[Federal Register: October 26, 2005 (Volume 70, Number 206)]
[Notices]
[Page 61803]
[DOCID:fr26oc05-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-36-000]

Young Gas Storage Company, Ltd.; Notice of Proposed Changes in
FERC Gas Tariff

October 20, 2005.
    Take notice that on October 17, 2005, Young Gas Storage Company,
Ltd. (Young) tendered for filing as part of its FERC Gas Tariff,
Original Volume No. 1, the following tariff sheets to become effective
November 17, 2005:

Eighth Revised Sheet No. 80
Third Revised Sheet No. 80C
First Revised Sheet No. 80F
First Revised Sheet No. 80G
First Revised Sheet No. 80H
Third Revised Sheet No. 80I

    Young states that the tariff sheets extend the nomination deadline
by fifteen minutes.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-5935 Filed 10-25-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 25, 2009 (Volume 74, Number 226)]
[Rules and Regulations]
[Page 61512-61516]
[DOCID:fr25no09-7]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. FDA-1977-N-0013] (formerly Docket No. 1977-N-0094L)
RIN 0910-AF36

Organ-Specific Warnings; Internal Analgesic, Antipyretic, and
Antirheumatic Drug Products for Over-the-Counter Human Use; Final
Monograph; Technical Amendment

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule; technical amendment.

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SUMMARY:  The Food and Drug Administration (FDA) is amending a final
rule that appeared in the Federal Register of April 29, 2009 (74 FR
19385) (as amended in the Federal Register of June 30, 2009 (74 FR
31177). The final rule requires important new organ-specific warnings
and related labeling for over-the-counter (OTC) internal analgesic,
antipyretic, and antirheumatic (IAAA) drug products. The new labeling
informs consumers about the risk of liver injury when using
acetaminophen and the risk of stomach bleeding when using nonsteroidal
anti-inflammatory drugs (NSAIDs). This document is intended to clarify
some provisions in the final rule which may be unclear. Specifically,
this document addresses how blister cards can be labeled to comply with
the new required labeling, clarifies the length of time that the ``See
new warnings'' flag is required to appear in the labeling, and provides
some optional wording to clarify the liver injury warning on OTC
acetaminophen products containing multiple active ingredients.

DATES: Effective Date: This final rule is effective April 29, 2010.
    Compliance Date: The compliance date for all products subject to
this final rule, including products with annual sales less than
$25,000, is April 29, 2010.

FOR FURTHER INFORMATION CONTACT:  Arlene Solbeck, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is amending the final rule that was published in the Federal
Register of

April 29, 2009, (the April 29, 2009, final rule) which requires
important new organ-specific warnings and related labeling for OTC IAAA
drug products. The new labeling informs consumers about the risk of
liver injury when using acetaminophen and the risk of stomach bleeding
when using NSAIDs. After the April 29, 2009, final rule was published,
we received feedback from manufacturers stating that some of the
requirements in the final rule are unclear (Refs. 1 and 2). We are
amending the final rule to address these issues raised by the
submissions (see section II of this document). One issue involves the
liver injury and stomach bleeding warnings that must appear on
immediate container labeling. Another issue concerns the posting of a
``See new warnings'' flag on the principal display panel (PDP) of the
retail packaging. The third issue concerns the wording of the first
bulleted statement in the liver injury warning.
    Publication of this document constitutes final action on the change
under the Administrative Procedures Act (5 U.S.C. 553). This technical
amendment merely clarifies the intent of the final rule with respect to
the three minor issues raised in the submissions. FDA therefore, for
good cause shown, has determined that notice and public comment are
unnecessary under 5 U.S.C. 553(b)(3)(B).

II. April 29, 2009, Final Rule Requirements Being Addressed in This
Document

A. Immediate Container Labeling

    In the final rule, we require that the new liver injury and stomach
bleeding warnings appear on the outer and the immediate container of
the retail packaging, where applicable (Sec.  201.326(a)(1)(iii)(A),
(a)(1)(iv)(A)(1), (a)(1)(v)(A), (a)(2)(iii)(A), (a)(2)(iv)(A)(1), and
(a)(2)(v)(A) (21 CFR 201.326(a)(1)(iii)(A), (a)(1)(iv)(A)(1),
(a)(1)(v)(A), (a)(2)(iii)(A), (a)(2)(iv)(A)(1), and (a)(2)(v)(A)). We
received feedback from manufacturers seeking clarification of these
final rule requirements for blister card packaging (Ref. 1). We did not
intend for the final rule to require liver injury or stomach bleeding
warnings to appear on each blister unit on a blister card. Rather, we
believe it is acceptable that the appropriate warning appear on the
blister card in one place, as long as the warning stays intact and
readable when drug product is removed from the blister card. Therefore,
in this document, we are stating explicitly that the liver injury and
stomach bleeding warnings are not required to appear on each blister
unit of a blister card, as long as the appropriate warning appears on
the blister card and remains intact and readable when drug is removed
from the blister card. These modifications appear in Sec.
201.326(a)(1)(iii)(A), (a)(1)(iv)(A)(1), (a)(1)(v)(A), (a)(2)(iii)(A),
(a)(2)(iv)(A)(1), and (a)(2)(v)(A) in the regulatory text of this
document.
    We also received feedback that certain immediate containers, such
as stick packs and sachets, also present space limitations for labeling
and that we should not require the liver injury and stomach bleeding
warnings to appear on these immediate container packages (Ref 1). We do
not agree that these types of immediate containers should be exempt
from the requirements in the final rule. Although these packages have
limited labeling space, we believe that there is adequate space to
accommodate the required warnings on these types of packages. We are
also concerned that consumers may routinely remove these packages from
the outer carton and, therefore, fail to see the liver injury and
stomach bleeding warnings if they are only printed on the carton. For
these reasons, we are not exempting these types of immediate containers
from the final rule requirements.

B. ``See New Warnings'' Flag

    In the April 29, 2009, final rule, we require a ``See new
warnings'' flag on the PDP of all OTC drug products containing
acetaminophen or NSAIDs to advise consumers of the new required
warnings. In the final rule, we state that ``we will require that the
`See New Warnings' flag appear on the PDP for one year after the final
rule is published, rather than for the 6 or 9 months suggested by the
submission'' (74 FR 19385 at 19388). We explained that ``we continue to
believe that educating consumers about the risks associated with OTC
IAAA drug products is very important and more likely to be successful
if the flag remains on products for 1 year'' (74 FR 19385 at 19388
through 19389). In Sec.  201.326(b) (21 CFR 201.326(b)), the final rule
states: ``The labeling of any drug product subject to this section that
is initially introduced or initially delivered for introduction into
interstate commerce before the effective date and within 12 months
after the effective date of the final rule must bear on its PDP, as
defined in Sec.  201.60, the statement `See new warnings
information.'''
    We intended this provision to require that the ``See new warnings''
statement appear on the PDPs of all OTC drug products containing
acetaminophen or NSAIDs that are introduced into interstate commerce by
the effective date of the final rule (i.e., by April 29, 2010). We did
not intend to require the ``See new warnings'' statement for those
products that are introduced into interstate commerce after the final
rule effective date. We also intended the provision to require that the
statement remain on the label for at least 1 year from the time the
product is introduced into interstate commerce. We did not intend to
require that the statement remain on the label for any longer than the
1-year period from the time of introduction into interstate commerce.
For example, if the ``See new warnings'' flag is included on the PDP of
a product introduced into interstate commerce 6 months after
publication of the final rule (i.e., October 29, 2009), then the flag
must remain on the PDP for a full year (i.e., until October 29, 2010).
To make this requirement clear, we are modifying Sec.  201.326(b) in
the regulatory text of this document.

C. Liver Injury Warning for OTC Acetaminophen Products Containing
Multiple Active Ingredients

    In the April 29, 2009, final rule, we require a liver injury
warning for all OTC drug products containing acetaminophen. The
introductory sentence and first bulleted statement of this warning
state: ``This product contains acetaminophen. Severe liver damage may
occur if you take [bullet] more than the [insert maximum number of
daily dosage units] in 24 hours, which is the maximum daily amount * *
*''. Our intention was that the warning would prevent consumers from
taking more than 4 grams (g) of an OTC acetaminophen product daily, the
proposed maximum safe daily dose for OTC acetaminophen. After the final
rule was published, we received feedback from manufacturers of OTC
acetaminophen products who were concerned that consumers may be
confused about the warning on OTC acetaminophen containing multiple
active ingredients (e.g., cold-cold/analgesic combination products)
(Refs. 1 and 2). For some combination products, the maximum number of
daily dosage units may be limited by an active ingredient other than
acetaminophen in the products. In such cases, the maximum number of
daily dosage units result in a maximum daily dose of acetaminophen
which is significantly below 4 g. To clarify that the maximum number of
daily dosage units may not be the maximal daily dose of acetaminophen,
we are allowing the optional statement ``for this product'' at the end
of the first bulleted statement: ``more than [insert maximum number of
daily dosage units] in 24 hours, which

is the maximum daily amount'' [optional: ``for this product'']. We
agree with manufacturers that this revision will clarify the warning
for OTC acetaminophen products containing multiple active ingredients.

III. Request for Enforcement Discretion

    We received feedback requesting that we exercise enforcement
discretion for manufacturers of OTC combination acetaminophen products
so that they could revise the first bulleted statement of the liver
injury warning to clarify that the maximum number of daily dosage units
may not be the maximal daily dose of acetaminophen for those products
(Ref. 2). As discussed in section II.C of this document, we are
allowing the optional statement ``for this product'' at the end of the
first bulleted statement: ``more than [insert maximum number of daily
dosage units] in 24 hours, which is the maximum daily amount.'' The
request asked us to exercise enforcement discretion until we revise
this bulleted statement in the final rule. Because we are amending this
bulleted statement in this document, the request that we exercise
enforcement discretion is no longer applicable.

IV. Analysis of Impacts

    We have examined the impacts of this rule under Executive Order
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
rule is not a significant regulatory action under the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Our April 29, 2009, final rule requires important
new organ-specific warnings (i.e., liver injury and stomach bleeding
warnings) and related labeling for OTC drug products containing
acetaminophen and NSAIDs to advise consumers of potential risks and
when to consult a doctor (74 FR 19385). We are amending the final rule
in this document to clarify some of the labeling requirements specified
in the final rule. Three amendments are being made. One amendment
specifies that manufacturers of OTC acetaminophen and NSAID drug
products are not required to put the liver injury or stomach bleeding
warning on each blister unit of a blister card as long as the
appropriate warning appears on the blister card and remains intact and
readable when drug is removed from the blister card (Sec.
201.326(a)(1)(iii)(A), (a)(1)(iv)(A)(1), (a)(1)(v)(A), (a)(2)(iii)(A),
(a)(2)(iv)(A)(1), and (a)(2)(v)(A)). The second amendment specifies
that the ``See new warnings'' flag (Sec.  201.326(b)) must remain on
the label for at least 1 year from the time the manufacturer puts the
statement on the PDP. The third amendment clarifies the liver injury
warning on OTC acetaminophen products containing multiple active
ingredients. We examined the impacts of the amended labeling
requirements described in this document when we developed the April 29,
2009, final rule. We determined that the final rule would not have a
significant impact on a substantial number of small entities. Because
this amendment does not add any new requirements that were not
considered in developing the final rule, we do not believe this rule
will have a significant economic impact on a substantial number of
small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. We do not expect the
final rule as amended to result in any 1-year expenditure that would
meet or exceed this amount.

V. Paperwork Reduction Act of 1995

    We conclude that the labeling requirements in this document are not
subject to review by the Office of Management and Budget because they
do not constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the labeling
statements are a ``public disclosure of information originally supplied
by the Federal government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).

VI. Environmental Impact

    We have determined under 21 CFR 25.31(a) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' The sole statutory provision giving preemptive
effect to the final rule is section 751 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379r).
    We believe that we have complied with all of the applicable
requirements under the Executive order and have determined that the
preemptive effects of this rule are consistent with Executive Order
13132.

VIII. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. FDA-1977-N-0013-0039.
    2. FDA-1977-N-0013-0040.

List of Subjects in 21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
201, (as added in the Federal Registers of April 29, 2009, and amended
June 30, 2009), is amended as follows:

PART 201--LABELING

0
1. The authority citation for 21 CFR part 201 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

0
2. Section 201.326, (as added at 74 FR 19385, April 29, 2009, and
amended at 74 FR 31177, June 30, 2009) is further amended by revising
paragraphs (a)(1)(iii)(A), (a)(1)(iv)(A)(1), (a)(1)(v)(A),
(a)(2)(iii)(A), (a)(2)(iv)(A)(1), (a)(2)(v)(A), and (b) to read as
follows:

Sec.  201.326  Over-the-counter drug products containing internal
analgesic/antipyretic active ingredients; required warnings and other
labeling.

    (a) * * *
    (1) * * *
    (iii) * * *
    (A) The liver warning states ``Liver warning [heading in bold
type]: This product contains acetaminophen. Severe liver damage may
occur if you take [bullet] more than [insert maximum number of daily
dosage units] in 24 hours, which is the maximum daily amount [optional:
`for this product'] [bullet] with other drugs containing acetaminophen
[bullet] 3 or more alcoholic drinks every day while using this
product''. This ``Liver'' warning must be the first warning under the
``Warnings'' heading. For products that contain both acetaminophen and
aspirin, this ``Liver'' warning must appear after the ``Reye's
syndrome'' and ``Allergy alert'' warnings in Sec.  201.66(c)(5)(ii)(A)
and (c)(5)(ii)(B) and before the ``Stomach bleeding'' warning in
paragraph (a)(2)(iii)(A) of this section. If there is an outer and
immediate container of a retail package, this warning must appear on
both the outer and immediate containers. If the immediate container is
a blister card, the warning must appear on the blister card and remain
intact and readable when drug product is removed from the blister card.
The warning does not need to be included on each blister unit.
* * * * *
    (iv) * * *
    (A) * * *
    (1) The liver warning states ``Liver warning [heading in bold
type]: This product contains acetaminophen. Severe liver damage may
occur if your child takes [bullet] more than 5 doses in 24 hours, which
is the maximum daily amount [optional: `for this product'] [bullet]
with other drugs containing acetaminophen''. This ``Liver'' warning
must be the first warning under the ``Warnings'' heading. If there is
an outer and immediate container of a retail package, this warning must
appear on both the outer and immediate containers. If the immediate
container is a blister card, the warning must appear on the blister
card and remain intact and readable when drug product is removed from
the blister card. The warning is not required to be included on each
blister unit.
* * * * *
    (v) * * *
    (A) The liver warning states ``Liver warning [heading in bold
type]: This product contains acetaminophen. Severe liver damage may
occur if [bullet] adult takes more than [insert maximum number of daily
dosage units] in 24 hours, which is the maximum daily amount [optional:
`for this product'] [bullet] child takes more than 5 doses in 24 hours
[bullet] taken with other drugs containing acetaminophen [bullet] adult
has 3 or more alcoholic drinks everyday while using this product.'' If
there is an outer and immediate container of a retail package, this
warning must appear on both the outer and immediate containers. If the
immediate container is a blister card, the warning must appear on the
blister card and remain intact and readable when drug product is
removed from the blister card. The warning is not required to be
included on each blister unit.
* * * * *
    (2) * * *
* * * * *
    (iii) * * *
    (A) The stomach bleeding warning states ``Stomach bleeding warning
[heading in bold type]: This product contains an NSAID, which may cause
severe stomach bleeding. The chance is higher if you [bullet] are age
60 or older [bullet] have had stomach ulcers or bleeding problems
[bullet] take a blood thinning (anticoagulant) or steroid drug [bullet]
take other drugs containing prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen, or others) [bullet] have 3 or more
alcoholic drinks every day while using this product [bullet] take more
or for a longer time than directed''. This ``Stomach bleeding'' warning
must appear after the ``Reye's syndrome'' and ``Allergy alert''
warnings in Sec.  201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). For products
that contain both acetaminophen and aspirin, the acetaminophen
``Liver'' warning in paragraph (a)(1)(iii) of this section must appear
before the ``Stomach bleeding'' warning in this paragraph. If there is
an outer and immediate container of a retail package, this warning must
appear on both the outer and immediate containers. If the immediate
container is a blister card, the warning must appear on the blister
card and remain intact and readable when drug product is removed from
the blister card. The warning is not required to be included on each
blister unit.
* * * * *
    (iv) * * *
    (A) * * *
    (1) The stomach bleeding warning states ``Stomach bleeding warning
[heading in bold type]: This product contains an NSAID, which may cause
severe stomach bleeding. The chance is higher if your child [bullet]
has had stomach ulcers or bleeding problems [bullet] takes a blood
thinning (anticoagulant) or steroid drug [bullet] takes other drugs
containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,
naproxen, or others) [bullet] takes more or for a longer time than
directed''. The ``Stomach bleeding'' warning must appear after the
``Reye's syndrome'' and ``Allergy alert'' warnings in Sec.
201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). If there is an outer and
immediate container of a retail package, this warning must appear on
both the outer and immediate containers. If the immediate container is
a blister card, the warning must appear on the blister card and remain
intact and readable when drug product is removed from the blister card.
The warning is not required to be included on each blister unit.
* * * * *
    (v) * * *
    (A) The Stomach bleeding warning states ``Stomach bleeding warning
[heading in bold type]: This product contains an NSAID, which may cause
severe stomach bleeding. The chance is higher if the user [bullet] has
had stomach ulcers or bleeding problems [bullet] takes a blood thinning
(anticoagulant) or steroid drug [bullet] takes other drugs containing
prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen,
or others) [bullet] takes more or for a longer time than directed
[bullet] is age 60 or older [bullet] has 3 or more alcoholic drinks
everyday while using this product''. The ``Stomach bleeding'' warning
must appear after the ``Reye's syndrome`` and ``Allergy alert''
warnings in Sec.  201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). If there is an
outer and immediate container of a retail package, this warning must
appear on both the outer and immediate containers. If the immediate
container is a blister card, the warning must appear on the blister
card and remain intact and readable when drug product is removed from
the blister card. The warning is not required to be included on each
blister unit.
* * * * *
    (b) New warnings information statement. The labeling of any drug
product subject to this section that is initially introduced or
initially delivered for introduction into interstate commerce before or
on April 29, 2010, must bear on its PDP, as defined in Sec.  201.60,
the statement ``See new warnings information''. This statement must
appear highlighted (e.g., fluorescent or color contrast) or in bold
type, be in lines generally parallel to the base on which the package
rests as it is designed to be displayed, and be in one

of the following sizes, whichever is greater:
    (1) At least one-quarter as large as the size of the most prominent
printed matter on the PDP, or
    (2) At least as large as the size of the ``Drug Facts'' title, as
required in Sec.  201.66(d)(2). The new warnings information statement
must remain on the PDP of the drug product for at least 1 year from the
date the product is initially introduced into interstate commerce.
* * * * *

    Dated: November 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28296 Filed 11-24-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 165 (Thursday, August 25, 2011)]
[Rules and Regulations]
[Pages 53050-53051]
[FR Doc No: 2011-21721]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 522

[Docket No. FDA-2011-N-0003]

New Animal Drugs; Ampicillin Trihydrate, Bacitracin Methylene
Disalicylate, Flunixin, Gonadotropin Releasing Factor Analog-Diphtheria
Toxoid Conjugate, Methylprednisolone, and Sulfamethazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect revised human food safety warnings on
dosage form new animal drug product labeling that have not been
codified. The regulations are also being amended to correct the wording
of certain other conditions of use, to correct minor errors, and to
revise some sections to reflect a current format. These actions are
being taken to comply with the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) and to improve the accuracy and readability of the
regulations.

DATES: This rule is effective August 25, 2011.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA has found that the animal drug
regulations do not reflect certain human food safety warnings that have
been updated on labeling of various dosage form new animal drug
products. At this time, the regulations are being amended to reflect
approved labeling. The regulations are also being amended to correct
the wording of certain other conditions of use and to correct minor
errors. As the opportunity has presented itself, some sections have
been revised to a current format. These actions are being taken to
comply with the FD&C Act and to improve the accuracy and readability of
the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Parts 520 and 522

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and
522 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  520.154a, revise the section heading and paragraphs
(d)(1)(i), (d)(2)(i), (d)(2)(ii), (d)(2)(ii)(A), and (d)(4)(i) to read
as follows:

Sec.  520.154a  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. 400 milligrams (mg) per gallon (gal) in drinking water.
* * * * *
    (2) * * *
    (i) Amount. 100 mg per gal in drinking water.
* * * * *

    (ii) Amount. 200 to 400 mg per gal in drinking water. Administer
continuously 5 to 7 days or as long as clinical signs persist, then
reduce to prevention levels (100 mg/gal).
    (A) Indications for use. Treatment of necrotic enteritis caused by
C. perfringens susceptible to bacitracin methylene disalicylate.
* * * * *
    (4) * * *
    (i) Amount. 400 mg per gal in drinking water.
* * * * *

0
3. Revise Sec.  520.970 to read as follows:

Sec.  520.970  Flunixin.

    (a) Specifications. (1) Each 10-gram (g) packet of granules
contains flunixin meglumine equivalent to 250 milligrams (mg) of
flunixin.
    (2) Each 30-g syringe of paste contains flunixin meglumine
equivalent to 1,500 mg of flunixin.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 0.5 mg of flunixin per
pound of body weight per day.
    (2) Indications for use. For alleviation of inflammation and pain
associated with musculoskeletal disorders.
    (3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.

Sec.  520.970a  [Removed]

0
4. Remove Sec.  520.970a.

Sec.  520.970b  [Removed]

0
5. Remove Sec.  520.970b.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
7. In Sec.  522.90b, revise paragraph (d)(2)(iii) to read as follows:

Sec.  522.90b  Ampicillin trihydrate.

* * * * *
    (d) * * *
    (2) * * *
    (iii) Limitations. Do not treat cattle for more than 7 days. Milk
from treated cows must not be used for food during treatment and for 48
hours (4 milkings) after the last treatment. Cattle must not be
slaughtered for food during treatment and for 144 hours (6 days) after
the last treatment. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.

0
8. In Sec.  522.1083, revise the section heading and paragraph (a) to
read as follows:

Sec.  522.1083  Gonadotropin releasing factor analog-diphtheria toxoid
conjugate.

    (a) Specifications. Each milliliter of solution contains 0.2
milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid
conjugate.
* * * * *

0
9. In Sec.  522.1410, revise the section heading, remove and reserve
paragraph (c), and revise paragraphs (a) and (d) to read as follows:

Sec.  522.1410  Methylprednisolone.

    (a) Specifications. Each milliliter of suspension contains 20 or 40
milligrams (mg) of methylprednisolone acetate.
    (b) * * *
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. Administer 2 to 40 mg
(up to 120 mg in extremely large breeds or dogs with severe
involvement) by intramuscular injection or up to 20 mg by intrasynovial
injection.
    (ii) Indications for use. For treatment of inflammation and related
disorders; treatment of allergic and dermatologic disorders; and as
supportive therapy to antibacterial treatment of severe infections.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 10 to 20 mg by intramuscular
injection.
    (ii) Indications for use. For treatment of inflammation and related
disorders; treatment of allergic and dermatologic disorders; and as
supportive therapy to antibacterial treatment of severe infections.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (3) Horses--(i) Amount. Administer 200 mg by intramuscular
injection or 40 to 240 mg by intrasynovial injection.
    (ii) Indications for use. For treatment of inflammation and related
disorders.
    (iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.

0
10. In Sec.  522.2260, revise paragraphs (a), (d)(1), and (d)(3) to
read as follows:

Sec.  522.2260  Sulfamethazine.

    (a) Specifications. Each milliliter (mL) of solution contains 250
milligrams (mg) sulfamethazine sodium.
* * * * *
    (d) * * *
    (1) Amount. Initially administer 20 mL for each 50 pounds (lb) of
body weight (100 mg/lb) by intravenous injection, followed by 20 mL per
100 lb of body weight (50 mg/lb) by intravenous injection, daily
thereafter. Treatment should not exceed a total of 5 consecutive days.
* * * * *
    (3) Limitations. Withdraw medication from cattle 10 days prior to
slaughter. Do not use in female dairy cattle 20 months of age or older.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.

    Dated: August 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-21721 Filed 8-24-11; 8:45 am]
BILLING CODE 4160-01-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2008-0780; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans; Virginia;
Amendments to Existing Regulation Provisions Concerning Case-by-Case
Reasonably Available Control Technology

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Commonwealth of Virginia.  This SIP revision
consists of amendments to the Commonwealth’s existing regulations in
order to clarify and recodify provisions covering case-by-case
reasonably available control technology (RACT), as well as to add the
1997 8-hour ozone standard RACT requirements to the Commonwealth’s
regulations.  This action is being taken under the Clean Air Act (CAA).

DATES:  Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2008-0780 by one of the following methods:

A.    www.regulations.gov.  Follow the on-line instructions for
submitting comments.

B.    E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

C.    Mail:  EPA-R03-OAR-2008-0780, Cristina Fernandez, Chief, Air
Quality Planning

Branch, Mailcode 3AP21, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D.    Hand Delivery:  At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket(s normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2008-0780.  EPA's policy is that all comments received will
be included in the public docket without change, and

may be made available online at www.regulations.gov, including any
personal information provided, unless the comment includes information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.  Do not submit
information that you consider to be CBI or otherwise protected through
www.regulations.gov or e-mail.  The www.regulations.gov website is an
(anonymous access( system, which means EPA will not know your identity
or contact information unless you provide it in the body of your
comment.  If you send an e-mail comment directly to EPA without going
through www.regulations.gov, your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet.  If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit.  If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.  Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 either electronically in www.regulations.gov or

in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.  Copies of the State submittal
are available at the Virginia Department of Environmental Quality, 629
East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT:  Gregory Becoat,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I.  Background

On September 8, 2008, the Commonwealth of Virginia submitted a
regulation revision for case-by-case RACT determinations, which consists
of amendments to the existing regulations in order to implement the
non-control techniques guidelines RACT specific 8-hour ozone
nonattainment area requirements of subpart X of 40 CFR Part 51, and to
restructure and recodify the regulations for clarity.  In addition to
clarifying and recodifying the existing provisions covering case-by-case
RACT determinations, the regulation amendments create a new Rule 4-51
(Article 51 of 9 VAC 5 Chapter 40) - Emission Standards for Stationary
Sources Subject to Case-by-Case RACT Determinations, in order to
separate the RACT specific requirements from the general process
requirements of Article 4 of 9 VAC 5 Chapter 40.  These amendments
consisted only of changes in style or form.

The regulation amendments also add the 1997 8-hour ozone standard
requirements set forth by the CAA.  Subpart X of 40 CFR Part 51
specifically defines the provisions for implementation of the 8-hour
ozone national ambient air quality standard (NAAQS).  The rule specifies
dates by when states must submit their RACT SIPs, and when RACT must be
implemented.   The rule also requires that nonattainment areas meet the
requirements of 40 CFR 51.900(f), which includes RACT and major source
applicability cut-offs for purposes of RACT.

II.  Summary of SIP Revision

Further details of the Commonwealth of Virginia’s regulation revisions
can be found in a Technical Support Document prepared for this
rulemaking.  This SIP revision consists of the following changes:

1.  Addition of Rule 4-51 - Emission Standards for Stationary Sources
Subject to Case-by-Case RACT Determinations, in order to separate the
RACT specific requirements from the general process requirements of
Article 4 of 9 VAC 5 Chapter 40.

2.  Administrative wording changes to regulations 9 VAC 5-40-250A. and 9
VAC 5-40-250B.

3.  Deletion of definition of “Reasonably available control
technology” in 9 VAC 5-40-250C. and addition of the definition to 9
VAC 5-40-7380 in Article 51 of 9 VAC 5 Chapter 40.

4.  Addition of the following definitions to regulation 9 VAC
5-40-7380C. – Terms defined: “Presumptive RACT,” “Theoretical
potential to emit” and “Tpy.”

5.  All the definitions in regulation 9 VAC 5-40-311B.3 – Terms
defined, were deleted and added to 9 VAC 5-40-7380C. in Article 51 of 9
VAC 5 Chapter 40.

6.  Repealed regulations 9 VAC 5-40-300 – Standard for volatile
organic compounds, 9 VAC 5-40-310 – Standard for nitrogen oxides, and
9 VAC 5-40-311 – Reasonably available control technology guidelines
for stationary sources of nitrogen oxides, in Article 4 of 9 VAC 5
Chapter 40 and replaced them with 9 VAC 5-40-7390 – Standard for
volatile organic compounds (one-hour standard), 9 VAC 5-40-7410 –
Standard for nitrogen oxides (one-hour ozone standard), and 9 VAC
5-40-7430 – Presumptive reasonably available control technology
guidelines for stationary sources of nitrogen oxides, respectively, in
Article 51 of 9 VAC 5 Chapter 40.

7.  Addition of the 1997 8-hour ozone standard requirements for RACT in
regulations 9 VAC 5-40-7400 – Standard for volatile organic compounds
(eight-hour ozone standard) and 9 VAC 5-40-7420 – Standard for
nitrogen oxides (eight-hour ozone standard).

III.  General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

In 1995, Virginia adopted legislation that provides, subject to certain
conditions, for an environmental assessment (audit) “privilege” for
voluntary compliance evaluations performed by a regulated entity.  The
legislation further addresses the relative burden of proof for parties
either asserting the privilege or seeking disclosure of documents for
which the privilege is claimed.  Virginia's legislation also provides,
subject to certain conditions, for a penalty waiver for violations of
environmental laws when a regulated entity discovers such violations
pursuant to a voluntary compliance evaluation and voluntarily discloses
such violations to the Commonwealth and takes prompt and appropriate
measures to remedy the violations.  Virginia's Voluntary Environmental
Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege
that protects from disclosure documents and information about the
content of those documents that are the product of a voluntary
environmental assessment. The Privilege Law does not extend to documents
or information (1) that are generated or developed before the
commencement of a voluntary environmental assessment; (2) that are
prepared independently of the assessment process; (3) that demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney
General provided a legal opinion that states that the Privilege law, Va.
Code Sec. 10.1-1198,  precludes granting a privilege to documents and
information “required by law,” including documents and information
(required by Federal law to maintain program delegation, authorization
or approval,” since Virginia must (enforce Federally authorized
environmental programs in a manner that is no less stringent than their
Federal counterparts. . . .”   The opinion concludes that
“[r]egarding ( 10.1-1198, therefore, documents or other information
needed for civil or criminal enforcement under one of these programs
could not be privileged because such documents and information are
essential to pursuing enforcement in a manner required by Federal law to
maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that ([t]o
the extent consistent with requirements imposed by Federal law,(  any
person making a voluntary disclosure of information to a state agency
regarding a violation of an environmental statute, regulation, permit,
or administrative order is granted immunity from administrative or civil
penalty.  The Attorney General's January 12, 1998 opinion states that
the quoted language renders this statute inapplicable to enforcement of
any Federally authorized programs, since (no immunity could be afforded
from administrative, civil, or criminal penalties because granting such
immunity would not be consistent with Federal law, which is one of the
criteria for immunity.(

Therefore, EPA has determined that Virginia's Privilege and Immunity
statutes will not preclude the Commonwealth from enforcing its program
consistent with the Federal requirements.  In any event, because EPA has
also determined that a state audit privilege and immunity law can affect
only state enforcement and cannot have any impact on Federal enforcement
authorities, EPA may at any time invoke its authority under the CAA,
including, for example, sections 113, 167, 205, 211 or 213, to enforce
the requirements or prohibitions of the state plan, independently of any
state enforcement effort.  In addition, citizen enforcement under
section 304 of the CAA is likewise unaffected by this, or any, state
audit privilege or immunity law.

IV.  Proposed Action

EPA is proposing to approve the Virginia SIP revision that clarifies and
recodifies provisions covering case-by-case RACT, as well as adds the
1997 8-hour ozone standard requirements to the Commonwealth’s
regulations.  EPA views the administrative changes and re-codifications
as non-substantive, as they do not affect the scope of the currently
approved Virginia SIP, and consequently, cannot interfere with timely
attainment or progress towards attainment of a NAAQS, nor interfere with
any other provision of the CAA.  However, regulation 9 VAC 5-40-7420F.
and G. incorrectly cross-references the Commonwealth’s VOC regulations
at 9 VAC 5-40-7390, instead of its nitrogen oxides regulation at 9 VAC
5-40-7410.  The Commonwealth is in the process of correcting the
cross-references in this regulation and will submit the correction to
EPA.  EPA does not intend to finalize this action until after the
Commonwealth formally submits the corrected versions of 9 VAC
5-40-7420F. and G. to EPA as part of this SIP revision.  EPA does not
intend to reopen the comment period before taking final action on this
SIP revision.  EPA is soliciting public comments on the issues discussed
in this document.  These comments will be considered before taking final
action.

V.  Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations.  42 U.S.C. 7410(k); 40 CFR 52.02(a).  Thus, in
reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  Accordingly,
this action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law.  For that reason, this proposed action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

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 (Public Law 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 Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with the
CAA; and

does not provide 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, this proposed rule, pertaining to amendments to
Virginia’s case-by-case RACT determinations, does not have tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

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

__October 22, 2009___
_____________/s/_______________

Dated:                             		   		William C. Early,

                          					Acting Regional Administrator,

Region III.

 PAGE

 PAGE   2

 PAGE  10


[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)]
[Rules and Regulations]
[Pages 40917-40922]
[FR Doc No: 2015-17060]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2015-0241; FRL-9930-35-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Low Emissions Vehicle Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve two revisions to the Maryland State
Implementation Plan (SIP). The Clean Air Act (CAA) provides authority
allowing California to adopt its own motor vehicle emissions

standards for newly manufactured vehicles, in lieu of federal vehicle
standards. The CAA also allows other states to adopt California's
vehicle standards, as long as they are identical to California's
standards. Maryland's recent SIP submittals serve to amend Maryland's
Clean Car Program to incorporate updates that California has made to
its Low Emission Vehicle (LEV) program rules. Maryland adopted
California's emission standards applicable to newly manufactured light
and medium-duty vehicles in 2007, and EPA approved Maryland's Clean Car
Program in prior rulemakings. However, since then California revised
its LEV program regulations on several occasions, and Maryland
subsequently amended its own rules to be consistent with those of
California. Since the Clean Car Program is part of the SIP, Maryland
then submits these amendments as a SIP revision. Maryland submitted
such SIP revision requests in July 2014 and again in April 2015 to
update its SIP to be consistent with California's latest LEV program
rules. EPA's action to approve Maryland's most recent Clean Car Program
SIP revisions is being taken under the CAA.

DATES: This rule is effective on September 14, 2015 without further
notice, unless EPA receives adverse written comment by August 13, 2015.
If EPA receives such comments, it will publish a timely withdrawal of
the direct final rule in the Federal Register and inform the public
that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2015-0241 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2015-0241, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2015-0241. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI, or otherwise protected, through www.regulations.gov or email.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Maryland Department of the Environment, 1800
Washington Boulevard, Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT: Brian Rehn,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Maryland originally adopted a Low Emissions
Vehicle Program in 2007 under Regulation .02 of COMAR 26.11.34 Low
Emission Vehicles. Since then, Maryland updated its program rule on
several occasions (in 2009 and 2011), to incorporate changes made by
California to its own LEV program rule. Maryland originally submitted
its Clean Car Program to EPA for inclusion in the SIP in December 2007
(Revision #07-16), with subsequent revisions in November 2010 (Revision
#10-08) and again in June 2011 (Revision #11-05), to reflect Maryland
regulatory updates made in 2009 and 2011. EPA approved Maryland's
original Clean Car SIP submittal (and the November 2010 and June 2011
revisions) in a rulemaking action published in the Federal Register on
June 11, 2013 (78 FR 34911). Maryland again submitted a revised SIP
submittal in August 2013 (Revision #13-02), to incorporate regulatory
changes made in 2012 to its Clean Car Program rule. EPA approved that
SIP revision in a final rulemaking action published in the Federal
Register on July 9, 2013 (79 FR 38787).
    On July 28, 2014, Maryland submitted a revision for the SIP
(Revision #14-01) to again amend its Clean Car Program SIP to include
regulatory updates made in 2014 to ensure consistency with California's
LEV rules. Maryland later submitted another revision for the SIP
(Revision #15-02) on April 13, 2015 to adopt additional regulatory
amendments made in 2015. It is these two most recent SIP revisions that
are the subject of this rulemaking.

Table of Contents

I. Background
    A. Maryland's Air Quality With Respect to the Federal National
Ambient Air Quality Standard (NAAQS) for Ozone
    B. Federal Vehicle Emission Standards
    C. California's Low Emission Vehicle Standards
    D. Maryland's Low Emissions Vehicle Program
II. Summary of SIP Revisions
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background

A. Maryland's Air Quality With Respect to the Federal National Ambient
Air Quality Standard (NAAQS) for Ozone

    The CAA, which was last amended in 1990, requires EPA to set NAAQS
for pollutants considered harmful to public health and the environment.
EPA establishes NAAQS for six principal pollutants, or ``criteria''
pollutants, which include: ozone, carbon monoxide (CO), lead, nitrogen
dioxide, fine particulate matter (PM), and sulfur dioxide. The CAA
establishes two types of NAAQS. Primary standards provide public health
protection, including protecting the health of ``sensitive''
populations such as asthmatics, children, and the elderly. Secondary
standards protect public welfare, including protection against
decreased

visibility and damage to animals, crops, vegetation, and buildings. The
CAA also requires EPA to periodically review the standards to ensure
that they provide adequate health and environmental protection, and to
update those standards as necessary.
    Ozone is formed in the atmosphere by photochemical reactions
between ozone precursor pollutants, including volatile organic
compounds (VOCs) and nitrogen oxides (NOX) in the presence
of sunlight. In order to reduce ozone concentrations in the ambient
air, the CAA directs areas designated as nonattainment to apply
controls on VOC and NOX emission sources to reduce the
formation of ozone.
    Although EPA has revised the ozone NAAQS several times since the
CAA was reauthorized in 1990, Maryland has historically had three areas
designated as nonattainment under each successive ozone NAAQS. These
include portions of the Baltimore metropolitan area, the Maryland
portion of the Washington, DC metropolitan area, and the Maryland
portion of the Philadelphia metropolitan area. Most recently, EPA
revised the 8-hour ozone NAAQS from 0.08 parts per million (ppm) to
0.075 ppm on March 27, 2008 (73 FR 16436). On May 21, 2012 (77 FR
30088), EPA finalized designations for this 2008 8-hour ozone NAAQS,
including as nonattainment the same three Maryland areas.

B. Federal Vehicle Emission Standards

    Vehicles sold in the United States are required by the CAA to be
certified to meet either Federal motor vehicle emission standards or
California emission standards. States other than California are
forbidden from adopting their own standards, but may elect to adopt
California emission standards for which EPA has granted a waiver of
preemption. Specifically, section 209 of the CAA prohibits states from
adopting or enforcing standards relating to the control of emissions
from new motor vehicles (or new vehicle engines), however, EPA may
waive that prohibition for any state that adopted its own standards
prior to March 30, 1966. As California was the only state to do so,
California has authority to adopt its own vehicle emissions standards.
California must demonstrate to EPA that its newly adopted standards
will be ``. . . in the aggregate, at least as protective of public
health and welfare as applicable Federal standards,'' after which time
EPA may then grant a waiver of preemption from Federal standards for
California's standards.
    Section 177 of the CAA authorizes other states to adopt
California's standards in lieu of Federal vehicle standards, provided
the state does so with at least two model years lead time prior to the
effective date of its program and EPA has issued a waiver of preemption
to California for such standards.
    EPA has adopted several iterations, or ``tiers,'' of federal
emissions standards since the CAA was reauthorized in 1990. When
Maryland first adopted its Clean Car Program in 2007, the federal
standards in effect were Tier 2 standards that were adopted by EPA on
February 10, 2000 (65 FR 6698) and were implemented beginning with 2004
model year federally certified vehicles. These Federal Tier 2 standards
set tailpipe emissions standards for passenger vehicles and light duty
trucks and also limited gasoline sulfur levels. EPA later finalized
Tier 3 Federal vehicle and fuel standards on April 28, 2014 (79 FR
23414). The Federal Tier 3 program set more stringent Federal vehicle
emissions standards and further limited allowable sulfur content of
gasoline for new cars, beginning in 2017. EPA attempted to closely
harmonize the Tier 3 standards with California's most current Low
Emissions Vehicle Program.
    On May 7, 2010 (75 FR 25324), EPA and the U.S. Department of
Transportation's National Highway Traffic Safety Administration (NHTSA)
jointly established a national program consisting of new standards for
light-duty motor vehicles to reduce greenhouse gases (GHG) emissions
and to improve fuel economy. This program affected new passenger cars,
light trucks, and medium-duty passenger vehicles sold in model years
2012 through 2016. On October 15, 2012 (77 FR 62624), EPA and NHTSA
issued another joint rule to further tighten GHG emissions standards
for model years 2017 through 2025. The Federal GHG standards were
harmonized with similar GHG standards set by California, to ensure that
automobile manufacturers would face a single set of national emissions
standards to meet both Federal and California emissions requirements.

C. California's Low Emission Vehicle Standards

    In 1990, California's Air Resources Board (CARB) adopted its first
generation of LEV standards applicable to light and medium duty
vehicles. California's LEV program standards were phased-in beginning
in model year 1994 through model year 2003. In 1999, California adopted
a second generation of LEV standards, known as LEV II, which were
phased-in beginning model year 2004 through model year 2010. EPA
granted a Federal preemption waiver for CA LEV II program on April 22,
2003 (68 FR 19811).
    California's LEV II program reduces emissions in a similar manner
to the Federal Tier 2 program by use of declining fleet average non-
methane organic gas (NMOG) emission standards, applicable to each
vehicle manufacturer each year. Separate fleet average standards are
not established for NOX, CO, PM, or formaldehyde as these
emissions are controlled as a co-benefit of the NMOG fleet average
(fleet average values for these pollutants are set by the certification
standards for each set of California prescribed certification
standards.) These allowable sets of standards range from LEV standards
(the least stringent standard set) to Zero Emission Vehicle (ZEV)
standards (the most stringent standard set). California's LEV II
program establishes various other standards: The Ultra-Low Emission
Vehicles (ULEV), Super-Ultra Low Emission Vehicles (SULEV), Partial
Zero Emission Vehicles (PZEV), and Advanced Technology-Partial Zero
Emission Vehicles (AT-PZEV). Each manufacturer may comply by selling a
mix of vehicles meeting any of these standards, as long as their sales-
weighted, overall average of the various standard sets meets the
overall fleet average and ZEV requirements.
    In January 2012, California approved a new emissions-control
program for model years 2017 through 2025, called the Advanced Clean
Cars Program, or the LEV III program. The program combines the control
of smog, soot, and GHG and requirements for greater numbers of ZEV
vehicles into a single package of standards. The regulations apply to
light duty vehicles, light duty trucks, and medium duty passenger
vehicles. Under California's Advanced Clean Cars Program, manufacturers
can certify vehicles to the standards before model year 2015. Beginning
with model year 2020, all vehicles must be certified to LEV III
standards. The ZEV amendments add flexibility to California's existing
ZEV program for 2017 and earlier model years, and establish new sales
and technology requirements starting with the 2018 model year. The LEV
III amendments establish more stringent criteria and GHG emission
standards starting with the 2015 and 2017 model years, respectively.
The California GHG standards are almost identical in stringency and
structure to the Federal GHG standards for model years from 2017 to
2025. Additionally, on December 2012, California adopted a ``deemed to
comply'' regulation that enables manufacturers to show

compliance with California GHG standards by demonstrating compliance
with Federal GHG standards. On June 9, 2013 (78 FR 2112), EPA granted a
Federal preemption waiver for California's Advanced Clean Cars Program.
California's LEV III program rules are codified in Title 13 of the
California Code of Regulations (CCR), under Division 3.

D. Maryland's Low Emissions Vehicle Program

    Maryland's legislature adopted and the Governor signed into law the
Maryland Clean Cars Act of 2007, establishing legal authority
compelling Maryland to adopt California's LEV standards. Maryland
adopted its ``Low Emission Vehicle Program,'' codified at COMAR
26.11.34 in 2007. Since then, Maryland has revised its program rules a
number of times to ensure consistency with California's LEV program. As
discussed in the Supplemental Information section, Maryland submitted
revisions in 2009 and 2011, which EPA approved (along with the original
2007 Clean Car revision) on June 11, 2013 (78 FR 34911). Since then,
Maryland amended its program in 2013 and submitted another SIP revision
to EPA in August 2013, which EPA approved on July 9, 2014 (79 FR
38787).
    The Maryland Clean Car Program has two objectives. The first is to
reduce emissions of NOX and VOCs, as precursors of ground
level ozone, from new motor vehicles sold in Maryland. The second
objective of the program is to reduce GHG emissions from motor
vehicles. The program requires 2011 and newer model year passenger
cars, light trucks, and medium-duty vehicles having a gross vehicle
weight rating (GVWR) of 14,000 pounds or less that are sold as new cars
or transferred in Maryland to meet the applicable California emissions
standards. For purposes of the Clean Car Program, transfer means to
sell, import, deliver, purchase, lease, rent, acquire, or receive a
motor vehicle for titling or registration in Maryland.

II. Summary of SIP Revisions

    On July 28, 2014, Maryland submitted a formal SIP Revision #14-01
containing Maryland's updated Clean Car regulations to reflect changes
made to adopt California's LEV III Program. This SIP submittal consists
of updates to make Maryland's Clean Car Program consistent with
California's program. Specifically, California amended its LEV III
program rule to allow as a compliance option the recent Federal GHG
standards for model years 2017 to 2025. Since California's LEV III
program addresses GHG pollutants, in addition to criteria pollutants
that are precursors to ozone pollution, Maryland incorporated by
reference this compliance alternative for California's LEV III program
to its own Clean Car Program rule.
    On April 30, 2015, Maryland submitted another revision to its SIP
to update the Clean Car Program rules. This latest change relates to
the ZEV requirements of California's rules, including adjustments to
optional compliance path (OCP) for manufacturers related to the
elimination of certain credits in qualifying for the OCP and pooling of
credits across model years. Another ZEV-related provision establishes a
minimum amount of ZEV credits to be used each year, specifically a
limit to use of non-ZEV credits to satisfy ZEV requirements. Further,
California amended the definition for fast refueling for purposes of
determining the ZEV type to limit credits to only technologies that
have actually been demonstrated in practice. Maryland incorporated by
reference in its Clean Car Program these latest changes to California's
LEV III program.
    These two most recent Maryland SIP submittals are the subject of
this rulemaking action. Maryland adopted California's updates to
portions of CCR Title 13, Division 3 by amending COMAR <IP_ADDRESS>,
relating to incorporation by reference of California's LEV standards.
The July 28, 2014 and April 13, 2015 SIP submittals include Maryland's
adopted regulatory amendments to the Clean Car Program rule (with the
exception of CCR, Title 13, Division 3, Article 5, Section 2030
``Liquefied Petroleum Gas or Natural Gas Retrofit Systems,'' which
Maryland requested EPA to exclude from the SIP). The April 13, 2015 SIP
submittal will replace in its entirety the existing regulation COMAR
<IP_ADDRESS> as approved in the SIP on July 9, 2014 with the revised
version of COMAR <IP_ADDRESS> effective February 16, 2015. See 79 FR
38787. A list of California's regulations being incorporated by
reference is included as part of Maryland's notice of proposed action
dated December 1, 2014, which is included in the State submittal and
available online at www.regulations.gov, Docket ID No. EPA-R03-OAR-
2015-0241. These revisions to Maryland's Clean Car Program, as approved
in the Maryland SIP, are important to ensure consistency with
California's LEV program. This will ensure that Maryland's Clean
Vehicle Program complies with the requirements for adoption of another
state's vehicle standards in lieu of Federal vehicle standards, per
section 177 of the CAA.

III. Final Action

    EPA is approving Maryland's July 28, 2014 and April 13, 2015 SIP
submittals. These revisions amend the prior approved Maryland Clean
Vehicle Program, specifically with respect to Maryland's updated
incorporation by reference (at COMAR <IP_ADDRESS>) of California's LEV
program rules (at Title 13, CCR, Division 3, with the exception of CCR,
Title 13, Division 3, Article 5, Section 2030). Maryland's SIP
revisions serve to ensure consistency of Maryland's Clean Vehicle
Program with California's LEV III program, satisfying Federal
requirements for state adoption of vehicle emission standards under
section 177 of the CAA. EPA is publishing this rule without prior
proposal because EPA views this as a noncontroversial amendment and
anticipates no adverse comment. However, in the ``Proposed Rules''
section of this Federal Register, EPA is publishing a separate document
that will serve as the proposal to approve the SIP revision if adverse
comments are filed. This rule will be effective on September 14, 2015
without further notice unless EPA receives adverse comment by August
13, 2015. If EPA receives adverse comment, EPA will publish a timely
withdrawal in the Federal Register informing the public that the rule
will not take effect. EPA will address all public comments in a
subsequent final rule based on the proposed rule. EPA will not
institute a second comment period on this action. Any parties
interested in commenting must do so at this time.

IV. Incorporation by Reference

    In this rulemaking action, EPA is finalizing regulatory text that
includes incorporation by reference. In accordance with requirements of
1 CFR 51.5, the EPA is finalizing the incorporation by reference of
Maryland's Clean Vehicle Program rules at COMAR <IP_ADDRESS>, as adopted
on January 20, 2015 and effective on February 16, 2015. EPA has made,
and will continue to make, these documents generally available
electronically through www.regulations.gov and in hard copy at the
appropriate EPA office (see the ADDRESSES section of this preamble for
more information).

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve SIP
submissions

that comply with the provisions of the CAA and applicable Federal
regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP
submissions, 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 Order
12866 (58 FR 51735, October 4, 1993);
     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 Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide 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, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    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. EPA will submit a report containing this action 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).

C. Petitions for Judicial Review

    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 September 14, 2015. 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of this Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking action. This action approving revisions to the Maryland
Clean Car Program 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: June 26, 2015.
William C. Early,
Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

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 V--Maryland

0
2. In Sec.  52.1070, the table in paragraph (c) is amended by revising
the entry for COMAR <IP_ADDRESS> to read as follows:

Sec.  52.1070  Identification of plan.

* * * * *
    (c) * * *

                EPA--Approved Regulations, Technical Memoranda, and Statutes in the Maryland SIP
----------------------------------------------------------------------------------------------------------------
       Code of  Maryland                                                                 Additional explanation/
  Administrative  Regulations       Title/subject         State       EPA approval date     citation at 40 CFR
       (COMAR)  citation                             effective date                              52.1100
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
26.11.34.......................                           Low Emissions Vehicle Program

                                                  * * * * * * *
<IP_ADDRESS> (except .02B(20))..  Incorporation by          02/16/15  07/14/15 [Insert    Update to incorporate
                                  Reference.                          Federal Register    by reference
                                                                      citation].          California's Advanced
                                                                                Clean Car Program
                                                                                rules, with the
                                                                                exception of Title 13,
                                                                                California Code of
                                                                                Regulations, Division
                                                                                3, Chapter 2, Article
                                                                                5, Section 2030.

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

* * * * *
[FR Doc. 2015-17060 Filed 7-13-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Proposed Rules]
[Pages 33586-33588]
[FR Doc No: 2021-13490]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0477; Airspace Docket No. 21-AGL-10]
RIN 2120-AA66

Proposed Amendment of Class D and Class E Airspace; Belleville,
IL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend the Class D and Class E airspace
at Scott AFB/MidAmerica St. Louis Airport, Belleville, IL. The FAA is
proposing this action as the result of a biennial airspace review. The
name of the airport would also be updated to coincide with the FAA's
aeronautical database.

DATES: Comments must be received on or before August 9, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2021-0477/Airspace Docket No. 21-AGL-10 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and

subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend the Class D airspace, the Class E airspace area
designated as an extension to Class D airspace, and the Class E
airspace extending upward from 700 feet above the surface at Scott AFB/
MidAmerica St. Louis Airport, Belleville, IL, to support instrument
flight rule operations at this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2021-0477/
Airspace Docket No. 21-AGL-10.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 by:
    Amending the Class D airspace at Scott AFB/MidAmerica St. Louis
Airport, Belleville, IL, by removing the city associated with the
airport to comply with changes to FAA Order 7400.2N, Procedures for
Handling Airspace Matters; updating the name (previously Scott AFB/
MidAmerica Airport) of the airport to coincide with the FAA's
aeronautical database; and replacing the outdated term ``Airport/
Facility Directory'' with ``Chart Supplement'';
    Amending the Class E airspace area designated as an extension to
Class D airspace at Scott AFB/MidAmerica St. Louis Airport by adding an
extension 1.3 miles each side of the 048[deg] bearing from the Scott
TACAN extending from the 4.9-mile radius of the airport to 5.7 miles
northeast of the Scott TACAN; amending the northwest extension to 1
mile (decreased from 1.5 miles) each side of the 314[deg] (previously
312[deg]) radial from the Scott TACAN extending from the 4.9-mile
radius from the airport to 9.5 miles (decreased from 10 miles)
northwest of the Scott TACAN; removing the city associated with the
airport to comply with changes to FAA Order 7400.2N; updating the name
of the airport (previously Scott AFB/MidAmerica Airport) to coincide
with the FAA's aeronautical database; and replacing the outdated term
``Airport/Facility Directory'' with ``Chart Supplement'';
    And amending the Class E airspace extending upward from 700 feet
above the surface to at Scott AFB/MidAmerica St. Louis Airport by
adding an extension 8 miles northwest and 10 miles southeast of the
048[deg] bearing from the Scott TACAN extending from the 7.4-mile
radius of the airport to 22 miles northeast of the Scott TACAN; adding
an extension 1 mile each side of the 137[deg] bearing from the airport
extending from the 7.4-mile radius of the airport to 8.1 miles
southeast of the airport; amending the southeast extension to 1.5 miles
(decreased from 1.7 miles) each side of the 142[deg] (previously
140[deg]) radial from the Scott TACAN extending from the 7.4-mile
radius of the airport to 12.7 miles (decreased from 14 miles) southeast
of the Scott TACAN; amending the northwest extension to 4 miles
(increased from 1.5 miles) each side of the 314[deg] (previously
312[deg]) radial from the Scott TACAN extending from the 7.4-mile
radius of the airport to 10.5 miles (increased from 10 miles) northwest
of the Scott TACAN; removing the city associated with the airport to
comply with changes to FAA Order 7400.2N; updating the name of the
airport (previously Scott AFB/MidAmerica Airport) to coincide with the
FAA's aeronautical database; and removing the exclusionary language as
it is not required.
    This action is due to a biennial airspace review.

    Class D and Class E airspace designations are published in
paragraph 5000, 6004, and 6005, respectively, of FAA Order 7400.11E,
dated July 21, 2020, and effective September 15, 2020, which is
incorporated by reference in 14 CFR 71.1. The Class D and E airspace
designation listed in this document will be published subsequently in
the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AGL IL D Belleville, IL [Amended]

Scott AFB/MidAmerica St. Louis Airport, IL
    (Lat. 38[deg]32'43'' N, long. 89[deg]50'07'' W)

    That airspace extending upward from the surface to and including
3,000 feet MSL within a 4.9-mile radius of the Scott AFB/MidAmerica
St. Louis Airport. This Class D airspace area is effective during
the specific dates and times established in advance by Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Chart Supplement.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area.

* * * * *

AGL IL E4 Belleville, IL [Amended]

Scott AFB/MidAmerica St. Louis Airport, IL
    (Lat. 38[deg]32'43'' N, long. 89[deg]50'07'' W)
Scott TACAN
    (Lat. 38[deg]32'43'' N, long. 89[deg]51'06'' W)

    That airspace extending upward from the surface within 1.3 miles
each side of the 048[deg] bearing from the Scott TACAN extending
from the 4.9-mile radius of Scott AFB/MidAmerica St. Louis Airport
to 5.7 miles northeast of the Scott TACAN, and within 1 mile each
side of the 314[deg] radial from the Scott TACAN extending from the
4.9-mile radius of the Scott AFB/MidAmerica St. Louis Airport to 9.5
miles northwest of the Scott TACAN. This Class E airspace area is
effective during the specific dates and times established in advance
by Notice to Airmen. The effective date and time will thereafter be
continuously published in the Chart Supplement.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL IL E5 Belleville, IL [Amended]

Scott AFB/MidAmerica St. Louis Airport, IL
    (Lat. 38[deg]32'43'' N, long. 89[deg]50'07'' W)
Scott TACAN
    (Lat. 38[deg]32'43'' N, long. 89[deg]51'06'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.4-mile radius of Scott AFB/MidAmerica St. Louis Airport,
and within 8 miles northwest and 10 miles southeast of the 048[deg]
bearing from the Scott TACAN extending from the 4.9-mile radius from
Scott AFB/MidAmerica St. Louis Airport to 22 miles northeast of the
Scott TACAN, and within 1 mile each side of the 137[deg] bearing
from the Scott AFB/MidAmerica St. Louis Airport extending from the
7.4-mile radius of Scott AFB/MidAmerica St. Louis Airport to 8.1
miles southeast of Scott AFB/MidAmerica St. Louis Airport, and
within 1.5 miles each side of the 142[deg] radial from the Scott
TACAN extending from the 7.4-mile radius of Scott AFB/MidAmerica St.
Louis Airport to 12.7 miles southeast of the Scott TACAN, and within
4 miles each side of the 314[deg] radial from the Scott TACAN
extending from the 7.4-mile radius of Scott AFB/MidAmerica St. Louis
Airport to 10.5 miles northwest of the Scott TACAN.

    Issued in Fort Worth, Texas, on June 21, 2021.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2021-13490 Filed 6-24-21; 8:45 am]
BILLING CODE 4910-13-P