MEMORANDUM
DATE:  	May 2, 2023
TO:	Docket EPA-HQ-OAR-2019-0424
FROM:  	Jennifer Bohman
--------------------------------------------------------------------------------
SUBJECT:	Proposed Reporting Determinations for Data Elements Assigned to the Inputs to Emission Equations Data Category in Proposed Supplemental Revisions to the Greenhouse Gas Reporting Rule
      In the rulemaking titled "Revisions and Confidentiality Determinations for Data Elements Under the Greenhouse Gas Reporting Rule; Supplemental notice of proposed rulemaking," the EPA proposes revisions to the current 40 CFR part 98 requirements. These proposed revisions include changes to improve the quality and consistency of the data collected under the rule and that would inform and be relevant to the EPA's carrying out of a wide variety of Clean Air Act provisions, including reporting from additional sectors of the economy.
      These proposed revisions include amendments to the reporting requirements of 40 CFR part 98, including substantial revisions to existing reporting requirements (i.e., the change requires additional or different data to be reported) and the addition of new data elements.  EPA proposes to designate certain of these new or substantially revised data elements as "Inputs to Emission Equations." The "Inputs to Emission Equations" data category includes data elements that are the inputs to the emission equations used by sources that directly emit GHGs to calculate their annual GHG emissions. The EPA evaluates and organizes data assigned to the "Inputs to Emission Equations" data category into two subcategories. The first subcategory includes "inputs to emission equations" that must be included in the annual report and directly reported to the EPA. The second subcategory includes "inputs to emission equations" that must be entered into e-GGRT's Inputs Verification Tool (IVT) and maintained as verification software records by the submitter; these data elements are not included in the annual report that is submitted to the EPA.
      EPA's process for evaluating "Inputs to Emissions Equations" was developed in 2011 and includes the following steps:
 Step 1: Determine whether each input is already publicly available.
 Step 2: For inputs that are not publicly available, evaluate whether release of the information is likely to result in substantial competitive harm.
 Step 3: For inputs that are likely to cause substantial competitive harm if disclosed, evaluate potential alternative calculation methods.
 Step 4: For inputs that are likely to cause substantial competitive harm if disclosed, evaluate potential alternative verification methods.
      As discussed in Section VI.C of the proposed rule, the EPA proposes to assign 31 new or substantially revised data elements to the "Inputs to Emission Equations" data category. EPA evaluated these 31 data elements to determine if they should be directly reported to EPA or if they should be entered into the IVT system. Based on the EPA's evaluation, the EPA found that 12 of these 31 evaluated data elements do not meet the criteria necessary for them to be entered into the IVT system, and, therefore, the EPA is proposing that these 12 data elements be directly reported to the EPA. The EPA considers these "inputs to emission equations" that do not meet the criteria necessary for them to be entered into the IVT system to be "emissions data". "Emissions data" are not eligible for confidential treatment. Therefore, these 12 data elements would  be directly reported to the EPA, and they would be published once received by the EPA without further notice to the submitter. Table 1 lists each of the 12 data elements that EPA proposes would (1) be placed in the inputs to emissions data category and (2) be directly reported to EPA.  For each data element, the table provides the subpart, the 40 CFR part 98 rule citation, a description of the data element, an indication of whether the data element is new or revised, and the EPA's rationale for why the data element would not be eligible for entering into IVT.
 	Also based on the EPA's evaluation discussed above, the EPA determined that 19 of the 31 evaluated data elements meet the criteria necessary to be entered into the IVT system.  These data elements include information such as quantities of materials produced, quantities of raw materials consumed, and operating characteristics of the reporting facility.  EPA found that these data are not publicly available and otherwise meet the criteria for entry int IVT. The EPA proposes that these 19 data elements be entered into IVT and maintained as verification software records by the submitter rather than being included in the annual report that is submitted to the EPA. A list of these 19 proposed verification software records is provided in Table 2. For each verification software record, the table provides the subpart, the 40 CFR part 98 rule citation, and a description of the verification software record.

Table 1. NEW AND SUBSTANTIALLY REVISED DATA ELEMENTS PROPOSED TO BE ASSIGNED TO THE INPUTS TO EMISSION EQUATIONS DATA CATEGORY AND DIRECTLY REPORTED TO EPA
Subpart
Citation in 40 CFR Part 98
Data Element Description
New or Revised
Rationale for the Proposed Reporting Determination
HH
98.346(j)(5)
For landfills with gas collection systems, the number of gas collection systems at the landfill facility.
New
This data element would indicate the number of gas collection systems at the landfill facility. This data element is similar to 40 CFR 98.346(i)(5)(i), the number of destruction devices associated with each measurement location for landfills with gas collection systems.  EPA previously assigned a reporting determination of "directly report" for this similar data element (78 FR 71904, November 29, 2013; Inputs Memo, September 4, 2013). This means that very similar data (i.e., data on the existence and extent of landfill gas collection systems) on the MSW landfill is already publicly available.  In addition, in the December 17, 2012, memorandum "Summary of Evaluation of Greenhouse Gas Reporting Program (GHGRP) Part 98 "Inputs to Emission Equations" Data Elements Deferred Until 2013," the EPA found that MSW landfill data are widely available in the public domain and not actually or customarily treated as confidential by the submitter. For these reasons, the EPA has determined that this new input to an emission equation should be directly reported.
HH
98.346(j)(6)(iii)
For each gas collection system at a landfill facility, the annual hours the gas collection system was operating normally (excluding periods of shut down or poor operation, such as times when pressure, temperature, or other parameters indicative of operation are outside of normal variances).
Revised
This data element would indicate the annual hours each gas collection system was operating normally at the landfill facility. As documented in the September 4, 2013, memorandum and the November 29, 2013, final rule (78 FR 71904), the EPA determined that the current version of this input to an emission equation in 40 CFR 98.346(i)(5)(ii) should be directly reported to EPA. This proposed revision to 40 CFR 98.346(i)(5)(ii) clarifies that the annual operating hours for each gas collection system excludes periods of shut down or poor operation, such as times when pressure, temperature, or other parameters indicative of operation are outside of normal variances.  This proposed revision would not change the EPA's previous determination; reporting the annual hours the gas collection system was operating normally reveals the same type of information as the annual operating hours of the gas collection system that is currently reported and published. In addition, in the December 17, 2012, memorandum "Summary of Evaluation of Greenhouse Gas Reporting Program (GHGRP) Part 98 "Inputs to Emission Equations" Data Elements Deferred Until 2013," the EPA found that MSW landfill data are widely available in the public domain and not actually or customarily treated as confidential by the submitter. For these reasons, the EPA has determined that this revised input to emission equation should be directly reported.
HH
98.346(j)(6)(iv)
For each gas collection system at a landfill facility, the number of measurement locations associated with the gas collection system.
New
This data element would indicate the number of measurement locations associated with each gas collection system at the landfill facility. This data element is similar to the input to an emission equation in 40 CFR 98.346(i)(5)(i) for municipal solid waste landfills, the number of destruction devices associated with each measurement location at the landfill facility, which we previously assigned a reporting determination of "directly report" (78 FR 71904, November 29, 2013; Inputs Memo, September 4, 2013). This means that very similar data (i.e., data about the existence and extent of landfill gas collection systems) is already publicly available.  In addition, in the December 17, 2012, memorandum "Summary of Evaluation of Greenhouse Gas Reporting Program (GHGRP) Part 98 "Inputs to Emission Equations" Data Elements Deferred Until 2013," the EPA found that MSW landfill data are widely available in the public domain and not actually or customarily treated as confidential by the submitter. For these reasons, the EPA has determined that this input to an emission equation should be directly reported.
HH
98.346(j)(7)(iv)
For landfills with gas collection systems for which you have indicated that surface methane concentration measurements were made during the reporting year, the total number of surface methane concentration measurements that exceeded 500 parts per million above background during the reporting year.
New
This data element would indicate the total number of surface methane concentration measurements that exceeded 500 parts per million above background during the reporting year for landfills with gas collection systems. This input to an emission equation is similar to the data element in 40 CFR 98.256(e)(9) for petroleum refineries using flares, number of SSM events exceeding 500,000 scf/day, which is reported to the EPA under 40 CFR 98.256(e)(9) and released to the public. In addition, in the December 17, 2012, memorandum "Summary of Evaluation of Greenhouse Gas Reporting Program (GHGRP) Part 98 "Inputs to Emission Equations" Data Elements Deferred Until 2013," the EPA found that MSW landfill data are widely available in the public domain and not actually or customarily treated as confidential by the submitter. For these reasons, the EPA has determined that this input to an emission equation should be directly reported.

HH
98.346(j)(7)(v)(C)
For landfills with gas collection systems, for each surface methane concentration measurement that exceeded 500 parts per million above background during the reporting year, the measured methane concentration (parts per million by volume).
New
This data element would indicate the measured methane concentration for each surface methane concentration measurement that exceeded 500 parts per million above background during the reporting year for landfills with gas collection systems. This input to an emission equation is similar to the input to an emission equation in 40 CFR 98.326(g) for underground coal mines, quarterly CH4 concentration for each ventilation monitoring point, which we previously assigned a reporting determination of "directly report" (Inputs Memo, December 17, 2012). In addition, in the December 17, 2012, memorandum "Summary of Evaluation of Greenhouse Gas Reporting Program (GHGRP) Part 98 "Inputs to Emission Equations" Data Elements Deferred Until 2013," the EPA found that MSW landfill data are widely available in the public and not actually or customarily treated as confidential by the submitter.  For these reasons, the EPA has determined that this input to an emission equation should be directly reported.
HH
98.346(j)(7)(v)(D)
For landfills with gas collection systems, for each surface methane concentration measurement that exceeded 500 parts per million above background during the reporting year, the leak duration (days).
New
This data element would indicate the leak duration for each surface methane concentration measurement that exceeded 500 parts per million above background during the reporting year for landfills with gas collection systems. This input to an emission equation is similar to the data element in 40 CFR 98.236(k)(2)(iii) for petroleum and natural gas systems, duration of time that the leak is counted as having occurred for scrubber dump valve leakage vented directly to the atmosphere, which is reported to the EPA under 40 CFR 98.236(k)(2)(iii) and released to the public (79 FR 70351, November 25, 2014; CBI Memo, November 10, 2014). In addition, in the December 17, 2012, memorandum "Summary of Evaluation of Greenhouse Gas Reporting Program (GHGRP) Part 98 "Inputs to Emission Equations" Data Elements Deferred Until 2013," the EPA found that MSW landfill data are widely available in the public domain and not actually or customarily treated as confidential by the submitter. For these reasons, the EPA has determined that this input to an emission equation should be directly reported.
XX
98.506(g)
For the calcium carbide production facility, the relevant information required by 40 CFR 98.36 for the Tier 4 calculation methodology (CEMS).
New
This data element would require calcium carbide facilities that use the Tier 4 calculation methodology (CEMS) to report the information required under 40 CFR 98.36 for that methodology.  EPA made a reporting determination for an applicable input to an emission equation, 40 CFR 98.36(b)(9)(iii),  in a previous rulemaking.  The existing determination would apply.
YY
98.516(h)
For the caprolactam, production facility, for each N2O abatement technology, the monthly abatement utilization factor.
New
These data elements would indicate the monthly abatement utilization factor for each N2O abatement technology at the caprolactam, glyoxal, or glyoxylic acid production facility. These inputs to emission equations are similar to the input to an emission equation in 40 CFR 98.56(h) for adipic acid production, the abatement utilization factor for each abatement technology, which we previously assigned a reporting determination of "directly report" (79 FR 63750, October 24, 2014; Inputs Memo, September 2014). This means that similar data (i.e., data on utilization for N2O abatement systems) is publicly available.  For these reasons, the EPA has determined that these proposed new inputs to emission equations should be directly reported.
YY
98.516(h)
For the glyoxal production facility, for each N2O abatement technology, the monthly abatement utilization factor.
New

YY
98.516(h)
For the glyoxylic acid production facility, for each N2O abatement technology, the monthly abatement utilization factor.
New

ZZ
98.526(a)
For a ceramics manufacturing facility, the total number of ceramics process units.
New
This data element would indicate the total number of ceramics process units at a ceramics manufacturing facility. This input to an emission equation is similar to the data element 40 CFR 98.146(b)(8) for glass production, total number of continuous glass melting furnaces, which is reported to the EPA under 40 CFR 98.146(b)(8) and released to the public. In addition, under the proposed rule, ceramics facilities would be reporting process emissions for each process under, and EPA is proposing that those emissions from each process unit would be published.  Therefore, this information would be readily determined from public information. For these reasons, the EPA has determined that this proposed new input to an emission equation should be directly reported.
ZZ
98.526(b)
For a facility containing a ceramics manufacturing process, the relevant information required under 40 CFR 98.36 for the Tier 4 calculation methodology (CEMS).
New
This proposed data element requires ceramics facilities that use the Tier 4 calculation methodology (CEMS) to report the information required under 40 CFR 98.36 for that methodology.  EPA made a reporting determination for an applicable input to an emission equation, 40 CFR 98.36(b)(9)(iii), in a previous rulemaking.  The existing determination would apply.

Table 2. NEW DATA ELEMENTS PROPOSED TO BE ASSIGNED TO THE INPUTS TO EMISSION EQUATIONS DATA CATEGORY, ENTERED INTO IVT, AND MAINTAINED AS VERIFICATION SOFTWARE RECORDS
Subpart
Citation in 40 CFR Part 98
Verification Software Record
WW
98.497(b)(1)
Monthly mass of green coke fed to the coke calcining unit from facility records (metric tons/year) (Equation WW-1 of 40 CFR 98.493).
WW
98.497(b)(2)
Monthly mass of marketable petroleum coke produced by the coke calcining unit from facility records (metric tons/year) (Equation WW-1 of 40 CFR 98.493).
WW
98.497(b)(3)
Monthly mass of petroleum coke dust removed from the process through the dust collection system of the coke calcining unit from facility records (metric tons/year) (Equation WW-1 of 40 CFR 98.493).
WW
98.497(b)(4)
Average monthly mass fraction carbon content of green coke fed to the coke calcining unit from facility measurement data (metric tons C per metric ton green coke) (Equation WW-1 of 40 CFR 98.493).
WW
98.497(b)(5)
Average monthly mass fraction carbon content of marketable petroleum coke produced by the coke calcining unit from facility measurement data (metric tons C per metric ton petroleum coke) (Equation WW-1 of 40 CFR 98.493).
XX
98.507(d)(1)
Carbon content in reducing agent (percent by weight, expressed as a decimal fraction) (Equation XX-1 of 40 CFR 98.503).
XX
98.507(d)(2)
Annual mass of reducing agent fed, charged, or otherwise introduced into the calcium carbide process unit (tons) (Equation XX-1 of 40 CFR 98.503).
XX
98.507(d)(3)
Carbon content of carbon electrode (percent by weight, expressed as a decimal fraction) (Equation XX-1 of 40 CFR 98.503).
XX
98.507(d)(4)
Annual mass of carbon electrode consumed in the calcium carbide process unit (tons) (Equation XX-1 of 40 CFR 98.503).
XX
98.507(d)(5)
Carbon content in product (percent by weight, expressed as a decimal fraction) (Equation XX-1 of 40 CFR 98.503).
XX
98.507(d)(6)
Annual mass of product produced/tapped in the calcium carbide process unit (tons) (Equation XX-1 of 40 CFR 98.503).
XX
98.507(d)(7)
Carbon content in non-product outgoing material (percent by weight, expressed as a decimal fraction) (Equation XX-1 of 40 CFR 98.503).
XX
98.507(d)(8)
Annual mass of non-product outgoing material removed from calcium carbide process unit (tons) (Equation XX-1 of 40 CFR 98.503).
YY
98.517(d)(1)
Monthly production quantity of caprolactam from all process lines at the caprolactam, glyoxal, or glyoxylic acid production facility.
YY
98.517(d)(2)
Monthly production quantity of glyoxal from all process lines at the caprolactam, glyoxal, or glyoxylic acid production facility.
YY
98.517(d)(3)
Monthly production quantity of glyoxylic acid from all process lines at the caprolactam, glyoxal, or glyoxylic acid production facility.
ZZ
98.527(d)(1)
Annual average decimal mass fraction of each carbonate-based mineral in each carbonate-based raw material for each ceramics process unit (specify the default value, if used, or the value determined according to 40 CFR 98.524) (percent by weight, expressed as a decimal fraction) (Equation ZZ-1 of 40 CFR 98.523).
ZZ
98.527(d)(2)
Annual mass of each carbonate-based raw material charged to each ceramics process unit (tons) (Equation ZZ-1 of 40 CFR 98.523).
ZZ
98.527(d)(3)
Decimal fraction of calcination achieved for each carbonate-based raw material for each ceramics process unit (specify the default value, if used, or the value determined according to 40 CFR 98.524) (percent by weight, expressed as a decimal fraction) (Equation ZZ-1 40 CFR 98.523).


determinations. The applicant must provide FDA any updated information
if the contact information changes.
    (5) No modified risk violations. To the extent information is
included in the health information summary or health information
provided upon request under paragraphs (j)(1) and (2) of this section
that is not required by section 910(a)(4) of the Federal Food, Drug,
and Cosmetic Act or paragraph (j) of this section, that information
must not contain a statement that would cause the tobacco product to be
in violation of section 911 of the Federal Food, Drug, and Cosmetic Act
upon the introduction or delivery for introduction of the proposed new
product into interstate commerce.
    (k) Compliance with 21 CFR part 25. (1) The SE Report must include
an environmental assessment prepared in accordance with Sec.  25.40 of
this chapter, or a valid claim of categorical exclusion. If the
applicant believes that the action qualifies for an available
categorical exclusion, the applicant must state under Sec.  25.15(a)
and (d) of this chapter that the action requested qualifies for a
categorical exclusion, citing the particular exclusion that is claimed,
and that to the applicant's knowledge, no extraordinary circumstances
exist under Sec.  25.21.

    (2) The environmental assessment must include a statement
explaining whether the new tobacco product is intended to replace the
predicate tobacco product once the new tobacco product receives market
authorization, is intended to be a line extension of the predicate
tobacco product, is intended to be introduced as an additional product
by the same manufacturer, or if the new tobacco product will be
introduced as an additional product but by a different manufacturer.
    (l) Certification Statement. (1) The SE Report must contain the
following certification, with the appropriate information inserted (as
indicated by parenthetical text), and be signed by an authorized
representative of the applicant. ``I (name of responsible official) on
behalf of (applicant), hereby certify that (applicant) will maintain
all records to substantiate the accuracy of this SE Report for the
period of time required in Sec.  1107.58 and ensure that such records
remain readily available to the FDA upon request. I certify that this
information and the accompanying submission are true and correct, that
no material fact has been omitted, and that I am authorized to submit
this on the applicant's behalf. I understand that under section 1001 of
title 18 of the United States Code anyone who knowingly and willfully
makes a materially false, fictitious, or fraudulent statement or
representation in any matter within the jurisdiction of the executive,
legislative, or judicial branch of the Government of the United States
is subject to criminal penalties.''
    (2) The SE Report must include the following certification if an
applicant chooses to certify that certain characteristics are identical
in lieu of providing data for each characteristic of the new and
predicate tobacco products. This certification must include the
appropriate information inserted (as indicated by parenthetical text)
and be signed by an authorized representative of the applicant. ``I,
(name of responsible official), on behalf of (name of company), certify
that (new tobacco product name) has the following modification(s) as
compared to (name of predicate tobacco product): (describe
modification(s), e.g., change in product quantity or change in
container closure system). Aside from these modifications, the
characteristics of (new tobacco product name) and (name of predicate
tobacco product) are identical. I certify that (name of company)
understands this means there is no other modification to the materials,
ingredients, design features, heating source, or any other feature. I
also certify that (name of company) will maintain records to support
the comparison information in 21 CFR 1107.19 that substantiate the
accuracy of this statement for the period of time required in 21 CFR
1107.58, and ensure that such records remain readily available to FDA
upon request.''

Sec.  1107.19  Comparison information.

    The SE Report must include a comparison of the characteristics of
the new tobacco product to the predicate tobacco product. The
comparison section of the SE Report must be organized in the following
manner:
    (a) Comparison of product design. The SE Report must include
descriptions of the product designs 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 each design parameter of
the new and predicate tobacco products. For each design parameter, the
target value and range of acceptable values, actual measured value
(where applicable), and range of measured values (where applicable)
with units of measure must be provided. In addition, for each
applicable design parameter, test data must be provided.
    (1) Cigarettes. For cigarettes, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:

                     Table 1 to Sec.   1107.19(a)(1)
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Cigarette length (mm)                     --Puff count
--Cigarette circumference (mm)              --Cigarette draw resistance
                                             (mm H2O)
--Cigarette draw resistance (mm H2O)        --Tobacco filler mass (mg)
--Tobacco filler mass (mg)                  --Tobacco moisture (%)
--Tobacco rod density (g/cubic centimeter   --Filter ventilation (%)
 (cm3))
--Tobacco moisture (%)                      --Cigarette paper base paper
                                             basis weight (g/m2))
--Filter ventilation (%)                    --Cigarette paper base paper
                                             porosity (CU)
--Tipping paper length (mm)                 --Filter efficiency (%) (If
                                             no filter efficiency data
                                             is available for the
                                             products, include
                                             information sufficient to
                                             show that the cigarette
                                             filter is unchanged (e.g.,
                                             denier per filament, total
                                             denier, and filter
                                             density))
--Cigarette paper base paper basis weight   --Filter pressure drop (mm
 (g/m2)                                      H2O)
--Cigarette paper base paper porosity (CU)
--Cigarette paper band width (mm)
--Cigarette paper band space (mm)
--Filter efficiency (%) (If no filter
 efficiency data is available for the
 products, include information sufficient
 to show that the cigarette filter is
 unchanged (e.g., denier per filament,
 total denier, and filter density))
--Filter length (mm)
--Filter pressure drop (mm H2O)
------------------------------------------------------------------------

    (2) Smokeless tobacco. For portioned and non-portioned smokeless
tobacco products, the required design parameter information to be
provided for each predicate and new tobacco product is as follows:

                     Table 2 to Sec.   1107.19(a)(2)
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
                  Portioned Smokeless Tobacco Products
------------------------------------------------------------------------
--Tobacco cut size (mm)                     --Tobacco cut size (mm).
--Tobacco moisture (%)                      --Tobacco moisture (%).
--Portion length (mm) (if applicable)       --Portion mass (mg) (if
                                             applicable).
--Portion width (mm) (if applicable)        --Pouch paper porosity (CU).
--Portion mass (mg) (if applicable)         --Pouch paper basis weight
                                             (g/m2).
 Portion thickness (mm) (if applicable)
 Pouch paper wicking
 Pouch paper porosity (CU)
 Pouch paper basis weight (g/m2)
------------------------------------------------------------------------
                 Nonportioned Smokeless Tobacco Products
------------------------------------------------------------------------
--Tobacco cut size (mm)                     --Tobacco cut size (mm).
--Tobacco moisture (%)                      --Tobacco moisture (%).
------------------------------------------------------------------------

    (3) Roll-your-own tobacco, rolling papers. For roll-your-own
tobacco rolling papers, the required design parameter information to be
provided for each predicate and new tobacco product is as follows:

                     Table 3 to Sec.   1107.19(a)(3)
------------------------------------------------------------------------
                                                   Provide test data
                                                (include test protocols,
 Provide target specification with upper and    quantitative acceptance
           lower range limits for:              criteria, data sets, and
                                               a summary of the results)
                                                          for:
------------------------------------------------------------------------
--Paper length(mm)                             --Mass per paper (mg).
--Paper width (mm)                             --Cigarette paper base
--Mass per paper (mg)                           paper basis weight (g/
--Cigarette paper base paper basis weight (g/   m2).
 m2)                                           --Cigarette paper base
                                                paper porosity (CU).
                                               --Cigarette paper band
                                                porosity (CU) (if
                                                applicable).
--Cigarette paper base paper porosity (CU)
--Cigarette paper band porosity (CU) (if
 applicable)
--Cigarette paper band width (mm) (if
 applicable)
--Cigarette paper band space (mm)
 (applicable)
------------------------------------------------------------------------

    (4) Roll-your-own tobacco, tubes. For roll-your-own tobacco tubes,
the required design parameter information to be provided for each
predicate and new tobacco product is as follows:

                     Table 4 to Sec.   1107.19(a)(4)
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Tube length (mm)                          --Total mass (mg).
--Tube circumference (mm)                   --Cigarette paper base paper
--Total mass (mg)                            basis weight (g/m2).
--Cigarette paper base paper basis weight   --Cigarette paper base paper
 (g/m2)                                      porosity (CU).
                                            --Cigarette paper band
                                             porosity (CU).
--Cigarette paper base paper porosity (CU)
--Cigarette paper band porosity (CU)
--Cigarette paper band width (mm)
--Cigarette paper band space (mm)
------------------------------------------------------------------------

    (5) Roll-your-own tobacco, filtered tubes. For roll-your-own
tobacco filtered tubes, the required design parameter information to be
provided for each new predicate and new tobacco product is as follows:

                     Table 5 to Sec.   1107.19(a)(5)
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Tube length (mm)                          --Total mass (mg).
--Tube circumference (mm)                   --Filter ventilation (%).
--Total mass (mg)                           --Cigarette paper base paper
--Tipping paper length (mm)                  basis weight (g/m2).
                                            --Cigarette paper base paper
                                             porosity (CU).

--Filter ventilation (%)                    --Cigarette paper band
--Cigarette paper base paper basis weight    porosity (CU).
 (g/m2)                                     --Filter denier per filament
--Cigarette paper base paper porosity (CU)   (DPF).
--Cigarette paper band porosity (CU)        --Filter total denier (g/
                                             9000m).
                                            --Filter density (g/cm3).
--Cigarette paper band width (mm)           --Filter pressure drop (mm
                                             H2O).
--Cigarette paper band space (mm)
--Filter length (mm)
--Filter denier per filament (DPF)
--Filter total denier (g/9000m)
--Filter density (g/cm3)
--Filter pressure drop (mm H2O)
------------------------------------------------------------------------

    (6) Roll-your-own tobacco. For roll-your-own tobacco, the required
design parameter information to be provided for each predicate and new
tobacco product is as follows:

                     Table 6 to Sec.   1107.19(a)(6)
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Tobacco filler mass (mg)                  --Tobacco filler mass (mg).
--Tobacco size (mm)                         --Tobacco size (mm).
--Tobacco moisture (%)                      --Tobacco moisture (%).
------------------------------------------------------------------------

    (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 value 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 ingredients other than
tobacco in each material and/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 material(s) 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, including grade and variety;
    (ii) The quantity 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 (with any specification variation, if applicable);
    (iii) The specification of tobacco used for the new tobacco product
and the predicate tobacco product (with any specification variation, if
applicable);
    (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 this section,
and identify any differences. If a specific feature specified in 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 and associated reference(s);
    (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;
and
    (J) 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.
    (2) Any other features. A description and comparison of any other
features of the new tobacco product and the predicate tobacco product.
    (e) Stability information. For smokeless tobacco products and
tobacco products that contain fermented tobacco, the SE Report must
contain information on the stability of the new and predicate tobacco
products, including the following information:
    (1) A description of how the stability is indicated on the tobacco
product, and an explanation as to whether the stability testing is
identical for the predicate and the new tobacco product;
    (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. For those products that contain
fermented tobacco, the SE Report must provide information on the
fermentation processing steps, including the composition of the
inoculum, with species name(s) and concentration(s); pH; temperature;
moisture content; water activity; duration; and added ingredients;
    (3) Detailed stability testing, including test protocols,
quantitative acceptance criteria, data sets, and a summary of the
results for all stability testing performed. Stability testing must be
performed at the beginning (zero time), middle, and end of the expected
storage time for the chemical and microbial endpoints as follows:
Microbial content data including total aerobic microbial count and
total yeast and mold count along with identification of detected
microbiological organisms by genus and species names (if applicable);
pH; moisture content; water activity; tobacco-specific nitrosamines
(total, N-nitrosonornicotine (NNN), 4-methylnitrosamino)-1-(3-
pydridyl)-1-butanone) (NNK)); nitrate and nitrite levels; preservatives
and microbial metabolic inhibitors (if any); and method of heat
treatment or pasteurization used to reduce microbial loads;
    (4) Testing information, including the storage conditions for
samples retained for testing; identification of the test methods used;
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 support for the expiration date (e.g., by showing
that an adequate number of batches was tested);
    (5) Stability testing laboratory or laboratories used and
documentation showing that the laboratory or laboratories is (or are)
accredited by a nationally or internationally recognized external
accreditation organization; and
    (6) Identification of microbiological organisms by genus and
species names, where applicable, and culture collection number either
used during the manufacturing process and/or detected through stability
testing.
    (f) 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 (Sec.
1107.19(a)); heating source (Sec.  1107.19(b)); materials and
ingredients (Sec.  1107.19(c)); and other features (Sec.  1107.19(d)).
In addition, to demonstrate that a new tobacco product with different
characteristics 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 does not raise
different questions of public health (Sec.  1107.18(e)). Similarly, for
smokeless tobacco products, an applicant must explain why any
difference in stability between the new tobacco product and the
predicate tobacco product does not raise different questions of public
health (Sec.  1107.19(e)).
    (g) Comparison to grandfathered 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
grandfathered tobacco product for that predicate, even if the
grandfathered tobacco product is back several predicate tobacco
products. FDA will request this information when necessary to ensure
that any order the Agency may issue 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 grandfathered 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 21 CFR 20.61 and
20.63.
    (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 Sec.  20.45 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 21 CFR part 20. 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, and FDA will make every attempt to
grant requests for meetings that involve important issues.
    (c) Acknowledgement of an SE Report. After receiving an SE Report
under Sec.  1107.18, FDA will either refuse to accept the SE Report or
issue an acknowledgement letter.
    (d) Notification of deficiencies in a 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 days of determining that the
predicate was found to be commercially marketed 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 will 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 a
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 if it does not comply with Sec.
1107.18;
    (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 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 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 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 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 substantial equivalence 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 a 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 substantial equivalence 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 grandfathered product, has been found ineligible because its
substantial equivalence 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 grandfathered 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. In general, FDA will rescind an
order only after notice and opportunity for a hearing under part 16 of
this chapter. However, 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.

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 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 the chapter (21 CFR 25.51),
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 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. If the applicant has submitted a SE Report
previously, the regulatory correspondence must also include any
identifying information for the previous submission; and
    (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: March 21, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-05787 Filed 3-28-19; 11:15 am]
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[Federal Register Volume 86, Number 128 (Thursday, July 8, 2021)]
[Notices]
[Page 36172]
[FR Doc No: 2021-14581]

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SECURITIES AND EXCHANGE COMMISSION

[Extension: Rule 17g-8 & 9; OMB Control No. 3235-0693]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule 17g-
8 and 17g-9 (17 CFR 240.17g-8 and 9) under the Securities Exchange Act
of 1934 (15 U.S.C. 78a et seq.) (``Exchange Act'').
    Rule 17g-8 contains certain requirements for Nationally Recognized
Statistical Rating Organizations (``NRSROs'') to have policies and
procedures with respect to the procedures and methodologies the NRSRO
uses to determine credit ratings, with respect to the symbols, numbers,
or scores it uses to denote credit ratings, to address instances in
which a look-back review determines that a conflict of interest
influenced a credit rating, and to consider certain prescribed factors
for an effective internal structure. Rule 17g-9 contains requirements
for NRSROs to ensure that any person employed by an NRSRO to determine
credit ratings meets standards necessary to produce accurate ratings.
Currently, there are 9 credit rating agencies registered as NRSROs with
the Commission. The Commission estimates that the total burden for
respondents to comply with Rule 17g-8 is 1,305 hours and to comply with
Rule 17g-9 is 32,335 hours.
    An agency may not conduct or sponsor a collection of information
unless it displays a currently valid OMB control number. No person
shall be subject to any penalty for failing to comply with a collection
of information subject to the PRA that does not display a valid OMB
control number.
    The public may view background documentation for this information
collection at the following website: >www.reginfo.gov<. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) >www.reginfo.gov/public/do/PRAMain< and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or by
sending an email to<EMAIL_ADDRESS>
    Dated: July 2, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-14581 Filed 7-7-21; 8:45 am]
BILLING CODE 8011-01-P