[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Rules and Regulations]
[Pages 38544-38546]
[FR Doc No: 2013-14979]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0314; Directorate Identifier 2013-CE-004-AD;
Amendment 39-17490; AD 2013-13-02]
RIN 2120-AA64

Airworthiness Directives; B-N Group Ltd. Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all B-N
Group Ltd. Models BN-2, BN-2A, BN2A MK. III, BN2A MK. III-2, BN2A MK.
III-3, BN-2A-2, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2A-3, BN-2A-
6, BN-2A-8, BN-2A-9, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN-2T, and
BN-2T-4R airplanes. This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as inadequate
sealing of the fuel filler cap (fuel tank cap) and the fuel filler
receptacle (fuel tank opening), which could lead to contaminated fuel
and result in in-flight shutdown of the engine. We are issuing this AD
to require actions to address the unsafe condition on these products.

DATES: This AD is effective August 1, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of August 1,
2013.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at Document Management Facility, U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC
20590.
    For service information identified in this AD, contact Britten-
Norman Aircraft Ltd, Commodore House, Mountbatten Business Centre,
Millbrook Road East, Southampton SO15 1HY, United Kingdom; telephone:
+44 01983 872511; fax: +44 01983 873246; email<EMAIL_ADDRESS>
Internet: www.britten-norman.com. You may review copies of the
referenced service information at the FAA, Small Airplane Directorate,
901 Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Taylor Martin, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on April 9, 2013 (78 FR
21072). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    Preliminary investigations into a recent engine failure on a BN2
aeroplane have attributed the event to water contaminated fuel. The
contamination is suspected to have occurred due to inadequate
sealing between a post-mod NB-M-477 fuel filler cap and a pre-mod
NB-M-477 fuel filler receptacle. This condition, if not detected and
corrected, could lead to fuel water contamination, possibly
resulting in in-flight shut down of the engine.
    For the reasons described above, this AD requires a one-time
inspection of the fuel filler cap and fuel filler receptacle to
determine whether they are at the same modification state and,
depending on findings, accomplishment of applicable corrective
action(s). To mitigate the risk of water contamination pending the
installation of matching fuel filler cap and receptacle, this AD
also requires daily pre-flight water contamination checks.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (78 FR 21072, April 9,
2013) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 21072, April 9, 2013) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 21072, April 9, 2013).

Costs of Compliance

    We estimate that this AD will affect 114 products of U.S. registry.
We also estimate that it will take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts will cost about $0 per product.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $9,690, or $85 per product.
    In addition, we estimate that any necessary follow-on actions will
take about 1 work-hour and require parts costing $400, for a cost of
$485 per product. We have no way of determining the number of products
that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the MCAI, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2013-13-02 B-N Group Ltd.: Amendment 39-17490; Docket No. FAA-2013-
0314; Directorate Identifier 2013-CE-004-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective August 1,
2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to B-N Group Ltd. Models BN-2, BN-2A, BN2A MK.
III, BN2A MK. III-2, BN2A MK. III-3, BN-2A-2, BN-2A-20, BN-2A-21,
BN-2A-26, BN-2A-27, BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2B-20,
BN-2B-21, BN-2B-26, BN-2B-27, BN-2T, and BN-2T-4R airplanes, all
serial numbers, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 28: Fuel.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as inadequate
sealing of the fuel filler cap (fuel tank cap) and the fuel filler
receptacle (fuel tank opening). We are issuing this AD to prevent,
detect, and correct inadequate sealing of the fuel filler cap (fuel
tank cap) and the fuel filler receptacle (fuel tank opening), which
could lead to contaminated fuel and result in in-flight shutdown of
the engine.

(f) Actions and Compliance

    Unless already done, do the following actions as specified in
paragraphs (f)(1) through (f)(5) of this AD:
    (1) Within the next 30 days after August 1, 2013 (the effective
date of this AD), inspect the aircraft fuel replenishment points on
the top surface of the wings to determine that the fuel filler cap
(fuel tank cap) matches the fuel filler receptacle (fuel tank
opening) following the instructions of paragraph 6 of Britten-Norman
Service Bulletin Number SB 332, Issue 1, dated December 6, 2012.
    (2) If a mismatch of the fuel filler cap and the fuel filler
receptacle is found during the inspection required by paragraph
(f)(1) of this AD, within 3 calendar months after August 1, 2013
(the effective date of this AD), install the correct fuel filler cap
to match the fuel filler receptacle installed on the airplane
following the instructions of paragraph 6 of Britten-Norman Service
Bulletin Number SB 332, Issue 1, dated December 6, 2012.
    (3) If a mismatch of the fuel filler cap and the fuel filler
receptacle is found during the inspection required by paragraph
(f)(1) of this AD, before further flight and thereafter during each
daily pre-flight check, do water contamination checks of the
gascolators and fuel tank sump drains, including those of the wing
tip tanks if installed. This check is in addition to the normal
daily checks already required.
    (4) The modification required by paragraph (f)(2) of this AD
terminates the daily pre-flight water contamination checks as
specified in paragraph (f)(3) of this AD.
    (5) After August 1, 2013 (the effective date of this AD), do not
install on any airplane a fuel filler cap that does not match the
fuel filler receptacle and has the correct seal.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Taylor Martin, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required

to assure the product is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2012-0270, dated December 20, 2012, for related information, which
can be found in the AD docket on the Internet at http://www.regulations.gov.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Britten-Norman Service Bulletin Number SB 332, Issue 1,
dated December 6, 2012.
    (ii) Reserved.
    (3) For B-N Group Ltd. service information identified in this
AD, contact Britten-Norman Aircraft Ltd, Commodore House,
Mountbatten Business Centre, Millbrook Road East, Southampton SO15
1HY, United Kingdom; telephone: +44 01983 872511; fax: +44 01983
873246; email<EMAIL_ADDRESS>Internet: www.britten-norman.com.
    (4) You may view this service information at FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on June 18, 2013.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-14979 Filed 6-26-13; 8:45 am]
BILLING CODE 4910-13-P


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Provide Target Specifications With Upper and Lower Range Limits for:
    --Cigar length (mm).
    --Cigar mass (mg).
    --Cigar overall diameter (mm).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
    --Cigar wrapper porosity or permeability (CU).
    --Cigar wrapper length (mm).
    --Cigar wrapper width (mm).
    --Cigar wrapper basis weight (g/m\2\).
    --Cigar binder porosity or permeability (CU).
    --Cigar binder width (mm) (if applicable).
    --Cigar binder basis weight (g/m\2\).
    --Cigar tip mass (mg) (if applicable).
    --Tip length (mm) (if applicable).
    --Tip inner diameter (mm) (if applicable).
    --Cigar binder band porosity or permeability (CU) (alternately, band
     diffusivity (cm\2\/s)) (if applicable).
    --Cigar binder band width (mm) (if applicable).
    --Cigar binder band space (mm) (if applicable).
    --Cigar wrapper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigar wrapper band width (mm) (if applicable).
    --Cigar wrapper band space (mm) (if applicable).
------------------------------------------------------------------------

                    Table 16 to Sec.   1107.19(a)(8)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Puff count.
    --Cigar mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco cut size (CPI or mm).
    --Tobacco moisture or oven volatiles (%).
    --Tobacco filler mass (mg).
    --Cigar wrapper basis weight (g/m\2\).
    --Cigar wrapper porosity or permeability (CU).
    --Cigar binder width (mm) (if applicable).
    --Cigar binder basis weight (g/m\2\).
    --Cigar binder porosity or permeability (CU).
    --Cigar wrapper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigar binder band porosity or permeability (CU) (alternately, band
     diffusivity (cm\2\/s)) (if applicable).
    --Cigar tip mass (mg) (if applicable).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
------------------------------------------------------------------------

    (9) Unfiltered, leaf-wrapped cigars. For unfiltered, leaf-wrapped
cigars, the required design parameter information to be provided for
each predicate and new tobacco product is as follows:

                    Table 17 to Sec.   1107.19(a)(9)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Cigar length (mm).
    --Cigar mass (mg).
    --Overall diameter (mm).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
    --Cigar wrapper length (mm).
    --Cigar wrapper width (mm).
    --Cigar wrapper basis weight (g/m\2\).
    --Cigar binder width (mm).
    --Cigar binder basis weight (g/m\2\).
------------------------------------------------------------------------

                    Table 18 to Sec.   1107.19(a)(9)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Puff count.
    --Cigar mass (mg).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco cut size (CPI or mm).
    --Cigar wrapper basis weight (g/m\2\).
    --Cigar binder basis weight (g/m\2\).
    --Tobacco moisture or oven volatiles (%).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
------------------------------------------------------------------------

    (10) Cigar filler. For cigar filler, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:

                    Table 19 to Sec.   1107.19(a)(10)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------

                    Table 20 to Sec.   1107.19(a)(10)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------

    (11) Cigar component. For cigar components, the required design
parameter information to be provided for each predicate and new tobacco
product is as follows:

                    Table 21 to Sec.   1107.19(a)(11)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Cigar wrapper length (mm).
    --Cigar wrapper width (mm).
    --Cigar wrapper porosity (CU).
    --Cigar wrapper basis weight (g/m\2\).
------------------------------------------------------------------------

                    Table 22 to Sec.   1107.19(a)(11)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Cigar wrapper length (mm).

    --Cigar wrapper width (mm).
    --Cigar wrapper basis weight (g/m\2\).
------------------------------------------------------------------------

    (12) Pipes. For pipes, the required design parameter information to
be provided for each predicate and new tobacco product is as follows:

                    Table 23 to Sec.   1107.19(a)(12)
------------------------------------------------------------------------

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Provide Target Specifications With Upper and Lower Range Limits for:
    --Bowl chamber outer diameter (mm).
    --Bowl chamber inner diameter (mm).
    --Draught hole diameter (mm).
    --Draught hole location.
    --Draught hole shape.
    --Bowl chamber hole shape.
    --Bowl chamber volume (cm\3\).
    --Stem length (mm).
    --Stem diameter (mm).
    --Shank length (mm).
    --Shank diameter (mm).
    --Draught hole area (mm\2\).
    --Pressure drop through air valve (mm H2O).
    --Air flow through air valve (cc/min).
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     filter is unchanged (e.g., DPF, total denier (g/9000m), and filter
     density (g/cm\3\))).
    --Filter pressure drop (mm H2O).
    --Filter length (mm).
------------------------------------------------------------------------

                    Table 24 to Sec.   1107.19(a)(12)
------------------------------------------------------------------------

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Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Bowl chamber volume (cm\3\).
    --Air flow through air valve (cc/min).
    --Filter length (mm).
    --Filter pressure drop (mm H2O).
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     filter is unchanged (e.g., DPF, total denier (g/9000m), and filter
     density (g/cm\3\))).
------------------------------------------------------------------------

    (13) Pipe filler. For pipe filler, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:

                    Table 25 to Sec.   1107.19(a)(13)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------

                    Table 26 to Sec.   1107.19(a)(13)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------

    (14) Waterpipes. For waterpipes, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:

                    Table 27 to Sec.   1107.19(a)(14)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Hose length (mm).
    --Hose internal diameter (mm).
    --Hose materials.
    --Stem length (mm).
    --Stem internal diameter (mm).
    --Base diameter (mm).

    --Base volume (cm\3\).
    --Base shape.
    --Pressure drop (mm H2O).
    --Water filter efficiency (%).
    --Hose air permeability (CU).
    --Head height (mm).
    --Head top diameter (mm).
    --Head bottom diameter (mm).
    --No. of holes.
    --Head volume (mm\3\).
    --Heating source type.
    --Head materials.
------------------------------------------------------------------------

                    Table 28 to Sec.   1107.19(a)(14)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Hose length (mm).
    --Hose internal diameter (mm).
    --Stem length (mm).
    --Stem internal diameter (mm).
    --Base diameter (mm).
    --Base volume (cm\3\).
    --Pressure drop (mm H2O).
    --Water filter efficiency (%).
    --Head height (mm).
    --Head top diameter (mm).
    --Head bottom diameter (mm).
    --Head volume (mm\3\).
------------------------------------------------------------------------

    (15) Waterpipe, heating source. For waterpipe heating sources, the
required design parameter information to be provided for each predicate
and new tobacco product is as follows:

                    Table 29 to Sec.   1107.19(a)(15)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Heating element mass (mg).
    --Heating element density (g/cm\3\).
    --Heating element resistance (ohms) (if applicable).
    --No. of heating elements.
    --Heating element configuration.
    --Heating element diameter (gauge).
    --Battery current rating (mA) (if applicable).
    --Battery capacity (mAh) (if applicable).
    --Battery voltage operating range (volts) (if applicable).
    --Battery current operating range (amps) (if applicable).
    --Power delivery unit (PDU) voltage operating range (volts) (if
     applicable).
    --PDU current operating range (amps) (if applicable).
    --PDU wattage operating range (watts) (if applicable).
    --PDU temperature cut-off ([deg]C) (if applicable).
------------------------------------------------------------------------

                    Table 30 to Sec.   1107.19(a)(15)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Heating element temperature range ([deg]C) (if applicable).
    --Heating element mass (mg).
    --Heating element density (g/cm\3\).
    --Heating element resistance (ohms) (if applicable).
    --Heating element diameter (gauge).
    --Battery current rating (mA) (if applicable).
    --Battery capacity (mAh) (if applicable).
    --Battery voltage operating range (volts) (if applicable).
    --Battery current operating range (amps) (if applicable).
    --Power delivery unit (PDU) voltage operating range (volts) (if
     applicable).
    --PDU current operating range (amps) (if applicable).
    --PDU wattage operating range (watts) (if applicable).
    --PDU temperature cut-off ([deg]C) (if applicable).
------------------------------------------------------------------------

    (16) Waterpipe component, head. For waterpipe heads, the required
design parameter information to be provided for each predicate and new
tobacco product is as follows:

                    Table 31 to Sec.   1107.19(a)(16)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    1--Head height (mm).
    --Head top diameter (mm).
    --Head bottom diameter (mm).
    --No. of holes.
    --Head volume (mm\3\).
    --Head materials.
------------------------------------------------------------------------

                    Table 32 to Sec.   1107.19(a)(16)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Head height (mm).
    --Head top diameter (mm).
    --Head bottom diameter (mm).
    --Head volume (mm\3\).
------------------------------------------------------------------------

    (17) Waterpipe component, foil. For waterpipe foil, the required
design parameter information to be provided for each predicate and new
tobacco product is as follows:

                    Table 33 to Sec.   1107.19(a)(17)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Length (mm) (for square or rectangular shape foil).
    --Width (mm) (for square or rectangular shape foil).
    --Diameter (mm) (for circular shape foil).
    --Foil thickness (mm).
    --No. of holes.
    --Diameter of the holes (mm).
------------------------------------------------------------------------

                    Table 34 to Sec.   1107.19(a)(17)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Length (mm) (for square or rectangular shape foil).
    --Width (mm) (for square or rectangular shape foil).
    --Diameter (mm) (for circular shape foil).
    --Foil thickness (mm).
    --Diameter of the holes (mm).
------------------------------------------------------------------------

    (18) Waterpipe filler. For waterpipe filler, the required design
parameter information to be provided for each predicate and new tobacco
product is as follows:

                    Table 35 to Sec.   1107.19(a)(18)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------

                    Table 36 to Sec.   1107.19(a)(18)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------

    (19) Electronic Nicotine Delivery System (ENDS). For ENDS (vapes),
the required design parameter information to be provided for each
predicate and new tobacco product is as follows:

                    Table 37 to Sec.   1107.19(a)(19)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Draw resistance (mm H2O).
    --Puff count (for full tank/cartridge).
    --Atomizer tank/cartridge volume (mL).
    --No. of heating elements (e.g., coil).
    --Heating element diameter (gauge).
    --Heating element length (mm).
    --Heating element resistance (Ohms).
    --Heating element temperature range ([deg]C).
    --Heating element configuration (target only).
    --Battery voltage operating range (V).
    --Battery current operating range (mA).
    --Battery capacity (mAh).
    --Battery nominal voltage (V).
    --Battery current rating (mA).
    --Battery charging temperature limits ([deg]C).
    --Battery discharge temperature limits ([deg]C).
    --Battery end of discharge voltage (V).
    --Battery maximum charging current (mA).
    --Battery maximum discharging current (mA).
    --Battery upper limits charging voltage (V).
    --Power Delivery Unit (PDU) voltage operating range (V).
    --PDU current operating range (mA).
    --PDU wattage operating range (watts).
    --PDU temperature cut-off ([deg]C) (if applicable).
    --PDU current cut-off (mA) (if applicable).
    --Airflow rate (L/min) (if applicable).
    --Ventilation (%).
    --Inhaled aerosol temperature ([deg]C).
------------------------------------------------------------------------

                    Table 38 to Sec.   1107.19(a)(19)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Draw resistance (mm H2O).
    --Puff count (for full tank/cartridge).
    --Atomizer tank/cartridge volume (mL).
    --Heating element diameter (gauge).
    --Heating element resistance (Ohms).
    --Heating element temperature range ([deg]C).
    --Battery voltage operating range (V).
    --Battery current operating range (mA).
    --PDU voltage operating range (V).
    --PDU current operating range (mA).
    --PDU wattage operating range (watts).
    --PDU current cut-off (mA) (if applicable).
    --Inhaled aerosol temperature ([deg]C).
    --PDU temperature cut-off ([deg]C) (if applicable).
    --Battery capacity (mAh).
    --Battery nominal voltage (V).
    --Battery current rating (mA).
    --Heating element length (mm).
    --Battery charging temperature limits ([deg]C).
    --Battery discharge temperature limits ([deg]C).
    --Battery maximum charging current (mA).
    --Battery maximum discharging current (mA).
    --Battery upper limits charging voltage (V).
    --Airflow rate (L/min) (if applicable).
    --Ventilation (%).
------------------------------------------------------------------------

    (20) E-liquids. For e-liquids, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:

                    Table 39 to Sec.   1107.19(a)(20)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --E-liquid viscosity (at 20[deg]C).
    --E-liquid volume (ml).
    --Particle number concentration (#/cm\3\).
    --Count median diameter (nm).

    --PM2.5 ([micro]g/m\3\).
------------------------------------------------------------------------

                    Table 40 to Sec.   1107.19(a)(20)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --E-liquid viscosity (at 20[deg]C).
    --E-liquid volume (ml).
    --Particle number concentration (#/cm\3\).
    --Count median diameter (nm).
    --PM2.5 ([micro]g/m\3\).
------------------------------------------------------------------------

    (21) Heated Tobacco Products (HTP). For HTPs, the required design
parameter information to be provided for each predicate and new tobacco
product is as follows:

                    Table 41 to Sec.   1107.19(a)(21)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Overall Device:
        --Mass (mg).
        --Length (mm).
        --Width (mm).
        --Height (mm).
        --Diameter (mm).
        --Draw resistance (mm H2O).
        --Puff count (for full tank/cartridge).
        --Puff volume (mL).
        --Product volume (mL).
        --Airflow rate (L/min) (if applicable).
        --Ventilation (%).
        --Operational temperature ([deg]C).
        --Temperature sensor (if applicable).
        --Material wrapper length (mm) (if applicable).
        --Material wrapper width (mm) (if applicable).
        --Material wrapper basis weight (g/m\2\) (if applicable).
        --Material porosity or permeability (CU) (if applicable).
    --Heating element:
        --Heating element source/type/approach (electrical, carbon,
         aerosol, etc.).
        --Heating element temperature range ([deg]C).
        --Heating element operational temperature ([deg]C).
        --Heating element maximum temperature (boost temperature)
         ([deg]C).
        --Heating element material.
        --Heating element configuration.
        --Heating element length (mm).
        --Heating element mass (mg).
        --Heating element location.
        --No. of heating elements (e.g., coil).
        --Heating element diameter (gauge) (if applicable).
        --Heating element resistance (Ohms) (if applicable).
    --Tobacco/E-liquid:
        --Tobacco mass (mg) (if applicable).
        --Tobacco density (g/cm\3\) (if applicable).
        --Tobacco moisture or oven volatiles (%) (if applicable).
        --Tobacco cut size (CPI or mm) (if applicable).
        --E-liquid volume (mL) (if applicable).
        --E-liquid viscosity (at 20[deg]C) (if applicable).
    --Battery (if applicable):
        --Battery capacity (mAh).
        --Battery voltage operating range (V) or wattage (W).
        --Battery current charging range (amps).
        --Battery nominal voltage (V).
        --Battery current rating (mA).
        --Battery charging temperature limits ([deg]C).
        --Battery discharge temperature limits ([deg]C).
        --Battery end of discharge voltage (V).
        --Battery maximum charging current (mA).
        --Battery maximum discharging current (mA).
        --Battery upper limits charging voltage (V).
        --Power Delivery Unit (PDU) voltage operating range (V).
        --PDU current operating range (mA).
        --PDU wattage operating range (watts).

        --PDU temperature cut-off ([deg]C) (if applicable).
        --PDU current cut-off (mA) (if applicable).
    --Aerosol:
        --Inhaled aerosol temperature ([deg]C).
        --Aerosol particle number concentration (#/cm\3\).
        --Count median diameter (nm).
        --PM2.5 ([micro]g/m\3\).
    --Filter (if applicable):
        --Filter efficiency (%) (If no filter efficiency data is
         available for the products, include information sufficient to
         show that the filter is unchanged (e.g., DPF, total denier (g/
         9000m), and filter density(g/cm\3\))).
        --Filter pressure drop (mm H2O).
        --Filter length (mm).
        --Filter diameter (mm).
        --Filter ventilation (%).
------------------------------------------------------------------------

                    Table 42 to Sec.   1107.19(a)(21)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Overall device:
        --Draw resistance (mm H2O).
        --Puff count (for full tank/cartridge) (dimensionless).
        --Product volume (mL).
        --Airflow rate (L/min) (if applicable).
        --Ventilation (%).
        --Operational temperature ([deg]C).
        --Temperature sensor (if applicable).
        --Material wrapper length (mm) (if applicable).
        --Material wrapper width (mm) (if applicable).
        --Material wrapper basis weight (g/m\2\) (if applicable).
        --Material porosity or permeability (CU) (if applicable).
    --Heating element:
        --Heating element diameter (gauge) (if applicable).
        --Heating element resistance (Ohms) (if applicable).
        --Heating element temperature range ([deg]C).
    --E-liquid:
        --E-liquid viscosity (at 20[deg]C) (if applicable).
        --E-liquid volume (ml) (if applicable).
    --Tobacco:
        --Tobacco moisture or oven volatiles (%) (if applicable).
        --Tobacco cut size (CPI or mm) (if applicable).
        --Tobacco density (g/cm\3\) (if applicable).
    --Battery:
        --Battery voltage operating range (V) or wattage (W).
        --Battery current operating range (mA).
        --PDU voltage operating range (V).
        --PDU current operating range (mA).
        --PDU wattage operating range (watts).
        --PDU current cut-off (mA) (if applicable).
        --PDU temperature cut-off ([deg]C) (if applicable).
        --Battery capacity (mAh).
        --Battery nominal voltage (V).
        --Battery current rating (mA).
        --Battery charging temperature limits ([deg]C).
        --Battery discharge temperature limits ([deg]C).
        --Battery maximum charging current (mA).
        --Battery maximum discharging current (mA).
        --Battery upper limits charging voltage (V).
    --Aerosol:
        --Inhaled aerosol temperature ([deg]C).
        --Aerosol particle number concentration (#/cm\3\).
        --Count median diameter (nm).
        --PM2.5 ([micro]g/m\3\).
    --Filter (if applicable):
        --Filter efficiency (%) (If no filter efficiency data is
         available for the products, include information sufficient to
         show that the filter is unchanged (e.g., DPF, total denier (g/
         9000m), and filter density(g/cm\3\))).
        --Filter ventilation (%).
        --Filter pressure drop (mm H2O).
------------------------------------------------------------------------

    (b) Comparison of heating sources. The SE Report must include a
description of the heating source for the new and predicate tobacco
products and identify any differences, or state that there is no
heating source.

    (c) Comparison of product composition. The SE Report must include
descriptions of the product composition of the new and predicate
tobacco products and identify any differences. The SE Report must
include, in a tabular format, a side-by-side comparison of the
materials and ingredients for each component or part of the new and
predicate tobacco products. For each material and ingredient quantity,
the target specifications and range of acceptable values, actual
measured value (where applicable), and range of measured values (where
applicable) reported as mass per component or part, must be provided.
    (1) Materials. For each material in the products include:
    (i) The material name and common name(s), if applicable;
    (ii) The component or part of the tobacco product where the
material is located;
    (iii) The subcomponent or subpart where the material is located, if
applicable;
    (iv) The function of the material;
    (v) The quantities (including ranges or means, acceptance limits)
of the material(s) in each new tobacco product and predicate tobacco
product (with any specification variation, if applicable);
    (vi) The specification(s) (including quality/grades, suppliers)
used for the new tobacco product and predicate tobacco product (with
any specification variations, if applicable); and
    (vii) Any other material properties necessary to characterize the
new and predicate tobacco products.
    (2) Ingredients other than tobacco. For each ingredient other than
tobacco in each material or component or part of the product include:
    (i) The International Union of Pure and Applied Chemistry (IUPAC)
chemical name and common name, if applicable;
    (ii) The Chemical Abstracts Service (CAS) number(s) or FDA Unique
Ingredient Identifier (UNII);
    (iii) The function of the ingredient;
    (iv) The quantity with the unit of measure (including ranges or
means, acceptance limits) of the ingredient in the new tobacco product
and predicate tobacco product reported as mass per gram of tobacco for
non-portioned tobacco products and as mass per portion for portioned
tobacco products (with any specification variation, if applicable);
    (v) The specification(s) (including purity or grade and supplier);
    (vi) For complex purchased ingredients, each single chemical
substance reported separately; and
    (vii) Any other ingredient information necessary to characterize
the new and predicate tobacco products.
    (3) Tobacco ingredients. For tobacco include:
    (i) The type (e.g., Bright, Burley, reconstituted);
    (ii) The curing method (e.g., flue cured, dark air cured);
    (iii) The quantity of each type with the unit of measure (including
ranges or means, acceptance limits) of tobacco in the new tobacco
product and predicate tobacco product reported as mass per gram of
tobacco for non-portioned tobacco products and as mass per portion for
portioned tobacco products;
    (iv) A description of any genetic engineering of the tobacco; and
    (v) Any other information necessary to characterize the new and
predicate tobacco products.
    (vi) If the new tobacco product does not contain tobacco, then
include a statement that the new tobacco product does not contain
tobacco.
    (4) Container closure system. A description of the container
closure system for the new and predicate tobacco products, including a
side-by-side quantitative comparison of the components and materials
and annotated illustrations.
    (d) Comparison of other features. The SE Report must include
descriptions of any other features of the new and predicate tobacco
products, such as those described in paragraphs (d)(1) and (2) of this
section, and identify any differences. If a specific feature specified
in paragraphs (d)(1) and (2) of this section is not applicable to the
product design, this must be stated clearly. If FDA requests a
scientific justification explaining why a feature is not applicable,
the applicant must provide the justification to FDA. The comparison of
other features must include information on:
    (1) Constituents. HPHCs and other constituents, as appropriate, to
demonstrate that:
    (i) The new tobacco product has the same characteristics as the
predicate tobacco product, or
    (ii) Any differences in characteristics between the new and
predicate product do not cause the new tobacco product to raise
different questions of public health, including:
    (A) The constituent names in alphabetical order;
    (B) The common name(s);
    (C) The Chemical Abstract Services number(s);
    (D) The mean quantity and variance with unit of measure;
    (E) The number of samples and measurement replicates for each
sample;
    (F) The analytical methods used, associated reference(s), and full
validation reports for each analytical method;
    (G) The testing laboratory or laboratories and documentation
showing that the laboratory or laboratories is (or are) accredited by a
nationally or internationally recognized external accreditation
organization;
    (H) Length of time between dates of manufacture and date(s) of
testing;
    (I) Storage conditions of the tobacco product before it was tested;
    (J) Reference product datasets (if applicable);
    (K) Full test data (including test protocols, any deviation(s) from
the test protocols, quantitative acceptance (pass/fail) criteria and
complete data sets) for all testing performed. Test data for combusted
or inhaled tobacco products must reflect testing conducted using both
intense and non-intense smoking or aerosol-generating regimens, where
established; and
    (L) Complete descriptions of any smoking or aerosol-generating
regimens used for analytical testing that are not standardized or
widely accepted by the scientific community, if applicable.
    (2) Any other features. A description and comparison of any other
features of the new tobacco product and the predicate tobacco product.
    (e) Comparison of tobacco processing. The SE Report must include
information on the tobacco processes in paragraphs (e)(1) and (2) of
this section for the new and predicate tobacco products, if applicable,
and identify any differences.
    (1) Fermentation process. For smokeless tobacco products and
tobacco products that contain fermented tobacco (including naturally
fermented tobacco), the SE Report must contain the following
information regarding the fermentation process of the new and predicate
tobacco products and identify any differences:
    (i) Description of the fermentation process;
    (ii) Composition of the inoculum (starter culture) with genus and
species name(s) and concentration(s) (if applicable);
    (iii) Any step(s) taken to reduce microbes already present during
processing (e.g., cleaning of contact surfaces);
    (iv) Specifications and test data for pH, temperature, and moisture
content or water activity;
    (v) Frequency of aeration or turning (if applicable);
    (vi) Duration of fermentation;
    (vii) Added ingredients;
    (viii) Method used to stabilize or stop fermentation ((e.g., heat
treatment), if

applicable), including parameters of the method (e.g., length of
treatment, temperature) and method validation data; and
    (ix) Storage conditions of the fermented tobacco prior to further
processing or packaging and duration of storage (if applicable).
    (2) Heat treatment process. For tobacco products that are heat
treated, the SE Report must contain the following information regarding
the heat treatment process of the new and predicate tobacco products
and identify any differences:
    (i) Description of the heat treatment process;
    (ii) Type of heat treatment;
    (iii) Conditions of heat treatment, including time, temperature,
and moisture; and
    (iv) Method validation data, including microbial loads (including
bacteria, spores, yeast and fungi) and tobacco-specific nitrosamines
(TSNAs) before and after heat treatment.
    (f) Shelf life and stability information. With the exception of SE
Reports for roll-your-own tobacco products and cigarettes that are not
HTPs, SE Reports for all tobacco products must contain information on
the stability of the new and predicate tobacco products over the shelf
life, including the following information:
    (1) The length of the shelf life, a description of how shelf life
is determined, and a description of how shelf life is indicated on the
tobacco product, if applicable. If a tobacco product does not have a
defined shelf life, state as such;
    (2) Any known or expected impacts of the differences between the
new and predicate products on the product stability. If no impact is
known or expected, state that;
    (3) Stability data assessed at the beginning (zero time), middle,
and end of the expected shelf life. If a tobacco product does not have
a defined shelf life, provide stability data over a specified amount of
time and a justification for why that time period is appropriate.
Stability testing must be performed for the microbial and chemical
endpoints as follows:
    (i) Microbial content data including total aerobic microbial count
and total yeast and mold count;
    (ii) Water activity; and
    (iii) Tobacco-specific nitrosamine yields (total, N-
nitrosonornicotine (NNN), and 4-methylnitrosamino)-1-(3-pydridyl)-1-
butanone) (NNK)).
    (4) Stability testing details for each microbial and chemical
endpoint, including:
    (i) The mean quantity and variance with unit of measure;
    (ii) The number of samples and measurement replicates for each
sample;
    (iii) The methods used, associated reference(s), and full
validation reports for each method (as applicable);
    (iv) The testing laboratory or laboratories and documentation
showing that the laboratory or laboratories is (or are) accredited by a
nationally or internationally recognized external accreditation
organization;
    (v) Length of time between dates of tobacco product manufacture and
date(s) of testing;
    (vi) Storage conditions of the tobacco products before they were
tested;
    (vii) A statement that the testing was performed on a tobacco
product in the same container closure system in which the tobacco
product is intended to be marketed; and
    (viii) Full test data (including test protocols, any deviation(s)
from the test protocols, quantitative acceptance (pass/fail) criteria,
complete data sets, and a summary of the results) for all stability
testing performed.
    (g) Applicant's basis for substantial equivalence determination.
The applicant must state that the new tobacco product has either:
    (1) The same characteristics as the predicate tobacco product and
the basis for this determination, or
    (2) Different characteristics than the predicate tobacco product.
Where an applicant states that its new tobacco product has different
characteristics than the predicate tobacco product, the applicant must
also include an explanation as to why a difference in any of the
following characteristics do not cause the new product to raise
different questions of public health: Product design (paragraph (a) of
this section); heating source (paragraph (b) of this section);
materials and ingredients (paragraph (c) of this section); and other
features (paragraph (d) of this section). In addition, to demonstrate
that a new tobacco product is substantially equivalent, an applicant
must also explain why any differences in the manufacturing process
between the new tobacco product and the predicate tobacco product would
not change the characteristics of the new tobacco product such that the
new tobacco product could raise different questions of public health
(Sec.  1107.18(e)). Similarly, for smokeless tobacco products and
tobacco products that contain fermented tobacco, an applicant must
explain why any difference in stability between the new tobacco product
and the predicate tobacco product does not cause the new tobacco
product to raise different questions of public health (paragraph (f) of
this section).
    (h) Comparison to original predicate tobacco product. If the
applicant is comparing the new tobacco product to a predicate tobacco
product that FDA has previously found to be substantially equivalent,
FDA may request that the applicant include information related to the
original predicate tobacco product that was commercially marketed
(other than for test marketing) in the United States as of February 15,
2007, even if that original predicate tobacco product is back several
predicate tobacco products. FDA will request this information when
necessary to ensure that any order the Agency issues finding the new
tobacco product substantially equivalent complies with section
910(a)(2)(A)(i)(I) of the Federal Food, Drug, and Cosmetic Act. FDA may
need to review the first SE Report that received a finding of
substantial equivalence using the original predicate tobacco product as
a predicate tobacco product in order to make this finding.

Sec.  1107.20   Amendments.

    (a) Except as provided in paragraphs (b) and (c) of this section,
the applicant may submit an amendment to an SE Report in accordance
with subpart C of this part. If an applicant chose to submit a health
information summary with its SE Report under Sec.  1107.18(j)(1), the
applicant must submit with the amendment a redacted copy of the
amendment that excludes research subject identifiers and trade secret
and confidential commercial information as defined in Sec. Sec.  20.61
and 20.63 of this chapter.
    (b) An applicant may not amend an SE Report to change the predicate
tobacco product.
    (c) An applicant may not amend an SE Report after FDA has closed
the SE Report under Sec.  1107.44 or it has been withdrawn under Sec.
1107.22.
    (d) In general, amendments will be reviewed in the next review
cycle as described in Sec.  1107.42.

Sec.  1107.22   Withdrawal by applicant.

    (a) An applicant may at any time make a written request to withdraw
an SE Report for which FDA has not issued an order. The withdrawal
request must state:
    (1) Whether the withdrawal is due to a health or safety concern
related to the tobacco product;
    (2) The submission tracking number; and
    (3) The name of the new tobacco product that is the subject of the
SE Report.

    (b) An SE Report will be considered withdrawn when FDA issues a
notice stating the SE Report has been withdrawn.
    (c) The SE Report is an Agency record, even if withdrawn. FDA will
retain the withdrawn SE Report under Federal Agency records schedules.
The availability of the withdrawn SE Report will be subject to FDA's
public information regulations in part 20 of this chapter.

Sec.  1107.24   Change in ownership of an SE Report.

    An applicant may transfer ownership of its SE Report. On or before
the time of transfer, the new and former applicants are required to
submit information to FDA as follows:
    (a) The former applicant must sign and submit a notice to FDA that
states that all of the former applicant's rights and responsibilities
relating to the SE Report have been transferred to the new applicant.
This notice must identify the name and address of the new applicant and
the SE Report transferred.
    (b) The new applicant must sign and submit a notice to FDA
containing the following:
    (1) The new applicant's commitment to agreements, promises, and
conditions made by the former applicant and contained in the SE Report;
    (2) The date that the change in ownership is effective;
    (3) Either a statement that the new applicant has a complete copy
of the SE Report and order (if applicable), including amendments and
records that are required to be kept under Sec.  1107.58, or a request
for a copy of the SE Report from FDA's files by submitting a request in
accordance with part 20 of this chapter. In accordance with the Freedom
of Information Act, FDA will provide a copy of the SE Report to the new
applicant under the fee schedule in FDA's public information
regulations in Sec.  20.45 of this chapter; and
    (4) A certification that no modifications have been made to the new
tobacco product since the SE Report was submitted to FDA.

Subpart D--FDA Review

Sec.  1107.40   Communications between FDA and applicants.

    (a) General principles. During the course of reviewing an SE
Report, FDA may communicate with applicants about relevant matters,
including scientific, medical, and procedural issues that arise during
the review process. These communications may take the form of telephone
conversations, letters, or emails, and will be documented in the SE
Report in accordance with Sec.  10.65 of this chapter.
    (b) Meeting. Meetings between FDA and applicants may be held to
discuss scientific and other issues. Requests for meetings will be
directed to the Office of Science, Center for Tobacco Products, and FDA
will make every attempt to grant requests for meetings that involve
important issues.
    (c) Acceptance of an SE Report for review. After receiving an SE
Report under Sec.  1107.18, FDA will either refuse to accept the SE
Report for review or issue an acceptance for review letter.
    (d) Notification of deficiencies in an SE Report submitted under
Sec.  1107.18. FDA will make reasonable efforts to communicate to
applicants the procedural, administrative, or scientific deficiencies
found in an SE Report and any additional information and data needed
for the Agency's review. The applicant must also provide additional
comparison information under Sec.  1107.19 if requested by FDA.
    (e) Withdrawal of SE Report. An SE Report will be considered
withdrawn when FDA issues a notice stating that the SE Report has been
withdrawn.

Sec.  1107.42   Review cycles.

    (a) Initial review cycle. FDA intends to review the SE Report and
either communicate with the applicant as described in Sec.  1107.40 or
take an action under Sec.  1107.44 within 90 calendar days of FDA's
receipt of the SE Report, or within 90 calendar days of determining
that the predicate was found to be commercially marketed (other than
for test marketing) in the United States as of February 15, 2007 (if
applicable), whichever is later. This 90-day period is called the
``initial review cycle.''
    (b) Additional review cycles. If FDA issues a deficiency
notification under Sec.  1107.40(d) during the initial review cycle,
FDA will stop reviewing the SE Report until it receives a response from
the applicant or the timeframe specified in the notification of
deficiencies for response has elapsed. If the applicant fails to
respond within the time period provided in the notification of
deficiency, FDA will issue an order denying marketing authorization
under the criteria set forth in Sec.  1107.48. If the applicant's
response to the notification of deficiencies provides the information
FDA requested, but FDA identifies additional deficiencies, FDA may
issue an additional deficiency notification. Each response will begin a
new 90-day review cycle.
    (c) Inadequate response. If the applicant's response to FDA's
deficiency notification(s) does not provide the information FDA
requested, or the applicant provides information but the SE Report is
still deficient, FDA generally intends to issue an order denying market
authorization under the criteria set forth in Sec.  1107.48. At any
time before FDA issues an order, an applicant may make a written
request to withdraw an SE Report under Sec.  1107.22.

Sec.  1107.44   FDA action on an SE Report.

    After receipt of an SE Report, FDA will:
    (a) Refuse to accept the SE Report for review if it does not comply
with Sec.  1107.18 and Sec.  1105.10 of this chapter;
    (b) Request additional information as provided in Sec.  1107.40(d);
    (c) Issue a letter administratively closing the SE Report if it is
not possible to make a determination on an SE Report;
    (d) Issue a letter canceling the SE Report if FDA finds the SE
Report was created in error;
    (e) Issue an order as described in Sec.  1107.46 finding the new
tobacco product to be substantially equivalent and in compliance with
the requirements of the Federal Food, Drug, and Cosmetic Act; or
    (f) Issue an order as described in Sec.  1107.48 denying marketing
authorization because the new tobacco product is:
    (1) Not substantially equivalent to a tobacco product commercially
marketed (other than for test marketing) in the United States on
February 15, 2007, or
    (2) Not in compliance with the requirements of the Federal Food,
Drug, and Cosmetic Act.

Sec.  1107.46   Issuance of an order finding a new tobacco product
substantially equivalent.

    If FDA finds that the information submitted in the SE Report
establishes that the new tobacco product is substantially equivalent to
a predicate tobacco product that was commercially marketed (other than
for test marketing) in the United States on February 15, 2007, and
finds that the new tobacco product is in compliance with the
requirements of the Federal Food, Drug, and Cosmetic Act, FDA will send
the applicant an order authorizing marketing of the new tobacco
product. A marketing authorization order becomes effective on the date
the order is issued.

Sec.  1107.48   Issuance of an order denying marketing authorization.

    (a) General. FDA will issue an order that the new tobacco product
cannot be marketed if FDA finds that:
    (1) The information submitted in the SE Report does not establish
that the new tobacco product is substantially

equivalent to a predicate tobacco product that was commercially
marketed (other than for test marketing) in the United States on
February 15, 2007; or
    (2) The new tobacco product is not in compliance with the Federal
Food, Drug, and Cosmetic Act.
    (b) Basis for order. The order will describe the basis for denying
marketing authorization.

Sec.  1107.50   Rescission of order.

    (a) Grounds for rescinding a substantially equivalent order. FDA
may rescind a substantially equivalent order allowing a new tobacco
product to be marketed if FDA determines that:
    (1) The tobacco product for which the order has been issued:
    (i) Does not have the same characteristics as the predicate tobacco
product; or
    (ii) Has different characteristics and there is insufficient
information demonstrating that it is not appropriate to require a
premarket tobacco product application under section 910(b) of the
Federal Food, Drug, and Cosmetic Act because the product does not raise
different questions of public health; or
    (2) The SE Report (including any submitted amendments) contains an
untrue statement of material fact; or
    (3) Concerning an SE Report that compared the new tobacco product
to a tobacco product that FDA previously found substantially
equivalent,
    (i) The predicate tobacco product relied on in the SE Report has
been found ineligible because its SE Report (including any amendments)
contains an untrue statement of material fact; or
    (ii) A predicate tobacco product on which any of the previous
substantial equivalence determinations was based, going back to the
original predicate tobacco product, has been found ineligible because
its SE Report (including any amendments) contains an untrue statement
of material fact; or
    (4) FDA or the applicant has removed from the market, due to a
health or safety concern related to the tobacco product:
    (i) The predicate tobacco product on which the substantial
equivalence determination is based; or
    (ii) A predicate tobacco product on which any of the previous
substantial equivalence determinations is based, going back to the
original predicate tobacco product, if the substantial equivalence SE
Report compared the new tobacco product to a tobacco product that FDA
previously found substantially equivalent.
    (b) Opportunity for a hearing. (1) Except as provided in paragraphs
(b)(2) and (3) of this section, FDA will rescind an order only after
notice and opportunity for a hearing under part 16 of this chapter.
    (2) FDA may rescind a substantially equivalent order prior to
notice and opportunity for a hearing under part 16 of this chapter if
it finds that there is a reasonable probability that continued
marketing of the tobacco product presents a serious risk to public
health. In that case, FDA will provide the manufacturer an opportunity
for a hearing as soon as possible after the rescission.
    (3) FDA may rescind a substantially equivalent order without notice
and opportunity for a hearing under part 16 of this chapter if the
applicant has notified the Agency of a mistake in the application, FDA
has determined that the mistake is part of the underlying scientific
determination of the order which makes the order invalid, and the
applicant has agreed that FDA can rescind the order without providing
notice and opportunity for a hearing under part 16 of this chapter.

Subpart E--Miscellaneous

Sec.  1107.58   Record retention.

    Each applicant that receives an order under Sec.  1107.46
authorizing the marketing of a new tobacco product must maintain all
records required by this subpart and that support the SE Report for a
substantial equivalence order. These records must be legible, in the
English language, and available for inspection and copying by officers
or employees duly designated by the Secretary. All records must be
retained for a period of not less than 4 years from the date of the
order even if such product is discontinued.

Sec.  1107.60   Confidentiality.

    (a) General. FDA will determine the public availability of any part
of an SE Report and other content related to such an SE Report under
this section and part 20 of this chapter.
    (b) Confidentiality of data and information prior to an order.
Prior to issuing an order under this section:
    (1) FDA will not publicly disclose the existence of an SE Report
unless:
    (i) The tobacco product has been introduced or delivered for
introduction into interstate commerce for commercial distribution; or
    (ii) The applicant has publicly disclosed or acknowledged the
existence of the SE Report (as such disclosure is defined in Sec.
20.81 of this chapter), or has authorized FDA in writing to publicly
disclose or acknowledge, that the applicant has submitted the SE Report
to FDA.
    (2) FDA will not disclose the existence of or contents of an FDA
communication with an applicant regarding its SE Report except to the
extent that the applicant has publicly disclosed or acknowledged, or
authorized FDA in writing to publicly disclose or acknowledge, the
existence of or contents of that particular FDA communication.
    (3) FDA will not disclose information contained in an SE Report
unless the applicant has publicly disclosed or acknowledged, or
authorized FDA in writing to publicly disclose or acknowledge, that
particular information. If the applicant has publicly disclosed or
acknowledged, or authorized FDA in writing to publicly disclose or
acknowledge, that particular information contained in an SE Report, FDA
may disclose that particular information.
    (c) Disclosure of data and information after issuance of an order
under Sec.  1107.46. After FDA issues an order under Sec.  1107.46
finding a new tobacco product substantially equivalent, it will make
the following information related to the SE Report and order available
for public disclosure upon request or at FDA's own initiative,
including information from amendments to the SE Report and FDA's
reviews of the SE Report:
    (1) All data previously disclosed to the public, as such disclosure
is defined in Sec.  20.81 of this chapter;
    (2) Any protocol for a test or study, except to the extent it is
shown to fall within the exemption established for trade secrets and
confidential commercial information in Sec.  20.61 of this chapter;
    (3) Information and data submitted to demonstrate that the new
tobacco product does not raise different questions of public health,
except to the extent it is shown to fall within the exemptions
established in Sec.  20.61 of this chapter for trade secrets and
confidential commercial information, or in Sec.  20.63 of this chapter
for personal privacy;
    (4) Correspondence between FDA and the applicant, including any
requests FDA made for additional information and responses to such
requests, and all written summaries of oral discussions between FDA and
the applicant, except to the extent it is shown to fall within the
exemptions in Sec.  20.61 of this chapter for trade secrets and
confidential commercial information, or in Sec.  20.63 of this chapter
for personal privacy; and
    (5) In accordance with Sec.  25.51 of this chapter, the
environmental assessment or, if applicable, the claim of categorical
exclusion from the requirement to

submit an environmental assessment under part 25 of this chapter.
    (d) Disclosure of data and information after issuance of an order
under Sec.  1107.48. After FDA issues an order under Sec.  1107.48
(denying marketing authorization), FDA may make certain information
related to the SE Report and the order available for public disclosure
upon request or at FDA's own initiative except to the extent the
information is otherwise exempt from disclosure under part 20 of this
chapter. Information FDA may disclose includes the tobacco product
category (e.g., cigarette), tobacco product subcategory (e.g.,
filtered), package size, and the basis for the order denying marketing
authorization.
    (e) Health information summary or statement. Health information
required by section 910(a)(4) of the Federal Food, Drug, and Cosmetic
Act, if submitted as part of the SE Report (which includes any
amendments), will be disclosed within 30 calendar days of issuing a
substantially equivalent order. If the applicant has instead submitted
a 910(a)(4) statement as provided in Sec.  1107.18(j)(2), FDA will make
publicly available on FDA's website the responsible official to whom a
request for health information may be made.

Sec.  1107.62   Electronic submission.

    (a) Electronic format requirement. Applicants submitting any
documents to the Agency under this part must provide all required
information to FDA using the Agency's electronic system, except as
provided in paragraph (b) of this section. The SE Report and all
supporting information must be in an electronic format that FDA can
process, read, review, and archive.
    (b) Waivers from electronic format requirement. An applicant may
submit a written request that is legible and written in English, to the
Center for Tobacco Products asking that FDA waive the requirement for
electronic format and content. Waivers will be granted if use of
electronic means is not reasonable for the person requesting the
waiver. To request a waiver, applicants can send the written request to
the address included on our website (www.fda.gov/tobaccoproducts). The
request must include the following information:
    (1) The name and address of the applicant, list of individuals
authorized for the applicant to serve as the contact person, and
contact information including an email address. If the applicant has
submitted an SE Report previously, the regulatory correspondence must
also include any identifying information for the previous submission.
    (2) A statement that creation and/or submission of information in
electronic format is not reasonable for the person requesting the
waiver, and an explanation of why creation and/or submission in
electronic format is not reasonable. This statement must be signed by
the applicant or by an employee of the applicant who is authorized to
make the declaration on behalf of the applicant.
    (c) Paper submission. An applicant who has obtained a waiver from
filing electronically must send a written SE Report through the
Document Control Center to the address provided in the FDA
documentation granting the waiver.

    Dated: September 21, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-21009 Filed 10-4-21; 8:45 am]
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