[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Page 47666]
[FR Doc No: 2021-18345]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92719; File No. SR-CboeBZX-2021-036]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Withdrawal of a Proposed Rule Change To Exclude a National Best Bid or
Offer From the Calculation of the BZX Official Closing Price, as
Provided in Rule 11.23(c)(2)(B)(ii)(b), That Is Outside the Bands
Provided Under the Plan To Address Extraordinary Market Volatility

August 20, 2021.
    On April 29, 2021, Cboe BZX Exchange, Inc. (the ``Exchange'') filed
with the Securities and Exchange Commission (``Commission''), pursuant
to Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'')
\1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to exclude a
National Best Bid or Offer \3\ (``NBBO'') from the calculation of the
BZX Official Closing Price, as provided in Rule 11.23(c)(2)(B)(ii)(b),
that is outside the bands provided under the National Market System
Plan to Address Extraordinary Market Volatility (``Limit Up-Limit Down
Plan'' or ``LULD Plan'').\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See BZX Rule 1.5(o).
    \4\ See Securities Exchange Act Release No. 88704 (April 21,
2020), 85 FR 23383 (April 27, 2020) (File No. 4-634) (Amendment No.
20 Approval Order).
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    The proposed rule change was published for comment in the Federal
Register on May 18, 2021.\5\ On June 25, 2021, pursuant to Section
19(b)(2) of the Act,\6\ the Commission extended the time period within
which to approve the proposed rule change, disapprove the proposed rule
change, or institute proceedings to determine whether to approve or
disapprove the proposed rule change to August 16, 2021.\7\ The
Commission has received no comment letters on the proposed rule change.
On August 12, 2021, the Exchange withdrew the proposed rule change (SR-
CboeBZX-2021-036).
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    \5\ See Securities Exchange Act Release No. 91875 (May 12,
2021), 86 FR 26982 (May 18, 2021) (SR-CboeBZX-2021-036)
(``Notice'').
    \6\ 15 U.S.C. 78s(b)(2).
    \7\ See Securities Exchange Act Release No. 92268 (June 25,
2021), 86 FR 35143 (July 1, 2021).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2021-18345 Filed 8-25-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 96 (Friday, May 17, 2019)]
[Notices]
[Pages 22543-22546]
[FR Doc No: 2019-10228]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85849; File No. SR-CboeEDGA-2019-010]

Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend the EDGA Equities Trading Platform Fee Schedule

May 13, 2019.
    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 May 1, 2019, Cboe EDGA Exchange, Inc. (``Exchange'' or ``EDGA'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III 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

    Cboe EDGA Exchange, Inc. (``EDGA'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to amend the fee schedule applicable to the EDGA
equities trading platform (``EDGA Equities'') as it relates to pricing
for the use of the ROBB and ROCO routing strategies. The text of the
proposed rule change is attached [sic] as Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/edga/), at the Exchange's Office of the Secretary, 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 Exchange 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 these 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 aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to amend the EDGA
Equities fee schedule to change the pricing applicable to orders routed
using the ROBB and ROCO routing strategies in connection with planned
changes to the System routing table.\3\ ROBB and ROCO are a routing
strategies offered by the Exchange that are used to target certain low
cost venues by routing to those venues after accessing available
liquidity on the EDGA Book. In February 2019, NYSE American LLC (``NYSE
American'') and NYSE National, Inc. (``NYSE National'') were added to
the System routing table as a low cost protected market centers.
Therefore, pursuant to Rule 11.11(g), the Exchange has determined to
add NYSE American and NYSE National as a low cost venues under the ROBB
and ROCO routing strategies. These changes to the ROBB and ROCO routing
strategies are scheduled to be introduced on May 1, 2019.
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    \3\ The term ``System routing table'' refers to the proprietary
process for determining the specific trading venues to which the
System routes orders and the order in which it routes them. See Rule
11.11(g). The Exchange reserves the right to maintain a different
System routing table for different routing options and to modify the
System routing table at any time without notice.
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    In recognition of the fact that NYSE American and NYSE National can
be accessed at a low cost today, for securities priced at or above
$1.00, the Exchange proposes to provide a fee to orders routed to NYSE
American using the ROBB or ROCO routing strategies and a rebate for
orders routed to NYSE National using the ROBB or ROCO routing
strategies. Specifically, the Exchange proposes to add ROBB and ROCO to
the list of routing strategies that yield fee code NX, which relates to
orders routed to NYSE National, and to the list of routing strategies
that yield fee code MX, which relates to orders routed to NYSE
American. As proposed, orders routed to NYSE National using the ROBB or
ROCO routing strategies would be provided a rebate of $0.00200 per
share in securities priced at or above $1.00, and no charge or rebate
would be applied for securities priced below $1.00. Orders routed to
NYSE American using the ROBB or ROCO routing strategies would be
assessed a fee of $0.00020, and no charge or rebate would be applied
for securities prices below $1.00. The fee and rebate are consistent
with those currently offered for orders routed to NYSE National and
NYSE American using a similar low cost routing strategy, ROUC, yielding
fee code NX and MX, respectively.
    In addition to this, the Exchange proposes to reduce the per share
rebate [sic] for orders routed to Cboe EDGX Exchange, Inc. (``EDGX'')
and to reduce the per share fee [sic] assessed for orders routed to
EDGX that add liquidity, including pre- and post-market orders.
Currently, the Exchange assesses a fee of $0.0030 per share for orders
routed to EDGX (yielding fee code I) in securities priced at or above
$1.00. The Exchange also currently provides a standard rebate of
$0.0027 per share for orders routed to EDGX that add liquidity,
including pre- and post-market orders, (yielding fee code P) in
securities priced at or above $1.00. The Exchange now proposes to
reduce the fee assessed for orders routed to EDGX (yielding fee code I)
in securities priced at or above $1.00 from $0.0030 to $0.00265. With
respect to orders routed to EDGX that add liquidity, including pre- and
post-market orders, (yielding fee code P) in securities priced at or
above $1.00, the Exchange proposes to reduce the per share rebate from
$0.0027 to $0.0017.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6 of the Act,\4\ in general, and furthers the requirements
of Section 6(b)(4),\5\ in particular, as it is designed to provide for
the equitable allocation of reasonable dues, fees and other charges
among its members and other persons using its facilities. The Exchange
believes the proposed routing fee changes are appropriate as they
reflect changes to the System routing table used to determine the order
in which venues are accessed using the ROBB and ROCO routing
strategies. As stated, ROBB and ROCO specifically target certain
equities exchanges that provide low cost executions or rebates to
liquidity removing orders, and routes to those venues after trading
with the EDGA Book. The Exchange believes that the proposed changes
reflect the intent of Members when they submit routable order flow to
the Exchange using the ROBB and ROCO routing strategies.
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    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that it is reasonable and equitable to begin
rebating orders routed to NYSE National using the ROBB and ROCO routing
strategies. As mentioned previously, the Exchange added these exchanges
to its list of low cost protected market centers, and wishes to provide
the benefit of the rebate or lower fee provided by those markets to
EDGA members using the ROBB and ROCO routing strategies. The Exchange
currently offers such incentives when routing to those markets using
another low cost routing strategy, ROUC. As is the case for orders
routed via the ROUC routing strategy to NYSE American or NYSE National,
the Exchange believes the proposed fees and rebates applicable to the
ROBB and ROCO routing strategies to these venues generally reflect the
current transaction fees and rebates available for accessing liquidity
on those markets.\6\ The Exchange believes that this change may
increase interest in the Exchange's

ROBB and ROCO routing strategies, in particular, by passing on better
pricing to EDGA Members that choose to enter such orders on the
Exchange, thereby encouraging additional order flow to be entered to
the EDGA Book.
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    \6\ NYSE American currently charges a fee for removing liquidity
that is $0.00020 per share in securities priced at or above $1.00,
and 0.25% of the total dollar value of the transaction in securities
priced below $1.00. See NYSE American Equities Price List, I.
Transaction Fees.
    NYSE National currently provides a rebate of $0.00200 per share
in securities priced at or above $1.00 for members that achieve
their taking tier. See NYSE National Schedule of Fees and Rebates,
I. Transaction Fees, B. Tiered Rates. Orders that remove liquidity
in securities below $1.00 are executed without charge or rebate. See
NYSE National, Schedule of Fees and Rebates, I. Transaction Fees, A.
General Rates.
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    In addition to this, the Exchange believes that the proposed
routing fee changes are equitable and not unfairly discriminatory as
the proposed rebate would apply equally to all Members that use the
Exchange to route orders using the associated routing strategies. The
proposed fees are designed to reflect the fees charged and rebates
offered by certain away trading centers that are accessed by Exchange
routing strategies, and are being made in conjunction with changes to
the System routing table designed to provide Members with low cost
executions for their routable order flow. Furthermore, if Members do
not favor the proposed pricing, they can send their routable orders
directly to away markets instead of using routing functionality
provided by the Exchange. Routing through the Exchange is voluntary,
and the Exchange operates in a competitive environment where market
participants can readily direct order flow to competing venues or
providers of routing services if they deem fee levels to be excessive.
    The Exchange also believes that its proposal to reduce rates for
orders routed to EDGX is reasonable because Members will pay lower
transaction fees for such orders. Additionally, the Exchange notes that
the proposed fee is lower than transaction fees assessed on other
Exchanges.\7\ The Exchange notes that the proposed fee reduction is not
unfairly discriminatory as it applies uniformly to Members.
---------------------------------------------------------------------------

    \7\ See NYSE Price List 2019, Routing Fees.
---------------------------------------------------------------------------

    Finally, the Exchange believes the proposed reduced rebates for
orders routed to EDGX that add liquidity (including pre- and post-
market orders) is reasonable, equitable and not unfairly discriminatory
because Members will still receive rebates for such orders, albeit at a
lower amount. The Exchange also believes the proposed reduction of
rebates for such orders is reasonable because the Exchange must balance
the revenue received for orders that add liquidity (and as described
above, the Exchange is reducing the rates assessed for orders routed to
EDGX). Rebates for orders that add liquidity incentivize members to
bring additional order flow through the Exchange, thereby promoting
price discovery and enhancing order execution opportunities for
Members.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
proposed routing fee changes are designed to reflect changes being made
to the System routing table used to determine where to send certain
routable orders, and generally provide better pricing to Members for
orders routed to low cost protected market centers using the Exchange's
routing strategies. The Exchange notes that the use of available
routing strategies is optional for all Members. Also, the proposed
rates and rebates would apply uniformly to all Members, and members may
opt to disfavor the Exchange's pricing if they believe that
alternatives offer them better value. Accordingly, the Exchange does
not believe that the proposed changes will impair the ability of
members or competing venues to maintain their competitive standing in
the financial markets. Further, excessive fees would serve to impair an
exchange's ability to compete for order flow and members rather than
burdening competition. Moreover, the proposed fee changes are designed
to incentivize liquidity, which the Exchange believes will benefit all
market participants by encouraging a transparent and competitive
market. The Exchange operates in a highly competitive market in which
market participants can readily direct their order flow to competing
venues. In such an environment, the Exchange must continually review,
and consider adjusting, its fees and rebates to remain competitive with
other exchanges. For the reasons described above, the Exchange believes
that the proposed fee changes reflect this competitive environment.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and paragraph (f) of Rule 19b-4 \9\
thereunder. 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. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f).
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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-CboeEDGA-2019-010 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CboeEDGA-2019-010. 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 website (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 website 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 10:00 a.m. and
3:00 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from

comment submissions. You should submit only information that you wish
to make available publicly. All submissions should refer to File Number
SR-CboeEDGA-2019-010 and should be submitted on or before June 7, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-10228 Filed 5-16-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Pages 21298-21299]
[FR Doc No: 2015-08786]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2012-0033]

Notice of Intent To Grant a Buy America Waiver to the New York
Metropolitan Transportation Authority for the Use of Transponders and
Temporary Speed Restriction Safety Servers

AGENCY: Federal Railroad Administration (FRA), United States Department
of Transportation (DOT).

ACTION: Notice of intent to grant Buy America waiver.

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SUMMARY:  FRA is issuing this notice to advise the public that it
intends to grant the New York Metropolitan Transportation Authority
(MTA) on behalf of its commuter railroad subsidiaries, Long Island Rail
Road (LIRR) and Metro-North Commuter Railroad Company (Metro-North), a
waiver from FRA's Buy America requirement for the use of (a)
transponders and (b) Temporary Speed Restriction (TSR) safety servers,
which are made in Sweden. Transponders and TSR safety servers are two
components of LIRR's and Metro-North's Positive Train Control system
(PTC). The two non-domestic components represent approximately 1% of
the $428 million total value of the contracts Metro-North and LIRR
entered into with a system integrator to design and furnish PTC (PTC
Contracts). The TSR safety servers cost less than $1 million and the
transponders approximately $4 million. FRA anticipates funding the PTC
Contracts, and other PTC-related projects, under a $967.1 million FRA
Railroad Rehabilitation & Improvement Financing loan.

DATES: Written comments on FRA's determination to grant MTA's Buy
America waiver request should be provided to the FRA on or before April
22, 2015.

ADDRESSES: Please submit your comments by one of the following means,
identifying your submissions by docket number FRA-2012-0033. All
electronic submissions must be made to the U.S. Government electronic
site at http://www.regulations.gov. Commenters should follow the
instructions below for mailed and hand-delivered comments.
    (1) Web site: http://www.regulations.gov. Follow the instructions
for submitting comments on the U.S. Government electronic docket site;
    (2) Fax:<PHONE_NUMBER>;
    (3) Mail: U.S. Department of Transportation, 1200 New Jersey Avenue
SE., Docket Operations, M-30, Room W12-140, Washington, DC 20590-0001;
or
    (4) Hand Delivery: Room W12-140 on the first floor of the West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: All submissions must make reference to the ``Federal
Railroad Administration'' and include docket number FRA-2012-0033. Due
to security procedures in effect since October 2001, mail received
through the U.S. Postal Service may be subject to delays. Parties
making submissions responsive to this notice should consider using an
express mail firm to ensure the prompt filing of any submissions not
filed electronically or by hand. Note that all submissions received,
including any personal information therein, will be posted without
change or alteration to http://www.regulations.gov. For more
information, you may review DOT's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19477), or visit
http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mr. John Johnson, Attorney-Advisor,
FRA Office of Chief Counsel, 1200 New Jersey Avenue SE., Mail Stop 25,
Washington, DC 20590,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    The letter granting MTA's request is quoted below:

Mr. Richard L. Gans
Vice President--General Counsel & Secretary
Long Island Rail Road
Jamaica Station
Jamaica, NY 11435-4380

Re: Request for Waiver of Buy America Requirement

Dear Mr. Gans:

    As you are aware, on February 19, 2015, the New York
Metropolitan Transportation Authority (MTA) on behalf of its
commuter railroad subsidiaries, Long Island Rail Road (LIRR) and
Metro-North Commuter Railroad Company (Metro-North), requested a
waiver from the Federal Railroad Administration's (FRA) Buy America
requirement to purchase (a) transponders and (b) Temporary Speed
Restriction (TSR) safety servers for use in LIRR's and Metro-North's
Positive Train Control system (PTC). The Rail Safety Improvement Act
of 2008 requires certain railroads, including LIRR and Metro-North,
to implement a PTC system on all nonexempt commuter main-line tracks
by December 31, 2015. Facilitating PTC implementation is one of
FRA's top priorities.
    MTA requested the waiver, stating that the components were not
produced in the U.S. in sufficient and reasonably available amounts
or are not of a satisfactory quality. The transponders and TSR
safety servers are manufactured in Sweden. The two non-domestic
components represent approximately 1% of the total value of the PTC
system integrator contracts (PTC Contracts). MTA values the TSR
safety servers at less than $1 million and the transponders at
approximately $4 million. Total contract costs are approximately
$428 million. For the reasons set forth below, FRA is granting a
waiver for the purchase of the transponders and TSR safety servers.
    A waiver is appropriate because domestically-produced
transponders and TSR safety servers meeting MTA's technical and
schedule requirements are not currently ``produced in sufficient and
reasonably available amount or are not of a satisfactory quality.''
Coordinating with FRA, MTA engaged the U.S. Department of Commerce's
National Institute of Standards and Technology's Hollings
Manufacturing Extension Partnership (NIST-MEP) to conduct market
research for the transponders and TSR safety servers. In conducting
that research, MTA contacted several potential manufacturers
identified by NIST-MEP. None produced the transponders or TSR safety
servers.
    On February 20, 2015, FRA provided public notice of this waiver
request and a 15-day opportunity for comment on its Web site. FRA
also emailed notice to over 6,000 persons who have signed up for Buy
America notices through ``GovDelivery.'' See http://www.fra.dot.gov/Page/P0784. FRA received one comment, which was not responsive to
this waiver request. FRA will publish this letter granting MTA's
request in the Federal Register and provide notice of such finding
and an opportunity for public comment after which this waiver will
become effective.
    Question about this letter can be directed to, John Johnson,
Attorney-Advisor, at<EMAIL_ADDRESS>or<PHONE_NUMBER>.

Sincerely,

Sarah Feinberg
Acting Administrator

    Issued in Washington, DC, on April 2015.
Melissa L. Porter,
Chief Counsel.
[FR Doc. 2015-08786 Filed 4-16-15; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 157 (Tuesday, August 14, 2018)]
[Notices]
[Pages 40275-40276]
[FR Doc No: 2018-17441]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2018-0102, FRL-9982-09-OEI]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; RCRA Expanded Public
Participation (Renewal)

AGENCY: Environmental Protection Agency (EPA)

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), RCRA Expanded Public
Participation (EPA ICR No. 1688.09, OMB Control No. 2050-0149), to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through August 31,
2018. Public comments were previously requested via the Federal
Register on March 21, 2018 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. 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.

DATES: Additional comments may be submitted on or before September 13,
2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-
2018-0102, to (1) EPA, either online using www.regulations.gov (our
preferred method), or by email to [email protected], or by mail to:
RCRA Docket (2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue NW, Washington, DC 20460; and (2) OMB via email to
[email protected]. Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Michael Pease, (5303P), Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The Resource Conservation and Recovery Act (RCRA) of
1976, as amended by the Hazardous and Solid Waste Amendments (HSWA) of
1984, requires EPA to establish a national regulatory program to ensure
that hazardous wastes are managed in a manner protective of human
health and the environment. Section 7004(b) of RCRA gives EPA broad
authority to provide for, encourage, and assist public participation in
the development, revision, implementation, and enforcement of any
regulation, guideline, information, or program under RCRA. In addition,
the statute

specifies certain public notices (i.e., radio, newspaper, and a letter
to relevant agencies) that EPA must provide before issuing any RCRA
permit. The statute also establishes a process by which the public can
dispute a permit and request a public hearing to discuss it. EPA
carries out much of its RCRA public involvement at 40 CFR parts 124 and
270.
    Form numbers: None.
    Respondents/affected entities: Businesses and other for-profit.
    Respondent's obligation to respond: Mandatory (RCRA 7004(b)).
    Estimated number of respondents: 46.
    Frequency of response: On occasion.
    Total estimated burden: 4,375 hours per year. Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $326,263 (per year), which includes $321,833
annualized labor and $4,430 annualized capital and operation &
maintenance costs.
    Changes in the estimates: There is a decrease in overall burden for
the ICR of 1,239 hours in the total estimated respondent burden
compared with the ICR currently approved by OMB. This decrease is due
to the decrease in the respondent universe from 59 to 46.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-17441 Filed 8-13-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 26, 2009 (Volume 74, Number 37)]
[Notices]
[Page 8842-8843]
[DOCID:fr26fe09-98]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2000-8398; FMCSA-2002-12294; FMCSA-2002-12844; FMCSA-
2004-17984; FMCSA-2005-20027]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
12 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent
to, or greater than, the level of safety maintained without the
exemptions for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective April 1, 2009. Comments must be
received on or before March 30, 2009.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2000-8398; FMCSA-2002-12294;
FMCSA-2002-12844; FMCSA-2004-17984; FMCSA-2005-20027, using any of the
following methods.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this Notice. Note that DOT posts all comments received without
change to http://www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://DocketInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 12 individuals who have requested a renewal
of their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 12 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:
David F. Breuer,
Wilford F. Christian,
Richard S. Cummings,
Joseph A. Dean,
Jimmy C. Killian,
Daniel L. Jacobs,
Jimmy C. Killian,
Jose M. Limon-Alvarado,
Eugene R. Lydick,
John W. Montgomery,
Billy L. Riddle,
Scottie Stewart,
Artis Suitt.
    These exemptions are extended subject to the following conditions:
(1) That each individual have a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provide a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retain a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two years unless rescinded
earlier by FMCSA. The exemption will be rescinded if: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer

than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 12 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (65 FR 78256; 66 FR 16311; 68 FR 13360; 70 FR 12265; 72 FR
11425; 67 FR 46016; 67 FR 57267; 69 FR 51346; 71 FR 50970; 67 FR 68719;
68 FR 2629; 70 FR 16887; 69 FR 33997; 69 FR 61292; 70 FR 2701). Each of
these 12 applicants has requested renewal of the exemption and has
submitted evidence showing that the vision in the better eye continues
to meet the standard specified at 49 CFR 391.41(b)(10) and that the
vision impairment is stable. In addition, a review of each record of
safety while driving with the respective vision deficiencies over the
past two years indicates each applicant continues to meet the vision
exemption standards. These factors provide an adequate basis for
predicting each driver's ability to continue to drive safely in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of two years is
likely to achieve a level of safety equal to that existing without the
exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by March 30, 2009.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 12 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was based on the merits of each
case and only after careful consideration of the comments received to
its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all of these drivers, are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

    Issued on: February 19, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-4147 Filed 2-25-09; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Proposed Rules]
[Pages 57137-57141]
[FR Doc No: 2015-23614]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 108

[Docket No. FDA-2015-N-2819]

Emergency Permit Control Regulations; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
amend certain regulations pertaining to registration and process
filings related to acidified foods and thermally processed low-acid
foods packaged in hermetically sealed containers (historically referred
to as ``low-acid canned foods'' or ``LACF''). The amendments would
reflect new FDA process filing form numbers and would make changes to
addresses or locations where such forms can be found or must be sent.
Additionally, the amendments would remove obsolete references to the
effective dates that occurred years ago and update a reference to
another Federal Agency.

DATES: Submit either electronic or written comments on the proposed
rule by December 7, 2015.

ADDRESSES: You may submit comments by any of the following methods.

Electronic Submissions

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

Written Submissions

    Submit written submissions in the following way:
     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-2015-N-2819) for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), 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: Susan Brecher, Center for Food Safety
and Applied Nutrition (HFS-302), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Among other things, current FDA regulations at part 108 (21 CFR
part 108) provide that a commercial processor, when first engaging in
the manufacture, processing, or packing of acidified foods or low-acid
canned foods, must, not later than 10 days after first so engaging,
register and file with FDA information including the name of the
establishment, principal place of business, the location of each
establishment in which that processing is carried on, the processing
method, and a list of foods so processed in each establishment (Sec.
108.25(c)(1) and Sec.  108.35(c)(1)). In addition, our regulations
require the submission of process filing forms. Specifically, our
regulations require that commercial processors engaged in the
processing of acidified foods must, not later than 60 days after
registration, and before packing any new product, provide FDA with
information on the scheduled processes for each acidified food in each
container size (Sec.  108.25(c)(2)). An analogous requirement for
process filing applies to commercial processors of low-acid canned
foods (Sec.  108.35(c)(2)). The regulations specify the specific
process filing forms to be used (Forms FDA 2541a and 2541c), and also
state where the forms can be obtained and where the forms should be
sent.
    We recently engaged in an effort to modernize our forms and to
provide a means for submitting the forms using electronic ``smart
form'' technology. This effort involved the drafting of four new draft
process filing forms: Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA
2541g. (For more information about the draft new process filing forms,
see ``Draft Guidance for Industry: Submitting Form FDA 2541 (Food
Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA
2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic
or Paper Format,'' available at http://www.fda.gov/FoodGuidances.) Once
completed, this effort will make it easier for firms to submit
information to us and will improve the accuracy of the information
submitted in the forms. In conjunction with these changes, the proposed
rule would make technical amendments to Sec.  108.25, ``Acidified
Foods,'' and Sec.  108.35, ``Thermal Processing of Low-Acid Foods
Packaged in Hermetically Sealed Containers.'' Specifically, the
proposed rule would incorporate the new FDA form numbers. FDA hopes to
finalize the new process filing forms later in 2015. By incorporating
the new FDA form numbers into part 108, the proposed rule would cause
the new forms to fully replace the forms currently listed in part 108
once this proposed rule becomes final and effective. At that point, FDA
would no longer accept the currently-listed forms.
    In addition, the proposed rule would make changes to the addresses
or locations where forms can be found or must be sent. Finally, the
proposed rule would remove obsolete references to dates that occurred
years ago and would update the name of the Agency of the U. S.
Department of Agriculture that administers the meat and poultry
inspection programs under the Federal Meat Inspection Act and the
Poultry Products Inspection Act.

II. Legal Authority

    We are issuing this proposed rule under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act). Section 404(a) of the FD&C Act (21 U.S.C.
344(a)) provides that whenever the Secretary finds after investigation
that the distribution in interstate commerce of any class of food may,
by reason of contamination with micro-organisms during the manufacture,
processing, or packing thereof in any locality, be injurious to health,
and that such injurious nature cannot be adequately determined after
such articles have entered interstate commerce, the Secretary then
shall issue regulations providing for the issuance, to manufacturers,
processors, or packers of such class of food in such locality, of
permits to which shall be attached such conditions governing the
manufacture, processing, or packing of such class of food, for such
temporary period of time, as may be necessary to protect the public
health. Under section 404 of the FD&C Act, FDA's regulations in part
108 have long required registration of food processing establishments,
filing of process information, and maintenance of processing and
production records for acidified foods and low-acid canned foods. Under
section 701(e) of the FD&C Act, any action for the issuance, amendment,
or repeal of any regulation under section 404(a) of the FD&C Act shall
be begun by a proposal made either by the Secretary on his own
initiative or by petition of any interested persons, showing reasonable
grounds therefor, filed with the Secretary.

III. Description of the Proposed Rule

    As stated in section I, the proposed rule would make technical
amendments to Sec.  108.25, ``Acidified Foods,'' and Sec.  108.35,
``Thermal Processing of Low-Acid Foods Packaged in Hermetically Sealed
Containers.'' These changes would incorporate the new FDA form

numbers and changes to the addresses or locations where forms can be
found or must be sent. These changes would also remove obsolete
references to dates that occurred years ago and would update the name
of the Agency of the U. S. Department of Agriculture that administers
the meat and poultry inspection programs under the Federal Meat
Inspection Act and the Poultry Products Inspection Act. Specifically,
the proposed rule would:
     Amend Sec.  108.25(c)(1) and (c)(2) and Sec.  108.35(c)(1)
and (c)(2) to replace the obsolete mailing code (HFS-618) listed in
those provisions with the current mailing code (HFS-303) for the FDA
office identified in those provisions.
     Amend Sec.  108.25(c)(1) and (c)(2) and Sec.  108.35(c)(1)
and (c)(2) to provide an Internet address where forms can be found or
submitted. The new text would state that the forms are available on our
Web site at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm and,
for electronic submission, would refer to FDA's Industry Systems Web
site at www.access.fda.gov.
     Amend Sec.  108.25(c)(1) by deleting ``Commercial
processors presently so engaged shall register within 120 days after
the effective date of this regulation.'' We propose to delete this
sentence because the effective date occurred years ago, so the sentence
is no longer necessary. We also propose to replace the sentence stating
that ``Foreign processors shall register within 120 days after the
effective date of this regulation or before any offering of foods for
import into the United States, whichever is later,'' with a new
sentence stating that ``Foreign processors shall register before any
offering of foods for import into the United States.'' We propose to
make this change because the effective date occurred years ago, so
reference to the effective date is no longer necessary.
     Amend Sec.  108.25(c)(2) by replacing ``form FDA 2541a
(food canning establishment process filing form for all methods except
aseptic)'' with ``Form FDA 2541e (Food Process Filing for Acidified
Method).'' This change would reflect the new form number and form that
FDA is introducing.
     Amend Sec.  108.35(c)(1) by deleting the sentence stating
that ``Commercial processors presently so engaged shall register not
later than July 13, 1973.'' Given the passage of time since Sec.
108.35(c)(1) was issued, reference to the date of July 13, 1973, is no
longer necessary.
     Amend Sec.  108.35(c)(2) by replacing ``Form FDA 2541a
(food canning establishment process filing for all methods except
aseptic), or Form FDA 2541c (food canning establishment process filing
for aseptic systems)'' with a list of the following new forms: Form FDA
2541d (Food Process Filing for Low-Acid Retorted Method); Form FDA
2541f (Food Process Filing for Water Activity/Formulation Control
Method); and Form FDA 2541g (Food Process Filing for Low-Acid Aseptic
Systems). These changes refer to the new form numbers and forms that
FDA is introducing.
     Amend Sec.  108.35(c)(2)(ii) by inserting ``LACF
Registration Coordinator (HFS-303)'' before ``Center for Food Safety
and Applied Nutrition.'' This change would provide greater specificity
as to the FDA office that should receive information for purposes of
Sec.  108.35(c)(2)(ii).
     Amend Sec.  108.35(i) (which refers to ``the meat and
poultry inspection program of the Animal and Plant Health Inspection
Service of the Department of Agriculture'') by replacing ``Animal and
Plant Health Inspection Service'' with ``Food Safety Inspection
Service.'' We are making this change because the Food Safety and
Inspection Service of the U.S. Department of Agriculture now
administers the meat and poultry inspection program under the Federal
Meat Inspection Act and the Poultry Products Inspection Act, and not
the Animal and Plant Health Inspection Service.

IV. Proposed Effective Date

    We propose that any final rule resulting from this rulemaking
process become effective 30 days after its date of publication in the
Federal Register.

V. Economic Analysis of Impacts

    We are publishing this proposed rule under the formal rulemaking
process. Executive Order 12866 does not require us to analyze the costs
and benefits of proposed rules that we publish under this rulemaking
process.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The proposed rule would amend Sec. Sec.  108.25 and
108.35 to delete obsolete references to long-expired effective dates,
make changes to FDA addresses or locations, and reflect new process
filing forms. With regard to the new process filing forms, FDA would
replace references to Forms FDA 2541a and FDA 2541c with references to
four new process filing forms: Forms FDA 2541d, FDA 2541e, FDA 2541f,
and FDA 2541g. Some of the data entry fields on the four new process
filing forms are not on current Forms FDA 2541a and FDA 2541c. The new
forms add certain data entry fields to improve the efficiency of FDA's
review of the process filings. For example, the new forms include data
entry fields for the ``food product group'' (such as liquid, ready-to-
eat ``breakfast foods''). In addition, the new forms provide for
``smart form'' technology using an electronic submission system. The
updated process filing portion of the electronic submission system
queries the processor about the processes used to produce the food and
presents only those data entry fields that are applicable. As a result,
processors will no longer need to evaluate whether particular data
entry fields are applicable to their products. For example, when a
processor submits a process filing for a product that is processed
using a low-acid retorted method with a process mode of ``agitating,''
smart form technology would bypass questions that are not applicable to
this process mode option. We estimate that the additional time it would
take processors to complete the new information requested on the new
forms would be offset by the time processors will save by not having to
evaluate whether certain data entry fields on Form FDA 2541a or FDA
2541c are applicable to their products. Hence, we propose to certify
that the rule, if finalized, will not have a significant economic
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

VI. Analysis of Environmental Impact

    FDA has determined, under 21 CFR 25.30(i), that this proposed rule
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.

VII. Paperwork Reduction Act of 1995

    This proposed 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 (44 U.S.C. 3501-3520). These
collections of information have been previously approved under OMB
control number 0910-0037 which expires September 30, 2017.

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
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 tentatively conclude that the proposed 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.

IX. Additional Information Regarding Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
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.

List of Subjects in 21 CFR Part 108

    Administrative practice and procedure, Foods, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 108 be amended as follows:

PART 108--EMERGENCY PERMIT CONTROL

0
1. The authority citation for 21 CFR part 108 continues to read as
follows:

    Authority:  21 U.S.C. 342, 344, 371.

0
2. In Sec.  108.25, revise paragraphs (c)(1) and (c)(2) to read as
follows:

Sec.  108.25  Acidified foods.

* * * * *
    (c)(1) Registration. A commercial processor, when first engaging in
the manufacture, processing, or packing of acidified foods in any
State, as defined in section 201(a)(1) of the act, shall, not later
than 10 days after first so engaging, register and file with the Food
and Drug Administration on Form FDA 2541 (food canning establishment
registration) information including, but not limited to, the name of
the establishment, principal place of business, the location of each
establishment in which that processing is carried on, the processing
method in terms of acidity and pH control, and a list of foods so
processed in each establishment. These forms are available from the
LACF Registration Coordinator (HFS-303), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at any Food and Drug Administration
district office. The completed form shall be submitted to the Center
for Food Safety and Applied Nutrition (HFS-565), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. These
forms also are available on the Food and Drug Administration's Web site
at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. For electronic submission go
to FDA's Industry Systems Web site at www.access.fda.gov. Foreign
processors shall register before any offering of foods for import into
the United States. Commercial processors duly registered under this
section shall notify the Food and Drug Administration not later than 90
days after the commercial processor ceases or discontinues the
manufacture, processing, or packing of the foods in any establishment,
except that this notification shall not be required for temporary
cessations due to the seasonal character of an establishment's
production or by temporary conditions including, but not limited to,
labor disputes, fire, or acts of God.
    (2) Process filing. A commercial processor engaged in the
processing of acidified foods shall, not later than 60 days after
registration, and before packing any new product, provide the Food and
Drug Administration information on the scheduled processes including,
as necessary, conditions for heat processing and control of pH, salt,
sugar, and preservative levels and source and date of the establishment
of the process, for each acidified food in each container size. Filing
of this information does not constitute approval of the information by
the Food and Drug Administration, and information concerning processes
and other data so filed shall be regarded as trade secrets within the
meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall
be submitted on Form FDA 2541e (Food Process Filing for Acidified
Method). Forms are available from the LACF Registration Coordinator
(HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at
Food and Drug Administration district office. The completed form shall
be submitted to the LACF Registration Coordinator (HFS-618), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740. These forms also are
available on the Food and Drug Administration's Web site at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. For electronic submission go
to FDA's Industry Systems Web site at www.access.fda.gov.
* * * * *
0
3. In Sec.  108.35, revise paragraphs (c)(1), (c)(2) introductory text,
(c)(2)(ii), and (i) to read as follows:

Sec.  108.35  Thermal processing of low-acid foods packaged in
hermetically sealed containers.

* * * * *
    (c) * * *
    (1) Registration. A commercial processor when first engaging in the
manufacture, processing, or packing of thermally processed low-acid
foods in hermetically sealed containers in any state, as defined in
section 201(a)(1) of the act, shall, not later than 10 days after first
so engaging, register with the Food and Drug Administration on Form FDA
2541 (food canning establishment registration) information including
(but not limited to) his name, principal place of business, the
location of each establishment in which such processing is carried on,
the processing method in terms of the type of processing equipment
employed, and a list of the low-acid foods so processed in each such
establishment. These forms are available from the LACF Registration
Coordinator (HFS-303), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or at any Food and Drug Administration district office. The
completed form shall be submitted to the LACF Registration

Coordinator (HFS-618), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740. These forms also are available on the Food and Drug
Administration's Web site at http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCanned/Foods/default.htm.
For electronic submission go to FDA's Industry Systems Web site at
www.access.fda.gov. Commercial processors duly registered in accordance
with this section shall notify the Food and Drug Administration not
later than 90 days after such commercial processor ceases or
discontinues the manufacture, processing, or packing of thermally
processed foods in any establishment: Provided, That such notification
shall not be required as to the temporary cessation necessitated by the
seasonal character of the particular establishment's production or
caused by temporary conditions including but not limited to strikes,
lockouts, fire, or acts of God.
    (2) Process filing. A commercial processor engaged in the thermal
processing of low-acid foods packaged in hermetically sealed containers
shall, not later than 60 days after registration and prior to the
packing of a new product, provide the Food and Drug Administration
information as to the scheduled processes including but not limited to
the processing method, type of retort or other thermal processing
equipment employed, minimum initial temperatures, times and
temperatures of processing, sterilizing value (Fo), or other equivalent
scientific evidence of process adequacy, critical control factors
affecting heat penetration, and source and date of the establishment of
the process, for each such low-acid food in each container size:
Provided, That the filing of such information does not constitute
approval of the information by the Food and Drug Administration, and
that information concerning processes and other data so filed shall be
regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18
U.S.C. 1905. This information shall be submitted on the following forms
as appropriate: Form FDA 2541d (Food Process Filing for Low-Acid
Retorted Method), Form FDA 2541f (Food Process Filing for Water
Activity/Formulation Control Method), or Form FDA 2541g (Food Process
Filing for Low-Acid Aseptic Systems). These forms are available from
the LACF Registration Coordinator (HFS-303), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at any Food and Drug Administration
district office. The completed form(s) shall be submitted to the LACF
Registration Coordinator (HFS-303), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740. These forms also are available on the Food and
Drug Administration's Web site at http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm.
For electronic submission, go to FDA's Industry Systems Web site at
www.access.fda.gov.
* * * * *
    (ii) If a packer intentionally makes a change in a previously filed
scheduled process by reducing the initial temperature or retort
temperature, reducing the time of processing, or changing the product
formulation, the container, or any other condition basic to the
adequacy of scheduled process, he shall prior to using such changed
process obtain substantiation by qualified scientific authority as to
its adequacy. Such substantiation may be obtained by telephone,
telegram, or other media, but must be promptly recorded, verified in
writing by the authority, and contained in the packer's files for
review by the Food and Drug Administration. Within 30 days after first
use, the packer shall submit to the LACF Registration Coordinator (HFS-
303), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 a
complete description of the modifications made and utilized, together
with a copy of his file record showing prior substantiation by a
qualified scientific authority as to the safety of the changed process.
Any intentional change of a previously filed scheduled process or
modification thereof in which the change consists solely of a higher
initial temperature, a higher retort temperature, or a longer
processing time, shall not be considered a change subject to this
paragraph, but if that modification is thereafter to be regularly
scheduled, the modified process shall be promptly filed as a scheduled
process, accompanied by full information on the specified forms as
provided in this paragraph.
* * * * *
    (i) This section shall not apply to the commercial processing of
any food processed under the continuous inspection of the meat and
poultry inspection program of the Food Safety Inspection Service of the
Department of Agriculture under the Federal Meat Inspection Act (34
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat.
791 (21 U.S.C. 451 et seq.)).
* * * * *

    Dated: September 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23614 Filed 9-21-15; 8:45 am]
 BILLING CODE 4164-01-P