[Federal Register Volume 77, Number 171 (Tuesday, September 4, 2012)]
[Notices]
[Pages 53952-53955]
[FR Doc No: 2012-21678]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67740; File No. SR-NYSEMKT-2012-37]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending NYSE MKT Rules
103B(IX)--Equities and 504--Equities To Provide That a Designated
Market Maker Unit May Trade at the Same Panel Securities Traded on the
Exchange and/or Securities Listed on the New York Stock Exchange LLC

August 28, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on August 22, 2012, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to

solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE MKT Rules 103B(IX)--Equities
and 504--Equities to provide that a Designated Market Maker (``DMM'')
unit may trade at the same panel securities traded on the Exchange and/
or securities listed on the New York Stock Exchange LLC (``NYSE''). The
text of the proposed rule change is available on the Exchange's Web
site at www.nyse.com, at the principal office of the Exchange, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend NYSE MKT Rules 103B- Equities
(``Rule 103B'') and 504--Equities (``Rule 504'') to provide that a DMM
unit may trade at the same panel securities traded at the Exchange and/
or securities listed on the NYSE.
    Background
    Rule 103B(IX) currently provides that securities listed on the
Exchange or admitted to dealings on the Exchange pursuant to a grant of
unlisted trading privileges, i.e., Nasdaq Securities,\3\ (collectively,
``Exchange-traded securities'') shall be assigned for trading only at
panels exclusively designated for trading securities on the Exchange.
The rule further provides that ``DMM units may only trade securities
listed on the Exchange or admitted to dealings on the Exchange pursuant
to a grant of unlisted trading privileges at panels exclusively
designated for trading securities on the Exchange.'' In practice, this
means that a DMM panel designated for trading in Exchange-traded
securities may not also be assigned securities listed on the New York
Stock Exchange, LLC (``NYSE'').\4\ This rule was adopted in 2008, when
the Exchange moved from the 86 Trinity Place location and trading
systems to 11 Wall Street and the NYSE trading systems,\5\ and amended
in 2010 when the Exchange began trading Nasdaq Securities.\6\ At the
time, the Exchange proposed that Exchange-traded Securities be traded
at separate panels designated for trading in NYSE securities to prevent
any potential confusion between Exchange and NYSE rules.
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    \3\ See Exchange Rule 501(c)--Equities.
    \4\ The restriction on trading Exchange-traded securities and
NYSE-listed securities at the same panel is only in Exchange rules;
NYSE rules do not have a counterpart.
    \5\ See Securities Exchange Act Release No. 58705 (Oct 1, 2008),
73 FR 58995 (Oct. 8. 2008) (SR-Amex-2008-63).
    \6\ See Securities Exchange Act Release No. 62479 (July 9,
2010), 75 FR 41264 (July 15, 2010) (SR-NYSEAmex-2010-31) (Amending
Rule 103B to permit trading of Exchange-traded securities on posts
throughout the Trading Floor).
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    Rule 504(b)(6) further provides that DMM units registered on both
the Exchange and the NYSE must commit staff, including DMMs and clerks,
for the trading of NYSE-listed securities separate from that for the
trading of Exchange-listed securities and/or Nasdaq Securities. The
rule further provides that ``[i]ndividual DMMs and support staff will
not be permitted to trade NYSE-listed securities together with
Exchange-listed securities and/or Nasdaq Securities at the same time.''
Rule 504(d) also provides that, in accordance with Rule 103B(IX),
Nasdaq Securities shall be allocated for trading only at panels
exclusively designated for trading Nasdaq Securities and/or securities
listed on the Exchange.
    As a result of these rule requirements, DMM units that are
registered in both Exchange-traded securities and NYSE-listed
securities must maintain separate panels and staff for NYSE-listed
securities. In addition, Exchange DMM units must maintain separate
panels and staff for Nasdaq Securities, separate from Exchange-listed
securities.
Proposed Amendments
    The Exchange proposes to eliminate the restrictions on a DMM unit
trading Exchange-listed, Nasdaq Securities, and NYSE-listed securities
at the same panel. To effect this change, the Exchange proposes to
amend Rule 103B(IX) to provide that Exchange-traded securities may be
assigned to panels that also trade NYSE-listed securities, delete Rule
504(b)(6), and amend Rule 504(d) to provide that Nasdaq Securities may
be allocated to DMM units for trading at panels that also trade
Exchange-listed and/or NYSE-listed securities.
    The Exchange notes that even if Exchange-traded securities and
NYSE-listed securities are assigned to a single panel, the Exchange
will keep them on separate Display Book systems. To the extent the
rules applicable to a security differ between the Exchange and NYSE,
the separate Display Book systems will operate in accordance with the
separate rules. In addition, the individual DMMs and clerks will be
able to sign into ID Track simultaneously for both Exchange-traded and
NYSE-listed securities so that the Exchange can continue to track which
securities a DMM and Floor clerk is operating in for a particular
day.\7\
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    \7\ See Exchange Rule 103.11--Equities.
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    The Exchange proposes these changes to reflect the changes in the
trading environment, as compared to 2010, when Rule 504 was adopted and
Rule 103B(IX) was last amended. In particular, the Exchange believes
the changes are warranted because they reflect the changing landscape
for DMM units. In 2010, when the rules relating to trading Nasdaq
Securities were adopted, only one of the DMM units registered to trade
on the Exchange was also registered to trade securities listed on the
NYSE. Now, all DMM units registered to trade on the Exchange are also
registered to trade securities listed on the NYSE. In addition, former
NYSE-only DMM units are now all either registered, or in the process of
registering, to trade Exchange-traded securities. Accordingly, all but
one DMM units that operate on the Trading Floor are now dually-
registered for Exchange-traded and NYSE-listed securities.
    The Exchange notes that the rationale provided in 2010 to maintain
separate panels was to reduce confusion between Exchange and NYSE
rules. However, the Exchange believes that now that DMM units and Floor
broker firms have had two years' experience managing Exchange-traded
and NYSE-listed securities on the Trading Floor, the risk of confusion
among trading rules has been obviated through experience. Accordingly,
the stated need in 2010 to maintain separate panels is no longer
necessary, and is outweighed by the inefficiencies in DMM unit
operations that maintaining separate panels entails.
    The Exchange further notes that the Exchange and NYSE already
operate in an integrated manner on a single physical Trading Floor, and
the proposed change is minimally

incremental. For example, in 2008, when the Exchange moved to its
current location, it adopted a rule that made clear that Exchange-
traded equity securities would be traded on the systems and facilities
of NYSE Market, Inc., which are located at 11 Wall Street and are the
same systems and facilities where NYSE-listed securities trade.\8\ In
recognition of the fact that the Exchange-traded and NYSE-listed
securities would be trading on the same physical space, in 2008, the
Exchange adopted Exchange Rule 2.10--Equities, which provides that any
registered broker dealer that is approved or deemed approved as a
member organization of the NYSE shall be approved as an Exchange member
organization. Similarly, pursuant to Exchange Rule 2.20--Equities, all
natural persons who were approved or deemed approved as a member of the
NYSE, i.e., all NYSE DMMs and Floor brokers, were similarly deemed
approved as members of the Exchange.\9\ Accordingly, as part of the
move of the Exchange to the NYSE facilities, all Floor brokers and DMMs
were approved as member organizations of both the Exchange and the
NYSE. As a practical matter, this meant that Floor brokers were
approved to operate from their Trading Floor booth premises to trade
both Exchange-traded and NYSE-listed securities.
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    \8\ See Exchanges [sic] Rule 0(b) and 0--Equities. In addition,
the Exchange's Equities Trading Floor is defined as the physical
locations commonly known as the ``Main Room'' and the ``Garage'',
which is the same definition of Trading Floor for the NYSE. See
Exchange Rule 6A--Equities and NYSE Rule 6A.
    \9\ NYSE adopted similar rules pursuant to which Exchange member
organizations and members were deemed approved as NYSE member
organizations and members. See NYSE Rules 2.10 and 2.20.
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    With respect to the physical location of DMM units assigned to
Exchange-listed securities, the Exchange notes that in 2008, Exchange-
listed securities were physically located at DMM posts in the
``Garage'' room of the Trading Floor. However, in 2010, when the
Exchange adopted its pilot program to trade Nasdaq Securities, the
Exchange further integrated Exchange-listed securities and Nasdaq
Securities at DMM posts throughout the Trading Floor, which had the
practical effect of moving Exchange-traded securities from the posts
located in the Garage and having them assigned to posts in both the
Main Room and the Garage, at panels that were contiguous with panels
that traded NYSE-listed securities.\10\ The Exchange believes that the
current proposal to permit Exchange-traded and NYSE-listed securities
to trade at a single panel within a post is an incremental change from
the existing physical integration between Exchange and NYSE trading
that raises no new or novel regulatory issues.
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    \10\ See supra footnote 6. In the approval order, the Commission
noted that the integration of Exchange-traded and NYSE-listed
securities trading at the same post was reasonable and consistent
with the Act.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange. In particular,
the Exchange believes that its proposal is consistent with Section 6(b)
of the Act,\11\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\12\ in particular, because it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposal promotes just and equitable
principles of trade because it will remove a restriction that is
applicable only to DMM units. Off-Floor market makers, and Exchange
supplemental liquidity provides [sic], do not have similar
restrictions, and may assign personnel to trade in equity securities
regardless of the listing venue. The Exchange therefore believes that
the proposed rule change would eliminate a restriction that places DMMs
at a competitive disadvantage as compared to off-Floor market
participants. The Exchange further believes that the proposed rule
change removes impediments to and perfects the mechanism of a free and
open market because it would eliminate rule-based requirements that
impose unnecessary restrictions on DMM units that in today's market
environment, serve only to force DMM units to operate in an inefficient
manner, and at a competitive disadvantage to off-Floor market
participants. Rather, the proposed rule change will perfect the
mechanism of a free and open market by assuring that DMM units staff
the securities registered with that DMM unit based on the needs of the
market, rather than on artificial constraints imposed by rule.
    Finally, the Exchange believes that the proposal to further
integrate trading of Exchange-traded and NYSE-listed securities at a
single panel of a DMM post is consistent with the Act because the
Commission has already approved the existing integration to permit
Exchange-traded and NYSE-listed securities to trade at the same DMM
post. The Exchange believes that permitting the securities to trade at
a single panel is an incremental change because currently, Exchange-
traded and NYSE-listed securities can trade at contiguous panels at the
same post. Therefore, the proposed change does not raise any new or
novel regulatory issues.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule

change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please
include File Number SR-NYSEMKT-2012-37 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEMKT-2012-37. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2012-37 and should
be submitted on or before September 25, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-21678 Filed 8-31-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Proposed Rules]
[Pages 8222-8224]
[FR Doc No: 2022-02983]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2020-0684, FRL-9402-01-R10]

Air Plan Approval; OR; Air Contaminant Discharge Permit Fee
Revision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the Oregon State Implementation Plan (SIP)
submitted on November 5, 2020. The revision establishes new fees to be
paid by stationary sources of air contaminants submitting notices of
intent to construct. The revision also adds a new basic air contaminant
discharge permit category to allow certain minor sources, that would
otherwise be required to obtain a general, simple, or standard permit,
the option to qualify for a basic permit.

DATES: Comments must be received on or before March 16, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2020-0684, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from https://www.regulations.gov. The EPA may
publish any comment received to its public docket. Do not
electronically submit any information you consider to be Confidential
Business Information (CBI) or other information the disclosure of which
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. The 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, the full EPA public comment policy, information
about CBI or multimedia submissions, and general guidance on making
effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kristin Hall, EPA Region 10, 1200
Sixth Avenue, Suite 155, Seattle, WA 98101, at<PHONE_NUMBER> or
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, wherever ``we'' or
``our'' is used, it is intended to refer to the EPA.

Table of Contents

I. Background
    A. State Implementation Plan
    B. Air Contaminant Discharge Permits
    C. Source Notification Requirements
II. Evaluation of Submission
III. Proposed Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background

A. State Implementation Plan

    Each state has a State Implementation Plan (SIP) containing the
control measures and strategies used to attain and maintain the
national ambient air quality standards (NAAQS) established by the EPA
for the criteria pollutants (carbon monoxide, lead, nitrogen dioxide,
ozone, particulate matter, sulfur dioxide). Section 110 of the Clean
Air Act spells out the requirements for each SIP, including but not
limited to air pollution control regulations, emissions inventories,
ambient air monitoring, enforcement mechanisms, and authority to revise
the SIP as needed.
    Revisions to the SIP are adopted by the state and submitted to the
EPA for review. The EPA approves and codifies

such SIP revisions as part of the Code of Federal Regulations (CFR),
making them federally enforceable. The Oregon Department of
Environmental Quality, as the Governor's designee, routinely revises
the SIP and submits the changes to the EPA for approval and
codification in 40 CFR part 52, subpart MM.

B. Air Contaminant Discharge Permits

    The Oregon air contaminant discharge permit (ACDP) program is a set
of air pollution control regulations in the Oregon SIP. The ACDP
program serves two SIP-related functions.\1\ First, it governs
operation of minor sources that are not subject to the major stationary
source Title V operating permit program. Second, it serves as the
administrative mechanism used to implement the notice of construction
and pre-construction permit program, also known as the ``new source
review'' program.
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    \1\ We note that the ACDP program serves other functions,
outside of the federally approved Oregon SIP. For example, the ACDP
program is the mechanism used to implement the risk-based toxics
permitting program known as Cleaner Air Oregon. Because the ACDP
program serves other functions, the EPA has approved the ACDP
program into the Oregon SIP only to the extent it applies to (1)
pollutants for which NAAQS have been established (criteria
pollutants) and precursors to those criteria pollutants as
determined by the EPA for the applicable geographic area; and (2)
any additional pollutants that are required to be regulated under
part C of title I of the Clean Air Act (prevention of significant
deterioration of air quality), but only for purposes of meeting or
avoiding the requirements of part C of title I of the Clean Air Act.
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    There are six types of permits in the Oregon ACDP program:
Construction, General, Short-Term Activity, Basic, Simple, and
Standard. Sources seeking permits must pay associated fees based on
specific categories and activities codified in Oregon Administrative
Rules (OAR) Chapter 340, Division 216 and approved into the Oregon SIP.
Oregon has adjusted these permit fees over time to help ensure there
are adequate resources to implement the ACDP program.

C. Source Notification Requirements

    Oregon requires stationary sources to submit notices of intent to
construct for certain types of activities. These notification
requirements are codified in OAR Chapter 340, Division 210 and are
approved into the Oregon SIP. Type 2 notices of intent to construct
generally cover existing sources with issued permits that are seeking
certain minor changes to those permits. Historically, Oregon has not
assessed fees to process these Type 2 notices of intent to construct.

II. Evaluation of Submission

    On November 5, 2020, Oregon submitted a SIP revision addressing
stationary source permitting and associated fees. Oregon subsequently
revised the scope of the SIP revision submitted for EPA approval in a
letter dated December 22, 2021.\2\ The SIP revision makes two
substantive changes. First, the SIP revision adds new fees to process
Type 2 notices of intent to construct. See OAR<PHONE_NUMBER> and 0240.
Second, the SIP revision adds a new Basic ACDP option, available to a
qualifying minor source if that source meets certain criteria,
including taking an enforceable limit on hours of operation and/or
production. See OAR<PHONE_NUMBER> Table 1, Part A, number 8. This second
change allows a source to obtain a Basic ACDP rather than a General,
Simple, or Standard ACDP, provided the source: (1) Is not a federal
major source under Title I or Title V of the Clean Air Act, (2) is not
subject to other source-specific SIP permitting requirements, (3)
requests an enforceable limit on actual, uncontrolled emissions, and
(4) control devices are not required to maintain the enforceable
limit.\3\ The enforceable limit is established in the Basic ACDP and
includes associated monitoring, recordkeeping, and reporting
requirements and any other elements needed to make the limit
practically enforceable.
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    \2\ Oregon clarified that OAR<PHONE_NUMBER>, which includes the
specific fee amounts to be paid by sources, is not submitted for SIP
approval. The letter has been placed in the docket for this action.
    \3\ Functionally, this option allows certain minor sources
otherwise required to obtain a General, Simple, or Standard ACDP
operating permit by virtue of OAR<PHONE_NUMBER> Table 1, Part B,
number 85 to obtain a Basic ACDP. See Footnote 4 to OAR<PHONE_NUMBER>
Table 1, Part B, number 85.
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    We have reviewed the submitted changes to Division 210 for
continued compliance with SIP-related permit fee requirements in Clean
Air Act section 110(a)(2)(L). We propose to find that the changes are
designed to increase major stationary source fees paid to the
permitting authority and are therefore consistent with Clean Air Act
section 110(a)(2)(L). See also our most recent approval of the Oregon
SIP as meeting the requirements of Clean Air Act section 110(a)(2)(L)
(84 FR 26347, June 6, 2019).
    We have reviewed the submitted changes to Division 216 for
continued compliance with the Clean Air Act, in particular, the SIP-
related minor new source review program requirements in Clean Air Act
section 110(a)(2)(C) and the EPA's implementing regulations at 40 CFR
51.160 through 51.164. The EPA previously approved Oregon's minor new
source review program as meeting these statutory and regulatory
requirements on October 11, 2017 (82 FR 47122). We propose to find that
the submitted changes to Division 216 continue to satisfy the statutory
and regulatory requirements. We note that qualifying minor sources are
required to apply for and obtain a Basic ACDP permit with enforceable
limits on hours of operation and/or production, a process that
includes: SIP-approved legal procedures that enable Oregon to
determine, among other things, if construction of the minor source will
violate applicable portions of the control strategy or interfere with
attainment or maintenance of the NAAQS; public availability of
information; and administrative processes. We have also reviewed the
submitted changes as they relate to the EPA's guidance on federally
enforceable state operating permit programs and propose to find that
Oregon's ACDP program continues to comply with this guidance (54 FR
27274, June 28, 1989). See the EPA's action approving the program on
January 22, 2003 (68 FR 2891).

III. Proposed Action

    The EPA is proposing to approve, and incorporate by reference,
revisions to the Oregon SIP submitted for purposes of SIP-related
permitting, as discussed in section II. of this preamble. Upon final
approval, the Oregon SIP will include the following regulations, State
effective September 21, 2020:
     OAR<PHONE_NUMBER>, Notice of Construction and Approval of
Plans: Notice to Construct;
     OAR<PHONE_NUMBER>, Notice of Construction and Approval of
Plans: Construction Approval; and
     OAR<PHONE_NUMBER>, Table 1--Activities and Sources.

IV. Incorporation by Reference

    In this document, the EPA is proposing to include in a final rule,
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the provisions described in section III. of this preamble.
The EPA has made, and will continue to make, these documents generally
available through https://www.regulations.gov and at the EPA Region 10
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Clean Air Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed 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 proposed 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 the requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the 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, this proposed action would not apply on any Indian
reservation land or in any other area in Oregon where the 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 as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen oxides, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.

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

    Dated: February 7, 2022.
Michelle L. Pirzadeh,
Acting Regional Administrator, Region 10.
[FR Doc. 2022-02983 Filed 2-11-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 21, 2009 (Volume 74, Number 97)]
[Proposed Rules]
[Page 23810-23811]
[DOCID:fr21my09-8]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Chapter I

[Docket No. PL09-4-000]

Smart Grid Policy; Notice Requesting Supplemental Comments

Issued May 19, 2009.
AGENCY: Federal Energy Regulatory Commission.

ACTION: Request for supplemental comments.

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SUMMARY: On March 19, 2009, the Federal Energy Regulatory Commission
(Commission) issued a Proposed Policy Statement and Action Plan
(Proposed Policy Statement) that, among other things, proposed an
interim rate policy to encourage the development of smart grid systems.
In this notice, the Commission seeks supplemental comments regarding
rate recovery for certain smart grid investments.

DATES: Comments are due May 28, 2009.

FOR FURTHER INFORMATION CONTACT:

Ray Palmer (Technical Information), Office of Energy Policy and
Innovation, Federal Energy Regulatory Commission, 888 First Street,
NE., Washington, DC 20426,<PHONE_NUMBER>.
Elizabeth Arnold (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    1. On March 19, 2009, the Federal Energy Regulatory Commission
(Commission) issued a Proposed Policy Statement and Action Plan
(Proposed Policy Statement) that, among other things, proposed an
interim rate policy to encourage the development of Smart Grid
systems.\1\ Subsequent to the Commission's issuance of the Proposed
Policy Statement, the U.S. Department of Energy (Department) announced
two Smart Grid funding opportunities to be offered by the Department
that may supply up to 50 percent of the funding for certain Smart Grid
projects. In addition, the Department plans to require applicants to
identify the source of non-Department funds, along with some evidence
as to the certainty of these funds. Given that applicants for these
programs might include jurisdictional public utilities that seek rate
recovery through FERC-jurisdictional rates for the non-Department
portion of funds for transmission-related projects, the Commission
seeks supplemental comments on this matter.
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    \1\ Smart Grid Policy, 126 FERC ] 61,253 (2009). As the Proposed
Policy Statement described, Smart Grid advancements will apply
digital technologies to the electric transmission system and enable
real-time coordination of information from various resources to
bring new efficiencies to the grid. Id. P 1.
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 I. Background

    2. In the Energy Independence and Security Act of 2007 (EISA),\2\
Congress enacted a number of provisions related to Smart Grid. Section
1301 of the EISA states that it is the policy of the United States to
support the modernization of the Nation's electricity transmission and
distribution system to maintain a reliable and secure electricity
infrastructure that can meet future demand growth and to achieve each
of several goals and characteristics, which together characterize a
Smart Grid.\3\ EISA authorizes the Department to carry out two separate
funding programs for Smart Grid projects: (1) Providing up to 50
percent of the cost of certain demonstration projects, as described in
section 1304; \4\ and (2) providing federal matching funds for Smart
Grid investment costs, as described in section 1306.\5\ EISA also
directed the development of a framework of protocols and standards to
achieve interoperability of Smart Grid devices and systems, which was
described in detail in the Proposed Policy Statement, and in which the
Commission plays a role.\6\
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    \2\ Public Law No. 110-140, 121 Stat. 1492 (2007).
    \3\ EISA sec. 1301, to be codified at 15 U.S.C. 17381.
    \4\ To be codified at 42 U.S.C. 17384, as amended by the
American Recovery and Reinvestment Act of 2009, Public Law No. 111-
5, Title IV, Subpart A (ARRA).
    \5\ To be codified at 42 U.S.C. 17386, as amended by the ARRA.
    \6\ See Proposed Policy Statement, 126 FERC ] 61,253 at P 7-8.
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    3. In the Proposed Policy Statement, the Commission proposed an
interim rate policy for Smart Grid investments, intended to encourage
investment in technologies that advance efficiency, security,
reliability and interoperability. Specifically, the Commission proposed
to accept single-issue rate filings submitted by public utilities under
section 205 of the Federal Power Act \7\ to recover the costs of Smart
Grid projects involving jurisdictional facilities, provided that
certain showings are made.\8\ The Commission specifically noted that,
``[w]e would also consider applying these rate treatments to the
portion of a smart grid pilot or demonstration project's cost that is
not already paid for by Department of Energy funds, such as those
authorized by EISA sections 1304 and 1306.'' \9\
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    \7\ 16 U.S.C. 824d.
    \8\ Proposed Policy Statement, 126 FERC ] 61,253 at P 46. The
Commission also discussed other rate treatments. Id. P 51-52.
    \9\ Id. P 52 (footnote omitted).
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    4. Subsequent to the Commission's issuance of the Proposed Policy
Statement, the Department released two documents relative to
forthcoming solicitations for applications for Smart Grid funding; one
of these solicitations was authorized by EISA section 1304, and one
authorized by EISA section 1306.\10\
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    \10\ For the section 1304 program, the Department's National
Energy Technology Laboratory issued a Draft Funding Opportunity
Announcement numbered DE-FOA-0000036 on April 16, 2009 (Draft
Funding Opportunity Announcement). For the section 1306 program, the
Department's Office of Energy Delivery and Electric Reliability
issued a Notice of Intent to Issue a Funding Opportunity
Announcement numbered DE-FOA-0000058A on April 16, 2009 (Notice of
Intent).
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    5. In the Notice of Intent, electric utilities are specifically
identified as a category of eligible bidders. While the Notice of
Intent does not specifically require that an applying electric utility
get approval from a regulatory commission for non-Federal funds, the
document could be read as indicating a preference for such
approval.\11\
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    \11\ The Notice of Intent states that the evaluation of
proposals will include ``* * * the likelihood that the proposed work
can be accomplished * * * with additional merit given to
applications that * * * [o]ffer the greatest extent of institutional
and organizational commitment with consideration given to: * * *
[r]equired approvals from regulatory organizations.'' Notice of
Intent at 12-13.
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    6. The Draft Funding Opportunity Announcement does not explicitly
address regulatory approvals, but does instruct applicants to submit a
funding plan that identifies all sources of project funds, and directs
applicants to include a commitment letter from third parties providing
a specific minimum dollar amount of cost sharing.\12\ For public
utilities that plan to match the Federal funds with charges to
ratepayers, it is possible that public utilities may seek to obtain an
order addressing rate recovery from this Commission for charges subject
to this Commission's jurisdiction.
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    \12\ Draft Funding Opportunity Announcement at 32-33.
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II. Request for Comments

    7. Given the requirements for potential applications by public
utilities

to the two Department programs referenced above, the Commission seeks
comments on how it should address requests for rate recovery that may
be necessary for public utilities to qualify for awards under these
programs. We also seek comment on whether some form of conditional
approval could be useful to public utility applicants with respect to
jurisdictional Smart Grid facilities. The Commission invites comments
on whether the Commission, consistent with its obligations to ensure
just and reasonable rates under the Federal Power Act (FPA), should
adopt processes for public utilities that may apply for funding for
jurisdictional Smart Grid facilities through the Department's Smart
Grid funding opportunities.

III. Document Availability

    8. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
Internet through FERC's Home Page (http://www.ferc.gov) and in FERC's
Public Reference Room during normal business hours (8:30 a.m. to 5 p.m.
Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426.
    9. From FERC's Home Page on the Internet, this information is
available on eLibrary. The full text of this document is available on
eLibrary in PDF and Microsoft Word format for viewing, printing, and/or
downloading. To access this document in eLibrary, type the docket
number excluding the last three digits of this document in the docket
number field.
    10. User assistance is available for eLibrary and the FERC's Web
site during normal business hours from FERC Online Support at 202-502-
6652 (toll free at 1-866-208-3676) or e-mail at
<EMAIL_ADDRESS>or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. E-mail the Public Reference Room at
<EMAIL_ADDRESS>
    By the Commission.
Kimberly D. Bose,
Secretary.
 [FR Doc. E9-12029 Filed 5-20-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35834-35841]
[FR Doc No: 2015-15394]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 107

[Docket No. FDA-2013-N-0067]

Infant Formula: The Addition of Minimum and Maximum Levels of
Selenium to Infant Formula and Related Labeling Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
regulations on nutrient specifications and labeling for infant formula
to add the mineral selenium to the list of required nutrients and to
establish minimum and maximum levels of selenium in infant formula.

DATES: This final rule is effective June 22, 2016. See section VII of
this document for information on the filing of objections. Submit
either electronic or written objections and requests for a hearing by
July 23, 2015.

ADDRESSES: You may submit either electronic or written objections and/
or requests for a hearing, identified by Docket No. FDA-2013-N-0067, by
any of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0067 for this rulemaking. All objections received may be
posted

without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
objections, see the ``Objections'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents,
comments, or objections received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Leila Beker, Center for Food Safety
and Applied Nutrition (HFS-850), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. What is the background and legal authority of this final rule?

A. Background

    Section 412(i) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 350a(i)) establishes requirements for the nutrient
content of infant formulas. Under section 412(i)(2) of the FD&C Act,
the Secretary of Health and Human Services (the Secretary) is
authorized to revise the list of required nutrients and the required
level for any required nutrient. This authority has been delegated to
the Commissioner of Food and Drugs (the Commissioner). The table in
section 412(i) of the FD&C Act, and in FDA regulations at Sec.
107.100(a) (21 CFR 107.100(a)), specifies that infant formulas must
contain 29 nutrients; minimum levels for each nutrient and maximum
levels for 9 of the nutrients are also specified. In 1989, the Food and
Nutrition Board of the National Research Council established a
Recommended Dietary Allowance for selenium for infants 0 to 6 months of
age of 10.0 micrograms per day ([mu]g/day), a level extrapolated from
adult values on the basis of body weight and with a factor allowed for
growth (Ref. 1).
    In the Federal Register of April 16, 2013 (78 FR 22442), we
proposed to amend the nutrient specifications for infant formula to
include selenium as a required nutrient in Sec.  107.100(a). We also
proposed to establish minimum and maximum levels for selenium in infant
formulas because evidence exists for both deficiency and toxicity of
selenium. We proposed 2.0 [mu]g selenium per 100 kilocalories (/100
kcal) as the minimum level of selenium in infant formulas and 7.0
[mu]g/100 kcal as the maximum level of selenium in infant formulas.
    Scientific evidence from multiple sources supported the proposed
levels. Specifically, for the proposed requirements, we considered
scientific evidence in: (1) The Institute of Medicine's (IOM) ``Dietary
Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids''
(Ref. 2); (2) the Life Sciences Research Office's ``Assessment of
Nutrient Requirements for Infant Formulas'' by Raiten et al. (Ref. 3);
(3) ``Global Standard for the Composition of Infant Formula.
Recommendations of an ESPGHAN [European Society for Paediatric
Gastroenterology, Hepatology and Nutrition] Coordinated International
Expert Group'' by Koletzko et al. (Ref. 4); and (4) ``Selenium Status
of Term Infants Fed Selenium-Supplemented Formula in a Randomized Dose-
Response Trial'' by Daniels et al. (Ref. 5). We also searched the
scientific literature from 1998 through 2012 for published studies not
included in these reports.
    In addition, we proposed to amend the labeling requirements for
infant formula in Sec.  107.10(a)(2) to add selenium to the list of
nutrients along with the requirement to list the amount of selenium per
100 kcal in the formula.

B. Legal Authority

    Section 412(i) of the FD&C Act contains a table of nutrients
(including minimum and, in some cases, maximum levels for nutrients)
that are required to be in an infant formula. Section 412(i)(2) of the
FD&C Act authorizes the Secretary to revise the statutory table of
nutrients and to revise the level of any required nutrient. The
Secretary has delegated this authority to the Commissioner. Our
regulations establishing the table of nutrients are codified at Sec.
107.100.
    The final rule amends Sec.  107.100 to add selenium to the list of
nutrients required for infant formula. The legal authority for the
amendment to Sec.  107.100 comes from section 412(i)(2) of the FD&C
Act.
    The final rule also requires adding selenium to the statement of
the amounts of nutrients required for infant formula labeling in Sec.
107.10(a)(2). ``Infant formula'' is defined as a food for ``special
dietary use'' under section 201(z) of the FD&C Act (21 U.S.C. 321(z)).
Under sections 403(j) and 701(e) of the FD&C Act (21 U.S.C. 343(j) and
21 U.S.C. 371(e)), the Secretary, and by delegation the Commissioner,
may prescribe regulations concerning the vitamin and mineral content of
foods for special dietary uses to fully inform purchasers as to the
value of the food for such uses. As such, FDA has the authority to
revise the statement of the amounts of nutrients required for infant
formula labeling in Sec.  107.10(a)(2) under sections 201(z), 403(j),
412(i), and 701(e) of the FD&C Act.

II. What issues did the comments raise? What are FDA's responses to the
comments?

    We invited public comment on the proposed rule. The comment period
closed on July 1, 2013. We received fewer than 20 comments. Overall,
the comments supported the addition of selenium to infant formula and
agreed that selenium is an essential nutrient. We summarize and respond
to the comments on the proposed rule and describe the final rule in
this section. For ease of reading, we preface each comment discussion
with a numbered ``Comment,'' and each response by a corresponding
numbered ``Response.'' We have numbered each comment to help
distinguish among different topics. The number assigned is for
organizational purposes only and does not signify the comment's value,
importance, or the order in which it was received.

A. The Addition of Selenium to the Statement of the Amounts of
Nutrients (Sec.  107.10(a)(2))

    The proposed rule would amend the infant formula nutrient labeling
and nutrient specification regulations at Sec. Sec.  107.10 and
107.100, respectively. Proposed Sec.  107.10(a)(2) would add selenium
to the statement of the amounts of nutrients required for infant
formula labeling.
    We did not receive any comments on proposed Sec.  107.10(a)(2).
However, we note that we have revised Sec.  107.10(a)(2) in this final
rule to correspond to changes resulting from an interim final rule that
appeared in the Federal Register on February 10, 2014 (79 FR 7934), and
later affirmed in a final rule that appeared in the Federal Register on
June 10, 2014 (79 FR 33057). In brief, Sec.  107.10(a)(2) was reworded
by replacing ``A statement of the amount of each of the following
nutrients supplied by 100 kilocalories'' with ``A statement of the
amount, supplied by 100 kilocalories, of each of the following
nutrients and of any other nutrient added by the manufacturer.''

B. Minimum and Maximum Levels of Selenium (Sec.  107.100)

    Proposed Sec.  107.100(a) would add selenium to the list of
required nutrients in infant formula. The proposal also

would establish minimum and maximum levels for selenium in infant
formula because evidence exists for both deficiency and toxicity of
selenium, and there is no room for error in production of a food that
serves as the sole source of nutrition for infants. We proposed to set
2.0 [mu]g selenium/100 kcal as the minimum level of selenium in infant
formulas and 7.0 [mu]g/100 kcal as the maximum level of selenium in
infant formulas. Since the publication of the proposed rule, we have
conducted a search of the scientific literature to identify whether
additional studies on selenium requirements of infants were published
after we issued our proposal. We did not find any relevant studies in
our search.
    (Comment 1) One comment suggested we decrease the minimum level of
selenium to 1.6 [mu]g/100 kcal. The comment pointed to analytical
variability that can occur between laboratories when testing the levels
of selenium. According to the comment, due to this analytical
variability, a minimum selenium level of 1.6 [mu]g/100 kcal will likely
result in manufacturers' formulating to deliver selenium levels close
to 2.0 [mu]g/100 kcal to ensure products do not fall below the minimum.
    (Response 1) We decline to lower the minimum level of selenium in
infant formula to 1.6 [mu]g/100 kcal to accommodate analytical
variability that can occur between laboratories as the comment
suggested. The level of any substance (including nutrients, food
additives, or contaminants) established for regulatory purposes must be
a value that is based on and true to the available scientific evidence.
We recognize that analytical variability is always present and manage
this matter under our compliance program. We also note that lowering
the minimum level of selenium would not change the analytical
variability, and the tested level of selenium might fall below whatever
minimum level is set, due to analytical variability. For example, if
the minimum level was lowered to 1.6 [mu]g/100 kcal, the tested level
of selenium might fall below 1.6 [mu]g/100 kcal due to analytical
variability. However, on our own initiative we have revised proposed
Sec.  107.100(a) to insert the word ``level'' between the words
``minimum'' and ``specified'' in light of an inadvertent omission in
the proposed rule.
    (Comment 2) One comment said that the minimum level of selenium
should be in the range reported in breast milk and specifically
recommended the level of 1.6 [mu]g selenium/100 kcal, consistent with
the mean concentration of selenium in breast milk reported by Daniels
et al. (2008). The comment continued, saying it was not aware of any
reports of selenium deficiency in breast-fed infants or at this
concentration of selenium in infant formula. The comment also stated
that we did not consider the data from the breast-fed control group in
the Daniels et al. study.
    (Response 2) With regard to this comment suggesting that the
selenium concentration in human milk (and more specifically, the level
of 1.6 [mu]g/100 kcal reported in the Daniels et al. study) be used as
the basis for the required minimum selenium level in infant formula,
the scientific evidence we discussed in the proposed rule (78 FR 22442
at 22444) was more broadly based. The discussion in the proposed rule
considered the levels of selenium in human milk from the studies used
to establish the adequate intake (AI) for selenium by the IOM and the
levels of selenium in infant formulas fed in the randomized and double-
blinded dose-response study in infants by Daniels et al. (2008).
    Specifically, as discussed in the proposed rule (78 FR 22442 at
22444), the IOM established an AI for selenium of 15.0 [mu]g/day
(approximately 2.1 [mu]g/kg body weight/day) for infants 0 to 6 months
of age based on the average concentration of selenium in human milk
from healthy women from 2 to 6 months of lactation as reported in four
studies. The study by Daniels et al. was published after the IOM
established the AI for selenium for infants 0 to 6 months of age, and
the concentration of selenium in human milk reported in that study was
not among the studies considered in the establishment of the AI. We
note that the mean concentration of selenium in human milk in the
studies included by the IOM in setting the AI for infants 0 to 6 months
of age was 18 [mu]g/L and that reported by Daniels et al. was 10.7
[mu]g/L.
    The study by Daniels et al. provides direct evidence of the effect
of selenium concentration of infant formula on the circulating
biochemical indicators of selenium status in infants. As described in
the proposed rule (78 FR 22442 at 22444), this study included a control
formula that contained 0.9 [mu]g selenium/100 kcal (considered by the
investigators to be a low-selenium formula) and two test formulas that
contained 1.9 [mu]g selenium/100 kcal or 3.1 [mu]g selenium/100 kcal.
The level of selenium in the formula containing 1.9 [mu]g/100 kcal was
somewhat higher than the level in human milk reported in the Daniels et
al. study and close to the AI set by the IOM. In our consideration of
the study by Daniels et al., we regarded the data from the human milk-
fed infants as reference data, with the direct comparators being the
indicators of selenium status of infants fed the formulas containing
the three levels of selenium. The plasma and erythrocyte indicators of
selenium status for both test formulas did not differ from each other
but differed with statistical significance from the control formula.
Compared to the infants fed the formula containing 1.9 [mu]g selenium/
100 kcal, infants fed the formula containing 3.1 [mu]g selenium/100
kcal excreted more selenium in the urine. This increase in urinary
selenium was found to be statistically significant. Combined with the
finding of no dose-related changes in the circulating indicators of
selenium status in infants fed formulas containing 1.9 [mu]g selenium/
100 kcal or 3.1 [mu]g selenium/100 kcal, this dose-related increase in
urinary selenium suggests that infants fed the formula containing a
level of 1.9 [mu]g selenium/100 kcal received sufficient selenium to
meet their nutritional needs. Much of the selenium intake above the
level of 1.9 [mu]g selenium/100 kcal was apparently eliminated from the
body through the body's homeostatic mechanisms.
    As effects on indicators of selenium status have not been evaluated
in infants fed formulas with concentrations of selenium between 0.9
[mu]g selenium/100 kcal and 1.9 [mu]g selenium/100 kcal, there are no
data to support lowering the minimum level of selenium in infant
formula from 2.0 [mu]g/100 kcal to 1.6 [mu]g/100 kcal. The scientific
evidence discussed previously and in section III.A. of the proposed
rule (78 FR 22442 at 22443) continues to justify 2.0 [mu]g selenium/100
kcal as the minimum level for selenium in infant formulas.
    (Comment 3) In support of a lower minimum level for selenium in
infant formula, one comment pointed out that the Codex Alimentarius
infant formula standard and the European Union Directive on Infant
Formulae and Follow-On Formulae recommend a minimum level of selenium
in infant formula of 1.0 [mu]g selenium/100 kcal.
    (Response 3) The level of 1.0 [mu]g/100 kcal as the minimum level
for selenium in infant formula was adopted by the Codex Alimentarius in
2007 for its Standard for Infant Formula and Formulas for Special
Medical Purposes Intended for Infants (Codex Stan 72-1981) (Ref. 6)
based on recommendation of this level by an International Expert Group
(IEG) of the ESPGHAN (Ref. 4). The IEG recommended 1.0 [mu]g selenium/
100 kcal for infant formula based on the median selenium content of
human milk and an established history of apparent safe use. However, as

described in the proposed rule (78 FR 22442 at 22444), no information
was provided regarding the details of how such information was used in
making the recommendation for 1.0 [mu]g selenium/100 kcal in infant
formula. In addition, the recommendation of the IEG was made in 2005
before the dose-response study of Daniels et al. was published in 2008,
and data from that study suggest that a level of 1.9 [mu]g selenium/100
kcal in infant formula meets infants' selenium needs. Further,
although, as noted in the comment, the level of 1.0 [mu]g/100 kcal was
also adopted as the minimum level for selenium by the European Union in
2006 for its Directive on Infant Formulae and Follow-On Formulae
(Commission Directive 2006/141/EC), identification of a scientific
basis for the selection of 1.0 [mu]g selenium/100 kcal was not included
in the European Union Commission Directive.
    (Comment 4) One comment suggested raising the maximum level of
selenium added to infant formula to 9.0 [mu]g/100 kcal. The comment
said that the 9.0 [mu]g selenium/100 kcal would align the maximum level
of selenium with the upper levels recommended in the Codex Alimentarius
Standard for Infant Formula and Formulas for Special Medical Purposes
Intended for Infants, and with the European Union Directive on Infant
Formulae and Follow-on Formulae. The comment also stated that 9.0 [mu]g
selenium/100 kcal is more aligned with the use of 8.0 [mu]g/100 kcal as
the maximum value for selenium in the FDA Compliance Program Guidance
Manual (CPGM).
    (Response 4) We decline to increase the maximum level of selenium
in infant formula to 9.0 [mu]g selenium/100 kcal as the comment
suggested. As noted in the response to comment 1 concerning the minimum
level of selenium in infant formula, the maximum level of any substance
(including nutrients, food additives, or contaminants) established for
regulatory purposes must also be a value that is based on and true to
the available scientific evidence.
    The level of 9.0 [mu]g selenium/100 kcal suggested in the comment
is the maximum level recommended by the ESPGHAN IEG for infant formula.
The report of the IEG stated that its recommendation was based on a
history of safe use (not further described) and did not identify
scientific data or other information relied upon for its recommendation
for a maximum level of 9.0 [mu]g selenium/100 kcal that was
subsequently adopted by Codex Alimentarius in 2007 for its Standard for
Infant Formula and Formulas for Special Medical Purposes Intended for
Infants (Codex Stan 72-1981). The level of 9.0 [mu]g selenium/100 kcal
was also listed in the European Union Directive on Infant Formulae and
Follow-on Formulae. We considered the level of 9.0 [mu]g selenium/100
kcal; however, we could not determine the scientific basis for this
level.
    Although we expressly invited comment regarding the proposed
maximum level in infant formula of 7.0 [mu]g selenium/100 kcal,
including whether such a maximum level is needed and the scientific
data or information that form the basis of any comments (78 FR 22442 at
22445), we did not receive any comments that disagreed with the need
for a maximum level or that provided a scientific basis that would
support a change from the proposed level. The report of the IOM, which
we relied upon to propose the maximum level of 7.0 [mu]g selenium/100
kcal, identified the data (concentration of selenium in human milk not
associated with known adverse effects) and the method of calculation
used to estimate a Tolerable Upper Intake Level (UL) of 7.0 [mu]g/kg
body weight/day for selenium intake of infants from 0 to 6 months of
age. (As explained in the proposed rule (78 FR 22442 at 22444), a level
of intake expressed as [mu]g/kg body weight/day is consistent with an
infant formula concentration expressed in [mu]g/100 kcal.)
    With regard to the use of 8.0 [mu]g/100 kcal as a maximum in our
CPGM, this level was incorporated into the CPGM when infant formula
manufacturers in the United States began adding selenium to infant
formulas starting as early as 1990 and preceded the establishment of
the UL for infants 0 to 6 months of age by the IOM. We will update the
minimum and maximum values for selenium in infant formula in our CPGM
to align with the final rule.
    (Comment 5) One comment said that setting 7.0 [mu]g selenium/100
kcal as the maximum level of selenium, which is the amount we proposed,
would mean some manufacturers would need to reformulate their products
that currently meet the 8.0 [mu]g selenium/100 kcal level that is
listed in the FDA CPGM.
    (Response 5) Although the comment said that some manufacturers
whose products currently meet the 8.0 [mu]g selenium/100 kcal level
listed in the FDA CPGM would need to reformulate, it did not specify
how many manufacturers or products would likely be affected or whether
label changes would be required following any reformulations. It also
did not provide estimates of possible costs resulting from establishing
a maximum of 7.0 [mu]g selenium/100 kcal. Other comments indicated that
any formula changes could be made in a cost effective and timely manner
with an effective date 12 months after publication of the final rule
(see comment 7).
    If some manufacturers who currently meet the 8.0 [mu]g selenium/100
kcal level need to reformulate their products to avoid exceeding a
selenium level of 7.0 [mu]g/100 kcal, such a reformulation would
involve only a small reduction in the amount of selenium added to the
formula. Manufacturers routinely make such small changes in the rates
of addition of ingredients (which may or may not result in the need for
label changes) as a fundamental part of their current good
manufacturing practices and quality control programs to ensure the
consistent production of infant formulas of high quality. These types
of changes are generally not considered to be major changes and are
reported to FDA in a ``before first processing'' submission by the
manufacturers if the change may adulterate the product, as required by
section 412(d)(3) of the FD&C Act and our regulations in 21 CFR
106.140.

C. Allowance for Analytical Variability

    (Comment 6) One comment suggested that, in the absence of setting a
higher maximum selenium level, FDA would need to establish a specific
allowance for method bias to ensure that manufacturers can meet both
the minimum and maximum selenium levels. The comment suggested an
allowance of 30 percent to account for analytical variability.
    (Response 6) As noted in the response to comment 4, the maximum
level of any substance must be a value that is based on and true to the
available scientific evidence. For this reason, we are not setting a
higher maximum value that would include an allowance for analytical
variability or method bias. We are not aware of method bias (consistent
over- or under-measurement of the actual concentration) in the analysis
of selenium in infant formula. We acknowledge that analytical
variability occurs between laboratories when testing the levels of
nutrients in infant formula, and we manage this matter under our
compliance program as necessary. Further, we decline to set a 30
percent allowance for analytical variation for the chemical analysis of
selenium in infant formula. The comment did not provide a reason for
setting such a high allowance for analytical variation, and 30 percent
variability is much higher than performance requirements for commonly
used methods for chemical

analysis of minerals in infant formula, which typically is about 10 to
15 percent.

D. Effective Date

    In the Regulatory Impact Analysis of the proposed rule, we analyzed
three options with respect to an effective date: (1) Take no new
regulatory action (baseline); (2) require the provisions of this
proposed rule and make the provisions of the rule effective 180 days
after publication; and (3) require the provisions of this proposed
rule, but make the provisions of the rule effective 12 months after
publication (78 FR 22442 at 22446).
    (Comment 7) Two comments supported FDA's option 3 in the proposed
rule to make the final rule effective 12 months after publication to
allow for cost effective and timely changes with no anticipated impact
on infant health. One comment explained that because there have been no
reports of full-term, breast-fed infants in the United States with
evidence of selenium deficiency, there would be no anticipated impact
to infant health due to a 6-month delay in the rule's effective date
(from 6 months in option 2 to 12 months in option 3 of the Regulatory
Impact Analysis of the proposed rule).
    (Response 7) The final rule will be effective 12 months after
publication of this document (see DATES). This will allow the industry
to make any needed reformulations and label changes to their infant
formula products in the 12-month period that the comment identified as
cost effective and timely for needed changes.

E. Miscellaneous Comments

    Several comments addressed matters that were not specific to a
particular provision in the proposed rule and/or that were not covered
by the rule. We summarize and address those comments here.
    (Comment 8) One comment suggested that FDA recommend or encourage
the use of the organic form of selenium, selenomethionine, rather than
the inorganic forms, sodium selenite or sodium selenate. The comment
explained that selenomethionine is the selenium compound incorporated
into body proteins and is available in dietary supplements or from
brewer's yeast.
    (Response 8) FDA's specifications for infant formula composition in
Sec.  107.100 identify nutrients that must be included in the formula.
The regulations do not specify ingredients that can serve as sources of
the nutrients, except for vitamin K in Sec.  107.100(c). We decline to
specify the form of selenium in infant formula because we do not have
information that indicates that any specific source of selenium should
be used in infant formula. Our recently published current good
manufacturing practices for infant formulas require that ingredients
used in infant formulas be safe and suitable for use in infant formula.
Specifically, under Sec.  106.40(a), the only substances that may be
used in an infant formula are substances that are safe and suitable for
use in infant formula under the applicable food safety provisions of
the FD&C Act; that is, a substance is used in accordance with the
Agency's food additive regulations, is generally recognized as safe for
such use, or is authorized by a prior sanction.
    (Comment 9) One comment agreed with the proposed selenium levels
``unless a pediatrician otherwise recommends an alternative dosage
because of a peculiar deficiency of selenium.'' The comment did not
explain the circumstances under which a pediatrician would recommend an
``alternative dosage.''
    (Response 9) The final rule adds selenium to the list of required
nutrients in infant formula and establishes minimum and maximum levels
of selenium in infant formula. Manufacturers will be required to add
selenium to infant formula within the established bounds as of the
effective date of this rule. The rule does not apply to what physicians
may do within the practice of medicine. Thus, matters pertaining to the
practice of pediatric medicine are outside the scope of this
rulemaking.
    (Comment 10) Another comment suggested that FDA consider
establishing a higher maximum for vitamin D based on recent American
Academy of Pediatrics and IOM recommendations.
    (Response 10) The final rule adds selenium to the list of required
nutrients in infant formula and establishes minimum and maximum levels
of selenium in infant formula. With respect to vitamin D and infant
formula, we may, as resources permit, reevaluate all the minimum and
maximum required nutrient levels for infant formula in separate
rulemakings.
    (Comment 11) One comment supported the proposal to require the
addition of selenium in infant formula. The comment stated that a child
that does not receive enough selenium in the diet is at risk of
developing Keshan disease.
    (Response 11) FDA agrees that Keshan disease is linked to selenium
deficiency. The preamble to the proposed rule discussed the known
biological functions of selenium and Keshan disease (a cardiomyopathy
that occurs almost exclusively in children) (see 78 FR 22442 at 22443).

III. What is the environmental impact of this final rule?

    FDA has determined under 21 CFR 25.32(n) 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.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have 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 have concluded that the
rule does not contain policies that have federalism implications as
defined in the Executive order and, consequently, a federalism summary
impact statement is not required.

V. Executive Order 12866 and Executive Order 13563: Cost Benefit
Analysis

    On April 16, 2013, we proposed to amend our regulations on nutrient
specifications and labeling for infant formula to add the mineral
selenium to the list of required nutrients and to establish minimum and
maximum levels of selenium in infant formula (78 FR 22442). The
Economic Impact Analysis in the proposed rule explained the economic
impact of the changes to regulations at part 107. We did not receive
any comments on the economic analysis of the proposed rule.
    FDA has examined the impacts of this final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies 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). FDA has developed a regulatory impact analysis that presents
the benefits and costs of this proposed rule (Ref. 7). We believe that
the final rule will not be a

significant regulatory action as defined by Executive Order 12866.

VI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown in the following paragraphs with an
estimate of the annual third-party disclosure burden. Included in the
estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
    Title: Third-Party Disclosure Requirements for Selenium in Infant
Formula
    Description of Respondents: The respondents to this information
collection are manufacturers of infant formula marketed in the United
States.
    Description: The final rule revises Sec.  107.10(a)(2) to require
that selenium be listed in the nutrient list on the label for all
infant formulas. In particular, in the nutrient list, selenium must be
listed between iodine and sodium and the amount per 100 calories
declared; and because selenium is a required ingredient in infant
formula, selenium is required to be declared in the formula's
ingredient statement by its common or usual name and positioned
according to the descending order of its predominance in the formula,
under Sec.  101.4 (21 CFR 101.4). The present version of Sec.
107.10(a)(2) is approved by OMB in accordance with the PRA and has been
assigned OMB control number 0910-0256. This final rule modifies the
information collection associated with the present version of Sec.
107.10(a)(2) by adding 23 hours to the burden associated with the
collection. A manufacturer not in compliance with the new minimum and
maximum levels for selenium in infant formula would be required to make
a one-time change to the nutrient list information disclosed to
consumers on the label of its infant formula, to account for the
required change in the amount of selenium in its products. The nutrient
information disclosed by manufacturers on the infant formula label is
necessary to inform purchasers of the value of the infant formula. As
discussed previously in this document, FDA has the authority to revise
the statement of the amounts of nutrients required for infant formula
labeling in Sec.  107.10(a)(2).
    FDA estimates the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
              21 CFR section                   Number of      disclosures    Total annual        Average burden per         Total hours    Total capital
                                              respondents   per respondent    disclosures            disclosure                                cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   107.10(a)(2)--Nutrient labeling for               1              46              46  0.5 (30 minutes)                          23        $792,439
 infant formula.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    FDA concludes that there will be no additional burden associated
with the requirement to disclose selenium in the ingredient statement
as required under Sec.  101.4 because all infant formula manufacturers
currently add selenium as an ingredient to their infant formula
products that are sold in the United States, and all manufacturers
currently disclose selenium in the ingredient statement, as specified
by Sec.  101.4. Additionally, all manufacturers currently disclose
selenium in the nutrient list, as required by Sec.  107.10(b)(5). Under
Sec.  107.10(a)(2), only one manufacturer would need to make a one-time
labeling change to modify the amount of selenium shown in the nutrient
list on the labels of its infant formula.
    The third-party disclosure burden consists of the setup time
required to design a revised label and incorporate it into the
manufacturing process. Based upon our knowledge of food and dietary
supplement labeling, we estimate that the affected manufacturer would
require less than 0.5 hour per product to modify the label's nutrient
list to reflect the addition of more selenium to the product. We
estimate that this manufacturer produces 46 separate infant formulas
that would require relabeling. The one-time third-party disclosure
burden is estimated in table 1 of this document.
    The final column of table 1 gives the estimated capital cost
associated with relabeling. This is the cost of designing a revised
label and incorporating it into the manufacturing process. The cost
stated in table 1, $792,439, is estimated based on an effective date of
1 year after publication. These costs are based on the cost model
estimate that, over a longer period of time, any labeling change is
more likely to be coordinated with a change in a label that may already
be scheduled, and will diminish the need to, for example, purchase and
apply stickers to packages affected by the change.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the PRA.
The requirements were approved and assigned OMB control number 0910-
0256. This approval expires on 04/30/2018.
    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.

VII. Objections

    This rule is effective as shown in the DATES section, except as to
any provisions that may be stayed by the filing of proper objections.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Division of Dockets Management (see
ADDRESSES) either electronic or written objections. You must number
each objection separately, and, within each numbered objection, you
must specify with particularity the provision(s) to which you object,
and the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, we will
consider the absence of such a request as waiving the right to a
hearing on that objection. If you request a hearing, your objection
should include a detailed description and analysis of the specific
factual information you intend to present in support of the objection
in the event that a hearing is held.
    It is only necessary to send one set of documents. Identify
documents with the

docket number found in brackets in the heading of this document. Any
objections received in response to the regulation may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.

VIII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

    1. Food and Nutrition Board, National Research Council,
``Recommended Dietary Allowances,'' 10th ed., Washington, DC: The
National Academies Press, p. 221, 1989.
    2. Food and Nutrition Board, Institute of Medicine, ``Dietary
Reference Intakes for Vitamin C, Vitamin E, Selenium, and
Carotenoids,'' Washington, DC: The National Academies Press, pp. 21-
33; 292-299; 315-316, 2000.
    3. Raiten, D. J., J. M. Talbot, and J. H. Waters, ``Assessment
of Nutrient Requirements for Infant Formulas,'' Journal of
Nutrition, 128:2059S-2249S, 1998.
    4. Koletzko, B., S. Baker, G. Cleghorn, U.F. Neto, et al.,
``Global Standard for the Composition of Infant Formula.
Recommendations of an ESPGHAN Coordinated International Expert
Group,'' Journal of Pediatric Gastroenterology and Nutrition,
41:584-599, 2005.
    5. Daniels, L., R. A. Gibson, K. Simmer, P. Van Dael, and M.
Makrides, ``Selenium Status of Term Infants Fed Selenium-
Supplemented Formula in a Randomized Dose-Response Trial,'' American
Journal of Clinical Nutrition, 88:70-76, 2008.
    6. Codex Alimentarius Commission, ``Standard for Infant Formula
and Formulas for Special Medical Purposes Intended for Infants,
Codex Stan 72-1981,'' 1981. Revised 2007.
    7. FDA/Center for Food Safety and Applied Nutrition, ``Infant
Formula: The Addition of Minimum and Maximum Levels of Selenium to
Infant Formula and Related Labeling Requirements, Final Regulatory
Impact Analysis and Regulatory Flexibility Analysis,'' 2015.
Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

List of Subjects in 21 CFR Part 107

    Food labeling, Infants and children, Nutrition, Reporting and
recordkeeping requirements, Signs and symbols.
    For the reasons discussed in the preamble, under the Federal Food,
Drug, and Cosmetic Act, and under authority delegated to the
Commissioner of Food and Drugs, the Food and Drug Administration amends
21 CFR part 107 as follows:

PART 107--INFANT FORMULA

0
1. The authority citation for 21 CFR part 107 continues to read as
follows:

    Authority: 21 U.S.C. 321, 343, 350a, 371.

0
2. In Sec.  107.10, revise paragraph (a)(2) to read as follows:

Sec.  107.10  Nutrient information.

    (a) * * *
    (2) A statement of the amount, supplied by 100 kilocalories, of
each of the following nutrients and of any other nutrient added by the
manufacturer:

------------------------------------------------------------------------
                 Nutrients                       Unit of measurement
------------------------------------------------------------------------
Protein....................................  Grams
Fat........................................  Do.
Carbohydrate...............................  Do.
Water......................................  Do.
Linoleic acid..............................  Milligrams
------------------------------------------------------------------------
                                Vitamins
------------------------------------------------------------------------
Vitamin A..................................  International Units
Vitamin D..................................  Do.
Vitamin E..................................  Do.
Vitamin K..................................  Micrograms
Thiamine (Vitamin B1)......................  Do.
Riboflavin (Vitamin B2)....................  Do.
Vitamin B6.................................  Do.
Vitamin B12................................  Do.
Niacin.....................................  Do.
Folic acid (Folacin).......................  Do.
Pantothenic acid...........................  Do.
Biotin.....................................  Do.
Vitamin C (Ascorbic acid)..................  Milligrams
Choline....................................  Do.
Inositol...................................  Do.
------------------------------------------------------------------------
                                Minerals
------------------------------------------------------------------------
Calcium....................................  Milligrams
Phosphorus.................................  Do.
Magnesium..................................  Do.
Iron.......................................  Do.
Zinc.......................................  Do.
Manganese..................................  Micrograms
Copper.....................................  Do.
Iodine.....................................  Do.
Selenium...................................  Do.
Sodium.....................................  Milligrams
Potassium..................................  Do.
Chloride...................................  Do.
------------------------------------------------------------------------

* * * * *

0
3. In Sec.  107.100, revise paragraph (a) to read as follows:

Sec.  107.100  Nutrient specifications.

    (a) An infant formula shall contain the following nutrients at a
level not less than the minimum level specified and not more than the
maximum level specified for each 100 kilocalories of the infant formula
in the form prepared for consumption as directed on the container:

----------------------------------------------------------------------------------------------------------------
                 Nutrients                         Unit of measurement          Minimum level     Maximum level
----------------------------------------------------------------------------------------------------------------
Protein....................................  Grams..........................               1.8               4.5
Fat........................................  Do.............................               3.3               6.0
                                             Percent calories...............                30                54
Linoleic acid..............................  Milligrams.....................               300  ................
                                             Percent calories...............               2.7  ................
----------------------------------------------------------------------------------------------------------------
                                                    Vitamins
----------------------------------------------------------------------------------------------------------------
Vitamin A..................................  International Units............               250               750
Vitamin D..................................  Do.............................                40               100
Vitamin E..................................  Do.............................               0.7  ................
Vitamin K..................................  Micrograms.....................                 4  ................
Thiamine (Vitamin B1)......................  Do.............................                40  ................
Riboflavin (Vitamin B2)....................  Do.............................                60  ................
Vitamin B6.................................  Do.............................                35  ................
Vitamin B12................................  Do.............................              0.15  ................
Niacin \1\.................................  Do.............................               250  ................
Folic acid (Folacin).......................  Do.............................                 4  ................
Pantothenic acid...........................  Do.............................               300  ................
Biotin \2\.................................  Do.............................               1.5  ................
Vitamin C (Ascorbic acid)..................  Milligrams.....................                 8  ................
Choline \2\................................  Do.............................                 7  ................
Inositol \2\...............................  Do.............................                 4  ................
----------------------------------------------------------------------------------------------------------------
                                                    Minerals
----------------------------------------------------------------------------------------------------------------
Calcium....................................  Do.............................                60  ................
Phosphorus.................................  Do.............................                30  ................
Magnesium..................................  Do.............................                 6  ................
Iron.......................................  Do.............................              0.15               3.0
Zinc.......................................  Do.............................               0.5  ................
Manganese..................................  Micrograms.....................                 5  ................
Copper.....................................  Do.............................                60  ................
Iodine.....................................  Do.............................                 5                75
Selenium...................................  Do.............................                 2                 7
Sodium.....................................  Milligrams.....................                20                60
Potassium..................................  Do.............................                80               200
Chloride...................................  Do.............................                55               150
----------------------------------------------------------------------------------------------------------------
\1\ The generic term ``niacin'' includes niacin (nicotinic acid) and niacinamide (nicotinamide).
\2\ Required only for non-milk-based infant formulas.

* * * * *

    Dated: June 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15394 Filed 6-22-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 138 (Wednesday, July 20, 2022)]
[Notices]
[Pages 43348-43349]
[FR Doc No: 2022-15439]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-0088, OMB Control No. 3235-0083]

Submission for OMB Review; Comment Request: Extension: Rule
15Ba2-1 and Form MSD

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

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for extension of the previously approved
collection of information provided for in Rule 15Ba2-1 (17 CFR
240.15Ba2-1) and Form MSD (17 CFR 249.1100) under the Securities
Exchange Act of 1934 (``Exchange Act'') (15 U.S.C. 78a et seq.).
    Rule 15Ba2-1 provides that an application for registration with the
Commission by a bank municipal securities dealer must be filed on Form
MSD. The Commission uses the information obtained from Form MSD filings
to The Commission uses the information obtained from Form MSD filings
to determine whether bank municipal securities dealers meet the
standards for registration set forth in the Exchange Act, to make
information about particular bank municipal securities dealers
available to customers and members of the public, and to develop risk
assessment information about bank municipal securities dealers.
    Form MSD is a one-time registration form that must be amended only
if it becomes inaccurate. Based upon past submissions of zero initial
filings and 14 amendments in 2019, zero initial filings and three
amendments in 2020, zero initial filings and one amendment in 2021, and
zero initial filings and zero amendments so far in 2022, the Commission
estimates that on an annual basis approximately one respondent will use
Form MSD for an initial registration application, and that
approximately six respondents will utilize Form MSD for an amendment,
for a total of seven respondents per year. The time required to
complete Form MSD varies with the size and complexity of the bank
municipal securities dealer's proposed operations. Bank personnel that
prepare Form MSD filings previously indicated that it can take up to 15
hours for a bank with a large operation and many employees to complete
the form, but that smaller banks with fewer personnel can complete the
form in one to two hours. We believe that most recent applications have
come from smaller banks. Also, amendments to form MSD are likely to
require significantly less time. We estimate that the total annual
burden is currently approximately 11 hours at an average of 1.5 hours
per respondent. (7 respondents/year x 1.5 hours/respondent = 10.5
hours/year rounded up to 11). The staff estimates that the average
internal compliance cost per hour is approximately $406.\1\ Therefore,
the estimated total annual internal cost of compliance is approximately
$4,263 per year (10.5 hours/year x $406/hour = $4,263/year).
---------------------------------------------------------------------------

    \1\ The estimate of $406 per hour is for a compliance attorney,
based on the Securities Industry and Financial Markets Association's
Management & Professional Earnings in the Securities Industry 2013,
modified by Commission staff to account for an 1800-hour work-year
and inflation, and multiplied by 5.35 to account for bonuses, firm
size, employee benefits and
---------------------------------------------------------------------------

    Rule 15Ba2-1 does not contain an explicit recordkeeping
requirement, but the rule does require the prompt correction of any
information on Form MSD that becomes inaccurate, meaning that bank
municipal securities dealers need to maintain a current copy of Form
MSD indefinitely. In addition, the instructions for filing Form MSD
state that an exact copy should be retained by the registrant.
Providing the information on the application is mandatory in order to
register with the Commission as a bank municipal securities dealer. The
information contained in the application will not be kept confidential.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent by

August 19, 2022 to (i) www.reginfo.gov/public/do/PRAMain and (ii) David
Bottom, Director/Chief Information Officer, Securities and Exchange
Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC 20549,
or by sending an email to: [email protected].

    Dated: July 14, 2022.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-15439 Filed 7-19-22; 8:45 am]
BILLING CODE 8011-01-P