16-75A50126R00001_RFP Att 16 Bill of Materials (BOM) Template.xlsx

XLSX spreadsheet 93 KB Posted

Attached to
Request for Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response
Solicitation number
75A50126R00001_RFP_NPIVS_27
Issued by

About this file

This is a Bill of Materials (BOM) template in Excel format designed for contractors responding to BARDA's Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program (Solicitation No. 75A50126R00001_RFP_NPIVS_27). The template is a blank data collection instrument requiring contractors to document comprehensive supply chain and material information for vaccine, antigen, and adjuvant manufacturing.

Contractors must complete the BOM by identifying all materials and services associated with product manufacturing, including critical and non-critical supplies. Required data fields encompass production steps (Drug Substance, Drug Product, Adjuvant, Formulation Development, etc.), supply descriptions with manufacturer trade names, unit quantities (minimum stocked, annually required, and per batch), storage conditions, material states, and packaging specifications. For each supply item, contractors must identify primary, secondary, and tertiary sourcing options with detailed supplier information including geographical addresses, part numbers, lead times (in days), shelf life, and any transportation or shipping restrictions. Additional required information includes Harmonized Tariff Schedule codes for imported materials and comments for essential contextual details. The template includes predefined dropdown categories for production steps, criticality designations, sourcing availability (Sole Source, Single Source, or Multiple Sources), material states, storage conditions, and sterilization methods (e-beam, EtO, Gamma, X-ray). Completed files must be saved in .xlsx format with the naming convention "PCT_BOMTemplate_CompanyName_ProductName.xlsx" and submitted to the contractor's BARDA contact.

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Other files

File Type Posted
23_75A50126R00001_RFP_0002 Att. 21 BARDA Responses to Contractor Question No's 1-10.pdf PDF
24_75A50126R00001_RFP_0002 SF_30..pdf PDF
01-75A50126R00001_RFP_Final.pdf PDF
21_75A50126R00001_RFP_0001_RFP File 1 of 3.pdf PDF
20_75A50126R00001_RFP_0001.SF30.pdf PDF
21_75A50126R00001_RFP_0001_RFP File 3 of 3.pdf PDF
22_75A50126R00001_RFP_0001 Att. 20 BARDA Responses to Contractor Question No's 1-7.pdf PDF
21_75A50126R00001_RFP_0001_RFP File 2 of 3.pdf PDF
18-75A50126R00001_RFP Att 18 BCP SCP Continuity Plans.pdf PDF
09-75A50126R00001_RFP Att 9 ACH Vendor Misc Payment Enrollment Form.docx DOCX document
04-75A50126R00001_RFP Att 3 Vendor Production Facilities.xlsx XLSX spreadsheet
11-75A50126R00001_RFP Att 11 SF LLL Disclosure of Lobbying Activities Form Instructions.pdf PDF
03-75A0126R00001_RFP Att 2 ASPR Security Requirements.pdf PDF
08-75A50126R00001_ RFP Att 8 Summary of Related Activities.docx DOCX document
10-75A50126R00001_RFP Att 10 SF LLL Disclosure of Lobbying Activities Form.pdf PDF
15-75A50126R00001_RFP Att 15 Contractor Questions.xlsx XLSX spreadsheet
17-75A50126R00001_RFP Att 17 Manufacturing Plan.pdf PDF
06-75A50126R00001_RFP Att 5 BARDA Dose Tracker Template.xlsx XLSX spreadsheet
12-75A50126R00001_RFP Att 12 HHS Subcontracting Plan Template.docx DOCX document
05-75A50126R00001_RFP Att 4 Agent Request Form.docx DOCX document
19_75A50126R0001_RFP Att 19 Surge Manufacturing and Supply Chain Readiness Assessment.pdf PDF
02-75A50126R00001_RFP Att 1 Prod Handling Guidance Don Nat.pdf PDF
07-75A50126R00001_RFP Att 7 Breakdown of Proposed Costs.xlsx XLSX spreadsheet
14-75A50126R00001_RFP Att 14 Past Perfomance Questionnaire Template.docx DOCX document
01-75A50126R00001_RFP_Final.pdf PDF
13-75A50126R00001_RFP Att 13 Risk Mitigation Plan Matrix Template.docx DOCX document
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Text version

Guidance

Instructions:
The original version of this file is an Excel Template file (.xltx) - edits and changes are not allowed in this file in this format.
1. If not already done, save the file to your desktop as an Excel Workbook (.xlsx format) with the file name PCT_BOMTemplate_CompanyName_ProductName.xlsx
2. Fill in all details for each material associated with the manufacturing of this product - please fill in as many of the columns as possible.
4. Save and send the completed file to your BARDA contact.
Expected Inputs
BARDA Product NameInternal BARDA reference to keep lists of suppliers straight when cross-checking for bottlenecks
Product ManufacturerName of primary contractor responsible for manufacturing the BARDA product
Production StepCategory of product production a given supply applies (e.g., Drug Substance, Drug Product, Adjuvant)
Self-ID Critical / Non-CriticalSelf-identification of critical and non-critical supplies/services. A critical supply/service is in contact with or in the final product.
Source AvailabilitySourcing Options of the given material/service:

Sole Source - Exists when only one source makes a product Single Source - Actively selected only one source although more than one is available Multiple Sources - Using two or more suppliers for the same or like products or services

CategoryType of Process Supply - Select from Drop-Down
DescriptionCommon description of the supply - ideally with the manufacturer trade name utilized
Unit(s)Unit of measure or how the supply is received for the process
Minimum Quantity StockedAmount of supply maintained on-site
Minimum Quantity AnnuallyMinimum amount of supply required annually
Quantity Per Batch of Final DosesAmount of supply required per batch or lot of final finished product to USG specification
Storage ConditionsLabeled storage conditions of given supply (ambient, refrigerated (4C), or frozen (-20C or -80C)); light exposure conditions, etc.
Material Statee.g., solid, liquid, gas, etc.
PackagingHow the supply is sold and received (e.g., 10 kg bottle, 55 gallon drum, 300 piece pallet, etc.)
Primary SupplierName of primary supplier
Primary Distributor Geographical AddressAddress of primary distributor
Primary Supplier Geographical AddressAddress of primary supplier
Primary Manufacturer Geographical AddressAddress of primary manufacturer (may be the same as supplier if not through a distributor)
Primary Manufacturer Part Number (MPN)Root part number of supplier. NOT internal tracking number of product manufacturer
Primary Lead time (Days)Lead time in days
Primary Shelf Life (Days)Shelf life in days
Primary Transportation / Shipping RestrictionsAny known transportation/shipping restrictions that may require USG intervention in a future public health emergency
Primary HST Code if ImportedHarmonized Tariff Schedule Code
Secondary SupplierName of secondary supplier
Secondary Distributor Geographical AddressAddress of secondary supplier
Secondary Supplier Geographical AddressAddress of secondary supplier
Secondary Manufacturer Geographical AddressAddress of secondary manufacturer (may be the same as supplier if not through a distributor)
Secondary Manufacturer Part Number (MPN)Root part number of supplier. NOT internal tracking number of product manufacturer
Secondary Lead time (Days)Lead time in days
Secondary Shelf Life (Days)Shelf life in days
Secondary Transportation / Shipping RestrictionsAny known transportation/shipping restrictions that may require USG intervention in a future public health emergency
Secondary HST Code if ImportedHarmonized Tariff Schedule Code
Tertiary SupplierName of tertiary supplier
Tertiary Distributor Geographical AddressAddress of tertiary supplier
Tertiary Supplier Geographical AddressAddress of tertiary supplier
Tertiary Manufacturer Geographical AddressAddress of tertiary manufacturer (may be the same as supplier if not through a distributor)
Tertiary Manufacturer Part Number (MPN)Root part number of supplier. NOT internal tracking number of product manufacturer
Tertiary Lead time (Days)Lead time in days
Tertiary Shelf Life (Days)Shelf life in days
Tertiary Transportation / Shipping RestrictionsAny known transportation/shipping restrictions that may require USG intervention in a future public health emergency
Tertiary HST Code if ImportedHarmonized Tariff Schedule Code
CommentsAny additional essential information recorded as free text for later reference

Component and Services List BARDA Product Name BARDA Product Manufacturer

BARDA Product NameProduct ManufacturerProduction StepSelf-ID Critical/Non-CriticalSource AvailabilityCategorySupply DescriptionUnit(s)Minimum Quantity StockedMinimum Quantity AnnuallyQuantity Per Batch of Final DosesStorage ConditionsMaterial StatePackagingPrimary DistributorPrimary Distributor Geographical AddressPrimary SupplierPrimary Supplier Geographical AddressPrimary ManufacturerPrimary Manufacturer Geographical AddressPrimary Manufacturer Part #Primary Lead time (Days)Primary Shelf Life (Days)Primary Transportation / Shipping RestrictionsPrimary HTS Code if ImportedSecondary DistributorSecondary Distributor Geographical AddressSecondary SupplierSecondary Supplier Geographical AddressSecondary ManufacturerSecondary Manufacturer Geographical AddressSecondary Manufacturer Part #Secondary Lead time (Days)Secondary Shelf Life (Days)Secondary Transportation / Shipping RestrictionsSecondary HST Code if ImportedTertiary DistributorTertiary Distributor Geographical AddressTertiary SupplierTertiary Supplier Geographical AddressTertiary ManufacturerTertiary Manufacturer Geographical AddressTertiary Manufacturer Part #Tertiary Lead time (Days)Tertiary Shelf Life (Days)Tertiary Transportation / Shipping RestrictionsTertiary HST Code if ImportedComments
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Categories - Do Not Change

Production_StepSelf_ID_Critical_NonCriticalSource_AvailabilityCategoryUoMStorage_ConditionsMaterial_State
AdjuvantCriticalMultiple SourcesActive Ingredientcase(-) 20 Cgas
Analytical TestingNon-CriticalSingle SourceAnalytical & Environmental Componentryfeet(-) 80 Cliquid
Cell BankingSole SourceAnalytical Reagents & Consumablesgrams2-8 Csolid
Drug ProductExcipientkilogramsAmbient
Drug SubstanceMachinery pieces/parts requiring replacement during processlitersControlled Room
Formulation DevelopmentMaterial Consumablemeters
Labeling or PackagingPrimary Packagingmilligrams
OtherRaw Materialmilliliters
Process DevelopmentSecondary Packagingpiece
SterilizationService - CDMOyard
WarehouseService - QA/QC
Service - Sterilization
Single-Use System
Software/firmware
Utility Materials

Comments Comment or Question Resolution Applies To

Internal Data Cleaning

BARDA Product NameProduct ManufacturerProduction StepSelf-ID Critical/Non-CriticalSource AvailabilityCategorySupply DescriptionM&R Internal DescriptionM&R Internal SubdescriptionUnit(s)Minimum Quantity StockedMinimum Quantity AnnuallyQuantity Per Batch of Final DosesStorage ConditionsMaterial StatePackagingPrimary SupplierPrimary Distributor Geographical AddressPrimary Supplier Geographical AddressPrimary Manufacturer Geographical AddressPrimary Manufacturer Part #Primary Lead time (Days)Primary Shelf Life (Days)Primary Transportation / Shipping RestrictionsPrimary HTS Code if ImportedSecondary SupplierSecondary Distributor Geographical AddressSecondary Supplier Geographical AddressSecondary Manufacturer Geographical AddressSecondary Manufacturer Part #Secondary Lead time (Days)Secondary Shelf Life (Days)Secondary Transportation / Shipping RestrictionsSecondary HST Code if ImportedTertiary SupplierTertiary Distributor Geographical AddressTertiary Supplier Geographical AddressTertiary Manufacturer Geographical AddressTertiary Manufacturer Part #Tertiary Lead time (Days)Tertiary Shelf Life (Days)Tertiary Transportation / Shipping RestrictionsTertiary HST Code if ImportedComments
AdjuvantCriticalMultiple SourcesRaw materialClampsEggsfeet(-) 80 C
Drug ProductNon-CriticalSingle SourceSecondary PackagingBottlesliters2-8 C
Drug SubstanceSole SourceExcipientFlaskspieceAmbient
Sterilization - e-beamCartons3D bagkilograms
Sterilization - EtO
Sterilization - GammaBags
Sterilization - Other
Sterilization - X-ray
Bags

File details come from the government source that posted it. Updated .