06-75A50126R00001_RFP Att 5 BARDA Dose Tracker Template.xlsx
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- 75A50126R00001_RFP_NPIVS_27
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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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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&"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.
Dictionary
| Spreadsheet Tab | Field | Notes | Responses | Definition | Required/Optional | Data Type | |
| Bulk Drug Substance | Data Reported as of | Date at which data was reported (i.e. when the data was confirmed accurate) | Required | Date | |||
| Bulk Drug Substance | Location | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet | Required | Enumerated list | ||
| Bulk Drug Substance | Starting Materials Lot # | Seed lot or other starting materials lot number used to promulgate bulk lot | Optional | Text | |||
| Bulk Drug Substance | BDS_SKU | From SKU Lookup / SKU | Select 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 tab | Required | Enumerated list | ||
| Bulk Drug Substance | BDS Lot # | Identifier for the batch of Bulk Material being produced | Required | Text | |||
| Bulk Drug Substance | Volume On Hand (L) | Volume, in liters, of the bulk material produced in the batch | Required | Numeric | |||
| Bulk Drug Substance | Expiration Date | Expiration Date of the bulk materials produced | Required | Date | |||
| Bulk Drug Substance | Mfg Start Date | Date on which manufacturing of bulk drug substance material began | Required | Date | |||
| Bulk Drug Substance | Mfg Date | Date of bulk drug substance manufacture (BDS leaves bulk suite) | Required | Date | |||
| Bulk Drug Substance | Potency Assay 1 | The 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. | Required | Numeric | |||||
| Bulk Drug Substance | Potency 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 provided | Required | Numeric | |||
| Bulk Drug Substance | Internal Lot Release Date | Date of manufacturer-internal lot release | Required | Date | |||
| Bulk Drug Substance | Remarks | Any comments/notes | Optional | Text | |||
| Critical Materials | Product | Prepopulated based on Master Data / Product Name | Required | Auto populated | |||
| Critical Materials | Dose Assumption | Prepopulated based on Master Data / Dose Assumption | Required | Auto populated | |||
| Critical Materials | Supplier | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet. | Required | Enumerated list | ||
| Critical Materials | Critical Material | Crimp, Seal, Stopper or vial | Select the appropriate critical material from the dropdown menu | Required | Enumerated list | ||
| Critical Materials | Product Description | Type or description of the critical material | Required | Text | |||
| Critical Materials | Part Number | Supplier's Part Number / SKU for the Crimp, Seal, Stopper, Vial or other critical material which is designated for COVID-19 response | Required | Text | |||
| Critical Materials | Stockpile Quantity | Current 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 date | Required | Numeric | |||
| Critical Materials | Purchase Status | Contracted or Identified | Select 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 quantity | Required | Enumerated list | |||||
| Critical Materials | Purchaser | Vendor or U.S. Government | Select Vendor if company is responsible for procurement from supplier | ||||
| Select U.S. Government if USG is responsible for procurement from supplier and delivery to company | Required | Enumerated list | |||||
| Critical Materials | Week starting | Projected 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) | Required | Numeric | |||
| Dose Projection | Product | Auto populated. Will match the Product from the Master Data sheet | Required | Auto populated | |||
| Dose Projection | Dose Assumption | Auto populated. Will match the Dose Assumption from the Master Data sheet | Required | Auto populated | |||
| Dose Projection | Manufacturing Facility (Location) | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet | Required | Enumerated list | ||
| Dose Projection | Material Type | Bulk, Finished | Each Dose Projection line item should be for either Bulk or Finished product. | Required | Enumerated list | ||
| Dose Projection | NDC | From SKU Lookup / NDC | NDC for which Projection is being provided. Must match an NDC in the [SKU Lookup] sheet | Optional | Text | ||
| Dose Projection | Week Of | Fill 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. | Required | Numeric | |||
| Filled Drug Product | Data Reported as of | Indicate the date on which the reported data for each row is accurate | Required | Date | |||
| Filled Drug Product | Location | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet | Required | Enumerated list | ||
| Filled Drug Product | Fill SKU | From SKU Lookup / SKU | Select 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 tab | Required | Enumerated list | ||
| Filled Drug Product | Date of Fill Start | Date filling of lot begins (may be same as fill completion) | Required | Date | |||
| Filled Drug Product | Date of Fill Completion | Date filling of lot is complete | Required | Date | |||
| Filled Drug Product | Fill Lot # | Identifier for the batch of Filled Drug Product being produced | Required | Text | |||
| Filled Drug Product | Fill Qty | Actual 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. | Required | Numeric | |||
| Filled Drug Product | Remarks | Optional | Text | ||||
| Final Released | Data Reported as of | Indicate the date on which the reported data for each row is accurate | Required | Date | |||
| Final Released | Location | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet | Required | Enumerated list | ||
| Final Released | Final / FDP SKU | From SKU Lookup / SKU | Select 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 tab | Required | Enumerated list | ||
| Final Released | Predecessor Fill Lot # | From Fill / Fill Lot # | The lot number of the fill lot that becomes this final lot | Required | Enumerated list | ||
| Final Released | Final / FDP Lot # | Identifier for the batch of Final Released Drug Product being produced | Required | Text | |||
| Final Released | Finish / FDP Qty | Actual 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. | Required | Numeric | |||
| Final Released | FDA Lot Submission Date | Date samples of lot are sent to FDA for confirmatory testing | Required | Date | |||
| Final Released | FDA Lot Approval Date | Date on which FDA Approval was granted for each listed Final Released Drug Product FDP Lot (batch) of the listed SKU. | Required | Date | |||
| Final Released | Expiration Date | Lot expiry date noted on final package | Required | Date | |||
| Final Released | Manufacture Date | Date of Final Drug Product Manufacture | Required | Date | |||
| Final Released | Manufacturer Release Date | Date of Final Drug Product release by Manufacturer | Required | Date | |||
| Final Released | Remarks | Optional | Text | ||||
| Reallocation | Location | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet | Required | Enumerated list | ||
| Reallocation | Lot # | Must be a valid Lot Number, one of: Bulk, Fill, Final | Select the Lot (Bulk, Fill, or Final) affected by the Reallocation | Required | Text | ||
| Reallocation | Reallocation Type | From reference list of Reallocation Types | Identify the end point of the reallocated quantity, such as clinical trials | Required | Enumerated list | ||
| Reallocation | Date | Date of reallocation event | Required | Date | |||
| Reallocation | Quantity | Quantity (in unit of SKU) of Final product reallocated | Required | Integer | |||
| Reallocation | Remarks | Free text remarks | Optional | Text | |||
| Reallocation | SKU | From SKU Lookup / SKU | SKU of the material Reallocated | Required | Enumerated list | ||
| Inventory | Data Reported as of | Indicate the date on which the reported data for each row is accurate | Required | Date | |||
| Inventory | Location | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet | Required | Enumerated list | ||
| Inventory | Material SKU | From SKU Lookup / SKU | Select 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 tab | Required | Enumerated list | |||||
| Inventory | Lot # | Lot number in inventory (can be bulk, fill, or final) | Required | Text | |||
| Inventory | Storage Location Within Facility | Indicate where in the storage facility the material in this row is located | Required | Text | |||
| Inventory | Inventory on Hand | Quantity of material on hand for this row's SKU and Lot | Required | Numeric | |||
| Inventory | Units of Inventory on Hand | Dropped, 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.] | Required | Text | ||
| Inventory | Remarks | Optional | Text | ||||
| Manufacturing Capacity | Product | Prepopulated based on Master Data / Product Name | Required | Auto populated | |||
| Manufacturing Capacity | Dose Assumption | Prepopulated based on Master Data / Dose Assumption | Required | Auto populated | |||
| Manufacturing Capacity | Manufacturing Facility (Location) | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet | Required | Enumerated list | ||
| Manufacturing Capacity | Material Type | Bulk or Finished | Required | Enumerated list | |||
| Manufacturing Capacity | Status | Reserved or Unreserved / Available | Contractual or other availability of location performing the work | Required | Enumerated list | ||
| Manufacturing Capacity | Batch Scale | Size of each batch. For instance, a 200 liter batch has a batch size of 200. | Required | Numeric | |||
| Manufacturing Capacity | Unit | Unit 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 template | Required | Text | |||
| Manufacturing Capacity | Week Starting | Projected 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 decimal | Required | Numeric | |||
| Master Data | Contract # | Contract number for the product manufacturing process | Required | Text | |||
| Master Data | Vendor Company | Name of the parent company/prime contractor associated with the contract. The parent company may have multiple company locations tracked in this spreadsheet. | Required | Text | |||
| Master Data | Task Order # (if applicable) | Task Order for the Contract Number | Optional | Text | |||
| Master Data | Mfr_Template_Id (do not edit) | Pre-Populated to support the data aggregation process. Do not change this number | Required | Numeric | |||
| Master Data | Product Name | Product Name | Required | Text | |||
| Master Data | Product Type | Therapeutic - 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 - Toxoid | Required | Enumerated list | |||
| Master Data | NDC Number (once available) | FDA NDC number for the product being produced | Optional | Text | |||
| Master Data | Dose Assumption / Central Estimate | The 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. | Required | Numeric | |||
| Master Data | Dose Assumption / Lower Estimate | The 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. | Optional | Numeric | |||
| Master Data | Dose Assumption / Upper Estimate | The 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. | Optional | Numeric | |||
| Master Data | Dose Assumption / Unit | Unit 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. | Required | Text | |||
| Master Data | Dose Assumption / Data Note | Any 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) | Optional | Text | |||
| Master Data | Regimen / Central Estimate | The number of doses expected to comprise a Course of Treatment of one patient. | Required | Numeric | |||
| Master Data | Regimen / Lower Estimate | The lowest number of doses required to make up a single treatment course | Optional | Numeric | |||
| Master Data | Regimen / Upper Estimate | The highest number of doses required to make up a single treatment course | Optional | Numeric | |||
| Master Data | Regimen / Unit | This unit is always "dose", do not edit. | Required | Text | |||
| Master Data | Regimen / Data Note | See dose assumption data note. | Optional | Text | |||
| Master Data | # Doses in MDV / Central Estimate | Number of full doses in the final vial as will be listed on the package insert | Required | Numeric | |||
| Master Data | # Doses in MDV / Lower Estimate | Not Required | Optional | Numeric | |||
| Master Data | # Doses in MDV / Upper Estimate | Not Required | Optional | Numeric | |||
| Master Data | # Doses in MDV / Unit | This unit is always "dose", do not edit. | Required | Text | |||
| Master Data | # Doses in MDV / Data Note | Any explanatory notes for # of doses in MDV | Optional | Text | |||
| Master Data | DS Release Time Fill To Finish / Central Estimate | Time, 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 separately | Required | Numeric | |||
| Master Data | DS Release Time Fill To Finish / Lower Estimate | Not Required | Optional | Numeric | |||
| Master Data | DS Release Time Fill To Finish / Upper Estimate | Not Required | Optional | Numeric | |||
| Master Data | DS Release Time Fill To Finish / Unit | This unit is always "day", do not edit. | Required | Numeric | |||
| Master Data | DS Release Time Fill To Finish / Data Note | Any explanatory notes for timing of bulk to fill | Optional | Text | |||
| Master Data | DP release for final distribution / Central Estimate | Time, in days, from fill completion to final release (not accounting for potential non-lot-specific delays awaiting FDA approval of product generally) | Required | Numeric | |||
| Master Data | DP release for final distribution / Lower Estimate | Not Required | Optional | Numeric | |||
| Master Data | DP release for final distribution / Upper Estimate | Not Required | Optional | Numeric | |||
| Master Data | DP release for final distribution / Unit | This unit is always "day", do not edit. | Required | Text | |||
| Master Data | DP release for final distribution / Data Note | Any explanatory notes for timing of fill completion to final release (especially if this timing could differ by location) | Optional | Text | |||
| Master Data | Bulk Loss Factor for Projections / Central Estimate | Enter 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. | Required | Numeric | |||
| Master Data | Bulk Loss Factor for Projections / Unit | This unit is always "ratio", do not edit. | Required | Text | |||
| Master Data | Bulk Loss Factor for Projections / Data Note | Any explanatory notes for Bulk Loss Factor for Projections | Optional | Text | |||
| Master Data | Bulk Potency Assumption for Projections / Central Estimate | Potency Assumption used in bulk dose projections, entered in the same units as Dose Assumption per milliliter of Bulk Drug Substance | Required | Numeric | |||
| Master Data | Bulk Potency Assumption for Projections / Unit | This unit is always the same unit as Dose Assumption, do not edit. | Required | Text | |||
| Master Data | Bulk Potency Assumption for Projections / Data Note | Any explanatory notes for Potency Assumption for Projections | Optional | Text | |||
| Master Data | Organization Name | Name of the company associated with the Contract location | Required | Text | |||
| Master Data | Contractor Entity Type | Prime, Sub-contractor, Supplier | Indicate if the organization is the Prime contractor or a subcontractor on the contract | Required | Enumerated list | ||
| Master Data | Street 1 | Address information associated the organization /location listed in the Master Data tab | Required | Text | |||
| Master Data | Street 2 | Address information associated the organization /location listed in the Master Data tab | Optional | Text | |||
| Master Data | City | Address information associated the organization /location listed in the Master Data tab | Required | Text | |||
| Master Data | State or Province | Address information associated the organization /location listed in the Master Data tab | Required | Text | |||
| Master Data | Zip or Postal Code | Address information associated the organization /location listed in the Master Data tab | Required | Text | |||
| Master Data | Country | Address information associated the organization /location listed in the Master Data tab | Required | Text | |||
| Master Data | DUNS # | Nine digit code used to identify a company and location. The DUNS code for the company and location should be registered with SAM | Required | Text | |||
| Master Data | CAGE Code | Five character alpha numeric id | Optional | Text | |||
| Master Data | IsGlobalHQ? | Yes, No | Yes, if the location is the company's Global HQ | Optional | Yes/No | ||
| Master Data | IsUSAHQ? | Yes, No | Yes, if the location is the company's US HQ | Optional | Yes/No | ||
| Master Data | IsPrimaryAwardedAddress? | Yes, No | Is the location the primary location for the contract | Required | Yes/No | ||
| Master Data | Location POC Last | Last name of manufacturing POC at location | Required | Text | |||
| Master Data | Location POC First | First name of manufacturing POC at location | Required | Text | |||
| Master Data | Location POC Email | Email address of manufacturing POC at location | Required | Text | |||
| Master Data | Location POC Phone | Phone Number of manufacturing POC at location | Required | Text | |||
| Master Data | Laboratory Testing | Yes, No | Yes, if the location can be used for Laboratory Testing for the product associated with the contract | Required | Yes/No | ||
| Master Data | Raw Materials Production | Yes, No | Yes, if the location can be used for Raw Materials Production for the product associated with the contract | Required | Yes/No | ||
| Master Data | Precursor Materials Production | Yes, No | Yes, if the location can be used for Precursor Materials Production for the product associated with the contract | Required | Yes/No | ||
| Master Data | Drug Substance (Bulk) Manufacturing | Yes, No | Yes, if the location can be used for Drug Substance (Bulk) Manufacturing for the product associated with the contract | Required | Yes/No | ||
| Master Data | Drug Product (Formulation/Filling) Activities | Yes, No | Yes, if the location can be used for Drug Product (Formulation/Filling) Activities for the product associated with the contract | Required | Yes/No | ||
| Master Data | Finishing Activities | Yes, No | Yes, if the location can be used for Finishing Activities for the product associated with the contract | Required | Yes/No | ||
| Master Data | Administrative | Yes, No | Yes, if the location can be used for Administrative activities for the product associated with the contract | Required | Yes/No | ||
| Master Data | Non-Clinical Studies | Yes, No | Yes, if the location can be used for Non-Clinical Studies for the product associated with the contract | Required | Yes/No | ||
| Master Data | Clinical Studies | Yes, No | Yes, if the location can be used for Clinical Studies for the product associated with the contract | Required | Yes/No | ||
| Master Data | Device Manufacturing | Yes, No | Yes, if the location can be used for Device Manufacturing for the product associated with the contract | Required | Yes/No | ||
| Master Data | Storage/Stability/Shipping | Yes, No | Yes, if the location can be used for Storage/Stability/Shipping activities for the product associated with the contract | Required | Yes/No | ||
| Shipped (out of inventory) | Data Reported as of | Indicate the date on which the reported data for each row is accurate | Required | Date | |||
| Shipped (out of inventory) | Location Shipped From | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet | Required | Enumerated list | ||
| Shipped (out of inventory) | BOL Shipment ID | Bill of Lading shipment identifier | Required | Text | |||
| Shipped (out of inventory) | SKU | From SKU Lookup / SKU | Select from the SKUs that have been entered on the SKU Lookup tab | Required | Enumerated list | ||
| Shipped (out of inventory) | Consignee | Entity financially responsible for receipt of shipment noted on bill of lading. If USG, specify which entity (e.g. HHS/CDC, HHS/BARDA, etc.) | Required | Text | |||
| Shipped (out of inventory) | Ship To | Destination Address | Required | Text | |||
| Shipped (out of inventory) | Carrier Name | Shipping Company (e.g. USPS, UPS, FedEx) | Required | Text | |||
| Shipped (out of inventory) | Carrier Alpha Code | Four-digit standard carrier alpha code (SCAC) for carrier (e.g. USPC for the United States Postal Service) | Required | Text | |||
| Shipped (out of inventory) | Trailer Number | Identifier number of trailer carrying goods | Required | Text | |||
| Shipped (out of inventory) | Seal Number | Seal number applied when leaving dock | Required | Text | |||
| Shipped (out of inventory) | Shipment Date | Date on which the shipment departs the originating location for the destination location | Required | Date | |||
| Shipped (out of inventory) | Packing List ID | Delivery / Packing List ID | Required | Text | |||
| Shipped (out of inventory) | Customer PO # | Customer Purchase Order Number | Required | Text | |||
| Shipped (out of inventory) | Quantity | Quantity of product (in units of sale) being shipped | Required | Text | |||
| Shipped (out of inventory) | Lot Number | Lot number of product being shipped (should match a final lot number) | Required | Text | |||
| Shipped (out of inventory) | Expiration Date | Lot expiry date noted on final package (should match the value for the lot being shipped) | Required | Date | |||
| Shipped (out of inventory) | Remarks | Optional | Text | ||||
| SKU Lookup | Manufacturer | Company Name. Should match "Organization" from the Master Data tab | Required | Text | |||
| SKU Lookup | SKU | SKUs 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. | Required | Text | |||||
| SKU Lookup | SKU Description | Description of each SKU | Required | Text | |||
| SKU Lookup | Product Component Type | Bulk, Bulk Adjuvant, Filled Adjuvant, Final Adjuvant, Final Released Product | Select the appropriate product component type for each listed SKU | Required | Enumerated list | ||
| SKU Lookup | Product Classification | Clinical, Commercial | Indicate if each SKU is Clinical or Commercial | Required | Enumerated list | ||
| SKU Lookup | High Variance | Bulk Only | Dose conversion variance for use in bulk to filled dose formula. Account for variability in assay. Expressed as a percentage, e.g. 125% | Required | Numeric | ||
| SKU Lookup | Low Variance | Bulk Only | Dose conversion variance for use in bulk to filled dose formula. Account for variability in assay. Expressed as a percentage, e.g. 75% | Required | Numeric | ||
| SKU Lookup | Loss Factor | Bulk and Fill Only | Required 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 Doses | Required | Numeric | |||||
| SKU Lookup | Unit of SKU | Unit of measure used to quantify any lots referencing this SKU | Required | Text | |||
| SKU Lookup | Presentation | Fill and Final Only | Final Container, e.g. Multi-Dose Vial (MDV), Pre-Filled Syringe (PFS), Nasal Sprayer, Jet Injector | Required | Text | ||
| SKU Lookup | Doses Per Unit | Fill and Final Only | Number of doses included in each unit of sale. e.g. 10 if the Unit of sale is Ten-pack single doses pre-filled syringe | Required | Numeric | ||
| SKU Lookup | Dose/Concentration Target | Fill and Final Only | Expected (and eventually FDA-confirmed) dose target as noted on package insert. Required for HHS calculation of projected doses. | Required | Numeric | ||
| SKU Lookup | Dose Target Units | Fill and Final Only | Units of dose target (e.g. ug, VP, or pfu). Required for HHS calculation of projected doses. | Required | Text | ||
| SKU Lookup | FDA Approval | Final Product Only | Approved, Emergency Use Authorization, Pending Approval, Pending Emergency Use Authorization | Current FDA approval for the product. Select from list. | Required | Enumerated list | |
| SKU Lookup | Age Indication | Final Product Only | Age indication of product. If pre-approval, list age indication sought and update upon FDA approval. | Required | Text | ||
| SKU Lookup | Subtype | Subtype of disease that is targeted | Enumerated list | ||||
| SKU Lookup | Strain | Strain that is targeted | Text | ||||
| SKU Lookup | Candidate Vaccine Virus | Specific virus used to create the seed or bulk | Text | ||||
| SKU Lookup | Regimen | Final Product Only | Number of doses in a treatment course | Integer | |||
| SKU Lookup | BDS Release Days To Finish | Bulk Only | Number of days from Bulk Lot release to Manufacture of Final | Integer | |||
| SKU Lookup | FDP Days to Final Release | Final Product Only | Number of days from Manufacture of Final to release | Integer | |||
| SKU Lookup | Separate Adjuvant Required | Final Product Only | Indicate if a separate adjuvant is required for the product | Yes/No | |||
| Seed | Data Reported as of | Indicate the date on which the reported data for each row is accurate | Required | Date | |||
| Seed | Location | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet | Required | Enumerated list | ||
| Seed | Seed_SKU | From SKU Lookup / SKU | Select 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 tab | Required | Enumerated list | ||
| Seed | Seed Lot # | Identifier for the batch of Seed Material being produced | Required | Text | |||
| Seed | Candidate Vaccine Virus | Long form identifier of Candidate Vaccine Virus used to generate Seed Lot | Required | Text | |||
| Seed | Volume Manufactured (L) | NEEDS REVIEW: Volume of seed material generated (need to change to number of ampules or some other quantity metric) | Required | Numeric | |||
| Seed | CVV Source | Location, including lab, the CVV was received from (or "Self" if generated internally). Should match a lab listed in the WHO Influenza Virus Traceability Mechanism. | Required | Text | |||
| Seed | Date CVV Received / Generated | Date the Candidate Vaccine Virus was received by company or was generated | Required | Date | |||
| Seed | Date Seed Produced | Date Working Seed Produced | Required | Date | |||
| Seed | Date Seed Sent to FDA | Date Working Seed Sent to FDA | Required | Date | |||
| Seed | Date FDA Certified Seed | Date of FDA Certification of Working Seed | Required | Date | |||
| Seed | Date CDC Concurs on Seed | Date of CDC Concurrence of Working Seed | Required | Date | |||
| Seed | Remarks | Optional | Text | ||||
| Stability | Data Reported as of | Indicate the date on which the reported data for each row is accurate | Required | Date | |||
| Stability | Location | From Master Data / Location Composite Name | Select the appropriate value from the list. The options are populated based on the Location Composite Name from the Master Data sheet | Required | Enumerated list | ||
| Stability | Material SKU | From SKU Lookup / SKU | Select 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 tab | Required | Enumerated list | |||||
| Stability | Lot # | Lot number in stability testing (can be bulk, fill, or final) | Required | Text | |||
| Stability | Lot Type | Bulk, Fill, Final | Type of Lot | Required | Enumerated list | ||
| Stability | Stability Date | Date stability value is taken | Required | Date | |||
| Stability | Stability Value | Measured stability value for this lot (in mcg/ml) | Required | Numeric | |||
| Stability | Stability Study | Ref Stability Study / Stability Study Number | Identifying number for the stability study; must be consistent for all lots in the same study, and should be unique compared to all other studies. | Required | Enumerated list | ||
| Stability | Remarks | Free text remarks | Optional | Text | |||
| Stability Study | Stability Study Number | Unique number of the stability study | Required | Text | |||
| Stability Study | Stability Study Description | Description of stability study (longer form identifier) | Required | Text | |||
| Stability Study | Remarks | Free text remarks | Optional | Text |
&"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 Template | Enter 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/BARDA | Initial locations have been generated from previously submitted data, where available. First line is for sample values. | ||||||||||||||||||||||||||||
| Template Version 3.2 August 20, 2025 | Mfr_Template_Id (do not edit) | 99 | |||||||||||||||||||||||||||
| All information submitted is Company Confidential | |||||||||||||||||||||||||||||
| Contract # | HHSO1TESTTESTTESTC | Parameter | Central Estimate | Lower Estimate | Upper Estimate | Unit | Data Note | ||||||||||||||||||||||
| Vendor Company | Test Company | Bulk Loss Factor for Projections | ratio | ||||||||||||||||||||||||||
| Task Order # (if applicable) | Dose Projection Tracking Basis | Dose | |||||||||||||||||||||||||||
| Product Name | Test | Bulk Potency Assumption for Projections | ug/ml | ||||||||||||||||||||||||||
| Product Type | Vaccine - Cell | ||||||||||||||||||||||||||||
| Location # | Location Composite Name | Organization Name | Contractor Entity Type | Street 1 | Street 2 | City | State or Province | Zip or Postal Code | Country | DUNS # | CAGE Code | IsGlobalHQ? | IsUSAHQ? | IsPrimaryAwardedAddress? | Location POC Last | Location POC First | Location POC Email | Location POC Phone | Laboratory Testing | Raw Materials Production | Precursor Materials Production | Drug Substance (Bulk) Manufacturing | Drug Product (Formulation/Filling) Activities | Finishing Activities | Administrative | Non-Clinical Studies | Clinical Studies | Device Manufacturing | Storage/Stability/Shipping |
| 1 | TEST | TEST Inc. | Prime | 1234 Main Street | Cambridge | MA | 02139 | USA | 99999999 | TEST1 | No | Yes | Yes | Test | Test | test@sdw.com | Yes | No | No | Yes | Yes | Yes | No | No | No | No | Yes | ||
| 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 Only | Bulk Only | Bulk Only | Fill and Final Only | Fill and Final Only | Final Product Only | Final Product Only | Final Product Only | Bulk Only | Final Product Only | Final Product Only | ||||||||||||
| Manufacturer | SKU | SKU Description | Product Component Type | Product Classification | NDC | High Variance | Low Variance | Loss Factor | Unit of SKU | Presentation | Doses Per Unit | Dose Target | Dose Target Units | FDA Approval | Age Indication | Subtype | Strain | Candidate Vaccine Virus | Regimen | BDS Release Days To Finish | FDP Days to Final Release | Separate Adjuvant Required |
| Test | FinalSKU01 | Test Final | Final/Released Product | Commercial | Test-Final-TestC-99464543 | Carton | Carton of MDVs | 100 | 7.5 | ug | 6mo+ | H5N1 | 2020TestStrain01 | 2 | No | |||||||
| Test | FillSKU01 | Test Fill | Fill | Commercial | Test-Fill-TestC-88553344 | Vial | MDV | 10 | 7.5 | ug | H5N1 | 2020TestStrain01 | ||||||||||
| Test | SeedSKU01 | Test Seed | Seed | Clinical | Test-Seed-TestC-88994466 | ml | H5N1 | 2020TestStrain01 | TEST/Virus | |||||||||||||
| Test | FillSKU-ADJ | Test Filled Adjuvant | Filled Adjuvant | Clinical | Test-Adjuvant-TestC-88779955 | Vial | Vial | 20 | 7.5 | ml | ||||||||||||
| Test | BULKSKU-ADJ | Test Bulk Adjuvant | Bulk Adjuvant | Clinical | Test-Adjuvant-TestC-22335588 | 10% | kg | 0.8 | ml | |||||||||||||
| Test | BULKSKU01 | Test Bulk | Bulk | Clinical | Test-Bulk-TestC-22335589 | 125% | 75% | 40% | kg | 7.5 | ug | H5N1 | 2020TestStrain01 |
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 of | Location | Seed_SKU | Seed Lot # | Quantity Produced | CVV Source | Date Seed Produced | Seed Certification Date | Remarks | Lot Owner | Contract Number | Requisition | Expiration Date |
| 4/30/24 | Test | SeedSKU01 | 138645 | 105 | WHO Collaborating Centre - CDC | 8/27/12 | 1/31/13 | Test | HHS | N/A | N/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 of | Location | Starting Materials Lot # | BDS_SKU | BDS Lot # | Quantity Produced | Expiration Date | Mfg Start Date | Mfg Date | Potency Assay 1 | Potency Assay 2 / Titer (Final) | Internal Lot Release Date | Remarks | Projected Dose Total | Lot Owner | Contract Number | Requisition | Stability Lot Number(s) |
| 6/14/26 | Test | 138645 | BULKSKU01 | 256279-1 | 50 | 12/3/28 | 6/3/23 | 101 | 6/20/23 | Test1c | 404,000 | HHS | HHSO1TESTTESTTESTC | ASP123456 | 256279-1 | ||
| 6/14/26 | Test | 138645 | BULKSKU01 | 256279-2 | 40 | 12/3/28 | 6/4/23 | 120 | 6/21/23 | Test1c | 384,000 | HHS | HHSO1TESTTESTTESTC | ASP123456 | 256279-2 | ||
| 6/14/26 | Test | 138645 | BULKSKU01 | 256279-3 | 45 | 12/3/28 | 6/5/23 | 108 | 6/22/23 | Test1c | 388,800 | HHS | HHSO1TESTTESTTESTC | ASP123456 | 256279-1, 256279-2 | ||
| 6/14/26 | Test | BULKSKU-ADJ | 1234-01 | 60 | 6/20/34 | 6/20/23 | 7/10/23 | Test1c-Adjuvant | 75,502 | HHS | HHSO1TESTTESTTESTC | ASP999999 | N/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 of | Location | Fill SKU | Date of Fill Start | Date of Fill Completion | Fill Lot # | Fill Qty | Remarks | Projected Fill Start Date | Projected Fill Quantity | Lot Owner | Contract Number | Requisition | Expiration Date |
| 6/14/24 | Test | FillSKU01 | 6/8/24 | 6/8/24 | 189032 | 36,000 | Test | HHS | HHSO1TESTTESTTESTC | Test111cc | 6/8/27 |
&"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 of | Location | Final / FDP SKU | Predecessor Fill Lot # | Final / FDP Lot # | Finish / FDP Qty | FDA Lot Submission Date | FDA Lot Approval Date | Expiration Date | Manufacture Date | Manufacturer Release Date | Remarks | Target Release Date | Target Finish FDP Qty | Lot Owner | Contract Number | Requisition |
| 3/6/24 | Test | FinalSKU01 | 189032 | 190039 | 2,400 | 7/23/24 | 4/1/28 | 4/1/25 | 4/20/25 | Test1c | HHS | HHSO1TESTTESTTESTC | Test111cc |
&"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 of | Location | Lot # | Lot Type | Stability Date | Stability Value | Stability Study | Remarks |
| 6/20/24 | Test | 256279-1 | Bulk | 6/20/24 | 99 | 2020TestStrain01 SRID | 0M |
| 9/20/24 | Test | 256279-1 | Bulk | 9/20/24 | 94 | 2020TestStrain01 SRID | 3M |
| 12/20/24 | Test | 256279-1 | Bulk | 12/20/24 | 97 | 2020TestStrain01 SRID | 6M |
| 6/20/25 | Test | 256279-1 | Bulk | 6/20/25 | 89 | 2020TestStrain01 SRID | 12M |
| 9/20/24 | Test | 256279-2 | Bulk | 6/20/24 | 116 | 2020TestStrain01 SRID | 0M |
| 9/20/24 | Test | 256279-2 | Bulk | 9/20/24 | 108 | 2020TestStrain01 SRID | 3M |
| 12/20/24 | Test | 256279-2 | Bulk | 12/20/24 | 112 | 2020TestStrain01 SRID | 6M |
| 6/20/25 | Test | 256279-2 | Bulk | 6/20/25 | 102 | 2020TestStrain01 SRID | 12M |
| 11/30/22 | Test | 189032 | Fill | 12/8/24 | 20 | 2020TestStrain01 Fill | 6M |
&"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 Number | Stability Study Description | Remarks | Use for Stability Calcs |
| 1 | 2020TestStrain01 SRID | Bulk | Yes |
| 2 | 2020TestStrain01 HPLC | Bulk | No |
| 3 | 2020TestStrain01 Fill | Fill | Yes |
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 | ||||||
| Location | Lot # | Reallocation Type | Date | Quantity | Remarks | SKU |
| TEST | 190039 | Clinical Trials | 10/13/24 | 5 | FinalSKU01 | |
| TEST | 256279-1 | Stability Study | 10/13/24 | 2 | Support 5yr extension to the stability study | BULKSKU01 |
| TEST | 256279-2 | Stability Study | 10/14/24 | 3 | Support 5yr extension to the stability study | BULKSKU01 |
&"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 of | Location | SKU | Lot # | Storage Location Within Facility | Inventory on Hand | Leave blank, Was: Units of Inventory on Hand | Remarks |
| 5/15/26 | TEST | FillSKU01 | 189032 | 12,000 | |||
| 5/15/26 | TEST | FinalSKU01 | 190039 | 2,395 | |||
| 5/15/26 | TEST | BULKSKU01 | 256279-1 | 48 | |||
| 5/15/26 | TEST | BULKSKU01 | 256279-2 | 37 | |||
| 5/15/26 | TEST | BULKSKU01 | 256279-3 | - 0 | Used to Fill Lot 189032 | ||
| 5/15/26 | TEST | BULKSKU-ADJ | 1234-01 | 60 |
&"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 of | Location Shipped From | BOL Shipment ID | SKU | Consignee | Ship To | Carrier Name | Carrier Alpha Code | Carrier Tracking Number | Trailer Number | Seal Number | Shipment Date | Packing List ID | Customer PO # | Customer PO Line # | Quantity | Lot Number | Expiration Date | Remarks | Special 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 Type | Bulk or Finished | Dose Unit | Product Component Type | Product Classification | FDA Approval | Status | Boolean | Contractor_Type | Critical Material | Purchaser | Purchase Status | Dose Unit | SKU Unit | Yes/No | Shipment Special Case | Dose Tracking Basis | Reallocation Type | Reallocation Lot Type |
| Therapautic - Convalescent Plasma | Bulk | Projected Bulk (final dose equivalents) | Seed | Clinical | Approved | Reserved | Yes | Prime | Crimp | U.S. Government | Contracted | pfu | Carton | No | Replace Damaged Product | Dose | Approved For Destruction | Bulk |
| Therapautic - Hyperimmune Globulin | Finished | Projected Finished Container (dose equivalent) | Bulk | Commercial | Emergency Use Authorization | Unreserved/Available | No | Sub-contractor | Seal | Vendor | Identified | ug | dose | Yes | Treatment Course | Clinical Trials | Fill | |
| Therapautic - Monoclonal Antibody | Adjuvant | Bulk Adjuvant | Pending Approval | Supplier | Stopper | VP | g | Clinical Trials USG Paid | Final | |||||||||
| Therapeutic - Other | Fill | Pending Emergency Use Authorization | Vial | kg | Damaged | Seed | ||||||||||||
| Therapautic - Small Molecule | Filled Adjuvant | L | Expired | |||||||||||||||
| Vaccine - Cell | Final Adjuvant | mg | Non-BARDA Market | |||||||||||||||
| Vaccine - Conjugate | Final/Released Product | ml | Quarantine | |||||||||||||||
| Vaccine - DNA | Syringe | Stability Study | ||||||||||||||||
| Vaccine - Inactivated | Vial | |||||||||||||||||
| 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 .