Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[INFO-97-09]

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 (404) 639-7090.

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 for other

forms of information technology. Send comments to Wilma Johnson, CDC

Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA

30333. Written comments should be received within 60 days of this

notice.

Proposed Projects

1. Annual Submission of the Quantity of Nicotine Contained in

Smokeless Tobacco Products Manufactured, Imported, or Packaged in the

United States--New--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 Centers for Disease Control and Prevention's (CDC)

Office on Smoking and Health (OSH) 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'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 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. 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.

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. The total cost to respondents is

$467,500.*

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Average

No. of No. of burden/ Total burden

Respondents respondents responses/ response (in hrs.)

respondent (in hrs.)

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Tobacco manufacturers............................. 11 1 1,706 18,766

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* Please note that these figures are based on the average reporting time and cost estimations for six major

smokeless tobacco manufacturers are reported by Patton Boggs, LLP.

__________

* Please note that these figures are based on the average reporting

time and cost estimations for six major smokeless tobacco

manufacturers as reported by Patton Boggs, LLP.

[[Page 24116]]

Note: The annual reporting of the quantity of nicotine contained

in smokeless tobacco products for calendar year 1997 is due on July

31. In future years, the annual report will be due on March 31 of

each year; this is the same date that lists the ingredients added to

tobacco in the manufacture of smokeless tobacco products are due.

Dated: April 24, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning and Evaluation, Centers

for Disease Control and Prevention (CDC).

[FR Doc. 97-11348 Filed 5-1-97; 8:45 am]

BILLING CODE 4163-18-P