Supplemental Information Justification

Supplemental Information Justification

Supporting Statement 2022

EXTENSION

Due to some changes and the some of the information being included elsewhere in the SSA, we have opted to not add a portion of this. We have indicated in separate sections the edits we have made and the reasoning behind them (e.g., we are no longer able to accept the information on a 3 in floppy disk due to outdated technology). The remaining comments in the SSA and SSB we have addressed within the document.

Overview of the Data Collection System

Respondents are commercial cigarette manufacturers, packagers, or importers (collectively called “manufacturers” throughout this ICR). The information outlined in the Recommended Cigarette Ingredient Reporting Format (Attachment 4a) must be submitted for each product.

OSH Response: This information is included in paragraph 1 of section A2.

Typically, manufacturers submit a summary report to CDC with the ingredient information for multiple products, often through a designated entity such as legal counsel.

OSH Response: This information is referenced in section A10, so we have not repeated it here.

The submission must be received on letterhead from the manufacturer or designated representative.

OSH Response: We have included this in section A2.

Reports may be submitted via mail or facsimile, but all faxed lists should be followed up with a mailed original. In addition, data may be submitted to CDC by mailing a CD, 3-inch floppy disk, or thumb drive. Electronic mail submissions are not accepted.

OSH Response: We have elected to remove submission on 3-in floppy disks or CDs as we cannot receive or process information with that format as it is outdated.

Ingredient reports are due annually on March 31.

OSH Response: Due to the information collection being paused in 2020, 2021 and 2022 due to COVID restrictions, we have framed this a bit differently in section A16.

Items of Information to be Collected

The Ingredient Report provides an itemized list of all ingredients in each cigarette product. CDC requires the list of ingredients to be submitted by chemical name and Chemical Abstract Service (CAS) Registration Number. This is consistent with accepted reporting practices for other companies currently required to report ingredients added to other consumer products. To the best of CDC’s knowledge, laboratory analysis is not available that would provide a complete representation of the ingredients added to tobacco in the manufacture of cigarettes. Laboratory analysis in lieu of the Ingredient Report is not acceptable.

This information collection involves information in identifiable form (IIF). For each manufacturer or designated representative, the name and contact information of a contact person is collected. No personal information about the contact person is collected.

Since 2003, background information about FCLAA, ingredient reporting requirements and instructions for reporting have been posted on OSH’s public web site, http://www.cdc.gov/tobacco/basic_information/tobacco_industry/reporting/instructions/index.htm (see Attachments 5a and 5b).

There is no website content directed at children less than 13 years of age.

OSH Response: Thank you, we have included the above information in section A2.