[Federal Register Volume 78, Number 71 (Friday, April 12, 2013)]
[Rules and Regulations]
[Pages 21839-21841]
[FR Doc No: 2013-08580]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0041]
RIN 1625-AA09

Drawbridge Operation Regulation; Green River, Small-house, KY and
Black River, Jonesboro, LA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is removing the existing drawbridge operation
regulation for the drawbridges across Green River, mile 79.6, Small-
house, KY and Black River, mile 41.0, Jonesboro, LA. The Green River
bridge was removed in 2008 and the Black River bridge was replaced with
a fixed bridge in 2008 and the operating regulations are no longer
applicable or necessary.

DATES: This rule is effective April 12, 2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0041]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Eric Washburn, Bridge Administrator, Western Rivers,
Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If
you have questions on viewing the docket, call Barbara Hairston,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

A. Regulatory History and Information

    The Coast Guard is issuing this final rule without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the CSX Transportation Railroad
bridge, that once required draw operations in 33 CFR 117.415(b), was
removed from the waterway in 2008 and the US84 bridge, that once
required draw operations in 33 CFR 117.427, was removed from the
waterway and replaced with a fixed bridge in 2008. Therefore, the
regulations are no longer applicable and shall be removed from
publication. It is unnecessary to publish an NPRM because this
regulatory action does not purport to place any restrictions on
mariners but rather removes a restriction that has no further use or
value.
    Under 5 U.S.C. 553(d)(1), a rule that relieves a restriction is not
required to provide the 30 day notice period before its effective date.
This rule removes the CSX Transportation Railroad bridge draw operation
requirements under 33

CFR 117.415(b) and the US84 bridge draw operation requirements under 33
CFR 117.427, thus removing a regulatory restriction on the public.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists
for making this rule effective in less than 30 days after publication
in the Federal Register. The CSX Transportation Railroad bridge and
US84 bridge have been removed for 5 years and these rules merely
require an administrative change to the Code of Federal Regulations, in
order to omit a regulatory requirement that is no longer applicable or
necessary.

B. Basis and Purpose

    The CSX Transportation Railroad bridge across Green River, mile
79.6, was removed in 2008 and the US84 bridge across Black River, mile
41.0 was removed and replaced with a fixed bridge in 2008. It has come
to the attention of the Coast Guard that the governing regulations for
these drawbridges were never removed subsequent to the removal of the
drawbridges. The elimination of these drawbridges necessitates the
removal of the drawbridge operation regulations, 33 CFR 117.415(b) and
33 CFR 117.427, that pertain to the former drawbridges.
    The purpose of this rule is to remove the section (b) of 33 CFR
117.415 that refers to the CSX Transportation Railroad bridge at mile
79.6 and 33 CFR 117.427 that refers to the US84 bridge at mile 41.0,
from the Code of Federal Regulations since it governs bridges that are
no longer able to be opened.

C. Discussion of Rule

    The Coast Guard is changing the regulations in 33 CFR 117.415(b)
and 33 CFR 117.427 by removing restrictions and the regulatory burden
related to the draw operations for these bridges that are no longer in
existence. The change removes the section (b) of the regulation
governing the CSX Transportation Railroad bridge since the bridge has
been removed from the waterway and the US84 bridge since the bridge has
been replaced with a fixed bridge. This Final Rule seeks to update the
Code of Federal Regulations by removing language that governs the
operation of the CSX Transportation Railroad bridge, which in fact no
longer exists and US84 bridge, which in fact is no longer a drawbridge.
This change does not affect waterway or land traffic. This change does
not affect nor does it alter the operating schedules in 33 CFR
117.415(a) and (c) that govern the remaining active drawbridges on the
Green River.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders.
    The Coast Guard does not consider this rule to be ``significant''
under that Order because it is an administrative change and does not
affect the way vessels operate on the waterway.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule will have no effect on small entities since these
drawbridges have been removed and/or replaced with a fixed bridge and
the regulations governing draw operations for these bridges are no
longer applicable. There is no new restriction or regulation being
imposed by this rule; therefore, the Coast Guard certifies under 5
U.S.C. 605(b) that this final rule will not have a significant economic
impact on a substantial number of small entities.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b) (2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health

Risks and Safety Risks. This rule is not an economically significant
rule and does not create an environmental risk to health or risk to
safety that might disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves removing 33 CFR 117.415(b) and 33 CFR
117.427 due to removal of drawbridges from the waterway. This rule is
categorically excluded, under figure 2-1, paragraph (32) (e), of the
Instruction.
    Under figure 2-1, paragraph (32) (e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

Sec.  117.415  [Amended]

0
2. In Sec.  117.415, remove paragraph (b), and redesignate paragraph
(c) as paragraph (b).

Sec.  117.427  [Removed]

0
3. Remove Sec.  117.427.

    Dated: March 28, 2013.
Roy A. Nash,
Rear Admiral, Commander, U.S. Coast Guard, Eighth Coast Guard District.
[FR Doc. 2013-08580 Filed 4-11-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Rules and Regulations]
[Pages 57447-57450]
[FR Doc No: 2014-22835]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2009-0596; FRL-9916-62-OW]
RIN 2040-AF50

Water Quality Standards for the State of Florida's Lakes and
Flowing Waters; Withdrawal

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is finalizing its
withdrawal of federal water quality standards applicable to waters of
the state of Florida now that Florida has adopted and EPA has approved
relevant state standards. On December 6, 2010, EPA published a rule
finalizing numeric nutrient standards for Florida's lakes, springs, and
flowing waters outside of the South Florida Nutrient Watershed Region.
The EPA established these water quality standards to protect Florida's
Class I and III freshwaters from nitrogen and phosphorus pollution. On
November 30, 2012, June 27, 2013, and September 26, 2013, EPA approved
numeric nutrient standards adopted by the state of Florida for certain
waters in the state.
    Some of the water body types and provisions covered by state-
adopted water quality standards were also included in EPA's final
inland waters rule (criteria for Florida's lakes and springs,
approaches to protect downstream lakes, and a provision for developing
Site-Specific Alternative Criteria). The EPA is now withdrawing the
overlapping federally-promulgated water quality standards to allow
Florida to implement its state-adopted, EPA-approved water quality
standards to address nutrient pollution in Florida's waters.
Additionally, this rule serves as final notice that EPA is not
finalizing three 2012 federal proposed rules related to nutrient
pollution in Florida.

DATES: This final rule is effective on October 27, 2014.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-OW-2009-0596. All documents in the docket are listed on the
www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) or other information of which disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the EPA Docket Center, EPA West Room 3334, 1301 Constitution
Avenue NW, Washington, DC 20004, Attention: Docket ID No. EPA-HQ-OW-
2009-0596. The Office of Water (OW) Docket Center is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
OW Docket Center telephone number is<PHONE_NUMBER>. 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>.

FOR FURTHER INFORMATION CONTACT: For information concerning this
rulemaking, contact: Erica Fleisig, U.S. EPA, Office of Water, Mailcode
4305T, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone
number<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This final rule is organized as follows:

I. General Information
    A. Which water bodies are affected by this action?
    B. What entities may be affected by this action?
    C. How can I get copies of this document and other related
information?
II. Background
    A. Background on EPA's Inland Rule, Amended Determinations, and
Approval of State Criteria
    B. 2014 District Court Ruling and Modification of Consent Decree
    C. Summary of and Response to Public Comments on the Proposed
Rule
    D. Withdrawal of Federal Criteria for Lakes, Springs, and DPVs
III. Statutory and Executive Order Reviews
    A. Executive Order 12866 (Regulatory Planning and Review) and
Executive Order 13563 (Improving Regulation and Regulatory Review)
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132 (Federalism)
    F. Executive Order 13175 (Consultation and Coordination With
Indian Tribal Governments)
    G. Executive Order 13045 (Protection of Children From
Environmental Health and Safety Risks)
    H. Executive Order 13211 (Actions That Significantly Affect
Energy Supply, Distribution, or Use)
    I. National Technology Transfer Advancement Act of 1995
    J. Executive Order 12898 (Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations)
    K. Congressional Review Act

I. General Information

A. Which water bodies are affected by this action?

    In this final rule, EPA is withdrawing federally promulgated water
quality standards (WQS) from a group of inland waters of the United
States within Florida. Specifically, as defined below and in EPA's
December 6, 2010 final inland waters rule (40 CFR 131.43), EPA is
withdrawing the federal criteria for Florida's Class I and III \1\
freshwater lakes and springs, as well as downstream protection values
(DPVs) to protect downstream lakes and a provision for developing site-
specific alternative criteria (SSAC) in all water bodies.
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    \1\ According to Subsection 62-302.400(1), Florida
Administrative Code (F.A.C.):
    Class I Potable Water Supplies.
    Class III Fish Consumption; Recreation, Propagation and
Maintenance of a Healthy, Well-Balanced Population of Fish and
Wildlife.
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    The EPA's final inland waters rule defined ``Predominantly fresh
waters'' to mean surface waters in which the chloride concentration at
the surface is less than 1,500 milligrams per liter (mg/L). The EPA
defined ``Lake'' as a slow-moving or standing body of freshwater that
occupies an inland basin that is not a stream, spring, or wetland.
Finally, EPA defined ``Spring'' as a site at which ground water flows
through a natural

opening in the ground onto the land surface or into a body of surface
water.

B. What entities may be affected by this action?

    This action withdraws federal WQS applicable to certain waters in
Florida for which the state has adopted criteria that EPA has
determined are consistent with the Clean Water Act (CWA) and EPA's
implementing regulations. Citizens concerned with water quality, as
well as the state of Florida, may be interested in this rulemaking.
Also, entities discharging nitrogen or phosphorus to waters of Florida
may be interested in this rulemaking because WQS are used in
determining National Pollutant Discharge Elimination System (NPDES)
permit limits. If you have questions regarding the applicability of
this action to a particular entity, consult the person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.

C. How can I get copies of this document and other related information?

    1. Docket. The EPA has established an official public docket for
this action under Docket Id. No. EPA-HQ-OW-2009-0596. The official
public docket consists of the document specifically referenced in this
action, any public comments received, and other information related to
this action. Although a part of the official docket, the public docket
does not include CBI or other information whose disclosure is
restricted by statute. The official public docket is the collection of
materials that is available for public viewing at the OW Docket,
William Jefferson Clinton West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC 20004. This Docket Facility is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>. A reasonable fee will be charged
for copies.
    2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. An electronic version of the
public docket is available through EPA's electronic public docket and
comment system, EPA Dockets. You may use EPA Dockets at http://www.regulations.gov to view public comments, access the index listing
of the contents of the official public docket, and access those
documents in the public docket that are available electronically. For
additional information about EPA's public docket, visit the EPA Docket
Center homepage at http://www.epa.gov/epahome/dockets.htm. Although not
all docket materials may be available electronically, you may still
access any of the publicly available docket materials through the
Docket Facility identified in Section I.C(1).

II. Background

A. Background on EPA's Inland Rule, Amended Determinations, and
Approval of State Criteria

    On December 6, 2010, pursuant to a January 14, 2009 EPA
determination and December 30, 2009 consent decree, EPA published the
inland waters rule to establish numeric nutrient criteria for Florida's
lakes, springs, and flowing waters outside of the South Florida
Nutrient Watershed Region \2\. These criteria also included three
approaches for deriving DPVs, applicable to flowing waters at the point
where they enter downstream lakes, which would ensure protection of
downstream lakes as required by EPA's implementing regulations (40 CFR
131.10(b)).
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    \2\ EPA defined the South Florida Nutrient Watershed Region as
the area south of Lake Okeechobee, the Caloosahatchee River
watershed (including Estero Bay) to the west of Lake Okeechobee, and
the St. Lucie watershed to the east of Lake Okeechobee.
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    On November 30, 2012, EPA amended its January 14, 2009
determination stating that numeric criteria for downstream protection
are not necessary to meet CWA requirements in Florida. With the
additional clarification provided in Florida's ``Implementation of
Florida's Numeric Nutrient Standards'' rule-referenced document on the
scope of waters covered by state-adopted numeric nutrient criteria, EPA
amended its January 2009 determination for a second time on June 28,
2013, concluding that numeric nutrient criteria are not necessary for a
limited number of waters in the state of Florida (specifically, flowing
waters in the South Florida Region, marine lakes, tidally-influenced
flowing waters, and conveyances primarily used for water management
purposes with marginal or poor stream habitat components).
    These actions, coupled with EPA's November 30, 2012, June 27, 2013,
and September 26, 2013 approvals of Florida's numeric nutrient
criteria, result in Florida having EPA-approved numeric nutrient
criteria for all fresh water lakes, springs, estuaries and coastal
waters, and the majority of flowing waters in the state.

B. 2014 District Court Ruling and Modification of Consent Decree

    On January 7, 2014, the U.S. District Court for the Northern
District of Florida granted an EPA motion to modify the consent decree
(Case No. 4:08-cv-324-RH, Florida Wildlife Fed'n v. McCarthy, 2014 WL
51360 (N.D. Fla. Jan. 7, 2014)). As a result of this ruling, EPA is no
longer obligated to promulgate numeric nutrient criteria for any of
Florida's waters, and will, therefore, not be finalizing its November
30, 2012 federal proposed rules addressing Florida's estuaries and
coastal waters, inland waters in the South Florida Nutrient Watershed
Region, and the remanded portions of the inland waters rule (77 FR
74923 and 77 FR 74985, December 18, 2012). In addition, EPA will no
longer be finalizing its December 14, 2012 proposal to temporarily stay
portions of the inland waters rule. The EPA can now withdraw already
promulgated federal criteria so Florida's nutrient criteria can take
effect.
    For more specifics on the Agency and court actions leading to this
rule, refer to the following:

EPA Determination Regarding Florida and Consent Decree: http://
water.epa.gov/lawsregs/rulesregs/floridaconsent.cfm
Florida Adoption of Numeric Nutrient Criteria in 2012 and EPA
Approval: http://www2.epa.gov/aboutepa/epa-florida
EPA's 2012 Proposed Rulemaking: http://water.epa.gov/lawsregs/
rulesregs/floridaindex.cfm
2013 EPA and FDEP Agreement in Principle and Path Forward: http://content.govdelivery.com/bulletins/gd/FLDEP-713cfb

C. Summary of and Response to Public Comments on the Proposed Rule

    The EPA received 12 comments on the proposed withdrawal of federal
criteria for lakes, springs, and downstream protection values for the
state of Florida (79 FR 18494, April 2, 2014). Eight of the commenters
supported the proposal to withdraw federal water quality standards in
Florida, arguing: (a) The primacy for establishing water quality
standards lies with the states, (b) EPA's approval of Florida's water
quality standards eliminates the need for federal standards, and (c)
the U.S. District Court's January 7, 2014 order relieves EPA of the
obligation to finalize numeric nutrient criteria within the state of
Florida.
    The EPA agrees that the basis to withdraw (and not finalize)
federal numeric nutrient criteria in the state of Florida is justified
by the following: (1) EPA's November 30, 2012, June 27, 2013, and
September 26, 2013 approvals of Florida-adopted numeric nutrient
criteria and other water quality standards, (2) EPA's November 30, 2012

and June 28, 2013 amended Clean Water Act section 303(c)(4)(B)
determinations, and (3) the U.S. District Court's January 7, 2014 order
modifying the consent decree to relieve EPA of the obligation to
finalize numeric nutrient criteria for various waters in Florida. These
three items are described in more detail in sections II.A and II.B of
this rule.
    The EPA received four comments requesting that federal water
quality standards for nutrients remain in effect in the state of
Florida, stating that aquatic resources in the state have experienced
detrimental effects resulting from nitrogen and phosphorus pollution
and Florida's water quality standards will be insufficient to address
the problem. The EPA disagrees that federal numeric nutrient standards
are necessary now that Florida has adopted and EPA has approved state
standards to address nitrogen and phosphorus pollution. The Clean Water
Act assigns to the states the primary authority for setting water
quality standards. The EPA's role is largely one of oversight, in which
it reviews and approves or disapproves a state's new or revised water
quality standards as they are adopted and submitted to EPA. Florida now
has state-adopted, EPA-approved criteria for lakes and springs that are
applicable for Clean Water Act purposes. Thus there is no need for
overlapping federal criteria for such waters.
    One comment requested that EPA not relinquish oversight authority
of Florida's water quality standards. Withdrawal of EPA's federal water
quality standards does not mean that EPA is relinquishing its Clean
Water Act oversight authority in Florida. Under section 303(d) of the
Clean Water Act, monitoring data as well as other information must be
used by the states every two years to develop a list of waters that
will not meet water quality standards for a particular pollutant. The
EPA reviews and approves or disapproves state 303(d) lists, and tracks
impaired waters nationally. Similarly, Florida controls water pollution
by issuing National Pollutant Discharge Elimination System (NPDES)
permits to point sources that discharge pollutants into waters of the
United States. The EPA retains oversight authority for such permits,
pursuant to section 402(d) of the CWA and 40 CFR 123.44(a), including
the authority to review and comment on the permits before they are
finalized.
    One commenter argued that EPA should not withdraw its federal
standards because the U.S. District Court's January 7, 2014 ruling on
the modification of the 2009 consent decree has been appealed to the
U.S. Circuit Court for the 11th Circuit. The EPA recognizes that a
decision from the Court of Appeals may affect that District Court
decision and may make it necessary for the Agency to reconsider its
obligations pursuant to the original January 14, 2009 necessity
determination and ensuing consent decree entered by the U.S. District
Court on December 30, 2009.
    Finally, several of the 12 comment letters that EPA received on
this rule included comments and attachments that addressed the content,
scope, or protectiveness of Florida's water quality standards. These
comments are directed at whether EPA should have reached the decisions
that serve, in part, as the basis for EPA withdrawing its federal water
quality standards in Florida. The EPA considered substantially similar
issues as those raised in the comments in deciding to approve Florida's
new or revised water quality standards and to amend its Clean Water Act
section 303(c)(4)(B) determination. Since these comments address EPA's
underlying decisions, rather than whether EPA should withdraw its
federal standards in light of those decisions, the comments are outside
the scope of this action and, therefore, EPA did not address them.

D. Withdrawal of Federal Criteria for Lakes, Springs, and DPVs

    Florida now has state-adopted, EPA-approved criteria for lakes and
springs that are applicable for CWA purposes. Thus there is no need for
overlapping federal criteria for such waters. With respect to federal
DPVs, EPA determined on November 30, 2012 that numeric criteria for
downstream protection are not necessary in Florida and that same day
approved Florida's quantitative downstream protection approach.
Finally, since Florida has its own process for developing SSAC, a
federal SSAC process is unnecessary. Thus, EPA is withdrawing the
federal criteria for lakes and springs and federal DPVs that took
effect on January 6, 2013, and the federal SSAC provision that went
into effect on February 4, 2011.

III. Statutory and Executive Order Reviews

A. Executive Order 12866 (Regulatory Planning and Review) and Executive
Order 13563 (Improving Regulation and Regulatory Review)

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is,
therefore, not subject to review under Executive Orders 12866 and 13563
(76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This rule does not impose any new information-collection burden
because it is administratively withdrawing federal requirements that
are no longer needed in Florida. It does not include any information-
collection, reporting, or recordkeeping requirements.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201 (2) a small governmental jurisdiction that is a government of a
city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This rule
will not impose any requirements on small entities.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or tribal governments or the private
sector. The action imposes no enforceable duty on any state, local or
tribal governments or the private sector. Therefore, this action is not
subject to the requirements of sections 202 or 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. This rule removes
federally-promulgated water quality standards addressing nutrient
pollution in Florida in order to allow Florida to implement its state-

adopted, EPA-approved water quality standards.

E. Executive Order 13132 (Federalism)

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. This rule removes federally-
promulgated water quality standards addressing nutrient pollution in
Florida in order to allow Florida to implement its state-adopted, EPA-
approved water quality standards. Thus, Executive Order 13132 does not
apply to this action.

F. Executive Order 13175 (Consultation and Coordination With Indian
Tribal Governments)

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This rule
imposes no regulatory requirements or costs on any tribal government.
It does not have substantial direct effects on tribal governments, the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes. Thus, Executive Order 13175 does not
apply to this action.

G. Executive Order 13045 (Protection of Children From Environmental
Health and Safety Risks)

    This rule is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it is not economically
significant as defined in Executive Order 12866 and because the
environmental health or safety risks addressed by this action do not
present a disproportionate risk to children.

H. Executive Order 13211 (Actions That Significantly Affect Energy
Supply, Distribution, or Use)

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act of 1995

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities, unless to do so would be inconsistent with applicable law
or otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This rulemaking does not involve technical standards. Therefore,
EPA is not considering the use of any voluntary consensus standards.

J. Executive Order 12898--Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this rule will not have disproportionately
high and adverse human health or environmental effects on minority or
low-income populations because: (1) Florida's WQS apply to waters
across the state, and thus this action will not disproportionately
affect any one group over another, and (2) EPA has previously
determined, based on the most current science, that Florida's adopted
and EPA-approved criteria are protective of human health and aquatic
life.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective on October 27, 2014.

List of Subjects in 40 CFR Part 131

    Environmental protection, Florida, Nitrogen and phosphorus
pollution, Numeric nutrient criteria, Nutrients, Water quality
standards.

    Dated: September 17, 2014.
Gina McCarthy,
Administrator.

    For the reasons set out in the preamble, 40 CFR part 131 is amended
as follows:

PART 131--WATER QUALITY STANDARDS

0
1. The authority citation for part 131 continues to read as follows:

     Authority: 33 U.S.C. 1251 et seq.

Subpart D--Federally Promulgated Water Quality Standards

Sec.  131.43  [Removed]

0
2. Remove Sec.  131.43.

[FR Doc. 2014-22835 Filed 9-24-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 12, 2009 (Volume 74, Number 112)]
[Notices]
[Page 28049]
[DOCID:fr12jn09-67]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0137]

Mary E. Sawaya a.k.a. Marty Sawaya; Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the act) permanently
debarring Dr. Mary E. Sawaya a.k.a. Marty Sawaya (Dr. Sawaya) from
providing services in any capacity to a person that has an approved or
pending drug product application. FDA bases this order on a finding
that Dr. Sawaya was convicted of a felony under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of a drug product, and conduct otherwise
relating to the regulation of a drug product under the act. After being
given notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation, Dr.
Sawaya failed to request a hearing. Dr. Sawaya's failure to request a
hearing constitutes a waiver of her right to a hearing concerning this
action.

DATES: This order is effective June 12, 2009.

ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Robert L. Hummel, Sr., Division of
Compliance Policy (HFC-230), Office of Enforcement, Office of
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the act (21 U.S.C. 335a(a)(2)(A)) requires
debarment of an individual if FDA finds that the individual has been
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of any drug product. Section 306(a)(2)(B) of the act requires
debarment of an individual if FDA finds that the individual has been
convicted of a felony under Federal law for conduct otherwise relating
to the regulation of any drug product under the act.
    On December 11, 2003, the U.S. District Court for the Middle
District of Florida accepted Dr. Mary E. Sawaya's plea of guilty and
convicted her of one count of making a false statement to a Federal
agency, a Federal felony offense under 18 U.S.C. 1001. This offense was
committed when Dr. Sawaya created a medical license by obtaining a copy
of a colleague's Florida medical license, altered that license using a
photocopy machine to reflect that the license was issued in her name,
and submitted the false and fraudulent Florida medical license to the
sponsor of a clinical trial, for which she was a clinical investigator.
The sponsor submitted that license to FDA as part of the drug approval
process. When the false license was due to expire, Dr. Sawaya once
again created a false and fraudulent medical license with a different
expiration date and submitted that license to the clinical trial
sponsor.
    As a result of this conviction, FDA sent Dr. Sawaya by certified
mail on November 26, 2008, a notice proposing to permanently debar her
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(a)(2)(A) and (a)(2)(B) of the act, that
Dr. Sawaya was convicted of a felony under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of a drug product, and conduct otherwise
relating to the regulation of a drug product under the act. The
proposal also offered Dr. Sawaya an opportunity to request a hearing,
providing her 30 days from the date of receipt of the letter in which
to file the request, and advised her that failure to request a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. Dr. Sawaya did not request a
hearing and has, therefore, waived her opportunity for a hearing and
any contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(A) and (a)(2)(B) of the
act, and under authority delegated to her, finds that Dr. Sawaya has
been convicted of a felony under Federal law for conduct relating to
the development or approval, including the process for development or
approval, of a drug product and conduct otherwise relating to the
regulation of a drug product under the act.
    As a result of the foregoing finding, Dr. Sawaya is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES). (See sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the
act (21 U.S.C. 321(dd)).) Any person with an approved or pending drug
product application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Dr. Sawaya, in any
capacity, during Dr. Sawaya's permanent debarment, will be subject to
civil money penalties (section 307(a)(6) of the act (21 U.S.C.
335b(a)(6))). If Dr. Sawaya , during her period of debarment, provides
services in any capacity to a person with an approved or pending drug
product application, she will be subject to civil money penalties
(section 307(a)(7) of the act). In addition, FDA will not accept or
review any abbreviated new drug applications submitted by or with the
assistance of Dr. Sawaya during her period of debarment (section
306(c)(1)(B) of the act).
    Any application by Dr. Sawaya for special termination of debarment
under section 306(d)(4) of the act should be identified with Docket No.
FDA-2008-N-0137 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 1, 2009.
Alyson L. Saben,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-13929 Filed 6-11-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Notices]
[Pages 43643-43644]
[FR Doc No: 2023-14462]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2023-0042]

Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillator (ICD)

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

ACTION: Notice of denials.

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

SUMMARY: FMCSA announces its decision to deny the application from one
individual treated with an Implantable Cardioverter Defibrillator (ICD)
who requested an exemption from the Federal Motor Carrier Safety
Regulations (FMCSRs) prohibiting operation of a commercial motor
vehicle (CMV) in interstate commerce by persons with a current clinical
diagnosis of myocardial infarction, angina pectoris, coronary
insufficiency, thrombosis, or any other cardiovascular disease of a
variety known to be accompanied by syncope (transient loss of
consciousness), dyspnea (shortness of breath), collapse, or congestive
heart failure.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room
W64-224, Washington, DC 20590-0001,<PHONE_NUMBER>,
[email protected]. Office hours are from 8:30 a.m. to 5 p.m. ET
Monday through Friday, except Federal holidays. If you have questions
regarding viewing materials in the docket, contact Dockets Operations,
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2023-0042) in the keyword box and click ``Search.'' Next,
sort the results by ``Posted (Newer-Older),'' choose the first notice
listed, and click ``Browse Comments.'' If you do not have access to the
internet, you may view the docket online by visiting Dockets Operations
on the ground floor of the DOT West Building, 1200 New Jersey Avenue
SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday
through Friday, except Federal holidays. To be sure someone is there to
help you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption requests. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov. As described in the system of records
notice DOT/ALL 14 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of
the submitter.

II. Background

    On May 18, 2023, FMCSA published a Federal Register notice (88 FR
31842) announcing receipt of one application from an individual treated
with an ICD and requested comments from the public. The individual
requested an exemption from 49 CFR 391.41(b)(4) which prohibits
operation of a CMV in interstate commerce by persons with a current
clinical diagnosis of myocardial infarction, angina pectoris, coronary
insufficiency, thrombosis, or any other cardiovascular disease of a
variety known to be accompanied by syncope, dyspnea, collapse, or
congestive heart failure. The public comment period ended on June 20,
2023, and no comments were received.
    FMCSA has evaluated the eligibility of the applicant and concluded
that granting an exemption would not provide a level of safety that
would be equivalent to, or greater than, the level of safety that would
be obtained by complying with Sec.  391.41(b)(4). A summary of the
applicant's medical history related to their ICD exemption request was
discussed in the May 18, 2023, Federal Register notice (88 FR 31842)
requesting comments and will not be repeated here.
    The Agency's decision regarding this exemption application is based
on information from the Cardiovascular Medical Advisory Criteria, an
April 2007 evidence report titled ``Cardiovascular Disease and
Commercial Motor Vehicle Driver Safety,'' \1\ and a December 2014
focused research report titled ``Implantable Cardioverter
Defibrillators and the Impact of a Shock in a Patient When Deployed.''
Copies of these reports are included in the docket.
---------------------------------------------------------------------------

    \1\ The report is available on the internet at https://rosap.ntl.bts.gov/view/dot/16462.
---------------------------------------------------------------------------

    FMCSA has published advisory criteria to assist medical examiners
in determining whether drivers with certain medical conditions are
qualified to operate a CMV in interstate commerce.\2\ The advisory
criteria for Sec.  391.41(b)(4) indicates that coronary artery bypass
surgery and pacemaker implantation are remedial procedures and thus,
not medically disqualifying. ICDs are disqualifying due to risk of
syncope.
---------------------------------------------------------------------------

    \2\ These criteria may be found in 49 CFR part 391, APPENDIX A
TO PART 391--MEDICAL ADVISORY CRITERIA, section D. Cardiovascular:
Sec.  391.41(b)(4), paragraph 4, which is available on the internet
at https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption.
    The Agency's decision regarding this exemption application is based
on an individualized assessment of the applicants' medical information,
available medical and scientific data concerning ICDs, and any relevant
public comments received.
    In the case of persons with ICDs, the underlying condition for
which the ICD was implanted places the individual at high risk for
syncope or other unpredictable events known to result in gradual or
sudden incapacitation. ICDs may discharge, which could result in loss
of ability to safely control a CMV. The December 2014 focused research
report referenced previously upholds the findings of the April 2007
report and indicates that the available scientific data on persons with
ICDs and CMV driving does not support that persons with ICDs who
operate CMVs are able to meet an equal or greater level of safety.

V. Conclusion

    The Agency has determined that the available medical and scientific
literature and research provides insufficient data to enable the Agency
to conclude that granting this exemption would achieve a level of
safety equivalent to, or greater than, the level of safety maintained
without the exemption. Therefore, Nicholas Steffler (NC) has been
denied an exemption from the physical qualification standards in Sec.
391.41(b)(4).
    The applicant has, prior to this notice, received a letter of final
disposition regarding their exemption request. The decision letter
fully outlined the basis for the denial and constitutes final action by
the Agency. The name of this individual published today summarizes the
Agency's recent denial as required under 49 U.S.C. 31315(b)(4).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-14462 Filed 7-7-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: March 25, 2010 (Volume 75, Number 57)]
[Notices]
[Page 14483]
[DOCID:fr25mr10-110]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Third Meeting: RTCA Special Committee 223: Airport Surface
Wireless Communications

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 223: Airport Surface Wireless
Communications meeting.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 223: Airport Surface Wireless
Communications.

DATES: The meeting will be held April 13-14, 2010 from 9 a.m.-5 p.m.

ADDRESSES:  The meeting will be held at RTCA, Inc., 1828 L Street, NW.,
Suite 805, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a RTCA Special Committee 223: Airport Surface
Wireless Communications meeting. The agenda will include:

Tuesday, April 13, 2010

Tuesday Morning--Plenary

     Opening Session (Welcome, Introductions, Administrative
Remarks, Approve/Review Meeting 2 Summary, RTCA Paper No. 045-
10/SC223-005)
     Special Committee Leadership
     Designated Federal Official (DFO): Mr. Brent Phillips
     Co-Chair: Mr. Aloke Roy, Honeywell International
     Co-Chair: Mr. Ward Hall, ITT Corporation
     Agenda Overview
     Report from EUROCAE WG 82 meeting
     AeroMACS Profile Working Group Status
     2nd Plenary action item status
     Assignment of MOPS working group leader

Tuesday Afternoon--Profiles WG Breakout Session

     Document Structure
     Technical work on AeroMACS Profile

Wednesday, April 14, 2010

Wednesday Morning--Profiles WG Breakout Session

     Continue AeroMACS Profile definition

Wednesday Afternoon--Reconvene Plenary

     Profiles WG Status Report and Plenary Guidance
     Establish Agenda, Date and Place for the next plenary
meeting
     Review of Meeting summary report
     Adjourn--Expected by 3 p.m. on April 14
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, 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 March 19, 2010.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. 2010-6668 Filed 3-24-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Pages 72300-72301]
[FR Doc No: 2021-27529]

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SECURITIES AND EXCHANGE COMMISSION

[Securities Act of 1933 Release No. 33-11014/December 15, 2021;
Securities Exchange Act of 1934 Release No. 34-93785/December 15, 2021]

Order Approving Public Company Accounting Oversight Board Budget
and Annual Accounting Support Fee for Calendar Year 2022

    The Sarbanes-Oxley Act of 2002, as amended (the ``Sarbanes-Oxley
Act''),\1\ established the Public Company Accounting Oversight Board
(``PCAOB''

or the ``Board'') to oversee the audits of companies that are subject
to the securities laws, and related matters, in order to protect the
interests of investors and further the public interest in the
preparation of informative, accurate, and independent audit reports.
Section 982 of the Dodd-Frank Wall Street Reform and Consumer
Protection Act (the ``Dodd-Frank Act'') \2\ amended the Sarbanes-Oxley
Act to provide the PCAOB with explicit authority to oversee auditors of
broker-dealers registered with the Securities and Exchange Commission
(the ``Commission''). The PCAOB is to accomplish these goals through
the registration of public accounting firms, standard setting,
inspections, and investigation and disciplinary programs. The PCAOB is
subject to the comprehensive oversight of the Commission.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 7201 et seq.
    \2\ Public Law 111-203, 124 Stat. 1376 (2010).
---------------------------------------------------------------------------

    Section 109 of the Sarbanes-Oxley Act provides that the PCAOB shall
establish a reasonable annual accounting support fee, as may be
necessary or appropriate to establish and maintain the PCAOB. Under
Section 109(f) of the Sarbanes-Oxley Act, the aggregate annual
accounting support fee shall not exceed the PCAOB's aggregate
``recoverable budget expenses,'' which may include operating, capital,
and accrued items. The PCAOB's annual budget and accounting support fee
are subject to approval by the Commission. In addition, the PCAOB must
allocate the annual accounting support fee among issuers and among
brokers and dealers.
    Section 109(b) of the Sarbanes-Oxley Act directs the PCAOB to
establish a budget for each fiscal year in accordance with the PCAOB's
internal procedures, subject to approval by the Commission. Rule 190 of
Regulation P (the ``Budget Rule'') governs the Commission's review and
approval of PCAOB budgets and annual accounting support fees.\3\ The
Budget Rule provides, among other things, a timetable for the
preparation and submission of the PCAOB budget and for Commission
actions related to each budget, a description of the information that
should be included in each budget submission, limits on the PCAOB's
ability to incur expenses and obligations except as provided in the
approved budget, procedures relating to supplemental budget requests,
requirements for the PCAOB to provide on a quarterly basis certain
budget-related information, and a list of definitions that apply to the
rule and to general discussions of PCAOB budget matters.
---------------------------------------------------------------------------

    \3\ 17 CFR 202.190.
---------------------------------------------------------------------------

    In accordance with the Budget Rule, in March 2021 the PCAOB
provided the Commission with a narrative description of its program
issues and outlook for the 2022 budget year. In response, the
Commission provided the PCAOB with economic assumptions and general
budgetary guidance for the 2022 budget year. The PCAOB subsequently
delivered a preliminary budget and budget justification to the
Commission. Staff from the Commission's Office of the Chief Accountant
and Office of Financial Management dedicated a substantial amount of
time to the review and analysis of the PCAOB's programs, projects, and
budget estimates and participated in several meetings with staff of the
PCAOB to further develop the understanding of the PCAOB's budget and
operations. During the course of this review, Commission staff relied
upon representations and supporting documentation from the PCAOB. Based
on this review, the Commission issued a ``passback'' letter to the
PCAOB on October 29, 2021. On November 23, 2021, the PCAOB adopted its
2022 budget and accounting support fee during an open meeting, and
subsequently submitted that budget to the Commission for approval.
    After considering the above, the Commission did not identify any
proposed disbursements in the 2022 budget adopted by the PCAOB that are
not properly recoverable through the annual accounting support fee, and
the Commission believes that the aggregate proposed 2022 annual
accounting support fee does not exceed the PCAOB's aggregate
recoverable budget expenses for 2022.
    Given the change in leadership of the PCAOB and potential changes
to its priorities for 2022 and beyond, the Commission requests the
PCAOB to perform an assessment of the PCAOB Strategic Plan by June 30,
2022 and provide the Commission staff with a report detailing the
results of the assessment.
    The Commission continues to emphasize the importance of the PCAOB's
identification of efficiencies and process improvements. Accordingly,
the Commission requests the Board evaluate its operational efficiency,
improvements, and budgetary needs and submit such assessments to the
Commission in connection with the 2023 budget cycle.
    Continuing uncertainty surrounding the impact of COVID-19 on the
PCAOB's operations reinforces the importance of continued coordination
between the SEC and PCAOB. The Commission directs the PCAOB during 2022
to continue to hold monthly meetings, as necessary, with the
Commission's staff to discuss important policy initiatives, changes
related to program areas, and significant impacts to the PCAOB's 2022
budget, including significant differences between actual and budgeted
amounts and anticipated cost-savings. Separately, the Commission
requests the PCAOB to continue its written quarterly updates on recent
activities, including strategic initiatives, for the PCAOB's Office of
Economic and Risk Analysis, Office of Data, Security, and Technology,
and Division of Registration and Inspections. The Commission expects
the PCAOB Board to make itself available to meet with individual
Commissioners on these and other topics. Further, the Commission
requests that the PCAOB submit its 2021 annual report to the Commission
by March 31, 2022.
    The Commission understands that the Office of Management and Budget
(``OMB'') has determined that the 2022 budget of the PCAOB is subject
to sequestration under the Budget Control Act of 2011.\4\ For 2021, the
PCAOB sequestered $16.4 million. That amount will become available in
2022. For 2022, the sequestration amount will be 5.7% or $17.7 million.
Consequently, we expect the PCAOB will have approximately $1.3 million
less funds available from the 2021 sequestration for spending in 2022.
Accordingly, the PCAOB decreased its accounting support fee for 2022 by
approximately $1.3 million.
---------------------------------------------------------------------------

    \4\ OMB Report to the Congress on the Joint Committee Reductions
for Fiscal Year 2021, February 10, 2020, available at https://www.whitehouse.gov/wp-content/uploads/2020/02/JC-sequestration_report_FY21_2-10-20.pdf.
---------------------------------------------------------------------------

    The Commission has determined that the PCAOB's 2022 budget and
annual accounting support fee are consistent with Section 109 of the
Sarbanes-Oxley Act. Accordingly,
    It is ordered, pursuant to Section 109 of the Sarbanes-Oxley Act,
that the PCAOB budget and annual accounting support fee for calendar
year 2022 are approved.

    By the Commission.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2021-27529 Filed 12-20-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Rules and Regulations]
[Pages 38853-38855]
[FR Doc No: 2019-16814]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0251; Product Identifier 2019-NM-057-AD; Amendment
39-19685; AD 2019-14-07]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

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

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus SAS Model A320-251N and -271N airplanes; and Model A321-
251N, -253N, -271N, and -272N airplanes. This AD was prompted by a
report that during a calibration check, some torqueing tools used on
the final assembly line have been found out of tolerance. This AD
requires retorqueing each affected connection of sense and fire
extinguishing lines within the pylon area to a correct torque value, as
specified in an European Union Aviation Safety Agency (EASA) AD, which
is incorporated by reference. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective September 12, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
12, 2019.

ADDRESSES: For the material incorporated by reference (IBR) in this AD,
contact the EASA, at Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 89990 1000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available in the AD docket on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2019-0251.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0251; 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, the regulatory evaluation, 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: Sanjay Ralhan, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Airbus SAS
Model A320-251N and -271N airplanes; and Model A321-251N, -253N, -271N,
and -272N airplanes. The NPRM published in the Federal Register on May
7, 2019 (84 FR 19879). The NPRM was prompted by a report that during a
calibration check, some torqueing tools used on the final assembly line
have been found out of tolerance. The NPRM proposed to require
retorqueing each affected connection of sense and fire extinguishing
lines within the pylon area to a correct torque value.
    The FAA is issuing this AD to address connections of sense and fire
extinguishing lines within the pylon area that have been under-torqued,
which could lead to leaks or

disconnections of those lines and possibly result in reduced engine
control and reduced safety margin in case of engine fire.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0081, dated April 3, 2019
(``EASA AD 2019-0081'') (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Airbus SAS Model A320-251N and -271N
airplanes; and Model A321-251N, -253N, -271N, and -272N airplanes. The
MCAI states:

    During periodic calibration check, some torqueing tools used on
the final assembly line have been found out-of-tolerance. The
subsequent investigation determined that connections of sense and
fire extinguishing lines within the pylon area have been under-
torqued on a group of aeroplanes.
    This condition, if not corrected, could lead to leaks or
disconnections of those lines, possibly resulting in reduced engine
control and/or reduced safety margin in case of engine fire.
    To address this potential unsafe condition, Airbus issued the
applicable SB [service bulletin], providing instructions to restore
the correct torque value of those affected connections.
    For the reason described above, this [EASA] AD requires re-
torqueing to the correct value the affected connections.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0251.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA has considered the comment
received. The Air Line Pilots Association, International (ALPA) stated
that it supports 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.

Explanation of Revised Exception Language

    In paragraph (i)(3) of the NPRM, which describes exceptions to
Required for Compliance (RC) procedures and tests, an exception for
paragraph (i)(2) of the NPRM was inadvertently left out. Also
inadvertently included were exceptions for paragraphs (h)(1) and (h)(2)
of the NPRM, which are standard exceptions that do not affect how to
accomplish the RC actions. Paragraph (i)(3) of this final rule has been
revised accordingly.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0081 describes procedures for retorqueing each
affected connection of sense and fire extinguishing lines within the
pylon area to a correct torque value.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 15 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
10 work-hours x $85 per hour = $850..........................              $0             $850          $12,750
----------------------------------------------------------------------------------------------------------------

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 because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

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 adding the following new airworthiness
directive (AD):

2019-14-07 Airbus SAS: Amendment 39-19685; Docket No. FAA-2019-0251;
Product Identifier 2019-NM-057-AD.

(a) Effective Date

    This AD is effective September 12, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus SAS Model A320-251N and -271N
airplanes; and Model A321-251N, -253N, -271N, and -272N airplanes;
certificated in any category, as identified in European Union
Aviation Safety Agency (EASA) AD 2019-0081, dated April 3, 2019
(``EASA AD 2019-0081'').

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection.

(e) Reason

    This AD was prompted by a report that during a calibration
check, some torqueing tools used on the final assembly line have
been found out of tolerance. The FAA is issuing this AD to address
connections of sense and fire extinguishing lines within the pylon
area that have been under-torqued, which could lead to leaks or
disconnections of those lines and possibly result in reduced engine
control and reduced safety margin in case of engine fire.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2019-0081.

(h) Exceptions to EASA AD 2019-0081

    (1) For purposes of determining compliance with the requirements
of this AD: Where EASA AD 2019-0081 refers to its effective date,
this AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0081 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (j) of this AD. Information may
be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0081 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2019-0081,
dated April 3, 2019.
    (ii) [Reserved]
    (3) For EASA AD 2019-0081, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 89990 6017; email
<EMAIL_ADDRESS>Internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this EASA AD at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. EASA AD
2019-0081 may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2019-0251.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on July 22, 2019.
Dionne Palermo,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-16814 Filed 8-7-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26254-26255]
[FR Doc No: 2015-10989]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL_XXXX-X]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of Florida

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's approval of the State of Florida's
request to revise/modify certain of its EPA-authorized programs to
allow electronic reporting.

DATES: EPA's approval is effective May 7, 2015.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an

acceptable regulatory alternative to paper reporting and establishes
requirements to assure that electronic documents are as legally
dependable as their paper counterparts. Subpart D of CROMERR requires
that state, tribal or local government agencies that receive, or wish
to begin receiving, electronic reports under their EPA-authorized
programs must apply to EPA for a revision or modification of those
programs and obtain EPA approval. Subpart D provides standards for such
approvals based on consideration of the electronic document receiving
systems that the state, tribe, or local government will use to
implement the electronic reporting. Additionally, Sec.  3.1000(b)
through (e) of 40 CFR part 3, subpart D provides special procedures for
program revisions and modifications to allow electronic reporting, to
be used at the option of the state, tribe or local government in place
of procedures available under existing program-specific authorization
regulations. An application submitted under the subpart D procedures
must show that the state, tribe or local government has sufficient
legal authority to implement the electronic reporting components of the
programs covered by the application and will use electronic document
receiving systems that meet the applicable subpart D requirements.
    On February 25, 2015, the Florida Department of Environmental
Protection (FDEP) submitted an application titled ``National Pollutant
Discharge Elimination System e-Reporting Tool (NeT)'' for revisions/
modifications of its EPA-authorized programs under title 40 CFR. EPA
reviewed FDEP's request to revise/modify its EPA-authorized programs
and, based on this review, EPA determined that the application met the
standards for approval of authorized program revisions/modifications
set out in 40 CFR part 3, subpart D. In accordance with 40 CFR
3.1000(d), this notice of EPA's decision to approve Florida's request
to revise/modify its following EPA-authorized programs to allow
electronic reporting under 40 CFR parts 122, 403, and 503 is being
published in the Federal Register:

Part 123--EPA Administered Permit Programs: The National Pollutant
Discharge Elimination System
Part 403--General Pretreatment Regulations For Existing And New Source
Of Pollution
Part 501--State Sludge Management Program Regulations

    FDEP was notified of EPA's determination to approve its application
with respect to the authorized programs listed above.

Matthew Leopard,
Acting Director, Office of Information Collection.
[FR Doc. 2015-10989 Filed 5-6-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: July 21, 2010 (Volume 75, Number 139)]
[Notices]
[Page 42446-42448]
[DOCID:fr21jy10-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0373]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety
and Applied Nutrition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions in the guidance document entitled ``Preparing a Claim of
Categorical Exclusion or an Environmental Assessment for Submission to
the Center for Food Safety and Applied Nutrition.''

DATES:  Submit either electronic or written comments on the collection
of information by September 20, 2010.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c)

and includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Preparing a Claim of Categorical Exclusion or an Environmental
Assessment for Submission to the Center for Food Safety and Applied
Nutrition (OMB Control Number 0910-0541)--Extension

    As an integral part of its decisionmaking process, FDA is obligated
under the National Environmental Policy Act of 1969 (NEPA) to consider
the environmental impact of its actions, including allowing
notifications for food contact substances to become effective and
approving food additive petitions, color additive petitions, GRAS
affirmation petitions, requests for exemption from regulation as a food
additive, and actions on certain food labeling citizen petitions,
nutrient content claims petitions, and health claims petitions. In
1997, FDA amended its regulations in part 25 (21 CFR part 25) to
provide for categorical exclusions for additional classes of actions
that do not individually or cumulatively have a significant effect on
the human environment (62 FR 40570, July 29, 1997). As a result of that
rulemaking, FDA no longer routinely requires submission of information
about the manufacturing and production of FDA-regulated articles. FDA
also has eliminated the previously required Environmental Assessment
(EA) and abbreviated EA formats from the amended regulations. Instead,
FDA has provided guidance that contains sample formats to help industry
submit a claim of categorical exclusion or an EA to FDA's Center for
Food Safety and Applied Nutrition (CFSAN). The guidance document
entitled ``Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety
and Applied Nutrition'' identifies, interprets, and clarifies existing
requirements imposed by statute and regulation, consistent with the
Council on Environmental Quality regulations (40 CFR 1507.3). It
consists of recommendations that do not themselves create requirements;
rather, they are explanatory guidance for FDA's own procedures in order
to ensure full compliance with the purposes and provisions of NEPA.
    The guidance provides information to assist in the preparation of
claims of categorical exclusion and EAs for submission to CFSAN. The
following questions are covered in this guidance: (1) What types of
industry-initiated actions are subject to a claim of categorical
exclusion? (2) what must a claim of categorical exclusion include by
regulation? (3) what is an EA? (4) when is an EA required by regulation
and what format should be used? (5) what are extraordinary
circumstances? and (6) what suggestions does CFSAN have for preparing
an EA? Although CFSAN encourages industry to use the EA formats
described in the guidance because standardized documentation submitted
by industry increases the efficiency of the review process, alternative
approaches may be used if these approaches satisfy the requirements of
the applicable statutes and regulations. FDA is requesting the
extension of OMB approval for the information collection provisions in
the guidance.
    Description of Respondents: The likely respondents include
businesses engaged in the manufacture or sale of food, food
ingredients, and substances used in materials that come into contact
with food.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
  21 CFR          No. of          Annual Frequency       Total Annual          Hours per
  Section       Respondents         per Response           Responses           Response           Total Hours
----------------------------------------------------------------------------------------------------------------
25.32(i)                    34                     1                  34                   1                  34
----------------------------------------------------------------------------------------------------------------
25.32(o)                     1                     1                   1                   1                   1
----------------------------------------------------------------------------------------------------------------
25.32(q)                     2                     1                   2                   1                   2
----------------------------------------------------------------------------------------------------------------
Total                                                                                37
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimates for respondents and numbers of responses are based on
the annualized numbers of petitions and notifications qualifying for
Sec.  25.32(i) and (q) that the agency has received in the past 3
years. Please note that, in the past 3 years, there have been no
submissions that requested an action that would have been subject to
the categorical exclusion in Sec.  25.32(o). To avoid counting this
burden as zero, FDA has estimated the burden for this categorical
exclusion at one respondent making one submission a year for a total of
one annual submission.
    To calculate the estimate for the hours per response values, we
assumed that the information requested in this guidance for each of
these three categorical exclusions is readily available to the
submitter. For the information requested for the exclusion in Sec.
25.32(i), we expect that the submitter will need to gather information
from appropriate persons in the submitter's company and to prepare this
information for attachment to the

claim for categorical exclusion. We believe that this effort should
take no longer than 1 hour per submission. For the information
requested for the exclusions in Sec.  25.32(o) and (q), the submitters
will almost always merely need to copy existing documentation and
attach it to the claim for categorical exclusion. We believe that
collecting this information should also take no longer than 1 hour per
submission.

    Dated: July 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17751 Filed 7-20-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: June 16, 2008 (Volume 73, Number 116)]
[Notices]
[Page 34012]
[DOCID:fr16jn08-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER08-859-000]

Luna Energy Investments LLC; Notice of Issuance of Order

June 6, 2008.
    Luna Energy Investments LLC (Luna Energy) filed an application for
market-based rate authority, with an accompanying rate schedule. The
proposed market-based rate schedule provides for the sale of energy and
capacity at market-based rates. Luna Energy also requested waivers of
various Commission regulations. In particular, Luna Energy requested
that the Commission grant blanket approval under 18 CFR Part 34 of all
future issuances of securities and assumptions of liability by Luna
Energy.
    On June 6, 2008, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development-West, granted the requests
for blanket approval under Part 34 (Director's Order). The Director's
Order also stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard concerning the
blanket approvals of issuances of securities or assumptions of
liability by Luna Energy, should file a protest with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure. 18 CFR 385.211, 385.214 (2004). The Commission
encourages the electronic submission of protests using the FERC Online
link at http://www.ferc.gov.
    Notice is hereby given that the deadline for filing protests is
July 7, 2008.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Luna Energy is authorized to issue
securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Luna Energy, compatible with
the public interest, and is reasonably necessary or appropriate for
such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Luna Energy's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-13422 Filed 6-13-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 64 (Thursday, April 2, 2020)]
[Notices]
[Page 18581]
[FR Doc No: 2020-06828]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3425-EM; Docket ID FEMA-2020-0001]

Commonwealth of the Northern Mariana Islands; Amendment No. 1 to
Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the Commonwealth of the Northern Mariana Islands (FEMA-3425-EM), dated
October 20, 2019, and related determinations.

DATES: This amendment was issued March 5, 2020.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective October 23, 2019.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-06828 Filed 4-1-20; 8:45 am]
BILLING CODE 9111-23-P