Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Manufactured, Imported, or Packaged in the U.S.

OMB 0920-0338

This is a legislatively mandated information collection. The Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4401 et seq. or Pub.L. 99-252) requires each person who manufactures, packages, or imports smokeless tobacco products to provide the Secretary of HHS with an annual list of ingredients added to tobacco in the manufacture of smokeless tobacco products, as well as a specification of quantity of nicotine contained in each product. Responsibility for collecting the information has been delegated to CDC's Office on Smoking and Health.

The latest form for Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Manufactured, Imported, or Packaged in the U.S. expires 2022-04-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 0920-0338 Smokeless Tobacco Product Manufacturers, Packagers, and Importers Form and Instruction
Form 0920-0338 Smokeless Tobacco Product Manufacturers, Packagers, and Importers Form and Instruction
0338 PN.pdf Supplementary Document
0338 Att 8b Civil Penalties for Disclosure of Confidential Info.pdf Supplementary Document
0338 Att 8a Gdelines to Control Protect Docs that Contain Privileged Info.pdf Supplementary Document
0338 Att 7 Compliance Cert Manufacs Pkgers & Imps of Smokeless Tobacco Products.pdf Supplementary Document
0338 Att 6b OSH Tobacco Ing and Nicotine Rptng Instructs Webpage.pdf Supplementary Document
0338 Att 6a OSH Comp Smokeless Tobacco Health Ed Act Webpage.pdf Supplementary Document
0338 Att 5 FRN Revs to Lab Protocol.pdf Supplementary Document
0338 Att 4d Human Subjects Non-research Determination.pdf Supplementary Document
0338 Att 4c Req for Addl Info from Manufacs, Pkgers & Imps of Tobacco Products.pdf Supplementary Document
0338 Att 3 Smokeless Tobacco Sub Req.pdf Supplementary Document
0338 Att 1 Comp Smokeless Tobacco Health Ed Act.pdf Supplementary Document
0920 0338 Research Determination Form Final.pdf Supplementary Document
0920 0338 Privacy Narrative Final.pdf Supplementary Document
0920 0338 Att 10b CDC Response to Comment 2 Final.pdf Supplementary Document
0920 0338 Att 9b CDC Response to Comment 1 Final.pdf Supplementary Document
0920 0338 Att 8 Disclosure of Confidential Info Final.pdf Supplementary Document
0920 0338 Att 7 Certificate of Compliance Final.pdf Supplementary Document
0920 0338 Att 6b CSLTHEA Web Page Final.pdf Supplementary Document
0920 0338 Att 6a OSH Tobacco Ing Rep Instructions Web Page Final.pdf Supplementary Document
0920 0338 Att 5 FRN Revisions to the Lab Protocol 2009 Final.pdf Supplementary Document
0920 0338 Att 4c Request for Additional Information Final.pdf Supplementary Document
0920 0338 Att 3b FRN 1994.pdf Supplementary Document
0920 0338 Att 3a Initial FRN 1994 Final.pdf Supplementary Document
0920 0338 Att 2 60d FRN Final.pdf Supplementary Document
0920 0338 Att 1 Smokeless Tobacco Health Education Act Final.pdf Supplementary Document
0338 SSB.docx Supporting Statement B
0338 SSA.docx Supporting Statement A
Smokeless Tobacco Product Manufacturers, Packagers, and Importers Form and Instruction
Smokeless Tobacco Product Manufacturers, Packagers, and Importers Form and Instruction

All Historical Document Collections

202204-0920-001 Approved without change	Extension without change of a currently approved collection	2022-04-19
201901-0920-001 Approved without change	Reinstatement without change of a previously approved collection	2019-02-27
201402-0920-001 Approved without change	Extension without change of a currently approved collection	2014-02-03
201212-0920-007 Approved without change	Reinstatement without change of a previously approved collection	2013-01-03
201207-0920-005 Improperly submitted and continue	Extension without change of a currently approved collection	2012-07-16
201102-0920-006 Approved without change	Extension without change of a currently approved collection	2011-02-02
200801-0920-001 Approved without change	Reinstatement with change of a previously approved collection	2008-01-03
200503-0920-005 Approved without change	No material or nonsubstantive change to a currently approved collection	2005-03-23
200409-0920-016 Approved without change	No material or nonsubstantive change to a currently approved collection	2004-09-30
200404-0920-010 Approved with change	Reinstatement without change of a previously approved collection	2004-04-21
200101-0920-007 Approved without change	No material or nonsubstantive change to a currently approved collection	2001-01-25
200008-0920-006 Approved without change	Extension without change of a currently approved collection	2000-08-23
199701-0920-002 Approved without change	Extension without change of a currently approved collection	1997-01-21
199311-0920-002 Approved without change	New collection (Request for a new OMB Control Number)	1993-11-03