Sources Sought and Presolicitation Notice with responses due on 19 May 2022. One response was received on 05 May 2022 from TK Education and Consulting Solutions PLLC. Per Program, the respondent cannot provide the required services. The respondent provides medical cannabis education. The Governments requires the services of someone who can help develop NIH research initiatives, and who understands the gaps in research and legal challenges associated with doing basic and clinical research related to the safety and efficacy of cannabinoids. The individual needs to know the NIH extramural procedures and policies for developing research initiatives. The response received from TK Education and Consulting Solutions LLC does not indicate that they are able to provide the services outlined in the SOW.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. The price will be determined to be fair and reasonable prior to award. It is anticipated that price reasonableness will be determined by comparing the quoted price to the Independent Government Cost Estimate.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

As noted above, a SAM.gov Contracting Opportunities notice (Combined Sources Sought and Pre-Solicitation Notice) was published as required by FAR Subpart 5.2. This notice afforded interested parties the chance to submit a capability statement. In addition, the AbilityOne Procurement List was searched for “consultant” services and no results were located.

9. Any other facts supporting the use of other than full and open competition.

Not Applicable

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. No other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. There are no plans to acquire the same type of service in the future beyond what is being requested in this acquisition.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.