2025-01217. Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Establishment Registration and Listing

Table 1—Estimated Annual Reporting Burden ¹

FDA form/activity/FD&C section	Number of respondents	Number of responses per respondent	Total annual responses	Hours per response	Total hours
Establishment Registration (Initial), the initial registration of a tobacco product establishment (Current) Form FDA 3741, Registration and Product Listing for Owners and Operators of Domestic Establishments; Form FDA 3741a-Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments (Electronic and Paper submissions) Sections 905(b), 905(c), 905(d), 905(h), or 905(i)	75	1	75	1.6 (96 minutes)	120
Establishment Registration (Initial), the initial registration of a tobacco product establishment (Updated) Form FDA 3741, Registration and Product Listing of Tobacco Product Manufacturing Establishments Sections 905(b), 905(c), 905(d), 905(h), or 905(i)	75	1	75	1.5 (90 mins)	113
Establishment Registration (Renewal), the registration renewal of a tobacco product establishment (Current) Form FDA 3741, Registration and Product Listing for Owners and Operators of Domestic Establishments; Form 3741a-Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments (Electronic and Paper submissions) Sections 905(b), 905(c), 905(d), 905(h), or 905(i)	1,003	1	1,003	.17 (10 minutes)	171
Establishment Registration (Renewal), the registration renewal of a tobacco product establishment (Updated) Form FDA 3741, Registration and Product Listing of Tobacco Product Manufacturing Establishments Sections 905(b), 905(c), 905(d), 905(h), or 905(i)	1,003	1	1,003	.33 (20 min)	331
Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, (New) Product List and Material File Information Spreadsheet	75	1	75	2 (120 mins)	150
Product Listing (Renewal) updates to the tobacco product listings (New) Form FDA 3741b, (New) Product List and Material File Information Spreadsheet	1,003	1	1,003	.5 (30 mins)	502
Tobacco Product Listing Form FDA 3742, Listing of Ingredients Section 904(a)(1)	16	1	16	2 (120 mins)	32
Tobacco Product Listing Form FDA 3742, Listing of Ingredients Section 904(c)	37	10	370	.40 (24 minutes)	148
Obtaining a Dun and Bradstreet D-U-N-S Number	100	1	100	0.5 (30 minutes)	50
Total			2,642		1,617