HHS DPA T3 RFI_Antimicrobials - Updated POC 1-22-25.docx

HHS Defense Production Act Title III Program Request for Information (RFI)

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ); IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI

TITLE

Public Health Industrial Base Capabilities and Capacities: Anti-Microbials

REQUEST FOR INFORMATION (RFI) ONLY

As set forth in FAR 15.201(e), the intent of this RFI is to gather market research on the domestic production capability and capacity of the Public Health Industrial Base (PHIB) as it relates to the list of antimicrobials identified, as of the date of Presidential Determination 2024-03 of December 27, 2023, pursuant to section 3(c) of Executive Order 13944 of August 6, 2020. This RFI is requesting data and information that would help the HHS Defense Production Act (DPA) Title III Program Office to better understand the PHIB capabilities and capacities used to produce and supply health resources considered essential to national defense, including but not limited to drug and biologic essential medicines, medical countermeasures, and critical inputs identified, as of the date of Presidential Determination 2024-03 of December 27, 2023, pursuant to section (c) of Executive Order 13944 of August 6, 2020.

This RFI is not a solicitation, nor is it a request for competitive proposals, and nor does it commit the HHS DPA Title III Program to issue a solicitation or make an award. Therefore, responses to this notice are not considered offers and cannot be accepted by the United States Government (USG) to form a binding contract. Companies that respond will not be paid for submitting information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the interested party’s expense. The USG intends to utilize the information gathered from this market research effort for planning purposes.

All responsible sources may submit information in response to this RFI.

Please note: Individual responses will be treated as confidential trade secrets or commercial information, consistent with section 552(b)(4) of Title 5, U.S.C., section 1905 of Title 18, and other applicable laws. Such data are exempt from FOIA requests. Data will be marked as business proprietary information, for official government use only and not to be distributed outside of the government.

REQUEST DETAILS:

1. Description The HHS DPA Title III Program invite industry partners to submit to the USG information that will aid in improving the understanding of current domestic production capabilities and capacities of domestic PHIB that specifically support the production and supply of anti-microbials. The USG goal is to identify and improve on those gaps in the marketplace that can potentially be addressed using HHS’ delegated Title III authorities. Industry responses to the RFI are intended to assist the HHS DPA Title III Program with planning and market research.

2. Background Within the Federal Government, the Department of Health and Human Services, Administration for Strategic Preparedness and Response (ASPR) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and the use of effective medical countermeasures to treat the adverse health effects resulting from intentional and unintentional exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents and infectious diseases. Within ASPR, the Defense Production Act and Emergency Response Authorities (DPA-ERA) Office is tasked with leveraging HHS’ delegated DPA Title III authorities to ensure the safe and equitable production and distribution of health resources deemed essential to national defense.

Title III of the Defense Production Act of 1950 (50 U.S.C. App. § 4501 et seq.) grants the President of the United States the authority to provide appropriate incentives to develop, maintain, modernize, restore, and expand the production capacities of domestic sources for critical components, critical technology items, and industrial resources essential to national defense. On December 27, 2023, the President of the United States (POTUS) signed Presidential Determination No. 2024-03, “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” wherein he determined that essential medicines, medical countermeasures, and critical inputs are industrial resources, materials, or critical technology items that are essential to national defense. HHS’ delegated Title III authorities and Presidential Determination 2024-03 enable HHS’ DPA Title III Program to make purchases to create or expand (scale-up) production capacity; improving quality and yield; purchasing test quantities for process validation and qualification testing; developing and implementing business and marketing plans, purchasing, and installing production equipment, and providing purchase commitments, subsidy payments, grants, and other actions pursuant to section 303 of the DPA to incentivize companies to establish domestic production capabilities and capacities.

DPA contains three criteria that every Title III project must meet before any funds may be obligated on a Title III activity. The DPA stipulates that the President must certify to the Congress that the activity satisfies the criteria. The statutory criteria state that: (1) The industrial resource, material, or critical technology item is essential to the national defense; (2) Without Presidential action under the DPA Title III, 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; and (3) Actions under Title III are the most cost-effective, expedient, and practical alternative for meeting the need.

Note that DPA Title III is only interested in sources that align with the formal definition of “domestic source” as defined in section 702(7) of the DPA. Title III cannot be used to create or expand a foreign source and must focus on domestic sources, regardless of the criticality of the technology to the U.S. national defense. The enacted FY 2024 National Defense Authorization Act (NDAA) provides an expanded definition of “domestic source” as a business concern that performs in the United States, Canada, United Kingdom, or Australia substantially all of the research and development, engineering, manufacturing, and production activities required of such business concern under a contract with the United States relating to a critical component or a critical technology item and that procures from such concerns substantially all of any components and assemblies required under a contract with the United States relating to a critical component or critical technology item. DPA Title III is therefore interested in receiving submissions from interested parties that produce and supply anti-microbials from the aforementioned countries that align with this expanded definition of “domestic source” and comprise the domestic PHIB.

DPA Title III investments are not intended for basic or applied research or for technologies with limited or no HHS advocacy. Typical Title III tasks include the procurement, installation, and qualification of production equipment; modernization of manufacturing capabilities and capital upgrades to the plant; manufacturing line prove-out; production of samples for customer and/or USG evaluations; implementation of quality systems and practices; manufacturing cost reduction and yield improvement activities; and the implementation of business and marketing plans. Title III investments typically have a broad, enterprise-wide impact on a sub-tier public health industrial base supplier. The overall goal is to secure and assure a viable, domestic supplier for the long-term.

Additional information about HHS DPA Title III Program is available on the following website: https://aspr.hhs.gov/legal/DPA/Pages/default.aspx.

This RFI seeks widest possible dissemination and feedback from industry professionals and those that develop, produce, and supply anti-microbials in the domestic PHIB. The goals are to meet and exceed the growing market demands in the domestic PHIB and to develop and consider a wide array of potential courses of actions and solutions to ensure preservation of health resources considered essential to national defense, including but not limited to the list of anti-microbials identified, as of the date of Presidential Determination 2024-03 of December 27, 2023, pursuant to section 3(c) of Executive Order 13944 of August 6, 2020.

3. Project Scope The HHS DPA Title III Program’s intention is to support either the establishment of new domestic capabilities or expansion/modernization of existing domestic facilities to support population-scale manufacturing and supply of anti-microbials. The primary objective of this initiative is to identify technologies or capabilities that produce anti-microbials at a minimum of a pilot scale (small-scale) either within the United States or abroad with the potential to onshore the capacity to the United States.

HHS DPA Title III encourages respondents to provide a full or partial solution to better understand the current state of the manufacturing and supply of anti-microbials.

4. Requested Information:

In addition to any market research that the respondent deems relevant to the RFI response, HHS DPA Title III is requesting responses to the following questions:

A. Technical Questions:

Please focus all responses on your company’s ability to produce and supply the precursors, key starting materials (KSMs), intermediates, active pharmaceutical ingredients (APIs), and finished dosage products (FDF) relevant to the medicines listed below, with special focus on the first eleven medicines:

1) Amoxicillin

2) Ampicillin

3) Azithromycin

4) Cefepime

5) Ceftazidime

6) Ceftriaxone

7) Doxycycline

8) Penicillin G

9) Piperacillin/Tazobactam

10) Trimethoprim/Sulfamethoxazole

11) Vancomycin

12) Amikacin

13) Amphotericin B

14) Ceftazidime – Avibactam

15) Ciprofloxacin HCl

16) Clindamycin

17) Daptomycin

18) Fluconazole

19) Imipenem

20) Linezolid

21) Levofloxacin

22) Meropenem

23) Metronidazole

24) Micafungin

25) Moxifloxacin HCl

26) Omadacycline

27) Rifampin

28) Voriconazole

29) Tigecycline

30) Tobramycin Ophthalmic solution 0.3%

i. For each of the precursors, key starting materials (KSMs), intermediates, active pharmaceutical ingredients (APIs), and finished dosage forms (FDFs) being produced by your company, please provide details regarding the following items below:

a. U.S. regulatory holdings (e.g., DMF, NDA, ANDA, BLA) either in possession or being pursued.

b. The scale at which your company is producing any of the above (i.e., pilot, engineering, and/or commercial scale) and the location of each facility producing these materials. Specify whether your facility(ies) can currently or, through additional investment, expand to address more than one medicine listed above.

c. Manufacturing equipment, manufacturing processes used, and the associated Manufacture Readiness Level (MRL): https://www.dodmrl.com/MRL_Deskbook_2022__20221001_Final.pdf. Describe the total production time from order to fulfillment.

d. List any key equipment or material(s) cited above that is/are sole-sourced, has a long lead time or other at-risk critical components in the production of the material(s). Provide specifics as to what equipment or material(s) are imported from non-domestic sources, including the country(ies) of origin.

e. Present operating capacity at relevant facilities (warm-base, typical monthly output, and surge (100%) capacity). Be specific about population-scale capabilities and if not current capable of supporting population-scale requirement, describe the required level of investment and associated timeline to reach population-scale manufacturing.

f. For the overall production of each product, define how much occurs in domestic facilities.

1. Location of the manufacturing site (i.e. Manufacturing at one location or manufacturing at multiple locations).

2. What would be needed for 100% of the procurement and production process to occur domestically?

g. Has the COVID-19 pandemic related supply chain disruptions and shifts in demand affect your business? If so, how has your company implemented any process changes or adjustments to your business in response to these challenges.

ii. List any existing facility(ies) that can be modernized or repurposed to address the manufacturing need for additional medicine(s) from the list above. Be specific about requirements, cost estimates, and timelines to reach operability.

iii. Provide a list of the existing customer base that sustains your current manufacturing capabilities and the ability for your company to include new medicines into your existing sales and marketing operations.

iv. Provide details regarding any forecast concerns or other challenges that may impact your ability to maintain current manufacturing capabilities and additional domestic capacities.

v. Status of manufacturing alliance (i.e., Co-development, production CMO).

vi. Capital assets associated with production/proposal (i.e., minimum equipment necessary to manufacture a given API and FDF).

vii. In general, what are your production bottlenecks?

B. General Questions

i. What challenges do you foresee with executing the scope of work as described above and what solution(s) have you identified that may mitigate these identified challenges?

ii. What USG investments will promote expansion of domestic manufacturing of the precursors, KSMs, intermediates, drug substances, drug products, and critical inputs (i.e., components, systems, single use technology (SUTs)) that are used to produce the medicines listed above?

iii. Would your organization prefer an Other Transactions Agreement (OTA) or a Federal Acquisition Regulations (FAR)-based contract for this effort? If so, then please state your rationale.

iv. Would your organization prefer a direct loan or loan guarantee over a cost-share? Also include any perceived difficulties in securing financing when pursuing capacity-related investments.

v. What is your 5-year plan for sustainment after USG funding, i.e., expansion to facilitate the production of the anti-microbials, offshoring plans, adding potential new sites, and purchasing special equipment?

vi. What is the general (rough order of magnitude) cost estimates/forecast for the total project?

The responses to this RFI will be used to identify potential future DPA Title III investments. Individual responses will be treated as confidential trade secrets or commercial information, consistent with section 552(b)(4) of Title 5, U.S.C., section 1905 of Title 18, and other applicable laws. Such data are exempt from FOIA requests. Data will be marked as business proprietary information, for official government use only, and not to be distributed outside of the government.

FORMAT AND PAGE LIMITATION:

RFI responses shall adhere to the following:

· 8.5 by 11-inch paper in a format compatible with either the Microsoft Office software package or Adobe Acrobat

· Limited to a maximum of 20 single-sided, double-spaced pages

· Font for text should be Times New Roman 12-point or larger.

· Numbered pages

· Microsoft Word or Adobe Acrobat format

Existing commercial documentation, technical specifications, and product literature can also be submitted and are not subject to a page limitation.

*** Responses must be marked UNCLASSIFIED *** ***Proprietary information provided must be marked appropriately***

To protect proprietary information, each line or paragraph on the pages containing such data must be specifically identified and marked with a legend similar to the following:

“The following contains proprietary information that (name of Responder) requests are not released to persons outside the Government, except for the purposes of review and evaluation.”

Please note that non-federal HHS DPA Title III Program staff performing advisory and assistance services will have access to all submissions received under this RFI. All non-federal HHS DPA Title III Program staff are required to sign a non-disclosure agreement prior to accessing the RFI responses.

All RFI submissions will become USG property and will not be returned.

Responses must be submitted in the following format:

E-mail Subject Line: RFI No/ Domestic Public Health Industrial Base Capabilities and Capacities: Anti-Microbials

PART I: Business Information

Provide the following business information for your company/institution:

· Company/Institute Name:

· Address:

· SAM UIE/DUNS

· Point of Contact:

· Phone Number:

· E-mail Address:

· Web Page URL:

· (If applicable) North American Industry Classification System (NAICS) Codes to be provided by Industry.

PART II: Optional Supplementary Information for Consideration by U.S. Government

In addition to the above requested information, use this space to provide any other information you wish the USG to consider as it assesses the health of the market and industry, recommendations you may have for reducing industry vulnerabilities, your view of the marketplace and global competitive playing field, what you believe would level the playing field for domestic manufacturers, or any thoughts on how to increase the long-term health and viability of the industry.

INFORMATION APPROACH:

The HHS DPA Title III Program may or may not use any of the information provided by industry as the basis for a Title III project. Projects developed from information provided by industry, as with all Title III projects, may be competed iin the open market using full and open competition. The HHS DPA Title III Program is not required to provide feedback to responders. However, USG may respond directly in order to obtain additional or clarifying information.

DISCLAIMERS (if any):

No telephone calls will be accepted requesting a bid package or solicitation. There is no bid package or solicitation currently. All RFI submission information received shall be safeguarded from unauthorized disclosure. Responses to this RFI may constitute proprietary information, Controlled Unclassified Information (CUI), or export-controlled information. Respondents are directed to contact the Contracting Office POCs for supplemental instructions related to the submission of proprietary information, CUI, or export-controlled data. If late information is received, it may be considered by the USG reviewers, depending on agency time constraints.

OPERATIONS SECURITY (OPSEC) REQUIREMENTS

All responses to this document shall follow appropriate OPSEC measures. This is required to reduce program vulnerability from successful adversary collection of possible sensitive unclassified and/or proprietary information, and violations of export control requirements. Guidance can be provided by HHS ASPR Security as needed. Please note, any potential critical program information (CPI) generated as part of this response will be reviewed to determine the need for a Program Protection Plan (PPP) or to be included as part of an existing PPP.

INDUSTRY CLARIFICATIONS/DISCUSSIONS

Interested vendors may request clarification regarding the RFI in writing from the Contracting Office for any requirement that is unclear by sending an e-mail to the Contracting Point of Contact: Chris Newell at IBMSC-Submissions@hhs.gov and Christopher.Newell@hhs.gov.

All RFI submissions and questions regarding this RFI shall be submitted to the above Point of Contact via email.

Any requests for clarification must be received no later than 10:00 AM ET on December 2nd, 2024 prior to the close of this RFI in order to receive a timely response. The USG may provide clarifications responses that will be posted via SAM.gov website to benefit all interested RFI responders. Interested responders are encouraged to periodically check the website during the response period for clarifications.

The HHS DPA Title III Program representatives may or may not choose to respond or meet with potential responders. Such discussions would only be intended to obtain additional or clarifying information. The HHS DPA Title III Program is not required to provide feedback to responders.

Submission of documentation The HHS DPA Title III Program intends to use electronic mail for all correspondence regarding this RFI. Electronic responses to this RFI are due no later than 10:00 AM ET on January 22th, 2025.

Documentation shall be submitted to the following individual: Chris Newell at IBMSC-Submissions@hhs.gov and Christopher.Newell@hhs.gov.

Please include RFI No./Title in the subject line of the email and on all correspondence concerning this RFI.

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