Title III – Expansion of Productive Capacity and Supply
HHS will leverage Defense Production Act (DPA) Title III authorities to strategically expand critical production, commercialize R&D efforts, and scale emerging technologies to support domestic public health resource manufacturing capabilities.
What is DPA Title III?
The HHS DPA Title III program will leverage DPA enabling authorities and provisions to help design, build, and sustain long-term domestic capabilities and capacities to manufacture medical countermeasures for future public health threats, including chemical, biological, radiological, and nuclear (CBRN) threats, emerging infectious diseases (EID), and other public health emergencies. The program works in partnership with both federal and non-federal partners to identify areas where critical industrial capacity is lagging or non-existent.
Once a shortfall is identified, HHS will evaluate and determine if use of its delegated authorities under sections 301-303 of the DPA (50 U.S.C. §4531-4533) is appropriate to reduce the United States' dependency on foreign supply chains, increase production resiliency, and ensure the supply of materials and services within the domestic public health industrial base.
Focus Areas
The DPA Title III program targets investments that create, maintain, protect, expand, or restore domestic industrial base capabilities that are critical to preparing for and responding to both current and future public health emergencies. The Title III program (50 U.S.C. §4531-4533) has three statutory priority areas, one of which must be met for a project to be considered:
Sustain Critical Production
Prospective programs addressing public health industrial base capabilities and capacities, whose primary focus is to create, maintain, protect, expand, or restore domestic industrial capabilities considered essential for National Defense.
Commercialize Research & Development Investments
Advanced R&D capabilities may require investments to commercialize viability and scaleup. Typical programs may begin with a product or technology that has demonstrated efficacy in a prototype or early-phase environment.
Scale Emerging Technologies
Emerging technology investments enable the rapid and affordable introduction of new capabilities into the commercial marketplace. The technologies may be developed to respond to an emerging threat, a capability gap, or may enhance interoperability of existing systems or platforms.
Statutory Criteria
To utilize DPA Title III authorities, the President must issue, on a non-delegable basis, a Presidential Determination identifying a specific domestic industrial base shortfall.
Note: Presidential Determinations are authorizations from the President to exercise specified DPA Title III authorities and are not an appropriation nor an obligation to expend funds or pursue a specific project.
The President is required by statute to notify Congress of the shortfall, which must meet all three statutory criteria (50 U.S.C. §4533):
- The industrial resource, material, or critical technology item is essential to national defense, which includes emergency preparedness activities such as preparedness for health emergencies.
See 50 USC § 4552(14); EO 13603.
- Without Presidential action under
50 U.S.C. §4533, United States industry cannot reasonably be expected to provide the capability for the needed industrial resource, material, or critical technology item in a timely manner
- Purchases, purchase commitments, or other action pursuant to
50 U.S.C. §4531-4533 are the most cost effective, expedient, and practical alternative method for meeting the need
Opportunities
Memorandum regarding the Presidential Determination and Waiver Pursuant to Section 303 of the Defense Production Act of 1950, as amended, on Essential Medicines, Medical Countermeasures, and Critical Inputs
On December 27th, 2023, President Biden issued HHS' first
Presidential Determination to broaden the Department's authorities under Title III of the Defense Production Act to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that have been deemed by the President as essential to the national defense. This Presidential Determination will help to minimize current and future drug shortages and mobilize our nation's public health industrial base to respond to longstanding drug shortages through expansion of domestic productive capacity and flexibility within public health supply chains, strengthening partnerships between the U.S. Government and industry, and promoting innovative and adaptable medical countermeasures development.
The HHS DPA Title III Program is in the process of preparing a Broad Agency Announcement (BAA) to allow industry to submit white papers or proposals directly to the ASPR DPA Mailbox (see below) for projects that fall under one of the three focus areas listed above. A public announcement will be made once the BAA has been published.
For information about current HHS DPA Title III opportunities, including other HHS funding opportunities and RFIs/RFPs where HHS DPA Title III is involved, please see the following links:
Contact Us
For more information about the Defense Production Act (DPA) and inquiries related to prospective projects, please contact the HHS ASPR DPA Mailbox at
aspr.dpa@hhs.gov
