Fda 3486a Bpdr Supplemental Information

Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms 3486 and 3486A

0458 WEB FORM ADDENDUM TO FORM3486A

Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A

OMB: 0910-0458

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WEB FORM ADDENDUM TO FORM 3486

COLLECTION OF INFORMATION FOR RECALL PROCESSING



The collection of additional information associated with a BPD for the purpose of recall classification will be requested through an e-mail notification to the submitter of the BPD and a web-based form to provide the information.


E-mail



Subject: BPD confirmation #_______, Establishment Tracking #_______


Thank you for the electronic submission of the above referenced Biologic Product Deviation Report (BPDR). The Center for Biologics Evaluation and Research has completed initial review of the BPDR. Additional information is necessary to complete the review. The form to provide the additional information is available at (hyperlink). Access to the form requires a username and password to the eBPDR system.


Web Form


FORM 3486A – BPDR SUPPLEMENTAL INFORMATION


Reporting Establishment ID #__________


Establishment Tracking #__________


BPD Confirmation #______________


(The items above will be filled in by the system, not the user)


Please provide the following additional information related to the above referenced BPDR. Only provide the requested information for products that were distributed to another facility (disposition code AF) and that the consignees were notified.


1. Distribution Pattern


Provide the States (for products distributed within the United States) and/or the countries (for products distributed outside the United States) where the products were distributed.










Notes: Text field, same number of characters as RES field (think about 4000 characters

Map to RES-Event Details-Distribution Pattern


2. Notification


Provide the methods and dates of consignee notification. If the notification method used was not one of the available choices, select "other" and describe the notification in the comment field.



mm/dd/yyyy

Initial Notification: Method Date




Further Notifications: Method Date




Method Date



Comments:






Notes: Allow for up to 10 further notification entries

Method will be picklist from RES-Start Recall-Initial Firm Notification field

Comments field is a text field, 1000 characters should be sufficient

Initial Notification Method maps to RES-Start Recall-Initial Firm Notification

Initial Notification Date maps to RES-Start Recall-Recall Initial Date; Date Distribution Chain Notified, and Voluntary/Mandated Date

All methods and dates map to RES-Event Details-Recall Strategy, display as "method, date; method, date…"


3. Consignees of Products for Further Manufacture


If any of the products were distributed for further manufacture (e.g., Recovered Plasma or Source Plasma), provide the names and addresses of the consignees. If products were distributed to more than one consignee, provide the unit/lot numbers that each consignee received.



Consignee Name



Street Address Line 1


Street Address Line 2


City



State/Province Postal Code


Country








Unit/lot numbers received by this consignee










Notes: Unit/lot numbers received is a large text field

Allow for entry of up to 10 consignees

Map consignee names to RES-Event Details-List of Consignees or Comments

Do not map specific unit/lot numbers – will need to be done manually


4. Additional Product Information


If you provided product information (e.g., there were more than 18 products) in either the Additional Information section on the Blood Product/Components Information page or the Comments Section page, provide the unit/lot numbers, product codes, and disposition of each product below. This information is only needed for products distributed to another facility and for which the consignee was notified.


Note: If you provided the additional product information on the BPDR in a manner that clearly relates this information for each additional product, you may skip this step.



















Notes: Large text field

No mapping


5. Updated Product Disposition



Provide any available updated product disposition information for products on the BPDR with the dispositions of: 1) no information, 2) distributed, 3) other, 4) sent for further manufacturing, or 5) sent for further manufacturing of non-injectable products only.







Notes: Large Text Field

Map to RES-Event Details-Recall Strategy and (maybe) RES-Summary and Termination-Product Disposition


6. Name of Products


If you used a non-specific product code on the BPDR (e.g., DB00), provide the name of the products. If you provided this information in either the Additional Information section on the Blood Product/Components Information page or the Comments Section page, you may skip this step.


















Notes: Large text field

No mapping



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File Typeapplication/msword
File TitleWEB FORM ADDENDUM TO FORM 3486
AuthorAdamst
Last Modified ByJonna Capezzuto
File Modified2007-02-05
File Created2007-02-05

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