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IR&D Reporting Requirements Reinstated

Client Alert | 1 min read | 01.30.12

In a final rule published today, the DFARS were amended to reinstate a requirement that was eliminated from the regulations in the early 1990s, providing that as a condition of allowability for Independent Research and Development (IR&D) costs, major contractors must submit to DoD at least annually technical descriptions of the IR&D projects that the contractor claims as allowable. In response to criticism of a draft regulation proposing a $50,000 coverage threshold, the final rule limits mandatory reporting to “major contractors” that allocate more than $11 million annually to “covered contracts” (a term that excludes fixed-price contracts without cost incentives), leaves largely to the contractor’s discretion how much detail needs to be reported in the on-line template through which the reports must be submitted, encourages voluntary reporting by contractors not subject to the mandatory requirement, and promises that the reports will be exempt from disclosure under the Freedom of Information Act.

Insights

Client Alert | 15 min read | 08.20.25

The New EU “Pharma Package”: Interplay with the Critical Medicines Act and other shortage initiatives

In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation. Our last alert looked at how the Pharma Package seeks to address these issues. However, the Pharma Package does not exist in isolation, and in this alert we will discuss the interplay between its measures and those contained in other important EU initiatives such as the proposed Critical Medicines Act (CMA), and the Medicinal Countermeasures Strategy and the EU Stockpiling Strategy....