[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Rules and Regulations]
[Pages 68334-68340]
[FR Doc No: 2019-27047]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 807, 812, and 814

[Docket No. FDA-2018-N-0628]
RIN 0910-AH48

Medical Device Submissions: Amending Premarket Regulations That
Require Multiple Copies and Specify Paper Copies To Be Required in
Electronic Format

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
issuing a final rule amending requirements for medical device premarket
submissions to remove paper and multiple copies and replace them with
requirements for a single submission in electronic format. This action
would reduce the number of copies in electronic format required, thus
improving and making more efficient the FDA's premarket submission
program for medical devices.

DATES: This rule is effective January 15, 2020.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Diane Garcia, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G609, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. General Overview of Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments and FDA Response
VI. Proposed Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Final Rule

    FDA is issuing this final rule to amend regulations on medical
device premarket submissions to remove requirements for paper and
multiple copies and replace them with requirements for a single
submission in electronic format to improve the FDA's medical device
premarket submission program and create a more efficient submission
program. Because a medical device premarket submission in electronic
format is easily reproducible, the requirement for multiple copies,
whether in electronic format or paper form, is no longer necessary. FDA
believes it is beneficial to the public to limit any burden and expense
to

submitters caused by requiring additional copies.

B. Summary of the Major Provisions of the Final Rule

    Under this final rule, FDA is amending its regulations on medical
device submissions to remove requirements for paper and multiple copies
and replace them with requirements for a single submission in
electronic format. This requirement for a single submission in
electronic format applies to all submission types enumerated in section
745A(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 379k-1); under this final rule, FDA is only amending those
regulations that specifically mention paper and/or multiple copies of
regulatory submissions and are not consistent with this final rule.
Therefore, this final rule will amend regulations for the following
submission types: Premarket Notification (510(k)) submissions (21 CFR
807.90); Confidentiality of Information Certifications (21 CFR 807.95);
Investigational Device Exemption (IDE) applications (21 CFR 812.20);
Premarket Approval Applications (PMAs) (21 CFR 814.20); PMA supplements
(21 CFR 814.39); and Humanitarian Device Exemption (HDE) Applications
(21 CFR 814.104). These regulations cover both Center for Devices and
Radiological Health (CDRH) and Center for Biologics Evaluation and
Research (CBER) regulated devices. Submissions in electronic format
include eCopies, submissions created and submitted on CD, DVD, or flash
drive and mailed to FDA, and eSubmissions, submission package produced
by an electronic submission template.
    This final rule will also amend sections of the regulations that
identify FDA's mailing address for submissions and replace those
addresses with a website address for CDRH and CBER that provides the
current mailing addresses.

C. Legal Authority

    FDA is issuing this final rule from the same authority under which
FDA initially issued these regulations: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 360h-360j, 360c-360j, 360bbb-8b, 371, 372, 373, 374,
375, 379, 379e, 381, 382, 393; 42 U.S.C. 216, 241, 262, 263b-263n, 264,
271. In addition, section 745A of the FD&C Act provides FDA authority
with respect to electronic format for submissions and any appeals, and
section 701(a) of the FD&C Act (21 U.S.C. 371(a)) grants FDA general
rulemaking authority to issue regulations for the efficient enforcement
of the FD&C Act.

D. Costs and Benefits

    The final rule amends device regulations describing the number of
copies firms must submit with a premarket presubmission or submission.
The final rule also amends all device regulations containing a
reference to the specific form of a submission to require a submission
in electronic format. The final rule will produce cost savings for
firms without imposing any additional regulatory burdens for
submissions or affecting the Agency's ability to review submissions.
Firms will incur minimal administrative costs to read and understand
the rule. We expect the economic impact of this regulation to be a
total net costs savings yielding positive net benefits.
    We estimate that the final rule will result in annualized benefits
of $1.76 million at a 3 percent discount rate and $1.76 million at a 7
percent discount rate, over 10 years. We also estimate that the final
rule will result in annualized costs of $0.75 million at a 3 percent
discount rate and $0.87 million at a 7 percent discount rate, over 10
years.

   II--Table of Abbreviations/Commonly Used Acronyms in This Document
------------------------------------------------------------------------
    Term,  abbreviation,  or acronym              What it means
------------------------------------------------------------------------
510(k).................................  Premarket Notification.
Agency.................................  Food and Drug Administration.
CFR....................................  Code of Federal Regulations.
eCopy..................................  Submissions created and
                                          submitted on CD, DVD, or flash
                                          drive and mailed to FDA.
eSubmissions...........................  Submission package produced by
                                          an electronic submission
                                          template.
EO.....................................  Executive Order.
FD&C Act...............................  Federal Food, Drug, and
                                          Cosmetic Act, 21 U.S.C. 301 et
                                          seq.
FDA....................................  Food and Drug Administration.
FDARA..................................  FDA Reauthorization Act of 2017
                                          (Pub. L. 115-52).
FDASIA.................................  Food and Drug Administration
                                          Safety and Innovation Act
                                          (Pub. L. 112-144).
HDE....................................  Humanitarian Device Exemption.
IDE....................................  Investigational Device
                                          Exemption
PMA....................................  Premarket Approval Application.
------------------------------------------------------------------------

II. Background

A. Need for the Regulation/History of the Rulemaking

    On February 24, 2017, E.O. 13777, ``Enforcing the Regulatory Reform
Agenda'' was issued. One of the provisions in the E.O. requires
Agencies to evaluate existing regulations and make recommendations to
the Agency head regarding their repeal, replacement, or modification,
consistent with applicable law. As part of this initiative, FDA is
updating regulations as specified in this final rule.
    FDA's current medical device regulations that require multiple
copies and paper submissions predate the authority provided to FDA in
the FD&C Act to require submissions in electronic format (see 21 CFR
parts 807, 812, and 814 and section 745A of the FD&C Act).
    The FD&C Act was amended by the Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L. 112-144) (see section 745A(b) of
the FD&C Act and section 1136 of FDASIA). The amendments in FDASIA
provided that after FDA issued guidance on the submission of electronic
copies (eCopies), the submission of eCopies would be required for
presubmissions and submissions and any supplements to these
presubmissions and submissions for medical devices. (For sections
requiring submission, see sections 510(k), 513(f)(2)(A), 515(c), (d)
and (f), 520(g) and (m), and 564 of the FD&C Act (21 U.S.C. 360(k),
360c(f)(2)(A), 360e(c), (d) and (f), 360j(g) and (m), and 360bbb-3 or
section 351 of the Public Health Service Act (42 U.S.C. 262).) Congress
granted explicit statutory authorization to FDA to implement eCopy
requirements by providing through guidance the standards and criteria
for waivers and exemptions (section 745(b)(1) and (2) of the FD&C Act).
    On January 2, 2013, FDA published the guidance entitled ``eCopy
Program for Medical Device Submissions'' (eCopy guidance). The issuance
of the eCopy guidance marked the beginning of the eCopy program. The
2013 guidance was superseded by an updated guidance of the same title
issued on December 3, 2015. The eCopy guidance recommends that one
paper copy should be submitted, and that any additional copies required
under the regulations be submitted as eCopies. While the eCopy guidance
did not change the overall number of copies required for any
submission, the guidance states that eCopies should be provided in lieu
of some of the paper copies. The guidance also outlines other
requirements for eCopies. The eCopy

guidance provides instructions for the processing and technical
standards for eCopies based on FDA's experience with the program (Ref.
1).
    In 2017, the FD&C Act was amended by the FDA Reauthorization Act of
2017 (FDARA) (Pub. L. 115-52) (see section 745A(b)(3) of the FD&C Act
and section 207 of FDARA). The amended provisions in the FD&C Act
require presubmissions and submissions (the same types of submissions
as required eCopies), any supplements to such presubmissions or
submissions for devices, and any appeals of action taken with respect
to such presubmissions or submissions, including devices under the
Public Health Service Act, to be submitted solely in electronic format
as specified by FDA in guidance (section 745A(b)(3) of the FD&C Act).
    FDA is amending current medical device regulations that require
multiple copies and paper submissions to improve the efficiency of the
review process by allowing immediate availability of an electronic
version for review, rather than relying solely on the paper version.
Because a submission in electronic format is easily reproducible, the
requirement for multiple copies (whether in electronic format or paper
form) is no longer necessary. Furthermore, FDA believes it is
beneficial to the public to limit any burdens and expenses to
submitters caused by requiring additional copies.
    In the Federal Register of September 13, 2018 (83 FR 46444), FDA
issued a proposed rule entitled ``Medical Device Submissions: Amending
Premarket Regulations That Require Multiple Copies and Specify Paper
Copies To Be Allowed in Electronic Format'' and requested public
comments by December 12, 2018.
    FDA believes this rule will result in meaningful burden reduction
while allowing the Agency to achieve our public health mission and
fulfill statutory obligations.

B. Summary of Comments to the Proposed Rule

    In response to the proposed rule, FDA received 14 comments--from
industry organizations, individuals, and anonymous. The comments on the
proposed rule were all generally supportive of the proposed amendments
regarding submissions in electronic format. Commenters expressed that
premarket submissions in electronic format will make the process more
efficient, faster, lower the costs, and promote innovation as well as
speed up accessibility for patient care. Commenters also noted that the
submissions in electronic format will reduce paper, errors and allow
storage and easy access to submissions. One of the commenters suggested
including additional regulations for submissions in electronic format
and recommended corresponding changes to the proposed amendments.

C. General Overview of the Final Rule

    FDA is issuing this final rule to amend regulations for medical
device premarket submissions to remove the requirements for multiple
copies of submissions and to instead require a single submission in
electronic format. The revised submissions include premarket
notification submissions (510(k) submissions) (Sec.  807.90);
confidentiality of information certification (Sec.  807.95);
investigational device exemption applications (Sec.  812.20); PMAs
(Sec.  814.20), including PMA supplements (Sec.  814.39); and
humanitarian device exemption applications (Sec.  814.104). This final
rule also affects submissions for CBER regulated devices.
    This final rule will also amend the regulations that identify FDA's
mailing addresses for submissions by replacing those addresses with
website addresses for CDRH and CBER that provide the current mailing
addresses.
    The submission of an eCopy is separate and distinct from FDA's
electronic submission programs (eSubmitter), which include the CDRH's
510(k) eSubmissions Pilot Program (79 FR 24732, May 1, 2014).
Nevertheless, FDA considers both eCopies, submissions created and
submitted on a CD, DVD, or flash drive and mailed to FDA, and
eSubmissions, submission package produced by an electronic submission
template, to be submissions in electronic format. While eCopy provides
for submissions to be in electronic format, the eCopy submissions must
still be mailed to FDA. By contrast, eSubmitter allows for electronic
submissions to be transmitted over the internet. FDA has been moving
toward transforming all regulatory submissions from mailed copies to
electronic means via the internet. Since January 1999, FDA has accepted
voluntary electronic submissions through eSubmitter. FDA presently
utilizes the Electronic Submission Gateway for the receipt and
processing of many types of electronic regulatory submissions (Ref. 2).

IV. Legal Authority

    FDA is issuing this final rule from the same authority under which
FDA initially issued these regulations: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 360h-360j, 360c-360j, 360bbb-8b, 371, 372, 373, 374,
375, 379, 379e, 381, 382, 393; 42 U.S.C. 216, 241, 262, 263b-263n, 264,
271. In addition, section 745A of the FD&C Act provides FDA authority
with respect to electronic format for submissions and any appeals, and
section 701(a) of the FD&C Act grants FDA general rulemaking authority
to issue regulations for the efficient enforcement of the FD&C Act.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    In response to the proposed rule announcing FDA's intent to amend
requirements for medical device premarket submissions to remove paper
and multiple copies and replace them with requirements for a single
submission in electronic format, FDA received 14 comments--from
industry organizations, individuals, and anonymous.
    We describe and respond to the comments in section V.B. We have
numbered each comment to help distinguish between different comments.
We have grouped similar comments under the same number for purposes of
our responses. The number assigned to each comment or comment topic is
purely for organizational purposes and does not signify the comment's
value or importance or the order in which comments were received.

B. Description of Comments and FDA Response

    Several commenters made general remarks supporting the proposed
rule without focusing on a particular proposed provision. In the
following paragraphs, we discuss and respond to such general comments
as well as more specific comments.
    (Comment 1) Several commenters were supportive of the
implementation of the proposed amendments to regulations on medical
device submissions to remove requirements for paper and multiple copies
and replace them with requirements for a single submission in
electronic format. The commenters suggested that single copy
submissions in electronic format will be easier, improve efficiency of
the review process, reduce paper, costs, errors, and support
innovation. The commenters also suggested that submissions in
electronic format will provide easy storage and access to records and
reduce the time for creating the submissions. Most of the commenters
did not suggest any further edits to the proposed rule. A commenter
suggested assigning IDs or reference numbers to each product to

advance post market surveillance of medical devices.
    (Response 1) FDA agrees with the commenters that submission in
electronic format will improve the efficiency with lower costs and
easier storage and access to records. Regarding the comment related to
the ID/reference numbers, FDA did not modify the final rule based on
this comment as it is outside the scope of the requirement for a single
submission in electronic format. Accordingly, in response to this
comment, FDA did not make any changes in the final rule.
    (Comment 2) A commenter supported the implementation of the rule
but also suggested that electronic submissions be made via the
internet, in an Extensible Markup Language (XML) format. The commenter
suggested that FDA should be developing specifications for industry
submission authoring software that would integrate directly into FDA's
review platform; the commenter explained that this type of submission
authoring software could create elements of structured data within a
submission.
    (Response 2) In response, FDA acknowledges the advantages of
electronic submissions. FDA notes that the rule is written broadly
enough to permit electronic submissions and allow for structured data
when such platforms are available. Accordingly, we have made no change
in the final rule.
    (Comment 3) A commenter suggested applying a logical and least
burdensome approach in all FDA guidances, regulatory decisions, and
administrative processes. The commenter further indicated that they
supported removing paper and multiple copies and replacing them with a
single submission in electronic format.
    (Response 3) FDA acknowledges this comment and agrees that the
least burdensome principles should be considered in all FDA guidances,
regulatory decisions and administrative processes (Ref. 3). FDA
believes this final rule limits any burdens and expenses to submitters
caused by requiring multiple copies of a submission. Accordingly, in
response to this comment, FDA did not make any changes in the final
rule.
    (Comment 4) A commenter acknowledged the benefits of the rule and
supported implementation with a recommendation to amend the rule and
include additional regulations within the scope and description of the
rule. Specifically, the commenter proposed revising FDA's regulation
for devices to remove the requirement for multiple copies of
submissions and to instead require one electronic version for those
regulations noted in the proposed rule in addition to the following:
Content and format of a 510(k) summary (Sec.  807.92); content and
format of a 510(k) statement (Sec.  807.93); format of a class III
certification (Sec.  807.94); supplemental applications (Sec.  812.35);
reports (Sec.  812.150); reports (Sec.  814.84); PMA amendments and
submitted PMAs (Sec.  814.37); and post approval requirements and
reports (Sec.  814.126).
    (Response 4) FDA agrees with the commenter that this rule should
apply to all premarket regulatory submissions that are specified in
section 745A(b) of the FD&C Act. The requirement for a single
submission in electronic format applies to all submission types that
fall within the provisions listed in section 745A(b) of the FD&C Act;
under this final rule, FDA is only amending those regulations that
specifically mention paper and/or multiple copies of such regulatory
submissions and are not consistent with this final rule. Any
regulations that are currently silent on the method for submitting such
regulatory submissions to the FDA will not be modified as they remain
consistent with the final rule. Accordingly, in response to this
comment, FDA did not make any changes in the final rule.

VI. Effective Date

    The final rule will become effective 30 days after the date of
publication in the Federal Register.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under E.O. 12866,
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
E.O.s 12866 and 13563 direct us to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). E.O. 13771 requires that
the costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' We believe that this
final rule is not a significant regulatory action as defined by E.O.
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the final rule amends the existing premarket
regulations requiring multiple copies and paper submissions to instead
require submissions in electronic format without imposing any new
requirements, we certify that the final rule will not have a
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $154 million, using the most current (2018) Implicit
Price Deflator for the Gross Domestic Product. This final rule will not
result in an expenditure in any year that meets or exceeds this amount.
    This final rule will amend the device regulations describing the
number of copies firms must submit with a premarket presubmission or
submission. The final rule will also amend all device regulations
containing a reference to the specific form of a submission media
(i.e., paper copies) to require a submission in electronic format. The
final rule will produce cost-savings for firms without imposing any
additional regulatory burdens for submissions or affecting the Agency's
ability to review submissions. Firms will incur minimal administrative
costs to read and understand the rule. We expect the economic impact of
this regulation to be a total net costs savings yielding positive net
benefits.
    We have developed a comprehensive final Economic Analysis of
Impacts that assesses the impacts of the final rule. The full analysis
of economic impacts is available in the docket for this final rule
(Ref. 4) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

Summary of Costs and Benefits

    Table 1 summarizes the benefits, costs, and distributional effects
of the final rule. We estimate that the final rule will result in
annualized net benefits of $1.76 million with a 3 percent discount rate
and $1.76 million with a 7 percent discount rate, over 10 years. We
also estimate that the final rule will result in annualized costs of
$0.75 million at a 3 percent discount rate and $0.87 million at a 7
percent discount rate, over 10 years.

                                      Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/          $1.76       $0.63       $3.73        2017           7          10  Benefits are cost savings.
     year.                                    1.76        0.63        3.73        2017           3          10  Benefits are cost savings.
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7  ..........
                                        ..........  ..........  ..........  ..........           3  ..........
                                       ------------------------------------------------------------------------
    Qualitative.......................

--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/           0.87        0.87        0.87        2017           7          10
     year.                                    0.75        0.75        0.75        2017           3          10
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7  ..........
                                        ..........  ..........  ..........  ..........           3  ..........
                                       ------------------------------------------------------------------------
    Qualitative.......................

--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized        ..........  ..........  ..........  ..........           7  ..........
     $millions/year.                    ..........  ..........  ..........  ..........           3  ..........
                                       ------------------------------------------------------------------------
                                        From:
                                        To:
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........  ..........           7  ..........
     $millions/year.                    ..........  ..........  ..........  ..........           3  ..........
                                       ------------------------------------------------------------------------
                                        From:
                                        To:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with E.O. 13771, in Table 2 we present annualized values of
costs and cost savings over an infinite time horizon. With a 7 percent
discount rate, the estimated annualized net cost-savings equal $1.31
million in 2016 dollars over an infinite horizon. Based on these cost
savings, this final rule, is considered a deregulatory action under
E.O. 13771.

 Table 2--Summary of the Executive Order 13771 Impacts of the Final Rule
                      Over an Infinite Time Horizon
                            [2016 $ millions]
------------------------------------------------------------------------
                                              Primary         Primary
                                          estimate  (7%)  estimate  (3%)
------------------------------------------------------------------------
Present Value of Costs..................           $6.43           $6.43
Present Value of Cost Savings...........           26.45           59.40
Present Value of Net Costs..............         (20.01)         (52.97)
Annualized Costs........................            0.42            0.19
Annualized Cost Savings.................            1.73            1.73
Annualized Net Costs....................          (1.31)          (1.54)
------------------------------------------------------------------------
Note: Values in parentheses denote net negative costs (i.e., cost-
  savings).

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and 25.34(a) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

IX. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no collection of
information subject to review by the Office of Management and Budget
under the Paperwork Reduction Act of 1995. Rather, the final rule
removes requirements to submit multiple paper copies of certain medical
device presubmissions and submissions and replaces them with one copy
in an electronic format.

X. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in E.O. 13132. FDA has determined that the rule does not
contain policies that have substantial direct effects on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. Accordingly, we conclude that the rule does not contain
policies that have federalism implications as defined in the E.O. and,
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this final rule in accordance with the principles
set forth in E.O. 13175. We have determined that the rule does not
contain policies that would have a substantial direct effect on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the

Executive Order and, consequently, a tribal summary impact statement is
not required.

XII. References

    The following references are on display at Dockets Management Staff
(see ADDRESSES) and are available for viewing by interested persons
between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

    1. ``eCopy Program for Medical Device Submissions; Guidance for
Industry and Food and Drug Administration Staff'' available at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions.
    2. Electronic Submission Gateway procedure for electronic
regulatory submission is available at: https://www.fda.gov/industry/electronic-submissions-gateway/about-esg.
    3. ``The Least Burdensome Provisions: Concept and Principles;
Guidance for Industry and Food and Drug Administration Staff''
available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles.
    4. Economic impacts analysis for this final rule available at:
https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/medical-device-submissions-amending-premarket-regulations-require-multiple-copies-and-specify-paper.

List of Subjects

21 CFR Part 807

    Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
parts 807, 812, and 814 are amended as follows:

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

0
1. The authority citation for part 807 is revised to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.

0
2. Amend Sec.  807.90 by revising paragraph (a), removing and reserving
paragraph (b), and revising paragraph (c) to read as follows:

Sec.  807.90  Format of a premarket notification submission.

* * * * *
    (a)(1) For devices regulated by the Center for Devices and
Radiological Health, be addressed to the current address displayed on
the website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation
and Research, be addressed to the current address displayed on the
website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm; or for devices
regulated by the Center for Drug Evaluation and Research, be addressed
to the Central Document Room, Center for Drug Evaluation and Research,
Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD
20705-1266. Information about devices regulated by the Center for
Biologics Evaluation and Research is available at https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/default.htm.
    (3) All inquiries regarding a premarket notification submission
should be sent to the address in this section or one of the current
addresses displayed on the Food and Drug Administration's website.
* * * * *
    (c) Be submitted as a single version in electronic format.
* * * * *

0
3. Amend Sec.  807.95 by revising paragraph (b)(1) introductory text to
read as follows:

Sec.  807.95  Confidentiality of information.

* * * * *
    (b) * * *
    (1) The person submitting the premarket notification submission
requests in the submission that the Food and Drug Administration hold
as confidential commercial information the intent to market the device
and submits a certification to the Commissioner:
* * * * *

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
4. The authority citation for part 812 is revised to read as follows:

    Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42
U.S.C. 216, 241, 262, 263b-263n.

0
5. Amend Sec.  812.19 by revising paragraphs (a)(1) and (2) to read as
follows:

Sec.  812.19  Addresses for IDE correspondence.

    (a) * * *
    (1) For devices regulated by the Center for Devices and
Radiological Health, send it to the current address displayed on the
website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *

0
6. Amend Sec.  812.20 by revising paragraph (a)(3) to read as follows:

Sec.  812.20  Application.

    (a) * * *
    (3) A sponsor shall submit a signed ``Application for an
Investigational Device Exemption'' (IDE application), together with
accompanying materials in electronic format, to one of the addresses in
Sec.  812.19, and if eCopy by registered mail or by hand. Subsequent
correspondence concerning an application or a supplemental application
shall be submitted in electronic format and if eCopy by registered mail
or by hand.
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
7. The authority citation for part 814 is revised to read as follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b,
371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

0
8. Amend Sec.  814.20 by:
0
a. Revising paragraph (b) introductory text and paragraph (b)(2);
0
b. Removing the phrase ``of the act'' and adding in its place ``of the
Federal Food, Drug, and Cosmetic Act'' in paragraphs (b)(5)
introductory text, (b)(5)(i), and (b)(10);

0
c. Removing the comma at the end of paragraph (b)(5)(i) and adding a
semicolon in its place;
0
d. Revising paragraphs (c) and (e) introductory text;
0
e. Removing the commas at the ends of paragraphs (e)(1) and (2) and
adding semicolons in their place; and
0
f. Revising paragraphs (f) and (h)(1) and (2).
    The revisions read as follows:

Sec.  814.20  Application.

* * * * *
    (b) Unless the applicant justifies an omission in accordance with
paragraph (d) of this section, a PMA shall include in electronic
format:
* * * * *
    (2) A table of contents that specifies the volume and page number
for each item referred to in the table. A PMA shall include separate
sections on nonclinical laboratory studies and on clinical
investigations involving human subjects. A PMA shall be submitted as a
single version. The applicant shall include information that it
believes to be trade secret or confidential commercial or financial
information in the PMA and identify the information that it believes to
be trade secret or confidential commercial or financial information.
* * * * *
    (c) Pertinent information in FDA files specifically referred to by
an applicant may be incorporated into a PMA by reference. Information
in a master file or other information submitted to FDA by a person
other than the applicant will not be considered part of a PMA unless
such reference is authorized in a record submitted to FDA by the person
who submitted the information or the master file. If a master file is
not referenced within 5 years after the date that it is submitted to
FDA, FDA will return the master file to the person who submitted it.
* * * * *
    (e) The applicant shall periodically update its pending application
with new safety and effectiveness information learned about the device
from ongoing or completed studies that may reasonably affect an
evaluation of the safety or effectiveness of the device or that may
reasonably affect the statement of contraindications, warnings,
precautions, and adverse reactions in the draft labeling. The update
report shall be consistent with the data reporting provisions of the
protocol. The applicant shall submit any update report in electronic
format and shall include in the report the number assigned by FDA to
the PMA. These updates are considered to be amendments to the PMA. The
time frame for review of a PMA will not be extended due to the
submission of an update report unless the update is a major amendment
under Sec.  814.37(c)(1). The applicant shall submit these reports--
* * * * *
    (f) If a color additive subject to section 721 of the Federal Food,
Drug, and Cosmetic Act is used in or on the device and has not
previously been listed for such use, then, in lieu of submitting a
color additive petition under part 71 of this chapter, at the option of
the applicant, the information required to be submitted under part 71
may be submitted as part of the PMA. When submitted as part of the PMA,
the information shall be submitted in electronic format. A PMA for a
device that contains a color additive that is subject to section 721 of
the Federal Food, Drug, and Cosmetic Act will not be approved until the
color additive is listed for use in or on the device.
* * * * *
    (h) * * *
    (1) For devices regulated by the Center for Devices and
Radiological Health, send it to the current address displayed on the
website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *

0
9. Amend Sec.  814.39 by revising paragraph (c)(1) to read as follows:

Sec.  814.39  PMA supplements.

* * * * *
    (c)(1) All procedures and actions that apply to an application
under Sec.  814.20 also apply to PMA supplements except that the
information required in a supplement is limited to that needed to
support the change. A summary under Sec.  814.20(b)(3) is required for
only a supplement submitted for new indications for use of the device,
significant changes in the performance or design specifications,
circuits, components, ingredients, principles of operation, or physical
layout of the device, or when otherwise required by FDA. The applicant
shall submit a PMA supplement in electronic format and shall include
information relevant to the proposed changes in the device. A PMA
supplement shall include a separate section that identifies each change
for which approval is being requested and explains the reason for each
such change. The applicant shall submit additional information, if
requested by FDA, in electronic format. The time frames for review of,
and FDA action on, a PMA supplement are the same as those provided in
Sec.  814.40 for a PMA.
* * * * *

0
10. Amend Sec.  814.104 by revising paragraphs (d) introductory text
and (d)(1) and (2) to read as follows:

Sec.  814.104  Original applications.

* * * * *
    (d) Address for submissions and correspondence. All original HDEs,
amendments and supplements, as well as any correspondence relating to
an HDE, must be provided in electronic format. These materials must be
sent or delivered to one of the following:
    (1) For devices regulated by the Center for Devices and
Radiological Health, send it to the current address found on the
website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *

    Dated: December 9, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-27047 Filed 12-13-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: July 20, 2006 (Volume 71, Number 139)]
[Notices]
[Page 41282-41283]
[DOCID:fr20jy06-91]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension: Rule 17Ac2-2; SEC File No. 270-298; OMB Control No. 3235-
0337; Form TA-2; SEC File No. 270-298; OMB Control No. 3235-0337.

    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 a request for extension of the previously approved
collection of information discussed below.

Rule 17Ac2-2 and Form TA-2; OMB Control No. 3235-0337; SEC File No.
270-298

    Rule 17Ac2-2 (17 CFR 240.17Ac2-2) and Form TA-2 (15 CFR 249b.102)
under the Securities Exchange Act of 1934 (17 U.S.C. 78a et seq.)
require transfer agents to file an annual report of their business
activities with the Commission. The amount of time needed to comply
with the requirements of Rule 17Ac2-2 and Form TA-2 varies. From the
total 786 registered transfer agents, approximately 197 registrants
would be required to complete only Questions 1 through 4 and the
signature section of amended Form TA-2, which we estimate would take
each registrant about 30 minutes, for a total burden of 99 hours (197 x
.5 hours). Approximately 262 registrants would be required to answer
Questions 1 through 5, 10, and 11 and the signature section, which we
estimate would take about 1 hour and 30 minutes, for a total of 393
hours (262 x 1.5 hours). The remaining registrants, approximately 327,
would be required to complete the entire Form TA-2, which we estimate
would take about 6 hours, for a total of 1,962 hours (327 x 6 hours).
We estimate that the total burden would be 2,454 hours (99 hours + 393
hours + 1,962 hours).
    We estimate that the total cost of reviewing and entering the
information reported on the Forms TA-2 for respondents is $31.50 per
hour. The Commission estimates that the total cost would be $77,301.00
annually ($31.50 x 2,454).
    Rule 17Ac2-2 does not involve the collection of confidential
information. Please note that an agency may not conduct or sponsor, and
a person is not required to respond to, a collection of information
unless it displays a currently valid control number.
    General comments regarding the estimated burden hours should be
directed to the following persons: (i) David Rostker, Desk Officer for
the

Securities and Exchange Commission, Office of Information and
Regulatory Affairs, Office of Management and Budget, Room 10102, New
Executive Office Building, Washington, DC 20503 or by sending an e-mail
to<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, Virginia 22312; or by
sending an e-mail to<EMAIL_ADDRESS>Comments must be submitted
to OMB within 30 days of this notice.

     Dated: June 29, 2006
J. Lynn Taylor,
Assistant Secretary.
 [FR Doc. E6-11498 Filed 7-19-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Notices]
[Pages 76998-76999]
[FR Doc No: 2014-29951]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14635-000]

Village of Gouverneur; Notice of Intent To File License
Application, Filing of Pre-Application Document, Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 14635-000.
    c. Date Filed: September 10, 2014.
    d. Submitted By: Village of Gouverneur.
    e. Name of Project: Gouverneur Hydroelectric Project.
    f. Location: On the Oswegatchie River, in St. Lawrence County, New
York. No federal lands are occupied by the project works or located
within the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Robert Leader, Case & Leader LLP,
107 East Main Street, Gouverneur, NY 13642;<PHONE_NUMBER>.
    i. FERC Contact: Jody Callihan at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>

    j. Village of Gouverneur (Gouverneur) filed its request to use the
Traditional Licensing Process on September 10, 2014. Gouverneur
provided public notice of its request on September 12, 2014. In a
letter dated December 16, 2014, the Director of the Division of
Hydropower Licensing approved Gouverneur's request to use the
Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service under section 7 of the Endangered
Species Act and the joint agency regulations thereunder at 50 CFR, part
402. We are also initiating consultation with the New York State
Historic Preservation Officer, as required by section 106, National
Historic Preservation Act, and the implementing regulations of the
Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. Gouverneur filed a Pre-Application Document (PAD; including a
proposed process plan and schedule) with the Commission, pursuant to 18
CFR. 5.6 of the Commission's regulations.
    m. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the offices of the Village of Gouverneur, 33 Clinton Street,
Gouverneur, NY 13642.
    n. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

     Dated: December 16, 2014.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-29951 Filed 12-22-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Rules and Regulations]
[Pages 8650-8654]
[FR Doc No: 2016-03490]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0379; FRL-9942-54-Region 5]

Air Plan Approval; Indiana; Particulate Matter Emissions Limits
Revision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: Under the Clean Air Act (CAA), the Environmental Protection
Agency (EPA) is approving a June 1, 2015, request by Indiana to revise
the State Implementation Plan (SIP) to incorporate changes to the
particulate matter (PM) rules contained in Title 326 of the Indiana
Administrative Code (IAC). This approval affects sources of PM in the
state of Indiana.

DATES: This direct final rule will be effective April 22, 2016, unless
EPA receives adverse comments by March 23, 2016. If adverse comments
are received, EPA will publish a timely withdrawal of the direct final
rule in the Federal Register informing the public that the rule will
not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0379 at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the Web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Anthony Maietta, Environmental
Protection Specialist, Control Strategies Section, Air Programs Branch
(AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background for this action?
II. What is EPA's analysis of the SIP revision?
III. What action is EPA taking?
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. What is the background for this action?

    On June 1, 2015, the Indiana Department of Environmental Management
(IDEM) submitted a request for EPA to approve revisions to PM rules
contained in 326 IAC 6.5 and 6.8. The revisions to these rules were
published in the May 28, 2015, edition of the Indiana Register. On
January 14, 2015, IDEM held the first of two public hearings on
revisions to these rules. IDEM received comments during its January 14,
2015, public hearing, and IDEM revised its rules in response to those
comments. IDEM's second public hearing was held on March 11, 2015. IDEM
did not receive any comments at its March 11, 2015, public hearing.

II. What is EPA's analysis of the SIP revision?

    Below is a discussion of changes to 326 IAC 6.5:

 Sections 4-2, 4-17 and 4-24

    Revisions to 326 IAC 6.5-4-2 and 326 IAC 6.5-4-17 consolidate the
identification numbers of the Kimball Office facilities in Jasper
Indiana from 00046 and 00042 to 00100. The revision to 326 IAC 6.5-4-24
revises the business name of the regulated source from Styline
Industries, Inc. Plant #8 to OFS Brands, Inc.--Plant #3. These
administrative revisions provide clarity to the existing rule and are
approvable into the Indiana SIP.

 Section 5-2

    Revisions to 326 IAC 6.5-5-2 update the business name of the
regulated source from Chrysler Group to FCA US, and the source
identification number for boiler 4 at the FCA US, LLC Kokomo
Transmission Plant from 00065 to 00078. Additionally, the revision
removes the following units, due to shut down and removal, at the FCA
US, LLC Kokomo Casting Plant: Reverberatory furnaces 1ARF, 1BRF, and
5RF (source identification numbers 2P, 3P, and 7P, respectively).
Overall, the revisions to Section 5-2 are approvable into the Indiana
SIP as they provide clarity to the existing rule, and the removal of
these units will reduce emissions.

 Section 5-5

    A revision to 326 IAC 6.5-5-5 updates the business name of the
regulated source from Delco Electronics Corporation to GM Components
Holdings, LLC.

 Section 6-2

    A revision to 326 IAC 6.5-6-2 removes boilers 1, 2, and 3 from
Allison Transmission due to shut down and removal. Further, a revision
to this section updates the source identification number for this
facility from 00017 to 00310, and consolidates reporting requirements
for this source. Overall, these revisions to Section 6-2 are approvable
into the Indiana SIP as they provide clarity to the existing rule, and
the removal of these units will help reduce emissions.

 Section 6-25 and 6-26

    A revision to Section 6.5-6-25 updates the business name of the
regulated source from National Starch and Chemical Company to Ingredion
Incorporated Indianapolis Plant. A revision to Section 6.6-6-26 updates
the business name of the regulated source from International Truck and
Engine Corporation & Indianapolis Casting Corporation to Navistar, Inc.

 Section 6-33

    A revision to 326 IAC 6.5-6-33 removes Boilers 0070 01 through 0070
04 from the Rolls-Royce Corporation facility due to their shutdown and
removal. In addition, a revision to Paragraph (3)(B) (post-revision,
paragraph (2)(B)) removes coal and adds #4 fuel oil to a list of
operating fuels for the facility. These revisions to Section 6-33 are
approvable into the Indiana SIP as the removal of these units will help
to reduce emissions.
326 IAC 6.8
    Below is a discussion of changes to 326 IAC 6.8:

 Section 2-18

    A revision to 326 IAC 6.8-2-18 removes three units and increases
the PM emission rates (in lbs/hour) for two units at the Jupiter
Aluminum Corporation's facility in Lake County. The aluminum
reverberatory furnaces 3, 4, and 5 were shut down and removed, and the
PM emission rates for the aluminum reverberatory furnaces 2 and 6 were
increased. Specifically, the PM emission rate for the aluminum
reverberatory furnace 2 was increased from 1.137 to 1.499 lbs/hour. The
PM emission rate for the aluminum reverberatory furnace 6 was increased
from 0.970 to 2.008 lbs/hour. The increase in PM emission rates are
offset by the reduction in PM emission rates due to the shut down and
removal of the aluminum reverberatory furnaces 3, 4, and 5. The
revision to this section is approvable into the Indiana SIP.

 Section 2-29

    Revisions to 326 IAC 6.8-2-29 update the business name of the
regulated source from Reed Minerals to Harsco Minerals. The revision
also removes the fluidized bed dryer and its associated PM emission due
to shut down and removal. These revisions to Section 2-29 are
approvable into the Indiana SIP as they provide clarity to the existing
rule, and the shutdown of the fluidized bed dryer will help reduce
emissions.

 Section 2-34

    Revisions to 326 IAC 6.8-2-34 remove one molded pulp dryer; revise
the PM emissions limits for the remaining molded pulp dryers; and
clarify the reporting and recordkeeping requirements for the Huhtamaki
Foodservice, Inc., in Lake County. Specifically, the PM emission rates
for the molded pulp dryers were revised as follows:

--Molded pulp dryer number 1: 0.290 lbs/hour
--Molded pulp dryer number 2: 0.290 lbs/hour
--Molded pulp dryer number 3: 0.342 lbs/hour
--Molded pulp dryer number 4: 0.342 lbs/hour
--Molded pulp dryer number 5: 0.290 lbs/hour
--Molded pulp dryer number 6: 0.290 lbs/hour
--Molded pulp dryer number 8: 0.615 lbs/hour
--Molded pulp dryer number 9: 0.615 lbs/hour
--Molded pulp dryer number 10: 0.615 lbs/hour

    The total facility PM emissions rate for molded pulp dryers remains
capped at 2.41 lbs/hour. Additional recordkeeping and reporting
requirements were included to ensure compliance with the capped PM
emissions rate under any operating scenario. Because this rule revision
retains the capped PM emission rate, and because this rule revision
includes requirements to ensure the facility complies with the PM
emission rates, these revisions are approvable into the Indiana SIP.
The revisions to 326 IAC 6-5 and 6-8 contain wording changes and
additions, improve and expand the applicability of the rule and its
impact on air quality statewide. On balance, EPA finds that the
revisions strengthen the existing SIP in Indiana and as such, deems the
submittal approvable.

III. What action is EPA taking?

    EPA is approving into the Indiana SIP revisions to the PM rules
contained in Title 326 of the Indiana Administrative Code (IAC),
Article 6, Rule 5 (326 IAC 6.5) and Rule 8 (326 IAC 6.8).
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective April 22, 2016
without further notice unless we receive relevant adverse written
comments by March 23, 2016. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
If we do not receive any comments, this action will be effective April
22, 2016.

IV. 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 the Indiana Regulations described in the
amendments to 40 CFR part 52 set forth below. EPA has made, and will
continue to make, these documents generally available electronically
through www.regulations.gov and/or in hard copy at the appropriate EPA
office (see the ADDRESSES section of this preamble for more
information).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action 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);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is 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.);
     Does 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);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is 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
     Does 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).
    In addition, the SIP is 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 rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    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 April 22, 2016. 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: February 3, 2016.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.

    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.

0
2. In Sec.  52.770, the table in paragraph (c) is amended under the
headings entitled ``Article 6.5. Particulate Matter Limitations Except
Lake County'' and ``Article 6.8. Particulate Matter Limitations for
Lake County'' by:
0
i. Removing the entries for Rules 6.5-3-7 and 6.5-3-8 under the
subheading entitled ``Rule 3. Dearborn County''.
0
ii. Revising the entries for Rules 6.5-4-2, 6.5-4-4, 6.5-4-17, and 6.5-
4-24 under the subheading entitled ``Rule 4. Dubois County''.
0
iii. Revising the entries for Rules 6.5-5-2 and 6.5-5-5 under the
subheading entitled ``Rule 5. Howard County''.
0
iv. Revising the entries for Rules 6.5-6-2, 6.5-6-25, 6.5-6-26, and
6.5-6-33, and removing the entries for Rules 6.5-6-3 and 6.5-6-15 under
the subheading entitled ``Rule 6. Marion County''.
0
v. Removing the entry for Rule 6.5-9-8 under the subheading entitled
``Rule 9. Vigo County''.
0
vi. Removing the entry for Rule 6.5-10-6 under the subheading entitled
``Rule 10. Wayne County''.
0
vii. Revising the entries for Rules 6.8-2-18, 6.8-2-29 and 6.8-2-34
under the subheading entitled ``Rule 2. Lake County: PM10
Emission Requirements''.
    The revised text reads as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *

                                                            EPA-Approved Indiana Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Indiana
         Indiana citation                  Subject         effective date             EPA Approval date                             Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Article 6.5. Particulate Matter Limitations Except Lake County
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Rule 4. Dubois County
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
6.5-4-2...........................  Kimball Office--           05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     Jasper 15th Street.                    citation].

                                                                      * * * * * * *
6.5-4-4...........................  DMI Furniture Plant        05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     No. 5.                                 citation].

                                                                      * * * * * * *
6.5-4-17..........................  Kimball Office--           05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     Jasper Cherry Street.                  citation].

                                                                      * * * * * * *
6.5-4-24..........................  Styline Industries,        05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     Inc. Plant #8.                         citation].
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Rule 5. Howard County
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
6.5-5-2...........................  Chrysler, LLC-Kokomo       05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     Casting Plant and                      citation].
                                     Kokomo Transmission
                                     Plant.
6.5-5-5...........................  Delco Electronics          05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     Corporation.                           citation].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Rule 6. Marion County
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
6.5-6-2...........................  Allison Transmission.      05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                                                            citation].

                                                                      * * * * * * *
6.5-6-25..........................  National Starch and        05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     Chemical Company.                      citation].
6.5-6-26..........................  International Truck        05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     and Engine                             citation].
                                     Corporation &
                                     Indianapolis Casting
                                     Corporation.

                                                                      * * * * * * *
6.5-6-33..........................  Rolls-Royce                05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     Corporation.                           citation].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Article 6.8. Particulate Matter Limitations for Lake County
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Rule 2. Lake County: PM10 Emission Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
6.8-2-18..........................  Jupiter Aluminum           05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     Corporation.                           citation].

                                                                      * * * * * * *
6.8-2-29..........................  Reed Minerals-Plant        05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     #14.                                   citation].

                                                                      * * * * * * *
6.8-2-34..........................  Huhtamaki                  05/29/2015  02/22/2016, [insert Federal Register     ....................................
                                     Foodservice, Inc..                     citation].

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

* * * * *
[FR Doc. 2016-03490 Filed 2-19-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Page 33453]
[FR Doc No: 2013-13191]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.
Extension:
    Rule 31 and Form R31, SEC File No. 270-537, OMB Control No.
3235-0597.

    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'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Section 31 of the Securities Exchange Act of 1934 (15 U.S.C. 78ee)
(``Exchange Act'') requires the Commission to collect fees and
assessments from national securities exchanges and national securities
associations (collectively, ``self-regulatory organizations'' or
``SROs'') based on the volume of their securities transactions. To
collect the proper amounts, the Commission adopted Rule 31 (17 CFR
240.31) and Form R31 (17 CFR 249.11) under the Exchange Act whereby the
SROs must report to the Commission the volume of their securities
transactions and the Commission, based on that data, calculates the
amount of fees and assessments that the SROs owe pursuant to Section
31. Rule 31 and Form R31 require the SROs to provide this data on a
monthly basis.
    Currently, there are 22 respondents under Rule 31: 17 national
securities exchanges, two security futures exchanges, and one national
securities association subject to the collection of information
requirements of Rule 31; there are additionally two registered clearing
agencies that are required to provide certain data in their possession
needed by the SROs to complete Form R31, although these two entities
are not themselves required to complete and submit Form R31. The
Commission estimates that the total burden for all 22 respondents is
366 hours per year. The Commission notes that, based on previous and
current experience, it estimates an additional two new national
securities exchanges will become registered and subject to the
reporting requirements of Rule 31 over the course of the authorization
period.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.
    Please direct your written comments to: Thomas Bayer, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, Virginia, 22312 or
send an email to<EMAIL_ADDRESS>
     Dated: May 30, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-13191 Filed 6-3-13; 8:45 am]
BILLING CODE 8011-01-P