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Other Than Small Business Sources Sought Notice OTSBSSN No.: BARDA-2020-Midazolam Autoinjectors I. INTRODUCTION The purpose of this Other Than Small Business Sources Sought Notice (01B) is to seek dec... Other Than Small Business Sources Sought Notice OTSBSSN No.: BARDA-2020-Midazolam Autoinjectors I. INTRODUCTION The purpose of this Other Than Small Business Sources Sought Notice (01B) is to seek declarations of technical capabilities, data, and materials from qualified other than small business concerns relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The proposed NAICS for this proposed requirement is 541714. Please note that a Small Business Sources Sought Notice (01A) has also been posted regarding this possible requirement, and is intended solely for prospective Offerors that are considered to be a Small Business. Prospective Offerors shall respond to the appropriate notice relative to their business size standard. THIS IS STRICTLY FOR MARKET RESEARCH. II. AUTHORITY The Office of Contracts Management Acquisition (CMA) issues this Other Than Small Business Sources Sought Notice (OTSBSSN) on behalf of the Biomedical Advanced Research and Development Authority (BARDA) pursuant to FAR paragraphs 5.205(c), 15.201(e) and FAR parts 10, 19. III. ACRONYM “CMA” means Contracts Management and Acquisition “ASPR” means Assistant Secretary for Preparedness and Response “BARDA” means Office of the Biomedical Advanced Research and Development Authority within the U.S. Department of Health and Human Services “CANA” means Convulsant Antidote Nerve Agent “CBRN” means Chemical, Biological, Radiological, and Nuclear “CDC” means Centers for Disease Control and Prevention “CONOPs” means Concepts of Operations “cGXP” means any of cGMP, current Good Manufacturing Practices; cGLP, current Good Laboratory Practices; cGTP, current Good Tissue Practices; or cGCP, current Good Clinical Practices “FAR” means Federal Acquisition Regulation “FDA” means the U.S. Food and Drug Administration “HHS” means the U.S. Department of Health and Human Services “Licensed” means approved for use by a regulatory authority, “MCM” means Medical Countermeasure “Notice” means this Sources Sought Notice “PHEMCE” means the Public Health Emergency Medical Countermeasures Enterprise “RFI” means Request for Information “SE” means Status Epilepticus “SNS” means Strategic National Stockpile “SSN” means Sources Sought Notice “USG” means United States Government IV. PURPOSE The Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use responses to this Other Than Small Business Sources Sought Notice (OTSBSSN) for planning potential future acquisitions. BARDA seeks pertinent marketplace data on availabilities and capabilities for procuring, stockpiling, and investing in the late stage development of midazolam autoinjectors for intramuscular injection. BARDA seeks information on availability, capabilities, and other pertinent marketplace data to support late-stage activities required for Food and Drug Administration (FDA) approval of midazolam autoinjectors for adult and pediatric populations. This information is intended to strengthen BARDA’s understanding of the current and future marketplace and enhance its ability to obtain quality services economically, and to efficiently and lawfully establish potential vendor source files and listings. BARDA will not award any contracts under this Notice. V. BACKGROUND The Office of the Biomedical Advanced Research and Development Authority intends to use responses to this SBSSN for planning purposes towards the possible procurement of Midazolam autoinjectors designed for use by adult and pediatric populations for the treatment of status epilepticus (SE), including SE caused by nerve agents. Within the Federal Government, the U.S. Department of Health and Human Services (HHS) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective Medical Countermeasures (MCMs) to treat the adverse health effects resulting from intentional release leading to exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemics, and emerging infectious diseases. Response and recovery were identified as key elements of national defense in the National Strategy to Combat Weapons of Mass Destruction issued in 2002 (National Security Presidential Directive-17/Homeland Security Presidential Directive-4, NSPD-17/HSPD-4) and in the National Military Strategy to Combat Weapons of Mass Destruction (NMS-CWMD), released in 2006. This procurement is also aligned with the Project Bioshield Act of 2004 (Pub. L. No. 108-276, www.gpo.gov/fdsys/pkg/PLAW-108publ276/pdf/PLAW-108publ276.pdf), which established the processes by which MCMs are procured for the Strategic National Stockpile (SNS). The lead role of HHS in the medical and public health response, including development and availability of MCMs, was emphasized in 2004 in Biodefense for the 21st Century (HSPD-10) and in 2007 in Medical Countermeasures against Weapons of Mass Destruction (HSPD-18). The importance of an effective MCM enterprise for development and provision of medical countermeasures was emphasized in 2009 in the National Health Security Strategy (NHSS). These documents represent the foundation for addressing the Nation’s CBRN MCM needs. Development of Midazolam Autoinjectors for Treatment of Nerve Agent Seizures The 2007 PHEMCE Implementation Plan for Chemical, Biological, Radiological, and Nuclear (CBRN) Threats called for updating the CHEMPACK formulary with improved medical countermeasures, such as anticonvulsants, as they became available. In 2011, the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) recommended that an improved anticonvulsant be developed and procured to address this need. Attributes of this product would include a non-IV route of administration (e.g. IM) that is fast acting, has greater efficacy than existing products, and is approved by the Food and Drug Administration (FDA) for adult and pediatric indications. More specifically, the PHEMCE recommended that all diazepam autoinjectors (Convulsant Antidote Nerve Agent, CANA) in the Strategic National Stockpile’s (SNS) CHEMPACK Program be replaced with the improved anticonvulsant midazolam in an autoinjector for rapid intramuscular administration. The CHEMPACK Program addresses some significant challenges to preparedness for a nerve agent attack. Prepositioning antidotes throughout the country addresses the time constraint on effective medical treatment and thus reduces the time for delivery relative to the time to provide a 12-hour Push Package released from a strategically placed SNS site. SNS/CHEMPACKs account for all of the CANA acquired and maintained by the SNS specifically for the treatment of nerve agent-induced seizures. Development and acquisition of pediatric and adult midazolam autoinjectors, and their approval as a drug/device combination product for the treatment of status epilepticus in both populations, would fulfill the requirement to replace all existing diazepam autoinjectors in the SNS/CHEMPACKs with midazolam autoinjectors. VI. PROJECT REQUIREMENTS This notice seeks information from small businesses with regard to their qualifications, experience and capability to develop and manufacture midazolam autoinjectors. Any proposed therapeutic/Sponsor should meet the following criteria: The Offeror must have the capability to manufacture midazolam autoinjectors that are FDA approved or at the Phase 3 clinical level of development. The Offeror must have demonstrated that their proposed autoinjectors are able to meet the FDA reliability standard for medical devices (99.999% reliability). The Offeror must have obtained FDA feedback regarding their regulatory approach. The Offeror must have demonstrated their autoinjectors can be used in emergency situations by first responders and untrained personnel (Human Factors Studies are acceptable). Proposed capability should include the ability to deliver midazolam autoinjectors, as a drug/device combination product, to SNS/CHEMPACKs. VII. CAPABILITY STATEMENT/INFORMATION SOUGHT Respondents are asked to provide only the most pertinent information, data, and materials necessary to adequately convey a declaration of capability in line with this notice. Respondents must submit separate Business and Technical Representation, and both shall not exceed 10 single sided pages (including all attachments, charts, etc.). Content contained in excess of the stated limit per section will not be reviewed. Respondents are asked to state in their capability statement, whether they are responding to the Small Business Sources Sought Notice or the Other Than Small Business Sources Sought Notice. 1. Business Representations Respondents shall make business representations to ASPR/BARDA in the following order: a) Business Information Provide potential respondent name, principal place of business, DUNS number, taxpayer identification number, number of employees, annual revenue of company, point of contact, and email address. b) NAICS Codes Provide your applicable NAICS Code. c) Compliance Statement Provide a statement assuring compliance with all applicable laws and this notice. d) Capability Statement Provide relevant business information on capability, experience, and business interests to provide the type of goods and services specified under Section VI, above. 2. Technical Representations Respondents shall submit the technical representations to ASPR/BARDA in the order listed below as separate sections. (Note: sections not relevant to the respondent may be left without information by marking ‘NA/Reserved,’ to maintain the section numbering). a) Response Specification In response to this notice, clearly describe the capability and experience that meets the requirements specified in Section VI. b) Technical Information: All respondents to this notice are required to provide the information on their products and capabilities by providing a short narrative and summarizing the stage of development, non-clinical and clinical studies completed to date, stability data, manufacturing accomplishments, and FDA interactions. The short narrative may include figures, schematics, diagrams, photographs, etc. and shall describe the proposed final products under consideration. NARRATIVE SECTIONS: Product Name: As marketed or published. Intended Indication for use as a therapeutic capable of meeting product requirements outlined in section VI. Regulatory Status or Stage of Development: Provide summaries of communications with the FDA describing current state of medical product development according to the FDA pathways. Clinical Development: Provide a summary of preclinical and clinical development. The Offeror must clearly state and demonstrate that their proposed autoiniectors meet the 99.999% reliability standards, as required by the FDA for drug/device combination products. Current Manufacturing Capacity: Provide a summary of manufacturing achievements, completed manufacturing runs, and manufacturing capacity. Shelf Life and Storage Conditions: Provide a summary of stability and storage as measured by time and temperature. 3. Other Information ASPR/BARDA encourages all respondents to submit currently available marketing or extant information, or to notify ASPR/BARDA of the publicly available location; thereof to the maximum extent consistent with this notice’s requirements and limitations. Respondents shall mark confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends. ASPR/BARDA will presume that any unmarked information, data, and materials were furnished with an “unlimited rights” license, as FAR subpart 27.4 defines that term, and ASPR/BARDA assumes no liability for the disclosure, use, or reproduction of the information, data, and materials. 4. Response Format, Transmission, and Closing Date Respondents shall provide declarations of capability and all information, data, and materials in Microsoft Office ®, or Adobe® Acrobat® format, and furnish responses electronically (via email) to Jessica.Coleman@hhs.gov for receipt by 4:00 P.M. ET on June 15, 2020. Any questions, comments, or concerns regarding this notice shall be written and transmitted via email to Jessica.Coleman@hhs.gov. VIII. DISCLAIMER AND IMPORTANT NOTES This notice does not obligate the Government to award a contract or otherwise pay for information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on beta.SAM.gov under Contract Opportunities in accordance with FAR part 5. However, responses to this notice will not be considered adequate responses to a solicitation. IX. CONFIDENTIALITY: Respondents shall mark confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends. ASPR/BARDA will presume that any unmarked information, data, and materials were furnished with an “unlimited rights” license, as FAR subpart 27.4 defines that term, and ASPR/BARDA assumes no liability for the disclosure, use, or reproduction of the information, data, and materials. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.