[Federal Register Volume 59, Number 21 (Tuesday, February 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2184]
[[Page Unknown]]
[Federal Register: February 1, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice Regarding Requirement for Submission of List of
Ingredients Added to Tobacco in the Manufacture of Smokeless Tobacco
Products
AGENCY: Centers for Disease Control and Prevention (CDC), Public Health
Service, HHS.
ACTION: Notice.
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SUMMARY: This notice implements the requirement of the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (Public Law 99-252) that
each person who manufactures, packages, or imports smokeless tobacco
shall provide the Secretary of Health and Human Services (HHS) annually
with a list of ingredients added to tobacco in the manufacture of
smokeless tobacco products. (This statute also requires reporting to
HHS the nicotine content of smokeless tobacco products. The nicotine
reporting requirement will be implemented at a later date.)
DATES: The first ingredient list is due on April 4, 1994, and shall
identify all ingredients added to tobacco in the manufacture of
smokeless tobacco products marketed on December 31, 1993. Beginning in
1994 and each subsequent calendar year, the ingredient list will be due
on December 31, and shall identify any changes in the ingredients added
to tobacco in the manufacture of smokeless tobacco products at any time
during the previous twelve months.
ADDRESSES: The list shall be submitted to: Michael P. Eriksen, Sc.D.,
Director,Office on Smoking and Health, National Center for Chronic
Disease Prevention and Health Promotion, Centers for Disease Control
and Prevention (CDC), 4770 Buford Highway, NE., Atlanta, GA 30341-3724.
FOR FURTHER INFORMATION CONTACT: Michael P. Eriksen, Sc.D., Director,
Office on Smoking and Health, (404) 488-5701.
SUPPLEMENTARY INFORMATION: Section 4(a) of Public Law 99-252 (15 U.S.C.
4403(a)) requires manufacturers, packagers, and importers of smokeless
tobacco products to provide the Secretary of HHS annually with a list
of all ingredients added to tobacco in the manufacture of smokeless
tobacco products. This statute also stipulates that the list need not
identify the company which uses the ingredients or the brand of
smokeless tobacco which contains the ingredients.
The implementation procedures HHS has established for submitting
the ingredient information require respondents to report each
ingredient by chemical name and Chemical Abstract Service (CAS)
Registry Number. This format for reporting ingredients is consistent
with accepted reporting practices for other companies currently
required to report ingredients added to other consumer products,
including cigarettes.
The statute permits a person or group of persons required to submit
an ingredient list to HHS to designate an individual or entity to
provide information on their behalf. In such case, HHS procedures
require the designated individual or entity to identify for HHS the
person or group of persons on whose behalf the ingredient list is being
submitted.
HHS has established strict procedures for assuring the
confidentiality of the information submitted in accordance with section
4(b)(2)(C) of Public Law 99-252 (15 U.S.C. 4403(b)(2)(c)). The
information will be treated as trade secret or confidential information
subject to 5 U.S.C. 552(b)(4). Access to the information will be
limited to those authorized by the Secretary in carrying out their
official duties and to duly-authorized committees or subcommittees of
the Congress that submit a written request for the information.
Information Collection Provisions:
This Notice contains information collections which have been
approved by the Office of Management and Budget under the Paperwork
Reduction Act of 1980 and assigned the control number 0920-0338. The
title, description, and respondent description of the information
collection are shown below with an estimate of the annual reporting and
record keeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Title: Ingredients Added to Tobacco in the Manufacture of Smokeless
Tobacco Products.
Description: The Comprehensive Smokeless Tobacco Health Education
Act of 1986 requires HHS to collect this information. HHS is authorized
to conduct research on the potential health effects of the ingredients,
and to report to the Congress as appropriate.
Description of Respondents: Businesses or Other For-Profit
Organizations.
Estimated Annual Reporting and Recordkeeping Burden: The Office on
Smoking and Health (OSH) contacted five smokeless tobacco
manufacturers, through the law firm of Patton, Boggs and Blow, which
will submit ingredient information in order to estimate the annualized
cost for reporting ingredient information to the Department of Health
and Human Services. The estimated average cost to industry for this
three year period is $4,314. This is based on an annualized estimated
cost of $1,438 per company with an annual estimated cost range of $250
to $3500 per company per year. The estimated cost to the government for
this collection and storage over a three year period is $18,000.00.
This cost is based on an annualized estimated cost of $6,000.00 for
collection and storage.
There are 11 manufacturers, packagers, and importers of smokeless
tobacco products in the U.S. In November 1992, OSH contacted five
companies, through the law firm of Patton, Boggs and Blow, which will
submit ingredient information to the Department of Health and Human
Services, regarding the estimated response burden to the industry.
Patton, Boggs and Blow reported that the annual response burden for
each company it represents ranges from 4 to 30 manhours, with an
average burden of 15 hours per company.
Dated: January 25, 1994.
Walter R. Dowdle,
Deputy Director, Centers for Disease Control and Prevention (CDC).
Guidelines for Maintaining and Releasing Privileged Information
Obtained in Accordance With Sec. 4(b)(2)(a) of Public Law 99-252 (15
U.S.C. 4403)
1. Purpose
These Guidelines establish minimum requirements to maintain,
protect and release documents that contain privileged information
regarding ingredients in smokeless tobacco products. The Guidelines
establish individual responsibility for the accountability and
protection of privileged information on ingredients added to tobacco in
the manufacture of smokeless tobacco products and the quantity of
nicotine in each such product. The Comprehensive Smokeless Tobacco
Education Act of 1986 (Pub. L. 99-252 (15 U.S.C. 4403)) requires
manufacturers, packagers, and importers of smokeless tobacco products
to submit such information annually to the Secretary of Health and
Human Services.
2. Policy
Employees of the Department of Health and Human Services shall take
such action as may be necessary to assure implementation of statutory
requirements to safeguard privileged information. In accordance with
Public Law 99-252 (15 U.S.C. 4403 (b)(2)), HHS shall treat the lists of
ingredients added to tobacco in the manufacture of smokeless tobacco
products as trade secret or confidential information. HHS shall not
reveal the information except as authorized by the statute. Privileged
information shall be released to Congress only as provided in section
4(b) of Public Law 99-252 (15 U.S.C. 4403 (b)) and to employees of the
Department authorized to review the information in carrying out their
official duties under Public Law 99-252 (15 U.S.C. 4403(b)(2)). All
other requests for the privileged information shall be denied.
If HHS receives a request for the privileged information under the
Freedom of Information Act, the Freedom of Information Officer shall
deny the request in accordance with the provisions of 5 U.S.C.
552(b)(3) and 552(b)(4), section 4(b)(2)(A) of Public Law 99-252 (15
U.S.C. 4403(b)(2)), which require the protection of confidential or
trade secret information.
3. Statutory Requirements
Statutory requirements for safeguarding the subject privileged
information are as follows:
a. Sections 4(b)(2) of Public Law 99-252 (15 U.S.C. 4403(b)(2))
(Comprehensive Smokeless Tobacco Health Education Act of 1986) 5 U.S.C.
552(b)(4) (Freedom of Information Act).
4. Definitions
a. Document Control Officer. This Officer is the Departmental
official designated in writing as having responsibility for the
Department's control of privileged information pertaining to the
smokeless tobacco product ingredients. The Document Control Officer
shall be the Director, Office on Smoking and Health, National Center
for Chronic Disease Prevention and Health Promotion, Centers for
Disease Control and Prevention (CDC).
b. Privileged Information. As used in this Guideline, privileged
information refers to (i) any information provided to HHS in accordance
with section 4(a)(1) of Public Law 99-252 (15 U.S.C. 4403(a)(1)), and
(ii) any other materials derived from the information provided.
c. Secure Files Area. A room or rooms that are locked during non-
duty hours.
d. Secure Files Containers. Any equipment that is locked when
unattended and that cannot be hand carried (e.g., Power Files and
Lektrievers, filing cabinets and shelf units, credenzas, desk
pedestals, etc.,).
5. Responsibilities
The Document Control Officer shall:
(1) Provide written guidance to HHS organizational components
regarding the action necessary to assure compliance with the provisions
of these Guidelines.
(2) Maintain and verify the operation of an effective document
control system.
(3) Assure adherence to the requirements these Guidelines
establish.
(4) Investigate reports of overdue documents.
6. Persons Authorized to Have Access to Privileged Information
The following may be granted access to privileged information under
the conditions specified:
a. Department Employees. Upon written authorization from the
Document Control Officer, regular or special employees of the
Department are permitted access to privileged information needed to
perform their official duties. Any employee permitted such access
shall, prior to receiving privileged information, read and execute a
Commitment to Protect Confidential Information form.
b. In accordance with section 4(b)(2)(B) of Public Law 99-252 (15
U.S.C. 4403(b)(2)(B)), the Department shall provide privileged
information submitted under that Act to a duly-authorized committee or
subcommittee of Congress upon its written request. When documents are
so released, the Department, at the same time, shall provide written
notice of the release to the person who provided the privileged
information.
Users of files containing privileged information are responsible
for complying with these HHS Guidelines and other accountability
procedures that the Document Control Officer establishes to protect the
files.
7. Document Accountability
The Document Control Officer shall authorize, in writing, the
release of the privileged information. Persons accessing the privileged
information shall execute a Commitment to Protect Confidential
Information form and provide personal identification to verify their
identity.
a. Charge-Outs. When privileged information documents are charged
out, the recipient shall sign a Commitment to Protect Confidential
Information form. This form, which includes identifying information and
anticipated date of return, also shall serve as a document receipt
form. The person who certifies to accept and protect the privileged
information is responsible for the file documents received. Receipts
shall be kept current so that documents can be located readily.
b. Control, Follow-up, and Verification of Locations. The Document
Control Officer shall require the return of each document by the return
date stipulated on the receipt. If use of the document is necessary for
an additional period, the Document Control Officer may authorize an
extension and shall document the files accordingly. When the privileged
information documents are returned, the actual date of return shall be
recorded on the receipt form.
c. Report of Lost Documents. Individuals who have received
privileged information documents shall notify the Document Control
Officer in writing when privileged information files cannot be located.
The notification shall include:
(1) The name and organizational location of the individual
authorized to possess the documents at the time of loss;
(2) The identification and description of each missing file;
(3) A summary of the efforts made to locate the missing file.
8. Document Protection
Document protection shall include the following:
a. During Non-Working Hours. All privileged information must be
locked in an approved secure files area or in an approved secure files
container during non-working hours.
b. During Working Hours. When not in actual use by an authorized
employee, privileged information shall be protected by using the
protective measures required for non-working hours.
9. Transfer of Privileged Information
Method of Transmission. The preferred method is person-to-person
transmission. When this is not practical, the privileged information is
to be sent through the U.S. Registered Mail system, unless a written
exception has been obtained on an individual basis from the Document
Control Officer.
10. Document Reproduction
Privileged information documents will be reproduced only as
required for the performance of official business, and only by those
persons so authorized by the Document Control Officer.
11. Document Disposition
The documents provided to the Department in accordance with Section
4(a)(1) of the Comprehensive Smokeless Tobacco Health Education Act of
1986 (15 U.S.C. 4403 (a)(1)) shall be maintained in accordance with the
Records Control Schedule of the Centers for Disease Control and
Prevention (CDC).
12. Violation
Misuse or loss of privileged information constitutes a violation of
statutory provisions and HHS rules for controlling and protecting such
information. Employees failing to comply with the provisions of these
Guidelines or other established document control procedures are subject
to action commensurate with the seriousness of the violation.
Attachment A--Commitment to Protect Confidential Information on the
Ingredients Added to Tobacco in the Manufacture of Smokeless Tobacco
Products
Whereas access to confidential information in the files of the
Public Health Service is required in the performance of official
duties, I ________________________ on this ________ day of
________________ 19__, hereby agree that I shall not further
release, publish, copy, or disclose such information, and that I
shall protect such information in accordance with the provisions of
5 U.S.C. 552(b)(4), and the Public Health Service guide for the
Control of Confidential Information on the Ingredients Added to
Tobacco in the Manufacture of Smokeless Tobacco Products.
I understand the provision of 5 U.S.C. 552(b)(4), and the PHS
guide, and that I am subject to penalties prescribed by law for any
violations thereof.
Signed:----------------------------------------------------------------
Date:------------------------------------------------------------------
Witnessed by:----------------------------------------------------------
Date:------------------------------------------------------------------
Attachment B--Receipt for Confidential Information in the Manufacture
of Smokeless Tobacco Products
To: Director, Office on Smoking and Health, Centers for Disease
Control and Prevention (CDC), Atlanta, Georgia 30341-3724.
From:------------------------------------------------------------------
Receipt of the following privileged information is hereby
acknowledged: File#--Description of Information--Anticipated
Date of Return.
Date:------------------------------------------------------------------
Signature:-------------------------------------------------------------
Attachment C--Authority to Remove Confidential Information on the
Ingredients Added to Tobacco in the Manufacture of Smokeless Tobacco
Products
____________________ (name) of __________________________ (government
agency or office) is hereby granted the authority to have the following
privileged information in his/her personal possession from __________
(hours), __________ (date) to __________ (hours), __________ (date).
Describe Privileged Information:
Document Number:
Title:
This information will be used for:
Authorized by: --------------------------------------------------------
Director, Office on Smoking and Health
Date: -----------------------------------------------------------------
[FR Doc. 94-2184 Filed 1-31-94; 8:45 am]
BILLING CODE 4160-18-P
