Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response | SAM.gov Opportunity | G2X

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Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

Solicitation75A50121R00013Notice typeCombined Synopsis/Solicitation, DC

Attachments

13 files

Name	Type	Posted	Actions
RFP 75A50121R00013 Pages 1-2 9-10-2021.pdf	PDF	Sep 10, 2021	Download
Amendment 4 - Summary.pdf	PDF	Sep 10, 2021	Download
RFP SOW-New Stockpile Updated with Responses 9-2-2021.pdf	PDF	Sep 3, 2021	Download
New Email Account 8-29-2021.pdf	PDF	Aug 29, 2021	Download
Amendment 3 - Past Performance Update v1.pdf	PDF	Aug 26, 2021	Download
Amendment 3 - Past Performance Update.pdf	PDF	Aug 25, 2021	Download
Response - Proposal Ext.pdf	PDF	Aug 18, 2021	Download
QA for Follow-On Stockpile - Additional Questions - 8-16-21 FINAL .pdf	PDF	Aug 17, 2021	Download
QA for Follow Stockpile - IDIQ 8-6-21 FINAL.pdf	PDF	Aug 7, 2021	Download
Amendment 2 - Summary.docx	DOCX	Jul 26, 2021	Download
RFP SOW-New Stockpile 6-29-2021 - Amendment 1.pdf	PDF	Jul 23, 2021	Download
Amendment 1 - Summary.pdf	PDF	Jul 23, 2021	Download
RFP SOW-New Stockpile 6-29-2021 - Program Updated - CLEAN.pdf	PDF	Jun 29, 2021	Download

Version History

Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

Combined Synopsis75A50121R00013Sep 10, 2021 · v12

Opportunity Summary

The Office of the Assistant Secretary for Preparedness and Response (ASPR) and the BARDA Division of Contracts Management and Acquisition issued this combined synopsis/solicitation for the acquisition of medical countermeasures to support pandemic influenza and emerging diseases preparedness and response. Classified under NAICS 325414 for Biological Product (except Diagnostic) Manufacturing and PSC 6505 for Drugs and Biologicals, the contract requires the production, testing, storage, and distribution of vaccine-related products. Specific deliverables include cGMP influenza vaccine master and working seed lots, research and investigational lots, commercial scale bulk lots, and adjuvants that have completed Phase 2 development. The scope further encompasses formulation and filling into various containers, storage and stability testing, potency reagent manufacture, clinical and non-clinical studies, and activities related to emerging pathogens.

The anticipated base period of performance is 36 months from the date of award, with the potential for two 12-month extensions via options, totaling a possible 60-month duration. Performance will take place in Washington, DC, and carries a minimum guarantee of $50,000.00 for the duration of the contract. Respondents are required to provide firm-fixed prices for most contract line items, while specific tasks such as shipping, analytical testing, and disposal will be determined through future requests for task order responses.

Solicitation number 75A50121R00013 was published on June 29, 2021, and updated on September 10, 2021, with a final response deadline of September 13, 2021. The solicitation includes 13 attachments, including multiple amendments, a statement of work updated as of September 2, 2021, and details regarding past performance and reporting requirements. Wendell Conyers serves as the primary point of contact for this requirement.

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Opportunity Details

Response deadline: Sep 13, 2021Expired 1727 days ago
NAICS: 325414 (opens in new tab)
PSC: 6505 (opens in new tab)
Set aside: —
Published: Jun 29, 2021
Updated: Sep 10, 2021
Agency: OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE (opens in new tab)
Office: ASPR BARDA DIV CONTRACTS MGMT & ACQ
Department: —
Source: View on SAM.gov (opens in new tab)

Contact and place of performance

Point of contact: Wendell Conyers

Place of performance

DC

USA

Original Description

Reference Amendment 1 PERIOD OF PERFORMANCE a. The base period of performance of this contract is anticipated for thirty-six (36) monthsfrom date of award. The period of performance may be extended up to 24 months withthe exercise of option(s), structured as CLINs. b. If the Government exercises its option(s), the period of performance will be increased as listed below: Option I Twelve (12) Months (Year 4) Option II...

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Reference Amendment 1 PERIOD OF PERFORMANCE a. The base period of performance of this contract is anticipated for thirty-six (36) monthsfrom date of award. The period of performance may be extended up to 24 months withthe exercise of option(s), structured as CLINs. b. If the Government exercises its option(s), the period of performance will be increased as listed below: Option I Twelve (12) Months (Year 4) Option II Twelve (12) Months (Year 5) The Statement of Work (SOW)delineates the specificsof the supplies or services to be furnished. The minimum guarantee is $50,000.00 for the duration of anyresultant contract (base + options). Provide firm-fixed prices for all CLINs, except those CLINs which have TBD or N/A in the EstimatedMaximum Quantity column. Provide pricing based upon the CLIN, item name and description in the SOWcontained in Section C for the three (3) year base period, and item name and description for the two 12-month option periods, as the numbers in SOW reflect base period numbering (SOW Numbering identifiedin SOW would be revised in conjunction with any resultant option award with description data unchanged). Price/Cost, e.g., Firm-fixed-price or cost reimbursable, for TBD CLINs, i.e., 0008, 0010, 0011, 0012,0013, and 0014 will be determined as a result of the issuance of a Request for Task Order Response(RTOR) to any or all resultant contract awardee(s). C.2.1. Detailed Description of Contract Line Item Numbers (CLINs): Reference attached RFP for additional detail CLINs will differ for option periods with item name and scope unchanged. CLIN 0001: cGMP Influenza Vaccine Master and Working Seed Lot The Contractor shall provide yield optimized master and working seed lots for inactivated, live attenuated,or recombinant influenza vaccine product. CLIN 0002: Influenza Vaccine Research Lot(s) The Contractor shall provide an influenza vaccine small scale, research lot. CLIN 0003: cGMP Influenza Vaccine: Investigational Lot(s) The Contractor shall provide influenza vaccine investigational lot(s). CLIN 0004: cGMP Influenza Vaccine: Commercial Scale Bulk Lot(s) The Contractor shall provide influenza vaccine bulk product. CLIN 0005: cGMP Adjuvant: Clinical or Commercial Scale Bulk Lot(s) The contractor shall provide adjuvant bulk product suitable for formulation and fill-finishing for use in theclinic, including clinical trial or use during a public health emergency. Proposed adjuvant shall havecompleted Phase 2 development in combination with a pandemic influenza or pre-pandemic influenza oremerging pathogen antigen. Clinical evidence of antigen sparing and/or adjuvant benefit for the pandemicinfluenza or pre-pandemic influenza or emerging pathogen antigen is required. CLIN 0006: Formulation and Filling The unit for this item is each (vial, syringe and sprayer) Submit standard data report according to instructions in Reporting Requirements. Provide a finalreport including, at minimum, the information identified in the Final Report Requirements. CLIN 0006A: Antigen: Single dose vials CLIN 0006B: Antigen: Syringes or sprayers CLIN 0006C: Antigen: Multi-dose vials CLIN 0006D: Adjuvant: Single dose vials CLIN 0006E: Adjuvant: Multi-dose vials CLIN 0006F: Co-formulated antigen and adjuvant: Single dose vials CLIN 0006G: Co-formulated antigen and adjuvant: Syringes CLIN 0006H: Co-formulated antigen and adjuvant: Multi-dose vials CLIN 0007: Storage and Stability Submit standard data report according to instructions in Reporting Requirements. Provide afinal report including, at minimum, the information identified in the Final Report Requirements CLIN 0007A: Storage and Stability of investigational lots of antigen.The unit for this item is a lot, which equals storage and stability for one (1) lot/month. CLIN 0007B: Storage and Stability of commercial scale bulk lots of antigen.The unit for this item is a lot, which equals storage and stability for one (1) lot/month. CLIN 0007C: Storage and Stability of antigen in final container.The unit for this item is a final container which equals storage and stability for a single (1)final container/month. CLIN 0007D: Storage and Stability of clinical/commercial scale lots of adjuvant.The unit for this item is a lot which equals a single (1) month of storage and stability for asingle (1) lot/month. CLIN 0007E: Storage and Stability of adjuvant in final container.The unit for this item is a final container which equals storage and stability for a single (1)final container/month. CLIN 0008: Shipping CLIN 0009: Candidate Vaccine Virus (CVV) CLIN 0010: Potency reagent and standards manufacture and testing .The Contractor shall provide influenza vaccine reagents and standards. CLIN 0011: Analytical Laboratory Testing/Assay CLIN 0012: Non-Clinical Studies CLIN 0013: Clinical Studies CLIN 0014: Disposal of product CLIN 0015: Standard Data Reporting Requirements CLIN 0016: Additional Reporting CLIN 0017: Storage and Stability of Materials from Prior Contracts CLIN 0017A: Storage and Stability of commercial scale bulk lots of antigen.The unit for this item is a lot, which equals storage and stability for one (1) lot/month. CLIN 0017B: Storage and Stability of antigen in final container.The unit for this item is a final container which equals storage and stability for a single (1)final container/month. CLIN 0017C: Storage and Stability of clinical/commercial scale lots of adjuvant.The unit for this item is a lot which equals a single (1) month of storage and stability for asingle (1) lot/month. CLIN 0017D: Storage and Stability of adjuvant in final container.The unit for this item is a final container which equals storage and stability for a single (1)final container/month. CLIN 0018: Emerging Pathogen.The contractor shall perform activities as required by HHS and as specified in an RTOR.