I. INTRODUCTION
This is a Small Business Sources Sought Notice (01A). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses (SB); Historically Underutilized Business Zone small businesses (HUB Zone); service-disabled veteran-owned small businesses (SDVOSB); 8(a) small businesses; veteran-owned small businesses (VOSB); woman-owned small businesses (WOSB); or small disadvantaged businesses (SDB); and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The proposed NAICS (North American Industry Classification System) for this proposed requirement is 541714. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The Administration for Strategic Preparedness and Response (ASPR) intends to provide maximum practicable opportunities in its acquisitions to all types and categories of small businesses. Statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address) as well as the eligible business concern’s name, point of contact, address, and DUNS number.
Please note that an Other Than Small Business Sources Sought Notice (OTSBSSN – 01B) will also be posted regarding this possible requirement and is intended solely for prospective Offerors that are considered to be Other Than Small Businesses. Prospective Offerors should respond to the appropriate FBO notice relative to their business size standard.
THIS NOTICE IS STRICTLY FOR MARKET RESEARCH.
II. AUTHORITY
The Office of Contracts Management and Acquisition (CMA) issues this Small Business Sources Sought Notice (SBSSN) 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
ADaM Analysis data model
ADCC Antibody-dependent cell-mediated cytotoxicity
ADCD Antibody-dependent complement deposition
ADCP Antibody-dependent cellular phagocytosis
ADDCP Antibody-dependent dendritic cell phagocytosis
ADNKA Antibody-dependent natural killer cell activation
ELLA Enzyme-linked lectin assay
ELISA Enzyme-linked immunosorbent assay
ELISpot Enzyme-linked immune-sorbent spot
HAI Haemagglutination inhibition
LLOQ Lower limits of quantification
LOD Limit of detection
MN Microneutralization
ULOQ Upper limits of quantification
IV. PURPOSE
The Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use responses to this Small Business Sources Sought Notice (SBSSN) for planning potential future acquisitions. BARDA seeks pertinent market data on availabilities and capabilities for providing central laboratory assay capacity to function as the central immune laboratory to assay samples collected from nonclinical studies and from subjects enrolled in influenza, SARS-CoV-2, and emerging infectious disease vaccine clinical trials and to perform cross-reactive immune response testing of samples for pandemic preparedness and response.
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 establish potential vendor source files and listings. BARDA will not award any contracts under this notice.
V. BACKGROUND
The potential for a human pandemic resulting from an emerging infectious disease continues to be a public health concern. The threat of a human virus pandemic has greatly increased over the past several years with the emergence of highly virulent avian influenza viruses like H5N1 and H7N9 viruses and SARS-CoV-2. Four influenza pandemics (1918, 1957, 1968, and 2009) occurred over the last century, and an unprecedented number of human infections with avian influenza A(H7N9) in the fifth epidemic wave during the winter of 2016-2017 in China, and their antigenic divergence from the viruses that emerged in 2013, have shown that influenza viruses are unpredictable – we can never be certain of when or from where the next pandemic will arise. However, another pandemic is inevitable in this interconnected world, and the question is not if we will have another pandemic, but when. The U.S. Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR), promotes pandemic readiness to mitigate the public health impact of a pandemic emergency through timely and accessible vaccination strategies.
This program will serve as a continuation and expansion of the U.S. Pandemic Preparedness Plan[1], the White House-issued Executive Order (EO) 13887: Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health[2], and the American Pandemic Preparedness Plan (2021)[3]. It is aimed at providing central laboratory assay capacity to function as the central immune laboratory to assay samples collected from clinical and nonclinical vaccine studies to support pandemic preparedness and response.
VI. PROJECT REQUIREMENTS
This notice seeks information from small businesses with regard to their qualifications, experience and capability.
The program objectives are:
- To establish a centralized immunogenicity testing capability for quality-assured immune assays to support advanced research and development of influenza virus, SARS-CoV-2, and emerging infectious disease vaccines. Data from these assays may be used as primary, secondary, and exploratory endpoint analyses for vaccine clinical studies. Data may be used to support a U.S. FDA Emergency Use Authorization (EUA) or a license application.
- To provide rapid response in terms of cross-reactive immune testing of clinical and/or nonclinical samples in the event of an influenza, COVID-19, or emerging infectious disease outbreak utilizing qualified, fit for use, or validated HAI and MN antibody assays.
- To qualify immunological assays such as HAI and MN assays with live virus (parental strain or PR8-reassortants), ELLA, ELISA, ELISpot, pseudovirion neutralization, flow cytometry, ADCP, ADCC, ADNKA, ADCD, ASNP, ADDCP, Fc Receptor Array, Antibody sub-classing and Isotyping, systems serology, or other novel assays and test immune responses to influenza virus vaccines (including to subtypes H5Nx [e.g., H5N1, H5N6, H5N8], H7N9, H9N2, H3N2(v), H1N1(v), H2Nx [e.g., H2N2, H2N3], B, or other emerging subtypes) or SARS-CoV-2 or emerging infectious diseases in such assays.
- To provide all data and documents for the generation of a BARDA-sponsored submission to FDA that are Document-Level Published and in eCTD submission format. BARDA will complete the FDA submission level publishing as needed.
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. Responses shall not exceed 10 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, Unique Entity Identity (UEI) number, number of employees, point of contact, and email address.
b) NAICS Codes
Provide your applicable NAICS Code.
c) Capability Statement
Provide relevant business information on capability, experience, and business interests to provide the type of services specified under Section V, above.
2. Technical Representations
Respondents shall submit the technical representations to ASPR/BARDA in the order listed below. (Note: sections not relevant to the respondent may be left without information by marking ‘NA/Reserved,’ to maintain the section numbering).
a) Response Specification
Clearly describe the capability and experience that meets the requirements specified in Section V – Project Requirements.
b) Technical Information:
All respondents to this notice are required to provide the information on their laboratory assay capabilities by providing a short narrative and summarizing the stage of development, nonclinical and clinical studies completed to date, and stage of assay development. The short narrative may include figures, schematics, diagrams, photographs, etc. and shall describe the proposed final assays under consideration.
NARRATIVE SECTIONS:
- Assay Name: As marketed, developed, or published. Provide references to publications.
- Biosafety Level Capability
- Stage of Influenza Virus HAI and MN Assay Development: Provide a summary of experience in HAI and MN assay qualification or validation for seasonal influenza virus strains and zoonotic (specifically non-H1, non-H3, non-B) influenza virus strains. Influenza virus subtypes may include, but are not limited to, H5Nx (e.g., H5N1, H5N6, H5N8), H7N9, H9N2, H3N2(v), H1N1(v), H2Nx (e.g., H2N2, H2N3), B, or other emerging subtypes. Assay qualification or validation may include assay precision, accuracy, dilutional linearity, Lower and Upper Limits of Quantification (LLOQ, ULOQ), limit of detection (LOD), robustness, and specificity.
- Stage of Influenza Virus and/or SARS-CoV-2 Immune Assay Development: Provide a summary of experience in assay qualification or validation of ELLA, ELISA, ELISpot, pseudovirion neutralization, flow cytometry, ADCP, ADCC, ADNKA, ADCD, ASNP, ADDCP, Fc Receptor Array, Antibody sub-classing and Isotyping, systems serology, or other novel assays and test immune responses to influenza virus vaccines (including to subtypes H5Nx [e.g., H5N1, H5N6, H5N8], H7N9, H9N2, H3N2(v), H1N1(v), H2Nx [e.g., H2N2, H2N3], B, or other emerging subtypes) or SARS-CoV-2 in such assays. Assay qualification or validation may include assay precision, accuracy, dilutional linearity, LLOQ, ULOQ, LOD, robustness, and specificity.
- Experience in bridging or concordance studies: Provide a summary of experience in immunological assay bridging or concordance studies for influenza virus or SARS-CoV-2 such as HAI, MN, ELLA, ELISA, ELISpot, pseudovirion neutralization, flow cytometry, ADCP, ADCC, ADNKA, ADCD, ASNP, ADDCP, Fc Receptor Array, Antibody sub-classing and Isotyping, systems serology, or other novel assays to test clinical samples from vaccine candidates.
- Regulatory: Provide a summary of appropriate regulatory permissions in place to work with zoonotic influenza viruses. Provide evidence of compliance with 21 CFR part 58 Good Clinical Laboratory Practice (GCLP).
- Current Assay Capacity: Provide a summary of immune assay achievements, completed immune assay runs, and immune assay capacity, particularly that which would be required to support a response to a Public Health Emergency.
3. Other Information
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 text-searchable Adobe® Acrobat® format, and furnish responses electronically (via email) to Jill.Johnson@hhs.gov and Ryan.Marion@hhs.gov for receipt by 4:00 P.M. ET on November 18, 2022. Any questions, comments, or concerns regarding this notice shall be written and transmitted via email to Jill.Johnson@hhs.gov and Ryan.Marion@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. Responses to this notice will not be considered 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.
[1] https://www.cdc.gov/flu/pandemic-resources/pdf/pandemic-influenza-strategy-2005.pdf, https://www.cdc.gov/flu/pandemic-resources/pdf/pandemic-influenza-implementation.pdf, https://www.cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-2017v2.pdf
[2] To further support improvement of influenza vaccines, the White House issued Executive Order (EO) 13887: Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health on September 19, 2019.
[3] American Pandemic Preparedness: Transforming our Capabilities (https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf)
