Document ID: FDA-2012-D-0049-0038
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful
and Potentially Harmful Constituents in Tobacco Products and Tobacco
Smoke Under the Federal Food, Drug, and Cosmetic Act
Posted Date: 2019-06-04T04:00Z

[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Notices]
[Pages 25812-25814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11526]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0049]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reporting Harmful and 
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke 
Under the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 5, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0732. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Reporting Harmful and Potentially Harmful Constituents in Tobacco 
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic 
Act

OMB Control Number 0910-0732--Extension

    The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act), enacted on June 22, 2009, amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) and provided FDA with 
the authority to regulate the manufacture, marketing, and distribution 
of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and 
smokeless tobacco products to protect the public health and to reduce 
tobacco use by minors. The Tobacco Control Act also gave FDA the 
authority to issue regulations deeming other products that meet the 
statutory definition of a tobacco product to be subject to chapter IX 
of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).
    In accordance with that authority, on May 10, 2016, FDA issued a 
final rule deeming all products that meet the statutory definition of 
tobacco product, except accessories of newly deemed tobacco products, 
to be subject to FDA's tobacco product authority (final deeming rule) 
(81 FR 28974).
    Chapter IX of the FD&C Act now applies to newly regulated products, 
including sections 904(a)(3) and (c)(1) (21 U.S.C. 387d(a)(3) and 
(c)(1)). Section 904(a)(3) of the FD&C Act requires the submission of 
an initial report from each tobacco product manufacturer or importer, 
or agents thereof, listing all constituents, including smoke 
constituents as applicable, identified as a harmful and potentially 
harmful constituent (HPHC) to health by FDA. Reports must be by brand 
and by quantity in each brand and subbrand. We note that for 
cigarettes, smokeless tobacco, cigarette filler, and RYO tobacco 
products, this initial reporting was completed in 2012.
    Section 904(c)(1) of the FD&C Act provides that manufacturers of 
tobacco products not on the market as of June 22, 2009, must also 
provide the information reportable under section 904(a)(3) at least 90 
days prior to introducing the product into interstate commerce.\1\
---------------------------------------------------------------------------

    \1\ Note that section 904(c)(1) testing and reporting 
requirements are separate from the requirements that must be 
satisfied before a new tobacco product (sections 905 and 910 of the 
FD&C Act (21 U.S.C. 387e and 387j)), or modified risk tobacco 
product (section 911 of the FD&C Act (21 U.S.C. 387k)) may be 
marketed.
---------------------------------------------------------------------------

    FDA has taken several steps to identify HPHCs to be reported under 
section 904 of the FD&C Act, including issuing a guidance discussing 
FDA's current thinking on the meaning of the

[[Page 25813]]

term ``harmful and potentially harmful constituent'' in the context of 
implementing the HPHC list requirement under section 904(e) of the FD&C 
Act (76 FR 5387, January 31, 2011, revised guidance issued August 
2016). The guidance is available on the internet at https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm. The current established list of HPHCs also is available 
on the internet at https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM297828.pdf (77 FR 20034, April 3, 
2012).
    The purpose of the information collection is to collect statutorily 
mandated information regarding HPHCs in tobacco products and tobacco 
smoke, by brand and by quantity in each brand and subbrand.
    To facilitate the submission of HPHC information, Forms FDA 3787a, 
3787b, and 3787c for cigarettes, smokeless tobacco products, and RYO 
tobacco products, respectively, in both paper and electronic formats, 
are available. Additionally, FDA is developing forms to facilitate the 
submission of HPHC information for the newly deemed tobacco products. 
We intend to model these forms on the current HPHC reporting forms 
(i.e., Forms FDA 3787a, 3787b, and 3787c). A proposed information 
collection for newly deemed products will be published in a separate 
Federal Register notice, and we will solicit comments on that 
collection at that time.
    Manufacturers or importers, or their agents, may submit HPHC 
information either electronically or in paper format. The FDA 
eSubmitter tool provides electronic forms to streamline the data entry 
and submission process for reporting HPHCs for cigarettes, smokeless 
tobacco products, and RYO tobacco products. Users of eSubmitter may 
populate an FDA-created Excel file and import data into eSubmitter. 
Whether respondents decide to submit reports electronically or on 
paper, each form provides instructions for completing and submitting 
HPHC information to FDA. The forms contain fields for company 
information, product information, and HPHC information.
    In the Federal Register of January 31, 2019 (84 FR 744), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment that referenced 
ingredient reporting; however, that comment is nonresponsive to this 
information collection, which specifically covers HPHCs. FDA notes that 
this information collection relates to section 904(a)(3) of the FD&C 
Act, which requires each tobacco product manufacturer or importer, or 
an agent, to report a listing of all constituents, including smoke 
constituents as applicable, identified by FDA as harmful or potentially 
harmful to health in each tobacco product, and as applicable in the 
smoke of each tobacco product.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
                                    Reporting for Section 904(c)(1) Products
      1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
Cigarette.......................              67            0.67              45            1.82              82
RYO.............................              46           0.033             1.5            0.43               1
Smokeless.......................              42            0.54              23            0.63              14
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              97
----------------------------------------------------------------------------------------------------------------
                                    2. Testing of HPHC Quantities in Products
----------------------------------------------------------------------------------------------------------------
Cigarette Filler and RYO........              46           0.033             1.5            9.42              14
Smokeless.......................              42            0.54              23           12.06             277
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             291
----------------------------------------------------------------------------------------------------------------
                                3. Testing of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
Cigarette: ISO Regimen..........              67            0.67              45           23.64           1,064
Cigarette: Health Canada Regimen              67            0.67              45           23.64           1,064
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           2,128
                                 -------------------------------------------------------------------------------
        Total Section 904(c)(1)   ..............  ..............  ..............  ..............           2,516
         Reporting Burden Hours.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden for this collection of information is estimated to be 
2,516 hours. The burden estimate for this collection of information 
includes the time it will take to read the instructions, test the 
products, and prepare the HPHC report.
    In arriving at this burden estimate, FDA estimated the number of 
tobacco products to be reported under the requirements of section 
904(c)(1) of the FD&C Act annually to FDA.
    Section 1 of table 1 estimates that 155 respondents (67 cigarette 
manufacturers or importers, 46 RYO tobacco manufacturers, 42 smokeless 
manufacturers) will submit 97 HPHC reports annually. This section 
addresses the time required for manufacturers and importers (or their 
agents), who must report their product information to FDA under section 
904(c)(1) of the FD&C Act at least 90 days prior to delivery for 
introduction into interstate commerce for all new products, to report 
their company information to FDA through the use of the electronic 
portal or paper forms.
    The company information reported includes: Company name; mailing 
address; telephone and Fax numbers; FDA Establishment Identifier 
number;

[[Page 25814]]

Data Universal Numbering System number; and point of contact name, 
mailing address, and telephone and Fax numbers, as applicable. It also 
addresses the time required for manufacturers and importers to report 
their product information by entering certain testing information into 
the electronic or paper forms.
    The product information includes: Brand and subbrand name; unique 
product identification number; type of product identification number; 
product category and subcategory; and mean weight and standard 
deviation of tobacco in product.
    We estimate that the burden to enter both the company and product 
information is no more than 1.82 hours for cigarettes, 0.43 hours for 
RYO, and 0.63 hours for smokeless tobacco products regardless of 
whether the paper or electronic Form FDA series 3787 is used. The time 
to report per tobacco product types varies because the number of HPHCs 
varies by tobacco product category.
    The estimated number of responses under section 904(c)(1) is based 
on FDA's experience and the past 3 years' actual responses to FDA under 
this provision of the FD&C Act for statutorily regulated products.
    Section 2 of table 1 estimates that 88 respondents (46 cigarette 
filler and RYO tobacco manufacturers and importers and 42 smokeless 
manufacturers) will test quantities of HPHCs in an average of 24.5 
products annually. This section addresses the time required for 
manufacturers and importers (or their agents) who must test HPHC 
quantities in products. The burden estimates include the burden to test 
the tobacco products, draft testing reports, and submit the report to 
FDA. The total expected burden for this section is 291 hours.
    Section 3 of table 1 addresses the time required for manufacturers 
and importers to test quantities for HPHCs in cigarette smoke. The 
burden estimates include: The burden to test the number of replicate 
measurements; test date range; manufacture date range; extraction 
method; separation method; detection method; and mean quantity and 
standard deviation of HPHCs and includes the burden to test the tobacco 
products, draft testing reports, and submit the report to FDA. The 
annual burden reflects our estimate of the time it takes to test the 
tobacco products (i.e., carry out laboratory work). The burden estimate 
assumes that manufacturers and importers report HPHC quantities in 
cigarette mainstream smoke according to the two smoking regimens. The 
total expected burden is 2,128 hours for this section.
    The total estimated burden for this information collection is 2,516 
hours and 139 responses.
    Our estimated burden for the information collection reflects an 
overall decrease of 2,125 hours and a corresponding decrease of 142 
responses. We attribute this decrease to updated information on the 
number of submissions we received over the last few years.

    Dated: May 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11526 Filed 6-3-19; 8:45 am]
BILLING CODE 4164-01-P