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. ( printed 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.

( printed page 60986)

( printed page 60987)

91 FR 60983