Smallpox_2021_OTSBSSN.doc

Other Than Small Business Sources Sought Notice OTSBSSN No.: BARDA-2021 Smallpox Antiviral (01B)

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

“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

“CBRN” means Chemical, Biological, Radiological, and Nuclear

“BLA” means Biologics License Application

“CDC” means Centers for Disease Control and Prevention

“FAR” means Federal Acquisition Regulation

“FDA” means the U.S. Food and Drug Administration

“FDP” means Final Drug Product

“HHS” means the U.S. Department of Health and Human Services

“NDA” means New Drug Application

“Notice” means this Sources Sought Notice “PDUFA” means Prescription Drug User Fee Act “RFI” means Request for Information

“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 development of FDA-approved smallpox antiviral(s) with alternative mechanism(s) of action to TPOXX®.

V. BACKGROUND

The Department of Homeland Security (DHS) issued a Material Threat Determination for smallpox in 2004, establishing it as a threat to national security. Periodic smallpox outbreaks were common prior to the twentieth century with fatality rates of greater than thirty percent. Smallpox was eliminated as an endemic disease by 1980 following an intensive focused international ring vaccination campaign. The eradication of the disease led the scientific community to reduce the number of laboratories holding live variola virus so that at present the only known repositories of live variola virus are the World Health Organization (WHO) Collaborating Centers at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia and the State Center of Virology and Technology (VECTOR) in Novosibirsk, Russian Federation. While variola virus no longer exists in nature, the possibility of preserved, unrecognized samples or clandestine stocks, the potential re-emergence from natural sources, and recent advances in synthetic biology describing the construction of poxvirus genomes de novo, mean the threat of the reemergence of smallpox, although small, still exists.

The approval and acquisition of TPOXX® provided the USG with a potent first step in assembling the therapeutic armamentarium against smallpox. The development of antivirals against smallpox was deemed important and essential in the Institute of Medicine report Live Variola Virus, Considerations for Continuing Research with the panel emphasizing the need for the development of multiple countermeasures with distinct mechanisms of action to obviate the potential for the evolution of viral resistance through selective pressure. Additionally, developments in molecular biology since the IOM report have increased the possibility of de novo synthesis of poxviruses genomes, leading to the possible creation of resistant virus and further emphasizing the danger of relying on a single therapeutic countermeasure. As such, BARDA is seeking pertinent marketplace data on availabilities and capabilities for procuring, stockpiling, and investing in the development of FDA-approved smallpox antiviral(s) with alternative mechanism(s) of action to TPOXX®.

VI. PROJECT REQUIREMENTS

This notice seeks information from other than small businesses with regard to their qualifications, experience and capability to develop and manufacture smallpox antiviral(s).

Any proposed antiviral/Sponsor must meet all of the following criteria:

1) The Offeror must have submitted an NDA or BLA related to the intended operational use of a product as a smallpox antiviral to the U.S. FDA;

2) In response to the NDA or BLA, the Offeror must have received a confirmed PDUFA date from the FDA.

Proposed capability should include the ability to manufacture and deliver the smallpox antiviral as FDP and fulfill all post-marketing requirements and commitments as described by the U.S. FDA.

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 each 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, prior experience, and business interests to provide the type of product(s) 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 it ‘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 sponsors responding 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:

1. Product Name: As marketed or published.

2. Intended Indication for use as a therapeutic antiviral capable of meeting product requirements outlined in section VI.

3. 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.

4. Clinical Development: Provide a summary of preclinical and clinical development. The Offeror must also provide evidence of non-clinical efficacy.

5. Current Manufacturing Capacity: Provide a summary of manufacturing achievements, completed manufacturing runs, and manufacturing capacity.

6. 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 Kevin.Restrepo@hhs.gov for receipt by 4:00 P.M. ET on April 8, 2021. Any questions, comments, or concerns regarding this notice shall be written and transmitted via email to Kevin.Restrepo@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.