06-75A50126R00001_RFP Att 5 BARDA Dose Tracker Template.xlsx

XLSX spreadsheet 115 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 Dose Tracker Template designed by the U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), and Biomedical Advanced Research and Development Authority (BARDA) for contractors to report manufacturing and inventory data for vaccines, therapeutics, and hyperimmune globulins. The template, Version 3.2 dated August 20, 2025, serves as a standardized Excel workbook for capturing real-time production metrics across multiple manufacturing stages, with data classified as FOUO, Proprietary, and Company Confidential.

The template comprises multiple interconnected tabs organized by color-coding to indicate update frequency and purpose. Green informational tabs include the introduction and dictionary; blue occasional-update tabs cover Master Data, SKU Lookup, and Dose Projections; orange daily-update tabs track Bulk Drug Substance, Filled Drug Product, Final Released Product, Inventory, Reallocation, and Shipped data; and black reference tabs provide validation values. Contractors must complete Master Data with organization, location, and facility capability details; SKU Lookup with product component information including unit measures, dose targets, and FDA approval status; and operational tabs recording lot numbers, quantities produced, manufacturing dates, potency assay results, expiration dates, and internal lot release dates. The template calculates projected doses using bulk potency assumptions, loss factors, and variance data. The Inventory tab captures point-in-time stock levels by lot and location, while the Reallocation tab accounts for product diverted to clinical trials, stability studies, or destroyed due to damage or expiration. The Shipped tab documents actual distribution with bill of lading information, carrier details, and consignee information. Data submission timing and refresh rates will be provided by the Contracting Officer's Representative (COR), with all submissions combining contractor data for centralized BARDA reporting to leadership.

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Other files

File Type Posted
01-75A50126R00001_RFP_Final.pdf PDF
21_75A50126R00001_RFP_0001_RFP File 2 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 3 of 3.pdf PDF
21_75A50126R00001_RFP_0001_RFP File 1 of 3.pdf PDF
20_75A50126R00001_RFP_0001.SF30.pdf PDF
14-75A50126R00001_RFP Att 14 Past Perfomance Questionnaire Template.docx DOCX document
13-75A50126R00001_RFP Att 13 Risk Mitigation Plan Matrix Template.docx DOCX document
01-75A50126R00001_RFP_Final.pdf PDF
19_75A50126R0001_RFP Att 19 Surge Manufacturing and Supply Chain Readiness Assessment.pdf PDF
18-75A50126R00001_RFP Att 18 BCP SCP Continuity Plans.pdf PDF
16-75A50126R00001_RFP Att 16 Bill of Materials (BOM) Template.xlsx XLSX spreadsheet
12-75A50126R00001_RFP Att 12 HHS Subcontracting Plan Template.docx DOCX document
11-75A50126R00001_RFP Att 11 SF LLL Disclosure of Lobbying Activities Form Instructions.pdf PDF
05-75A50126R00001_RFP Att 4 Agent Request Form.docx DOCX document
03-75A0126R00001_RFP Att 2 ASPR Security Requirements.pdf PDF
10-75A50126R00001_RFP Att 10 SF LLL Disclosure of Lobbying Activities Form.pdf PDF
09-75A50126R00001_RFP Att 9 ACH Vendor Misc Payment Enrollment Form.docx DOCX document
07-75A50126R00001_RFP Att 7 Breakdown of Proposed Costs.xlsx XLSX spreadsheet
04-75A50126R00001_RFP Att 3 Vendor Production Facilities.xlsx XLSX spreadsheet
15-75A50126R00001_RFP Att 15 Contractor Questions.xlsx XLSX spreadsheet
17-75A50126R00001_RFP Att 17 Manufacturing Plan.pdf PDF
08-75A50126R00001_ RFP Att 8 Summary of Related Activities.docx DOCX document
02-75A50126R00001_RFP Att 1 Prod Handling Guidance Don Nat.pdf PDF
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Text version

Intro

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
Please complete as completely as possible and provide updates as necessary. Specific instructions regarding timing and refresh rate will be provided by the COR.
BARDA is using these forms to capture Vaccine, Therapeutic, and Hyperimmune globulin tracking, so some generalizations are unavoidable while these data should be specific enough to identify potential concerns and explain projection-to-actual discrepancies. Certain columns will not be appropriate for particular products (e.g. "Potency Assay 1" is not relevant for Hyperimmune globulin).
Data is intended to be submitted by various manufacturers under contract to BARDA, ASPR and/or DoD using the structure specified. It will then be combined centrally and reported on for BARDA leadership.
Submitted data and all data products will be considered FOUO, Proprietary and Company Confidential.
Tab Color Key
Green - Informational (Intro, Dictionary, Estimated Actual Report Example)
Blue - Occaisional/as-needed updates only (Master Data, SKU Lookup, Dose Projection)
Orange - Potential for daily updates during commercial-scale manufacturing (Bulk, Fill, Final Released, Inventory, Reallocation, Shipped)
Black - Reference/validation, do not edit (Reference Values)
Guidelines
The Dictionary tab gives details on the description and datatype for each field in this template - please reference this for specific guidance.
The first Estimated Actual tab simply gives an example of how this information is to be used; no action is requested.
The Master Data tab presents previously collected data regarding the organization, however needs to be supplemented with updated data. Please complete in full, as many of these items will be used in subsequent tabs as dropdown options.
The SKU Lookup tab, similar to the Master Data tab, will be used to help populate dropdown/lookup values in other tabs. We understand that a full list of SKUs may be unavailable initially and that this data would be filled in over time.
The Dose Projection Template tab provides a simplified table for reporting your manufacturing projections for the remainder of the year. This is used to complete the Projected rows in the Estmated Actual Report. Naturally we expect there will be some variance between this projection and actual manufacturing data.
Bulk, Fill, FinalReleased, Inventory, and Shipped tabs contain the bulk of the data ask. We ask that lot information be recorded as soon as known, and that these tabs become a ledger, including all prior data (except for Inventory, see below). This data ask has been customized to minimize the disruption to the company, and to maximze the amount of data that can be exported directly from ERP/MRP systems.
Inventory tab data should record the inventory at that reported time. That is, it should only report on those lots and volumes/quantities that are in inventory at the time of the "Data reported as of" datetime recorded in the first column.
The Reallocation tab is for recording damaged, expired, non-BARDA market, or other instances where portions of a lot may no longer be available for BARDA. This is to assist with accounting for all product manufacturered, and ensures that data in the BDS, Fill, and Final Released tabs can match quality paperwork - e.g. COA)
Shipped data should only include shipments that have occurred, and not project shipments that will/may occur in the future. Shipped doses plus inventory should equal the total doses manufactured.
The Reference Values tab shows dropdown options for many fields throughout the workbook and should not be edited. If you believe a new value needs to be added, please contact your COR or manufacturing POC who will be able to route your inquiry.
Any questions on this request should be addressed to the COR, who wil be able to appropriately route your inquiry.

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It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Dictionary

Spreadsheet TabFieldNotesResponsesDefinitionRequired/OptionalData Type
Bulk Drug SubstanceData Reported as ofDate at which data was reported (i.e. when the data was confirmed accurate)RequiredDate
Bulk Drug SubstanceLocationFrom Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheetRequiredEnumerated list
Bulk Drug SubstanceStarting Materials Lot #Seed lot or other starting materials lot number used to promulgate bulk lotOptionalText
Bulk Drug SubstanceBDS_SKUFrom SKU Lookup / SKUSelect the appropriate SKU for the Bulk Material being produced and reported in each row. The list of available SKUs is based on the SKUs entered in the SKU Lookup tabRequiredEnumerated list
Bulk Drug SubstanceBDS Lot #Identifier for the batch of Bulk Material being producedRequiredText
Bulk Drug SubstanceVolume On Hand (L)Volume, in liters, of the bulk material produced in the batchRequiredNumeric
Bulk Drug SubstanceExpiration DateExpiration Date of the bulk materials producedRequiredDate
Bulk Drug SubstanceMfg Start DateDate on which manufacturing of bulk drug substance material beganRequiredDate
Bulk Drug SubstanceMfg DateDate of bulk drug substance manufacture (BDS leaves bulk suite)RequiredDate
Bulk Drug SubstancePotency Assay 1The quantity of active ingredient in a batch per ml. The unit of measure (one of: ug. Pfu, or VP) must be the same as set in the Dose Assumption parameter in the [Master Data] sheet.
Required for HHS calculation of projected doses.RequiredNumeric
Bulk Drug SubstancePotency Assay 2 / Titer (Final)Updated Potency Assay if a new value is available. This Potency Assay value will be used for HHS calculation of projected doses if it is providedRequiredNumeric
Bulk Drug SubstanceInternal Lot Release DateDate of manufacturer-internal lot releaseRequiredDate
Bulk Drug SubstanceRemarksAny comments/notesOptionalText
Critical MaterialsProductPrepopulated based on Master Data / Product NameRequiredAuto populated
Critical MaterialsDose AssumptionPrepopulated based on Master Data / Dose AssumptionRequiredAuto populated
Critical MaterialsSupplierFrom Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet.RequiredEnumerated list
Critical MaterialsCritical MaterialCrimp, Seal, Stopper or vialSelect the appropriate critical material from the dropdown menuRequiredEnumerated list
Critical MaterialsProduct DescriptionType or description of the critical materialRequiredText
Critical MaterialsPart NumberSupplier's Part Number / SKU for the Crimp, Seal, Stopper, Vial or other critical material which is designated for COVID-19 responseRequiredText
Critical MaterialsStockpile QuantityCurrent number of Crimps, Seals, Stoppers or Vials in product manufacturer's inventory, set aside for USG COVID-19 response use, within the manufacturer's control as of the reporting dateRequiredNumeric
Critical MaterialsPurchase StatusContracted or IdentifiedSelect Contracted if material is formally contracted for

Select Identified if material has been identified but not yet formally contracted for

For material not included in the stockpile quantityRequiredEnumerated list
Critical MaterialsPurchaserVendor or U.S. GovernmentSelect Vendor if company is responsible for procurement from supplier
Select U.S. Government if USG is responsible for procurement from supplier and delivery to companyRequiredEnumerated list
Critical MaterialsWeek startingProjected weekly delivery quantity of the critical material for large scale (non-clinical trial), US government, COVID-19 response use. (Exclude material included in stockpile quantity)RequiredNumeric
Dose ProjectionProductAuto populated. Will match the Product from the Master Data sheetRequiredAuto populated
Dose ProjectionDose AssumptionAuto populated. Will match the Dose Assumption from the Master Data sheetRequiredAuto populated
Dose ProjectionManufacturing Facility (Location)From Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheetRequiredEnumerated list
Dose ProjectionMaterial TypeBulk, FinishedEach Dose Projection line item should be for either Bulk or Finished product.RequiredEnumerated list
Dose ProjectionNDCFrom SKU Lookup / NDCNDC for which Projection is being provided. Must match an NDC in the [SKU Lookup] sheetOptionalText
Dose ProjectionWeek OfFill in projected numbers of projected Dose Equivalents of Bulk and/or Finished product Respectively for each week starting on the date at the top of each 'Week of' column. If the "Dose Projection Tracking Basis" parameter in the [Master Data] sheet is set to "Treatment Course", fill in the number of Treatment Courses trather than doses.RequiredNumeric
Filled Drug ProductData Reported as ofIndicate the date on which the reported data for each row is accurateRequiredDate
Filled Drug ProductLocationFrom Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheetRequiredEnumerated list
Filled Drug ProductFill SKUFrom SKU Lookup / SKUSelect the appropriate SKU for the Filled Drug Product being produced and reported in each row. The list of available SKUs is based on the SKUs entered in the SKU Lookup tabRequiredEnumerated list
Filled Drug ProductDate of Fill StartDate filling of lot begins (may be same as fill completion)RequiredDate
Filled Drug ProductDate of Fill CompletionDate filling of lot is completeRequiredDate
Filled Drug ProductFill Lot #Identifier for the batch of Filled Drug Product being producedRequiredText
Filled Drug ProductFill QtyActual quantity of units included in the Fill Lot, using the same unit defined for the referenced SKU. For instance if, the SKU references Vials (which is typical) then this is the number of vials in the Fill Lot.RequiredNumeric
Filled Drug ProductRemarksOptionalText
Final ReleasedData Reported as ofIndicate the date on which the reported data for each row is accurateRequiredDate
Final ReleasedLocationFrom Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheetRequiredEnumerated list
Final ReleasedFinal / FDP SKUFrom SKU Lookup / SKUSelect the appropriate SKU for the Final Released Drug Product being produced and reported in each row. The list of available SKUs is based on the SKUs entered in the SKU Lookup tabRequiredEnumerated list
Final ReleasedPredecessor Fill Lot #From Fill / Fill Lot #The lot number of the fill lot that becomes this final lotRequiredEnumerated list
Final ReleasedFinal / FDP Lot #Identifier for the batch of Final Released Drug Product being producedRequiredText
Final ReleasedFinish / FDP QtyActual quantity of units included in the Final Lot, using the same unit defined for the referenced SKU. For instance if, the SKU references Cartons (which is typical) then this is the number of cartons in the Final Lot.RequiredNumeric
Final ReleasedFDA Lot Submission DateDate samples of lot are sent to FDA for confirmatory testingRequiredDate
Final ReleasedFDA Lot Approval DateDate on which FDA Approval was granted for each listed Final Released Drug Product FDP Lot (batch) of the listed SKU.RequiredDate
Final ReleasedExpiration DateLot expiry date noted on final packageRequiredDate
Final ReleasedManufacture DateDate of Final Drug Product ManufactureRequiredDate
Final ReleasedManufacturer Release DateDate of Final Drug Product release by ManufacturerRequiredDate
Final ReleasedRemarksOptionalText
ReallocationLocationFrom Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheetRequiredEnumerated list
ReallocationLot #Must be a valid Lot Number, one of: Bulk, Fill, FinalSelect the Lot (Bulk, Fill, or Final) affected by the ReallocationRequiredText
ReallocationReallocation TypeFrom reference list of Reallocation TypesIdentify the end point of the reallocated quantity, such as clinical trialsRequiredEnumerated list
ReallocationDateDate of reallocation eventRequiredDate
ReallocationQuantityQuantity (in unit of SKU) of Final product reallocatedRequiredInteger
ReallocationRemarksFree text remarksOptionalText
ReallocationSKUFrom SKU Lookup / SKUSKU of the material ReallocatedRequiredEnumerated list
InventoryData Reported as ofIndicate the date on which the reported data for each row is accurateRequiredDate
InventoryLocationFrom Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheetRequiredEnumerated list
InventoryMaterial SKUFrom SKU Lookup / SKUSelect the appropriate SKU for the Final Released Drug Product captured in each row of the inventory.
The list of available SKUs is based on the SKUs entered in the SKU Lookup tabRequiredEnumerated list
InventoryLot #Lot number in inventory (can be bulk, fill, or final)RequiredText
InventoryStorage Location Within FacilityIndicate where in the storage facility the material in this row is locatedRequiredText
InventoryInventory on HandQuantity of material on hand for this row's SKU and LotRequiredNumeric
InventoryUnits of Inventory on HandDropped, do not fill in[Instead of using a unit value from here, the Units of Inventory in hand are defined per the referened SKU. For instance, if the SKU is based on cartons, then the quantity of inventory should be entered in cartons.]RequiredText
InventoryRemarksOptionalText
Manufacturing CapacityProductPrepopulated based on Master Data / Product NameRequiredAuto populated
Manufacturing CapacityDose AssumptionPrepopulated based on Master Data / Dose AssumptionRequiredAuto populated
Manufacturing CapacityManufacturing Facility (Location)From Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheetRequiredEnumerated list
Manufacturing CapacityMaterial TypeBulk or FinishedRequiredEnumerated list
Manufacturing CapacityStatusReserved or Unreserved / AvailableContractual or other availability of location performing the workRequiredEnumerated list
Manufacturing CapacityBatch ScaleSize of each batch. For instance, a 200 liter batch has a batch size of 200.RequiredNumeric
Manufacturing CapacityUnitUnit of measure for each batch. For instance, a 200 liter batch has a Unit of L. If the vendor needs to enter a unit beyond the set of available choices, please provide information about the proposed unit, and BARDA will provide instructions on how to update the templateRequiredText
Manufacturing CapacityWeek StartingProjected Manufacturing Capacity represented as the number of batches of the product/material each week starting on the date at the top of each 'Week Starting' column. May be expressed as a decimalRequiredNumeric
Master DataContract #Contract number for the product manufacturing processRequiredText
Master DataVendor CompanyName of the parent company/prime contractor associated with the contract. The parent company may have multiple company locations tracked in this spreadsheet.RequiredText
Master DataTask Order # (if applicable)Task Order for the Contract NumberOptionalText
Master DataMfr_Template_Id (do not edit)Pre-Populated to support the data aggregation process. Do not change this numberRequiredNumeric
Master DataProduct NameProduct NameRequiredText
Master DataProduct TypeTherapeutic - Convalescent Plasma, Therapeutic - Hyperimmune Globulin, Therapeutic - Monoclonal Antibody, Therapeutic - Other, Therapeutic - Small Molecule, Vaccine - Cell, Vaccine - Conjugate, Vaccine - DNA, Vaccine - Inactivated, Vaccine - Live Attenuated, Vaccine - mRNA, Vaccine – Other, Vaccine - Recombinant, Vaccine - SubUnit, Vaccine - ToxoidRequiredEnumerated list
Master DataNDC Number (once available)FDA NDC number for the product being producedOptionalText
Master DataDose Assumption / Central EstimateThe quantity of active ingredient, for instance as measured in ug, VP, or pfu, included in one dose of the vaccine. The Central Estimate is required, and should be the vendor's best estimate of the expected dose based on currently available information.RequiredNumeric
Master DataDose Assumption / Lower EstimateThe lowest dose being evaluated in current vaccine trials, or that is otherwise in a realistic range of what could be the final dose after trials are completed.OptionalNumeric
Master DataDose Assumption / Upper EstimateThe highest dose being evaluated in current vaccine trials, or that is otherwise in a realistic range of what could be the final dose after trials are completed.OptionalNumeric
Master DataDose Assumption / UnitUnit of measure for Dose Assumption being one of: ug, pfu, or VP. If the vendor needs to enter the Dose Assumption in a different unit, please provide information about the unit of measure, and BARDA will provide instruction for updating the template.RequiredText
Master DataDose Assumption / Data NoteAny notes specific to dose assumption. For clarity, prefer an explicit textual re-representation of dose and regimen in treatment course (e.g.: Central estimate assumes a 15ug dose administered twice spaced 21 days apart for a total of 30ug antigen delivered in the treatment course)OptionalText
Master DataRegimen / Central EstimateThe number of doses expected to comprise a Course of Treatment of one patient.RequiredNumeric
Master DataRegimen / Lower EstimateThe lowest number of doses required to make up a single treatment courseOptionalNumeric
Master DataRegimen / Upper EstimateThe highest number of doses required to make up a single treatment courseOptionalNumeric
Master DataRegimen / UnitThis unit is always "dose", do not edit.RequiredText
Master DataRegimen / Data NoteSee dose assumption data note.OptionalText
Master Data# Doses in MDV / Central EstimateNumber of full doses in the final vial as will be listed on the package insertRequiredNumeric
Master Data# Doses in MDV / Lower EstimateNot RequiredOptionalNumeric
Master Data# Doses in MDV / Upper EstimateNot RequiredOptionalNumeric
Master Data# Doses in MDV / UnitThis unit is always "dose", do not edit.RequiredText
Master Data# Doses in MDV / Data NoteAny explanatory notes for # of doses in MDVOptionalText
Master DataDS Release Time Fill To Finish / Central EstimateTime, in days, from bulk manufacture to internal lot release of material making it available for formulation/fill/finish activities. Do not account for formulation/filling at-risk; these will be accounted for separatelyRequiredNumeric
Master DataDS Release Time Fill To Finish / Lower EstimateNot RequiredOptionalNumeric
Master DataDS Release Time Fill To Finish / Upper EstimateNot RequiredOptionalNumeric
Master DataDS Release Time Fill To Finish / UnitThis unit is always "day", do not edit.RequiredNumeric
Master DataDS Release Time Fill To Finish / Data NoteAny explanatory notes for timing of bulk to fillOptionalText
Master DataDP release for final distribution / Central EstimateTime, in days, from fill completion to final release (not accounting for potential non-lot-specific delays awaiting FDA approval of product generally)RequiredNumeric
Master DataDP release for final distribution / Lower EstimateNot RequiredOptionalNumeric
Master DataDP release for final distribution / Upper EstimateNot RequiredOptionalNumeric
Master DataDP release for final distribution / UnitThis unit is always "day", do not edit.RequiredText
Master DataDP release for final distribution / Data NoteAny explanatory notes for timing of fill completion to final release (especially if this timing could differ by location)OptionalText
Master DataBulk Loss Factor for Projections / Central EstimateEnter the Bulk Loss Factor used for Dose Projections. This should be entered as a decimal ratio. For instance a 30% loss factor is entered as 0.3.RequiredNumeric
Master DataBulk Loss Factor for Projections / UnitThis unit is always "ratio", do not edit.RequiredText
Master DataBulk Loss Factor for Projections / Data NoteAny explanatory notes for Bulk Loss Factor for ProjectionsOptionalText
Master DataBulk Potency Assumption for Projections / Central EstimatePotency Assumption used in bulk dose projections, entered in the same units as Dose Assumption per milliliter of Bulk Drug SubstanceRequiredNumeric
Master DataBulk Potency Assumption for Projections / UnitThis unit is always the same unit as Dose Assumption, do not edit.RequiredText
Master DataBulk Potency Assumption for Projections / Data NoteAny explanatory notes for Potency Assumption for ProjectionsOptionalText
Master DataOrganization NameName of the company associated with the Contract locationRequiredText
Master DataContractor Entity TypePrime, Sub-contractor, SupplierIndicate if the organization is the Prime contractor or a subcontractor on the contractRequiredEnumerated list
Master DataStreet 1Address information associated the organization /location listed in the Master Data tabRequiredText
Master DataStreet 2Address information associated the organization /location listed in the Master Data tabOptionalText
Master DataCityAddress information associated the organization /location listed in the Master Data tabRequiredText
Master DataState or ProvinceAddress information associated the organization /location listed in the Master Data tabRequiredText
Master DataZip or Postal CodeAddress information associated the organization /location listed in the Master Data tabRequiredText
Master DataCountryAddress information associated the organization /location listed in the Master Data tabRequiredText
Master DataDUNS #Nine digit code used to identify a company and location. The DUNS code for the company and location should be registered with SAMRequiredText
Master DataCAGE CodeFive character alpha numeric idOptionalText
Master DataIsGlobalHQ?Yes, NoYes, if the location is the company's Global HQOptionalYes/No
Master DataIsUSAHQ?Yes, NoYes, if the location is the company's US HQOptionalYes/No
Master DataIsPrimaryAwardedAddress?Yes, NoIs the location the primary location for the contractRequiredYes/No
Master DataLocation POC LastLast name of manufacturing POC at locationRequiredText
Master DataLocation POC FirstFirst name of manufacturing POC at locationRequiredText
Master DataLocation POC EmailEmail address of manufacturing POC at locationRequiredText
Master DataLocation POC PhonePhone Number of manufacturing POC at locationRequiredText
Master DataLaboratory TestingYes, NoYes, if the location can be used for Laboratory Testing for the product associated with the contractRequiredYes/No
Master DataRaw Materials ProductionYes, NoYes, if the location can be used for Raw Materials Production for the product associated with the contractRequiredYes/No
Master DataPrecursor Materials ProductionYes, NoYes, if the location can be used for Precursor Materials Production for the product associated with the contractRequiredYes/No
Master DataDrug Substance (Bulk) ManufacturingYes, NoYes, if the location can be used for Drug Substance (Bulk) Manufacturing for the product associated with the contractRequiredYes/No
Master DataDrug Product (Formulation/Filling) ActivitiesYes, NoYes, if the location can be used for Drug Product (Formulation/Filling) Activities for the product associated with the contractRequiredYes/No
Master DataFinishing ActivitiesYes, NoYes, if the location can be used for Finishing Activities for the product associated with the contractRequiredYes/No
Master DataAdministrativeYes, NoYes, if the location can be used for Administrative activities for the product associated with the contractRequiredYes/No
Master DataNon-Clinical StudiesYes, NoYes, if the location can be used for Non-Clinical Studies for the product associated with the contractRequiredYes/No
Master DataClinical StudiesYes, NoYes, if the location can be used for Clinical Studies for the product associated with the contractRequiredYes/No
Master DataDevice ManufacturingYes, NoYes, if the location can be used for Device Manufacturing for the product associated with the contractRequiredYes/No
Master DataStorage/Stability/ShippingYes, NoYes, if the location can be used for Storage/Stability/Shipping activities for the product associated with the contractRequiredYes/No
Shipped (out of inventory)Data Reported as ofIndicate the date on which the reported data for each row is accurateRequiredDate
Shipped (out of inventory)Location Shipped FromFrom Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheetRequiredEnumerated list
Shipped (out of inventory)BOL Shipment IDBill of Lading shipment identifierRequiredText
Shipped (out of inventory)SKUFrom SKU Lookup / SKUSelect from the SKUs that have been entered on the SKU Lookup tabRequiredEnumerated list
Shipped (out of inventory)ConsigneeEntity financially responsible for receipt of shipment noted on bill of lading. If USG, specify which entity (e.g. HHS/CDC, HHS/BARDA, etc.)RequiredText
Shipped (out of inventory)Ship ToDestination AddressRequiredText
Shipped (out of inventory)Carrier NameShipping Company (e.g. USPS, UPS, FedEx)RequiredText
Shipped (out of inventory)Carrier Alpha CodeFour-digit standard carrier alpha code (SCAC) for carrier (e.g. USPC for the United States Postal Service)RequiredText
Shipped (out of inventory)Trailer NumberIdentifier number of trailer carrying goodsRequiredText
Shipped (out of inventory)Seal NumberSeal number applied when leaving dockRequiredText
Shipped (out of inventory)Shipment DateDate on which the shipment departs the originating location for the destination locationRequiredDate
Shipped (out of inventory)Packing List IDDelivery / Packing List IDRequiredText
Shipped (out of inventory)Customer PO #Customer Purchase Order NumberRequiredText
Shipped (out of inventory)QuantityQuantity of product (in units of sale) being shippedRequiredText
Shipped (out of inventory)Lot NumberLot number of product being shipped (should match a final lot number)RequiredText
Shipped (out of inventory)Expiration DateLot expiry date noted on final package (should match the value for the lot being shipped)RequiredDate
Shipped (out of inventory)RemarksOptionalText
SKU LookupManufacturerCompany Name. Should match "Organization" from the Master Data tabRequiredText
SKU LookupSKUSKUs associated with products for the contract. A full list of SKUs may be unavailable initially and that this data would be filled in over time.
This should not include Critical Materials.RequiredText
SKU LookupSKU DescriptionDescription of each SKURequiredText
SKU LookupProduct Component TypeBulk, Bulk Adjuvant, Filled Adjuvant, Final Adjuvant, Final Released ProductSelect the appropriate product component type for each listed SKURequiredEnumerated list
SKU LookupProduct ClassificationClinical, CommercialIndicate if each SKU is Clinical or CommercialRequiredEnumerated list
SKU LookupHigh VarianceBulk OnlyDose conversion variance for use in bulk to filled dose formula. Account for variability in assay. Expressed as a percentage, e.g. 125%RequiredNumeric
SKU LookupLow VarianceBulk OnlyDose conversion variance for use in bulk to filled dose formula. Account for variability in assay. Expressed as a percentage, e.g. 75%RequiredNumeric
SKU LookupLoss FactorBulk and Fill OnlyRequired for HHS calculation of projected doses. Percentage of the total volume or units that can be expected to be lost, wasted or unusable at the completion of the production process.
((Volume*Potency Assay)/Dose)*(1-Loss Factor)=Projected Final DosesRequiredNumeric
SKU LookupUnit of SKUUnit of measure used to quantify any lots referencing this SKURequiredText
SKU LookupPresentationFill and Final OnlyFinal Container, e.g. Multi-Dose Vial (MDV), Pre-Filled Syringe (PFS), Nasal Sprayer, Jet InjectorRequiredText
SKU LookupDoses Per UnitFill and Final OnlyNumber of doses included in each unit of sale. e.g. 10 if the Unit of sale is Ten-pack single doses pre-filled syringeRequiredNumeric
SKU LookupDose/Concentration TargetFill and Final OnlyExpected (and eventually FDA-confirmed) dose target as noted on package insert. Required for HHS calculation of projected doses.RequiredNumeric
SKU LookupDose Target UnitsFill and Final OnlyUnits of dose target (e.g. ug, VP, or pfu). Required for HHS calculation of projected doses.RequiredText
SKU LookupFDA ApprovalFinal Product OnlyApproved, Emergency Use Authorization, Pending Approval, Pending Emergency Use AuthorizationCurrent FDA approval for the product. Select from list.RequiredEnumerated list
SKU LookupAge IndicationFinal Product OnlyAge indication of product. If pre-approval, list age indication sought and update upon FDA approval.RequiredText
SKU LookupSubtypeSubtype of disease that is targetedEnumerated list
SKU LookupStrainStrain that is targetedText
SKU LookupCandidate Vaccine VirusSpecific virus used to create the seed or bulkText
SKU LookupRegimenFinal Product OnlyNumber of doses in a treatment courseInteger
SKU LookupBDS Release Days To FinishBulk OnlyNumber of days from Bulk Lot release to Manufacture of FinalInteger
SKU LookupFDP Days to Final ReleaseFinal Product OnlyNumber of days from Manufacture of Final to releaseInteger
SKU LookupSeparate Adjuvant RequiredFinal Product OnlyIndicate if a separate adjuvant is required for the productYes/No
SeedData Reported as ofIndicate the date on which the reported data for each row is accurateRequiredDate
SeedLocationFrom Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheetRequiredEnumerated list
SeedSeed_SKUFrom SKU Lookup / SKUSelect the appropriate SKU for the Seed Material being produced and reported in each row. The list of available SKUs is based on the SKUs entered in the SKU Lookup tabRequiredEnumerated list
SeedSeed Lot #Identifier for the batch of Seed Material being producedRequiredText
SeedCandidate Vaccine VirusLong form identifier of Candidate Vaccine Virus used to generate Seed LotRequiredText
SeedVolume Manufactured (L)NEEDS REVIEW: Volume of seed material generated (need to change to number of ampules or some other quantity metric)RequiredNumeric
SeedCVV SourceLocation, including lab, the CVV was received from (or "Self" if generated internally). Should match a lab listed in the WHO Influenza Virus Traceability Mechanism.RequiredText
SeedDate CVV Received / GeneratedDate the Candidate Vaccine Virus was received by company or was generatedRequiredDate
SeedDate Seed ProducedDate Working Seed ProducedRequiredDate
SeedDate Seed Sent to FDADate Working Seed Sent to FDARequiredDate
SeedDate FDA Certified SeedDate of FDA Certification of Working SeedRequiredDate
SeedDate CDC Concurs on SeedDate of CDC Concurrence of Working SeedRequiredDate
SeedRemarksOptionalText
StabilityData Reported as ofIndicate the date on which the reported data for each row is accurateRequiredDate
StabilityLocationFrom Master Data / Location Composite NameSelect the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheetRequiredEnumerated list
StabilityMaterial SKUFrom SKU Lookup / SKUSelect the appropriate SKU for the Bulk Drug Substance, Filled Drug Product, or Final Released Drug Product captured in each row of the Stability table.
The list of available SKUs is based on the SKUs entered in the SKU Lookup tabRequiredEnumerated list
StabilityLot #Lot number in stability testing (can be bulk, fill, or final)RequiredText
StabilityLot TypeBulk, Fill, FinalType of LotRequiredEnumerated list
StabilityStability DateDate stability value is takenRequiredDate
StabilityStability ValueMeasured stability value for this lot (in mcg/ml)RequiredNumeric
StabilityStability StudyRef Stability Study / Stability Study NumberIdentifying number for the stability study; must be consistent for all lots in the same study, and should be unique compared to all other studies.RequiredEnumerated list
StabilityRemarksFree text remarksOptionalText
Stability StudyStability Study NumberUnique number of the stability studyRequiredText
Stability StudyStability Study DescriptionDescription of stability study (longer form identifier)RequiredText
Stability StudyRemarksFree text remarksOptionalText

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Master Data

Dose Tracking TemplateEnter just one Contract # / Task # and just one Product, plus a collection of Locations supporting manufacture of that product
US Department of Health and Human Services, ASPR/BARDAInitial locations have been generated from previously submitted data, where available. First line is for sample values.
Template Version 3.2 August 20, 2025Mfr_Template_Id (do not edit)99
All information submitted is Company Confidential
Contract #HHSO1TESTTESTTESTCParameterCentral EstimateLower EstimateUpper EstimateUnitData Note
Vendor CompanyTest CompanyBulk Loss Factor for Projectionsratio
Task Order # (if applicable)Dose Projection Tracking BasisDose
Product NameTestBulk Potency Assumption for Projectionsug/ml
Product TypeVaccine - Cell
Location #Location Composite NameOrganization NameContractor Entity TypeStreet 1Street 2CityState or ProvinceZip or Postal CodeCountryDUNS #CAGE CodeIsGlobalHQ?IsUSAHQ?IsPrimaryAwardedAddress?Location POC LastLocation POC FirstLocation POC EmailLocation POC PhoneLaboratory TestingRaw Materials ProductionPrecursor Materials ProductionDrug Substance (Bulk) ManufacturingDrug Product (Formulation/Filling) ActivitiesFinishing ActivitiesAdministrativeNon-Clinical StudiesClinical StudiesDevice ManufacturingStorage/Stability/Shipping
1TESTTEST Inc.Prime1234 Main StreetCambridgeMA02139USA99999999TEST1NoYesYesTestTesttest@sdw.comYesNoNoYesYesYesNoNoNoNoYes
2
3
4
5
6
7
8
9

To add a line in addition to the lines provided, INSERT above the last line

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

&"Arial,Regular"&08&I&K000000The information in this document is proprietary to Leidos.

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

mailto:test@sdw.com SKU Lookup

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
Bulk OnlyBulk OnlyBulk OnlyFill and Final OnlyFill and Final OnlyFinal Product OnlyFinal Product OnlyFinal Product OnlyBulk OnlyFinal Product OnlyFinal Product Only
ManufacturerSKUSKU DescriptionProduct Component TypeProduct ClassificationNDCHigh VarianceLow VarianceLoss FactorUnit of SKUPresentationDoses Per UnitDose TargetDose Target UnitsFDA ApprovalAge IndicationSubtypeStrainCandidate Vaccine VirusRegimenBDS Release Days To FinishFDP Days to Final ReleaseSeparate Adjuvant Required
TestFinalSKU01Test FinalFinal/Released ProductCommercialTest-Final-TestC-99464543CartonCarton of MDVs1007.5ug6mo+H5N12020TestStrain012No
TestFillSKU01Test FillFillCommercialTest-Fill-TestC-88553344VialMDV107.5ugH5N12020TestStrain01
TestSeedSKU01Test SeedSeedClinicalTest-Seed-TestC-88994466mlH5N12020TestStrain01TEST/Virus
TestFillSKU-ADJTest Filled AdjuvantFilled AdjuvantClinicalTest-Adjuvant-TestC-88779955VialVial207.5ml
TestBULKSKU-ADJTest Bulk AdjuvantBulk AdjuvantClinicalTest-Adjuvant-TestC-2233558810%kg0.8ml
TestBULKSKU01Test BulkBulkClinicalTest-Bulk-TestC-22335589125%75%40%kg7.5ugH5N12020TestStrain01

To add a line in addition to the lines provided, INSERT above the last line

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Seed

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
Data Reported as ofLocationSeed_SKUSeed Lot #Quantity ProducedCVV SourceDate Seed ProducedSeed Certification DateRemarksLot OwnerContract NumberRequisitionExpiration Date
4/30/24TestSeedSKU01138645105WHO Collaborating Centre - CDC8/27/121/31/13TestHHSN/AN/A

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Bulk Drug Substance

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
Data Reported as ofLocationStarting Materials Lot #BDS_SKUBDS Lot #Quantity ProducedExpiration DateMfg Start DateMfg DatePotency Assay 1Potency Assay 2 / Titer (Final)Internal Lot Release DateRemarksProjected Dose TotalLot OwnerContract NumberRequisitionStability Lot Number(s)
6/14/26Test138645BULKSKU01256279-15012/3/286/3/231016/20/23Test1c404,000HHSHHSO1TESTTESTTESTCASP123456256279-1
6/14/26Test138645BULKSKU01256279-24012/3/286/4/231206/21/23Test1c384,000HHSHHSO1TESTTESTTESTCASP123456256279-2
6/14/26Test138645BULKSKU01256279-34512/3/286/5/231086/22/23Test1c388,800HHSHHSO1TESTTESTTESTCASP123456256279-1, 256279-2
6/14/26TestBULKSKU-ADJ1234-01606/20/346/20/237/10/23Test1c-Adjuvant75,502HHSHHSO1TESTTESTTESTCASP999999N/A – Adjuvant

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Filled Drug Product

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
Data Reported as ofLocationFill SKUDate of Fill StartDate of Fill CompletionFill Lot #Fill QtyRemarksProjected Fill Start DateProjected Fill QuantityLot OwnerContract NumberRequisitionExpiration Date
6/14/24TestFillSKU016/8/246/8/2418903236,000TestHHSHHSO1TESTTESTTESTCTest111cc6/8/27

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Final Released

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
Data Reported as ofLocationFinal / FDP SKUPredecessor Fill Lot #Final / FDP Lot #Finish / FDP QtyFDA Lot Submission DateFDA Lot Approval DateExpiration DateManufacture DateManufacturer Release DateRemarksTarget Release DateTarget Finish FDP QtyLot OwnerContract NumberRequisition
3/6/24TestFinalSKU011890321900392,4007/23/244/1/284/1/254/20/25Test1cHHSHHSO1TESTTESTTESTCTest111cc

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Stability

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
Data Reported as ofLocationLot #Lot TypeStability DateStability ValueStability StudyRemarks
6/20/24Test256279-1Bulk6/20/24992020TestStrain01 SRID0M
9/20/24Test256279-1Bulk9/20/24942020TestStrain01 SRID3M
12/20/24Test256279-1Bulk12/20/24972020TestStrain01 SRID6M
6/20/25Test256279-1Bulk6/20/25892020TestStrain01 SRID12M
9/20/24Test256279-2Bulk6/20/241162020TestStrain01 SRID0M
9/20/24Test256279-2Bulk9/20/241082020TestStrain01 SRID3M
12/20/24Test256279-2Bulk12/20/241122020TestStrain01 SRID6M
6/20/25Test256279-2Bulk6/20/251022020TestStrain01 SRID12M
11/30/22Test189032Fill12/8/24202020TestStrain01 Fill6M

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Stability Study

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
Stability Study NumberStability Study DescriptionRemarksUse for Stability Calcs
12020TestStrain01 SRIDBulkYes
22020TestStrain01 HPLCBulkNo
32020TestStrain01 FillFillYes

Reallocation

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
LocationLot #Reallocation TypeDateQuantityRemarksSKU
TEST190039Clinical Trials10/13/245FinalSKU01
TEST256279-1Stability Study10/13/242Support 5yr extension to the stability studyBULKSKU01
TEST256279-2Stability Study10/14/243Support 5yr extension to the stability studyBULKSKU01

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Inventory

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
Data Reported as ofLocationSKULot #Storage Location Within FacilityInventory on HandLeave blank, Was: Units of Inventory on HandRemarks
5/15/26TESTFillSKU0118903212,000
5/15/26TESTFinalSKU011900392,395
5/15/26TESTBULKSKU01256279-148
5/15/26TESTBULKSKU01256279-237
5/15/26TESTBULKSKU01256279-3- 0Used to Fill Lot 189032
5/15/26TESTBULKSKU-ADJ1234-0160

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Shipped (out of inventory)

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
Data Reported as ofLocation Shipped FromBOL Shipment IDSKUConsigneeShip ToCarrier NameCarrier Alpha CodeCarrier Tracking NumberTrailer NumberSeal NumberShipment DatePacking List IDCustomer PO #Customer PO Line #QuantityLot NumberExpiration DateRemarksSpecial Case

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

Reference Values

Dose Tracking Template
US Department of Health and Human Services, ASPR/BARDA
Template Version 3.2 August 20, 2025
All information submitted is Company Confidential
DO NOT EDIT ANY VALUES IN THIS SHEET
Product TypeBulk or FinishedDose UnitProduct Component TypeProduct ClassificationFDA ApprovalStatusBooleanContractor_TypeCritical MaterialPurchaserPurchase StatusDose UnitSKU UnitYes/NoShipment Special CaseDose Tracking BasisReallocation TypeReallocation Lot Type
Therapautic - Convalescent PlasmaBulkProjected Bulk (final dose equivalents)SeedClinicalApprovedReservedYesPrimeCrimpU.S. GovernmentContractedpfuCartonNoReplace Damaged ProductDoseApproved For DestructionBulk
Therapautic - Hyperimmune GlobulinFinishedProjected Finished Container (dose equivalent)BulkCommercialEmergency Use AuthorizationUnreserved/AvailableNoSub-contractorSealVendorIdentifiedugdoseYesTreatment CourseClinical TrialsFill
Therapautic - Monoclonal AntibodyAdjuvantBulk AdjuvantPending ApprovalSupplierStopperVPgClinical Trials USG PaidFinal
Therapeutic - OtherFillPending Emergency Use AuthorizationVialkgDamagedSeed
Therapautic - Small MoleculeFilled AdjuvantLExpired
Vaccine - CellFinal AdjuvantmgNon-BARDA Market
Vaccine - ConjugateFinal/Released ProductmlQuarantine
Vaccine - DNASyringeStability Study
Vaccine - InactivatedVial
Vaccine - Live Attenuated
Vaccine - mRNA
Vaccine - Other
Vaccine - Recombinant
Vaccine - SubUnit
Vaccine - Toxoid

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Arial,Regular"&09&I&K000000Leidos Proprietary

&"Calibri,Regular"&10

&"Calibri,Regular"&10

It may not be used, reproduced, disclosed, or exported without the written approval of Leidos.

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