Nonmanufacturer Rule Applies to Procurements for Services
Client Alert | 1 min read | 09.25.14
In Rotech Healthcare Inc. v. U.S. (Sept. 19), the Court of Federal Claims enjoined the Department of Veterans Affairs from moving forward with a procurement for home oxygen supplies and services issued under a NAICS Code for services, finding that the solicitation violated the statutory "nonmanufacturer rule" (NMR)—a provision that requires nonmanufacturer recipients of small business set-aside contracts for products to provide the products of domestic small business manufacturers or processors. Relying on a 2006 CFC decision instead of a subsequent, unambiguous SBA regulation that limited the NMR to procurements assigned manufacturing or supply NAICS codes, the court explained that Congress intended the NMR to apply to mixed service and supply contracts irrespective of NAICS code.
Insights
Client Alert | 2 min read | 05.09.25
FDA Seeks Stakeholder Consultation on Prescription Drug User Fee Reauthorization
On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization.
Client Alert | 2 min read | 05.09.25
New SF-328 for Foreign Ownership, Control, and Influence Assessments Approved, Publication Imminent
Client Alert | 4 min read | 05.08.25
Client Alert | 4 min read | 05.07.25
