From/To.............................  From:
                                          To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business:.....................................................................................................................................
    One-time costs per small entity are between 0.06% and 0.11% of their average annual revenue. Due to many missing values from Census data, average
     small-entity impacts are likely subject to large variability, due to the significant amount of heterogeneity in small-entity impacts across
     entities of different sizes (See Ref. 184)..
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (as Ref. 184) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by the OMB under the PRA (44 U.S.C. 3501-3521). A
description of these provisions is given in the Description section of
this document with an estimate of the annual reporting, recordkeeping,
and third-party disclosure 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 each
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.
    Title: Requirements for Tobacco Product Manufacturing Practice.
    Description: The Tobacco Control Act was enacted on June 22, 2009,
amending the FD&C Act and providing FDA with the authority to regulate
tobacco products. Section 101(b) of the Tobacco Control Act amends the
FD&C Act by adding new chapter IX, which provides FDA with authorities
to regulate tobacco products and imposes certain obligations on tobacco
product manufacturers, retailers, and importers. Among the amendments
are provisions that relate to tobacco product manufacturing practice
requirements. The proposed provisions include, among other things, the
authority to issue regulations relating to good manufacturing practice
requirements; hereinafter TPMP, in order to assure that the public
health is protected and

tobacco products are in compliance with the requirements of the FD&C
Act.
    Description of Respondents: This proposed rule applies to
manufacturers (foreign and domestic) of finished and bulk tobacco
products. Finished tobacco products include tobacco products, including
all components and parts, sealed in final packaging (e.g., rolling
papers, filters, filter tubes, or e-liquids sold to consumers. Bulk
tobacco products are tobacco products that are not sealed in final
packaging but otherwise suitable for consumer use as tobacco products
(e.g., bulk cigarettes, bulk filters, bulk e-liquids).
    Subpart B prescribes the proposed requirements pertaining to
finished and bulk tobacco product manufacturers' management systems
that cover a manufacturer's organization and personnel (Sec.  1120.12),
tobacco product complaints (Sec.  1120.14), and CAPA (Sec.  1120.16).
    Proposed Sec.  1120.12 would require manufacturers to establish and
maintain an organizational structure; have sufficient personnel to
carry out the requirements under part 1120; designate, in writing,
appropriate responsibility for all personnel who perform an activity
subject to part 1120 and designate, in writing, management with
executive responsibility who have the duty, power, and responsibility
to implement the requirements under part 1120; establish and maintain
training procedures; and maintain records of personnel qualifications
and training records. Manufacturers would be required to keep records
of all activities required under this provision.
    Proposed Sec.  1120.14 would require manufacturers to establish and
maintain procedures to receive, evaluate, investigate, and document
complaints. Manufacturers would be required to keep records of all
activities required under this provision.
    Proposed Sec.  1120.16 would require manufacturers to establish and
maintain procedures for implementing CAPA. These procedures are to
require review of various sources of data for identifying and
investigating existing and potential causes of nonconformities and
design problems, acting to correct and prevent nonconformities and
design problems, verifying or validating the CAPAs, implementing and
documenting the changes needed, and communicating that information to
specified personnel. Manufacturers must maintain records of all
activities conducted under this section. Manufacturers would be
required to keep records of all activities required under this
provision.
    Subpart C prescribes the proposed requirements that are specific to
personnel practices (Sec.  1120.32), building, facilities, and grounds
(Sec.  1120.34), equipment (Sec.  1120.36), and environmental controls
(Sec.  1120.38).
    Proposed Sec.  1120.32 would require manufacturers to establish and
maintain procedures for the cleanliness, personal practices, and
apparel, which must include requirements to ensure that contact between
personnel and the tobacco product or environment would not result in
contamination of the tobacco product.
    Proposed Sec.  1120.34 would require manufacturers to ensure each
building, facility, and grounds is maintained in appropriate condition
to prevent contamination and ensure that buildings and facilities are
of suitable construction, design, and location to facilitate
sanitation, maintenance, and proper operation. The provision also would
require controls for water quality, and record keeping, as well as
require manufacturers to establish and maintain procedures for cleaning
and sanitation and animal and pest control. Manufacturers would be
required to keep records of all activities required under this
provision.
    Proposed Sec.  1120.36 would require manufacturers to ensure that
equipment used in manufacturing operations is appropriately designed,
constructed, and suitable for its intended purpose, and must establish
and maintain procedures for the routine cleaning and maintenance of
equipment, as well as for the routine calibration of testing,
monitoring, and measuring equipment to ensure proper performance. The
provision also would require identification of major equipment and all
processing lines. Manufacturers would be required to keep records of
all activities required under this provision.
    Proposed Sec.  1120.38 would require manufacturers to establish and
maintain procedures to adequately control environmental conditions,
where appropriate, and maintain and monitor environmental control
systems to verify that the environmental controls are adequate and
functioning properly. Manufacturers would be required to keep records
of all activities required under this provision.
    Subpart D of the proposed rule prescribes the requirements for
design and development activities (Sec.  1120.42) and MMRs (Sec.
1120.44).
    Proposed Sec.  1120.42 would require manufacturers to establish and
maintain procedures to control the design and development of each
finished and bulk tobacco product and its package, including the
control of risks associated with the product, production process,
packing, and storage. To control for risks, manufacturers would be
required to conduct a risk assessment: (1) risk identification of all
known or reasonably foreseeable risks associated with the tobacco
product and its package, production process, packing, and storage,
including risks normally associated with the use of the tobacco
product; (2) risk analysis of the nature and level of risk for each
identified known or reasonably foreseeable risk; and (3) risk
evaluation of each identified risk to determine the significance of the
risk and the type of risk treatment needed. In addition, manufacturers
would be required to perform risk treatment to significantly minimize
or prevent risks identified that are reasonably likely to occur and
that may cause serious illness, injury, or death not normally
associated with the use of the tobacco product, or that the
manufacturer determines constitutes an unacceptable level of risk as
well as to address risks for any applicable tobacco product standards
to ensure that the tobacco product will conform to the specifications
and requirements established in the tobacco product standard. Finally,
manufacturers would be required to conduct a risk reassessment whenever
the manufacturer becomes aware of new information that could change the
risks assessment and risk treatment, including information about
previously unidentified risks or the adequacy of risk treatment
measures. Manufacturers would maintain records of all activities
required under this section.
    Proposed Sec.  1120.44 would require that manufacturers establish
and maintain an MMR for each tobacco product manufactured.
Manufacturers would also establish and maintain procedures for the
review and approval of the MMR.
    Subpart E of the proposed rule prescribes the proposed requirements
for purchasing controls (Sec.  1120.62), acceptance activities (Sec.
1120.64), production and process controls (Sec.  1120.66), laboratory
controls (Sec.  1120.68), production records (Sec.  1120.70), sampling
(Sec.  1120.72), nonconforming tobacco products (Sec.  1120.74),
returned tobacco products (Sec.  1120.76), and reprocessing and rework
(Sec.  1120.78).
    Proposed Sec.  1120.62 would require manufacturers to establish and
maintain purchasing procedures, purchasing records, and procedures for
qualifying its suppliers. Manufacturers would be required to keep
records of all activities required under this provision.
    Proposed Sec.  1120.64 would require manufacturers to establish and
maintain procedures for acceptance activities

including inspections, evaluations, tests, and other verification
methods manufacturers use in the manufacturing process. The written
procedures would also be required to contain procedures and records for
ensuring that each accepted incoming tobacco product is designated by a
unique identifier, which must be maintained throughout the
manufacturing process and documented in the production record.
    Proposed Sec.  1120.66 would require manufacturers to establish and
maintain production procedures that describe the process specifications
and process controls used in the manufacturing of tobacco products.
Process controls include monitoring and acceptance activities such as
inspection, testing, evaluation, or other verification activities. The
procedures should also address removal of manufacturing material if it
could reasonably be expected to have an adverse effect on the product,
if applicable; changes to a production process; and process validation
procedures to demonstrate that the process will be maintained in a
state of control to ensure that tobacco products conform to their
established specifications and other requirements when it cannot be
fully verified that tobacco product specifications conform to the MMR.
Manufacturers would be required to keep records of all activities
required under this provision.
    Proposed Sec.  1120.68 would require manufacturers to establish and
maintain procedures for any laboratory controls employed to satisfy
requirements in the proposed rule. The procedures include
scientifically valid laboratory methods that are accurate, precise, and
appropriate for their intended purpose, sampling plans that comply with
Sec.  1120.72 of the proposed rule, and demonstration of analytical
control. Manufacturers would also be required to demonstrate the
laboratory's competence to perform laboratory activities associated
with the manufacture of finished or bulk tobacco products.
Manufacturers would be required to keep records of all activities
required under this provision.
    Proposed Sec.  1120.70 would require manufacturers to establish and
maintain procedures for the preparation of a production record for each
manufactured tobacco product batch.
    Proposed Sec.  1120.72 would require manufacturers to have an
adequate sampling plan using representative samples.
    Proposed Sec.  1120.74 would require manufacturers to establish and
maintain procedures for the control and disposition of nonconforming
tobacco products. These procedures include: (1) identification and
segregation of potential nonconforming products; (2) investigation of
all potential nonconforming products, including determination of the
scope and cause of the nonconformance and the risk of illness or injury
posed by the nonconformance; and (3) disposition and followup.
Manufacturers would be required to keep records of all activities
required under this provision.
    Proposed Sec.  1120.76 would require manufacturers to establish and
maintain procedures for the control and disposition of returned
products. These procedures must address identification, segregation,
evaluation, and disposition of returned products. Returned products
must be segregated in a manner that prevents mix-ups and use of
returned products prior to evaluation and disposition. Returned product
must be evaluated to determine its disposition. Manufacturers would be
required to keep records of all activities required under this
provision.
    Proposed Sec.  1120.78 would require manufacturers to establish and
maintain procedures for reprocessing and reworking tobacco products.
These procedures would require evaluation of the tobacco product to
determine whether the product is appropriate for reprocessing or rework
and authorization of any reprocessing or rework by a designated
individual; and must include the production processes, including
process controls, and acceptance activities, used to ensure the
reprocessed or reworked tobacco product conforms to the requirements
established in the MMR for the subsequently manufactured tobacco
product. Manufacturers would be required to maintain records of all
activities required under this provision.
    Subpart F of the proposed rule prescribes the proposed requirements
for packaging and labeling activities (Sec.  1120.92), repackaging and
relabeling activities (Sec.  1120.94), manufacturing codes on the
packaging or label of tobacco products (Sec.  1120.96), and warning
plans for packaging (Sec.  1120.98).
    Proposed Sec.  1120.92 would require manufacturers to establish and
maintain procedures to control packaging and labeling activities.
Manufacturers would be required to maintain records of all activities
required under this provision.
    Proposed Sec.  1120.94 would require manufacturers to establish and
maintain procedures to control repackaging and relabeling activities
for those establishments engaging in such activities. Manufacturers
would be required to maintain records of all activities required under
this provision.
    Proposed Sec.  1120.96 would require manufacturers to apply a
manufacturing code to the packaging or label of all finished and bulk
tobacco products. Manufacturers would be required to maintain records
of all activities required under this provision.
    Proposed Sec.  1120.98 would require finished tobacco product
manufacturers, who are required to comply with a warning plan for
tobacco product packaging, to establish and maintain procedures to
implement the requirements of such warning plan. Manufacturers would be
required to keep records of all activities required under this
provision.
    Subpart G of the proposed rule prescribes the proposed requirements
for activities associated with handling and storage (Sec.  1120.102)
and distribution (Sec.  1120.104).
    Proposed Sec.  1120.102 would require tobacco product manufacturers
to establish and maintain procedures for the handling and storage of
tobacco products.
    Proposed Sec.  1120.104 would require tobacco product manufacturers
to establish and maintain procedures for the distribution of finished
and bulk tobacco products and to keep distribution records and records
of direct accounts.
    Proposed subpart H of the proposed rule prescribes the proposed
general recordkeeping and document control requirements (Sec.
1120.122).
    Proposed Sec.  1120.122(a) would establish general requirements
that apply to all documents and records required under proposed part
1120. Proposed Sec.  1120.122(a)(1) would require that documents and
records required under proposed part 1120 be written in English, or an
accurate English translation must be made available upon request. All
documents and records required by proposed part 1120, that are
associated with a batch of finished or bulk tobacco product, must be
retained for a period of not less than 4 years from the date of
distribution of the batch or until the product reaches its expiration
date if one exists, whichever is later. Documents and records not
associated with a batch must be retained for not less than 4 years from
the date they were last in effect. Furthermore, all documents and
records required under proposed part 1120 be maintained at the
manufacturing establishment or another location that is readily
accessible to responsible officials of the tobacco product manufacturer
and to FDA. FDA interprets ``readily accessible'' to FDA as the
documents and records being made available to FDA upon request within
the course of an inspection.

Proposed Sec.  1120.122(b) would require that records required under
the proposed rule are attributable, legible, contemporaneously
recorded, original, and accurate. Proposed Sec.  1120.122(c) would
require tobacco product manufacturers to establish and maintain
procedures to control all documents established to meet the
requirements under proposed part 1120.
    As required by section 906(e)(2) of the FD&C Act, subpart J of the
proposed rule sets forth the procedures and requirements for
petitioning for an exemption or variance from a TPMP requirement.
    Proposed Sec.  1120.140 explains that, under section 906(e)(2) of
the FD&C Act, any person subject to any requirement of the TPMP
regulations may petition FDA for a permanent or temporary exemption or
variance from such requirement. The requirements under this part remain
in effect unless FDA grants the petition for an exemption or variance
under Sec.  1120.146. Thus, any person who petitions FDA for an
exemption or variance must follow the TPMP regulations while the
petition is being considered and until FDA grants the petition. Under
proposed Sec.  1120.140, an individual petitioning for an exemption or
variance must submit all information supporting the petition in an
electronic form that FDA can process, review, and archive. Because of
the broad availability of the internet, FDA does not anticipate any
need to submit a petition for an exemption or variance and supporting
materials in a non-electronic format. However, if the petitioner is
unable to submit a petition in an electronic format, the petitioner may
submit a written request to FDA requesting that FDA allow the
submission in an alternative format and explain in detail why the
petitioner cannot submit the petition in an electronic format.
    Proposed Sec.  1120.142 would require that a petition for an
exemption or variance contain: (1) the petitioner's name, address, and
contact information; (2) identification of the tobacco product; (3) the
requirement in this part for which an exemption or variance is
requested; (4) a detailed explanation of why the exemption or variance
is requested; the duration of the proposed exemption or variance; (5) a
detailed explanation setting forth the methods proposed to be used in,
and the facilities and controls proposed to be used for, the
manufacture, packing, and storage of the tobacco product in lieu of the
requirement in this part as well as the basis for the petitioner's
determination that the proposed methods will be sufficient to assure
that the public health is protected and the tobacco product(s) will be
in compliance with chapter IX of the FD&C Act (for a petition for a
variance); (6) a detailed explanation setting forth the basis for the
petitioner's determination that compliance with the requirement is not
required to assure that the public health is protected and that the
tobacco product will be in compliance with chapter IX of the FD&C Act
(for a petition for exemption); (7) any other information justifying
the exemption or variance; a statement certifying that, to the best of
the petitioner's knowledge and belief, the petition includes all
information and views on which the petition relies including
representative data and information known to the petitioner which are
unfavorable to the petition; and (8) an EA under part 25 of this
chapter prepared in accordance with the requirements of Sec.  25.40 of
this chapter.
    FDA recognizes that many of the proposed provisions of the proposed
rule are consistent with quality control and manufacturing practices
that have already been voluntarily adopted by manufacturers. As a part
of usual and customary business practices, FDA expects some baseline
level of manufacturer compliance with the provisions of the proposed
rule.
    FDA's burden estimates are based on the PRIA, FDA inspection
reports, estimates of the number of deemed tobacco product
manufacturers published in the Deeming Rule (part 1143), and 2017 data
on permits issued to tobacco manufacturers by the Alcohol and Tobacco
Tax and Trade Bureau. The requirements in the proposed rule would apply
to both domestic and foreign manufacturers of finished and bulk tobacco
products.
    As discussed in the PRIA, we estimate the number of affected
entities, by major tobacco product group and size of operation group.
We estimate that there is a total of 1,935 domestic entities and 3,273
foreign entities manufacturers potentially affected by the proposed
rule. For purposes of the PRA estimates, FDA used a weighted average of
the median hours and entities affected to calculate the respondents and
burden hours. These estimates are a combination of small and large
manufacturers and foreign and domestic manufactures. The estimated
numbers of manufacturers in the tables below represent an estimated
average portion of all domestic and foreign tobacco product
manufacturers by the percentage of manufacturers that are currently not
practicing one or more of the proposed requirements set forth in the
proposed rule.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 2--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR part and activity        Number of      responses per     Total annual    Average burden  Total hours
                                   respondents       respondent       responses       per response
----------------------------------------------------------------------------------------------------------------
1120.40, 1120.142, and 1120.146               1                1                1               59           59
 Petition for Exemption or
 Variance and Environmental
 Assessment (EA)...............
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 2 describes the annual reporting burden as a result of the
proposed requirements in Sec.  1120.142 for submitting petitions for
exemption or variance (including EA). FDA believes this will be
infrequent, so we have assigned 1 token response acknowledging the
requirement.

                                                  Table 3--Estimated One-Time Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                    Average burden
                21 CFR part and activity                     Number of      records per      One-time           per         Total hours    Total capital
                                                           recordkeepers   recordkeeper       records      recordkeeping                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart B
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.12 Organization and personnel procedures and                  1,598               3           4,794            4.12          19,751  ..............
 training...............................................
1120.14 Tobacco product complaints......................           1,946               8          15,568            1.82          28,334  ..............
1120.16 Corrective and preventive actions...............           1,814               8          14,512            1.82          26,412  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart B.....................................  ..............  ..............  ..............  ..............          74,497  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart C
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.32 Personnel.......................................           1,416              67          94,872            0.59          55,974  ..............
1120.34 Buildings, facilities, and grounds..............           1,642              20          32,840            2.62          86,041  ..............
1120.36 Equipment.......................................           1,186              86         101,996            1.62         165,234  ..............
1120.38 Environment controls............................           2,965               8          23,720            2.42          57,402  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart C.....................................  ..............  ..............  ..............  ..............         364,651  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart D
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.42 Product development controls....................           2,853              12          34,236            2.90          99,284  ..............
1120.44 Master manufacturing record.....................           1,381              14          19,334            1.91          36,928  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart D.....................................  ..............  ..............  ..............  ..............         136,212  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart E
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.62 Purchasing controls.............................           2,539              17          43,163            3.39         146,323  ..............
1120.64 Acceptance activities...........................           2,029              26          52,754            1.85          97,595  ..............
1120.66 Process controls................................           1,677              35          58,695            1.84         107,999      $1,014,697
1120.68 Laboratory controls.............................           1,293               9          11,637            1.79          20,830      10,996,249
1120.70 Production record...............................           2,163               9          19,467            0.96          18,688  ..............
1120.72 Representative samples..........................           3,631               8          29,048            1.86          54,029  ..............
1120.74 Nonconforming product...........................           1,458               9          13,122            1.80          23,620  ..............
1120.76 Returned product................................           1,594               9          14,346            1.80          25,823  ..............
1120.78 Reprocessing and rework.........................           1,833               8          14,664            1.86          27,275  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart E.....................................  ..............  ..............  ..............  ..............         522,182      12,010,946
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart F
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.92 Packaging and labeling controls.................           1,683               8          13,464            3.34          44,970  ..............
1120.94 Repackaging and Relabeling......................           1,523               8          12,184            3.18          38,745  ..............
1120.98 Warning plans...................................           1,448               8          11,584            3.18          36,837  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart F.....................................  ..............  ..............  ..............  ..............         120,552  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart G
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.102 Handling and storage...........................           1,855              12          22,260            1.82          40,513  ..............
1120.104 Distribution...................................           2,028              12          24,336            1.82          44,292  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart G.....................................  ..............  ..............  ..............  ..............          84,805  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart H
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.124 Document controls..............................           3,155               1           3,155            6.99          22,053  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart H.....................................  ..............  ..............  ..............  ..............          22,053  ..............
    Total One-Time Burden...............................  ..............  ..............  ..............  ..............       1,324,952      12,010,946
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

                         Table 4--Estimated Annual (Recurring) Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
    21 CFR part and activity        Number of      records per    Total annual         per          Total hours
                                  recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart B
----------------------------------------------------------------------------------------------------------------
1120.12 Organization and                  1,598               3           4,794                2           9,588
 personnel Procedures and
 training......................
1120.14 Tobacco product                   1,946               8          15,568                4          62,272
 complaints....................
1120.16 Corrective and                    1,814               8          14,512                4          58,048
 preventive actions............
                                --------------------------------------------------------------------------------
    Total Subpart B............  ..............  ..............  ..............  ...............         129,908
----------------------------------------------------------------------------------------------------------------

                                      Annual Recordkeeping Burden Subpart C
----------------------------------------------------------------------------------------------------------------
1120.32 Personnel..............           1,416              67          94,872             0.03           2,846
1120.34 Buildings, facilities,            1,642              20          32,840             0.55          18,062
 and grounds...................
1120.36 Equipment..............           1,186              86         101,996             0.14          14,279
1120.38 Environment controls...           2,965               8          23,720             0.28           6,642
                                --------------------------------------------------------------------------------
    Total Subpart C............  ..............  ..............  ..............  ...............          41,829
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart D
----------------------------------------------------------------------------------------------------------------
1120.42 Product development               2,853              12          34,236                1          34,236
 controls......................
1120.44 Master manufacturing              1,381              14          19,334             0.36           6,960
 record........................
                                --------------------------------------------------------------------------------
    Total Subpart D............  ..............  ..............  ..............  ...............          41,196
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart E
----------------------------------------------------------------------------------------------------------------
1120.62 Purchasing controls....           2,539              17          43,163             0.27          11,654
1120.64 Acceptance activities..           2,029              26          52,754                1          52,754
1120.66 Process controls.......           1,677              35          58,695                1          58,695
1120.68 Laboratory controls....           1,293               9          11,637                5          58,185
1120.70 Production record......           2,163               9          19,467                3          58,401
1120.72 Representative samples.           3,631               8          29,048             0.27           7,843
1120.74 Nonconforming product..           1,458               9          13,122             4.77          62,592
1120.76 Returned product.......           1,594               9          14,346             4.37          62,692
1120.78 Reprocessing and rework           1,833               8          14,664             0.28           4,106
                                --------------------------------------------------------------------------------
    Total Subpart E............  ..............  ..............  ..............  ...............         376,922
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart F
----------------------------------------------------------------------------------------------------------------
1120.92 Packaging and labeling            1,683               8          13,464             0.28           3,770
 controls......................
1120.94 Repackaging and                   1,523               8          12,184             0.27           3,290
 Relabeling....................
1120.98 Warning plans..........           1,448               8          11,584             0.28           3,244
                                --------------------------------------------------------------------------------
    Total Subpart F............  ..............  ..............  ..............  ...............          10,304
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart G
----------------------------------------------------------------------------------------------------------------
1120.102 Handling and storage..           1,855              12          22,260             0.15           3,339
1120.104 Distribution..........           2,028              12          24,336             0.15           3,650
                                --------------------------------------------------------------------------------
    Total Subpart G............  ..............  ..............  ..............  ...............           6,989
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart H
----------------------------------------------------------------------------------------------------------------
1120.124 Document controls.....           3,155               1           3,155             2.66           8,392
                                --------------------------------------------------------------------------------
    Total Subpart H............  ..............  ..............  ..............  ...............           8,392
    Total Annual Burden........  ..............  ..............  ..............  ...............         615,540
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 3 represents the one-time recordkeeping requirements in the
rule. FDA believes that there will be a total of 5,208 recordkeepers
(the sum of 1,935 domestic and 3,273 foreign entities) who would keep
records. Most of the provisions in the proposed rule require tobacco
manufacturers to establish and maintain procedures. In table 3, the
columns entitled ``number of recordkeepers'' and ``one-time total
responses'' is totaled in the text, but not the chart. For economic
purposes, the numbers in these columns are not additive because the
numbers representing each section are not mutually exclusive. However,
for PRA purposes these numbers are additive. We total these columns in
the narrative for PRA purposes of describing and matching the data that
will be submitted to OMB for approval.
    Subpart B describes the proposed requirements applicable to
finished and bulk tobacco product manufacturers' management systems
that cover a manufacturer's organization and personnel (Sec.  1120.12),
tobacco product complaints (Sec.  1120.14), and CAPA (Sec.  1120.16).
FDA estimates that under proposed subpart B 5,358 recordkeepers will
establish a total of 34,874 one-time records for a total of 74,497 one-
time hours.
    Subpart C of the proposed rule prescribes the proposed requirements
that are specific to personnel practices (Sec.  1120.32), building,
facilities, and grounds (Sec.  1120.34), equipment (Sec.  1120.36), and
environmental controls (Sec.  1120.38). FDA estimates that under
proposed subpart C 7,209 recordkeepers

will establish a total of 253,428 one-time records for a total of
364,651 one-time hours.
    Subpart D of the proposed rule prescribes the proposed requirements
for design and development activities (Sec.  1120.42) and MMRs (Sec.
1120.44). FDA estimates that under proposed subpart D 4,234
recordkeepers will establish a total of 53,570 one-time records for a
total of 136,212 one-time hours.
    Subpart E of the proposed rule prescribes the proposed requirements
for purchasing controls (Sec.  1120.62), acceptance activities (Sec.
1120.64), production and process controls (Sec.  1120.66), laboratory
controls (Sec.  1120.68), production records (Sec.  1120.70), sampling
(Sec.  1120.72), nonconforming tobacco products (Sec.  1120.74),
returned tobacco products (Sec.  1120.76), and reprocessing and rework
(Sec.  1120.78). FDA estimates that under proposed subpart E 18,217
recordkeepers will establish a total of 256,896 one-time records for a
total of 522,182 one-time hours.
    To conduct activities related to Sec. Sec.  1120.64, 1120.66, and
1120.68, some tobacco product manufacturers may purchase capital
equipment such as metal detectors, pH meters, thermometers, ultrasonic
flow meters, scanners, and densimeters. We estimate one-time capital
costs of $1,014,697 combined under Sec.  1120.64 acceptance activities
and Sec.  1120.66 Production and process controls, and $10,996,249
under Sec.  1120.68 Laboratory controls for a total of $12,010,946.
    Subpart F of the proposed rule prescribes the proposed requirements
for packaging and labeling controls (Sec.  1120.92), repackaging and
relabeling (Sec.  1120.94), and warning plans (Sec.  1120.98). FDA
estimates that under proposed subpart F 4,654 respondents will
establish a total of 37,232 one-time records for a total of 120,552
one-time hours.
    Subpart G of the proposed rule prescribes the proposed requirements
for activities associated with handling and storage (Sec.  1120.102)
and distribution (Sec.  1120.104). FDA estimates that under proposed
subpart G 3,883 respondents will establish a total of 46,596 one-time
records for a total of 84,805 one-time hours.
    Proposed subpart H of the proposed rule prescribes the proposed
general recordkeeping and document control requirements (Sec.
1120.122). FDA estimates that under proposed subpart H 3,155
respondents will establish a total of 3,155 one-time records for a
total of 22,053 one-time hours.
    FDA estimates a total of 1,324,952 one-time hours and $12,010,946
one-time capital costs.
    Table 4 estimates the annual recurring burden under the proposed
rule. FDA believes that there will be a total of 5,208 recordkeepers
(the sum of 1,935 domestic and 3,273 foreign entities) who would keep
records. In table 4, the columns number of annual recordkeepers, and
total annual responses is totaled in the text, but not in the chart.
For economic purposes the numbers in these columns are not additive
because the numbers representing each section are not mutually
exclusive. However, for PRA purposes these numbers are additive. We
total these columns in the narrative for PRA purposes of describing and
matching the data that will be submitted to OMB for approval.
    FDA estimates that under proposed subpart B (Management System
Requirements) 5,358 recordkeepers will maintain a total of 34,874
records annually for a total of 129,908 annual hours.
    FDA estimates that under proposed subpart C (Buildings, Facilities,
and Equipment) 7,209 recordkeepers will maintain a total of 253,428
records annually for a total of 41,829 annual hours.
    FDA estimates that under proposed subpart D (Design and Development
Controls) 4,234 recordkeepers will maintain a total of 53,570 records
annually for a total of 41,196 annual hours.
    FDA estimates that under proposed subpart E (Process Controls)
18,217 recordkeepers will maintain a total of 256,896 records annually
for a total of 376,922 annual hours.
    FDA estimates that under proposed subpart F (Packaging and Labeling
Controls) 4,654 recordkeepers will maintain a total of 37,232 records
annually for a total of 10,304 annual hours.
    FDA estimates that under proposed subpart G (Handling, Storage and
Distribution) 3,883 recordkeepers will maintain a total of 46,596
records annually for a total of 6,989 annual hours.
    FDA estimates that under proposed subpart H (Recordkeeping and
Document Controls) 3,155 recordkeepers will maintain a total of 3,155
records annually for a total of 8,392 annual hours.
    FDA estimates a total of 615,540 annual hours for this proposed
rule.

                           Table 5--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
   21 CFR part and activity        Number of      disclosures per    Total annual   Average  burden  Total hours
                                  respondents       respondent       disclosures    per  disclosure
----------------------------------------------------------------------------------------------------------------
1120.96 Manufacturing code....               1                 1                1                1            1
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Proposed Sec.  1120.96 would require that manufacturers apply a
manufacturing code to the packaging and label of tobacco products. FDA
lacks data on the percentage of manufacturers who apply such codes to
the packaging and label of tobacco products but based on a cursory
review of manufactured products it appears that many, if not all,
manufacturers already apply a manufacturing code to their products. For
purposes of the PRA, we have assigned one token burden hour for this
activity.
    Per the requirements of this proposed rule, FDA estimates the total
burden will be 1,940,552 hours (59 + 1 + 1,324,952 + 615,540) and
$12,010,946 one-time capital costs.
    To ensure that comments on 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:<PHONE_NUMBER>,
or emailed to [email protected]. All comments should be
identified with the title ``Requirements for Tobacco Product
Manufacturing Practice.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), we have submitted the information collection provisions of
this proposed rule to OMB for review. These information collection
requirements will not be effective until FDA publishes a final rule,
OMB approves

the information collection requirements, and the rule goes into effect.
FDA will announce OMB approval of these requirements in the Federal
Register.

VIII. Analysis of Environmental Impact

    The proposed regulation is issued pursuant to section 906(e) of the
FD&C Act, which directs FDA to prescribe regulations requiring that the
methods used in, and the facilities and controls used for, the
manufacture, preproduction design validation, packing, and storage of a
tobacco product conform to cGMP, or HACCP methodology to assure that
the public health is protected and that the tobacco product is in
compliance with chapter IX of the FD&C Act. Under Sec.  25.30(j),
classes of actions that are categorically excluded include the issuance
of cGMP and HACCP regulations. As a result, the proposed rule falls
within a class of actions that are categorically excluded under Sec.
25.30(j) and, therefore, ordinarily do not require the preparation of
an EA or environmental impact statement (EIS).
    An EA or EIS is required for categorically excluded actions only if
extraordinary circumstances indicate that the specific proposed action
may significantly affect the quality of the human environment (Sec.
25.21). The proposed action is of a type that does not individually or
cumulatively have a significant effect on the human environment. The
proposed action is not anticipated to pose the potential for serious
harm to the environment or to adversely affect a species or the
critical habitat of a species described in Sec.  25.21(b). Thus, FDA
has determined that no extraordinary circumstances exist that would
require preparation of an EA or an EIS.

IX. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13132. Section 4(a) of the E.O. requires
Agencies to ``construe . . . a Federal statute to preempt State law
only where the statute contains an express preemption provision or
there is some other clear evidence that the Congress intended
preemption of State law, or where the exercise of State authority
conflicts with the exercise of Federal authority under the Federal
statute.''
    Section 916(a)(2) of the FD&C Act (21 U.S.C. 387p) is an express
preemption provision. Section 916(a)(2) provides that ``no State or
political subdivision of a State may establish or continue in effect
with respect to a tobacco product any requirement which is different
from, or in addition to, any requirement under the provisions of this
chapter relating to . . . good manufacturing standards.''
    This rule is being issued under section 906(e) of the FD&C Act,
which directs FDA to prescribe regulations relating to good
manufacturing practice. Thus, if this proposed rule is made final, the
final rule would create requirements that fall within the scope of
section 916(a)(2) of the FD&C Act.

X. Consultation and Coordination With Indian Tribal Governments

    FDA has analyzed this proposed rule in accordance with the
principles set forth in E.O. 13175. We have tentatively concluded that
the rule does not contain policies that would have a substantial direct
effect on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes.
The Agency solicits comments from tribal officials on any potential
impact on Indian tribes from this proposed action.

XI. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright or
other restrictions. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. FDA has verified the website addresses,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.

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List of Subjects in 21 CFR Part 1120

    Smoking, Tobacco, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act [LEGAL
CITATION] and under authority delegated to the Commissioner of Food and
Drugs, amend chapter I of title 21 of the Code of Federal Regulations
by adding part 1120 to subchapter K to read as follows:

PART 1120--REQUIREMENTS FOR TOBACCO PRODUCT MANUFACTURING PRACTICE

Sec.
Subpart A--General Provisions
1120.1 Scope.
1120.3 Definitions.
Subpart B--Management System Requirements
1120.12 Organization and personnel.
1120.14 Tobacco product complaints.
1120.16 Corrective and preventive actions.
Subpart C--Buildings, Facilities, and Equipment
1120.32 Personnel practices.
1120.34 Buildings, facilities, and grounds.
1120.36 Equipment.
1120.38 Environmental controls.
Subpart D--Design and Development Controls
1120.42 Design and development activities.
1120.44 Master manufacturing record.
Subpart E--Process Controls
1120.62 Purchasing controls.
1120.64 Acceptance activities.

1120.66 Production processes and controls.
1120.68 Laboratory controls.
1120.70 Production record.
1120.72 Sampling.
1120.74 Nonconforming tobacco product.
1120.76 Returned tobacco product.
1120.78 Reprocessing and rework.
Subpart F--Packaging and Labeling Controls
1120.92 Packaging and labeling controls.
1120.94 Repackaging and relabeling.
1120.96 Manufacturing code.
1120.98 Warning plans.
Subpart G--Handling, Storage, and Distribution
1120.102 Handling and storage.
1120.104 Distribution.
Subpart H--Recordkeeping and Document Controls
1120.122 Recordkeeping and document control requirements.
Subpart I--Small Tobacco Product Manufacturers
1120.130 Compliance date for small tobacco product manufacturers.
Subpart J--Exemptions and Variances
1120.140 Exemptions and variances.
1120.142 Petition for an exemption or variance.
1120.144 Referral to the Tobacco Products Scientific Advisory
Committee.
1120.146 Petition determination.
1120.148 Hearing.

    Authority:  21 U.S.C. 371, 21 U.S.C. 374, 21 U.S.C. 381, 21
U.S.C. 387b, 21 U.S.C. 387c, 21 U.S.C. 387e(g), 21 U.S.C. 387f(e),
and 21 U.S.C. 387i.

Subpart A--General Provisions

Sec.  1120.1  Scope.

    (a) This part sets forth the current tobacco product manufacturing
practice (TPMP) requirements under the Federal Food, Drug, and Cosmetic
Act. The requirements of this part apply to manufacturers of all
finished and bulk tobacco products that are subject to chapter IX of
the Federal Food, Drug, and Cosmetic Act, except finished and bulk
accessories of cigarettes, cigarette tobacco, roll-your-own tobacco,
smokeless tobacco, and tobacco products containing nicotine that is not
made or derived from tobacco. Manufacturers of finished and bulk
tobacco products include specification developers, contract
manufacturers, and repackagers/relabelers. The requirements in this
part govern the methods used in, and the facilities and controls used
for, the preproduction design validation, manufacture, packing, and
storage of finished and bulk tobacco products by finished and bulk
tobacco product manufacturers.
    (b) If a tobacco product manufacturer engages in some operations
subject to the requirements of this part, and not others, that
manufacturer need only comply with those requirements applicable to the
operations in which it is engaged.
    (c) The term ``where appropriate'' is used several times in this
part. When a requirement is qualified with ``where appropriate,'' it is
deemed to be appropriate unless the tobacco product manufacturer
documents in writing an adequate justification prior to abstaining from
implementing the requirement. An adequate justification would address
why abstaining from the requirement would not result in a nonconforming
tobacco product, or in the manufacturer not being able to carry out
necessary corrective actions.
    (d) The requirements in this part are intended to protect the
public health and assure that tobacco products are in compliance with
the relevant provisions of the Federal Food, Drug, and Cosmetic Act.
The failure to comply with any applicable provision in this part
renders a product adulterated under section 902(7) of the Federal Food,
Drug, and Cosmetic Act.

Sec.  1120.3  Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product; or
    (2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product but
    (i) Solely controls moisture and/or temperature of a stored tobacco
product; or
    (ii) Solely provides an external heat source to initiate but not
maintain combustion of a tobacco product.
    Additive means any substance the intended use of which results or
may reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristic of any
tobacco product (including any substances intended for use as a
flavoring or coloring or in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding),
except that such term does not include tobacco or a pesticide chemical
residue in or on raw tobacco or a pesticide chemical.
    Batch means a specific identified amount of a tobacco product
produced in a unit of time or quantity and that is intended to have the
same specifications.
    Brand means a variety of tobacco product distinguished by the
tobacco used, tar content, nicotine content, flavoring used, size,
filtration, packaging, logo, registered trademark, brand name(s),
identifiable pattern of colors, or any combination of such attributes.
    Bulk tobacco product means a tobacco product not sealed in final
packaging but otherwise suitable for consumer use as a tobacco product.
    Characteristic means the materials, ingredients, design,
composition, heating source, or other features of a tobacco product.
    Component or part means any software or assembly of materials
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance,
composition, constituents, or characteristics or
    (2) To be used with or for the human consumption of a tobacco
product. Component or part excludes anything that is an accessory of a
tobacco product.
    Contaminated tobacco product means a tobacco product that contains
a substance not ordinarily contained in that tobacco product. An
example of a contaminated tobacco product is a smokeless tobacco
product with metal fragments in the tobacco filler.
    Design means the form and structure concerning and the manner in
which components or parts, ingredients, additives, and materials are
integrated to produce a tobacco product.
    Direct accounts means all persons who are customers of the tobacco
product manufacturer that receive finished or bulk tobacco products
directly from the manufacturer or from any person under control of the
manufacturer. Direct accounts may include wholesalers, distributors,
and retailers. Direct accounts do not include individual purchasers of
tobacco products for personal consumption.
    Establish and maintain means to define, document in writing,
implement, follow, and update.
    Equipment means any machinery, tool, instrument, utensil, or other
similar or related article, used in the manufacture, preproduction
design validation, packing, or storage of a tobacco product.
    Finished tobacco product means a tobacco product, including any
component or part, sealed in final packaging. Examples of finished
tobacco products include a pack of cigarettes, a

can of moist snuff, and rolling papers, filters, filter tubes, or e-
liquids sold to consumers.
    Ingredient means tobacco, substances, compounds, or additives
contained within or added to the tobacco, paper, filter, or any other
component or part of a tobacco product, including substances and
compounds reasonably expected to be formed through chemical action
during tobacco product manufacturing.
    Label means a display of written, printed, or graphic matter upon
the immediate container of any article.
    Labeling means all labels and other written, printed, or graphic
matter:
    (1) Upon any article or any of its containers or wrappers; or
    (2) Accompanying such article.
    Management with executive responsibility means one or more
designated personnel who have the authority and responsibility to
ensure compliance with TPMP requirements, including allocating
resources or making changes to the organizational structure, buildings,
facilities, equipment, or the manufacture, preproduction design
validation, packing, and storage of a tobacco product.
    Manual method, process, or procedure means any nonautomated method,
process, or procedure, including processes performed by hand with or
without the use of equipment.
    Manufacturing means the manufacturing, fabricating, assembling,
processing, or labeling, including the repackaging or relabeling, of a
tobacco product. Manufacturing includes establishing the specifications
of a finished or bulk tobacco product.
    Manufacturing code means any distinctive sequence or combination of
letters, numbers, or symbols that begins with the manufacturing date
followed by the batch number.
    Manufacturing date means the month, day, and year in 2-digit
numerical values in the format (MMDDYY) that a finished or bulk tobacco
product is packaged for distribution.
    Manufacturing material means material used in or used to facilitate
the manufacturing process that is not equipment and is not intended to
be part of the product.
    Master manufacturing record (MMR) means a document or designated
compilation of documents containing the established specifications for
a tobacco product, including acceptance criteria for those
specifications, all relevant manufacturing methods and production
process procedures for the tobacco product, and all approved packaging,
labeling, and labels for the tobacco product.
    Nonconforming tobacco product means any tobacco product that does
not meet a product specification in the MMR (see Sec.  1120.44(a)(1));
has packaging, labeling, or labels other than those included in the MMR
(see Sec.  1120.44(a)(3)); or is a contaminated tobacco product.
    Not normally associated means not an inherent risk of using the
tobacco product. For example, bodily injury caused by an exploding
electronic nicotine delivery system (ENDS) battery would be considered
not normally associated with the use of ENDS products.
    Package or packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane), in
which a finished tobacco product is offered for sale, sold, or
otherwise distributed to consumers (this is also referred to as final
package or final packaging), or in which a bulk tobacco product is
offered for sale, sold, or otherwise distributed (including commercial
distribution and interplant transfers).
    Personnel means all persons, including managers, staff,
consultants, contractors, and third-party entities, performing services
for the manufacturer subject to this part. This definition includes
independent contractors performing services for the manufacturer.
    Relabeling means operations in which the labeling of a finished
tobacco product is subsequently changed or replaced.
    Repackaging means operations in which the packaging of a finished
tobacco product is subsequently changed or replaced.
    Representative sample means a sample that consists of a number of
units that are drawn based on a valid scientific rationale (such as
random sampling) and intended to ensure that the sample accurately
reflects the material being sampled.
    Reprocessing means using a tobacco product that has been previously
recovered from manufacturing in the subsequent manufacture of a
finished or bulk tobacco product.
    Returned tobacco product means a commercially distributed finished
or bulk tobacco product returned to the tobacco manufacturer by any
person not under the control of the tobacco product manufacturer,
including a wholesaler/distributor, retailer, consumer, or a member of
the public.
    Rework means action taken on a nonconforming or returned tobacco
product to ensure the product meets the specifications and other
requirements of the MMR of a subsequently manufactured tobacco product
before it is released for further manufacturing or distribution.
    Small tobacco product manufacturer means a tobacco product
manufacturer that employs fewer than 350 employees. For purposes of
determining the number of employees of a manufacturer under the
preceding sentence, the employees of a manufacturer are deemed to
include the employees of each entity that controls, is controlled by,
or is under common control with such manufacturer.
    Specification means any requirement with which a product, process,
service, or other activity must conform.
    Tobacco product means any product made or derived from tobacco, or
containing nicotine from any source, that is intended for human
consumption, including any component, part, or accessory of a tobacco
product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product).
The term ``tobacco product'' does not mean an article that is a drug
under section 201(g)(1) (21 U.S.C. 321(g)(1)), a device under section
201(h) (21 U.S.C. 321(h)), or a combination product described in
section 503(g) of the FD&C Act (21 U.S.C. 353(g)). The term ``tobacco
product'' does not mean an article that is a food under section 201(f)
(21 U.S.C. 321(f)), if such article contains no nicotine, or no more
than trace amounts of naturally occurring nicotine.
    Tobacco product-contact surface means a surface that comes into
contact with a tobacco product and a surface from which drainage (or
other transfer) ordinarily occurs onto the tobacco product or onto
surfaces that come into contact with the tobacco product during the
normal course of operations. For example, tobacco product-contact
surfaces include surfaces of equipment that come into contact with the
tobacco product.
    Tobacco product manufacturer means any person(s), including a
repacker or relabeler, who: manufactures, fabricates, assembles,
processes, or labels a tobacco product; or imports a finished tobacco
product for sale or distribution in the United States. Tobacco product
manufacturer includes any person(s) establishing specifications for a
tobacco product.
    Unique identifier means information, such as a code or number, that
is maintained for each accepted incoming tobacco product that would
enable the tobacco product manufacturer and FDA to identify the
supplier and unique shipment of the incoming product.

    Validation means confirmation by examination and objective evidence
that the particular requirements can be consistently fulfilled.
    Verification means confirmation by examination and objective
evidence that specified requirements have been fulfilled.

Subpart B--Management System Requirements

Sec.  1120.12  Organization and personnel.

    (a) Organization. Each finished and bulk tobacco product
manufacturer must establish and maintain an organizational structure to
ensure that manufacturing operations meet the requirements of this
part.
    (b) Personnel qualifications. Each finished and bulk tobacco
product manufacturer must have sufficient personnel to carry out the
requirements of this part. Personnel must have the background,
education, training, and experience, or any combination thereof, needed
to carry out the requirements under this part. Each manufacturer must
maintain appropriate written records of the background, education,
training, and experience of its personnel.
    (c) Responsibility. Each finished and bulk tobacco product
manufacturer must designate, in writing, appropriate responsibility and
authority for all personnel who perform an activity subject to this
part.
    (d) Management with executive responsibility. Each finished and
bulk tobacco product manufacturer must designate, in writing,
management with executive responsibility that has the duty, power, and
responsibility to implement the requirements under this part.
Management with executive responsibility must establish and maintain
required processes and procedures to ensure compliance with the
requirements under this part. Management with executive responsibility
must ensure the requirements of this part are communicated, understood,
implemented, and followed at all levels of the organization.
    (e) Training. Each finished and bulk tobacco product manufacturer
must establish and maintain training procedures for identifying
training needs and establishing training frequency for personnel based
on the work the employee performs. The manufacturer must train
personnel on their assigned responsibility and on the tobacco product
manufacturing practice requirements relevant to their responsibility.
    (f) Records. The training records required under Sec.  1120.12(b)
must include:
    (1) The type and description of the training;
    (2) The training date;
    (3) The names of parties performing and taking the training; and
    (4) Documentation supporting completion.

Sec.  1120.14  Tobacco product complaints.

    (a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures for the receipt, evaluation,
investigation, and documentation of all complaints. The procedure must
ensure that all complaints are:
    (1) Processed upon receipt in a uniform and timely manner;
    (2) Evaluated and, if necessary, investigated with any followup
action taken, according to paragraphs (b) and (c) of this section; and
    (3) Documented according to paragraph (e) of this section.
    (b) Evaluation. All complaints must be evaluated to determine
whether the complaint could be related to:
    (1) A nonconforming tobacco product;
    (2) A product design issue; or
    (3) Any adverse experience that is required to be reported under a
regulation promulgated under section 909(a) of the Federal Food, Drug,
and Cosmetic Act.
    (c) Investigation. (1) If the evaluation determines that the
complaint could be related to paragraphs (b)(1) through (3) of this
section, an investigation must be performed except as provided in
paragraph (d) of this section.
    (2) The investigation must include:
    (i) The scope and cause of the issue;
    (ii) The risk of illness or injury posed by the issue;
    (iii) Whether any other followup action is necessary, including
whether a corrective and preventative action is necessary under Sec.
1120.16.
    (d) Exception. An investigation required under paragraph (c) of
this section must be completed unless an investigation has already been
performed for a similar complaint and the tobacco product manufacturer
determines and documents that the previous investigation results apply
and another investigation is not necessary.
    (e) Complaint records. Each finished and bulk tobacco product
manufacturer must maintain complaint records. The record documenting
the complaint, including all evaluation, investigation, and any
followup action, must be maintained according to the procedures
identified under paragraph (a) of this section. Complaints received
that could be related to a nonconforming tobacco product, design
issues, or any adverse experience that is required to be reported under
a regulation promulgated under section 909(a) of the Federal Food,
Drug, and Cosmetic Act, and that may result in a risk of illness,
injury, or death not normally associated with the use of tobacco
products must be clearly identified or separated. Complaint records
must include the following information, if available:
    (1) Name of the product, including brand and sub-brand;
    (2) Description of the product;
    (3) Manufacturing code;
    (4) Date complaint received;
    (5) Format of complaint (i.e., oral or written);
    (6) Name, address, and phone number of complainant;
    (7) Nature and details of complaint, including how the product was
used;
    (8) Identification of individual(s) receiving complaint;
    (9) Record of evaluation by the manufacturer including the name of
the individual(s) performing the evaluation;
    (10) If no investigation is undertaken, the name of the
individual(s) responsible for that decision and the rationale for the
decision;
    (11) Investigation date(s);
    (12) Record of investigational activities performed and who
performed the activity;
    (13) Results of investigation; and
    (14) Followup action taken, including any reply to the complainant
or any corrective and preventive action.
    (f) Unavailable complaint records. If information identified under
paragraph (e) of this section is unavailable, the record must include:
    (1) Documentation of the attempt(s) to obtain the information; and
    (2) Why the information is not included.

Sec.  1120.16  Corrective and preventive actions.

    (a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures for implementing corrective and
preventive actions. The procedures must include requirements for:
    (1) Reviewing and analyzing processes, process control records,
complaints, production records, returned products, reprocessed
products, reworked products, and other sources of data to identify
existing and potential causes of nonconforming tobacco product and
design problems. Appropriate statistical methodology must be employed
where necessary to detect recurring problems;

    (2) Investigating the cause of design problems or nonconformities
relating to the product or manufacturing process;
    (3) Identifying and taking the action needed to correct and prevent
the recurrence of design problems and nonconformities and other related
problems;
    (4) Verifying or validating the corrective and preventive action to
ensure that the action taken is effective and does not adversely affect
the tobacco product;
    (5) Implementing and documenting changes to tobacco product
specifications, manufacturing methods and production process
procedures, and packaging, labeling, and labels needed to correct and
prevent identified causes of the design problem or nonconformity; and
    (6) Disseminating information related to the design problem or
nonconforming product and the corrective and preventive action taken
to:
    (i) Management with executive responsibility;
    (ii) Those responsible for acceptance activities of a tobacco
product; and
    (iii) Personnel responsible for identifying training needs in
accordance with Sec.  1120.12(e).
    (b) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities conducted under this section.
Records must include the date and time, individual performing the
activity, any information that demonstrates the requirement was met,
and any data or calculations necessary to reconstruct the results.

Subpart C--Buildings, Facilities, and Equipment

Sec.  1120.32  Personnel practices.

    Each finished and bulk tobacco product manufacturer must establish
and maintain procedures for the cleanliness, personal practices, and
apparel of personnel. Such procedures must include requirements to
ensure that contact between the personnel and the tobacco product or
the environment would not result in contamination of the tobacco
product.

Sec.  1120.34  Buildings, facilities, and grounds.

    (a) Buildings and facilities. Each finished and bulk tobacco
product manufacturer must ensure that any buildings and facilities used
in or for the manufacture, packaging, or storage of a tobacco product
are of suitable construction, design, and location to facilitate
cleaning and sanitation, maintenance, and proper operations. Each
building and facility must be maintained in an appropriate condition to
prevent contamination. Buildings and facilities must have adequate:
    (1) Lighting;
    (2) Heating, ventilation, and cooling;
    (3) Plumbing (including control of drainage, backflow, sewage, and
waste) to avoid being a source of contamination or creating insanitary
conditions;
    (4) Waste collection, storage, and disposal (including not creating
malodors that contaminate tobacco products or result in an attraction,
harborage, or breeding place for animals and pests); and
    (5) Readily accessible handwashing and toilet facilities. The
facilities must provide for water at suitable temperatures and
appropriate cleaning and sanitation materials.
    (b) Grounds. Each finished and bulk tobacco product manufacturer
must maintain facility grounds in a condition to prevent contamination.
    (c) Water. Each finished and bulk tobacco product manufacturer must
ensure water used in the manufacturing process, including water that is
or may become part of the tobacco product (e.g., water used as an
ingredient or water used on tobacco product-contact surface) is
potable, will not contaminate the tobacco product, is maintained under
positive pressure, and is supplied from sources that comply with all
applicable Federal, State, and local requirements.
    (d) Cleaning and sanitation. Each finished and bulk tobacco product
manufacturer must establish and maintain procedures for the cleaning
and sanitation of buildings, facilities, and grounds, including
procedures for the use of any cleaning compounds, sanitizing agents,
pesticide chemicals, rodenticides, insecticides, fungicides, fumigating
agents, and other toxic materials.
    (1) These procedures must detail the cleaning schedules, equipment,
and materials to be used in the cleaning and sanitizing, as
appropriate, of the buildings, facilities, and grounds.
    (2) The procedures must include measures to ensure that materials
used for cleaning and sanitation are identified, held, used, and stored
in a manner to protect against contamination of tobacco products and
tobacco product-contact surfaces.
    (3) The use of cleaning and sanitation materials must also comply
with all applicable Federal, State, and local requirements related to
their application, use, or storage.
    (e) Animal and pest control. Each finished and bulk tobacco product
manufacturer must establish and maintain procedures for monitoring,
controlling, and minimizing the presence of animals and pests in the
buildings, facilities, and grounds to protect against contamination of
tobacco products. These procedures must include requirements for
establishing threshold criteria for animals and pests. The procedures
also must include requirements that any pesticide used in the
buildings, facilities, and grounds be registered in accordance with the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135) and
used in accordance with its label, as applicable, and used in a manner
that protects against contamination of the tobacco product.
    (f) Records. Each finished and bulk tobacco product manufacturer
must maintain records of cleaning and sanitation, and animal and pest
control activities required under this section. These records must
include the date and time, individual performing the activity, type of
activity performed, any information that demonstrates the requirement
was met, and any data or calculations necessary to reconstruct the
results.

Sec.  1120.36  Equipment.

    (a) Design and construction. Each finished and bulk tobacco product
manufacturer must ensure that all equipment is appropriately designed
and constructed and is suitable for its intended purpose.
    (b) Maintenance. Each finished and bulk tobacco product
manufacturer must establish and maintain procedures, including the
methods and schedules, for the routine cleaning and maintenance of
equipment, to ensure proper performance of equipment and prevent
contamination. The procedures must provide for any change over of
tobacco product and account for changes, limitations, or adjustment to
the equipment.
    (c) Identification. Each finished and bulk tobacco product
manufacturer must identify (electronically, by signage, or other method
of identification), if applicable, all processing lines and major
equipment to be used during manufacturing to prevent mixups and
contamination.
    (d) Testing, monitoring, and measuring equipment. (1) Each finished
and bulk tobacco product manufacturer must establish and maintain
procedures for all testing, monitoring, and measuring equipment to
ensure the equipment is capable of producing accurate and reliable
results.
    (2) All testing, monitoring, and measuring equipment must be
identified and disabled, removed, replaced, or

repaired when it is no longer suitable for its intended purpose or when
it is no longer capable of producing accurate and reliable results.
    (3) Each finished and bulk tobacco product manufacturer must
establish and maintain procedures for the routine calibration of
testing, monitoring, and measuring equipment. These procedures must
describe an appropriate reference standard and include specific
directions and acceptance criteria for the limits of accuracy and
precision. Equipment must be calibrated:
    (i) Before its first use;
    (ii) Thereafter, at a frequency determined by the equipment
manufacturer or at intervals necessary to ensure accurate and reliable
results; and
    (iii) After repair or maintenance.
    (e) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
These records must include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results.

Sec.  1120.38  Environmental controls.

    (a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures to adequately control
environmental conditions, where appropriate. Environmental control
systems must be maintained and monitored to verify that the
environmental controls, including necessary equipment, are adequate and
functioning properly.
    (b) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section,
including maintenance and monitoring. Records must include the date and
time, individual performing the activity, type of activity performed,
any information that demonstrates the requirement was met, and any data
or calculations necessary to reconstruct the results.

Subpart D--Design and Development Controls

Sec.  1120.42  Design and development activities.

    (a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures to control the design and
development of each finished and bulk tobacco product and its package,
including the control of risks associated with the product, production
process, packing, and storage. These procedures must include the
following requirements:
    (1) Risk management process. These procedures must use a risk
management process that includes the following:
    (i) Risk assessment. Each finished and bulk tobacco product
manufacturer must perform a risk assessment that includes risk
identification, risk analysis, and risk evaluation. Risk identification
is identification of all known or reasonably foreseeable risks
associated with the tobacco product and its package, as well as its
production process, packing, and storage. Risk identification must
include risks that may occur with normal use and with reasonably
foreseeable misuse of a tobacco product. Risk analysis is an analysis
of the nature and level of risk for each identified known or reasonably
foreseeable risk that takes into account the likelihood of occurrence
of the risk and the consequences of occurrence of the risk (i.e.,
severity of the potential harm). Risk evaluation is a determination of
the significance of the risk and what type of risk treatment is needed.
    (ii) Risk treatment. Each finished and bulk tobacco product
manufacturer must treat all identified risks, including risks addressed
in applicable tobacco product standards. Risk treatment must
significantly minimize or prevent risks:
    (A) That are reasonably likely to occur and that may cause serious
illness, injury, or death not normally associated with the use of the
tobacco product, or
    (B) That the manufacturer determines constitute an unacceptable
level of risk. Risks addressed in any applicable tobacco product
standards must be treated in a manner that ensures the tobacco product
will conform to the specifications and requirements established in the
tobacco product standard.
    (iii) Reassessment. Each finished and bulk tobacco product
manufacturer must reassess the risks whenever the manufacturer becomes
aware of new information that could change the risk assessment and risk
treatment, including information about previously unidentified risks or
the adequacy of risk treatment measures, in accordance with paragraphs
(a)(1)(i) and (ii) of this section.
    (2) Design verification and validation. For finished and bulk
tobacco products first commercially marketed or modified after the
effective date of this rule, each finished and bulk tobacco product
manufacturer must perform design verification to confirm that the
tobacco product and its package meet specifications and design
validation to assess the performance of the tobacco product;
    (3) Design approval. For finished and bulk tobacco products first
commercially marketed or modified after the effective date of this
rule, each finished and bulk tobacco product manufacturer must ensure
the product and package design is approved by a designated, authorized
individual;
    (4) Design transfer. For finished and bulk tobacco products first
commercially marketed or modified after the effective date of this
rule, each finished and bulk tobacco product manufacturer must transfer
the approved product and package specifications to the master
manufacturing record; and
    (5) Design changes. Each finished and bulk tobacco product
manufacturer must, where appropriate, utilize the processes under
paragraphs (a)(2) to (4) of this section for design changes before the
changes are implemented.
    (b) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
Records must include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results.

Sec.  1120.44  Master manufacturing record.

    (a) Each tobacco product manufacturer must establish and maintain a
master manufacturing record (MMR) for each finished and bulk tobacco
product they manufacture for distribution. The MMR must include the
following information:
    (1) Tobacco product specifications (including any physical,
chemical, and biological specifications) and acceptance criteria for
those specifications. The tobacco product specifications must include:
    (i) The identity and amount of any components or parts,
ingredients, additives, and materials in the finished or bulk tobacco
product;
    (ii) The finished or bulk tobacco product design, an identification
of the product's heating source (if any), a discussion of intended user
operation, and any relevant product drawings or schematics;
    (iii) Any specification necessary to ensure that the tobacco
product meets any applicable product standard established under section
907 of the Federal Food, Drug, and Cosmetic Act; and
    (iv) Specification(s) for pesticide chemical residue(s) for raw
tobacco.
    (2) All relevant manufacturing methods and production process
procedures. The manufacturing methods

and production process procedures must include any process controls,
process specifications with relevant acceptance criteria, and
monitoring and acceptance activities (inspections, testing, evaluation,
and other verification activities); and
    (3) All packaging, labeling, and labels approved by the tobacco
product manufacturer for use with the finished or bulk tobacco product.
    (b) Each finished and bulk tobacco product manufacturer must
establish and maintain procedures for the review and approval of the
MMR, including any changes made to the MMR after initial approval.
Under these procedures, a designated, qualified individual must review
and approve all MMR information before it is implemented in the
manufacture of finished and bulk tobacco products for distribution. The
designated, qualified individual's approval of the MMR must be
documented by date, name, and signature of the individual(s) approving
the document. The procedures for MMR review and approval must ensure
that the designated, qualified individual confirms that any design
activities conducted to support the tobacco product specifications have
been completed in accordance with the product design and development
procedures established by the manufacturer under Sec.  1120.42 and that
the resulting production specifications are correctly transferred into
the MMR.
    (c) The MMR must describe which methods and procedures established
under paragraph (a)(2) of this section and related sections, including
Sec. Sec.  1120.62 (Purchasing controls), 1120.64 (Acceptance
activities), 1120.66 (Production processes and controls), and 1120.68
(Laboratory controls), are used to ensure that the tobacco product is
in conformance with each tobacco product specification established
under paragraph (a)(1) of this section.

Subpart E--Process Controls

Sec.  1120.62  Purchasing controls.

    (a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures to ensure that each purchased or
otherwise received product or service related to the manufacture of a