Notice2026-19646
Request for Information; Domestic and Near Shore Manufacturing of Essential Medicines on the ASPR 86 List
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 25, 2026
Issuing agencies
Management and Budget Office
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.
Full Text
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<title>Federal Register, Volume 91 Issue 185 (Friday, September 25, 2026)</title>
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[Federal Register Volume 91, Number 185 (Friday, September 25, 2026)]
[Notices]
[Pages 60983-60987]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19646]
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OFFICE OF MANAGEMENT AND BUDGET
Request for Information; Domestic and Near Shore Manufacturing of
Essential Medicines on the ASPR 86 List
AGENCY: Office of Management and Budget.
ACTION: Request for information.
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SUMMARY: 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.
DATES: Responses to this request for information will be accepted for
consideration until October 26, 2026.
[[Page 60984]]
ADDRESSES: Responses must be submitted electronically through
<a href="http://regulations.gov">regulations.gov</a>. Mailed paper submissions will not be accepted, and
electronic submissions received after the deadline may not be
considered.
Instructions: Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>
search ``Domestic and Near Shore Manufacturing of Essential Medicines
RFI'' to submit your comments electronically. Information on how to use
Regulations.gov, including instructions for accessing agency documents,
submitting comments, and viewing the docket, is available on the site
under ``FAQ'' (<a href="https://www.regulations.gov/faq">https://www.regulations.gov/faq</a>). Should you choose to
include proprietary information or confidential business information in
your submission, please ensure you use appropriate markings and
handling instructions to alert OMB as to the nature of information
being submitted and maintain proper handling. Your response will be
shared with other Federal agencies and entities.
Privacy Act Statement: OMB is issuing this request for information
(RFI) pursuant to its authorities under 31 U.S.C. 501 et seq. Comments
and commenter information are maintained under the OMB Public Input
System of Records, OMB/INPUT/01. The system of records notice
accessible at 88 FR 20913 (<a href="https://www.federalregister.gov/documents/2023/04/07/2023-07452/privacy-act-of-1974-system-of-records">https://www.federalregister.gov/documents/2023/04/07/2023-07452/privacy-act-of-1974-system-of-records</a>) includes a
list of routine uses associated with the collection of this
information.
Disclaimer: Participation in this RFI is strictly voluntary. OMB
will use your feedback to inform sound decision-making on topics
related to this RFI regarding potential government-wide actions to
revitalize the domestic manufacturing base, create new opportunities
for U.S. firms and workers, and position U.S. businesses to compete and
lead globally in strategic industries. This announcement should not be
construed as a commitment of any kind by the U.S. Government. The U.S.
Government is in no way liable to pay for or reimburse any companies or
entities that respond to this announcement. Nothing in this
announcement constitutes an obligation on the part of the U.S.
Government. A response to this RFI will not be viewed as a binding
commitment to develop or pursue the project or ideas discussed.
FOR FURTHER INFORMATION CONTACT: Please direct questions regarding this
Notice to Robert Orr, Deputy to the Associate Director of Economic
Policy, Office of Management and Budget, tel: 202-395-1390, or email
the Made in America Office at <a href="/cdn-cgi/l/email-protection#1f527e7b7a56715e727a6d767c7e5f70727d317a706f31787069"><span class="__cf_email__" data-cfemail="a1ecc0c5c4e8cfe0ccc4d3c8c2c0e1ceccc38fc4ced18fc6ced7">[email protected]</span></a> with ``Domestic
and Near Shore Manufacturing of Essential Medicines on the ASPR 86
List'' in the subject line.
SUPPLEMENTARY INFORMATION:
1. Executive Summary
OMB is conducting market research to identify new and idle
domestic, U.S.-based, and near shore production capabilities for FDF,
APIs, and KSMs associated with the ASPR 86 list of essential medicines.
The list is provided as an attachment to this RFI. OMB is also seeking
equivalent information on the following antibiotics which are not on
the ASPR 86 list: Amoxicillin and Ciprofloxacin, due to potential
supply chain vulnerabilities. This RFI is open to participation from
all entities that are not Foreign Entities of Concern (FEOC). For
purposes of this RFI, FEOC means a person owned by, controlled by, or
subject to the jurisdiction or direction of a government of China,
Russia, Iran, or North Korea.
Information is requested from qualified manufacturers within the
pharmaceutical, chemical, and petrochemical sectors. 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. Feedback may be used to
help inform near-term federal acquisition efforts (both enterprise and
government-wide), which might include limiting competition for a
federal contract to a particular source or sources to achieve
industrial mobilization, and related efforts to inform potential
sources of financial assistance.
2. Background
This RFI is driven by the urgent need to ensure domestic and near
shore production of pharmaceutical products for the American people as
a matter of national security. The initiative directly supports the
established objective to secure the domestic production of the
essential medicines, and their precursors, listed in the ASPR 86 list
in eighteen months. And to reduce or eliminate dependence on medicines
produced by FEOCs.
Most essential medicine APIs are not made domestically, leaving the
country vulnerable to foreign supply disruptions, especially from
adversarial nations. A majority of KSMs needed to produce generic
medicines are not manufactured in the United States.
This RFI is seeks information both to optimize use of existing
domestic or near shore capacity and to better understand ongoing or
planned actions to create new domestic or near shore capacity for
essential generic pharmaceuticals on the ASPR 86 list. Schedule 2
Controlled substances and branded drugs on the ASPR 86 list are not
priorities for this RFI.
3. Statement of Need
The primary objective is to identify existing and new domestic,
U.S.-based or near shore production capabilities for FDFs, APIs, and
KSMs associated with the ASPR 86 list of essential medicines. We are
seeking information on all aspects of the manufacturing lifecycle, from
raw material sourcing to finished product. This information will be
used to shape federal policies, programs and potential partnerships to
re-shore production and eliminate supply chain risks.
4. Data Availability
To facilitate a comprehensive assessment of market opportunities to
leverage existing or new capabilities, the Government intends to
provide qualified respondents with access to historical federal spend
data related to the essential medicines categorized under the ASPR 86
list and a comprehensive list of associated APIs and KSMs. Access
protocols and confidentiality requirements for this data will be
distributed to interested parties upon request.
5. Feedback
a. Entity Overview
If your entity has idle capacity or is planning new capacity to
produce FDFs, APIs, or KSMs on the ASPR 86 list domestically or at a
near shore location, please provide the following information:
i. legal entity name.
ii. headquarters location.
iii. unique entity identifier, if registered in the System for
Award Management.
b. Feasibility Feedback--Idle Capacity
If your entity has idle capacity to produce FDFs, APIs, or KSMs on
the ASPR 86 list domestically or at a near shore location, please
provide and the following information, broken out by FDF, API, and KSM:
i. Identifier: Molecule name, description, national drug code.
ii. Manufacturing site: Location of existing site.
iii. Available capacity: Amount of current production, amount of
unused capacity and estimated timeline to reach full operational
capacity.
[[Page 60985]]
iv. Regulatory compliance: Current FDA registration status for each
molecule/NDC.
v. Technical capabilities: Confirmation of FDF, API, and KSM
synthesis or formulation capabilities relevant to the ASPR 86 list.
vi. Sourcing strategies: Supply chain mapping for upstream inputs,
including specific countries of origin.
vii. Required demand: Price per unit needed to operate at full
capacity.
viii. Financing: A description of financing that may be sought to
fill or increase production--debt, equity, offtake contract, other.
Reason for financing (e.g., restart cost, additional labor).
ix. Cost considerations: Industry perspectives on key cost drivers.
4.3. Feasibility Feedback--New Capacity
If your entity is actively planning to domestically produce FDFs,
APIs, or KSMs on the ASPR 86 list domestically or at a near shore
location, please provide the following information broken out by FDF,
API, and KSM:
i. Identifier: Molecule name, description, national drug code.
ii. Manufacturing site: Location of existing or planned site for
new production.
iii. Facility status: Identify if site is existing, brownfield, or
greenfield. If not existing, identify if funding has been secured for
construction and/or renovation.
iv. Anticipated capacity: Level of planned production.
v. Required demand: Level of demand and projected cost per unit
needed to produce the product and maintain long-term domestic
viability.
vi. Regulatory compliance: Current FDA registration status.
vii. Technical capabilities: Confirmation of FDF, API, and KSM
synthesis or formulation capabilities relevant to the ASPR 86 list.
viii. Sourcing strategies: Supply chain mapping for upstream
inputs, including specific countries of origin.
ix. Financing: A description of financing that may be sought to
establish new production--debt, equity, offtake contract, other. Reason
for financing (e.g., restart cost, additional labor).
x. Cost considerations: Industry perspectives on key cost drivers.
Michael Stumo,
Director, Made in America Office.
BILLING CODE 3110-01-P
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[FR Doc. 2026-19646 Filed 9-24-26; 8:45 am]
BILLING CODE 3110-01-C
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