IBMSC Consortium RFI_FINAL.pdf

Type: Request for Information - IBMSC Resilient Industry and Supply Chain Enterprise (RISE) OTA Consortium NAICS Codes: 325412 - Pharmaceutical Preparation Manufacturing; 325413 - In-Vitro Diagnostic Substance Manufacturing; 339113 - Surgical Appliance and Supplies Manufacturing Object Class Code: 25230 Non-Federal Temporary Help Services

Place of Performance: HHS ASPR IBMSC

To: Prospective Partners & Interested Parties

The Center for Industrial Base Management and Supply Chain (IBMSC), Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is issuing this Request for Information (RFI) to collect feedback from current and potential pharmaceutical and biomanufacturing industry partners. Information collected from this RFI will serve as continued market research for the development of a possible program where IBMSC would partner with industry to achieve the pandemic preparedness goals set forth by the U.S. Government (USG).

Background: The Department of Health and Human Services (DHHS) is collaborating and engaging with other Federal agencies in a whole-of-Government activity to expand and sustain the domestic public health industrial base. These activities align with Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. The Executive Order specifies that “The United States must protect our citizens, critical infrastructure, military forces, and economy against outbreaks of emerging infectious diseases and chemical, biological, radiological, and nuclear (CBRN) threats. To achieve this, the United States must have a strong Public Health Industrial Base with resilient domestic supply chains for Essential Medicines, Medical Countermeasures, and Critical Inputs deemed necessary for the United States.”

This executive order is also directly tied to the Title III Presidential Determination 2024-03 under the Defense Production Act. This determination states that “(i) the essential medicines, medical countermeasures, and critical inputs referenced in subsection (b) of this section are industrial resources, materials, or critical technology items essential to the national defense;” and “(ii) without Presidential action under section 303 of the Act, United States industry cannot reasonably be expected to provide the capability for the needed industrial resources, materials, or critical technology items in a timely manner.”

These activities also align with Executive Order 14017, America’s Supply Chains. This Executive Order states, “The United States needs resilient, diverse, and secure supply chains to ensure our economic prosperity and national security. Pandemics and other biological threats, cyber-attacks, climate shocks and extreme weather events, terrorist attacks, geopolitical and economic competition, and other conditions can reduce critical manufacturing capacity and the availability and integrity of critical goods, products, and services. Resilient American supply chains will revitalize and rebuild domestic manufacturing capacity, maintain America's competitive edge in research and development, and create well-paying jobs.”

The subject of this RFI pertains to IBMSC’s ongoing endeavors to expand and sustain the public health industrial base for drug substances, drug products, personal protective equipment (PPE) and diagnostics.

Description: To transform and build core capabilities that will expand and sustain the domestic public health industrial base, IBMSC is contemplating consortia comprising industry partners across the drug, personal protective equipment (PPE) and diagnostic manufacturing supply chain, including the manufacturers of required raw material inputs and consumables, as well as suppliers of services. IBMSC is also interested in ushering in a new era of scalable manufacturing responses for patient safety built upon a secure digital infrastructure of medical product designs and a network of industry manufacturers ready to produce badly needed medical and pharmaceutical supplies during supply chain disruptions.

The consortia will establish the physical infrastructure, agile manufacturing platforms, and supply chains capable of producing key starting materials, drug substances, and various dosage forms of drug products, including performing fill/finish of drug products at population scale. The consortia will also establish the physical infrastructure for production of required raw materials, consumables, and diagnostic and PPE products to meet US market demands during the time of a declared public health emergency. The projects awarded under the Resilient Industry and Supply-Chain Enterprise (RISE) Consortium will develop solutions that vary from early to late stages of technological and manufacturing readiness.

Effective consortium management requires a substantial quantity of resources to standup, grow, and continuously engage with consortium members as well as handle the activities involved in individual solicitations, from announcement through award and execution. As such, IBMSC has a specific need to identify, review and establish a consortium agreement, and a consortium lead through ASPR’s Other Transaction Authority (OTA). The selected consortium lead will engage in overall day to day management of the RISE Consortium under the guidance of IBMSC, including technical, programmatic, reporting, financial, administrative, and contractual matters and administer project agreements for performance.

IBMSC aims to identify industry and private sector partners interested in participating in such consortia, supported by IBMSC, that will anticipate and respond to emerging and ongoing public health emergencies focused on developing, establishing, and manufacturing capabilities to counter a broad array of threats.

Projects will be end-to-end and inclusive of everything from research and development, buildout, commissioning, validation, commercial transition and establishment of vehicles to ensure availability of critical countermeasures. IBMSC is interested in establishing and sustaining:

• Facilities and organizations with experience manufacturing and/or supplying any of the following:

o single-use consumables such as sterile packaging, tubing, connectors, assemblies, needles and syringes o fill-finish services and supplies for drug manufacturing, including capabilities for producing diverse dosage forms such as tablets, capsules, and injectables.

o raw materials such as solvents, reagents, and other key inputs, key starting materials

(KSMs) and/or active pharmaceutical ingredients (APIs) and excipients o drug products o raw materials and consumables for diagnostics o raw materials and consumables for (PPE) o finished PPE products o diagnostic products for point-of-care and at-home use and the commercial market;

o a digital stockpile and manufacturing response network using the infrastructure and network of companies that will leverage American manufacturing might to enable the production of clinically acceptable medical supplies to support disaster response, public health emergencies, compliment federal and state stockpiles to adapt to everchanging demand signals and expand overall manufacturing supply chain resilience. The capability to:

• pre-position virtual designs of certified manufacturers

• establish product acceptability while matching clinical demands to alternative suppliers

• enabling adoption of emerging technologies

• surging manufacturing capacity on demand

• thwarting opportunistic counterfeiters to safeguard patient health and national public health security

• Trained workforce to oversee all aspects of drug, PPE and diagnostic manufacturing and digital stockpiling

• Robust supply chain to support large-scale manufacturing with resilient capabilities to mitigate risk of disruption

• Rapid contracting/agreement mechanisms

• Capabilities to proactively identify and mitigate supply chain risks and enhance supply chain resilience

• Technologies that provide end-to-end visibility across the supply chain, from sourcing to distribution, emphasizing early signal detection, predictive modeling, and use of artificial intelligence

• Innovative technology platforms to accelerate development, such as novel advanced manufacturing and biomanufacturing tools, computational modeling, and high-throughput systems, ensuring scalability and adaptability to emerging threats.

• Sustainable infrastructure models that maintain operational readiness during non-emergency periods, incorporating cost-sharing strategies and flexible capacity preservation to support long-term viability.

• To evolve an ever-increasing network of manufacturing capabilities intended to provide speedy responses to supply chain disruptions, while buying time for the United States domestic medical and pharmaceutical industrial base to ramp up production satisfying the needs of national security and public health.

Interested firms are requested to submit company contact information and responses to the following questions relating to the establishment of, and participation in, potential consortia as a consortium lead:

• Brief description (10 pages or less) of company experience and existing infrastructure related to manufacture and/or supply of any of the aforementioned resources or services; plus additional pages comprising:

• Discussion/perspective on potential barriers (financial, technological, legal, etc.) to, and/or concerns over, participating in consortia of industry participants to meet preparedness and response requirements;

• Perspective on granting the USG access/rights to USG-funded infrastructure and technologies on a preferential basis (“priority access”) in the event of a declared public health emergency (PHE);

• Perspective on sustainment of capacities and capabilities during periods without declared PHE’s or other sharp drops in demand.

• Discussion/perspective on data sharing with respect to supply chain signals, prime and subprime contractor production and risks, overall supply chain risk management plans, as well as inflow/outflows of materials.

DISCLAIMER

THIS INFORMATION IS REQUESTED FOR MARKET RESEARCH PURPOSES ONLY. NO CONSORTIUM

OR SOLICITATION CURRENTLY EXISTS. IBMSC will use this information to guide decisions and plans regarding establishing domestic biopharmaceutical consortia and to establish a contact list of potential industry participants for future outreach efforts. The Government will not reimburse respondents for costs incurred in preparing a response to this RFI.

Please note that contractors performing advisory and assistance services that support IBMSC will have access to any submission under this RFI. Please do not include any business sensitive information that is not relevant to your technical capabilities being offered for consideration and potential acceptance into the consortium.

Responses Due By: July 13, 2025 Submit Responses To: Primary POC Ashia.Everett@hhs.gov and Secondary POC Annette.Wright@hhs.gov Subject Line: RFI Response – IBMSC RISE OTA Consortium mailto:Ashia.Everett@hhs.gov mailto:Annette.Wright@hhs.gov