[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Proposed Rules]
[Pages 36498-36499]
[FR Doc No: 2015-15553]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2014-0385; FRL-9928-56-Region 5]

Approval and Promulgation of Air Quality Implementation Plans;
Ohio; Ohio PM2.5 NSR

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve, under the Clean Air Act (CAA), revisions to Ohio's state
implementation plan (SIP) as requested by the Ohio Environmental
Protection Agency on

June 19, 2014. The changes to the SIP include revisions related to
particulate matter smaller than 2.5 micrometers (PM2.5)
defining a significance level for PM2.5 for nonattainment
areas, baseline for determining credit for emission offsets, location
of offsetting emissions in nonattainment areas, and offset
requirements. The revisions also include establishing definitions for
emergency, emergency engine, publicly owned treatment works, and semi-
public disposal system and incorporating minor organizational or
typographical changes.

DATES: Comments must be received on or before July 27, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2014-0385, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Genevieve Damico, Chief, Air Permits Section, Air Programs
Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Genevieve Damico, Chief, Air Permits Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only
accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Charmagne Ackerman, Environmental
Engineer, Air Permits Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and public comments will be
addressed in a subsequent final rule based on this proposed rule. EPA
will not institute a second comment period. Any parties interested in
commenting on this action should do so at this time. Please note that
if EPA receives adverse comment on an amendment, paragraph, or section
of this rule and if that provision may be severed from the remainder of
the rule, EPA may adopt as final those provisions of the rule that are
not the subject of an adverse comment. For additional information, see
the direct final rule which is located in the Rules section of this
Federal Register.

    Dated: May 19, 2015.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2015-15553 Filed 6-24-15; 8:45 am]
 BILLING CODE 6560-50-P


FILE NAME:  Valent.doc (August 6, 2012)

EPA Registration Division contact:  Marianne Lewis<PHONE_NUMBER>)

[Insert Petition Number] amend 40 CFR

Summary of Petition

EPA has received a pesticide petition (Insert Petition Number) from
SEQ CHAPTER \h \r 1 Valent U.S.A. Corporation, P.O. Box 8025 Walnut
Creek, CA 94596 , proposing, pursuant to section 408(d) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR
part 180.586 (a), by  deleting the tolerances for residues of the
insecticide chemical clothianidin,
(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or
on the vegetable, fruiting , group 8 and fruit, pome  and establishing
the tolerances for residues of the insecticide chemical clothianidin,
(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or
on the following agricultural commodities:

Commodity	Proposed Tolerance

Parts per million

(For parent only unless indicated otherwise)

Vegetables, fruiting , group (08-10) 	0.2

 Fruit , pome, group (11-10)	1.0

Rice, grains 	 0.01

EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
 Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism of clothianidin is adequately
understood for the purpose of granting the proposed tolerances.

2.  Analytical method.  Adequate enforcement methodology (liquid
chromatography/mass spectroscopy/mass spectroscopy, LC/MS/MS analysis)
is available to enforce the tolerance expression.

3. Magnitude of residues.  No additional residue data is needed to
support the updated crop groupings of vegetables, fruiting , group
(08-10) and fruit , pome, group (11-10)  since the proposed tolerance
levels remain the same as the established tolerances for vegetable,
fruiting , group 8 and fruit, pome.    A rational along wit residue data
have been submitted which adequately support the requested tolerances
for rice grains.

B. Toxicological Profile

A complete, valid and reliable database of mammalian and genetic
toxicology studies has been submitted to EPA that supports the proposed
tolerances for clothianidin. The nature of the toxic effects caused by
clothianidin, as well as the no observed adverse effect level (NOAEL)
and the lowest observed adverse effect level (LOAEL) from the toxicity
studies reviewed, are discussed in the Federal Register of May 30, 2003
(68 FR 32390) (FRL-7306-8)
[http://www.epa.gov/EPA-PEST/2003/May/Day-30/p13564.htm and in the HED
memorandum dated 8/13/2009 from Dr. Michael Doherty to Kable Davis/Venus
Eagle “Clothianidin: Human Health Risk Assessment for Proposed Uses on
Berries (Group 13-07H), Brassica Vegetables (Group 5), Cotton, Cucurbit
Vegetables (Group 9), Fig, Fruiting Vegetables (Group 8), Leafy Green
Vegetables (Group 4A), Peach, Pomegranate, Soybean, Tree Nuts (Group
14), and Tuberous and Corm Vegetables (Group 1C). PC Code: 044309” (DP
Barcodes: D355373, D362354).

C. Aggregate Exposure and Risk Assessment

 i. Dietary Exposure.  Dietary exposure (food and water) assessments
were conducted by EPA to evaluate the potential risk due to acute and
chronic dietary exposure of the U.S. population and various subgroups to
combined residues of clothianidin and its metabolite TMG plus residues
of clothianidin resulting from the use of thiamethoxam.  . Details of
the model parameters can be found in the HED risk assessment memorandum
mentioned above (M. Doherty, D355373, D362354, 08/13/2009). No
additional dietary exposure is anticipated since the proposed tolerance
levels for the updated crop groupings of vegetables, fruiting , group
(08-10) and fruit , pome, group (11-10)  remain the same as the
established tolerances for vegetable, fruiting , group 8 and fruit,
pome.  .  Residues from the use of clothianidin on rice were not
included in the current assessment because the contribution to the
overall aggregate exposure is considered negligible. The residues in
rice grains are less than, LOQ (Limit of Quantitation) of 0.01 ppm.

ii. Non-Dietary Exposure – residential/recreational turf.  Non-dietary
exposure to clothianidin from residential or recreational (turf grass)
application scenarios was assessed using conservative residential adult
applicator and post-application assumptions.

iii. Aggregate Assessment of Risks.  The aggregate acute risk assessment
includes food, water and residential exposures.  Because chronic
exposure scenarios are not expected from residential uses of
clothianidin, the chronic exposure risk assessment only includes food
and water exposures.  No additional exposure is anticipated since the
proposed tolerance levels for the updated crop groupings of vegetables,
fruiting , group (08-10) and fruit , pome, group (11-10) remain the same
as the established tolerances for vegetable, fruiting , group 8 and
fruit, pome.   Residues from use of clothianidin on rice were not
included in the current assessment because the contribution to the
overall aggregate exposure is considered negligible.

For acute risk assessment scenarios, the acute population adjusted dose
(aPAD) of 0.25 mg/kg was used to assess risks from acute dietary
exposure to the general population and to various sub-populations.  The
aPAD is based on the NOAEL of 25 mg/kg/day from an acute neurotoxicity
study (general population) or a developmental toxicity study (females
13-49 years of age) with an FQPA safety factor of 1.

For chronic risk assessment scenarios, the chronic population adjusted
dose (cPAD) used for the U.S. population and all subpopulations is 0.098
mg/kg/day based on a 2-generation reproduction study NOAEL of 9.8
mg/kg/day and an FQPA safety factor of 1.

Based on these risk assessments, the margins of exposure (MOE) for all
routes of exposure and all population subgroups exceed 100 and therefore
do not exceed EPA’s level of concern.

D. Cumulative Effects.  Section 408(b) (2) (D) (v) requires that the
Agency must consider available information concerning the cumulative
effects of a particular pesticide's residues and other substances that
have a common mechanism of toxicity. Clothianidin is a member of the
neonicotinoid class of pesticides and is a metabolite of thiamethoxam.
Structural similarities or common effects do not constitute a common
mechanism of toxicity and there is currently no evidence that
neonicotinoids share a common mechanism of toxicity.  For purposes of
this petition, clothianidin residues from use of clothianidin and
thiamethoxam have been considered.

E. Safety Determination.  The toxicological database for clothianidin is
complete.  The available data indicate that there are no consistent
specific target organs in mammals.  Based on the completeness of the
database and the observed effects, the FQPA Safety Factor has been
reduced to 1X, leaving a 100X safety factor to account for
within-species (10X) and across-species (10X) variability.  Clothianidin
has been classified as not likely to be carcinogenic to humans.

The results of the aggregate exposure risk assessment indicate the
MOE’s do not exceed EPA’s level of concern.  There is therefore a
reasonable certainty that no harm will result to the general population
or to any population subgroup resulting from aggregate exposure to
residues of clothianidin.

F. International Tolerances   Canadian maximum residue limits (MRL) have
been established for residues of clothianidin at 0.01 milligram/kilogram
(mg/kg) in milk, corn, canola, stone fruits, grape, potato and pome
fruits. Clothianidin is being evaluated by the JMPR and there are no
Codex Maximum Residue Limits (MRL) established.


[Federal Register: July 20, 2009 (Volume 74, Number 137)]
[Notices]
[Page 35202-35203]
[DOCID:fr20jy09-74]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2009-0116]

Collection of Information Under Review by Office of Management
and Budget: OMB Control Numbers: 1625-0033 and 1625-0039

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
request for comments announces that the U.S. Coast Guard is forwarding
two Information Collection Requests (ICRs), abstracted below, to the
Office of Information and Regulatory Affairs (OIRA), Office of
Management and Budget (OMB) requesting an extension of its approval for
the following collections of information: (1) 1625-0033, Display of
Fire Control Plans for Vessels; and (2) 1625-0039, Declaration of
Inspection Before Transfer of Liquid Cargo in Bulk. Review and comments
by OIRA ensure we only impose paperwork burdens commensurate with our
performance of duties.

DATES: Please submit comments on or before August 19, 2009.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2009-0116] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) or to OIRA. To avoid
duplication, please submit your comments by only one of the following
means:
    (1) Electronic submission. (a) To Coast Guard docket at http://
www.regulation.gov. (b) To OIRA by e-mail via: oira_
<EMAIL_ADDRESS>    (2) Mail or Hand delivery. (a) DMF (M-30), DOT, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590-0001. Hand deliver between the hours of 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays. The telephone number is 202-
366-9329. (b) To OIRA, 725 17th Street, NW., Washington, DC 20503,
attention Desk Officer for the Coast Guard.
    (3) Fax. (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in time, mark the fax, attention Desk
Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-611), Attn Paperwork Reduction Act Manager, US Coast
Guard, 2100 2nd St., SW., Stop 7101, Washington, DC 20593-7101.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Arthur Requina, Office of
Information Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>, for
questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION: The Coast Guard invites comments on whether
these ICRs should be granted based on it being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
collections; (2) the accuracy of the estimated burden of the
collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the collections; and (4) ways to minimize the
burden of collections on respondents, including the use of automated
collection

techniques or other forms of information technology.
    Comments to Coast Guard or OIRA must contain the OMB Control Number
of the ICR. They must also contain the docket number of this request,
[USCG 2009-0116]. For your comments to OIRA to be considered, it is
best if they are received on or before the August 19, 2009.
    Public participation and request for comments: We encourage you to
respond to this request by submitting comments and related materials.
We will post all comments received, without change, to http://
www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.
    Submitting comments: If you submit a comment, please include the
docket number [USCG-2009-0116], indicate the specific section of the
document to which each comment applies, providing a reason for each
comment. We recommend you include your name, mailing address, an e-mail
address, or other contact information in the body of your document so
that we can contact you if we have questions regarding your submission.
You may submit comments and material by electronic means, mail, fax, or
delivery to the DMF at the address under ADDRESSES; but please submit
them by only one means. If you submit them by mail or delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. In response to your comments, we
may revise the ICR or decide not to seek an extension of approval for
this collection. The Coast Guard and OIRA will consider all comments
and material received during the comment period.
    Viewing comments and documents: Go to http://www.regulations.gov to
view documents mentioned in this Notice as being available in the
docket. Enter the docket number [USCG-2009-0116] in the Search box, and
click, ``Go>>.'' You may also visit the DMF in room W12-140 on the West
Building Ground Floor, 1200 New Jersey Avenue, SE., Washington, DC,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Privacy Act: Anyone can search the electronic form of all comments
received in dockets by the name of the individual submitting the
comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). You may review the Privacy
Act statement regarding our public dockets in the January 17, 2008
issue of the Federal Register (73 FR 3316).

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (74 FR 10750, March 12,
2009) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments.

Information Collection Request

    1. Title: Display of Fire Control Plans for Vessels.
    OMB Control Number: 1625-0033.
    Type of Request: Revision of a currently approved collection.
    Respondents: Owners and operators of vessels.
    Abstract: Under 46 U.S.C. 3305 and 3306, the Coast Guard is
responsible for the safety of inspected vessels and has promulgated
regulations to ensure standards are met.
    Forms: None.
    Burden Estimate: The estimated burden has decreased from 859 hours
to 514 hours a year.
    2. Title: Declaration of Inspection Before Transfer of Liquid Cargo
in Bulk.
    OMB Control Number: 1625-0039.
    Type of Request: Revision of a currently approved collection.
    Respondents: Persons-in-charge of transfers.
    Abstract: Title 33 U.S.C. 1221 authorizes the Coast Guard to
establish regulations preventing the discharge of oil and hazardous
material from vessels and facilities. The Declaration of Inspection
regulations appear at 33 CFR 156.150 and 46 CFR 35.35-30.
    Forms: None.
    Burden Estimate: The estimated burden has decreased from 68,534
hours to 67,825 hours a year.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: July 13, 2009.
M.B. Lytle,
Captain, U.S. Coast Guard, Acting Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. E9-17096 Filed 7-17-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: February 23, 2009 (Volume 74, Number 34)]
[Rules and Regulations]
[Page 8007-8009]
[DOCID:fr23fe09-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0046]
RIN 1625-AA00

Safety Zone; Naval Underwater Detonation; Northwest Harbor, San
Clemente Island, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone on the navigable
waters of the Northwest Harbor of San Clemente Island in support of the
Naval Underwater Detonation. This safety zone is necessary to ensure
non-authorized personnel and vessels remain safe by keeping clear of
the hazardous area during the training activity. Persons and vessels
are prohibited from entering into, transiting through, or anchoring
within this safety zone unless authorized by the Captain of the Port
(COTP) or his designated representative.

DATES: This rule is effective from February 1, 2009 through April 1,
2009.

ADDRESSES: Comments and materials received from the public, as well as
documents mentioned in this preamble as being available in the docket
are part of docket USCG-2009-0046 and are available online by going to
http://www.regulations.gov, selecting the Advanced Docket Search option
on the right side of the screen, inserting USCG-2009-0046 in the Docket
ID box, pressing Enter, and then clicking on the item in the Docket ID
column. This material is also available for inspection or copying at
two locations: The Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays, and the U.S. Coast
Guard Sector San Diego, 2710 N. Harbor Dr., San Diego, CA 92101 between
8 a.m. and 3 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call Petty Officer Kristen Beer, USCG, Waterways
Management, U.S. Coast Guard Sector San Diego at<PHONE_NUMBER>. If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary 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)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because immediate action is necessary to
ensure the safety of commercial and recreational vehicles in the
vicinity of the Naval Underwater Detonation on the dates and times this
rule will be in effect and delay would be contrary to the public
interest.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date would
be contrary to the public interest, since immediate action is needed to
ensure the public's safety. Any delay in the effective date of this
rule would expose mariners to the dangers posed by the detonation of
underwater explosives.

Background and Purpose

    The Officer in Charge (OIC) of the Southern California Offshore
Range will be conducting intermittent training involving the detonation
of military grade explosives underwater throughout February and March
2009. This safety zone is necessary to ensure non-authorized personnel
and vessels remain safe by keeping clear of the hazardous area during
the training activity.

Discussion of Rule

    The Coast Guard is establishing a safety zone that will be enforced
from February 1, 2009 through April 1, 2009. The limits of the safety
zone will be the navigable waters of the Northwest Harbor of San
Clemente Island bounded by the following coordinates: 33[deg]02'06'' N,
118[deg]35'36'' W; 33[deg]02'00'' N, 118[deg]34'36'' W; thence along
San Clemente shoreline to 33[deg]02'06'' N, 118[deg]35'36'' W. This
safety zone is necessary to ensure non-authorized personnel and vessels
remain safe by keeping clear of the hazardous area during the training
activities. Persons and vessels are prohibited from entering into,
transiting through, or anchoring within this safety zone unless
authorized by the Captain of the Port, or his designated
representative.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this rule to be so minimal that a
full Regulatory Evaluation is unnecessary. This determination is based
on the size and location of the safety zone. Recreational vessels will
not be allowed to transit through the designated safety zone during the
specified times while training is being conducted.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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 affect the following entities, some of which
may be small entities: The owners or operators of vessels intending to
transit or anchor in a portion of the Northwest Harbor of San Clemente
Island from February 1, 2009 through August 1, 2009.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. Vessel
traffic can pass safely around the safety zone. Although the safety
zone will apply to the harbor, traffic will be allowed to pass through
the zone with the permission of the Coast Guard patrol commander.
Before the effective period, the Coast Guard will issue a broadcast
notice to mariners (BNM) alerts.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

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).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 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.

Taking of Private Property

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

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.

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 may
disproportionately affect children.

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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 5100.1 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
under the Instruction that there are no factors in this case that would
limit the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295; 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add a new temporary Sec.  165.T11-148 to read as follows:

Sec.  165.T11-148  Safety Zone; Naval Underwater Detonation; Northwest
Harbor, San Clemente Island, CA.

    (a) Location. The limits of the safety zone will include the
navigable waters of the Northwest Harbor of San Clemente Island bounded
by the following coordinates: 33[deg]02'06'' N, 118[deg]35'36'' W;
33[deg]02'00'' N, 118[deg]34'36'' W; thence along the coast of San
Clemente Island to 33[deg]02'06'' N, 118[deg]35'36'' W.
    (b) Enforcement Period. This section will be enforced from February
1, 2009 through April 1, 2009. If the training is concluded prior to
the scheduled termination time, the COTP will cease enforcement of this
safety zone and will announce that fact via Broadcast Notice to
Mariners.
    (c) Definitions. The following definitions apply to this section:
designated representative, means any Commissioned, Warrant, or Petty
Officers of the Coast Guard, Coast Guard Auxiliary, or local, state,
and federal law enforcement vessels who have been authorized to act on
the behalf of the COTP; non-authorized personnel and vessels, means any
civilian boats, fishermen, divers, and swimmers.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the COTP San
Diego or his designated representative.
    (2) Non-authorized personnel and vessels requesting permission to
transit through the safety zone may request authorization to do so from
the COTP San Diego or his designated representative. They may be
contacted on VHF-FM Channel 16, or at telephone number<PHONE_NUMBER>.
    (3) Naval units involved in the exercise are allowed in confines of
the established safety zone.
    (4) All persons and vessels shall comply with the instructions of
the Coast Guard COTP or his designated representative.
    (5) Upon being hailed by U.S. Coast Guard or other official
personnel by siren, radio, flashing light, or other means, the operator
of a vessel shall proceed as directed.
    (6) The Coast Guard may be assisted by other federal, state, or
local agencies and the U.S. Navy.

    Dated: February 3, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-3764 Filed 2-20-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 87, Number 145 (Friday, July 29, 2022)]
[Rules and Regulations]
[Pages 45627-45629]
[FR Doc No: 2022-16101]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 87, No. 145 / Friday, July 29, 2022 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-1075; Project Identifier MCAI-2021-00856-T;
Amendment 39-22077; AD 2022-12-05]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

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

ACTION: Final rule.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2020-26-
01, which applied to all Airbus SAS Model A318-111, -112, -121, and -
122 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and
-133 airplanes; and Model A320-211, -212, -214, -216, -231, -232, and -
233 airplanes. AD 2020-26-01 required repetitive general visual
inspections of the affected main landing gear (MLG) sliding tubes for
cracks, and replacement if necessary. This AD was prompted by reports
of cracks found on MLG sliding tubes that may have been subject to
improperly performed magnetic particle inspection. This AD requires
repetitive general visual inspections of the affected MLG sliding tubes
(both retained affected parts and additional affected parts) for
cracks, and replacement if necessary, as specified in a European Union
Aviation Safety Agency (EASA) AD, which is incorporated by reference.
This AD also adds airplanes to the applicability. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective September 2, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September 2,
2022.

ADDRESSES: For material incorporated by reference (IBR) in this AD,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; 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 material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket at www.regulations.gov by searching for and locating Docket No.
FAA-2021-1075.

Examining the AD Docket

    You may examine the AD docket at www.regulations.gov by searching
for and locating Docket No. FAA-2021-1075; 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 mandatory
continuing airworthiness information (MCAI), 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: Vladimir Ulyanov, Aerospace Engineer,
Large Aircraft Section, FAA, International Validation Branch, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0175, dated July 22, 2021;
corrected July 23, 2021 (EASA AD 2021-0175) (also referred to as the
MCAI), to correct an unsafe condition for all Airbus SAS Model A318-
111, A318-112, A318-121, A318-122, A319-111, A319-112, A319-113, A319-
114, A319-115, A319-131, A319-132, A319-133, A320-211, A320-212, A320-
214, A320-215, A320-216, A320-231, A320-232, A320-233, A321-111, A321-
112, A321-131, A321-211, A321-212, A321-213, A321-231, and A321-232
airplanes. Model A320-215 airplanes are not certificated by the FAA and
are not included on the U.S. type certificate data sheet; this AD
therefore does not include those airplanes in the applicability.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2020-26-01, Amendment 39-21356 (85 FR
82299, December 18, 2020) (AD 2020-26-01). AD 2020-26-01 applied to all
Airbus SAS Model A318-111, -112, -121, and -122 airplanes; Model A319-
111, -112, -113, -114, -115, -131, -132, and -133 airplanes; and Model
A320-211, -212, -214, -216, -231, -232, and -233 airplanes. The NPRM
published in the Federal Register on December 27, 2021 (86 FR 73197).
The NPRM was prompted by reports of cracks found on MLG sliding tubes
that may have been subject to improperly performed magnetic particle
inspection. The NPRM proposed to require repetitive general visual
inspections of the affected MLG sliding tubes (both retained affected
parts and additional affected parts) for cracks, and replacement if
necessary, as specified in EASA AD 2021-0175. The NPRM also proposed to
add airplanes to the applicability.
    The FAA is issuing this AD to address cracks on the MLG sliding
tubes, which could cause MLG sliding tube fracture, and could result in
the MLG collapsing, damage to the airplane, and injury to occupants.
See the MCAI for additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from the Air Line Pilots Association,
International (ALPA), who supported the NPRM without change.
    The FAA also received a comment from Delta Air Lines (DAL). The
following presents the comment received on the NPRM and the FAA's
response.

Request for Clarification of Inspection Requirements

    DAL requested clarification of the language specified in paragraph
(6) of EASA AD 2021-0175 that ``following installation, the part is
inspected as required by this [EASA] AD.'' DAL stated that more than
one interpretation is possible, but it presumed the intent to be that
an affected part can only be

installed if it is inspected within the compliance time specified in
paragraph (1) of EASA AD 2021-0175 (rather than requiring an inspection
immediately after installing an affected part on-wing).
    The FAA agrees to clarify the referenced quote. The statement
``following installation, the part is inspected as required by this
[EASA] AD'' does not mean an inspection is required before further
flight after installing an affected part. Instead, it means that the
part must meet the inspection requirements of paragraph (1) of EASA AD
2021-0175 at the applicable compliance times specified in paragraph (1)
of EASA AD 2021-0175.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety requires adopting this AD as
proposed. Except for minor editorial changes, this AD is adopted as
proposed in the NPRM. None of the changes will increase the economic
burden on any operator. Accordingly, the FAA is issuing this AD to
address the unsafe condition on these products.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0175 describes procedures for repetitive general
visual inspections of the MLG sliding tubes for cracks, and replacement
if necessary. EASA AD 2021-0175 also describes terminating actions for
the repetitive inspections of affected MLG sliding tubes by either
overhauling an affected MLG sliding tube or replacing an affected MLG
sliding tube with an MLG sliding tube that is not affected.
    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 1,524 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.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2020-26-01...  2 work-hours x $85 per                $0            $170        $259,080
                                         hour = $170.
New proposed actions..................  2 work-hours x $85 per                 0             170         259,080
                                         hour = $170.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need these on-condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
19 work-hours x $85 per hour = $1,615.            $185           $1,800
------------------------------------------------------------------------

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.

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.

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:
0
a. Removing Airworthiness Directive (AD) 2020-26-01, Amendment 39-21356
(85 FR 82299, December 18, 2020); and
0
b. Adding the following new AD:

2022-12-05 Airbus SAS: Amendment 39-22077; Docket No. FAA-2021-1075;
Project Identifier MCAI-2021-00856-T.

(a) Effective Date

    This airworthiness directive (AD) is effective September 2,
2022.

(b) Affected ADs

    This AD replaces AD 2020-26-01, Amendment 39-21356 (85 FR 82299,
December 18, 2020) (AD 2020-26-01).

(c) Applicability

    This AD applies to all Airbus SAS airplanes identified in
paragraphs (c)(1) through (4) of this AD, certificated in any
category.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
gear.

(e) Reason

    This AD was prompted by reports of cracks found on main landing
gear (MLG) sliding tubes that may have been subject to improperly
performed magnetic particle inspection. The FAA is issuing this AD
to address cracks on the MLG sliding tubes, which could cause MLG
sliding tube fracture, and could result in the MLG collapsing,
damage to the airplane, and injury to occupants.

(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, European Union Aviation Safety Agency (EASA) AD
2021-0175, dated July 22, 2021; corrected July 23, 2021 (EASA AD
2021-0175).

(h) Exceptions to EASA AD 2021-0175

    (1) Where EASA AD 2021-0175 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2021-0175 refers to July 10, 2018 (the
effective date of EASA AD 2018-0136, dated June 26, 2018), this AD
requires using April 9, 2019 (the effective date of AD 2019-03-18,
Amendment 39-19570 (84 FR 7804, March 5, 2019)).
    (3) Where EASA AD 2021-0175 refers to December 2, 2020 (the
effective date of EASA AD 2020-0258, dated November 18, 2020;
corrected November 19. 2020), this AD requires using January 4, 2021
(the effective date of AD 2020-26-01).
    (4) Where paragraph (1) of EASA AD 2021-0175 specifies
compliance times to do the initial inspection, for this AD, the
initial inspection must be done within the applicable compliance
time specified in paragraph (1) of EASA AD 2021-0175, or within 30
days after the effective date of this AD, whichever occurs later.
    (5) The ``Remarks'' section of EASA AD 2021-0175 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2021-0175
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (k) of this
AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards 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, Large Aircraft
Section, International Validation 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): Except as required by
paragraph (j)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those 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.

(k) Related Information

    For more information about this AD, contact Vladimir Ulyanov,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected].

(l) 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 2021-0175,
dated July 22, 2021; corrected July 23, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0175, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; 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 material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (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, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 4, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-16101 Filed 7-28-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 198 (Friday, October 12, 2012)]
[Notices]
[Page 62273]
[FR Doc No: 2012-25092]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Interactive Data; SEC File No. 270-330, OMB Control No. 3235-
0645.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') this request for extension of the previously
approved collection of information discussed below.
    The ``Interactive Data'' collection of information requires issuers
filing registration statements under the Securities Act of 1933 (15
U.S.C. 77a et seq.) and reports under the Securities Exchange Act of
1934 (15 U.S.C. 78a et seq.) to submit specified financial information
to the Commission and post it on their corporate Web sites, if any, in
interactive data format using eXtensible Business Reporting Language
(XBRL). This collection of information is located primarily in
registration statement and report exhibit provisions, which require
interactive data, and Rule 405 of Regulation S-T (17 CFR 232.405),
which specifies how to submit and post interactive data. The exhibit
provisions are in Item 601(b)(101) of Regulation S-K (17 CFR
229.601(b)(101)), Forms F-9 and F-10 under the Securities Act (17 CFR
239.39 and 17 CFR 239.40) and Forms 20-F, 40-F and 6-K under the
Exchange Act (17 CFR 249.220f, 17 CFR 249.240f and 17 CFR 249.306).
    In interactive data format, financial statement information could
be downloaded directly into spreedsheets and analyzed in a variety of
ways using commercial off-the-shelf software. The specified financial
information already is and will continue to be required to be submitted
to the Commission in traditional format under existing requirements.
The purpose of the interactive data requirement is to make financial
information easier for investors to analyze and assist issuers in
automating regulatory filings and business information processing. We
estimate that 10,229 respondents per year will each submit an average
of 4.5 reponses per year for an estimated total of 46,031 responses. We
further estimate an internal burden of 59 hours per response for a
total annual internal burden of 2,715,829 hours (59 hours per response
x 46,031 responses).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon,
6432 General Green Way, Alexandria, VA 22312 or send an email to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: October 5, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-25092 Filed 10-11-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41475-41477]
[FR Doc No: 2021-16356]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0758]

Antimicrobial Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Antimicrobial Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to FDA on regulatory issues. The meeting will be
open to the public. FDA is establishing a docket for public comment on
this document.

DATES: The meeting will be held on October 7, 2021, from 9 a.m. to 5
p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2021-N-0758. The docket will close on October
6, 2021. Submit either electronic or written comments on this public
meeting by October 6, 2021. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before October 6, 2021. The https://www.regulations.gov
electronic filing

system will accept comments until 11:59 p.m. Eastern Time at the end of
October 6, 2021. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
    Comments received on or before September 23, 2021, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0758 for ``Antimicrobial Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-2894, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The committee
will discuss new drug application (NDA) 215596, for maribavir oral
tablets, submitted by Takeda Pharmaceuticals USA, Inc., for the
treatment of adults with post-transplant cytomegalovirus infection and/
or disease, including infections resistant and/or refractory to
ganciclovir, valganciclovir, cidofovir, or foscarnet.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before September 23, 2021, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of

proposed participants, and an indication of the approximate time
requested to make their presentation on or before September 15, 2021.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by September 16, 2021.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Moon Hee V. Choi (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16356 Filed 7-30-21; 8:45 am]
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[Federal Register Volume 86, Number 187 (Thursday, September 30, 2021)]
[Rules and Regulations]
[Pages 54098-54100]
[FR Doc No: 2021-20974]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2021-0360; FRL-8707-02-R7]

Air Plan Approval; Approval of Missouri Air Quality
Implementation Plans; Revisions to St. Louis 2008 8-Hour Ozone
Maintenance Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a State Implementation Plan (SIP) revision submitted
by the State of Missouri on November 12, 2019, revising the maintenance
plan demonstrating continued maintenance of the 2008 ozone National
Ambient Air Quality Standard (NAAQS), the 1979 1-Hour and 1997 8-Hour
ozone standards in the St. Louis area. This revision demonstrates that
the St. Louis area no longer needs to rely on the vehicle Inspection
and Maintenance (I/M) program and the use of Reformulated Gasoline
(RFG) for continued maintenance throughout the maintenance period for
the 2008 8-Hour ozone NAAQS, the 1979 1-Hour ozone NAAQS and 1997 8-
Hour ozone NAAQS. The EPA has determined that this revision meets the
requirements of the Clean Air Act (CAA).

DATES: This final rule is effective on November 1, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R07-OAR-2021-0360. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e.,
confidential business information (CBI) or other information whose
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 through https://www.regulations.gov or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional information.

FOR FURTHER INFORMATION CONTACT: Steven Brown, Environmental Protection
Agency, Region 7 Office, Air Quality Planning Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219; telephone number<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to EPA.

Table of Contents

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What Action is the EPA taking?
IV. Statutory and executive order reviews

I. What is being addressed in this document?

    The EPA is taking final action to approve SIP revisions submitted
by the State of Missouri on November 12, 2019, revising the 2008 8-hour
ozone maintenance plan previously approved on September 20, 2018 (83 FR
47572). This SIP revision demonstrates continued maintenance of the
2008 8-Hour ozone NAAQS, the 1979 1-Hour ozone NAAQS and 1997 8-Hour
ozone NAAQS in the St. Louis area through the future year of 2030. The
maintenance area boundary includes the Missouri counties of Franklin,
Jefferson, St. Charles, and St. Louis along with the City of St. Louis.
    Since the 2008 ozone standard is more stringent than the 1979 and
1997 ozone standards, and the boundary area

for all three designations are identical, we are approving this SIP
revision to also replace the previously approved maintenance plans
under those older standards.
    Through this final action, the EPA is approving this maintenance
plan into Missouri's SIP pursuant to the CAA section 175A as a
replacement to the maintenance plans previously approved by EPA on
October 2, 2018 (83 FR 38033), May 12, 2003 (68 FR 25413), and February
20, 2015 (80 FR 9207).
    On May 12, 2003, EPA published a final rule stating the St. Louis
area attained the 1979 1-hour ozone standard, redesignated the area to
attainment, and approved the State's plan for maintaining the 1-hour
ozone NAAQS (68 FR 25413).
    On February 20, 2015, EPA issued a final rulemaking approving the
State of Missouri's request to redesignate the Missouri portion of the
St. Louis nonattainment area to attainment and their demonstration for
maintaining the 1997 8-hour ozone NAAQS through the ten-year
maintenance period (2025) (80 FR 9207).
    This SIP revision we are acting on in this final action, removes
the reliance on the St. Louis Inspection and Maintenance (I/M) program,
and Reformulated Gasoline (RFG) for continued maintenance of the 2008,
1979 and 1997 standard. To support this revision, Missouri utilized
EPA's 2014 Motor Vehicle Emissions Simulator (MOVES2014b) emission
modeling system to project revised mobile source emissions by removing
emissions reductions related to I/M and RFG throughout the maintenance
period to the future year of 2030.
    EPA is approving this revised maintenance plan based on information
provided in the emissions projections, modeling results, and an
evaluation of quality assured air monitoring data submitted as part of
this revision and in a previously reviewed analysis as part of the St.
Louis Nonattainment Area 2008 8-hour Ozone NAAQS Redesignation
rulemaking on September 20, 2018 (83 FR 47572). Current and future
projections of air quality and emissions data for this revision
demonstrates maintenance for the 2008, 1979 and 1997 ozone NAAQS.
    This revision only affects maintenance for the 2008, 1979 and 1997
ozone standards, only removes the reliance upon the I/M program and RFG
programs and meets the requirements of the Clean Air Act.
    The full text of the plan revisions including Missouri's technical
demonstration can be found in the State's submission, which is included
in the docket for this action. The EPA solicited comments on these
proposed revision to Missouri's SIP published on July 30, 2021 (86 FR
40977), and received one individual's comment in favor of approval.
Therefore, the EPA is finalizing the approval of these revisions to the
SIP.

II. Have the requirements for approval of a SIP revision been met?

    The State's submission has met the public notice requirements for
SIP submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice on this SIP revision from July 29, 2019
through September 13, 2019 and received one comment from the Missouri
Petroleum Marketers and Convenience Store Association, one comment from
Abel Realty, and thirteen comments from EPA. After receiving comments,
the State revised the SIP prior to submitting the plan to EPA. In
addition, as explained above and in more detail in the Missouri
submittal document, which is part of the docket, the revision meets the
substantive SIP requirements of the CAA, including section 110 and
implementing regulations.

III. What Action is the EPA taking?

    The EPA is taking final action to approve a SIP revision submitted
by the State of Missouri on November 12, 2019, revising the 2008 8-hour
ozone maintenance plan. EPA has determined that this revision does not
interfere with attainment or maintenance of the NAAQS or with any other
CAA requirement.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 29, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone.

    Dated: September 22, 2021.
Edward H. Chu,
Acting Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA amends 40 CFR part 52
as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart AA--Missouri

0
2. In Sec.  52.1320, the table in paragraph (e) is amended by adding
the entry ``(79)'' in numerical order to read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (e)* * *

                                EPA-Appoved Missouri Nonregulatory Sip Provisions
----------------------------------------------------------------------------------------------------------------
                                     Applicable
   Name of nonregulatory SIP        geographic or         State       EPA approval date        Explanation
           provision             nonattainment area  submittal date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(79) Revisions to St. Louis      St. Louis Area:         11/12/2019  9/30/2021, [insert  EPA-R07-OAR-2015-0513;
 2008 8-Hour Ozone Maintenance    Missouri counties                   Federal Register    This action replaces
 Plan.                            of Franklin,                        citation].          Maintenance plans for
                                  Jefferson, St.                                          the following ozone
                                  Charles, and St.                                        NAAQS: 1979 1-hour
                                  Louis along with                                        (published in the
                                  the City of St.                                         Federal Register on
                                  Louis.                                                  May 12, 2003), 1997 8-
                                                                                hour (published in the
                                                                                Federal Register on
                                                                                February 20, 2015),
                                                                                2008 8-hour (published
                                                                                in the Federal
                                                                                Register on September
                                                                                20, 2018).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-20974 Filed 9-29-21; 8:45 am]
BILLING CODE 6560-50-P