Human dorsal root ganglia (hDRG) samples from four normal (non-pain) donors
(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95019Q00131 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5- Simplified Procedures for Certain Commercial Items; and FAR Part 12- Acquisition of Commercial Items, and is expected to exceed the simplified acquisition teshold. (iii) The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular 2019-02, effective June 5, 2019. (iv) The associated NAICS code is 621991 and the small business size standard is $32.5M. This requirement is full and open with no set aside restrictions. Description (v) The National Center for Advancing Translational Sciences (NCATS) at the National Institues of Health (NIH) seeks to purchase high-quality human dorsal root ganglia (hDRG) that is ethicallysourced 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. Quotations should also include the availability of singles when a pair is not available. 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 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). (vi) Delivery is to occur within six (6) weeks after receipt of order. Samples must be delivered in domestic, temperature controlled, overnight shipping. Delivery shall be made to the below address with FOB Destination, to the point of contact designated on the purchase order. National Center for the Advancement of Translational Sciences 9800 Medical Center Drive Rockville, MD 20850 (vii) The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. (viii) The Government plans to award a contract resulting from this solicitation. The resulting award will be made to the responsible offeror whose offer will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotations: Technical Capability, Past Performance, and Price. Comparative evaluations will be conducted. (ix) The anticipated award date is July 18, 2019. Provisions and Clauses (x) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998). This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at www.acquisition.gov. The following provisions apply to this acquisition and are incorporated by reference: The provision at FAR 52.204-7, System for Award Management (Oct 2018) The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul 2016) The provision at FAR 52.212-1, Instructions to Offerors - Commercial Items (Oct 2018) The provision at 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018) (xi) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at www.acquisition.gov. In addition to the clauses checked in FAR 52.212-5 (attached), the following clauses also apply to this acquisition and are incorporated by reference: The clause at FAR 52.204-13, System for Award Management Maintenance (Oct 2018) The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016) The clause at FAR 52.212-4, Contract Terms and Conditions - Commercial Items (Oct 2018) The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employement Opportunity Investigations (December 18, 2015) (xii) The following provisions and clauses apply to this acquisition and are attached in full text: Addendum to the clause at FAR 52.212-4, Contract Terms and Conditions - Commercial Items (Oct 2018) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (May 2019) NIH Invoice and Payment Provisions (2/2014) (xiii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. Post Award Evaluation of Contractor Performance (xv) Contractor performance evaluations: Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. The Final evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted fourteen days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions. (xvi) Electronic access to contractor performance evaluations: Contractors may access evaluations tough a secure Web site for review and comment at: http://www.cpars.gov. (xvii) Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, product or catalog number(s); product description; what the warranty covers; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. The Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received by 11:59am EDT on Monday, July 15, 2019, and reference solicitation number 75N95019Q00131. Responses must be submitted via email to Kimberly Espinosa, Contract Specialist, at kimberly.espinosa@nih.gov, with a copy to Jeff Schmidt, Contracting Officer, at Jeffrey.schmidt@nih.gov. (xviii) The name and telephone number of the individual to contact for information regarding the solicitation is Kimberly Espinosa, Contract Specialist, 301-827-3546, kimberly.espinosa@nih.gov. (xix) All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. 75N95019Q00131 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
7/1/19, 1:54 PM 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). 75N95019Q00131 Department of Health and Human Services National Institutes of Health
5/8/19, 4:10 PM