OMB seeks info on making essential drugs closer to home
Published Date: 9/25/2026
Notice
Summary
The Office of Management and Budget wants to find out which U.S. and nearby companies can make important medicines on the ASPR 86 list. They’re asking for info by October 26, 2026, to help boost local medicine production and keep us ready for health emergencies. This is a great chance for manufacturers to share their capabilities and possibly get involved in future government plans.
Analyzed Economic Effects
8 provisions identified: 4 benefits, 4 costs, 0 mixed.
Manufacturers can be identified for federal contracts
If your company makes finished drug forms, active ingredients, or key starting materials, you can submit information so federal agencies can find you. OMB says feedback may be used to inform near-term federal acquisition efforts, which might include limiting competition to particular sources or informing potential sources of financial assistance.
Access to federal spend data for qualified respondents
Qualified respondents can request access to historical federal spend data related to the ASPR 86 medicines and a list of associated APIs and KSMs. The government will provide access protocols and confidentiality requirements to interested parties.
Foreign Entities of Concern cannot participate
This RFI is open only to entities that are not Foreign Entities of Concern (FEOC). FEOC means a person owned by, controlled by, or subject to the jurisdiction or direction of the governments of China, Russia, Iran, or North Korea.
Specific request includes two antibiotics
In addition to the ASPR 86 list, OMB is requesting equivalent information on the antibiotics amoxicillin and ciprofloxacin due to potential supply chain vulnerabilities. Respondents can include data for these two molecules even though they are not on the ASPR 86 list.
18-month goal to secure domestic production
OMB states the initiative supports an objective to secure domestic production of the essential medicines and their precursors listed in ASPR 86 within eighteen months. The RFI seeks information to help achieve that timeline.
Deadline and electronic-only submission requirement
You must submit your response electronically through regulations.gov by October 26, 2026; mailed paper submissions will not be accepted and late electronic submissions may not be considered. Search 'Domestic and Near Shore Manufacturing of Essential Medicines RFI' on regulations.gov to submit.
Responses are voluntary and not paid
Participation in the RFI is voluntary and the U.S. Government will not pay or reimburse companies for responding. A response will not create any binding commitment by the Government.
Schedule II and branded drugs are not priorities
The RFI states that Schedule II controlled substances and branded drugs on the ASPR 86 list are not priorities for this effort. The RFI focuses on generic essential medicines, their APIs, and KSMs.
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