[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12501-12503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05213]


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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.

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SUMMARY: The Food and Drug Administration (FDA) 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 April 
8, 2016.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31) into law. This law 
amended the Food Drug and Cosmetic Act (the FD&C Act) and granted FDA 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to

[[Page 12502]]

protect public health generally and to reduce tobacco use by minors. 
Section 904(a)(3) of the FD&C Act (21 U.S.C. 387d(a)(3)) required each 
tobacco product manufacturer or importer, or an agent, to begin 
reporting to FDA no later than June 22, 2012, ``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.'' Reports must be 
by the brand and by quantity in each brand and sub-brand. Section 
904(c)(1) of the FD&C Act states that manufacturers of tobacco products 
not on the market as of June 22, 2009, must also provide information 
reportable under section 904(a)(3) at least 90 days prior to 
introducing the product into interstate commerce.
    FDA has taken several steps to identify harmful and potentially 
harmful constituents (HPHCs) to be reported under sections 904(a)(3) 
and (c)(1) of the FD&C Act, including issuing a guidance discussing 
FDA's current thinking on the meaning of the 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). The guidance is available on the Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm.
    In addition, in the Federal Register of April 3, 2012 (77 FR 
20034), FDA published a notice (the HPHC list notice) announcing the 
established list of HPHCs as required by section 904(e) of the FD&C Act 
and describing the criteria we used in identifying the HPHCs for the 
established list. Previously, FDA sought comment on both the criteria 
that would be used to identify HPHCs for the established list and a 
list of chemicals and chemical compounds that met the proposed 
criteria.
    The purpose of the information collection is to collect statutorily 
mandated information regarding HPHCs in tobacco products and tobacco 
smoke, by quantity in each brand and sub-brand.
    To facilitate the submission of HPHC information, FDA has developed 
Forms 3787a, 3787b, and 3787c in both paper and electronic formats. 
Manufacturers or importers, or their agents, may submit 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. 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. Respondents finished reporting initial HPHC 
information under section 904(a)(3) in 2012, and this collection of 
information is in connection with the reporting requirements under 
section 904(c)(1) of the FD&C Act for tobacco products introduced into 
interstate commerce after June 22, 2009.
    In the Federal Register of November 13, 2015 (80 FR 70232), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Four comments were received; however, only 
one was PRA related.
    A comment stated that FDA has dramatically underestimated the 
annual number of responses that will be submitted from tobacco product 
manufacturers and importers. The comment contended that our estimate 
does not appear to be based on the Agency's experience with respect to 
``new'' tobacco product submissions under section 910 of the FD&C Act.
    We have reconsidered our estimates, and agree with what we 
understand the comment to be saying, that we have not accounted for the 
submission of the two streamlined alternative substantial equivalent 
(SE) reports, one for label changes and one for product quantity 
changes, referred to as the ``Same Characteristics SE Report'' and the 
``Product Quantity Change SE Report,'' respectively, and subsequent 
premarket authorization for a ``new tobacco product'' as defined under 
section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1)). Based on FDA 
data, we estimate between 500 and700 (i.e., approximately 600) new 
tobacco products annually, as a result of manufacturers and importers 
submitting these streamlined submissions. We also estimate that the 
report of HPHC data in connection with these new tobacco products will 
take approximately 1 hour to prepare and submit. FDA has added a new 
line in the table for this category of new tobacco products.
    A comment also stated that the burden estimated for testing the 
quantities of HPHCs in cigarette filler and roll-your-own, smokeless, 
and smoke as 9.42 hours, 12.06 hours and 23.64 hours respectively, per 
product, has been dramatically underestimated. The comment contends 
that HPHC testing may more realistically be expected to take 7 to 12 
weeks per product. FDA does not agree with this comment. The Agency 
based its estimates on its understanding as to how long the tests 
themselves take, as opposed to the length of time between when a 
manufacturer or importer may first request that a test be done and then 
receives the test results from an internal or independent laboratory.
    Furthermore, a comment stated that the burden estimated for the 
time required to report HPHC information to the Agency has been 
underestimated. The comment contends that in one entity's experience, 
the time required to report on the testing of a cigarette may be 
expected to take around 200 hours, taking into account the time 
required to compile the requisite information and to complete, review 
and edit the associated form.
    FDA disagrees with this comment as we believe the estimates for 
testing the quantities of HPHCs are accurate. Additionally, we note 
that the comment did not contain any data to support its contention.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
     Information collected         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.................              78            0.79              62  1.82............             113
    Roll-Your-Own.............              39            0.21               8  0.43 (26                       3
                                                                                 minutes).
    Smokeless.................              52            0.21              11  0.63 (38                       7
                                                                                 minutes).
                               ---------------------------------------------------------------------------------

[[Page 12503]]

 
        Total.................  ..............  ..............  ..............  ................             123
2. Testing of HPHC Quantities
 in Products:
    Cigarette Filler..........              78            0.79              62  9.42............             584
    Roll-Your-Own.............              39            0.21               8  9.42............              75
    Smokeless.................              52            0.21              11  12.06...........             133
                               ---------------------------------------------------------------------------------
        Total.................  ..............  ..............  ..............  ................             792
3. Testing of HPHC Quantities
 in Mainstream Smoke:
    Cigarette: International                78            0.79              62  23.64...........           1,466
     Oraganization for
     Standardization (ISO)
     Regimen.
    Cigarette: Health Canada                78            0.79              62  23.64...........           1,466
     Regimen.
                               ---------------------------------------------------------------------------------
        Total.................  ..............  ..............  ..............  ................           2,932
4. Additional HPHC reports:
 \2\
    Cigarette Filler..........              78            2.56             200  1...............             200
    Roll-Your-Own.............              39            5.12             200  1...............             200
    Smokeless.................              52            3.84             200  1...............             200
                               ---------------------------------------------------------------------------------
        Total.................  ..............  ..............  ..............  ................             600
                               ---------------------------------------------------------------------------------
            Total Section       ..............  ..............  ..............  ................           4,447
             904(c)(1)
             Reporting Burden
             Hours.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ HPHC reports for identical products (e.g., under different brand or sub-brand names) in which the HPHC
  measures will be the same as the original report.

    Table 1 contains estimates for new product information received 
annually under section 904(c)(1) of the FD&C Act. Manufacturers must 
report HPHC information under section 904(c)(1) of the FD&C Act at 
least 90 days prior to delivery for introduction into interstate 
commerce. The total annual burden for this collection of information is 
estimated to be 4,447 hours. The burden estimate for this collection of 
information includes the time it will take to test the products and 
prepare the HPHC report. Table 1 indicates that 169 respondents will 
submit HPHC reports when new products enter the market.
    Section 1 of the table addresses the time required for 
manufacturers to report their company information. We estimate that the 
time to report HPHC information is no more than 1.82 hours for 
cigarettes, 0.42 hours for roll-your-own, and 0.63 hours for smokeless 
tobacco products for each response regardless of whether the paper or 
electronic form (Form FDA 3787) is used. (The estimated times to report 
smokeless tobacco products (0.63 hour) and roll-your-own tobacco 
products (0.43 hour) are lower than the estimated reporting time for 
cigarette products because fewer HPHCs are normally reported for these 
two types of products. The total annual burden for reporting company 
and product information is 123 hours.
    Section 2 of the table addresses the time required for 
manufacturers to test quantities of HPHCs in their products. The burden 
hour estimates include the time needed to test the tobacco products, 
draft testing reports, and draft the report for FDA. For cigarette 
filler, smokeless, and roll-your-own products, we estimate the burden 
to be 792 annual burden hours. The burden for each product type 
reflects our estimate of the time to test the tobacco products (i.e., 
carry out laboratory work).
    In addition to addressing the time required to report information 
and test quantities of HPHCs in tobacco products, section 3 of table 1 
addresses the time required for manufacturers to test quantities of 
HPHCs in cigarette smoke. The burden estimates include testing the 
tobacco products, drafting testing reports, and drafting the report for 
FDA. We estimate the annualized burden for this section to be 2,932 
hours. The annual burden reflects our estimate to test the tobacco 
products (i.e., carry out laboratory work). The burden estimate assumes 
that manufacturers report HPHC quantities in cigarette mainstream smoke 
according to the two smoking regimens described in the table.
    As stated previously, FDA expects to receive 600 additional HPHC 
reports at 1 hour per response for a total of 600 hours. The estimated 
total annual burden for the reporting of HPHC under section 904(c)(1) 
of the FD&C Act is 4,447 hours.

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05213 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P