Notice2022-08214
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 18, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 74 (Monday, April 18, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22889-22890]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08214]
[[Page 22889]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-0338]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Annual Submission of the Ingredients Added
to, and the Quantity of Nicotine Contained in, Smokeless Tobacco
Manufactured, Imported, or Packaged in the U.S.'' to the Office of
Management and Budget (OMB) for review and approval. CDC previously
published a ``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on September 27, 2021, to obtain comments from
the public and affected entities. CDC did not receive comments related
to the FRN. This notice serves to allow an additional 30 days for
public and affected entities' comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information
to be collected;
(d) Minimize the burden of the collection of information on
those who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g.,
permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Annual Submission of the Ingredients Added to, and the Quantity of
Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or
Packaged in the U.S. (OMB Control No. 0920-0338, Exp. 04/30/2022)--
Extension--National Center for Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Smokeless tobacco products (SLT) are associated with many health
problems. Using smokeless tobacco can lead to nicotine addiction;
causes cancer of the mouth, esophagus, and pancreas; is associated with
diseases of the mouth; can increase risks for early delivery and
stillbirth when used during pregnancy; can cause nicotine poisoning in
children; and may increase the risk for death from heart disease and
stroke.
The CDC's Office on Smoking and Health (OSH) has the primary
responsibility for the HHS smoking and health program. As required by
the Comprehensive Smokeless Tobacco Health Education Act of 1986
(CSTHEA, 15 U.S.C. 4401 et seq., Pub. L. 99-252), CDC collects a list
of ingredients added to tobacco in the manufacture of smokeless tobacco
products and a specification of the quantity of nicotine contained in
each product. HHS has delegated responsibility for implementing the
required information collection to CDC's Office of Smoking and Health
(OSH). Respondents are the manufacturers, packagers, or importers (or
their representatives) of smokeless tobacco products. Respondents are
not required to submit specific forms; however, they are required to
meet reporting guidelines and to submit the ingredient and nicotine
reports. Ingredient reports must be submitted by chemical name and
Chemical Abstract Service (CAS) Registration Number, consistent with
accepted reporting practices for other companies that are required to
report ingredients added to other consumer products. Typically,
respondents submit a summary report to CDC with the ingredient
information for multiple products, or a statement that there are no
changes to their previously submitted ingredient report. Respondents
may submit the required information to CDC through a designated
representative. The information collection is subject to strict
confidentiality provisions.
Ingredient and nicotine reports for new SLT products are due at the
time of first importation. Thereafter, ingredient and nicotine reports
are due annually on March 31. Information is submitted to CDC by
mailing a written report on the respondent's letterhead. Electronic
mail submissions are not accepted. Annual submission reports are mailed
to Attention: FCLAA Program Manager, Office on Smoking and Health,
National Center for Chronic Disease Prevention and Health Promotion,
Centers for Disease Control and Prevention, 4770 Buford Highway, NE, MS
S107-7, Atlanta, GA 30341-3717.
Upon receipt and verification of the annual nicotine and ingredient
report, CDC issues a Certificate of Compliance to the respondent. As
deemed appropriate by the Secretary of HHS, HHS is authorized to use
the information to report to Congress the health effects of
ingredients, research activities related to the health effects of
ingredients, and other information that the Secretary determines to be
of public interest.
OMB approval is requested for three years. CDC requests OMB
approval for an estimated 18,843 annual burden hours. There are no
costs to respondents other than their time to participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Smokeless Tobacco Manufacturers, SLT Ingredient Report... 11 1 6.5
Packagers, and Importers.
[[Page 22890]]
Smokeless Tobacco Manufacturers, SLT Nicotine Report..... 11 1 1,706.5
Packagers, and Importers.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-08214 Filed 4-15-22; 8:45 am]
BILLING CODE 4163-18-P
</pre></body>
</html>Indexed from Federal Register on April 18, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.