List of Ingredients Added to Tobacco in the
Manufacture of Cigarette Products
OMB Control No. 0920-0210
Request for Reinstatement with Change
Supporting Statement Part A and Part B
Submitted by:
Office of Smoking and Health
National Center of Chronic Disease Prevention
and Health Promotion
Centers for Disease Control and Prevention
Department of Health and Human Services
Project Officer:
Sherrill E. Brady
Policy Team Leader
Telephone: 770-488-5474
Fax: 770-488-5767
E-Mail: [email protected]
December 7, 2007
Table of Contents
Part A. Justification
Circumstances Making the Collection of Information Necessary
Purpose and Use of the Information Collection
Use of Improved Information Technology and Burden Reduction
Efforts to Identify Duplication and Use of Similar Information
Impact on Small Businesses or Other Small Entities
Consequences of Collecting the Information Less Frequently
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
Comments in Response to the FRN and Efforts to Consult Outside the Agency
a. Federal Register Notification
b. Other Consultations
Explanation of Any Payment or Gift to Respondents
Assurance of Confidentiality Provided to Respondents
Justification for Sensitive Questions
Estimates of Annualized Burden Hour and Costs
Estimated Burden
Estimated Costs
Estimate of Other Total Annual Cost Burden to Respondents or
Record Keepers
Total Capital and Start-up Costs
Total Operation and Maintenance
Annualized Cost to the Government
Explanation for Program Changes or Adjustments
Plans for Tabulation and Publication and Project Time Schedule
Reason(s) Display of OMB Expiration Date is Inappropriate
Exceptions to Certification for Paperwork Reduction Act Submissions
Part B. Collections of Information Employing Statistical Methods
Data Collection Procedures
List of Attachments
ATTACHMENT 1: Comprehensive Smoking Education Act of 1984 (15 U.S.C. ‘ 1335a; Public Law 98-474), relevant portions
ATTACHMENT 2: Statutory Provisions on Confidentiality (18 U.S.C. ‘ 1905, 5 U.S.C. ‘ 552)
ATTACHMENT 3: Reminder Notification Postcard to Manufacturers, Packagers and Importers of Tobacco Products
ATTACHMENT 4a: HHS/CDC/OSH Tobacco Ingredient Reporting Web Page
ATTACHMENT 4b: OSH Web Page on the Comprehensive Smokeless Tobacco Education Act
ATTACHMENT 5: Federal Register Notice, August 16, 2007, Vol. 72, p. 19207
ATTACHMENT 6: Guidelines to Control and Protect Documents that Contain Privileged Information Obtained in Accordance with Sec. 5 (a) of Public Law 98-474
ATTACHMENT 7: Federal Register Notice, December 3, 1985, Vol. 50, p. 49617-49619
ATTACHMENT 8: Request for Additional Information from Manufacturers, Packagers and Importers of Tobacco Products
ATTACHMENT 9: Federal Register Notice, November 8, 1994, Vol. 59, p. 55669-55670
This Supporting Statement describes CDC’s request to reinstate a Congressionally-mandated information collection, “List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products,” OMB control no. 0920-0210, which expired and was discontinued August 31, 2007. There are no changes to the previously approved estimated number of respondents (143) or estimated burden hours (930). Changes effective with this reinstatement relate to the redesign of the HHS/CDC/Office on Smoking and Health web site, which hosts the Tobacco Ingredient and Nicotine Reporting web page for this clearance. Changes are being instituted to improve compliance with E-government (e-gov) specifications, to improve organization of web site material, and to incorporate new features benefiting web site usability.
A. JUSTIFICATION
Circumstances Making the Collection of Information Necessary
Cigarette smoking is the leading preventable cause of premature death and disability in our Nation. Each year more than 440,000 premature deaths occur as the result of cigarette smoking related diseases.
The Centers for Disease Control and Prevention (CDC), Office on Smoking and Health (OSH) has the primary responsibility for the Department of Health and Human Services (HHS) smoking and health program. HHS’s overall goal is to reduce death and disability resulting from cigarette smoking and other forms of tobacco use through programs of information, education and research.
The Comprehensive Smoking Education Act of 1984 (15 U.S.C. ' 1335a or Pub.L. 98-474) requires each person who manufactures, packages, or imports cigarettes to provide the Secretary of Health and Human Services with a list of ingredients added to tobacco in the manufacture of cigarettes. Commonly known as the Ingredient Report; this list of ingredients is due to the CDC annually by March 31, or the time of first importation for importers of new products. This legislation also authorizes HHS to undertake research, and to report to the Congress, as deemed appropriate, on the health effects of the ingredients. A copy of this legislation is provided in Attachment 1. HHS is required to treat the Ingredient Reports as proprietary information per the trade secret and privacy acts. A copy of the Statutory Provisions on Confidentiality is in Attachment 2.
The legislation requires annual reporting of all such ingredients. A reminder notice is sent to each cigarette manufacturer, packager, and importer requesting the ingredient additives. For the first year of this data collection, the legislative requirements were published in the Federal Register (1985) and each potential respondent was sent a request letter. For many companies, the initial reporting year was 1986. Beginning in 1988, a comprehensive request letter was sent to all respondents, but a notice was not published in the Federal Register. In 2003, a post card (Attachment 3) was mailed and a web site (Attachment 4) developed to notify and provide information to manufacturers, importers and packagers of the requirements of the law and to provide instructions and information to facilitate reporting.
Purpose and Use of Information Collection
HHS uses the information collected to exercise its authority under the Comprehensive Education Act to conduct research on the health effects of ingredients added to tobacco in the manufacture of cigarettes. Also, as authorized in the statute, HHS will report to the Congress information regarding its current and proposed research relative to the health effects of the ingredients; information pertaining to any such ingredient which, in the judgment of the Secretary poses a health risk to users of cigarettes; and any other information which the Secretary determines to be in the public interest. If this information is not collected, those who manufacture, package, or import cigarettes will neither have means to comply with requirements of this law nor will CDC be able to effectively report on the health consequences of cigarette use.
3. Use of Improved Information Technology and Burden Reduction
In order to reduce burden to the respondents, only the minimum information necessary to comply with provisions of the Comprehensive Smoking Education Act is being requested. CDC requires the list of ingredients 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. OMB previously approved this format for reporting of cigarette ingredients.
The legislation requires annual reporting. Respondents are not required, however, to use a complex format or to complete a questionnaire. Respondents are required to submit a new list or a statement that there are no changes to their previously submitted ingredient report every year. Legal obstacles to reduce the burden of collecting this information include the confidential and proprietary nature of the ingredients which makes it impracticable for companies to submit electronically.
4. Efforts to Identify Duplication and Use of Similar Information
The Comprehensive Smoking Education Act is the only statute to mandate ingredient reporting for cigarettes. No other information collection activity of the Federal government or private sector has compiled such information. The information required is trade secret and cannot be compiled unless the tobacco companies provide it to HHS as required by the Comprehensive Smoking Education Act.
In 1994, the four largest tobacco manufacturers released a public list of ingredients used in the manufacture of cigarette products. While this list provided information similar to that being requested, it only covered one year and did not provide Chemical Abstract Service numbers. Additionally, it did not cover all tobacco manufacturers.
No other data collections pertain to the information being requested exists.
5. Involvement of Small Business or Other Small Entities
Some of the companies affected by the reporting requirements are small businesses. The burden on these companies has been considered. To ease potential burden on both small and large entities, the data collection process does not require respondents to use a cumbersome format or to complete an unwieldy form or questionnaire. Each respondent may select and use the response option that is most convenient for their organization.
6. Consequences of Collecting the Information Less Frequently
The Comprehensive Smoking Education Act stipulates that respondents shall report ingredient information annually. If the data collection were less frequent, the collection and reporting provisions would not comport with statutory requirements; HHS and respondents submitting information less frequently would not be in compliance with the law. Also, analysis of the potential health effects of the reported ingredients would likely be delayed.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this request.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
A) On August 16, 2007, a Federal Register Notice (Volume 72, pp. 46084-46085) was published on this collection (Attachment 5). The Centers for Disease Control and Prevention received no public comments in response to the Federal Register Notice.
B) Other Consultations
In 1989 and 1990, consultations were held with the designated legal counsel and representative for the major cigarette companies, the Federal Trade Commission, and the Oak Ridge National Laboratory regarding the data collection. There were no major problems that could not be resolved during consultation. The designated legal counsel has been contacted prior to each OMB submission and asked to provide a revised estimate of the respondent burden hours and cost to respondents.
Stanley L. Temko
Attorney
Covington and Burling
201 Pennsylvania Avenue, NW
P.O. Box 7566
Washington, D.C. 20044
Telephone: (202) 662-6000
(Designated legal counsel and representative for the major cigarette companies in the U.S.)
Michael R. Guerin, Ph.D.
Organic Chemistry Section Head
Analytical Chemistry Division
Oak Ridge National Laboratory
P.O. Box 2008
Oak Ridge, Tennessee 37831-6120
Telephone: (615) 574-4862
Judith Wilkenfeld
Assistant Director
Division of Advertising Practices
Federal Trade Commission
Washington, D.C. 20580
Telephone: (202) 326-3150
In 1993, James W. Fox, Jr. at Covington and Burling was contacted to provide a revised estimate of person-hours and financial resources for this information collection. In 1996, Joseph Doss at Covington and Burling was contacted to provide an updated estimate of person-hours and financial resources for this information collection.
b) There were no major problems that could not be resolved during consultation.
c) Not applicable.
9. Explanation of Any Payment or Gift to Respondents
There are no plans to provide any form of payment or remuneration to respondents.
10. Assurance of Confidentiality Provided to Respondents
In the review of this application, it has been determined that the Privacy Act is not applicable. Respondents are business entities, not individuals. Each respondent entity is represented by a contact person, however, no personal information is being collected. All information is filed and retrieved by company name or the attorney representing the company, therefore, the information does not fall under the purview of the Privacy Act.
In accordance with provisions in the Comprehensive Smoking Education Act, the collected information is to be treated as trade secret or confidential information subject to 5 U.S.C. ' 552 (b)(4) (Freedom of Information Act) and 18 U.S.C. ' 1905 (Criminal Code) (Attachment 2), and shall not be revealed except as authorized in the statute. The law also requires HHS to establish written procedures to assure the confidentiality of the information provided. Consistent with these statutory provisions, HHS has developed strict procedures for treating and protecting relevant documents, including secured file storage and strictly limiting access to the information. These procedures have proven workable, effective, and acceptable to the companies required to report the confidential information. Copies of the HHS procedures are provided in Attachment 6.
11. Justification for Sensitive Questions
The proposed information collection is sensitive in that the industry has expressed concern about possible unintentional or unauthorized release of the ingredient information that the law requires to be reported. The sensitive information must be collected in order to meet the requirements of the Comprehensive Smoking Education Act of 1984.
12. Estimates of Annualized Burden Hours and Costs
The burden estimate for the period of this reinstatement is based on experience with the information collection in the prior approval period. As before, the average burden per response is estimated at 6.5 hours, the number of respondents is estimated at 143, and the total burden hours are estimated at 930.
a) Estimated Annualized Burden Hours
Type of Respondents |
Number of Respondents |
Number of Responses per Respondent |
Average Burden Per Response (in hours) |
Total Burden (in hours) |
Cigarette Manufacturers, Packagers, and Importers |
143 |
1 |
6.5 |
930 |
b) Estimated Annualized Cost to Respondents
Type of Respondents |
Number of Respondents |
Number of Responses per Respondent |
Average Burden Per Response (in hours) |
Hourly Wage Rate |
Total Cost |
Cigarette Manufacturers, Packagers, and Importers |
143 |
1 |
6.5 |
$47.56 |
$44,207 |
The estimated total annualized cost to respondents is $44,207, based on an average hourly wage of $47.56 per hour for compiling and reporting the response.
13. Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers
a) Total Capital and Start-up Costs
None.
b) Total Operation and Maintenance
None.
14. Annualized Cost to the Government
The estimated annualized cost to the government is $140,000. The table below describes itemized cost components.
Item |
Estimated Annualized Cost |
CDC Supervisor (3% FTE) |
$3,000 |
Contractor for data collection, data management, communications and logistical support related to compilation and analysis of ingredient reports |
$100,000 |
Secure storage of confidential materials |
$5,000 |
Computing equipment |
$12,000 |
Support services provided by the HHS/CDC/National Center for Environmental Health for laboratory research on chemical substances added to smokeless tobacco products |
$20,000 |
Total |
$140,000 |
15. Explanation for Program Changes or Adjustments
The requested burden is the same as in the prior approval period.
16. Plans for Tabulation and Publication and Project Time Schedule
Information collection occurs annually; ingredient information is to be submitted by March 31 of each year for ingredients used in the previous calendar year. Because the information collection occurs annually, in accordance with the Comprehensive Smoking Education Act, we request a maximum (3-year) clearance.
HHS is authorized, but not required, to analyze submitted data and to submit a report to the Congress. Reports are only submitted to Congress when requested. Requested reports were submitted to Congress in February 1990, July 1990, and March 1993.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
The OMB expiration date is displayed on the reminder postcard (Attachment 3) mailed to respondents, along with the OMB approval number and burden estimate. As discussed in Section A.3, respondents are required to report information but are not required to use a standardized form. OMB has previously approved display of the expiration date on the reminder postcard, in lieu of displaying the expiration date on a standardized data collection instrument.
18. Exceptions to Certification
There are no exceptions to the certification statement.
B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
This data collection does not require the use of statistical methods to select respondents, as all relevant companies are required to respond.
Data collection procedures
HHS initially announced the information collection through a 1985 Federal Register Notice (December 3, 1985, vol. 50, p. 49617-49619) outlining provisions of the law and reporting requirements. A copy of the notice is provided in Attachment 7. At that time, OSH wrote to the companies and trade associations known to be involved in the manufacture, packaging or distribution of cigarettes informing them of the requirements of the Comprehensive Smoking Education Act and the procedures established for submission of the ingredient lists. OSH also advised Covington and Burling, the designated legal counsel and representative for the major cigarette companies in the U.S., of the reporting requirements.
For subsequent data collections, OSH reviews and revises the mailing list of cigarette manufactures, packagers, and importers by comparing it to lists available from the tobacco industry, the Federal Trade Commission, the National Association of Attorneys General and updating the files as new companies submit ingredient lists. OSH sends a notice to each manufacturer, packager and importer, or respective attorney, reminding them of the reporting requirements and the due date. If an incomplete submission is received, OSH sends a request for additional information (Attachment 8.) 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 9.
Page
| File Type | application/msword |
| File Title | OMB Supporting Statement |
| Author | sxc7 |
| Last Modified By | arp5 |
| File Modified | 2007-12-07 |
| File Created | 2007-12-07 |