Change Request Memo 4.2021

FDA3852_Change Request Memo 4.2021.docx

Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products

Change Request Memo 4.2021

OMB: 0910-0749

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U.S. Food and Drug Administration

Center for Tobacco Products

“Report of Tobacco Product Removals Subject to Tax”

(OMB Control Number 0910-0749)

April 2021 Change Request

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to incorporate edits to improve the clarity of the FDA 3852 form and provide instructions for filling out the form. Specifically, pages 1 and 2 were edited to provide better user understanding of form fields and a new page was added to provide clarifying instructions on filling out the form fields.

FDA 3852 Form Change Log

Form Section

Description of Change

Page 1, OMB No. block

Updated PRA Statement page from page “3” to page “2”

Updated Expiration date to 8/31/2022

Page 1, first section

Removed "by mail" from the instructions for submission

Resorted submission options to indicate that email is the preferred method

Bottom of Page 1

Removed the text: PSC Publishing Services (301) 443-6740 EF

Bottom of pages 1-3

Updated edition date to 4/21

Block 1

Updated block 1 to show 1.A. and 1.B.

In block 1.A., removed “/” and updated to include "and mailing" for address request

In block 1.B., updated to include "mailing" for address request

In block 1.B., removed ", for FDA notifications"

Block 2

Changed block 2 from "Contact Person Name" to "Employer Identification Number (EIN)"

Block 3

Changed block 3 from "TTB Permit Number" to "Contact Person Name"

Shifted block 3 to same row as block 2

Block 4

Shifted block 4 to the left

Block 5

Changed block 5 from "Employer Identification Number (EIN)" to "Email (for all FDA communication)"

Shifted block 5 to same row as block 4

Block 6

Changed block 6 from "Email" to "TTB Permit Number"

Added "(list all current permits reported on this form)"

Shifted block 6 to the left

Block 7

Changed block 7 from "Period of Activity" to "Final Report (list applicable permit)"

Added a line of space in between the block title and check box to allow for entry of the permit number

Added a checkbox with "Check here if this will be your final report to the FDA (i.e., you have returned your permit to TTB or closed your business). Attached relevant documentation with date of closure."

Shifted block 7 to same row as block 6

Block 8

Added block 8 for "Period of Activity"

Added "(month/year of reported removals)"

Updated A. to 8.A.

Updated B. to 8.B.

Page 2

Reorganized and renumbered blocks 8.A. through 14.C.; now listed as 9.A. through 15.C.

Moved PRA section from page 3 to page 2

Shifted block numbers for 9.A through 14.D. into same cell as text field and placed block numbers in upper left corner of each cell so text field can be fully extended from left to right in the cell.

Added parenthetical to the “Removal Volume” and “Excise Tax” column headers to say “(in sticks or pounds)” and “(in dollars)” respectively

Split block “Signature (print and sign)” and separated into two blocks. One for signature and one for print name.

Page 3

Added instructions page

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