Membership with HL7

8/4/2022 Pre-solicitation Notice: Intent to Award a Sole-Source Contract Intended Source: Health Level Seven International, Inc 3300 Washtenaw Avenue, Suite 227 Ann Arbor, MI 48104 Estimated Value: $35,000.00 for a base period of 12 months with no options Description: Health Level Seven International, Inc (HL7) is a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. Membership with HL7 provides the FDA Data Standards Advisory Board active participation and votes on national data standards that impact FDA Data Standards across the agency. Membership ensures a unified approach to standards implementation within the FDA Capabilities and Requirements. HL7 Membership also provides cross-agency coordination for the FDA (and for the regulated industry) to address, collaborate, develop, and implement international data standards. The FDA requires HL7 membership to meet its mission required by law: • Section 745 of the Federal Food, Drug and Cosmetic Act (Added by FDASIA) - Requires submissions in electronic format • 21st Century Cures Act - Directs modernization of product review processes • Federal Open Data Policy (M-13-13) - The Executive Branch must make its non-confidential data publicly available in open format, using data standards, and machine-readable, Section 351 of the Public Health Service Act (electronic listing of certain biological products and registration of the manufacturing establishments for certain biological products). In accordance with FAR Part 13.106-1(b), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available to meet the government’s needs. For the reasons stated above, The Government intends to solicit and negotiate directly with HL7 and no solicitation will be issued. Product Service Code: R499 Support - Professional: Other NAICS Code: 813910 - Business Associations Set-Aside: No Set-Aside Used Agency: Department of Health and Human Services Office: Food and Drug Administration Contracting Office: Office of Acquisitions and Grants Services Primary Point of Contact: Robert Waite [email protected] Secondary Point of Contact: Roosevelt Walker [email protected]