Cancer and autoimmunity data in an older adult population in the U.S.

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS 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 Acquisitions (OA) on behalf of the National Institute on Aging (NIA) intends to negotiate and award a purchase order without providing for full and open competition to Information Management Services, Inc for SEER-Medicare linked and non-linked files.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 518210 – Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services with Size Standard of $40 million.

STATUTORY AUTHORITY This acquisition is for a commercial item or service and is conducted under the authority of the FAR Subpart 13—Simplified Acquisition Procedures, U.S.C 41 §1901 Simplified acquisition procedures, the statutory authority of 41 USC § 3304 – Use of noncompetitive procedures.

REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2024-05, dated May 22, 2024. This acquisition is conducted under the procedures as prescribed in FAR subpart 13—Simplified Acquisition Procedures.

DESCRIPTION OF REQUIREMENT Project Title: Cancer and autoimmunity data in an older adult population in the U.S. Background Cancer is a major public health concern worldwide, characterized by dysregulation of the immune system. The overall incidence of cancer has been increasing over time, with cancer being most prevalent in older adults aged 65 or older.

According to cancer statistics, the lifetime probability of being diagnosed with cancer is 31.9%, with men and women experiencing a 24.3% probability during the 65-84 years period, respectively. Given this growing burden, it is imperative to understand the impact of cancer on the immune systems of these older individuals. While the immune response serves as an important defense mechanism against external elements, cancer cells can proliferate by evading immune surveillance.

Similarly, autoimmune diseases involve dysregulated immune responses but in different contexts; cancer involves uncontrolled proliferation of abnormal cells, while autoimmune diseases result from the immune system attacking healthy tissues. Recent research has revealed a potential bidirectional association between cancer and autoimmune diseases, suggesting that cancer may influence the development or exacerbation of autoimmune diseases and vice versa.

However, there is limited evidence regarding the quantitative assessment of cancer’s implications in autoimmune diseases, as previous studies have predominantly focused on the association between autoimmune diseases and the risk of cancer. In the context of cancer therapy, various treatments such as chemotherapy, radiation therapy, and immunotherapy are used to target cancer cells. However, several studies suggest that cancer therapy can increase the risk of autoimmune diseases.

For instance, hormone therapy and androgen deprivation therapy may elevate the risk of autoimmune diseases, including rheumatoid arthritis. Additionally, targeted cancer drugs have been associated with autoimmune thyroid disease and pulmonary alveolar proteinosis. Despite these findings, the studies are often limited to specific cancer types or small sample sizes.

Therefore, comprehensive studies, especially in the older adult population, are needed to assess the risk of autoimmune diseases in patients with cancer, providing insights into potential autoimmune diseases in these patients. Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment but can lead to immune-related adverse events (irAEs), highlighting the need to understand the risk of autoimmune diseases among ICI users compared to those receiving other cancer therapies.

Purpose and Objectives To investigate the risk of autoimmune diseases in patients with cancer compared to those without and to assess the risk of autoimmune diseases among immune checkpoint inhibitor (ICI) users compared to other cancer therapy users and to estimate the annual prevalence/incidence of autoimmune diseases in those groups. Period of Performance The government anticipates the award of a fixed price purchase order with a period of performance of 24 months after award.

Intended Source Information Management Services, Inc 3901 Calverton Blvd, Suite 200 Calverton, MD 20705 Project Description The contractor shall provide the SEER-Medicare linked database dataset requested by the government. The presence of medical conditions will be assessed using Medicare claims from the MedPar, NCH, and Outpatient files.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The essential characteristics of SEER-Medicare that limit the availability to a sole source are its unique and comprehensive linkage of cancer registry with Medicare claims data.

Only this suggested source can furnish the requirements, to the exclusion of other sources, because SEER-Medicare data provides an unparalleled resource for epidemiological research, offering detailed clinical, demographic, and treatment information for cancer patients across the United States. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include:

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 technical proposal must include CV information for proposed Key Personnel that meet the minimum requirements to perform the specified work as described above. It must include the Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size.

All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Karen Mahon, Contracting Officer, at e-mail address Karen.Mahon@nih.gov. The response must be received on or before June 25, 2024, 9:00 am, Eastern Daylight Time. “All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”