01-27529. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call the CDC Reports Clearance Officer on [phone].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Send comments to Anne O'Connor, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments should be received within 60 days of this notice.

Proposed Project: Annual Submission of the Quantity of Nicotine Contained in Smokeless Tobacco Products Manufactured, Imported, or Packaged in the United States—Renewal—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Oral use of smokeless tobacco represents a significant health risk, which can cause cancer and a number of noncancerous oral conditions, and can lead to nicotine addiction and dependence. The Office on Smoking and Health (OSH) within the National Center for Chronic Disease Prevention and Health Promotion, CDC has been delegated the authority for implementing major components of the Department of Health and Human Services' (HHS) tobacco and health program, including collection of tobacco ingredients information. HHS 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 Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252) requires that each person who manufactures, packages, or imports smokeless tobacco provide the Secretary of HHS annually with a report on the quantity of nicotine contained in smokeless tobacco products. This notice implements this nicotine reporting requirement. CDC is requesting OMB clearance to collect this information for three years. All companies are required to submit this information for all brands. A standard methodology for measurement of quantity of nicotine in smokeless tobacco has been developed. The methodology (“Protocol for Analysis of Nicotine, Total Moisture, and pH in Smokeless Tobacco Products”) is intended to provide standardized measurement of nicotine, total moisture, and pH in smokeless tobacco products. This information should be submitted in the prescribed format. In addition, we ask that companies provide an electronic copy of this information on a floppy disk or CD-ROM.

Background

In 1989, the smokeless industry submitted a business review letter to the Department of Justice (DOJ), in accordance with 28 CFR 50.6. This letter requested approval of a collaborative industry effort to determine standard nicotine reporting. In January 1993, DOJ extended permission to the smokeless industry to begin the development of uniform methods for analyzing smokeless tobacco products for nicotine or moisture content. The first meeting of the work group, which represented the ten major domestic manufacturers of smokeless tobacco, was convened on July 7, 1993. After a series of meetings of the joint industry work group, a standard methodology was approved by the work group and submitted to OSH for approval. The protocol was revised by OSH based on individual comments received from peer reviewers and the Division of Environmental Health Laboratory Sciences, National Center for Environmental Health, CDC. There are no costs to respondents.

Respondents	Number of respondents	Number of responses/respondent	Average burden/response (in hrs.)	Total burden (in hrs.)
Tobacco Manufacturers	11	1	1,706	18,766
Total				18,766

Dated: October 25, 2001.

Nancy E. Cheal,

Acting Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention.