[Federal Register Volume 77, Number 64 (Tuesday, April 3, 2012)]
[Notices]
[Pages 20030-20034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry: Reporting Harmful and Potentially 
Harmful Constituents in Tobacco Products and Tobacco Smoke Under the 
Federal Food, Drug, and Cosmetic Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Reporting 
Harmful and Potentially Harmful Constituents in Tobacco Products and 
Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and 
Cosmetic Act.'' The purpose of this draft guidance is to assist persons 
reporting to FDA the quantities of harmful and potentially harmful 
constituents (HPHCs) in tobacco products and tobacco smoke under the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance 
explains that FDA does not intend, at this time, to enforce reporting 
on the entire established HPHC list where a manufacturer or importer 
completes testing and reporting for an abbreviated list of HPHCs within 
the timeframes specified in the guidance.

DATES: Although you can comment on any guidance at any time (21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 4, 2012. Submit either electronic or written comments 
on the proposed collection of information by June 4, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Center for Tobacco Products, Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send 
one self-addressed adhesive label to assist that office in processing 
your request or a fax number to which the draft guidance may be sent. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit electronic comments on the draft guidance, including 
comments on the proposed collection of information to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: 
James Flahive, Center for Tobacco Products, Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 1-877-
287-1373, [email protected].
    With regard to the proposed collection of information: Daniel 
Gittleson, Office of Information Management, Food and Drug 
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-5156, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 
111-31) into law. The Tobacco Control Act amends the FD&C Act and 
grants FDA authority to regulate the manufacture, marketing, and 
distribution of tobacco products to 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)) requires 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, 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 
subbrand. Section 904(c)(1) 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 HPHCs to be reported under 
section 904(a)(3), including issuing a final guidance discussing FDA's 
current thinking on the meaning of ``harmful and potentially harmful 
constituent'' in the context of implementing the HPHC list requirement 
(76 FR 5387, January 31, 2011). The guidance is available on the 
Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm. In addition, on 
August 12, 2011, FDA issued a document (the HPHC notice; 76 FR 50226) 
in the Federal Register describing the criteria we tentatively 
concluded we would use in identifying the HPHCs for the established 
list, including a table of the 96 HPHCs we identified using those 
criteria, and asking the public and interested parties to submit 
relevant scientific and other information by October 11, 2011. FDA 
reviewed comments received in response to the HPHC notice. Elsewhere in 
this issue of the Federal Register, FDA is publishing a notice 
announcing the established list of HPHCs as required by section 904(e) 
of the FD&C Act.
    This draft guidance discusses the information to be reported on 
HPHCs in tobacco products and tobacco smoke under section 904(a)(3) of 
the FD&C Act. This draft guidance document discusses, among other 
things: The statutory requirement for testing and

[[Page 20031]]

reporting quantities of HPHCs, who tests and reports quantities of 
HPHCs to FDA, what HPHCs will be the focus of FDA enforcement at this 
time, when reports are submitted to FDA, what information is reported 
to FDA, and how the reports should be submitted to FDA. The draft 
guidance notifies manufacturers and importers that at this time, while 
industry is developing laboratory capacity to comply with section 
904(a)(3), FDA does not intend to enforce the statutory requirement to 
submit quantities of all constituents identified by FDA as HPHCs by 
June 22, 2012, where manufacturers or importers complete testing and 
reporting for an abbreviated list of HPHCs as set forth in the draft 
guidance. In particular, at this time, for products that were first 
marketed before June 22, 2012, FDA does not intend to enforce the 
section 904(a)(3) requirement to test and report quantities of all 
HPHCs on FDA's established list where: (1) A manufacturer or importer 
(or agents thereof), other than a small tobacco product manufacturer, 
submits quantities of the HPHCs on an abbreviated list described in the 
draft guidance for all of its products, by brand and subbrand, no later 
than September 22, 2012; or (2) a small tobacco product manufacturer 
(or agents thereof) submits quantities of HPHCS on the abbreviated list 
for all of its products, by brand and subbrand, by December 22, 2012. 
In addition, for products first marketed on or after June 22, 2012, the 
draft guidance explains that FDA does not intend, at this time, to 
enforce the requirement in section 904(c)(1) to test and report 
quantities of all HPHCs on FDA's established list for products not 
previously on the market if a manufacturer or importer reports 
quantities for the abbreviated list of HPHCs at least 90 days prior to 
marketing the product in the United States. In addition, the draft 
guidance explains that at this time, FDA intends to enforce the HPHC 
reporting requirements with respect to manufacturers of finished 
tobacco products for consumer use--cigarettes, smokeless tobacco, and 
roll-your-own tobacco--and not with respect to manufacturers and 
importers of other products, such as components sold to manufacturers 
or consumers for incorporation into finished products.
    Although this draft guidance announces an intent to exercise 
enforcement discretion for a limited time, FDA intends to move toward 
full implementation and enforcement of the statutory requirement to 
test and report quantities of all HPHCs on FDA's established list, as 
appropriate. We anticipate that this guidance will be revised or 
withdrawn as we move toward full implementation. We intend to use the 
information submitted under sections 904(a)(3) and 904(c)(1) of the 
FD&C Act to meet the requirements of section 904(e) of the FD&C Act 
regarding a list of HPHCs in each tobacco product by brand and by 
quantity in each brand and subbrand. Also, the information will be used 
to comply with section 904(d)(1) of the FD&C Act, which requires FDA to 
publish a list of HPHCs, by brand and by quantity in each brand and 
subbrand, in a format that is understandable and not misleading to lay 
persons.

II. Significance of Guidance

    FDA is issuing this draft guidance document consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the Agency's current thinking on 
reporting HPHCs in tobacco products and tobacco smoke under section 
904(a)(3) of the FD&C Act. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing a notice 
of the proposed collection of information set forth in the draft 
guidance for industry entitled ``Reporting Harmful and Potentially 
Harmful Constituents in Tobacco Products and Tobacco Smoke Under 
Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act.''
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Draft Guidance for Industry: Reporting Harmful and Potentially Harmful 
Constituents in Tobacco Products and Tobacco Smoke Under Section 
904(a)(3) of the Federal Food, Drug, and Cosmetic Act (OMB Control 
Number 0910-NEW)

    The purpose of the proposed information collection is to allow FDA 
to collect statutorily mandated information regarding HPHCs in tobacco 
products and tobacco smoke, by brand and by quantity in each brand and 
subbrand. The draft guidance provides an abbreviated list of HPHCs on 
which FDA intends to focus enforcement at this time for each of the 
following: Cigarette smoke, smokeless tobacco products, and roll-your-
own tobacco and cigarette filler.
    To facilitate the submission of HPHC information, FDA has developed 
forms in both paper and electronic formats. Manufacturers or importers, 
or an agent, 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 also populate an Excel file and import data into 
eSubmitter. FDA also provides paper forms for the submission of section 
904(a)(3) reports. FDA intends to place draft copies of the paper forms 
and screen shots of the electronic form and spreadsheet in this docket.
    Whether respondents decide to submit reports electronically or on 
paper, each form provides instructions for filling out and submitting 
HPHC information to FDA. The forms contain fields for company 
information, product information, and HPHC information. The draft 
guidance provides an abbreviated list of HPHCs on which FDA intends to 
focus enforcement at this time, and information to assist in the 
testing and reporting of HPHCs for cigarette smoke and filler, 
smokeless tobacco, and roll-your-own tobacco. FDA has created forms to 
assist in the

[[Page 20032]]

reporting of HPHC information for each of these product types.
    Description of Respondents: The respondents to this collection of 
information include manufacturers or importers who complete testing and 
reporting for HPHCs in tobacco products and tobacco smoke under section 
904(a)(3) of the FD&C Act. Respondents could also include agents of 
manufacturers or importers who complete HPHC testing and reporting.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
      Information collected          Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
            Part 1--Section 904(a)(3) of the FD&C Act (Annualized Estimate of One-time Reporting) \2\
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
    Cigarette...................             120           10.10           1,212               2           2,424
    Roll-Your-Own...............              46            3.22             148               2             296
    Smokeless...................             200            1.44             288               2             576
                                                                                                 ---------------
        Total...................  ..............  ..............  ..............  ..............           3,296
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2. Testing of HPHC Quantities in Products
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    Cigarette Filler............             120           10.1            1,212            9.42          11,417
    Roll-Your-Own...............              46            3.22             148            9.42           1,394
    Smokeless...................             200            1.44             288           12.06           3,473
                                                                                                 ---------------
        Total...................  ..............  ..............  ..............  ..............          16,284
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3. Testing of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
    Cigarette: International                 120           10.1            1,212           23.64          28,652
     Organization for
     Standardization (ISO)
     Regimen....................
    Cigarette: Health Canada                 120           10.1            1,212           23.64          28,652
     Regimen....................
                                                                                                 ---------------
        Total...................  ..............  ..............  ..............  ..............          57,304
                                                                                                 ---------------
        Total Section 904(a)(3)   ..............  ..............  ..............  ..............          76,884
         Annualized One-Time
         Burden.................
----------------------------------------------------------------------------------------------------------------
             Part 2--Reporting of Section 904(c)(1) New Products (15% of One-Time Burden Totals) \3\
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
    Cigarette...................              18           10.10             182               2             364
    Roll-Your-Own...............               7            3.22              23               2              46
    Smokeless...................              30            1.44              43               2              86
                                                                                                 ---------------
        Total...................  ..............  ..............  ..............  ..............             496
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2. Reporting of HPHC Quantities
 in Products
----------------------------------------------------------------------------------------------------------------
    Cigarette Filler............              18           10.1              182            9.42           1,714
    Roll-Your-Own...............               7            3.22              23            9.42             217
    Smokeless...................              30            1.44              43           12.06             519
                                                                                                 ---------------
        Total...................  ..............  ..............  ..............  ..............           2,450
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3. Reporting of HPHC Quantities in Mainstream Smoke
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    Cigarette: ISO Regimen......              18           10.1              182           23.64           4,302
    Cigarette: Health Canada                  18           10.1              182           23.64           4,302
     Regimen....................
                                                                                                 ---------------
        Total...................  ..............  ..............  ..............  ..............           8,604
                                                                                                 ---------------
        Total Section 904(c)(1)   ..............  ..............  ..............  ..............          11,550
         Burden.................
                                                                                                 ---------------
        Total Reporting Burden    ..............  ..............  ..............  ..............          88,434
         Hours..................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ One-time actual first year burden hours have been annualized over the 3-year OMB period of approval to avoid
  overcounting the burden each year.
\3\ Annual new product reporting under section 904(c)(1) is estimated to be 15% of the annualized one-time
  burden.


[[Page 20033]]

    FDA estimates the one-time reporting burden for this guidance would 
be 230,652 hours during the first year for section 904(a)(3) reporting 
plus ongoing annual burden of 11,550 hours for section 904(c)(1) 
reporting. The burden estimate for this collection of information 
includes the time it will take to read the guidance document, test the 
products, and prepare the HPHC report.
    To avoid overcounting the one-time reporting burden, FDA has 
divided the first year burden by three, annualizing the one-time burden 
over the 3-year expected OMB period of approval to avoid double-
counting the one-time projected burden. The one-time burden for year 
one is located in part 1 of table 1 of this document, and includes 
burden for collections of information gathered under section 904(a)(3). 
The annualized total one-time burden in part 1 of table 1 is 76,884 
hours (230,652 hours divided by 3), which includes 3,296 hours for 
reporting manufacturer or importer company and product information, 
16,284 hours for reporting HPHC quantities in products, and 57,304 
hours for reporting HPHC quantities in mainstream smoke.
    As shown in table 1, the total annual burden for this collection of 
information is estimated to be 88,434 hours, which is the annualized 
one-time burden estimate for section 904(a)(3) associated with the 
submission of an HPHC (76,884 hours) and the annual burden estimate for 
section 904(c)(1) (11,550 hours). We have assumed a one-time burden for 
section 904(a)(3) because this draft guidance is intended to remain in 
effect while industry is developing laboratory capacity to comply fully 
with section 904(a)(3) of the FD&C Act. We also assume any new product 
reporting requirements under section 904(c)(1) will be provided 
annually to FDA. We also anticipate this guidance will be revised or 
withdrawn as FDA moves toward full implementation and enforcement of 
the statutory requirement to report quantities by brand and subbrand of 
all HPHCs on FDA's established HPHC list.
    Part one of table 1 estimates that 366 respondents (120 cigarette 
manufacturers or importers, 200 smokeless manufacturers, and 46 roll-
your-own tobacco manufacturers) will submit 4,942 HPHC reports on a 
one-time basis (e.g., 1,648 reports on an annualized basis). As noted 
previously, FDA estimates that it will take the manufacturer, importer, 
or their agents 230,652 hours on a one time basis, or 76,884 hours 
annually, to collect the information necessary to test the products and 
submit an HPHC report by brand and subbrand.
    Part one, section one of table 1 addresses the time required for 
manufacturers and importers to report their company information: 
Company name; mailing address; telephone and FAX numbers; FDA 
Establishment Identifier (FEI) number; Data Universal Numbering System 
(D-U-N-S) number; and point of contact name, mailing address, and 
telephone and FAX numbers. The first section of table 1 also addresses 
the time required for manufacturers and importers to report their 
product information by entering testing information onto the forms: 
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 is no more than 2 hours per response to report company 
and product information testing regardless of whether the paper or 
electronic form (Form FDA 3787) is used. This estimate is not dependent 
on product type, so the estimated burden is the same for cigarettes, 
roll-your-own tobacco, and smokeless tobacco products. We estimate that 
there are 3,636 cigarette subbrands, 445 roll-your-own tobacco 
subbrands, and 861 smokeless tobacco subbrands (4,942 total subbrands) 
that must comply with section 904(a)(3) of the FD&C Act. Therefore, the 
total annualized burden for reporting company and product information 
is 3,296 hours (4,942 respondents x 2 hours = 9,884 one-time hours 
divided by 3).
    Part one, section two of table 1 addresses the time required from 
manufacturers and importers to report quantities for HPHCs in their 
products: Number of replicate measurements; test date range; 
manufacture date range; extraction method; separation method; detection 
method; and mean quantity and standard deviation of HPHCs. The burden 
hour estimates in this section include the time needed to test the 
tobacco products, draft testing reports, draft the report for FDA, and 
submit the report to FDA. For cigarette filler, smokeless, and roll 
your own products, we estimate the burden to draft testing reports, 
draft the report for FDA, and submit the report to FDA to be 48,852 
one-time hours, or 16,284 annualized burden hours. The burden for each 
product type reflects our estimate of the burden to test the tobacco 
products (i.e., carry out laboratory work). The per-response burden for 
testing cigarette filler and roll-your-own tobacco is the same, as the 
same HPHCs must be measured for both product types. The per-response 
burden for testing smokeless products is greater than that for the 
other two product types because more HPHCs must be tested for smokeless 
products than the other two product types.
    Part one, section three of table 1 addresses the time required for 
manufacturers and importers to report quantities for HPHCs in cigarette 
smoke: 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. The burden 
estimates include the burden to test the tobacco products, draft 
testing reports, draft the report for FDA, and submit the report to 
FDA. We estimate the one-time burden for this section to be 171,912 
hours, or 57,304 annualized hours. The annualized burden reflects our 
estimate of the burden 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 recommended smoking regimens. The total annualized 
burden for part one of table 1 (section 904(a)(3) reporting) is 76,884 
hours (3,296 hours plus 16,284 hours plus 57,304 hours).
    Part two of table 1 contains estimates for new product information 
received under section 904(c)(1). Manufacturers and importers must 
report HPHC information under section 904(c)(1) at least 90 days prior 
to delivery for introduction into interstate commerce. We estimate that 
approximately 15 percent of FDA currently regulated tobacco products in 
any given year will require submission of this information. The 
estimated total annual burden for section 904(c)(1) is 11,550 hours, 
which includes 496 hours to report manufacturer/importer company and 
product information, 2,450 hours to report HPHC quantities in products, 
and 8,604 hours to report HPHC quantities in mainstream smoke.
    The estimated total annual burden for the reporting of HPHC under 
sections 904(a)(3) and 904(c)(1) is 88,434 hours (76,884 annualized 
burden hours for section 904(a)(3) reporting plus 11,550 annual burden 
hours for section 904(c)(1) reporting).
    We have not estimated any capital costs because we do not believe 
there are any capital costs associated with this collection. However, 
you may comment on any specific capital costs that you have identified.

[[Page 20034]]

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received documents may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of this guidance document at http://www.regulations.gov and 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: March 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7766 Filed 3-30-12; 11:15 am]
BILLING CODE 4160-01-P