Human dorsal root ganglia (hDRG) samples from normal donors

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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.
Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting).
Purpose and Objectives
The 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 National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its tremendously productive pipeline and is innovative in several ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in to ultimately translate basic science into real products and services that help improve people's lives.
This requirement is needed for research projects in support of the HEAL Initiative. This Initiative, launched by NIH in April of 2018, is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. This Initiative will build on extensive, well-established NIH research, including basic science of the complex neurological pathways involved in pain and addiction, implementation science to develop and test treatment models, and research to integrate behavioral interventions with Medication-Assisted Treatment (MAT) for opioid use disorder (OUD).
Project Requirements
NCATS seeks to purchase high-quality human dorsal root ganglia (hDRG) that is ethically-sourced from four normal (non-pain), consenting donors. These samples will enable NCATS scientists to develop new cell differentiation protocols for pluripotent stem cells. NCATS scientists are interested in deriving nociceptors/dorsal root ganglion from stem cells. In order to further characterize and compare these cells to their in-vivo counterparts, hDRG must be purchased for molecular characterization and establishing a new dataset that will be shared with the scientific community.
The entire requirement includes four complete sets of hDRG sample pairs (T1-S1), one set from each of four different donors, as listed below. However, due to the limited availability of complete sets, sources that can provide at least 12 pairs for each of the four different donors will be considered.
Complete Requirement
Donor 1: 18 pairs (T1-S1)
Donor 2: 18 pairs (T1-S1)
Donor 3: 18 pairs (T1-S1)
Donor 4: 18 pairs (T1-S1)
Required characteristics of the hDRG include:
I. The samples must be preserved using cryopreservation or RNAlater.
II. Cells and tissue samples must have minimal degradation and maintain cellular integrity, and be well-preserved in accordance with the preservation requirement discussed in Paragraph I.
III. The quality of the cultures must be demonstrated in recent studies and publications reporting the physiological activity of human neurons isolated from these DRG samples.
IV. The hDRG must be ethically-sourced from fully consented organ donors and treated with the utmost respect and dignity. The vendor must partner with one or more transplant centers to facilitate the recovery of biological material, and each transplant center must be subject to one or more forms of Federal oversight including: Informed Consent, Donor Screening, Medical/Social History, Medical Chart Review, Physical Examination, and Infectious Disease Testing. In each case, informed consent is provided either via first person consent (driver's license or other legally binding document) or from the donor's legal next of kin. Consent procedures utilized meet the standard guidelines concerning informed consent for organ donation for research in a "for profit" environment as established by industry practice and governed by the Uniform Anatomical Gift Act.
V. The vendor must provide demographic details, including sex, age, race, and BMI of the four donors. This information is anonymous and/or de-identified patient information as defined in the Health Insurance Portability and Accountability Act (HIPAA).
Delivery
Delivery shall occur within 6 weeks after receipt of order (ARO). Delivery shall be made to the address below, to the point of contact designated on the purchase order.
National Center for Advancing Translational Sciences (NCATS)
9800 Medical Center Drive
Rockville, MD 20850
Product must be delivered in domestic, temperature controlled, overnight shipping.
Required Information
All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code.
Submission Instructions and Due Date
Written capability statements must be submitted no later than 11:59AM Eastern Time on Wednesday, May 15, 2019 to the below Contracting Office Address, Attn: Kimberly Espinosa. Electronic capability statements will be accepted by the primary point of contact listed below.
Disclaimer and Important Notes
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in 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 a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality
No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)..