[Federal Register Volume 83, Number 240 (Friday, December 14, 2018)]
[Rules and Regulations]
[Pages 64285-64289]
[FR Doc No: 2018-26247]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R04-OAR-2018-0296; FRL-9987-13-Region 4]

Air Plan and Operating Permit Program Approval: AL, GA and SC;
Revisions to Public Notice Provisions in Permitting Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
portions of State Implementation Plan (SIP) revisions and the Title V
Operating Permit Program revisions submitted on May 19, 2017, by the
State of Alabama, through the Alabama Department of Environmental
Management (ADEM); submitted on November 29, 2017, by the State of
Georgia, through the Georgia Environmental Protection Division (Georgia
EPD); and submitted on September 5, 2017, by the State of South
Carolina, through the South Carolina Department of Health and
Environmental Control (SC DHEC). These revisions address the public
notice rule provisions for the New Source Review (NSR) and Title V
Operating Permit programs (Title V) of the Clean Air Act (CAA or Act)
that remove the mandatory requirement to provide public notice of a
draft air permit in a newspaper and that allow electronic notice (``e-
notice'') as an alternate noticing option. EPA is approving these
revisions pursuant to the CAA and implementing federal regulations.

DATES: This rule is effective January 14, 2019.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2018-0296. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Ms. Kelly Fortin of the Air Permitting
Section, Air Planning and Implementation Branch, Air, Pesticides and
Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Fortin
can be reached by telephone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In a notice of proposed rulemaking (NPRM) published on August 10,
2018 (83 FR 39638), EPA proposed to approve the portions of Alabama's
May 19, 2017, Georgia's November 29, 2017, and South Carolina's
September 5, 2017, SIP revisions and the Title V program revisions
addressing the public notice requirements for CAA permitting. The
details of Alabama's, Georgia's, and South Carolina's submittals and
the rationale for EPA's actions are explained in the NPRM and briefly
summarized below. The comment period for the proposed rule closed on
September 10, 2018, and EPA did not receive any adverse comments.
    On October 5, 2016, EPA finalized revised public notice rule
provisions for the NSR, Title V, and Outer Continental Shelf permitting
programs of the CAA. See 81 FR 71613 (October 18, 2016). These rule
revisions remove the mandatory requirement to provide public notice of
a draft air permit through publication in a newspaper and allow for
internet e-notice as an option for permitting authorities implementing
their own EPA-approved SIP rules and Title V rules, such as the
Alabama, Georgia, and South Carolina EPA-approved programs. Permitting
authorities are not required to adopt e-notice. Nothing in the final
rules prevents a permitting authority of an EPA-approved permitting
program from continuing to use newspaper notification and/or from
supplementing e-notice with newspaper notification and/or additional
means of notification. When e-notice is provided, EPA's rule requires
electronic access (e-access) to the draft permit. Generally, state and
local agencies intend to post the draft permits and public notices in a
designated location on their agency websites. For the noticing of draft
permits issued by permitting authorities with EPA-approved programs,
the rule requires the permitting authority to use ``a consistent
noticing method'' for all permit notices under the specific permitting
program.
    Alabama revised Chapter 335-3-14, Air Permits and Chapter 335-3-15,
Synthetic Minor Operating Permits, and Chapter 335-3-16, Major Source
Operating Permits, to incorporate EPA's amendments to the federal
public notice regulations discussed above.
    Georgia revised Rule 391-3-1-.02(7)(a)1, Prevention of Significant
Deterioration of Air Quality, and Rule 391-3-1-.03(10), Title V
Operating Permits, of Georgia's Rules for Air Quality Control, Chapter
391-3-1, to incorporate EPA's amendments to the federal public notice
regulations, as discussed above.
    South Carolina revised Regulation 61-62.5, Standard No. 7,
Prevention of Significant Deterioration, and Regulation 61-62.70, Title
V Operating Permit Program of the South Carolina Air Pollution Control
Regulations and Standards, to incorporate EPA's amendments to the
federal public notice regulations discussed above.

II. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Alabama's
Chapter 335-3-14, ``Air Permits'' at 335-3-14-.01, .04, and .05 and
Chapter 335-3-15 ``Synthetic Minor Operating Permits'' at 335-3-15-.05,
which address the public notice rule provisions for the NSR program,
state effective December June 9, 2017; Georgia Rule 391-3-1-.02(7),
Prevention of Significant Deterioration of Air Quality, which addresses
the public notice rule provisions for the NSR program, state effective
July 20, 2017; and South Carolina Regulation 61-62.5, Standard No. 7,
``Prevention of Significant Deterioration,'' which address the public
notice rule provisions for the NSR program, state effective August 25,
2017.\1\ EPA has

made, and will continue to make, these materials generally available
through www.regulations.gov and at the EPA Region 4 Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information). Therefore, these
materials have been approved by EPA for inclusion in the SIP, have been
incorporated by reference by EPA into that plan, are fully federally
enforceable under sections 110 and 113 of the CAA as of the effective
date of the final rulemaking of EPA's approval, and will be
incorporated by reference in the next update to the SIP compilation.\2\
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    \1\ EPA is taking this opportunity to make administrative
corrections to the entries in the ``Explanation'' columns in 40 CFR
52.50(c) for Alabama Rule 335-3-14-.04; 40 CFR 52.570(c) for Georgia
Rule 391-3-1-.02(7); and 40 CFR 52.2120(c) for South Carolina
Regulation 61-62.5, Standard No. 7 to more clearly reflect the
federally-approved versions of these rules in the states' respective
SIPs.
    \2\ See 62 FR 27968 (May 22, 1997).
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III. Final Action

    EPA is approving the portions of Alabama's May 19, 2017, Georgia's
November 29, 2017, and South Carolina's September 5, 2017, SIP
revisions and the Title V program revisions addressing the public
notice requirements for CAA permitting. EPA has concluded that the
States' submissions meet the plan revisions requirements of CAA section
110 and the SIP requirements of 40 CFR 51.161, 51.165, and 51.166, as
well as the public notice and revisions requirements of 40 CFR 70.4 and
70.7.

IV. Statutory and Executive Order Reviews

    In reviewing SIP and Title V submissions, EPA's role is to approve
such submissions, provided that they meet the criteria of the CAA and
EPA's implementing regulations. These actions merely approve state law
as meeting Federal requirements and do not impose additional
requirements beyond those imposed by state law. For that reason, these
actions:
     Are not significant regulatory actions subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Are not Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory actions because the actions are not significant under
Executive Order 12866;
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIPs subject to these actions, with the exception of the South
Carolina SIP, are not approved to apply on any Indian reservation land
or in any other area where EPA or an Indian tribe has demonstrated that
a tribe has jurisdiction. In those areas of Indian country, the rules
regarding SIPs do not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), nor will they
impose substantial direct costs on tribal governments or preempt tribal
law. With respect to the South Carolina SIP, EPA notes that the Catawba
Indian Nation Reservation is located within the boundary of York
County, South Carolina, and pursuant to the Catawba Indian Claims
Settlement Act, S.C. Code Ann. 27-16-120, ``all state and local
environmental laws and regulations apply to the Catawba Indian Nation
and Reservation and are fully enforceable by all relevant state and
local agencies and authorities.'' Thus, the South Carolina SIP applies
to the Catawba Reservation; however, because the action related to
South Carolina is merely modifying public notice provisions for certain
types of air permits issued by SC DHEC, EPA has determined that there
are no substantial direct effects on the Catawba Indian Nation. EPA has
also determined that the action related to South Carolina's SIP will
not impose any substantial direct costs on tribal governments or
preempt tribal law.
    Furthermore, the rules regarding Title V Operating Permit programs
do not have tribal implications because they are not approved to apply
to any source of air pollution over which an Indian Tribe has
jurisdiction, nor will these rules impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 12, 2019. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects

40 CFR Part 52

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Reporting and recordkeeping requirements.

 40 CFR Part 70

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Operating Permits,
Reporting and recordkeeping requirements.

    Dated: November 15, 2018.
Onis ``Trey'' Glenn, III,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart B--Alabama

0
2. Section 52.50(c) is amended by:
0
a. Revising under the heading ``Chapter No. 335-3-14 Air Permits'' the
entries for ``Section 335-3-14-.01'', ``Section 335-3-14-.04'',
``Section 335-3-14-.05''; and
0
b. Revising under the heading ``Chapter No. 335-3-15 Synthetic Minor
Operating Permits'' the entry for ``Section 335-3-15-.05''
    The revisions read as follows:

Sec.  52.50  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Alabama Regulations
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                                                            State
          State citation               Title/subject      effective    EPA  approval  date       Explanation
                                                             date
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                                                  * * * * * * *
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                                        Chapter No. 335-3-14 Air Permits
----------------------------------------------------------------------------------------------------------------
Section 335-3-14-.01.............  General Provisions..     6/9/2017  12/14/2018, [Insert
                                                                       citation of
                                                                       publication].

                                                  * * * * * * *
Section 335-3-14-.04.............  Air Permits              6/9/2017  12/14/2018, [Insert   Except for changes
                                    Authorizing                        citation of           to 335-3-14-
                                    Construction in                    publication].         .04(2)(g)2. and the
                                    Clean Air Areas                                          addition of 335-3-
                                    (Prevention of                                           14-.04(2)(bbb),
                                    Significant                                              state effective May
                                    Deterioration                                            29, 2012, which EPA
                                    Permitting (PSD)).                                       proposed to approve
                                                                                on August 24, 2017.
                                                                                Except for changes
                                                                                to 335-3-14-
                                                                                .04(2)(w)1., state
                                                                                effective July 11,
                                                                                2006, which lists a
                                                                                100 ton per year
                                                                                significant net
                                                                                emissions increase
                                                                                for regulated NSR
                                                                                pollutants not
                                                                                otherwise specified
                                                                                at 335-3-14-
                                                                                .04(2)(w).
                                                                                Except for the
                                                                                significant impact
                                                                                levels at 335-3-14-
                                                                                .04(10)(b) which
                                                                                were withdrawn from
                                                                                EPA consideration
                                                                                on October 9, 2014.
Section 335-3-14-.05.............  Air Permits              6/9/2017  12/14/2018, [Insert   With the exception
                                    Authorizing                        citation of           of: The portion of
                                    Construction in or                 publication].         335-3-14-.05(1)(k)
                                    Near Nonattainment                                       stating ``excluding
                                    Areas.                                                   ethanol production
                                                                                facilities that
                                                                                produce ethanol by
                                                                                natural
                                                                                fermentation''; and
                                                                                335-3-14-.05(2)(c)3
                                                                                (addressing
                                                                                fugitive emission
                                                                                increases and
                                                                                decreases). Also
                                                                                with the exception
                                                                                of the state-
                                                                                withdrawn elements:
                                                                                335-3-14-.05(1)(h)
                                                                                (the actual-to-
                                                                                potential test for
                                                                                projects that only
                                                                                involve existing
                                                                                emissions units);
                                                                                the last sentence
                                                                                at 335-3-14-
                                                                                .05(3)(g), stating
                                                                                ``Interpollutant
                                                                                offsets shall be
                                                                                determined based
                                                                                upon the following
                                                                                ratios''; and the
                                                                                NNSR interpollutant
                                                                                ratios at 335-3-14-
                                                                                .05(3)(g)1-4.
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                             Chapter No. 335-3-15 Synthetic Minor Operating Permits
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 335-3-15-.05.............  Public Participation     6/9/2017  12/14/2018, [Insert   ....................
                                                                       citation of
                                                                       publication].

                                                  * * * * * * *
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* * * * *

Subpart L--Georgia

0
3. Section 52.570(c) is amended in the table by revising the entry for
``391-3-1-.02(7)'' to read as follows:

Sec.  52.570  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Georgia Regulations
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                                                            State
          State citation               Title/subject      effective    EPA  approval  date       Explanation
                                                             date
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                                                  * * * * * * *
391-3-1-.02(7)...................  Prevention of           7/20/2017  12/14/2018, [Insert   Except 391-3-1-
                                    Significant                        citation of           .02(7)(a)(2)(iv).
                                    Deterioration of                   publication].         See March 4, 2016
                                    Air Quality (PSD).                                       publication.
                                                                                The version of
                                                                                Georgia Rule 391-3-
                                                                                1-.02(7) in the SIP
                                                                                does not
                                                                                incorporate by
                                                                                reference: (1) The
                                                                                provisions amended
                                                                                in the Ethanol Rule
                                                                                to exclude
                                                                                facilities that
                                                                                produce ethanol
                                                                                through a natural
                                                                                fermentation
                                                                                process from the
                                                                                definition of
                                                                                ``chemical process
                                                                                plants'' in the
                                                                                major NSR source
                                                                                permitting program
                                                                                found at 40 CFR
                                                                                52.21(b)(1)(i)(a)
                                                                                and (b)(1)(iii)(t),
                                                                                or (2) the
                                                                                provisions at 40
                                                                                CFR 52.21(b)(2)(v)
                                                                                and (b)(3)(iii)(c)
                                                                                that were stayed
                                                                                indefinitely by the
                                                                                Fugitive Emissions
                                                                                Interim Rule, see
                                                                                March 30, 2011
                                                                                publication.

                                                  * * * * * * *
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* * * * *

Subpart PP--South Carolina

0
4. Section 52.2120(c), is amended in the table under ``Regulation No.
62.5 Air Pollution Control Standards'' by revising the entry for
``Standard No. 7'' to read as follows:

Sec.  52.2120  Identification of plan.

* * * * *
    (c) * * *

                              Air Pollution Control Regulations for South Carolina
----------------------------------------------------------------------------------------------------------------
                                                            State
          State citation               Title/subject      effective    EPA  approval  date       Explanation
                                                             date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Regulation No. 62.5..............
Standard No. 7...................  Prevention of           8/25/2017  12/14/2018, [Insert   EPA did not take
                                    Significant                        citation of           action on the
                                    Deterioration.                     publication].         version of
                                                                                Regulation 61-62.5,
                                                                                Standard No. 7,
                                                                                paragraph
                                                                                (b)(32)(i)(a) state
                                                                                effective on
                                                                                December 27, 2013,
                                                                                included in a SIP
                                                                                revision submitted
                                                                                by the State on
                                                                                April 10, 2014,
                                                                                because this
                                                                                version contains
                                                                                changes to a phrase
                                                                                regarding ethanol
                                                                                production
                                                                                facilities that is
                                                                                not in the SIP.
                                                                                South Carolina
                                                                                submitted a SIP
                                                                                revision on April
                                                                                14, 2009, that
                                                                                includes the phrase
                                                                                ``except ethanol
                                                                                production
                                                                                facilities
                                                                                producing ethanol
                                                                                by natural
                                                                                fermentation under
                                                                                the North American
                                                                                Industry
                                                                                Classification
                                                                                System (NAICS)
                                                                                codes 325193 or
                                                                                312140,'' as
                                                                                amended in the
                                                                                Ethanol Rule (May
                                                                                1, 2007), at
                                                                                Standard No. 7,
                                                                                paragraphs
                                                                                (b)(32)(i)(a),
                                                                                (b)(32)(iii)(b)(t),
                                                                                and (i)1(vii)(t)
                                                                                and at Standard No.
                                                                                7.1, paragraphs
                                                                                (c)7(C)(xx) and
                                                                                (e)(T). EPA has not
                                                                                taken action to
                                                                                approve that
                                                                                portion of the
                                                                                April 14, 2009, SIP
                                                                                revision and
                                                                                incorporate this
                                                                                phrase into the
                                                                                SIP. The version of
                                                                                Standard No. 7,
                                                                                paragraphs
                                                                                (b)(32)(i)(a),
                                                                                (b)(32)(iii)(b)(t),
                                                                                and (i)1(vii)(t)
                                                                                and Standard No.
                                                                                7.1, paragraphs
                                                                                (c)(7)(C)(xx) and
                                                                                (e)(T) was state
                                                                                effective on June
                                                                                24, 2005 and
                                                                                conditionally
                                                                                approved by EPA on
                                                                                June 2, 2008, and
                                                                                were fully approved
                                                                                on June 23, 2011.
                                                                                Except Regulation 61-
                                                                                62.5, Standard No.
                                                                                7(b)(30)(v) and
                                                                                (b)(34)(iii)(d),
                                                                                state effective
                                                                                June 26, 2015,
                                                                                which were
                                                                                withdrawn from EPA
                                                                                consideration on
                                                                                December 20, 2016.
                                                                                Except changes to
                                                                                Regulation 61-62.5,
                                                                                Standard No.
                                                                                7(b)(34)(iii)(c),
                                                                                state effective
                                                                                June 26, 2015,
                                                                                which were
                                                                                withdrawn from EPA
                                                                                consideration on
                                                                                June 27, 2017.
                                                                                Except changes to 61-
                                                                                62.5, Standard No.
                                                                                7(b)(34), (w)(1)-
                                                                                (3), (aa), and
                                                                                (bb), state
                                                                                effective August
                                                                                25, 2017, which EPA
                                                                                proposed to approve
                                                                                on September 21,
                                                                                2018.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

PART 70--STATE OPERATING PERMIT PROGRAMS

0
5. The authority citation for part 70 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
6. Amend appendix A to part 70 by:
0
a. Adding paragraph (a)(3) under the heading ``Alabama'';
0
b. Adding paragraph (d) under the heading ``Georgia''; and
0
c. Adding paragraph (d) under the heading ``South Carolina''.
    The additions read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs

* * * * *

Alabama

    (a) * * *
    (3) Revisions to Alabama Chapter 335-3-16-.15(4), submitted on
May 19, 2017, to allow for electronic noticing of operating permits,
are approved on November 15, 2018.
* * * * *

Georgia

* * * * *
    (d) Revisions to Georgia Rule 391-3-1-.03(10) submitted on
November 29, 2017, to allow for electronic noticing of operating
permits, are approved on November 15, 2018.
* * * * *

South Carolina

* * * * *
    (d) Revisions to South Carolina Regulation 61-62.70, submitted
on September 5, 2017, to allow for electronic noticing of operating
permits, are approved on November 15, 2018.
* * * * *
[FR Doc. 2018-26247 Filed 12-13-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 186 (Wednesday, September 29, 2021)]
[Notices]
[Pages 53965-53967]
[FR Doc No: 2021-21135]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0872]

Electronic Submission Template for Medical Device 510(k)
Submissions; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Electronic Submission
Template for Medical Device 510(k) Submissions.'' FDA is issuing this
draft guidance to introduce submitters of premarket notification
(510(k)) submissions to the Center for Devices and Radiological Health
and Center for Biologics Evaluation and Research to the current
resources and associated content developed to support 510(k) electronic
submissions to FDA. This draft guidance, when finalized, is intended to
represent one of several steps in meeting FDA's commitment to the
development of electronic submission templates to serve as guided
submission preparation tools for industry to improve submission
consistency and enhance efficiency in the review process. This draft
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by November 29, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0872 for ``Electronic Submission Template for Medical Device
510(k) Submissions.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Electronic Submission Template for Medical Device 510(k)
Submissions'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 379k-1(b)), amended by section 207 of the FDA
Reauthorization Act of 2017 (Pub. L. 115-52), requires that pre-
submissions and submissions for devices under section 510(k),
513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the
FD&C Act

(21 U.S.C. 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g),
360j(m), or 360bbb-3) or section 351 of the Public Health Service Act
(42 U.S.C. 262) and any supplements to such pre-submissions or
submissions, including appeals of those submissions, be submitted in
electronic format specified by FDA beginning on such date as specified
by FDA in final guidance. It also mandates that FDA issue a draft
guidance not later than October 1, 2019, providing for further
standards for the submission by electronic format, a timetable for
establishment of these further standards, and criteria for waivers of
and exemptions from the requirements.
    In addition, in the Medical Device User Fee Amendments of 2017
(MDUFA IV) Commitment Letter \1\ from the Secretary of Health and Human
Services to Congress, FDA committed to developing ``electronic
submission templates that will serve as guided submission preparation
tools for industry to improve submission consistency and enhance
efficiency in the review process'' and ``by FY [fiscal year] 2020, the
Agency will issue a draft guidance document on the use of the
electronic submission templates.'' In addition, the Commitment Letter
states that ``[n]o later than 12 months after the close of the public
comment period, the Agency will issue a final guidance.'' FDA's
guidance document ``Providing Regulatory Submissions for Medical
Devices in Electronic Format--Submissions Under Section 745A(b) of the
Federal Food, Drug, and Cosmetic Act'' issued July 15, 2020 (the
``parent guidance'') \2\ was intended to satisfy the final guidance
documents referenced in section 745A(b)(3) of the FD&C Act and the
MDUFA IV Commitment Letter. A notice of availability of the parent
guidance appeared in the Federal Register of July 15, 2020 (85 FR
42864).
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/media/102699/download.
    \2\ ``Providing Regulatory Submissions for Medical Devices in
Electronic Format--Submissions Under Section 745A(b) of the Federal
Food, Drug, and Cosmetic Act, Guidance for Industry and Food and
Drug Administration Staff'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab.
---------------------------------------------------------------------------

    In the parent guidance, the Agency concluded that it is not
feasible to describe and implement the electronic format(s) that would
apply to all the submissions covered by section 745A(b) of the FD&C Act
in one guidance document. Accordingly, the parent guidance describes
how FDA interprets and plans to implement the requirements of section
745A(b)(3) of the FD&C Act, while individual guidances will be
developed to specify the formats for specific submissions and
corresponding timetables for implementation. The current draft guidance
``Electronic Submission Template for Medical Device 510(k)
Submissions'' is the first of these individual guidances that, when
finalized, will specify the format for 510(k) submissions and a
corresponding timetable for implementation.
    In section 745A(b) of the FD&C Act, Congress granted explicit
statutory authorization to FDA to specify in guidance the statutory
requirement for electronic submissions solely in electronic format by
providing standards, a timetable, and criteria for waivers and
exemptions. To the extent that this draft guidance provides such
requirements under section 745A(b)(3) of the FD&C Act (i.e., standards,
timetable, criteria for waivers of and exemptions), indicated by the
use of the mandatory words, such as must or required, this document is
not subject to the usual restrictions in FDA's good guidance practice
regulations, such as the requirement that guidances not establish
legally enforceable responsibilities. (See Sec.  10.115(d).)
    To the extent that this draft guidance describes recommendations
that are not standards, timetable, criteria for waivers of, or
exemptions under section 745A(b)(3) of the FD&C Act, it is being issued
in accordance with FDA's good guidance practices regulation (Sec.
10.115). This draft guidance, when finalized, will represent the
current thinking of FDA on this topic. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This draft guidance, when finalized, will
contain both binding and nonbinding provisions.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download
an electronic copy of ``Electronic Submission Template for Medical
Device 510(k) Submissions'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 19006 and complete title to identify the
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                           OMB  control
          21 CFR part                     Topic                 No.
------------------------------------------------------------------------
801 and 809....................  Medical Device Labeling       0910-0485
                                  Regulations.
807, subpart E, including forms  Premarket Notification        0910-0120
 FDA 4062 ``Electronic            Submission, including
 Submission Template and          submissions via eSTAR.
 Resource (eSTAR)'' and FDA
 4078 ``Electronic Submission
 Template and Resource
 (eSTAR)'' (for In Vitro
 Diagnostic (IVD) 510(k)
 submissions).
------------------------------------------------------------------------

IV. Other Issues for Consideration

    The Agency invites comments on the ``Electronic Submission Template
for Medical Device 510(k) Submissions'' draft guidance, in general, and
on the following questions, in particular:
     Is a minimum of 1 year an adequate amount of time to
transition to submissions solely in electronic format for 510(k)
submissions using the eSTAR template?
     If a minimum of 1 year is not adequate, how much time
would be necessary for you to transition to use of eSTAR as the
required format for 510(k) submission?

    Dated: September 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21135 Filed 9-28-21; 8:45 am]
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