JA.UMD.07.17.2019_.docx

National Institute of Nursing Research (NINR) Justification and Approval for Sole Source (J&A)

Justification and Approval for Sole Source

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS/NIH/OD/OLAO

b. Sponsoring organization. NIH/NINR

c. Project Officer information.

· Project Officer name. Marisa Sheelor

· Mailing address.

9000 Rockville Pike Bldg. 31, Room 5B13D Bethesda, MD 20892

· E-mail address. Marisa.Sheelor@nih.gov

· Telephone number. 301-594-2132

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The services provided are imperative for Dr. Joseph’s program of research focused on sensory biology. Dr. Dorsey’s lab at University of Maryland (UMD) has the expertise developing several mouse models including for chronic pain following nerve injury, opioid use disorder, and mice with both chronic pain and opioid use disorder. Dr. Dorsey generated this unique murine model and they are not commercially available. The goal is to understand the fundamental molecular, behavioral, and neural mechanisms associated with pain and OUD. These goals support the NIH mission in fostering fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving human health globally.

b. Project background.

The NINR is one of the 27 Institutes that comprise the National Institutes of Health (NIH). The mission of NINR is to promote and improve the health of individuals, families, communities, and populations. NINR supports and conducts clinical and basic research and research training on health and illness across the lifespan. The research focus encompasses health promotion and disease prevention, quality of life, health disparities, and end-of-life.

Mapping gene expression to distinguish opioid use disorder from chronic pain uses existing mechanistic insight into the potential factors that contribute to susceptibility to develop opioid use disorder and/or chronic pain. Many of these factors are sociodemographic in nature or are subjective and fail to replicate across studies. Thus, there is an urgent unmet need to identify the mechanisms that confer susceptibility to, or resilience against, the development of each in isolation and, the chronic pain patient with concomitant opioid use disorder.

The main goal of this collaboration between NIH investigators and Dr. Dorsey’s laboratory and the University of Maryland is to gain mechanistic insight into the genes/biological pathways that are activated or repressed in response to chronic opioid use, chronic pain, and the combination of opioid use and chronic pain. Results could be used to develop biomarkers of opioid use disorder, chronic pain, or the combination. In addition, new therapeutic targets may be identified.

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

Project title. Sensing: Mapping gene expression networks that distinguish opioid use disorder from chronic pain.

Project description.

This work has four components. (1) Creation of testing materials, (2) the ascertainment and testing of experimental subjects, (3) the collection of saliva samples for evaluation of genotype, and (4) data engineering and analysis.

· Requirement type.

X Research & development (R&D)

· Type of action.

X New requirement

· Proposed contract/order type.

X Firm-fixed-price

· Acquisition identification number.

HHS-NIH-OD-OLAO-SS-19-006

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

(INTERNAL USE ONLY)

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

X This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(_1_) as set forth in Federal Acquisition Regulation (FAR) 6.302- _1_.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

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).

University fo Maryland School of Nursing 655 W Lombard St Baltimore, MD 21201

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Dr. Dorsey at UMD generated this unique murine model and they are not commercially available. This lab has unique resources, unavailable at NINR, to generate the mouse models, perform the behavioral phenotyping, and examine the gene expression profiles from tissues and perform RNA sequence analysis.

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 Notice of Intent to Sole Source will be posted in the Federal Business Opportunities website.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Contracting Officer intends to award based on the best value to the Government.

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.

Only Dr. Dorsey’s lab at the University of Maryland School of Nursing can provide the unique mice for this project. While there are a number of preclinical pain laboratories in the US that we could potentially work with on this project, in order to ensure consistency of these sequencing results and behavioral data with prior studies by this group (Dorsey lab at UMD), UMD require the mice to undergo the surgery, testing, tissue harvest and analysis in the same environment, conducted by the same personnel. This group has a long history of rigorous scientific studies of mice, including the strains of mice that we plan to use (C57BL/6J from Jackson laboratories, trkB.T1 CRE mice generated and bred by the Dorsey lab [not commercially available]).

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

The trkB.T1 CRE mice were generated by Dr. Dorsey and published (Dorsey et al., 2006 Neuron, 51, 21-28). Her lab maintains and breeds/genotypes this murine line of mice. They were the first to publish a pain phenotype in these mice, comparing them with the wildtype background strain (C57BL/6J), including the following papers (Renn et al., 2009 Molecular Pain, 5: 61; Wu et al., 2013 J Neurosci 33, 12447-12463; Matyas et al., 2017 J Neurosci 37, 3956-3971). Indeed, the Dorsey lab is the only lab to phenotype pain in trkB.T1 mice compared with C57BL/6J mice, thus they have the experience to conduct the proposed study. This group has been conducting nocifensive (pain) testing in mice since 2004.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Only UMD provides specific sequencing result and behavioral data that are home grown in Dr. Dorsey’s lab. Work on this project will ensure consistency and maintain the integrity of the research. Therefore, no other contractor can provide this service.

There are other laboratories in the US that use mice in pain research, but the trkB.T1 CRE comparison with C57BL/6J is not being performed in any other lab in the US that UMD are aware of. In terms of the RNA sequencing, there are both academic and commercial sources of RNA sequencing; of which, the Institute for Genome Sciences Genomics Research Core (GRC) is one of the preeminent groups. We require the use of UMD and the GRC for this study in order to be consistent with prior RNA sequencing studies in trkB.T1 CRE and C57BL/6J mice that the Dorsey lab has conducted. Use of the same facility and sequencing platform, including the same personnel who extract the RNA, perform quality checks and prepare the sequencing libraries will ensure that we do not experience a “batch effect” due to site of sequencing and not due to biological variation. Use of the UMD GRC will enable us to compare the new results with prior results in these same murine strains in different pain models (e.g., chemotherapy, inflammatory). Finally, we will be working with an internationally renowned laboratory, Dr. Todd Gould’s lab, at UMD. He is a neuropharmacologist, expert in drug abuse, and importantly for this project, has significant expertise in mice behavioral analysis for mood and anxiety and his lab has specialized equipment for the conditioning and opioid experiments proposed in this study. He has published two textbooks on mood and anxiety behavioral testing in mice (Gould TD Mood and Anxiety related phenotypes in mice Characterization using behavioral tests Vol 1 and Vol 2 Springer protocols 2009 and 2011).

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.

Only Dr. Dorsey’s lab at UMD possess the unique, non-commercial resource with the trkB.T1 CRE mice, significant expertise with mouse behavioral testing for both pain and mood/drug use and RNA sequencing facilities. As outlined above, not only does the group at UMD have significant expertise, as reflected in the publication of high impact papers and textbooks, but they have conducted this type of work in the past. Thus, only UMD can directly compare our results with their prior results if we utilize the same environment, testing apparatus, personnel and sequencing platform. To outsource this work to another contractor could result in “batch effects”, whereby the results are due to the site of testing or the platform used and not due to biological variation. Only Dr. Dorsey’s lab at UMD can ensure consistency with prior work.