(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 75N95024R00121 and the solicitation is issued as a request for proposal (RFP).
This acquisition is for a commercial item or service 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 threshold.
THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).
The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to the Eversana Life Sciences, LLC 17877 Chesterfield Airport Road Chesterfield, MO 63005-1211 for research support services.
This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).
(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-06, with effective date May 26, 2022.
(iv) The associated NAICS code 541690 Other Scientific and Technical Consulting Services and the small business size standard of $19 Million. There are no set-aside restrictions for this requirement.
(v) The National Center for Advancing Translational Sciences (NCATS) Division of Rare Diseases Research Innovation (DRDRI) is seeking support services from EVERSANA to enable the generation of independent analyses, computational tools, and methodologies to facilitate earlier and more accurate identification of rare disease patients. These services will build on previous DRDRI IDeaS efforts done in collaboration with EVERSANA that detailed the prevalence, clinical course, cost, and utilization impact of patients with rare diseases. This next iteration of the IDeaS pilot initiative intends to use the results of the initial pilot study to inform methods for clinical decision support tools to alert clinicians to possible cases of rare diseases. NCATS DRDRI seeks to identify utilization patterns prior to accurate diagnosis and estimate costs of medical care during the diagnostic odyssey, with the larger goal of using this information to inform the development of approaches to diagnose and identify rare disease patients sooner, while improving overall patient care management.
(vi) The mission of The National Center for Advancing Translational Sciences (NCATS) is to catalyze the generation of innovative methods and technology that will enhance the development testing and implementation of diagnostics and therapeutics across a wide range of human disease and conditions. NCATS’ mission is to improve health through smarter science that results in better treatments faster for all diseases, rare or common. Within that remit, the NCATS DRDRI’s mission is to advance rare disease research to benefit patients. Currently, there are about 7,000-10,000 known rare diseases that affect people in the United States, yet only a few hundred (less than 5%) have a treatment and even fewer a cure. A rare disease is defined in US law (Orphan Drug Act (ODA) of 1983,1 Rare Diseases Act (RDA) of 2002)2 as a disease or condition that affects fewer than 200,000 people in the United States. Most rare diseases affect far fewer patients than this, with most rare diseases affecting only a few hundreds to thousands of patients.
Collectively, however, rare diseases are not rare at all, and in total are estimated to affect as many as 25-30 million patients in the United States, making rare diseases a large public health consideration.
Given the large number of different rare diseases, each of which affects only a small number of patients, assessing the true impact of rare diseases on healthcare systems in the United States is challenging. Many patients with rare diseases have difficulty obtaining a timely and accurate diagnosis (referred to as the diagnostic odyssey) and there is a lack of data regarding the likely and relatively large number of patients, who have not yet received a rare disease diagnosis.
Additionally, International Classification of Disease (ICD) codes largely do not exist for many rare diseases (>50%), leading to myriad downstream effects including difficulty in identifying rare disease patients within healthcare systems databases, imprecise coding of patients under larger “umbrella” (e.g., developmental delay) or “not elsewhere classified (NEC)” terms, poor tracking within databases, and fiscal invisibility given their fragmentation under 1,000s of different terms. This is particularly problematic for (1) characterizing the clinical course of rare disease patients, (2) quantifying (and alleviating) the cost of medical care for people with rare diseases (by disease and in aggregate), (3) and identifying undiagnosed or misdiagnosed rare disease patients.
NCATS DRDRI has performed several preliminary feasibility assessments of medical utilization in an initial set of fourteen representative rare diseases and assessed the impacts (utilization and cost) of rare diseases on healthcare systems by leveraging large health databases and analytics support. This next iteration of the IDeaS (Impact of Rare Diseases on Patients and Healthcare Systems) initiative intends to use the results of the initial pilot study to inform methods for clinical decision support tools to alert clinicians to possible cases of rare diseases.
These next steps to gather, quantify, and delineate the data for rare disease patients will not only accumulate much-needed rare disease knowledge and help to identify research gaps but will also advance both common and rare disease research, care, and segmentation associated with precision medicine. NCATS DRDRI seeks to identify utilization patterns prior to accurate diagnosis and estimate costs of medical care during the diagnostic odyssey, with the larger goal of using this information to inform the development of approaches to diagnose and identify rare disease patients sooner, while improving overall patient care management.
(vii) The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated period of performance is within 12 months after contractor receipt of order (ARO).
(viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html
(End of provision)
The following provisions apply to this acquisition and are incorporated by reference:
- FAR 52.204-7, System for Award Management (Oct 2018)
- FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)
- FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021)
- FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021)
- HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)
The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses:
https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html
(End of clause)
The following clauses apply to this acquisition and are incorporated by reference:
- FAR 52.204-13, System for Award Management Maintenance (Oct 2018)
- FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)
- FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021). Addendum to this FAR clause applies to this acquisition and is attached.
- HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015)
The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal.
- FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
- FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)
- FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2022)
- NIH Invoice and Payment Provisions (Feb 2021)
(ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:
a. Technical capability of the item offered to meet the Government requirement;
b. Price; and
c. Past performance [see FAR 13.106-2(b)(3)].
The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).
(x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.
(xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.
(xii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices.
DELIVERY OR DELIVERABLES
Contract Kickoff Meeting
The Contractor shall schedule and conduct a contract kickoff meeting with NCATS DRDRI staff within one (1) week of the contract award date. A contract kickoff meeting should include a detailed presentation of the contractor’s host data platform, previous experience with RDs, and proposed methodology to complete the below tasks. The Contractor shall develop and present an Analytics Plan for iterative results of the analyses under Task Area 1. The Analytics Plan should include a milestone timeline, detailing the types of analyses being completed by certain dates across the contract year.
Bi-Weekly Meetings
Beginning two (2) weeks after the contract kick-off meeting, the Contractor and appropriate NCATS DRDRI staff will meet on a bi-weekly basis, unless otherwise agreed upon, to share and iterate on results of the support activities performed during the previous two weeks. These bi- weekly meetings will alternate as sprint and detailed report meetings.
- Sprint Report Meetings: The contractor shall arrange, plan and conduct an hourly meeting on the second week of every month with NCATS IDeaS project staff to report on the work performed in the 2-week period prior to this meeting (i.e., since prior detailed report meeting). The contractor shall follow Agile recommendations for sprints, and the meeting shall include, but is not limited to, additional analyses performed, detailed descriptions of methodologies used and findings from these analyses, problems encountered in the analyses, and discussion with NCATS staff to overcome problems, identify areas of additional analysis, and context of where analyses fit within the overall intent of the project. Meeting materials for sprints are to include an agenda and Powerpoint or other slide representation of the findings and other materials to facilitate the discussion that will be prepared by the contractor and sent to the NCATS IDeaS team at least 1 day prior to the meeting and final version to follow within 2 days after the meeting.
- Detailed Report Meetings: This meeting shall be similar, but more detailed than the sprint meeting, and may include citations to any literature or other references and sources used. The contractor shall arrange, plan and conduct a one to two (1-2) hour meeting on the fourth week of every month with NCATS IDeaS project staff to provide a detailed report on the work performed in the 2-week period prior to this meeting (i.e., since prior sprint meeting). The meeting shall include, but is not limited to, a written description of additional analyses performed, detailed descriptions of methodologies used and findings from these analyses, problems encountered in the analyses, and discussion with NCATS staff to overcome problems, identify areas of additional analysis, and context of where analyses fit within the overall intent of the project. A Powerpoint or other slide format may be used to write and describe these results that will be shared with NCATS staff as a draft at least 1-day prior to the scheduled meeting, and final version to follow within 2 days after the meeting.
The Contractor shall present data analysis findings to NCATS DRDRI orally and through written presentations and summaries of the data in charts, tables and figures, where applicable. All iterative results shall be housed within an electronic system, in the Contractor’s environment, accessible to NCATS staff at all times to do further analysis and download (if necessary) to monitor progress.
Item Description/ Delivery/ Method/ Delivery Schedule
1
Analytics Plan
Electronically
to COR
Within 21 days of contract award
date
2
Monthly Sprint Meeting Report
Electronically
to COR
Monthly within 2 days of each
Sprint Meeting
3
Monthly Detailed Meeting Report
Electronically
to COR
Monthly within 2 days of each
Detailed Meeting
4
Annual Report
Electronically
to COR
Annually by the end date for
each contract year
5
Medical Publication
Electronically
to COR
Within 30 days after
identification of need by NCATS
Note: timely submission of deliverables is essential to successful completing this requirement. All deliverables are to be submitted in “electronic copy” form.
REPORTING REQUIREMENTS
All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."
1. Analytics Plan: Within 21 days after the contract award date, the Contractor shall develop and present an Analytics plan and plan for iterative results of the analyses, to generate: (1) better estimates of rare disease prevalence; (2) understand the clinical course of rare diseases, such as testing, treatments received, and interim diagnoses, among others, to improve understanding of the diagnostic odyssey and healthcare utilization for rare diseases; (3) quantify the cost and impact of rare diseases on the healthcare system and patients; and (4) perform additional analyses (such as subgroup analyses) that may be identified during the course of this work.
2. Monthly Sprint Meeting Report: Within 2 days after each meeting, the contractor shall provide the final version of the agenda and Powerpoint or other slide representation of the meeting’s findings and other materials.
3. Monthly Detailed Meeting Report: Within 2 days after each meeting, the contractor shall provide the final version of the agenda and Powerpoint or other slide representation of the meeting’s findings and other materials. Any relevant materials in suitable formats shall also be included, e.g., graphics/data tables, written descriptions of analyses conducted (e.g., Word), code/algorithms developed, etc.
4. Annual Report: Annual report on work conducted and work products. This detailed written annual report is to include all analyses conducted and findings from the detailed analyses conducted during the prior year, computational methods and algorithms generated, written summaries and publication quality figures generated from the analyses. Where applicable, comparison of the findings to existing medical literature, references and other publication sources relevant to the analyses are to be provided.
5. Medical Publication: In collaboration with NCATS Staff, the contractor shall draft and finalize up to four medical publications-quality documents related to the data analysis findings, inclusive of figures and tables (as needed) for submission to medical journals.
(xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.
(xiv) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.
The Unique Entity ID from SAM.gov, 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 quotations must be received by 9:00 AM, Eastern Daylight/ Standard Time, on September 3, 2024. and reference Solicitation Number 75N95024R00121. Responses must be submitted electronically to Kaitlyn Landi, Contract Specialist at Kaitlyn.landi@nih.govFax responses will not be accepted.
Attachments:
- Statement of Work
- FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
- FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
- Addendum to FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services.
- FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Products and Commercial Services (May 2024)
- Invoice and Payment Provisions
