Summary of changes to 3486A ComparisonDoc

Summary of changes to 3486A ComparisonDoc.doc

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

Summary of changes to 3486A ComparisonDoc

OMB: 0910-0458

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Revision Summary and Burden Comparison

0910-0458 – 3486A OMB Approval 6-6-07


Section Name

Summary of Approved 3486a Section

Original Estimated Burden

Summary of Revised 3486a Section

(revision in bold)

Revised

Estimated Burden

Distribution Pattern

Provide (in a text field) the States and/or Countries where products were distributed.

3 minutes

Provide (by selecting from pick list) the States and/or Countries where products were distributed.

Provide distribution pattern counts and provide comment if consigned to US Govt., DoD, or Canada.


3 - 6 minutes

Notification

Provide the methods and dates of consignee notification (Up to 11 in total).


Provide Comments.

3 – 10 minutes

Provide the methods and dates of consignee notification. (Up to 5 in total).


Provide Comments.


Provide Recall Completion Date.


2 - 5 minutes

Consignees of Products for Further Manufacture

Provide (up to 10) names and addresses for consignees of products for Further Manufacture.


Provide (in a text field) the unit/lot numbers that each (up to 10) consignee received if products were distributed to more than one consignee.

3 - 10 minutes


Removed



Removed

0

minutes

Additional Product Information

Provide (in a text field) the unit/lot numbers, product codes and disposition of each product below, if there were more than 18 products.

3 - 15 minutes


Removed

0 minutes

Updated Product Disposition

Provide (in a text field) any updated product disposition information for products on the BPDR.

2 - 6 minutes

Provide (by selecting from pick list) updated product disposition information distribution date, and notified value (y/n) for the displayed products.


Provide the name of the products for non-specific product codes on the BPDR.

2 - 6 minutes

Name of Products

Provide the name of the products for non-specific product codes on the BPDR.

1 minute

Moved to Product Disposition Section.

0 minutes

Industry Recall Contacts


0 minutes

Provide Name and Contact Information for the Most Responsible Individual and Recall Contact.

3 minutes


Original Estimated Burden

(Average 30 minutes)

15 to 45 minutes

Revised Estimated Burden

(Average 15 minutes)

10 - 20 minutes


File Typeapplication/msword
File TitleDistribution Pattern
AuthorHieronymus
Last Modified ByJonna Capezzuto
File Modified2008-09-26
File Created2008-09-26

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