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OMB reopens essential-medicine manufacturing responses through November 27, with online submissions required

2 min read

Fictional editorial illustration reused from the Hugin archive; pharmacy-work setting; not an identified manufacturing facility or evidence of medicine supply. Not documentary evidence.

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An OMB notice scheduled for Federal Register publication November 2 reopens an essential-medicine manufacturing inquiry through November 27. It seeks information about new and unused domestic and near-shore production capabilities associated with the ASPR 86 List. Responses must go through Regulations.gov; the notice is not a procurement promise, funding award or finding that production capacity has increased.

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The Office of Management and Budget is reopening responses to its inquiry about domestic and near-shore production capabilities for essential medicines until November 27, 2026. The notice is scheduled to be published in the Federal Register on November 2; its public-inspection copy already prints that response deadline.

What information OMB seeks

The inquiry concerns new and unused, or idle, production capabilities associated with the Administration for Strategic Preparedness and Response's 86 List of essential medicines. It covers finished-dose forms, active pharmaceutical ingredients and key starting materials.

OMB says the original request appeared September 25 and its response period closed October 26. The agency received requests to reopen the period and says the additional time will allow interested parties to prepare information and responses.

The reopening notice does not report how much usable capacity exists, identify a newly secured medicine supply or announce a manufacturing contract. It provides another opportunity to submit evidence about production capabilities.

Submit electronically

Responses must be submitted through Regulations.gov. The notice instructs readers to search for “Domestic and Near Shore Manufacturing of Essential Medicines RFI.” Mailed paper submissions will not be accepted, and electronic submissions received after the deadline may not be considered.

OMB says responses will be shared with other federal agencies and entities. Anyone choosing to include proprietary or confidential business information must use appropriate markings and handling instructions to alert OMB to that information's nature. That instruction should not be mistaken for a promise that an unmarked submission stays confidential.

Participation is voluntary

The notice says the government makes no commitment through the inquiry and is not liable to pay or reimburse respondents. A response also is not a binding commitment to pursue a proposed project or idea.

The agency issuing this reopening is OMB. ASPR supplies the essential-medicines list referenced in its subject; the notice is not a new HHS funding program.

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