2022-0210 Ssb_040522

2022-0210 SSB_040522.docx

List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products

OMB: 0920-0210

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List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products



OMB NO. 0920-0210 OMB Expiration Date: 04/30/2022




Supporting Statement B







Program Official/Contact

Kathy Gallagher

Associate Director, Policy Unit

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

P: 678-733-5349

F: 770-488-5767

[email protected]









March 24, 2022








TABLE OF CONTENTS




ATTACHMENTS



1a. Comprehensive Smoking Education Act of 1984 (15 U.S.C. 1335a)

1b. Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1331-1341)

2. Federal Register Notice (2021)

3. Initial Federal Register Notice (1985)

4a. Recommended Cigarette Ingredient Report Format

4b. Request for Additional Information from Manufacturers, Packagers, and Importers of Tobacco Products

4c. Human subjects document

5a. OSH Web Page on the Federal Cigarette Labeling Advertising Act

5b. OSH Web Page on Tobacco Ingredient Reporting

6. Certificate of Compliance for Manufacturers, Packagers, and Importers of Tobacco Products

7a. Guidelines to Control and Protect Documents that Contain Privileged Information Obtained in Accordance with Sec. 5 (a) of Public Law 98-474

7b. Civil Penalties for Disclosure of Confidential Information (18 U.S.C. 1905)

8. Federal Register Notice (1994)

9. Federal Register Notice (2020)

 

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

B1. Respondent Universe and Sampling Methods


This data collection does not require the use of statistical methods to select respondents. Responses are required from all cigarette manufacturers, distributors, and importers in the U.S. (referred to collectively as “manufacturers” in this Information Collection Request).


B2. Procedures for the Collection of Information


Each manufacturer is required to annually submit to HHS information about the ingredients in each product in its cigarette product line. The information should conform to the specifications established by the Recommended Cigarette Ingredient Report Format (Attachment 4a); however, manufacturers are not required to submit specific forms. Typically, manufacturers submit a summary report to CDC by mail or fax with the ingredient information for multiple products, often through a designated entity such as legal counsel. The submission must be received on letterhead belonging to the manufacturer or designated representative. Reports may also be submitted via facsimile, but all faxed lists should be followed up with a mailed original. Electronic mail submissions are not accepted.


The original submission deadline was December 31 of each year. In 1994, HHS published an additional Federal Register Notice (November 8, 1994, vol. 59, p. 55669-55670) that changed the due date from December 31 to March 31. A copy of this notice is provided in Attachment 8.


Information for each calendar year is submitted no later than March 31 of the following year. OSH may follow up by sending a request for additional information (Attachment 4b) if a submission contains incomplete entries or possible errors. Upon submission and verification of its complete ingredient list, OSH sends a Certificate of Compliance to the manufacturer (Attachment 6).


Of note, on April 27, 2020, a Federal Register Notice was published Vol. 85, No. 84, pp. 23359-23360, (Attachment 9), to indicate the CDC/OSH was extending the March 31st deadline for submissions required under the Federal Cigarette Labeling and Advertising Act (FCLAA). Within the April 2020 Federal Register Notice, CDC/OSH stated that due to unforeseen circumstances in light of COVID-19, OSH was rendered unable to accept any ingredient submissions or to issue Certificates of Compliance. This same language was inserted on OSH’s website under the webpage entitled Tobacco Ingredient and Nicotine Reporting | CDC.


B3. Methods to Maximize Response Rates and Deal with No Response


Response is required. Failure to respond will result in legal non-compliance, and inability of manufacturers, packagers, and importers to obtain the Certificate of Compliance required for state-based commercial activity.


B4. Tests of Procedures or Methods to be Undertaken


OSH plans to continue the data collection using previously filed information collection methods.


B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data



Name

Contact Info

Organization

Role

Kathy Gallagher

678-733-5349

[email protected]

OSH, Policy Unit

Project Officer

Ruth Hayes, Contractor

770-488-5743

[email protected]

Katmai Government Services

OSH, Policy Unit

Data collection






File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleSupporting Statement B template
SubjectSupporting Statement B template
AuthorCenters for Disease Control and Prevention
File Modified0000-00-00
File Created2022-05-10

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