[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19658-19659]
[FR Doc No: 2015-08400]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-57-000]

GenOn Energy Management, LLC v. ISO New England Inc.; Notice of
Complaint

    Take notice that on April 6, 2015, pursuant to sections 206 and 306
of the Federal Power Act, 16 U.S.C. 824e and 825e and Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206, GenOn Energy Management, LLC
(Complainant), filed a formal complaint against ISO New England Inc.
(Respondent or ISO-NE), alleging, that the Respondent improperly
submitted a demand bid on behalf of the Complainant in the annual
reconfiguration auction for the 2015-2016 Capacity Commitment Period.
Alternatively, the Complainant requests waiver of the ISO-NE
Transmission, Markets and Services Tariff in order to permit ISO-NE to
use the results of the Seasonal Claimed Capability Audit that was
approved by ISO-NE on January 29, 2015, for the purposes of calculating
the qualified capacity of Unit 2 at the Canal Generating Plant.
    The Complainant certifies that copies of the complaint were served
on the contacts for the Respondent, as listed on the Commission's list
of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on May 6, 2015.

    Dated: April 7, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-08400 Filed 4-10-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 177 (Friday, September 11, 2020)]
[Rules and Regulations]
[Pages 56161-56162]
[FR Doc No: 2020-20001]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0463; Product Identifier 2013-SW-041-AD; Amendment
39-21246; AD 2015-17-01R1]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; removal of airworthiness directive (AD).

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SUMMARY: The FAA is removing AD 2015-17-01, which applied to certain
Airbus Helicopters Model AS350B, AS350BA, AS350B1, AS350B2, AS350B3,
AS350C, AS350D, AS350D1, AS355E, AS355F, AS355F1, AS355F2, AS355N, and
AS355NP helicopters. AD 2015-17-01 required inspections of each tail
rotor pitch horn assembly (pitch horn) for a crack, replacement of a
cracked pitch horn, and a repetitive visual inspection of certain pitch
horns. AD 2015-17-01 is no longer necessary because the cause of the
unsafe condition has been removed from all affected helicopter models.
Accordingly, the FAA is removing AD 2015-17-01.

DATES: This AD becomes effective September 11, 2020.

ADDRESSES:

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0463; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, AD Program Manager,
Continued Operational Safety Branch, Airworthiness Products Section,
General Aviation and Rotorcraft Unit, FAA, 10101 Hillwood Pkwy., Fort
Worth, TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by removing AD 2015-17-01, Amendment 39-18234 (80 FR 50554,
August 20, 2015) (``AD 2015-17-01''), that applied to certain Airbus
Helicopters Model AS350B, AS350BA, AS350B1, AS350B2, AS350B3, AS350C,
AS350D, AS350D1, AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355NP
helicopters. The NPRM published in the Federal Register on June 12,
2020 (85 FR 35814). The NPRM was prompted by a determination that AD
2015-17-01 is no longer necessary because the unsafe condition no
longer exists on Model AS350 and AS355 helicopters. The NPRM proposed
to remove AD 2015-17-01. The FAA is issuing this AD to remove AD 2015-
17-01.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA has considered the comment
received. Mr. Warren LaBare indicated support for the NPRM.

Conclusion

    The FAA reviewed the relevant data, considered the comment
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor
editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Costs of Compliance

    This AD adds no cost. This AD removes AD 2015-17-01 from 14 CFR
part 39; therefore, operators are no longer required to show compliance
with that AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce.

This regulation is within the scope of that authority.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2015-17-01, Amendment 39-18234 (80 FR 50554, August 20, 2015), and
adding the following new AD:

2015-17-01R1 Airbus Helicopters: Amendment 39-21246; Docket No. FAA-
2020-0463; Product Identifier 2013-SW-041-AD.

(a) Effective Date

    This AD is effective September 11, 2020.

(b) Affected ADs

    This AD replaces AD 2015-17-01, Amendment 39-18234 (80 FR 50554,
August 20, 2015).

(c) Applicability

    This AD applies to Airbus Helicopters Model AS350B, AS350BA,
AS350B1, AS350B2, AS350B3, AS350C, AS350D, AS350D1, AS355E, AS355F,
AS355F1, AS355F2, AS355N, and AS355NP helicopters, certificated in
any category, with tail rotor hub pitch horn (pitch horn) assembly,
part number (P/N) 350A121368.01, 350A121368.02, 350A121368.03, or
350A121368.04, with a pitch horn, P/N 350A121368.XX, where XX stands
for a two-digit dash number, installed. The pitch horn may be marked
with either the pitch horn assembly P/N or pitch horn P/N.

(d) Related Information

    For more information about this AD, contact Matt Fuller, AD
Program Manager, Continued Operational Safety Branch, Airworthiness
Products Section, General Aviation and Rotorcraft Unit, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
    Issued on September 3, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-20001 Filed 9-10-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 6 (Wednesday, January 9, 2013)]
[Rules and Regulations]
[Pages 1759-1760]
[FR Doc No: 2012-31649]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR PART 52

[FRL-9767-5]

Notice of Approval of Clean Air Act Outer Continental Shelf Minor
Source/Title V Minor Permit Modification Issued to Shell Offshore, Inc.
for the Kulluk Conical Drilling Unit

AGENCY: United States Environmental Protection Agency (EPA).

ACTION: Notice of final action.

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SUMMARY: This notice announces that EPA Region 10 has issued a final
decision granting Shell Offshore Inc.'s (``Shell'') request for minor
modifications of Clean Air Act Outer Continental Shelf (``OCS'') Minor
Source/Title V Permit No. R10OCS03000 (``permits''). The permits
authorize air emissions associated with Shell's operation of the Kulluk
Conical Drilling Unit (``Kulluk'') in the Beaufort Sea to conduct
exploratory oil and gas drilling.

DATES: January 9, 2013.

ADDRESSES: The documents relevant to the above-referenced permits are
available for public inspection during normal business hours at the
following address: U.S. Environmental Protection Agency, Region 10,
1200 Sixth Avenue, Suite 900, AWT-107, Seattle, WA 98101. To arrange
for viewing of these documents, call Natasha Greaves at<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Natasha Greaves, Office of Air Waste
and Toxics, U.S. Environmental Protection Agency, Region 10, 1200 6th
Avenue, Suite 900, AWT-107, Seattle, WA 98101.

SUPPLEMENTARY INFORMATION: EPA Region 10 issued a final decision on the
minor modifications of the permits on September 28, 2012. The modified
permits also became effective on that date, and the 30-day period
provided by 40 CFR 71.11(l) to file with the Environmental Appeals
Board (``EAB'')

a petition to review the minor modifications of the permits ended on
October 29, 2012. Pursuant to section 307(b)(1) of the Clean Air Act,
42 U.S.C. 7607(b)(1), judicial review of these final permit decisions,
to the extent it is available, may be sought by filing a petition for
review in the United States Court of Appeals for the Ninth Circuit
within 60 days of January 9, 2013.
    On April 12, 2012, EPA issued a final decision on the permits which
authorize air emissions from Shell's operation of the Kulluk in the
Beaufort Sea to conduct exploratory drilling. Shell submitted an
application to EPA Region 10 requesting minor modifications of the
permits on July 5, 2012. EPA Region 10 reviewed and issued the
requested minor modifications of the permits on September 28, 2012.
    All conditions of the Kulluk permit, issued by EPA on September 28,
2012, are final and effective.

    Dated: November 6, 2012.
Kate Kelly,
Director, Office of Air, Waste & Toxics, Region 10.
[FR Doc. 2012-31649 Filed 1-8-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 98 (Tuesday, May 21, 2019)]
[Proposed Rules]
[Pages 22995-22996]
[FR Doc No: 2019-10470]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2019-0157, FRL-9993-68-Region 2]

Approval of Air Quality Implementation Plans; New York; Cross-
State Air Pollution Rule; NOX Ozone Season Group 2, NOX Annual and SO2
Group 1 Trading Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the New York State Implementation Plan (SIP)
addressing requirements of the Cross-State Air Pollution Rule (CSAPR).
Under the CSAPR, large electricity generating units in New York are
subject to Federal Implementation Plans (FIPs) requiring the units to
participate in CSAPR federal trading programs for ozone season
emissions of nitrogen oxides (NOX), annual emissions of
NOX, and annual emissions of sulfur dioxide
(SO2). This action proposes to approve into New York's SIP
the State's regulations that replace the default allowance allocation
provisions of the CSAPR federal trading programs for ozone season
NOX, annual NOX, and annual SO2
emissions.

DATES: Comments must be received on or before June 20, 2019.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-
R02-OAR-2019-0157, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or withdrawn. The EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kenneth Fradkin, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, 25th Floor, New York,
New York 10007-1866,<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The EPA proposes to approve New York's
November 30, 2018 SIP submittal concerning CSAPR \1\ trading programs
for ozone-season emissions of NOX, annual emissions of
NOX, and annual emissions of SO2. The EPA also
proposes to approve New York's revised list of definitions that was
submitted to the EPA on July 23, 2015. We have published a direct final
rule approving the State's SIP revision(s) in the Rules and Regulations
section of this Federal Register, because we view this as a
noncontroversial action and anticipate no relevant adverse comment. We
have explained our reasons for this action in the preamble to the
direct final rule. If we receive no adverse comment, we will not take
further action on this proposed rule. If we receive adverse comment, we
will withdraw the direct final rule and it will not take effect. We
would address all public comments in any subsequent final rule based on
this proposed rule. We do not intend to institute a second comment
period on this action. Any parties interested in commenting must do so
at this time. For further information, please see the information
provided in the ADDRESSES section of this document.
---------------------------------------------------------------------------

    \1\ Federal Implementation Plans; Interstate Transport of Fine
Particulate Matter and Ozone and Correction of SIP Approvals, 76 FR
48208 (August 8, 2011) (codified as amended at 40 CFR 52.38 and
52.39 and 40 CFR part 97).
---------------------------------------------------------------------------

    Large Electric Generating Units (EGUs) in New York are subject to
CSAPR FIPs that require the units to participate in the federal CSAPR
NOX Ozone Season Group 2 Trading Program, the federal CSAPR
NOX Annual Trading Program, and the federal CSAPR
SO2 Group 1 Trading Program. CSAPR provides a process for
the submission and approval of SIP revisions to replace certain
provisions of the CSAPR FIPs while the remaining FIP provisions
continue to apply. This type of CSAPR SIP is termed an abbreviated SIP.
    The New York State Department of Environmental Conservation (DEC)
amended portions of Title 6 of the New York Codes, Rules and
Regulations (6 NYCRR) in order to incorporate CSAPR requirements into
the State's rules and allow the DEC to allocate CSAPR allowances to
regulated entities in New

York. 6 NYCRR Part 243, ``Transport Rule NOX Ozone Season
Trading Program,'' has been repealed and replaced in its entirety with
a new rule, 6 NYCRR Part 243, ``CSAPR NOX Ozone Season Group
2 Trading Program.'' 6 NYCRR Part 244, ``Transport Rule NOX
Annual Trading Program,'' has been repealed and replaced in its
entirety with a new rule, 6 NYCRR Part 244, ``CSAPR NOX
Annual Trading Program.'' 6 NYCRR Part 245, ``Transport Rule
SO2 Group 1 Trading Program,'' has also been repealed and
replaced in its entirety with a new rule, 6 NYCRR Part 245, ``CSAPR
SO2 Group 1 Trading Program.'' Attendant revisions were made
to 6 NYCRR Part 200, ``General Provisions,'' to update the list of
referenced materials at Subpart 200.9 that are cited in the amended New
York regulations.
    The EPA is proposing to approve into the New York SIP the revised
versions of 6 NYCRR Parts 200 (Subpart 200.9), 243, 244, and 245
included in the November 30, 2018 submission.
    The EPA is also proposing to repeal from the SIP previous versions
of 6 NYCRR Part 243, 6 NYCRR Part 244, and 6 NYCRR Part 245 which
implemented New York's discontinued CAIR program. New York adopted
amendments to 6 NYCRR Part 243, 6 NYCRR Part 244, and 6 NYCRR Part 245
that repealed and replaced CAIR trading program rules with CSAPR
trading rules on November 10, 2015. Subsequently, on November 11, 2018,
New York adopted amendments to 6 NYCRR Part 243, 6 NYCRR Part 244, and
6 NYCRR Part 245 that repealed and replaced the November 15, 2015
adopted rules that implemented New York's CSAPR program with new
versions of New York's CSAPR trading program rules. The rules that are
proposed to be repealed from the SIP are 6 NYCRR Part 243, ``CAIR
NOX Ozone Season Trading Program,'' 6 NYCRR Part 244, ``CAIR
NOX Annual Trading Program,'' and 6 NYCRR Part 245, ``CAIR
SO2 Trading Program.''
    The EPA is also proposing to approve into the New York SIP a
revised version of 6 NYCRR Part 200 (Subpart 200.1) to address updated
definitions at Part 200.1(f) that were submitted to the EPA on July 23,
2015 and that were associated with a repeal of 6 NYCRR Part 203,
``Indirect Sources of Air Contamination.''
    The revised versions of 6 NYCRR Parts 200 (Subpart 200.9), 243,
244, and 245 included in the November 30, 2018 SIP submission replace
the previous versions of those rules that were included in a December
1, 2015 SIP submission. The EPA identified deficiencies in the December
1, 2015 submission but on November 20, 2017 conditionally approved
those previous versions of Parts 200, 244, and 245 (but not Part 243)
into the SIP (82 FR 57362, December 5, 2017). In a July 6, 2017 letter
to the EPA, New York committed to submitting a SIP revision that
addressed the identified deficiencies by December 29, 2017. However,
New York's response to the conditional approval was not submitted to
the EPA by December 29, 2017. The November 30, 2018 SIP submittal
addresses the identified deficiencies, but was submitted approximately
11 months late, so the conditional approval is treated as a
disapproval.
    The EPA did not take action on the previous version of 6 NYCRR Part
243 included in New York's December 1, 2015 submission. Following that
submission, the EPA finalized the CSAPR Update rule \2\ to address
Eastern states' interstate air pollution mitigation obligations with
regard to the 2008 Ozone National Ambient Air Quality Standard (NAAQS).
Among other things, starting in 2017 the CSAPR Update required New York
EGUs to participate in the new CSAPR NOX Ozone Season Group
2 Trading Program instead of the earlier CSAPR NOX Ozone
Season Trading Program (now renamed the ``Group 1'' program) and
replaced the ozone season budget for New York with a lower budget
developed to address the revised and more stringent 2008 Ozone NAAQS.
In a July 14, 2016 letter to the EPA, New York indicated that the State
would revise 6 NYCRR Part 243 to conform with the final CSAPR Update.
As indicated earlier in this section New York repealed 6 NYCRR Part 243
and replaced the rule in its entirety with a new rule, 6 NYCRR Part
243, ``CSAPR NOx Ozone Season Group 2 Trading Program''.
---------------------------------------------------------------------------

    \2\ 81 FR 74504 (October 26, 2016).
---------------------------------------------------------------------------

    This action proposes to approve into New York's SIP state-
determined allowance allocation procedures for ozone-season
NOX allowances that would replace EPA's default allocation
procedures for the control periods in 2021 and beyond. Additionally,
EPA is proposing to approve into New York's SIP state-determined
allowance allocation procedures for annual NOX and
SO2 allowances that would replace EPA's default allocation
procedures for the control periods in 2023 and beyond. The proposed
approval of this SIP revision does not alter any provision, other than
the allowance allocation provisions, of either the CSAPR NOX
Ozone Season Group 2 Trading Program, the CSAPR NOX Annual
Trading Program or the CSAPR SO2 Group 1 Trading Program as
applied to New York units. The FIP provisions requiring those units to
participate in the programs (as modified by this SIP revision) remain
in place.

List of Subjects in 40 CFR Part 52

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements, Sulfur oxides.

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

    Dated: May 2, 2019.
Peter D. Lopez,
Regional Administrator, Region 2.
[FR Doc. 2019-10470 Filed 5-20-19; 8:45 am]
 BILLING CODE 6560-50-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I started smoking cigarettes when I was 16 years old. By the age of 21, I was developing respiratory issues due to the smoking. I would wake up and cough up mucus, I could barely exert myself physically without wheezing, and I had trouble sleeping. E-cigarettes, or vaping, has changed all of that.  I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Notices]
[Pages 56254-56255]
[FR Doc No: 2012-22460]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twentieth Meeting: RTCA Special Committee 213, Enhanced Flight
Vision Systems/Synthetic Vision Systems (EFVS/SVS)

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Meeting Notice of RTCA Special Committee 213, Enhanced Flight
Vision Systems/Synthetic Vision Systems (EFVS/SVS).

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SUMMARY: The FAA is issuing this notice to advise the public of the
twentieth meeting of the RTCA Special Committee 213, Enhanced Flight
Vision Systems/Synthetic Vision Systems (EFVS/SVS).

DATES: The meeting will be held October 2-4, 2012 from 9 a.m.-5 p.m.

ADDRESSES: The meeting will be held at the following facilities at
Jetcraft Corporation, CH-4030 Basel-Airport, Basel, Switzerland, +41 58
158 4958 (Phone), +41 58 158 4988 (Fax), Web Site: www.jetcraft.com.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th
Street, NW., Suite 910, Washington, DC, 20036, or by telephone at (202)
330-0652/(202) 833-9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org. Additional contact information: Please contact Tim
Etherington<EMAIL_ADDRESS>telephone<PHONE_NUMBER> or
mobile at<PHONE_NUMBER>, to register for the meeting.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a) (2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 213. The agenda will
include the following:

Tuesday, October 2, 2012

Plenary Discussion (sign in at 9:00 a.m.)

 Introductions and administrative items.
 Review and approve minutes from last full plenary meeting.
 Review of terms of reference.
 Status of DO-XXX.
 WG-1 DO-315C draft review.

Wednesday, October 3, 2012

Plenary Discussion

 WG-1 DO-315C draft review.
 WG-2 objectives and overview.

Thursday, October 4, 2012

Plenary Discussion

 WG-1 DO-315C draft review.
 Administrative items.
 Adjourn.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on September 6, 2012
David Sicard,
Manager, Business Operations Group, Federal Aviation Administration.
[FR Doc. 2012-22460 Filed 9-11-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 134 (Thursday, July 14, 2022)]
[Proposed Rules]
[Page 42135]
[FR Doc No: 2022-14977]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 282

[EPA-R01-UST-2022-0269; FRL-9580-01-R1]

Connecticut: Final Approval of State Underground Storage Tank
Program Revisions, Codification, and Incorporation by Reference

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Pursuant to the Resource Conservation and Recovery Act (RCRA
or Act), the Environmental Protection Agency (EPA) is proposing to
approve revisions to the State of Connecticut's Underground Storage
Tank (UST) program submitted by the Connecticut Department of Energy
and Environmental Protection (CT DEEP). This action is based on EPA's
determination that these revisions satisfy all requirements needed for
program approval. This action also proposes to codify EPA's approval of
Connecticut's State program and to incorporate by reference those
provisions of the State regulations that we have determined meet the
requirements for approval. The provisions will be subject to EPA's
inspection and enforcement authorities under sections 9005 and 9006 of
RCRA subtitle I and other applicable statutory and regulatory
provisions.

DATES: Send written comments by August 15, 2022.

ADDRESSES: Submit any comments, identified by EPA-R01-UST-2022-0269, by
one of the following methods:
    1. Federal eRulemaking Portal: https://www.regulations.gov. Follow
the on-line instructions for submitting comments.
    2. Email: [email protected].
    Instructions: Direct your comments to Docket ID No. EPA-R01-UST-
2022-0269. EPA's policy is that all comments received will be included
in the public docket without change and may be available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://www.regulations.gov, or email. The Federal https://www.regulations.gov
website is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email comment directly to EPA
without going through https://www.regulations.gov, your email address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD-ROM you submit. 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. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. EPA encourages electronic submittals, but if
you are unable to submit electronically, please reach out to the EPA
contact person listed in the notice for assistance. You can view and
copy the documents that form the basis for this codification and
associated publicly available materials either through
www.regulations.gov or at the EPA Region 1 Office, 5 Post Office
Square, 1st floor, Boston, MA 02109-3912. The facility is open from
8:30 a.m. to 4:00 p.m., Monday through Friday, excluding Federal
holidays and facility closures due to COVID-19. We recommend that you
telephone Andrea Beland, RCRA Waste Management, UST, and Pesticides
Section, at<PHONE_NUMBER>, before visiting the Region 1 office.
Interested persons wanting to examine these documents should make an
appointment with the office at least two weeks in advance.

FOR FURTHER INFORMATION CONTACT: Andrea Beland,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: For additional information, see the direct
final rule published in the ``Rules and Regulations'' section of this
issue of the Federal Register.

    Authority: This rule is issued under the authority of Sections
2002(a), 9004, and 7004(b) of the Solid Waste Disposal Act, as
amended, 42 U.S.C. 6912, 6991c, 6991d, and 6991e.

    Dated: June 30, 2022.
David W. Cash,
Regional Administrator, EPA Region 1.
[FR Doc. 2022-14977 Filed 7-13-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Rules and Regulations]
[Pages 62101-62104]
[FR Doc No: 2021-24268]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0326; FRL-9180-01-OCSPP]

Calcium Bisulfate; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of calcium bisulfate when used as an inert
ingredient (acidifying/buffering agent) in antimicrobial formulations
applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils,
limited to 2,000 parts per million (ppm). Burdock Group on behalf of
SCG Solutions, LLC., submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of calcium bisulfate.

DATES: This regulation is effective November 9, 2021. Objections and
requests for hearings must be received on or before January 10, 2022,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0326, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0326 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
January 10, 2022. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0326, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of June 28, 2021 (86 FR 33890) (FRL-10025-
08), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11436) by
the Burdock Group (859 Outer Road, Orlando, FL 32814) on behalf of SCG
Solutions, LLC (1358 South 9th St., DePere, WI 54115). The petition
requested that 40 CFR 180.940(a) be amended by establishing an
exemption from the requirement of a tolerance for residues of calcium
bisulfate when used as an inert ingredient (acidifying/buffering agent)
in antimicrobial formulations applied to food-contact surfaces in
public eating places, dairy-processing equipment, and food-processing
equipment and utensils, limited to 2,000 parts per million (ppm) in the
final formulation. That document referenced a summary of the petition
prepared by the Burdock Group on behalf of SCG Solutions, LLC, the
petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and

diatomaceous earth; thickeners such as carrageenan and modified
cellulose; wetting, spreading, and dispersing agents; propellants in
aerosol dispensers; microencapsulating agents; and emulsifiers. The
term ``inert'' is not intended to imply nontoxicity; the ingredient may
or may not be chemically active. Generally, EPA has exempted inert
ingredients from the requirement of a tolerance based on the low
toxicity of the individual inert ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for calcium bisulfate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with calcium bisulfate
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by calcium bisulfate as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document ``Calcium Bisulfate; Human Health
Risk Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2021-0326.
    Calcium bisulfate readily dissociates to the bisulfate anion and
the respective calcium cation. Similarly, sodium bisulfate readily
dissociates to the bisulfate anion and the sodium cation. Since the
bisulfate anion is converted to sulfate in aqueous solution, toxicology
studies for sodium sulfate are generally considered relevant for sodium
bisulfate and calcium bisulfate. Therefore, toxicity data on sodium
sulfate are used as surrogate data for calcium bisulfate.
    The acute oral and dermal toxicity of calcium bisulfate is low in
rats. It is slightly irritating to the rabbit skin. It is expected to
be mildly irritating to the eyes.
    Based on the toxicity database for sodium sulfate, no toxicity is
observed in a 30-day oral toxicity study and developmental study in
rats at >2,000 mg/kg/day. No toxicity and no tumors are seen in a 27
and 44-week oral toxicity study in rats up to 400 mg/kg/day, the
highest dose tested. No mutagenicity is seen in the Ames test.
    Neurotoxicity and immunotoxicity toxicity studies are not available
for review. However, no evidence of neurotoxicity or immunotoxicity is
seen in the available studies.
    Calcium bisulfate is expected to readily undergo hydrolysis and
dissociate to calcium ions and sulfate ions in the body. Sulfate anions
are excreted mainly in the urine.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that calcium bisulfate has
a very low overall toxicity. No toxicity was observed in any of the
available studies. In the 30-day oral and the developmental toxicity
studies with the calcium bisulfate surrogate (sodium sulfate), no
toxicity is seen at >2,000 mg/kg/day which is well above the limit dose
of 1,000 mg/kg/day. In addition, calcium bisulfate readily dissociates
to the bisulfate anion and the calcium cation. Bisulfate/sulfate anion
is a naturally occurring constituent in many food substances as well as
an essential component in a large number of mammalian (human) metabolic
processes. The sulfate anion is a normal constituent in the body,
predominantly resulting from the body's metabolism of sulfur-containing
food sources such as foods containing the essential amino acids
cysteine and methionine. Sulfate anions are vital components in a
number of human biosynthetic pathways such as cartilage production and
the formation of pancreatic digestive enzymes. Also, the sulfate anion
is an important conjugate in the Phase II conjugation/elimination of
oxidized (OH) aromatic ring metabolites and for hydroxyl steroid
hormones. The Agency did not identify an endpoint of concern for risk
assessment purposes because no signs of toxicity were observed, and
calcium and sulfate ions are present ubiquitously in the human body.
Since no endpoint of concern was identified for the acute and chronic
dietary exposure assessment and short and intermediate dermal and
inhalation exposure, a quantitative risk assessment for calcium
bisulfate is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to calcium bisulfate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from calcium bisulfate in food as follows:
    Dietary exposure (food and drinking water) to calcium bisulfate may
occur following ingestion of foods with residues from their use in
accordance with this exemption. However, a quantitative dietary
exposure

assessment was not conducted and is not necessary since a toxicological
endpoint for risk assessment was not identified.
    2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Calcium bisulfate may be used in pesticide products and non-
pesticide products that may be used in and around the home. Based on
the discussion above regarding the low toxicity of the calcium
bisulfate, a quantitative residential exposure assessment was not
conducted and is not necessary.
    3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Based on the lack of toxicity in the available data, calcium
bisulfate and its metabolites are not expected to share a common
mechanism of toxicity with other chemicals. For the purposes of this
action, therefore, EPA has assumed that calcium bisulfate do not have a
common mechanism of toxicity with other substances.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of the FFDCA requires EPA to retain an
additional tenfold margin of safety in the case of threshold effects to
ensure that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. Based on the lack of threshold effects, EPA has not identified
any toxicological endpoints of concern and is conducting a qualitative
assessment of calcium bisulfate. The qualitative assessment does not
use safety factors for assessing risk, and no additional safety factor
is needed for assessing risk to infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on calcium
bisulfate, EPA has determined that there is a reasonable certainty that
no harm to the general population or any population subgroup, including
infants and children, will result from aggregate exposure to calcium
bisulfate residues. Therefore, the establishment of exemptions from the
requirement of a tolerance under 40 CFR 180.940(a) for residues of
calcium bisulfate when used as an inert ingredient in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils at a maximum end-use concentration of 2,000 ppm
is safe under FFDCA section 408.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
calcium bisulfate in or on any food commodities. EPA is establishing a
limitation on the amount of calcium bisulfate that may be used in
pesticide formulations. This limitation will be enforced through the
pesticide registration process under the Federal Insecticide,
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA
will not register any pesticide formulation for food use that exceeds
2,000 ppm calcium bisulfate in the final pesticide formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180. 940(a) for calcium bisulfate when used as
an inert ingredient (acidifying/buffering agent) in antimicrobial
formulations applied to food-contact surfaces in public eating places,
dairy-processing equipment, and food-processing equipment and utensils
under 40 CFR 180.940(a), limited to 2,000 ppm in the final formulation.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal

Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: November 1, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.940, in paragraph (a), amend table 180.940(a) by adding
in alphabetical order an entry for the inert ingredient ``Calcium
bisulfate'' to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (a) * * *

                                                Table 180.940(a)
----------------------------------------------------------------------------------------------------------------
                        Inert ingredients                          CAS Reg. No.               Limits
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Calcium bisulfate...............................................  ..............  When ready for use, the end-
                                                                                use concentration is not to
                                                                                exceed 2,000 ppm.

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

* * * * *
[FR Doc. 2021-24268 Filed 11-8-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Notices]
[Pages 47960-47962]
[FR Doc No: 2019-19600]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-E-0298; FDA-2018-E-0299; FDA-2018-E-0301; and
FDA-2018-E-0321]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Edwards Pericardial Aortic Bioprosthesis

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has

determined the regulatory review period for EDWARDS PERICARDIAL AORTIC
BIOPROSTHESIS (Models 11000A and 11500A) and is publishing this notice
of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that medical
device.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
November 12, 2019. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by March 9,
2020. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 12, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-E-0298; FDA-2018-E-0299; FDA-2018-E-0301; and FDA-2018-E-0321
for ``Determination of Regulatory Review Period for Purposes of Patent
Extension; EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device EDWARDS
PERICARDIAL AORTIC BIOPROSTHESIS. EDWARDS PERICARDIAL AORTIC

BIOPROSTHESIS MODEL 11000A and MODEL 11500A are indicated for the
replacement of native or prosthetic aortic heart valves. Subsequent to
this approval, the USPTO received patent term restoration applications
for EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS MODEL 11000A and MODEL
11500A (U.S. Patent Nos. 7,972,376; 8,007,992; 8,357,387; and
9,029,418) from Edwards Lifesciences Corporation, and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated April 5, 2018, FDA advised
the USPTO that this medical device had undergone a regulatory review
period and that the approval of EDWARDS PERICARDIAL AORTIC
BIOPROSTHESIS represented the first permitted commercial marketing or
use of the product. Thereafter, the USPTO requested that FDA determine
the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS is 1,858 days. Of this time,
1,491 days occurred during the testing phase of the regulatory review
period, while 367 days occurred during the approval phase. These
periods of time were derived from the following dates:
    1. The date an exemption for this device, under section 520(g) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360j(g)), became effective: May 30, 2012. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) for human tests to begin, as required under section 520(g) of the
FD&C Act, became effective May 30, 2012.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): June 28,
2016. FDA has verified the applicant's claim that the premarket
approval application (PMA) for EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS
(PMA P150048) was initially submitted June 28, 2016.
    3. The date the application was approved: June 29, 2017. FDA has
verified the applicant's claim that PMA P150048 was approved on June
29, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 572 days, 992 days, or 1,111 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: September 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19600 Filed 9-10-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7180-7181]
[FR Doc No: 2014-02571]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2005-0161; FRL-9906-21-OAR]

Proposed Information Collection Request; Comment Request;
Production Outlook Reports for Un-Registered Renewable Fuels Producers

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Production Outlook
Reports for Un-Registered Renewable Fuels Producers'' (EPA ICR No.
2409.02, OMB Control No. 2060-0640 to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). Before doing so, EPA is
soliciting public comments on specific aspects of the proposed
information collection as described below. This is a proposed extension
of the ICR, which is currently approved through May 31, 2014. 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: Comments must be submitted on or before April 7, 2014.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2005-0161, online using www.regulations.gov (our preferred method), or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
    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: Geanetta Heard, Fuels Compliance
Center, 6406J, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
202-565-2085; email address<EMAIL_ADDRESS>
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.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: With this information collection request (ICR), we are
seeking permission to accept production outlook reports from domestic
or foreign renewable fuel producers who are not currently regulated
parties under the RFS2 program. The respondents for this ICR are not
regulated parties under the RFS2 program and are therefore, not
required to register or report under the RFS2 regulations. Submission
of production outlook information to EPA under this ICR will be on a
voluntary basis.
    The information that respondents provide will allow EPA to more
accurately project cellulosic biofuel volumes for the following
calendar year, and these volume projections will form the basis of the
percentage standards EPA sets under the RFS2 program. Without
information from these respondents, EPA's volume projections are more
likely to fall below actual projection volumes. Under such
circumstances, actual supply for cellulosic biofuel will exceed the
demand created by the standards EPA sets, and the value of cellulosic
biofuel Renewable Identification Numbers (RINs) will fall. RINs are
marketable credits that correspond to a given volume of renewable fuel.
Since RIN market price directly affects the economic viability of
cellulosic biofuel production, low RIN prices could present economic
difficulties to producers. Thus, it is in the interests of these
respondents to provide this information to EPA, as doing so could
ensure that the market price of RINs appropriately reflects the value
of their cellulosic biofuel. This information also serves a more
general program purpose, because it will assist EPA in setting the
annual RFS2 standards more accurately for biomass-based diesel,
advanced biofuel, and total renewable fuel. Compiling this information
may also assist respondents with their planning and compliance
activities. We believe that many parties would wish to submit this
information in order to receive better assistance in understanding and
complying with the RFS2 regulations.
    Form Numbers: 5900-283 (RFS2 0900 Production Outlook Report).
    Respondents/affected entities: 35.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 35 (total).
    Frequency of response: Yearly.
    Total estimated burden: 140 hours (per year). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $16,100 (per year), includes no annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is no increase of hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB. The respondent universe and responses also remained the same in
this collection. There was in increase in cost to the industry of
$6,160 per year due to better numbers used to calculate the industry
burden and to account for inflation.

    Dated: January 28, 2014.
Byron Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2014-02571 Filed 2-5-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Rules and Regulations]
[Pages 41507-41508]
[FR Doc No: 2023-13657]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2023-0474]

Safety Zone; Recurring Events in Captain of the Port Duluth--
Duluth Fourth Fest Fireworks

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a safety zone for the Duluth
Fourth Fest Fireworks in Duluth, MN from 10 p.m. through 10:30 p.m.
This action is necessary to protect participants and spectators during
the Duluth Fourth Fest Fireworks. During the enforcement period, entry
into, transiting, or anchoring within the safety zone is prohibited
unless authorized by the Captain of the Port Duluth or their designated
on-scene representative.

DATES: The regulations in 33 CFR 165.943, table 1, paragraph (5) will
be enforced from 10:00 p.m. through 10:30 p.m. on July 4, 2023.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email LT Joe McGinnis, telephone 218-
725-3818, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
in 33 CFR 165.943, table 1, paragraph (5) on all waters of Duluth
Harbor bounded by the arc of a circle with a 1,120-foot radius from the
fireworks launch site with its center in position 46[deg]46'14'' N,
092[deg]06'16'' W from 10 p.m. through 10:30 p.m. on July 4, 2023. This
action is necessary to protect participants and spectators during the
Duluth Fourth Fest Fireworks.
    Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring
within the safety zone is prohibited unless authorized by the Captain
of the Port Duluth or their designated on-scene representative. The
Captain of the Port's designated on-scene representative may be
contacted via VHF Channel 16.
    This document is issued under authority of 33 CFR 165.943 and 5
U.S.C. 552(a). In addition to this publication in the Federal Register,
the Coast Guard will provide the maritime community with advance
notification of the enforcement of this safety zone via Broadcast
Notice to Mariners. The Captain of the Port Duluth or their on-scene
representative may be contacted via VHF Channel 16.

    Dated: June 20, 2023.
J.M. DeWitz,
Commander, U.S. Coast Guard, Captain of the Port Duluth.
[FR Doc. 2023-13657 Filed 6-26-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: March 9, 2006 (Volume 71, Number 46)]
[Notices]
[Page 12192-12194]
[DOCID:fr09mr06-50]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8043-5]

Federal Advisory Committee on Detection and Quantitation
Approaches and Uses in Clean Water Act Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; FACA Committee Meetings Announcement.

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

SUMMARY: As required by the Federal Advisory Committee Act, Public Law
92-463, the Environmental Protection Agency is announcing two separate
two-day meetings of the Federal Advisory Committee on Detection and
Quantitation Approaches and Uses in Clean Water Act (CWA) Programs.

DATES: A meeting of the Federal Advisory Committee on Detection and
Quantitation Approaches and Uses in Clean Water Act (CWA) Programs will
be held on Wednesday and Thursday, March 29, 2006, and March 30, 2006.
Another meeting of this committee will be held on Thursday, July 13,
2006, and Friday, July 14, 2006. The meetings on March 29 and July 13
will be from 9 a.m. until 5 p.m. e.s.t., and on March 30 and July 14,
from 8 a.m. to 4 p.m. e.s.t. All times are eastern time.

ADDRESSES: The meetings will be held at the L. William Seidman Center,
3501 North Fairfax Drive, Arlington, Virginia, across from the Virginia
Square Metro stop on the Orange line. Members of the public may attend
in person or via teleconference. The public may obtain the call-in
number and access code for the teleconference lines from Marion Kelly,
whose contact information is listed under the FOR FURTHER INFORMATION
CONTACT section of this notice.
    Document Availability: The draft agenda for both meetings are
provided in the General Information section of this notice or from
Marion Kelly whose contact information is listed under the FOR FURTHER
INFORMATION CONTACT section of this notice. The draft agenda may also
be viewed through EDOCKET, as provided in section I.A. of the
SUPPLEMENTARY INFORMATION section of this notice.
    Any member of the public interested in making an oral presentation
at these meetings may contact Richard Reding, whose contact information
is listed under FOR FURTHER INFORMATION CONTACT section of this notice.
Requests for making oral presentations will be accepted up to two
business days prior to each meeting date. In general, each oral
presentation will be limited to a total of three minutes.

Submitting Comments

    Written comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in section I.B of the SUPPLEMENTARY INFORMATION section.
Written comments will be accepted up to two business days prior to each
meeting date.

FOR FURTHER INFORMATION CONTACT: Marion Kelly, Engineering and Analysis
Division, 4303T, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; Telephone number:<PHONE_NUMBER>; Fax
number:<PHONE_NUMBER>; E-mail address<EMAIL_ADDRESS>Richard
Reding, Designated Federal Officer, Environmental Protection Agency,
Office of Water, 4303T, 1200 Pennsylvania Ave., NW., Washington, DC
20460; Telephone number:<PHONE_NUMBER>; Fax number:<PHONE_NUMBER>; E-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

    This notice announces two meetings of the Federal Advisory
Committee on Detection and Quantitation Procedures and Uses in Clean
Water Act (CWA) Programs. The purpose of these meetings is to continue
to evaluate and recommend detection and quantitation procedures for use
in EPA's analytical methods programs for compliance monitoring under 40
CFR part 136. The Committee will analyze and evaluate relevant
scientific and statistical approaches, protocols, review data and
interpretations of data using current and

recommended approaches. The major objectives are to provide advice and
recommendations to the EPA Administrator on policy issues related to
detection and quantitation, and scientific and technical aspects of
procedures for detection and quantitation.
    The draft agenda for March 29-30, 2006 includes a report and
discussion of issues posed by the Policy Work Group on the uses of
detection and quantitation procedures and their results. The Technical
Work Group will report its results on designs for pilot testing by a
single laboratory or by multiple laboratories. The advisory committee
will provide direction to both the Policy and the Technical Work Groups
on additional work to be carried out in advance of the committee's July
2006 meeting. The draft agenda for the July 2006 meeting includes a
continuation of discussions about recommended uses of detection and
quantitation limits in CWA programs, and approval of the design of a
laboratory pilot of candidate procedures for calculation of these
limits.

Information on Services for Individuals With Disabilities

    For information on access or services for individuals with
disabilities, please contact Marion Kelly at<PHONE_NUMBER> or e-mail:
<EMAIL_ADDRESS>to request accommodation of a disability, at least

ten days prior to the meeting, to give EPA as much time as possible to
process your request.
A. How Can I Get Copies of Related Information?
    1. Docket. EPA has established a docket for this committee under
Docket ID No. EPA-HQ-OW-2004-0041 in the EPA Docket Center (EPA/DC),
EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the OW Docket is<PHONE_NUMBER>.
    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 http://www.regulations.gov. You may

use http://www.regulations.gov 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 identification number (OW-2004-0041).
    For those wishing to make public comments, it is important to note
that EPA's policy is that comments, whether submitted electronically or
on 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, confidential business
information (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 mailed or delivered to
the docket will be transferred to EPA's electronic public docket.
Written public comments mailed or delivered to the Docket will be
scanned and placed in EPA's electronic public docket.
B. 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 identification number (OW-2004-0041) in the subject
line on the first page of your comment. Please ensure that your
comments are submitted within the specified comment period.
    1. Electronically. If you submit an electronic comment as
prescribed below, EPA recommends that you include your name, mailing
address, and an e-mail 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
comment, and it allows EPA to contact you if further information on the
substance of the comment is needed or if your comment cannot be read
due to technical difficulties. 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 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. http://www.regulations.gov. 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 http://www.regulations.gov
 and follow the online instructions for submitting

comments. To access EPA's electronic public docket from the EPA
Internet Home Page, http://www.epa.gov, select ``Information Sources,''

``Dockets,''. Once in the system, select ``search,'' and then key in
Docket ID No. EPA-HQ-OW-2004-0041. 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 electronic mail (e-mail) to
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-OW-2004-0041. 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
mailed to the mailing address identified in section I.B.2 of this
notice. These electronic submissions will be accepted in Word,
WordPerfect or rich text files. Avoid the use of special characters and
any form of encryption.
    2. By Mail. Send your comments to: U.S. Environmental Protection
Agency, OW Docket, EPA Docket Center (EPA/DC), Mailcode: 2822T, 1200
Pennsylvania Ave., NW., Washington, DC, 20460, Attention Docket ID No.
OW-2004-0041.
    3. By Hand Delivery or Courier. Deliver your comments to: EPA
Docket Center (EPA/DC), Room B102, EPA West Building, 1301 Constitution
Avenue, NW., Washington, DC, Attention Docket ID No. OW-2004-0041
(Note: this is not a mailing address). Such deliveries are only
accepted during the docket's normal hours of operation as identified in
section I.A.1 of this notice.

    Dated: March 2, 2006.
Richard Reding,
Designated Federal Officer.
[FR Doc. E6-3343 Filed 3-8-06; 8:45 am]

BILLING CODE 6560-50-P


IMPORTANT NOTE TO USER:

This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font ( Times New Roman 8pt).

 Do not change table lines ( although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5.1, so the text will scramble. PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance 2. OMB control number b. G None a. 2060  0111 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS for Phosphate Rock Plants ( 40 CFR part 60, subpart NN) ( Renewal)

8. Agency form number( s) ( If applicable) 1078.07 9. Keywords Phosphate rock, mining 10. Abstract This NSPS affects owners and operators of phosphate rock plants. Owners and operators must make initial notifications and conduct initial performance tests and comply with an opacity and mass particulate standard. In addition, each owner or operator must comply with the recordkeeping and reporting requirements of the NSPS including the submittal of semi annual excess emissions reports.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 13 b. Total annual responses 29 1. Percentage of these responses collected electronically 10 % c. Total hours requested 1,602 d. Current OMB inventory 3,002 e. Difference ( 1,400) f. Explanation of difference 1. Program Change 0 2. Adjustment ( 1,400) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 12 b. Total annual costs ( O& M) 112 c. Total annualized cost requested 124 d. Current OMB inventory 327 e. Difference ( 203) f. Explanation of difference 1. Program change 0 2. Adjustment ( 203)

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. X Other ( describe) Initial 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Gregory Fried Phone: ( 202) 564 7016 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of:

"( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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."

OMB 83 I ( Instructions) 10/ 95