# 2026-19646: OMB seeks info on making essential drugs closer to home

2026-19646, Request for Information; Domestic and Near Shore Manufacturing of Essential Medicines on the ASPR 86 List, is a Federal Register notice from Management and Budget Office published 2026-09-25, effective 2026-09-25; PRIA reads it as touching household money (as of 2026-10-02).

- Canonical: https://policyrisk.com/federal-register/2026-19646
- As of: 2026-10-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-19646
- Title: Request for Information; Domestic and Near Shore Manufacturing of Essential Medicines on the ASPR 86 List
- Type: Notice
- Agencies: Management and Budget Office
- Citation: 91 FR 60983
- Published: 2026-09-25
- Effective: 2026-09-25
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-10-02

## In one line

OMB seeks info on making essential drugs closer to home

## 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.

## Abstract

The Office of Management and Budget (OMB) is conducting market research to identify new and unused (idle) domestic, U.S.-based, and near shore production capabilities for Finished Dose Forms (FDF), Active Pharmaceutical Ingredients (API), and Key Starting Materials (KSM) associated with the Administration for Strategic Preparedness and Response (ASPR) 86 list of essential medicines. Responses will be shared with federal agencies that have requirements for essential medicines or responsibilities for strengthening the domestic industrial base for essential generic pharmaceuticals.

## Effects PRIA read

- Manufacturers can be identified for federal contracts: benefit, medium. 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 inf…
- Access to federal spend data for qualified respondents: benefit, medium. 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.
- Deadline and electronic-only submission requirement: cost, low. 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: cost, low. 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.
- Foreign Entities of Concern cannot participate: cost, medium. 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.
- Schedule II and branded drugs are not priorities: cost, low. 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.
- Specific request includes two antibiotics: benefit, medium. 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: benefit, medium. 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.

## Related documents

- [2026-19160](https://policyrisk.com/federal-register/2026-19160): Federal Acquisition Regulation: Revolutionary Federal Acquisition Regulation Overhaul Parts 16, 17, and 35, 2026-09-18
- [2026-20270](https://policyrisk.com/federal-register/2026-20270): Information Collection; Presolicitation Notice and Response, 2026-10-02
- [2026-20271](https://policyrisk.com/federal-register/2026-20271): Information Collection; Federal Acquisition Regulation Part 11 Requirements, 2026-10-02
- [2026-20128](https://policyrisk.com/federal-register/2026-20128): Submission for OMB Review; Preaward Survey Forms (Standard Forms 1403, 1404, 1405, 1406, 1407, and 1408), 2026-10-01
- [2026-20127](https://policyrisk.com/federal-register/2026-20127): Submission for OMB Review; Acquisition 360 Voluntary Survey, 2026-10-01
- [2026-20126](https://policyrisk.com/federal-register/2026-20126): Submission for OMB Review; Certain Federal Acquisition Regulation Part 28 Requirements, 2026-10-01

## Sources
- [2026-19646 on federalregister.gov](https://www.federalregister.gov/documents/2026/09/25/2026-19646/request-for-information-domestic-and-near-shore-manufacturing-of-essential-medicines-on-the-aspr-86)
- [2026-19646 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-09-25/pdf/2026-19646.pdf)

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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-19646 (as of 2026-10-02).
