Inactive
Notice ID:75N95021Q00316
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 avai...
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. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: 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 by supporting and making medical discoveries. The National Center for Advancing Translational Sciences (NCATS) is the only center at the NIH that focuses exclusively on all aspects of the translation of research with an innovative pipeline of treatment discoveries for all diseases. 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 ORDR’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 US, 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, Rare Diseases Act (RDA) of 2002] as a disease or condition that affects fewer than 200,000 people in the US. 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 US, 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 (US) 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. In order to better assess the healthcare utilization, diagnostic journey and clinical course, and cost/utilization impacts of rare diseases on patients and healthcare systems, NCATS ORDR is undertaking pilot assessments in order to develop methods to more accurately identify rare disease patients and assess the impacts (utilization and cost) of rare diseases on healthcare systems by leveraging large health databases and analytics support. Such efforts to gather, quantify, and delineate the data behind 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 ORDR 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. An initial set of fourteen representative rare diseases has been chosen to pilot these efforts and subsequently could be broadened to a larger set of rare diseases. Purpose and Objectives: The National Center for Advancing Translational Sciences (NCATS) Office of Rare Diseases Research (ORDR) is seeking research support services to enable the generation of independent analyses, computational tools, and methodologies on the prevalence, clinical course, cost, and utilization impact of patients with rare diseases, that leverage large healthcare systems databases and data sources. Project requirements: Generate independent analyses and analytics support to capture the prevalence, clinical course, and cost/utilization impact of rare diseases leveraging large healthcare databases. In addition, generate computational tools and generalizable methodologies that could be tested/used at various health care provision sites for more accurately identifying patients with a potential rare disease to shorten the diagnostic odyssey for rare disease patients. Organizations must demonstrate the following capabilities: Access to a large US healthcare system database(s), such as health insurance or hospital system databases that include a large and diverse population of US patients inclusive of pediatric and adult populations (no less than 100 million people), inpatient and outpatient data, and under both commercial and public health insurance. 3-5 years experience querying healthcare databases for a broad range of complex and rare medical conditions. Personnel consisting of a physician with Medical Doctor (MD) or Doctor of Osteopathic Medicine (DO) degree with additional training that includes medical expertise in both rare and common diseases to enable building and interpreting data queries in a broad range of rare and serious diseases. Expertise in generating computational analyses on healthcare systems databases in support of work to better understand the impact of rare diseases. In particular, analyses to: (1) establish 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 disease 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. Ability to generate computational tools and generalizable methodologies for publication that could be tested or used at various healthcare provision sites to improve the diagnostic accuracy and timeliness of diagnosis or rare disease patient identification (e.g., algorithms for identifying undiagnosed or misdiagnosed rare disease patients), and to quantify the impact of rare disease patients on healthcare systems. Experience publishing work. Anticipated period of performance: Award is anticipated in September 2021, with a one-year base period and one-year option period. Capability statement /information sought: Responses to this notice must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the service. Information regarding respondents’: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. All responses to this notice must be submitted electronically to Contracting Officer Mark McNally, mark.mcnally@nih.gov. Responses must be received by 10:00 AM, Eastern Time, July 30, 2021. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. 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 presolicitation 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).
