[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Rules and Regulations]
[Pages 45416-45418]
[FR Doc No: 2019-18605]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0739]
RIN 1625-AA00

Safety Zone; Apple Vacations Fireworks; Lake Michigan, Chicago IL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Lake Michigan in Chicago, Illinois, in order to protect vessels and
persons from the potential hazards associated with a barge based
fireworks display. The temporary safety zone will encompass all waters
within a 560 foot radius from the designated barge responsible for the
display. The barge will be located in approximate position
41[deg]55'42.62'' N, 87[deg]37'34.28'' W. Vessels will not be allowed
to enter, transit through, or anchor within the safety zone without the
permission of the Captain of the Port Lake Michigan or a designated
representative.

DATES: This rule is effective from 9:35 p.m. through 10:05 p.m. on
September 9, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2019-0739 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email LT Tiziana Garner, Marine Safety Unit Chicago, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to the public interest. The final details for this event were
not known to the Coast Guard until there was insufficient time
remaining before the event to publish an NPRM. Delaying the effective
date of this rule to wait for a comment period to run would inhibit the
Coast Guard's ability to protect the public and vessels from the
hazards associated with a barge based fireworks display.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date would
be contrary to the rule's objectives of protecting safety of life on
the navigable waters in the vicinity of the fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Lake
Michigan has determined that the barge based fireworks display will
pose a significant risk to public safety and property. Such hazards
include premature and accidental detonations, falling and burning
debris, and collisions among spectator vessels. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the safety zone while the fireworks display takes place.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9:35 p.m. through 10:05
p.m. on September 9, 2019. The safety zone will encompass all waters
within a 560 foot radius centered on the designated barge responsible
for the fireworks. The barge will be located in approximate position
41[deg]55'42.62'' N, 87[deg]37'34.28'' W. Vessels will not be allowed
to enter, transit through, or anchor within the safety zone without the
permission of the Captain of the Port Lake Michigan or a designated
representative. The Captain of the Port Lake Michigan or a designated
on-scene representative may be contacted via VHF Channel 16.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the conclusion
that this rule is not a significant regulatory action. We anticipate
that it will have minimal impact on the economy, will not interfere
with other agencies, will not adversely alter the budget of any grant
or loan recipients, and will not raise any novel legal or policy
issues. The safety zone created by this rule will be

relatively small and enforced for a short time. Also, the safety zone
is designed to allow vessels to transit around it. Thus, restrictions
on vessel movement within that particular area are expected to be
minimal. Under certain conditions, moreover, vessels may still transit
through the safety zone when permitted by the Captain of the Port.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone lasting one half hour
that will prohibit entry within 560 feet of approximate location
41[deg]55'42.62'' N, 87[deg]37'34.28'' W. It is categorically excluded
from further review under paragraph L60(a) in Table 3-1 of U.S. Coast
Guard Environmental Planning Implementing Procedures 5090.1. A Record
of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0739 to read as follows:

Sec.  165.T09-0739   Safety Zone; Apple Vacations Fireworks; Lake
Michigan, Chicago, IL.

    (a) Location. The safety zone will encompass all waters within a
560 foot radius centered on a designated barge during a barge based
fireworks display. The barge will be located in approximate position
41[deg]55'42.62'' N, 87[deg]37'34.28'' W.
    Effective and enforcement period. This safety zone will be enforced
from 9:35 p.m. until 10:05 p.m. on September 9, 2019.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Lake Michigan or a designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Lake Michigan or a designated
on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port Lake
Michigan is any Coast Guard commissioned, warrant, or petty officer who
has been designated by the Captain of the Port

Lake Michigan to act on his or her behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Lake Michigan or an on-scene
representative to obtain permission to do so. The Captain of the Port
Lake Michigan or an on-scene representative may be contacted via VHF
Channel 16 or at<PHONE_NUMBER>. Vessel operators given permission to
enter or operate in the safety zone must comply with all directions
given to them by the Captain of the Port Lake Michigan, or an on-scene
representative.

    Dated: August 22, 2019.
Thomas J. Stuhlreyer,
Captain, U.S. Coast Guard, Captain of the Port Lake Michigan.
[FR Doc. 2019-18605 Filed 8-28-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Notices]
[Page 25344]
[FR Doc No: 2013-10076]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2013-0037]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    In accordance with Part 235 of Title 49 Code of Federal Regulations
and 49 U.S.C. 20502(a), this document provides the public notice that
by a document dated March 26, 2013, the Western New York & Pennsylvania
Railroad, LLC (WNYP) has petitioned the Federal Railroad Administration
(FRA) seeking approval for the discontinuance or modification of a
signal system. FRA assigned the petition Docket Number FRA-2013-0037.
    Applicant: Western New York & Pennsylvania Railroad, LLC, Mr. Carl
P. Belke, President and Chief Operating Officer, 3146 Constitution
Avenue, Olean, New York 14760.
    WNYP seeks approval of the proposed discontinuance of the remaining
automatic block signal, interlocking, and traffic control system from
Control Point (CP) South Olean at Milepost (MP) BR73.0 up to and
including CP North Olean at MP BR66.49 on WNYP's Buffalo Line, as well
as on WNYP's Main Line from MP JC-393 to MP JC-397.86, which crosses
the Buffalo Line at grade at CP Olean in Olean, NY. All power-operated
switches in the application area will be converted to hand operation.
Operation will be governed by the General Code of Operating Rules track
warrant control limit rules, using a computer-aided dispatching system.
    In its petition, WNYP states that it requests the proposed changes
due to the reduction in train service activity and a need to eliminate
unused and unnecessary track and track appurtenances.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's Docket Operations Facility, 1200 New Jersey Avenue
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received by June 14, 2013 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

    Issued in Washington, DC, on April 24, 2013.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2013-10076 Filed 4-29-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 85, Number 93 (Wednesday, May 13, 2020)]
[Notices]
[Page 28658]
[FR Doc No: 2020-10201]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4532-DR; Docket ID FEMA-2020-0001]

Vermont; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Vermont (FEMA-4532-DR), dated April 8, 2020, and
related determinations.

DATES: This amendment was issued April 30, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Vermont is hereby amended to include Individual
Assistance limited to the Crisis Counseling Program for those areas
determined to have been adversely affected by the event declared a
major disaster by the President in his declaration of April 8, 2020.

    Individual Assistance limited to the Crisis Counseling Program
for all areas in the State of Vermont (already designated for
emergency protective measures [Category B] not authorized under
other Federal statutes, including direct Federal assistance).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-10201 Filed 5-12-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84575-84576]
[FR Doc No: 2016-28191]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER17-184-001.
    Applicants: SociVolta Inc.
    Description: Tariff Amendment: Amendment to 1 to be effective 1/1/
2017; also filed was SociVolta Inc. tariff filing Amendment (Asset
Appendix).
    Filed Date: 11/17/16.
    Accession Number: 20161117-5119, 20161117-5122.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-369-000.
    Applicants: Benson Power, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 1/17/2017.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5035.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-370-000.
    Applicants: CPV Biomass Holdings, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 1/17/2017.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5037.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-371-000.
    Applicants: CPV Keenan II Renewable Energy Company.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 1/17/2017.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5039.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-372-000.
    Applicants: CPV Maryland, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 1/17/2017.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5042.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-373-000.
    Applicants: CPV Shore, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 1/17/2017.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5043.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-374-000.
    Applicants: CPV Towantic, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 1/17/2017.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5044.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-375-000.
    Applicants: CPV Valley, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 1/17/2017.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5045.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-376-000.
    Applicants: Public Service Company of New Hampshire.
    Description: Tariff Cancellation: Cancellation of PSNH Rate
Schedule No. IA-PSNH-08 Springfield Power, LLC to be effective 10/25/
2016.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5051.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-377-000.
    Applicants: NorthWestern Corporation.
    Description: Tariff Cancellation: Notice of Cancellation and
Termination--Service Agreements to be effective 11/18/2016.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5052.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-378-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 794--Agreement with
Phillips County re Malta Bridge Project to be effective 11/18/2016.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5072.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-379-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: BPA NITSA (CEC Load) Rev 1
to be effective 11/30/2016.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5103.
    Comments Due: 5 p.m. ET 12/8/16.

    Docket Numbers: ER17-380-000.
    Applicants: Stored Solar J&WE, LLC.
    Description: Baseline eTariff Filing: Baseline new to be effective
12/1/2016.
    Filed Date: 11/17/16.
    Accession Number: 20161117-5120.
    Comments Due: 5 p.m. ET 12/8/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings

must file in accordance with Rules 211 and 214 of the Commission's
Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern
time on the specified comment date. Protests may be considered, but
intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    DATED: November 17, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-28191 Filed 11-22-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 214 (Wednesday, November 5, 2014)]
[Notices]
[Pages 65739-65741]
[FR Doc No: 2014-26234]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73477; File No. SR-EDGA-2014-24]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Rule
11.12, Limitation of Liability

October 30, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 27, 2014, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') 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 Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend Rule 11.12, Limitation of
Liability, to harmonize its liability caps with those set forth under
BATS Exchange, Inc. (``BATS'') Rule 11.16 and BATS Y-Exchange, Inc.
(``BYX'') Rule 11.16.\5\
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    \5\ See BATS Rule 11.16(d)(1)-(3); BYX Rule 11.16(d)(1)-(3).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at http://www.directedge.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 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 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 Rule 11.12, Limitation of Liability,
to harmonize its liability caps with those set forth under BATS Rule
11.16 and BYX Rule 11.16.\6\ Earlier this year, the Exchange and its
affiliate EDGX Exchange, Inc. (``EDGX'') received approval to effect a
merger (the ``Merger'') of the Exchange's parent company, Direct Edge
Holdings LLC, with BATS Global Markets, Inc., the parent of BATS and
BYX (together with BATS, BYX, EDGA and EDGX, the ``BGM Affiliated
Exchanges'').\7\ In the context of the Merger, the BGM Affiliated
Exchanges are working to align certain rules, retaining only intended
differences between the BGM Affiliated Exchanges. As part of this
effort, BATS and BYX recently filed proposed rule changes with the
Commission to amend paragraph (f) of Rule 11.16 to align with EDGA Rule
11.12(d)(3) and (e) as well as EDGX Rule 11.12(d)(3) and (e).\8\ Thus,
the proposal set forth below harmonizes remaining sections of Exchange
Rule 11.12 and BATS and BYX Rules 11.16 by aligning the liability caps
in order to provide consistent member reimbursement requirements for
users of the BGM Affiliated Exchanges.\9\
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    \6\ Id.
    \7\ See Securities Exchange Act Release No. 71449 (January 30,
2014), 79 FR 6961 (February 5, 2014) (SR-EDGX-2013-43; SR-EDGA-2013-
34).
    \8\ See Securities Exchange Act Release Nos. 73356 (October 15,
2014) (SR-BATS-2014-045); and 73357 (October 15, 2014) (SR-BYX-2014-
027). In sum, BATS and BYX amended Rule 11.16 to align with Exchange
Rule 11.12 to provide members with additional time within which to
submit a written claim for compensation for ``losses resulting
directly from the malfunction of the Exchange's physical equipment,
devices and/or programming or the negligent acts or omissions of its
employees'' and add a new paragraph (g) to Rule 11.16 to permit the
Exchange, subject to certain conditions and limitations, to
compensate Members for certain losses incurred in connection with
orders or portions of orders routed by the Exchange through its
affiliated routing broker-dealer, BATS Trading, Inc., to Trading
Centers where such losses are claimed by the Member to have resulted
directly from a malfunction of the physical equipment, devices and/
or programming, or the negligent acts or omissions of the employees,
of such Trading Centers.
    \9\ The Exchange understands that EDGX is to file a proposed
rule change with the Commission to adopt similar requirements.
---------------------------------------------------------------------------

    Rule 11.12 currently states that, except as provided in subsection
(d) of the Rule, the Exchange and its affiliates shall not be liable
for any losses, damages, or other claims arising out of the Exchange or
its use. Exchange Rule 11.16(d) provides a limited exception to its
general limitation of liability that allows for the payment of
compensation to Members for ``losses resulting directly from the
malfunction of the Exchange's physical equipment, devices and/or
programming or the negligent acts or omissions of its employees''
(``Exchange Systems Issues''), subject to certain conditions.
Subsection (d)(1) of Rule 11.12 limits the aggregate limits of all
claims made by all Members during a single calendar month to the larger
of $500,000, or the amount of any recovery obtained by the Exchange
under any applicable insurance maintained by the Exchange.
    The Exchange now proposes to renumber subsection (d)(1) of the Rule
11.12 and adopt new subsections (d)(1) and (2) under Rule 11.12 to
harmonize its liability caps with those set forth under existing rules
of BATS and BYX.\10\ Under the proposed rule change, the Exchange would
cap its liability for Exchange Systems Issues under proposed Rule
11.12(d)(1) and (2): (i) To a single Member at the greater of $100,000
or the amount recovered under any applicable insurance policy on a
single trading day; (ii) to all Members at the greater of $250,000 or
the amount recovered under any applicable insurance policy on a single
trading day. Current Rule 11.12(d)(1) would be re-numbered as
subsection (d)(3) and continue to cap the Exchange's liability to all
Members at the greater of $500,000 or the amount recovered under any
applicable insurance policy in a single calendar month.\11\
---------------------------------------------------------------------------

    \10\ See supra note 5.
    \11\ The Exchange notes that under renumbered Rule 11.12(g)(4)
any compensation paid to Members from reimbursement recovered from a
Trading Center for a routed order will not count against the
Exchange's liability limits set forth in Rule 11.12(d), nor any
applicable insurance maintained by the Exchange. Securities Exchange
Act Release Nos. 71061 (December 12, 2013), 78 FR 76685 (December
18, 2013) (SR-EDGA-2013-36) (Notice of Filing and Immediate
Effectiveness of Proposed Rule Change To Amend EDGA Rule 11.12,
Limitations of Liability); and 71062 (December 12, 2013), 78 FR
76693 (December 18, 2013) (SR-EDGX-2013-45) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change To Amend EDGX Rule
11.12, Limitations of Liability).
---------------------------------------------------------------------------

    The Exchange also proposes to amend Rule 11.12(d)(2) to align with
the proposed liability caps for a single trading day. Specifically,
proposed Rule 11.12(d)(2) would be amended to clarify that, to the
extent that all claims resulting from Exchange Systems Issues cannot be
fully satisfied because in the aggregate they exceed the applicable
maximum amount of liability provided for, then the Exchange proposes to
allocate the maximum amount among all such claims arising on a single
trading day or during a single calendar month, as applicable, based on
the proportion that each such claim bears to the sum of all such
claims. Rule 11.12(d)(2) would also be renumbered as Rule 11.12(e).
    The Exchange also proposes to amend Rule 11.12(e)(4) to align with
the amended liability caps as well as to renumber other sections within
Rule 11.12 to mirror BATS Rule 11.16 and BYX Rule 11.16.
Implementation Date
    The Exchange intends to implement the proposed rule change on or
about November 6, 2014, which is the anticipated operative date of
recently filed BATS and BYX proposed rule changes to align BATS and BYX
Rules 11.16 with EDGA and EDGX Rules 11.12(d)(3) and (e).\12\ The
Exchange will announce the implementation of the proposed rule change
via a trading notice to be posted on the Exchange's Web site.
---------------------------------------------------------------------------

    \12\ See supra note 8.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \13\ and furthers the objectives of
Section 6(b)(5) of the Act,\14\ in that it is designed promote just and
equitable principles of trade, remove impediments to, and perfect the
mechanism of, a free and open market and a national market system, and,
in general, protect investors and the public interest. The proposal, in
effect, would allow the Exchange to ensure that compensation for a
single incident did not exceed the monthly cap of $500,000, thereby
providing [sic] enabling the Exchange to possibly compensate Members
for instances on multiple trading days per month subject to Rule
11.12(d)(3). The Exchange believes that the proposed rule change is not
designed to permit unfair discrimination between customers, issuers,
brokers or dealers. The proposed rule change is substantially similar
to the existing rules of BATS and BYX.\15\ The proposed rule change is
intended to align the liability caps for Member reimbursements with
that currently provided by BATS and BYX in order to provide a
consistent rules across the BGM Affiliated Exchanges. Consistent rules,
in turn, will simplify

the regulatory requirements for Members of the Exchange that are also
participants on EDGA and EDGX. The proposed rule change would provide
greater harmonization between EDGX and EDGA rules of similar purpose,
resulting in greater uniformity and less burdensome and more efficient
regulatory compliance. As such, the proposed rule change would foster
cooperation and coordination with persons engaged in facilitating
transactions in securities and would remove impediments to and perfect
the mechanism of a free and open market and a national market system.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ See supra note 5.
---------------------------------------------------------------------------

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

    The proposed rule change would not impose any burden on
competition. The Exchange believes that the proposed rule changes will
not burden intramarket competition because all Members would be subject
to the same liability caps for claims resulting from Exchange Systems
Issues. The proposed rule change is not designed to address any
competitive issues but rather is designed to provide greater
harmonization among Exchange and BATS and BYX rules of similar purpose,
resulting in less burdensome and more efficient regulatory compliance
for common members of the BGM Affiliated Exchanges.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \16\ and Rule 19b-4(f)(6) thereunder.\17\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6)
thereunder.\18\
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ 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.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\19\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. Waiver of the 30-day
operative delay would provide consistent rules across the BGM
Affiliated Exchanges which will simplify the regulatory requirements
for Members of the Exchange that are also participants on EDGX, BATS
and BYX. In addition, the Commission notes that the proposed rule
change is identical to the existing rules of BATS and BYX. Based on the
foregoing, the Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest.\20\ The Commission hereby grants the Exchange's request and
designates the proposal operative upon filing.
---------------------------------------------------------------------------

    \19\ 17 CFR 240.19b-4(f)(6)(iii).
    \20\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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 shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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-EDGA-2014-24 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-EDGA-2014-24. 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
10:00 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; 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-EDGA-2014-24 and should be
submitted on or before November 26, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2014-26234 Filed 11-4-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Notices]
[Page 45633]
[FR Doc No: 2020-15976]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD20-18-000]

Offshore Wind Integration in RTOs/ISOs; Supplemental Notice of
Technical Conference

    On June 17, 2020, the Commission issued a notice in the above-
captioned proceeding and provided self-nomination instructions for
those wishing to participate as panelists. However, due to unforeseen
circumstances, the self-nomination form is not accepting submissions.
Therefore, in this supplemental notice,\1\ we request that individuals
interested in participating as panelists--including individuals who
used the web-based form prior to the date of this notice--submit their
self-nominations by Friday, August 14, 2020 at 5:00 p.m., via email to
Ben Foster<EMAIL_ADDRESS>and to Sarah McKinley,
<EMAIL_ADDRESS>---------------------------------------------------------------------------

    \1\ 18 CFR 2.1(a)(1)(xi) (2019).
---------------------------------------------------------------------------

    The subject line of your email should specify, ``Speaker nomination
for Offshore Wind Integration Technical Conference.'' Please include
the following information in your nomination:

 First name
 Last name
 Title
 Company or organization
 Address
 City, State, and Zip Code
 Email address
 Telephone number
 Whether you are speaking on behalf of an organization
 Speaker bio (1-2 paragraphs)
 Topic(s) to be addressed

    For more information, please contact Ben Foster,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Sarah McKinley,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
    Dated: July 17, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-15976 Filed 7-28-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 27, 2010 (Volume 75, Number 186)]
[Notices]
[Page 59268-59272]
[DOCID:fr27se10-99]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0434]

Draft Guidance for Industry: Acidified Foods; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Acidified Foods.'' The draft guidance, when finalized, will complement
FDA's regulations regarding acidified foods, including regulations for
specific current good manufacturing practice (CGMP), establishment
registration, and process filing. The draft guidance is intended to
assist commercial food processors in determining whether their food
products are subject to these regulations. The draft guidance also is
intended to assist processors of acidified foods in ensuring safe
manufacturing, processing, and packing processes and in employing
appropriate quality control procedures. Under the draft guidance,
processors of non-acidified foods (e.g., some acid foods or fermented
foods) who are not subject to the acidified food regulations may choose
to voluntarily register and file scheduled processes with us using
existing forms (Forms FDA 2541 and 2541a). If such processors
voluntarily submit this information, we plan to make the results of any
FDA evaluation of the information available to our investigators, e.g.,
during inspections of food facilities and during evaluations of foods
offered for import.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments concerning the
draft guidance by December 27, 2010. Submit either electronic or
written comments concerning the collection of information provisions by
December 27, 2010.

ADDRESSES:  Submit electronic comments on the draft guidance and the
proposed collection of information provisions to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit written requests for single
copies of the draft guidance entitled ``Guidance for Industry:
Acidified Foods'' to the Office of Food Safety, Center for Food Safety
and Applied Nutrition (HFS-302), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed
adhesive labels to assist that office in processing your request, or
fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:
    With regard to the draft guidance document: Michael Mignogna,
Center for Food Safety and Applied Nutrition (HFS-302), Food and Drug
Administration, 5100 Paint Branch Parkway, College Park, MD 20740, 301-
436-1565.
    With regard to the information collection: Denver Presley, Jr.,
Office of Information Management, Food and Drug Administration, 1350
Piccard Dr., PI50-400B, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Acidified Foods.'' The draft guidance, when
finalized, will complement FDA's regulations regarding acidified foods,
including regulations for specific CGMP, establishment registration,
and process filing. The draft guidance is intended to assist commercial
food processors in determining whether their food products are subject
to these regulations. Under the draft guidance, processors of acid
foods and fermented foods who conclude that such foods they produce are
not also acidified foods\1\ may voluntarily register and file scheduled
processes with us using existing forms (Forms FDA 2541 and 2541a) for
acidified foods. Processors of

acid foods and fermented foods, which foods are not also acidified
foods, would not be subject to the acidified food regulations. When
processors of such acid foods or fermented foods voluntarily register
and file scheduled processes with us using existing forms, we plan to
make the results of any FDA evaluation of such information available to
our investigators, e.g., during inspections of food facilities and
during evaluations of foods offered for import, to facilitate
investigators' decisions about the regulatory status of those food
products. The draft guidance recommends that such processors, who
voluntarily file scheduled processes with us, file a single scheduled
process for each product, rather than filing a separate form for each
container size, as required for processors of acidified foods. The
draft guidance also is intended to assist processors of acidified foods
in ensuring safe manufacturing, processing, and packing processes and
in employing appropriate quality control procedures. FDA is issuing
this draft guidance as a level 1 draft guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent FDA's current thinking on this topic. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.
---------------------------------------------------------------------------

    \1\ Fermented foods, such as some kinds of sauerkraut, cucumber
pickles, and green olives, are low-acid foods subjected to the
action of acid-producing microorganisms to reduce the pH of the
food. Not all fermented foods meet the definition of ``acidified
foods'' in 21 CFR 114.3(b). However, some fermented foods that
contain acid are also acidified foods. We also note that fermented
dairy products, such as yogurt, belong to a separate category that
is not relevant to the fermented foods that are discussed in this
guidance.
---------------------------------------------------------------------------

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Recommendations for Establishment-Specific Written Quality
Control Plans and Recordkeeping for Acidified Foods, and Voluntary
Registration and Process Filing.
    Description of respondents: The likely respondents to this proposed
collection of information are processors of acidified foods as well as
processors of foods that may not be acidified foods who voluntarily
choose to provide us with information about these foods.
    Description: The draft guidance is intended to assist processors of
acidified foods in ensuring safe manufacturing, processing, and packing
processes and in employing appropriate quality control procedures.
Further, this guidance notes that processors who are not certain as to
whether specific food products, including foods that may be acid or
fermented foods, are acidified foods subject to registration and
process filing requirements may provide us with information about these
products by voluntarily submitting Forms FDA 2541 and 2541a. This
guidance also recommends that firms prepare a written plan to
investigate product lots for signs of spoilage and document any
investigation and corrective actions relevant to spoilage.
    This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in Sec.  108.25 (21 CFR 108.25) and part 114 (21 CFR part 114) have
been approved under OMB control no. 0910-0037.
    Under the draft guidance, when processors voluntarily submit Forms
FDA 2541 and 2541a for foods that they conclude are not acidified
foods, we intend to continue to evaluate the process information to
determine whether it is consistent with a processor's conclusion that a
food is not an acidified food. The burden approved under OMB control
no. 0910-0037 does not include the burden associated with voluntary
reporting.
    The burden approved under OMB control no. 0910-0037 also does not
include the burden associated with the recommendations in the draft
guidance to prepare a written plan (the establishment-specific written
plan) that includes quality control procedures with respect to spoilage
and to document spoilage events if they occur. We estimate the
recordkeeping burden of the draft guidance by assuming that those in
the industry that process acidified foods and that do not currently
follow the recommendations put forth in the draft guidance will find it
of value to do so. The conservative assumptions and estimates made in
this analysis regarding the recordkeeping burden are intended to
provide the upper bound estimates of anticipated impact of the guidance
on the acidified food industry and others that choose to file voluntary
submissions with FDA. These burdens would be realized if every
operation, plant, or processor of acidified foods that does not already
follow the recommendations of the draft guidance would choose to do so.
    We estimate the proposed collection of information consists of one-
time and recurring recordkeeping burdens, summarized in table 1 of this
document.
    We estimate the reporting burden of the draft guidance by assuming
that processors who conclude that their specific food products are acid
foods or fermented foods, rather than acidified foods subject to
registration and process filing requirements, will find it of value to
provide us with information about their products by voluntarily
submitting Forms FDA 2541 and 2541a. The conservative assumptions and
estimates made in this analysis regarding the reporting burden are
intended to provide the upper bound estimates of anticipated impact of
the guidance on such processors. These burdens would be realized if
every operation, plant, or processor that concludes that specific food
products are acid or fermented foods that are not also acidified foods,
would choose to submit Forms FDA 2541 and 2541a. We estimate that the
proposed collection of information consists of one-time and recurring
reporting burdens, summarized in table 2 of this document.
    Current Information Available to FDA
    The existing reporting requirements in Sec.  108.25 provide us with
information about the acidified foods industry, including the total
number of establishment registrations, the annual number of
establishment registrations, and the annual number of processes filed.
As of February 4, 2010, there are a total of 4,872 establishments
registered with FDA in accordance with Sec.  108.25 as commercial
processors of acidified foods.

    The available data for the past 6 years (2004 through 2009)\2\
indicate that, on average, there are 6,754 process filings submitted by
an average of 892 acidified foods establishments each year. In
addition, since 2004, when we began implementing an electronic filing
system, approximately 750 establishments that registered using Form FDA
2541 submitted process filings to us for food products that we
determined were not covered by either part 113 (21 CFR part 113) or
part 114. The available information includes the number of
establishments that submitted such filings, but not the number of
filings.
---------------------------------------------------------------------------

    \2\ We began implementing an electronic filing system in 2004
and used information available in that system for this analysis.
---------------------------------------------------------------------------

    We also have data on estimated reporting burdens, available to us
from our most recent analysis of the reporting burden under parts 113
and 114 (OMB control no. 0910-0037; 73 FR 11649 at 11650, March 4,
2008). In that analysis, we estimated that there are 8,950
establishments that keep records on an annual basis as processors of
acidified foods or low-acid canned foods (LACF), that 515
establishments submit a registration form (Form FDA 2541) on an annual
basis, for either acidified foods or LACF; that it takes 0.17 hours to
complete Form FDA 2541; that 1,489 establishments each submit 8.62
process filings (Form FDA 2541a) on an annual basis; and that it takes
0.33 hours to complete Form FDA 2541a. We use this information to
estimate the reporting burden associated with the draft guidance.
    In addition to establishment registration and process filing under
Sec.  108.25, acidified food establishments also must promptly report
to us any instance of spoilage when the nature of the spoilage is such
that it has potential health-endangering significance and any lot of
such food has in whole or in part entered distribution in commerce
(Sec.  108.25(d)). In the period from 2004 to January 2010, we received
1 report of spoilage of a commercially distributed acidified food.
Therefore, for this analysis, we assume that such spoilage events are
rare.

Recordkeeping Burden

    Establishment-Specific Written Plan Including Quality Control
Procedures for Acidified Foods (One-Time Burden): Currently, acidified
foods establishments must employ appropriate quality control procedures
to ensure that finished foods do not present a health hazard (Sec.
114.80(a)). To assist manufacturers in employing appropriate quality
control procedures under Sec.  114.80(a), the draft guidance recommends
that each acidified food establishment prepare a written plan (the
establishment-specific written plan) that includes quality control
procedures with respect to spoilage, regardless of whether the spoilage
has potential health-endangering significance. Currently existing
models (e.g., Ref. 1) suitable for use in developing such a written
plan are readily available to acidified foods establishments.
    Because we rarely receive reports under Sec.  108.25(d) regarding
spoilage of commercially distributed acidified foods with potential
health-endangering significance, for this analysis we assume that the
quality control procedures of all acidified foods establishments
currently address spoilage. Because the potential health consequences
of spoilage may not be apparent in the initial stages of an
investigation of spoilage, we assume that these establishments address
spoilage regardless of the potential for health consequences. We also
assume that the quality control procedures of 80 percent of registered
establishments address spoilage through an establishment-specific
written plan such as the one recommended in the draft guidance. We
further assume that the quality control procedures of the remaining 20
percent of registered establishments (i.e., 4,872 x 0.20 = 974.4,
rounded to 974 establishments) address spoilage by relying on a
generally available document (e.g., Ref. 1), the establishment's
unwritten procedures, or a combination of both. Based on our experience
with quality control procedures, we estimate it would take 8 hours for
an acidified foods establishment to prepare an establishment-specific
written plan. If all of the 974 registered establishments that do not
currently have an establishment-specific written plan develop such a
plan, the associated recordkeeping burden would be 7,792 hours (974
establishments x 8 hours/establishment). This would be a one-time
recordkeeping burden. Table 1 of this document includes the estimated
one-time recordkeeping burden associated with preparation of
establishment-specific written plans.
    Documentation of Spoilage for Acidified Foods (Recurring Burden):
The draft guidance recommends that an acidified food establishment
document all investigations and corrective actions relevant to
spoilage. We assume that an acidified food establishment that currently
has an establishment-specific written plan in place to address spoilage
also currently documents investigations and corrective actions relevant
to spoilage. We assume that spoilage problems are relatively rare and,
therefore, estimate that one spoilage event per establishment occurs
every 5 years. Accordingly, we estimate 195 spoilage events requiring
recordkeeping will occur (974 establishments that do not currently have
an establishment-specific written plan x 0.2 events/establishment =
194.8 events, rounded to 195). Assuming that establishments follow
procedures such as those in Ref. 1, and based on our experience with
investigations and corrective actions, we estimate it would take 2
hours to document a spoilage event. Thus, we estimate a recurring
recordkeeping burden of 390 hours (195 events x 2 hours/event = 390
hours). Table 1 of this document includes the estimated recurring
recordkeeping burden associated with documenting investigations of
spoilage events.

                       Table 1.--Estimated One-Time and Recurring Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                  No. of          Annual Frequency       Total Annual
 Activity      Recordkeepers      per Recordkeeping         Records        Hours per  Record      Total Hours
----------------------------------------------------------------------------------------------------------------
Quality                    974                     1                 974                8.00               7,792
 control
 plan to
 address
 spoilage\
 2\
----------------------------------------------------------------------------------------------------------------
Spoilage                   195                     1                 195                2.00                 390
 event
 documenta
 tion
----------------------------------------------------------------------------------------------------------------
Total one-time burden                                                                                7,792
----------------------------------------------------------------------------------------------------------------

Total recurring burden                                                                                390
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ One-time recordkeeping burden.

Reporting Burden

    Voluntary Registration (Form FDA 2541) (One-Time and Recurring
Burdens): Currently, we place information documenting whether acidified
food establishments have made appropriate submissions on Forms FDA 2541
and 2541a in an acidified food database that is readily available to
our investigators who inspect food facilities or evaluate foods offered
for import. This information facilitates decisions by our investigators
about the regulatory status of specific food products.
    In our experience, establishments are cautious about decisions they
make about the regulatory status of their products, and many
establishments that process non-acidified fermented foods and/or acid
foods have contacted us with information about their facilities and the
products they make. For example, our records show that, since 2004, we
have informed approximately 750 different registered establishments
that submitted electronic process filings that a food product that was
the subject of a process filing was not covered by either part 113 (as
a low-acid food) or part 114 (as an acidified food). In the past, we
did not add information about these products to the acidified foods
databases that are available to our investigators.
    The draft guidance clarifies that establishments that conclude that
the foods they process are acid foods or fermented foods that are not
also acidified foods, may voluntarily register and file scheduled
processes with us using Forms FDA 2541 and 2541a. As we do currently,
if we receive information from such establishments, we would evaluate
the submitted information to determine whether it is consistent with
the establishment's conclusion that a product is not an acidified food.
We plan to make the results of these evaluations available to our
investigators, for example, during inspections of food facilities and
during evaluations of foods offered for import. If we conclude that the
submitted information is not consistent with the processor's conclusion
that its products are not acidified foods, we may request additional
information to assist us in evaluating the processor's conclusion about
its products or take other action as appropriate. From our past
experience, we believe that many processors of foods that may be acid
foods or fermented foods that are not also acidified foods would choose
to submit information to us on Forms FDA 2541 and 2541a because doing
so would facilitate decisions by our investigators about the regulatory
status of specific food products.
    We estimate that there are 3,000 establishments that process
products that they would conclude are acid foods or fermented foods
that are not also acidified foods--4 times the approximate number of
registered establishments (750) that have submitted process filings to
FDA for food products we determined were not covered by either part 113
or part 114. We assume that all 3,000 establishments are not already
registered as processors of acidified foods or LACF. Because 750 of
these establishments have already registered voluntarily using Form FDA
2541, we estimate that the number of establishments that may register
for the first time under the draft guidance is 2,250 establishments
(3,000 - 750 = 2,250), resulting in a one-time reporting burden of 383
hours (2,250 establishments x 0.17 hours/establishment = 382.5 hours,
rounded to 383 hours). Table 2 of this document includes the estimated
one-time reporting burden for establishments that conclude that their
foods are acid foods or fermented foods that are not also acidified
foods, and voluntarily register their facilities in the first year
after the draft guidance is issued.
    After this initial registration, we also estimate that, on average,
a number of establishments equal to 6 percent of the 3,000 total
estimated establishments that will voluntarily register in the first
year (i.e., 0.06 x 3,000 establishments = 180 establishments) will
voluntarily register using Form FDA 2541 each year, resulting in an
annual reporting burden of 31 hours (180 establishments x 0.17 hours/
establishment = 30.6 hours, rounded to 31 hours). Proportionally, this
would be comparable to the current percentage of acidified foods and
LACF establishments that, on average, register using Form FDA 2541 each
year (515 establishments that register on an annual basis/8,950
establishments that keep records on an annual basis x 100 = 5.75
percent rounded to 6 percent). Table 2 of this document includes the
estimated recurring annual reporting burden for establishments that
process foods that they conclude are acid foods or fermented foods that
are not also acidified foods, and that would voluntarily register their
facilities.
    Voluntary Process Filing (Form FDA 2541a) (One-Time and Recurring
Burdens): As discussed, we do not have information about the number of
process filings voluntarily submitted by firms that registered their
establishments but whose food products we determined were not covered
by either part 113 or part 114. However, we do have information that,
on average, over the 6-year period from 2004 through 2009, there was a
total of 6,754 annual process filings submitted by an average of 892
acidified foods establishments each year, and that there were 4,872
registered acidified foods establishments; from this information we
calculate that, on average, 18 percent of registered acidified foods
establishments submit process filings each year (892 establishments/
4,872 establishments x 100 = 18.3 percent, rounded to 18 percent). To
be conservative, we also estimate that, on average, acidified foods
establishments submitted process filings for 3 container sizes per
product and that the total number of products reported by acidified
foods establishments each year during that period was thus 2,251
products (6,754 process filings/3 container sizes/product = 2,251.33
products, rounded to 2,251 products). For the purpose of this analysis,
we estimate that, on average, 18 percent of establishments that process
foods that they conclude are acid foods or fermented foods that are not
also acidified foods in a given year will submit process filings; i.e.,
540 establishments (0.18 x 3,000 establishments = 540 establishments).
To be conservative, we also estimate that, on average, the 540
establishments that would submit process filings in a given year will
submit process filings for twice as many products as would be submitted
by acidified foods establishments; per the

recommendations in the draft guidance, these establishments could
submit a single process form that covers all container sizes of a
product. Thus, the estimated number of annual voluntary process filings
is 2,725 process filings (2,251 products/892 establishments x 540
establishments x 2 = 2,725.4 process filings, rounded to 2,725). On
average, we calculate that the annual frequency of reporting would be 5
process filings (2,725 process filings/540 establishments = 5.04,
rounded to 5). For the purpose of this analysis, we use the rounded
number of process filings (i.e., 5) and, thus, calculate that the
estimated recurring reporting burden for submission of Form 2541a is
2,700 process filings rather than 2,725 process filings (540
establishments x 5 process filings per establishment = 2,700 process
filings), resulting in an annual reporting burden of 891 hours (2,700
process filings x 0.33 hours/process filing = 891 hours). Table 2 of
this document includes the estimated one-time and recurring reporting
burden for establishments that voluntarily submit process filings for
foods that they conclude are acid foods or fermented foods that are not
also acidified foods.
    We also estimate that all 3,000 establishments that process foods
that they conclude are acid foods or fermented foods that are not also
acidified foods and voluntarily register their establishments will
submit a total of 30,000 process filings in the first year--i.e., twice
as many process filings as would be submitted, on average, by any given
establishment on an annual basis (2 x 5 process filings/establishment
on an annual basis x 3,000 establishments = 30,000 process filings),
resulting in a one-time reporting burden of 9,900 hours (30,000 process
filings x 0.33 hours/establishment = 9,900 hours). Table 2 of this
document includes the estimated one-time reporting burden for
establishments that voluntarily submit process filings for fermented
foods and/or acid foods.

                         Table 2.--Estimated One-Time and Recurring Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                  Annual Frequency       Total Annual
 Activity    No. of  Reporters      per Reporter            Records        Hours per  Record      Total Hours
----------------------------------------------------------------------------------------------------------------
Registrati               2,250                     1               2,250                0.17                 383
 on (Form
 FDA
 2541)\2\
----------------------------------------------------------------------------------------------------------------
Registrati                 180                     1                 180                0.17                  31
 on (Form
 FDA 2541)
----------------------------------------------------------------------------------------------------------------
Process                  3,000                    10              30,000                0.33               9,900
 filing
 (Form FDA
 2541a)\2\
----------------------------------------------------------------------------------------------------------------
Process                    540                     5               2,700                0.33                 891
 filing
 (Form FDA
 2541a)
----------------------------------------------------------------------------------------------------------------
Total one-time burden                                                                                10,283
----------------------------------------------------------------------------------------------------------------
Total recurring burden                                                                                922
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ One-time reporting burden.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov or at http://www.fda.gov/FoodGuidances.

V. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen between
9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web
site address, but FDA is not responsible for any subsequent changes to
Web site after this document publishes in the Federal Register.)
    1. Codex Alimentarius Commission, Recommended International Code
of Hygienic Practice for Low and Acidified Low Acid Canned Foods
CAC/RCP 23-1979, Rev. 2 (1993), Available at http://
www.codexalimentarius.net/download/standards/24/CXP_023e.pdf,
Accessed and printed on June 17, 2008.

    Dated: September 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24089 Filed 9-24-10; 8:45 am]
BILLING CODE 4160-01-S


19995 Federal Register / Vol. 68, No. 78 / Wednesday, April 23, 2003 / Notices ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0117; FRL   7301   9]

Experimental Use Permit; Receipt of Amendment/ Extension Application AGENCY: Environmental Protection Agency ( EPA).

ACTION: Notice.

SUMMARY: This notice announces receipt of an application 52   EUP   93 from Monsanto Company requesting an amendment/ extension of an experimental use permit ( EUP) for the Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production ( vector ZMIR13L) in corn. The Agency has determined that the application may be of regional and national significance. Therefore, in accordance with 40 CFR 172.11( a), the Agency is soliciting comments on this application.

DATES: Comments, identified by docket ID number OPP   2003   0117, must be received on or before May 23, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and Pollution Prevention Division ( 7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8715; e mail address: mendelsohn. mike@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

This action is directed to the public in general. This action may, however, be of interest to those persons who are interested in agricultural biotechnology or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act ( FFDCA) or the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0117. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the VerDate Jan< 31> 2003 14: 42 Apr 22, 2003 Jkt 200001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23APN1. SGM 23APN1 19996 Federal Register / Vol. 68, No. 78 / Wednesday, April 23, 2003 / Notices comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2003   0117. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID Number OPP   2003   0117. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID Number OPP   2003   0117. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP   2003   0117. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI To the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background Monsanto has applied to test Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production ( vector ZMIR13L) in corn on 2,304 acres in Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, and Wisconsin for breeding and observation nursery, inbred seed increase production, line per se and hybrid yield, insect efficacy, product characterization and performance/ labeling, insect resistance management, non target organism and benefit, and seed treatment trials. This plantincorporated protectant is being tested against corn rootworm species. The tolerance exemption under 40 CFR 180.1214 applies to this plantincorporated protectant. A tolerance exemption in 40 CFR part 180 applies to the associated marker gene and its product, which the Agency considers a plant incorporated protectant inert ingredient.

III. What Action is the Agency Taking?

Following the review of the Monsanto Company application and any comments and data received in response to this notice, EPA will decide whether to issue or deny the EUP request for this EUP program, and if issued, the conditions under which it is to be conducted. Any issuance of an EUP will be announced in the Federal Register.

IV. What is the Agency's Authority for Taking this Action?

The specific legal authority for EPA to take this action is under FIFRA section 5.

List of Subjects Environmental protection, Experimental use permits.

Dated: April 11, 2003.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

[ FR Doc. 03   10069 Filed 4   22   03; 8: 45 am]

BILLING CODE 6560   50   S VerDate Jan< 31> 2003 14: 42 Apr 22, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23APN1. SGM 23APN1