[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27878-27879]
[FR Doc No: 2014-11176]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-E-0711; FDA-2011-E-0712; FDA-2011-E-0715]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BENLYSTA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for BENLYSTA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.

ADDRESSES: Submit written petitions (two copies are required) and
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human biological product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product, BENLYSTA
(belimumab). BENLYSTA is indicated for treatment of adult patients with
active, autoantibody-positive, systemic lupus erythematosus who are
receiving standard therapy. Subsequent to this approval, the Patent and
Trademark Office received patent term restoration applications for
BENLYSTA (U.S. Patent Nos. 6,403,770; 7,138,501; and 7,879,328) from
Human Genome Sciences Inc., and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated July 2, 2012, FDA advised
the Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of BENLYSTA
represented the first permitted commercial marketing or use of the
product. Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
BENLYSTA is 3,426 days. Of this time, 3,152 days occurred during the
testing phase of the regulatory review period, while 274 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: October 23,
2001. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on October
23, 2001.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): June 9, 2010. The applicant claims June
10, 2010, as the date the biologics license application (BLA) for
BENLYSTA (BLA 125370/0) was initially submitted. However, FDA records
indicate that BLA 125370/0 was submitted on June 9, 2010.
    3. The date the application was approved: March 9, 2011. FDA has
verified the applicant's claim that BLA 125370/0 was approved on March
9, 2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 1,733 days or
610 days or 37 days of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 14, 2014. Furthermore, any interested person
may

petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by November 12, 2014. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
    Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11176 Filed 5-14-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
[Notices]
[Pages 39253-39255]
[FR Doc No: 2020-14008]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89141; File No. SR-NSCC-2020-011]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing and Immediate Effectiveness of a Proposed
Rule Change To Modify the Clearing Fund Maintenance Fee

June 24, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 16, 2020, National Securities Clearing Corporation (``NSCC'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been prepared by the clearing agency. NSCC filed the
proposed rule change pursuant to Section 19(b)(3)(A) of the Act \3\ and
Rule 19b-4(f)(2) thereunder.\4\ The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of amendments to the Clearing
Fund Maintenance Fee (``Maintenance Fee'') set forth in Addendum A of
the NSCC Rules & Procedures (``Rules'').\5\
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    \5\ Capitalized terms not defined herein are defined in the
Rules available at www.dtcc.com/~/media/Files/Downloads/legal/rules/
nscc_rules.pdf.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency included
statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. The clearing agency has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to modify the existing
Maintenance Fee set forth in Addendum A of the Rules.\6\
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    \6\ Addendum A, Rules, supra note 5.
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Maintenance Fee
    The Maintenance Fee was implemented in 2016 pursuant to a proposed
rule change (``2016 Rule Change'') in order to (i) diversify NSCC's
revenue sources, mitigating NSCC's dependence on revenues driven by
trading volumes, and (ii) add a stable revenue source that would
contribute to NSCC's operating margin by offsetting increasing costs
and expenses.\7\ The fee is charged to all NSCC Members and Limited
Members that are required to make deposits to the NSCC Clearing Fund
(collectively, ``Members'') in proportion to the Member's average
monthly cash deposit to the Clearing Fund.
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    \7\ Securities Exchange Act Release No. 78525 (August 9, 2016),
81 FR 54146 (August 15, 2016) (SR-NSCC-2016-002).
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    Since the 2016 Rule Change, the Maintenance Fee has been calculated
monthly, in arrears, as the product of (A) 0.25 percent and (B) the
average of the Member's actual cash deposit to the NSCC Clearing Fund
as of the end of each day of the month, multiplied by the number of
days in that month and divided by 360. However, by its terms, the fee
is waived if the monthly rate of return on NSCC's investment of the
cash portion of the Clearing Fund was less than 0.25 percent for the
month (``Waiver Provision'').
    NSCC represents that the Waiver Provision was included for the
benefit of Members. NSCC believed that if its monthly rate of return on
the investment of cash from the Clearing Fund was less than 0.25
percent, then Members would likely be experiencing similarly low
interest income on their deposits, including excess reserves, if
applicable; in which case, NSCC would waive the fee. Although this
approach exposed NSCC to the risk of not receiving revenue from the
Maintenance Fee at a time of increased costs, NSCC did not believe that
such an exposure would be common, significant, or long-term. Moreover,
at the time of adoption, NSCC's default liquidity resources were not as
diversified and robust as they are now, nor were such resources as
costly or expensive to secure and maintain, as described below.
Increased Costs and Expenses
    Due to the coronavirus global pandemic and overall reaction by the
financial markets, NSCC's cost of funding has risen sharply in 2020,
particularly for three of NSCC's key

default liquidity resources: NSCC's committed 364-day line-of-credit
facility with a consortium of banks (``LOC''); \8\ the proceeds of the
issuance and private placement of short-term, unsecured notes in the
form of commercial paper and extendable notes (``CP''); \9\ and
proceeds of the issuance of medium-term notes (``MTNs'').\10\ This
year's annual renewal of the LOC cost substantially more than past
renewals due to a significant fee increase that NSCC had to pay to the
lenders in order for NSCC to reach its target commitment size in the
current economic environment. Meanwhile, for the CP program and the
MTNs, the spread between the CP rates and MTN coupons that NSCC must
pay and the interest it earns on the cash proceeds from those liquidity
resources has widened significantly, making the resources considerably
more expensive than they have been or would have been in past economic
conditions.
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    \8\ See Securities Exchange Act Release No. 80605 (May 5, 2017),
82 FR 21850 (May 10, 2017) (SR-NSCC-2017-802).
    \9\ See Securities Exchange Act Release Nos. 75730 (August 19,
2015), 80 FR 51638 (August 25, 2015) (SR-NSCC-2015-802); 82676
(February 9, 2018), 83 FR 6912 (February 15, 2018) (SR-NSCC-2017-
807).
    \10\ See Securities Exchange Act Release No. 87912 (January 8,
2020), 85 FR 2187 (January 14, 2020) (SR-NSCC-2019-802).
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    Collectively, the unexpected increases in cost and expense to
secure and maintain those default liquidity resources has added
millions of dollars to NSCC's non-operating expense. If unaddressed,
the increases could negatively impact NSCC's 2020 financial results and
its access to default liquidity resources. A deteriorating operating
margin could jeopardize NSCC's credit ratings. A downgrade to an NSCC
credit rating could further increase such costs and expenses, but more
importantly, could reduce the overall availability of default liquidity
resources to NSCC, if investors or lending banks reduce their current
levels of engagement with NSCC.
Modifications to the Maintenance Fee
    To help address this immediate issue and better position NSCC going
forward, with respect to its ability to fund its default liquidity
resources in various economic environments, as well as to improve the
overall functioning of the Maintenance Fee, NSCC is modifying the fee
in three ways. First, NSCC is removing the Waiver Provision. Second,
instead of using the fixed rate of 0.25 percent when calculating the
Maintenance Fee, NSCC will calculate the fee using the corresponding
month's average Interest Rate on Excess Reserves (i.e., the IOER rate)
that is determined by the Board of Governors of the Federal Reserve
System (``Federal Reserve'').\11\ Third, NSCC is setting a ceiling of
0.25 percent and a floor of 0.00 percent on the IOER rate used in the
fee calculation.
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    \11\ Policy Tools, Interest on Required Reserve Balances and
Excess Balances, https://www.federalreserve.gov/monetarypolicy/reqresbalances.htm.
---------------------------------------------------------------------------

    NSCC is removing the Waiver Provision so that NSCC will be able to
generate revenue from the Maintenance Fee even if NSCC's monthly rate
of return on the investment of cash deposits from the Clearing Fund is
less than 0.25 percent. The ability to generate such revenue under such
circumstances is important in helping NSCC offset its costs and
expenses in any economic environment.
    NSCC is replacing the current fixed rate of 0.25 percent with the
month's average IOER rate when calculating the Maintenance Fee because
the IOER rate is (i) publicly available, well established, and a widely
used benchmark (i.e., the rate is transparent); (ii) determined by the
Federal Reserve (i.e., the rate is reliable); and (iii) the same rate
that NSCC receives on the cash deposits it holds in its cash deposit
account at the Federal Reserve Bank of New York (i.e., the rate is
impartial).
    NSCC is setting a ceiling of 0.25 percent on the IOER rate that it
uses to calculate the Maintenance Fee so that Members will not be
charged an amount greater than what is possible under the original
calculation. However, it is setting a floor of 0.00 percent so if the
IOER rate turns negative, NSCC will not owe Members an amount based on
the calculation.
Changes to the Rules
    To effectuate the changes described above, Subsection G (Clearing
Fund Maintenance Fee) of Section V (Pass-Through and Other Fees) of
Addendum A (Fee Structure) to the Rules will be modified to (i) remove
the Waiver Provision, (ii) replace the existing fixed rate of 0.25
percent with the month's average IOER rate, and (iii) set a ceiling of
0.25 percent and a floor of 0.00 percent on the IOER rate used in the
fee's calculation.
Implementation Timeframe
    The above described changes to the Maintenance Fee will take effect
immediately upon filing with the Commission, with the next assessment
of the fee using those changes being for the month of July 2020.
2. Statutory Basis
    Section 17A(b)(3)(D) of the Act \12\ requires that NSCC's Rules
provide for the equitable allocation of reasonable dues, fees, and
other charges among its participants. NSCC believes that the changes to
the Maintenance Fee are consistent with this provision of the Act.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78q-1(b)(3)(D).
---------------------------------------------------------------------------

    As described above, the proposal will modify the existing
Maintenance Fee in three ways: (i) Removing the Waiver Provision, (ii)
calculating the fee using the month's average IOER rate, instead of the
current fixed rate of 0.25 percent, and (iii) setting a ceiling of 0.25
percent and a floor of 0.00 percent on the IOER rate used in the
calculation.
    Because these changes do not alter how the Maintenance Fee is
currently allocated (i.e., charged) to Members, NSCC believes the fee
will continue to be equitably allocated. More specifically, as
mentioned above, the Maintenance Fee is and will continue to be charged
to all Members in proportion to the Member's average monthly cash
deposit to the Clearing Fund. As such, and as is currently the case,
Members that make greater use of NSCC's guaranteed services or which
have activity in those services that present greater risk to NSCC will
generally be subject to a larger Maintenance Fee because such Members
will typically be required to maintain larger Clearing Fund deposits
pursuant to the Rules.\13\ Conversely, Members that use NSCC's
guaranteed services less or which have activity that presents less risk
will generally be subject to a smaller Maintenance Fee because such
Members will typically be required to maintain smaller Clearing Fund
deposits pursuant to the Rules.\14\ The described changes do not adjust
that allocation. For this reason, NSCC believes the Maintenance Fee
will continue to be equitably allocated among Members.
---------------------------------------------------------------------------

    \13\ See Rule 4 and Procedure XV, Rules, supra note 5.
    \14\ Id.
---------------------------------------------------------------------------

    Similarly, NSCC believes that the Maintenance Fee will continue to
be a reasonable fee under the described changes. First, use of the IOER
rate in calculating the fee is reasonable because, as described above,
the IOER rate is (i) transparent, (ii) reliable, and (iii) impartial.
Second, use of the IOER rate, coupled with a ceiling of 0.25 percent,
will not only ensure that Members are not assessed an amount greater
than the original calculation, but that Members will be charged less at
times when the IOER rate is less than 0.25 percent. Third, instituting
a floor of

0.00 percent will avoid the unreasoned situation of NSCC having to pay
Members based on calculating the fee with a negative IOER rate.
Finally, although removal of the Waiver Provision means that Members
could be assessed a Maintenance Fee at times when they may not
otherwise have been assessed the fee, the removal of this provision
enables NSCC to collect needed revenue from the fee in almost any
economic environment. For this reason, NSCC believes the Maintenance
Fee will continue to be reasonable.
    Based on the forgoing, NSCC believes the proposed rule change is
consistent with Section 17A(b)(3)(D).\15\
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    \15\ 15 U.S.C. 78q-1(b)(3)(D).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    NSCC does not believe that the changes to the Maintenance Fee will
have an impact on competition. First, as described above, the
Maintenance Fee is charged ratably based on Members' use of NSCC's
guaranteed services, as reflected in Members' cash deposits to the
Clearing Fund. Thus, the fee is designed to be reflective of each
Member's individual activity at NSCC.
    Second, NSCC does not believe the changes to set a ceiling of 0.25
percent and a floor of 0.00 percent on the IOER rate used in
calculating the Maintenance Fee will have any impact on competition
because (i) a ceiling of 0.25 percent means that Members cannot be
assessed an amount greater than what could have been assessed under the
original calculation of the fee, and (ii) a floor of 0.00 percent means
that NSCC will not have to pay Members if the fee were to be calculated
with a negative IOER rate. In other words, both of these changes
maintain the status quo in how the fee operates in these two respects.
    Third, appreciating that the value of a dollar is not consistent
for each Member, the change to remove the Waiver Provision could be a
perceived burden on competition because Members could be assessed a fee
at a time when they would not otherwise have been under the original
calculation. However, the change to calculate the Maintenance Fee using
the month's average IOER rate, instead of the current fixed rate of
0.25 percent, could relieve a competitive burden or promote competition
because Members could be assessed a smaller fee than what may have been
assessed using the original calculation. Members could choose to direct
such savings to competitive aspects of their business. Therefore, in
making these two changes together, NSCC believes the competitive
aspects are possibly offsetting.
    Notwithstanding the above, if removal of the Waiver Position, and
the resulting imposition of the Maintenance Fee at a time when a Member
would not have otherwise been assessed the fee, would prove to be a
greater competitive burden for any one Member than the counterbalancing
aspects of calculating the fee using the month's average IOER rate,
instead of the current fixed rate of 0.25 percent, NSCC believes such a
burden would be necessary and appropriate. The burden would be
necessary because it is essential that NSCC offset some of its costs
and expenses with revenue generated from the Maintenance Fee. As
described above, not doing so could adversely affect NSCC's credit
ratings, which could further increase funding or, possibly, decrease
the availability of crucial liquidity resources for NSCC. The burden
would be appropriate because, as described above, the Maintenance Fee
is calculated, using a balanced formula, to assess a fee that is
reflective of the Member's use of NSCC's guaranteed services, so that
NSCC can defray some of its costs and expenses in providing those
services.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    NSCC has not received or solicited any written comments relating to
this proposal. NSCC will notify the Commission of any written comments
received by NSCC.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \16\ and paragraph (f) of Rule 19b-4
thereunder.\17\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NSCC-2020-011 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549.

All submissions should refer to File Number SR-NSCC-2020-011. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of NSCC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NSCC-2020-011 and should be submitted on
or before July 21, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-14008 Filed 6-29-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65821-65822]
[FR Doc No: 2019-25901]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0163]

Hospira, Inc., et al.; Withdrawal of Approval of Six Abbreviated
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of six abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of December 30, 2019.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040806.................  Mepivacaine           Hospira, Inc., 275
                               Hydrochloride (HCl)   North Field Dr.,
                               Injection USP, 3%,    Bldg. H, Lake
                               30 milligrams (mg)/   Forest, IL 60045.
                               milliliter (mL).

ANDA 077523.................  Fluconazole for Oral  IVAX
                               Suspension, 50 mg/5   Pharmaceuticals,
                               mL and 200 mg/5 mL.   Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 078772.................  Epinephrine and       Hospira, Inc.
                               Lidocaine HCl, 0.01
                               mg/mL; 2% and 0.02
                               mg/mL; 2%.
ANDA 079138.................  Articaine HCl and     Do.
                               Epinephrine
                               Bitartrate
                               Injection, 4%; EQ
                               0.017 mg base/1.7
                               mL, 4%; EQ 0.01 mg
                               base/mL.
ANDA 204236.................  Norethindrone         Aurobindo Pharma
                               Acetate Tablets, 5    Ltd., 279 Princeton-
                               mg.                   Hightstown Rd.,
                                                     East Windsor, NJ
                                                     08520.
ANDA 204421.................  Tramadol HCl          Do.
                               Extended-Release
                               Tablets, 100 mg,
                               200 mg, and 300 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
December 30, 2019. Approval of each entire application is withdrawn,
including any strengths or products inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on December 30, 2019 may continue to be dispensed
until the inventories have been depleted or the drug products have
reached their expiration dates or otherwise become violative, whichever
occurs first.

    Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25901 Filed 11-27-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 86 (Thursday, May 4, 2023)]
[Notices]
[Pages 28563-28564]
[FR Doc No: 2023-09490]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1553]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

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

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Vaccines and Related
Biological Products Advisory Committee (VRBPAC). The general function
of the committee is to provide advice and recommendations to FDA on
regulatory issues. On June 15, 2023, the committee will meet in open
session to discuss and make recommendations on the selection of
strain(s) to be included in the periodic updated COVID-19 vaccines for
the 2023-2024 vaccination campaign. The meeting will be open to the
public. FDA is establishing a docket for public comment on this
document.

DATES: The meeting will be held virtually on June 15, 2023, from 8:30
a.m. to 5 p.m. Eastern Time.

ADDRESSES: Please note that all meeting participants will be joining
this advisory committee meeting via an online teleconferencing
platform. The online web conference meeting will be available at the
following link on the day of the meeting: https://youtube.com/live/gBOyPREXGh8.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-1553. The docket will close on June 14,
2023. Either electronic or written comments on this public meeting must
be submitted by June 14, 2023. Please note that late, untimely filed
comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 14, 2023. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.
    Comments received on or before June 7, 2023, will be provided to
the committee. Comments received after June 7, 2023, and by June 14,
2023, will be taken into consideration by FDA. In the event that the
meeting is canceled, FDA will continue to evaluate any relevant
applications or information, and consider any comments submitted to the
docket, as appropriate. You may submit comments as follows:

Electronic Submissions

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

public, submit the comment as a written/paper submission and in the
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-1553 for ``Vaccines and Related Biological Products Advisory
Committee (VRBPAC); Notice of Meeting; Establishment of a Public
Docket; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sussan Paydar or Prabhakara Atreya,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD
20993-0002,<PHONE_NUMBER>, [email protected]; or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On June 15,
2023, the committee will meet in open session to discuss and make
recommendations on the selection of strain(s) to be included in the
periodic updated COVID-19 vaccines for the 2023-2024 vaccination
campaign. This discussion will include consideration of the vaccine
composition for fall to winter, 2023-2024.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the time of the
advisory committee meeting, and the background material will be posted
on FDA's website after the meeting. Background material is available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Dockets (see
ADDRESSES) on or before June 7, 2023, will be provided to the
committee. Comments received after June 7, 2023, and by June 14, 2023,
will be taken into consideration by FDA. Oral presentations from the
public will be scheduled between approximately 1 p.m. and 2 p.m.
Eastern Time. Those individuals interested in making formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, along with their names, email addresses, and direct contact
phone numbers of proposed participants, on or before 12 p.m. Eastern
Time on June 7, 2023. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by 6 p.m.
Eastern Time June 9, 2023.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Sussan Paydar or Prabhakara Atreya (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09490 Filed 5-3-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 12 (Thursday, January 18, 2018)]
[Notices]
[Pages 2723-2724]
[FR Doc No: 2018-00809]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described

herein. Each mode of transportation for which a particular special
permit is requested is indicated by a number in the ``Nature of
Application'' portion of the table below as follows: 1--Motor vehicle,
2--Rail freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-
carrying aircraft.

DATES: Comments must be received on or before February 20, 2018.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, Washington, DC
20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Approvals and Permits Division, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-30, 1200 New
Jersey Avenue Southeast, Washington, DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on January 12, 2018.
Donald Burger,
Chief, General Approvals and Permits Branch.

----------------------------------------------------------------------------------------------------------------
                                                                                Nature of the special permits
       Application No.                 Applicant          Regulation(s) affected              thereof
----------------------------------------------------------------------------------------------------------------
                                              SPECIAL PERMITS DATA
----------------------------------------------------------------------------------------------------------------
20598-N......................  Cylinder Testing          180.209(a), 180.209(b)..  To authorize the
                                Solutions LLC.                                      transportation in commerce
                                                                                of certain hazardous
                                                                                materials in DOT
                                                                                Specification 3AL cylinders
                                                                                manufactured from aluminum
                                                                                alloy 6061-T6 that are
                                                                                requalified every ten years
                                                                                rather than every five years
                                                                                using 100% ultrasound
                                                                                examination. (modes 1, 2)
20599-N......................  ALAMEDA COUNTY OFFICES..  172.320(a), 173.56(b)...  To authorize the
                                                                                transportation in commerce
                                                                                of lifesaving pyrotechnic
                                                                                marine signal devices to
                                                                                disposal by motor vehicle
                                                                                without the use of a
                                                                                manufacturers EX number.
                                                                                (mode 1)
20602-N......................  THE BOEING COMPANY......  173.1...................  To authorize the
                                                                                transportation in commerce
                                                                                of spacecraft containing
                                                                                certain hazardous materials
                                                                                in non-DOT specification
                                                                                packagings. (mode 1)
20603-N......................  FIBA TECHNOLOGIES, INC..  173.301(f)..............  To authorize the manufacture,
                                                                                mark, sale, and use of
                                                                                cylinders with pressure
                                                                                relief devices meeting the
                                                                                Fourteenth Edition of CGA S-
                                                                                1.1. (modes 1, 2, 3, 4)
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-00809 Filed 1-17-18; 8:45 am]
BILLING CODE 4909-60-P


[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Proposed Rules]
[Pages 76597-76598]
[FR Doc No: 2022-27184]

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

40 CFR Part 721

[EPA-HQ-OPPT-2021-0847; FRL-9972-03-OCSPP]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (22-
1.5e); Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; correction.

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

SUMMARY: EPA is issuing a correction to a proposed rule that published
in the Federal Register of Friday, December 2, 2022, in which EPA
proposed significant new use rules (SNURs) under the Toxic Substances
Control Act (TSCA) for chemical substances that were the subject of
premanufacture notices (PMNs) and are also subject to Orders issued by
EPA pursuant to TSCA. This document corrects an inadvertent error in
the Chemical Abstracts Service (CAS) Registry number identified for
Phosphonium, tributyl (2-methoxypropyl)-, salt with 1,1,2,2,3,3,4,4,4-
nonafluoro-N-methyl-1-butanesulfonamide (1:1) (PMN Number P-03-77).

DATES: Comments on the proposed rule must be received on or before
January 3, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0847, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
William Wysong, New Chemicals Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-4163; email address: [email protected].

SUPPLEMENTARY INFORMATION: EPA is correcting an inadvertent error in
the Chemical Abstracts Service (CAS) Registry number identified for
Phosphonium, tributyl (2-methoxypropyl)-, salt with 1,1,2,2,3,3,4,4,4-
nonafluoro-N-methyl-1-butanesulfonamide (1:1) (PMN Number P-03-77) in
the proposed rule that published in the Federal Register of Friday,
December 2, 2022 (87 FR 74072; FRL-9972-01-OCSPP), in which EPA
proposed significant new use rules (SNURs) under the Toxic Substances
Control Act (TSCA) for chemical substances that were the subject of
premanufacture notices (PMNs) and are also subject to Orders issued by
EPA pursuant to TSCA. EPA proposed to codify this SNUR as 40 CFR
721.11727.

Correction

    In FR Doc. 2022-26252 appearing on page 74072 in the Federal
Register of Friday, December 2, 2022, the following corrections are
made:
    1. On page 74079, in the first column, the phrase ``CAS or
Accession Number: CAS No. 332350-93-3.'' is corrected to read ``CAS or
Accession Number: CAS No. 332350-90-0.''
    2. On page 74088, in the first column, the proposed regulatory text
for 40 CFR 721.11727(a)(1) is corrected to read as follows:
    ``(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Phosphonium,
tributyl (2-

methoxypropyl)-, salt with 1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-
butanesulfonamide (1:1) (PMN P-03-77; CAS No. 332350-90-0) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.''

    Dated: December 9, 2022.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2022-27184 Filed 12-14-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 22, 2007 (Volume 72, Number 55)]
[Notices]
[Page 13490-13491]
[DOCID:fr22mr07-47]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

March 16, 2007.

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

    Docket Numbers: ER07-421-001.
    Applicants: Wisconsin Power and Light Company.
    Description: Wisconsin Power and Light Company submits a revised
Power Supply Agreement in compliance with FERC's 2/16/07 Order.
    Filed Date: 03/14/2007.
    Accession Number: 20070315-0084.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 04, 2007.

    Docket Numbers: ER07-612-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits
corrected tariff sheets for its Market Administration and Control Area
Services Tariff and its Open Access Transmission Tariff.
    Filed Date: 03/09/2007.
    Accession Number: 20070315-0086.
    Comment Date: 5 p.m. Eastern Time on Friday, March 23, 2007.

    Docket Numbers: ER07-613-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits certain amendments to the currently-effective ISO Tariff
designed to facilitate implementation of the Market Redesign and
Technology Upgrade Program.
    Filed Date: 03/09/2007.
    Accession Number: 20070315-0087.
    Comment Date: 5 p.m. Eastern Time on Friday, March 30, 2007.

    Docket Numbers: ER07-614-000.
    Applicants: American Transmission Systems, Incorporated.
    Description: American Transmission Systems, Inc submits a
Construction Agreement designated as Service Agreement 349, FERC
Electric Tariff, Second Revised Volume 1, effective 1/5/07.
    Filed Date: 03/09/2007.
    Accession Number: 20070315-0088.
    Comment Date: 5 p.m. Eastern Time on Friday, March 30, 2007.

    Docket Numbers: ER07-619-000.
    Applicants: NSTAR Electric Company.
    Description: NSTAR Electric Company submits the Cost Allocation
Agreement for Braintree Tap Upgrades between NSTAR and Braintree
Electric Light Department, designated as Rate Schedule 215.
    Filed Date: 03/14/2007.
    Accession Number: 20070315-0085.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 04, 2007.

    Any person desiring to intervene or to protest in any of the above
proceedings 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) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First, St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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 dockets(s). For assistance
with any FERC Online service, please e-mail

<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
 [FR Doc. E7-5204 Filed 3-21-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 15, 2007 (Volume 72, Number 220)]
[Proposed Rules]
[Page 64177-64179]
[DOCID:fr15no07-29]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[CGD08-06-010]
RIN 1625-AA09

Drawbridge Operation Regulations; Liberty Bayou, Slidell, LA

AGENCY: Coast Guard, DHS.

ACTION: Supplemental notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to change the operating schedule
for the State Route 433 (S433) pontoon span bridge across Liberty
Bayou, mile 2.0, at Slidell, St. Tammany Parish, Louisiana. The
proposed rule would allow the Louisiana Department of Transportation
and Development, owner of the bridge, to reduce the hours of manned
operation of the bridge in order to make more efficient use of
personnel and operating resources.

DATES: Comments and related material must reach the Coast Guard on or
before January 14, 2008.

ADDRESSES: You may mail comments and related material to Commander
(dpb), Eighth Coast Guard District, 500 Poydras Street, New Orleans,
Louisiana 70130-3310. The Commander, Eighth Coast Guard District,
Bridge Administration Branch maintains the public docket for this
rulemaking. Comments and material received from the public, as well as
documents indicated in this preamble as being available in the docket,
will become part of this docket and will be available for inspection or
copying at the Bridge Administration office between 7 a.m. and 3 p.m.,
Monday through Friday except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Phil Johnson, Bridge Administration
Branch, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related material. If you do so, please include your name
and address, identify the docket number for this rulemaking [CGD08-06-
010], indicate the specific section of this document to which each
comment applies, and give the reason for each comment. Please submit
all comments and related material in an unbound format, no larger than
8\1/2\ by 11 inches, suitable for copying. If you would like to know
they reached us, please enclose a stamped, self-addressed postcard or
envelope. We will consider all comments and material received during
the comment period. We may change this proposed rule in view of them.

Public Meeting

    We do not now plan to hold a public meeting. You may submit a
request for a meeting by writing to Commander, Eighth Coast Guard
District, Bridge Administration Branch at the address under ADDRESSES
explaining why one would be beneficial. If we determine that one would
aid this rulemaking, we will hold one at a time and place announced by
a later notice in the Federal Register.

Background and Purpose

    The Coast Guard previously published a Notice of Proposed
Rulemaking in the Federal Register [CGD08-06-010] on May 4, 2006 (86 FR
26290). The proposed rule would have changed the notice required for an
opening from 12 hours to 4 hours. The Coast Guard did not receive any
comments as a result of the Notice of Proposed Rulemaking, but a final
rule was not published. Subsequently, the bridge owner requested that
the operating regulation for the bridge again be revised so that the
bridge will open on signal, except that from 7 p.m. to 7 a.m., the
bridge will open on signal if at least 2 hours notice is given.
    The Louisiana Department of Transportation and Development has
requested that the operating regulation of the S433 pontoon span bridge
be changed in order to make more efficient use of operating resources.
Currently, the draw of the S433 Bridge opens on signal except that from
9 p.m. to 5 a.m. the draw will open on signal if at least 12 hours
notice is given, as required by 33 CFR 117.469.
    Traffic counts indicate that an average of 6000 vehicles cross the
bridge daily and approximately 1025, or 17.1% of those, cross between
the hours of 7 p.m. and 7 a.m. Bridge tender logs for a three-month
period show that the bridge opened 540 times, or an average of 6 times
per day, to pass vessels. Of those vessel openings during the three-
month period, 56, or 10.2% of them, were between the hours of 7 p.m.
and 7 a.m. Most of the boats requesting openings are recreational
fishing vessels, recreational powerboats and sailboats that routinely
transit this waterway and are able to give advance notice.
    Concurrent with the publication of the Notice of Proposed
Rulemaking, a Test Deviation [CGD08-07-032] has been issued to allow
the Louisiana Department of Transportation and Development to test the
proposed schedule and to obtain data and public comments. The test
period will be in effect during the entire Notice of Proposed
Rulemaking comment period. The Coast Guard will review the logs of the
drawbridge and evaluate public comments from this Supplemental Notice
of Proposed Rulemaking and the above referenced Test Deviation to
determine if a permanent special drawbridge operating regulation is
warranted.
    The Test Deviation allows the draw of the S433 Bridge to open on
signal, except that between 7 p.m. and 7 a.m. daily, the bridge will
open on signal if at least 2 hours notice is given.
    On November 24, 2006 a Coast Guard Bridge Permit was issued
approving the construction of a new swing span bridge to be constructed
to replace the existing pontoon span bridge. Upon completion of
construction, the new bridge will provide a vertical clearance of 7.59
feet above the 2% flow line. While this vertical clearance will
accommodate many small recreational boats, larger vessels will still
require an opening of the draw for passage. The schedule proposed in
this SNPRM would be carried over to this new bridge.

Discussion of Proposed Rule

    The proposed rule change to 33 CFR 117.469 would require that,
between the hours of 7 p.m. and 7 a.m., a 2-hour notice be given for
the Louisiana Department of Transportation and Development to open the
draw of the S433 Bridge. This change would reduce the amount of time
that a bridge tender would need to man the bridge, making more
efficient use of operating resources.

Regulatory Evaluation

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary.
    This conclusion is based on the fact that all vessel traffic will
still be able to transit through the bridge between 7 p.m. and 7 a.m.
after providing the two-hour advance notice for bridge openings.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities. This proposed rule would affect a limited
number of small entities. These entities include operators of
recreational fishing vessels, powerboats and sailboats using the
waterway. This proposed rule will have no impact on any small entities
because they are able to give notice prior to transiting through this
bridge and most vessel operators that require an opening are currently
providing advance notice.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact the Eighth Coast Guard District
Bridge Administration Branch at the address above. The Coast Guard will
not retaliate against small entities that question or complain about
this rule or any policy or action of the Coast Guard.

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

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

Energy Effects

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

Technical Standards

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

Environment

    We have analyzed this proposed rule under Commandant Instruction
M16475.lD and Department of Homeland Security Management Directive
5100.1, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination

that there are no factors in this case that would limit the use of a
categorical exclusion under section 2.B.2 of the Instruction.
Therefore, we believe that this rule should be categorically excluded,
under figure 2-1, (32)(e), of the Instruction, from further
environmental documentation. Under figure 2-1, paragraph (32)(e), an
``Environmental Analysis Check List'' or ``Categorical Exclusion
Determination'' is not required for this rule. Comments on this section
will be considered before we make the final decision on whether to
categorically exclude this rule from further environmental review.

List of Subjects in 33 CFR Part 117

    Bridges.

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

PART 117--DRAWBRIDGE OPERATION REGULATIONS

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

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

    2. Sec.  117.469 is revised to read as follows:

Sec.  117.469  Liberty Bayou.

    The draw of the S433 Bridge, mile 2.0 at Slidell, shall open on
signal, except that between 7 p.m. and 7 a.m., the draw shall open on
signal if at least 2 hours notice is given.

    Dated: November 6, 2007.
J.H. Korn,
Captain, U.S. Coast Guard, Acting Commander, 8th Coast Guard Dist.
[FR Doc. E7-22365 Filed 11-14-07; 8:45 am]

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[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Rules and Regulations]
[Pages 29039-29041]
[FR Doc No: 2022-09923]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-1030; Airspace Docket No. 21-ASW-10]
RIN 2120-AA66

Amendment of VOR Federal Airways V-47, V-54, V-69, V-94, V-140,
V-278, V-305, and Revocation of V-397; Southeastern United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends VHF Omnidirectional Range (VOR) Federal
airways V-47, V-54, V-140, V-278, V-305, and removes V-397, in
association with the Graceland VOR Minimum Operational Network (MON)
project in the southeastern United States. This action is necessary due
to the planned decommissioning of the following ground-based navigation
aids: Dyersburg, TN, (DYR) VOR Tactical Air Navigation (VORTAC);
Malden, MO, (MAW) VORTAC; Monticello, AR, (MON) VOR/Distance Measuring
Equipment (VOR/DME); and the Muscle Shoals, AL, (MSL) VORTAC. VOR
Federal airways V-69 and V-94 are removed from this docket action for
further planning and coordination.

DATES: Effective date 0901 UTC, July 14, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, 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 Rules and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

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
the 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 modify the route structure as necessary to
preserve the safe and efficient flow of air traffic within the National
Airspace System (NAS).

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA-2021-1030 in the Federal Register (86 FR 70776; December 13, 2021),
amending seven VOR Federal airways and removing one airway in the
southeastern United States. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal. No comments were received.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

Differences From the NPRM

    VOR Federal airways V-69 and V-94 are removed from this docket
action for further planning and coordination. They will be addressed in
a subsequent docket action at a later date.
    This rule includes changes to VOR Federal airways V-140, V-278, and
V-305 to enable ongoing review by the Department of Defense. So as to
avoid the premature removal of route segments, the three airways are
being revise to implement only those structural changes necessary due
to the scheduled decommissioning of the Dyersburg, TN (DYR) VORTAC;
Malden, MO (MAW) VORTAC; Monticello, AR (MON) VOR/DME; and the Muscle
Shoals, AL (MSL) VORTAC.
    As described below, V-140 is amended to retain the Walnut Ridge, AR
(ARG) VORTAC. A separate docket action removed the Kingfisher, OK (IFI)
VORTAC from the route. V-278 is amended to retain the segments between

the Greenville, MS (GLH) VOR/DME, and the Vulcan, AL (VUZ) VORTAC. V-
305 is amended to retain the segments between the Little Rock AR, (LIT)
VORTAC and the Walnut Ridge, AR (ARG) VORTAC.
    For clarification, V-47, V-54, and V-397 will remain as proposed in
the NPRM.
    Domestic VOR Federal airways are published in paragraph 6010(a) of
FAA Order JO 7400.11F, dated August 10, 2021 and effective September
15, 2021, which is incorporated by reference in 14 CFR 71.1. The VOR
Federal airways listed in this document will be subsequently published
in, or removed from FAA Order JO 7400.11.

The Rule

    The FAA is amending 14 CFR part 71 to amend VOR Federal airways V-
47, V-54, V-140, V-278, V-305, and to remove V-397, in support of the
FAA's VOR MON program. The route changes are described below.
    V-47: V-47 currently consists of two separate parts: From Pine
Bluff, AR, to Pocket City, IN; and From Cincinnati, KY, to Flag City,
OH. The FAA is removing the segments from Pine Bluff, AR, to Dyersburg,
TN. Therefore, the first part of V-47 extends from Cunningham, KY, to
Pocket City, IN. The second part of the route extends from Cincinnati,
KY to Flag City, OH, as currently charted.
    V-54: V-54 currently consists of two separate parts: From Waco, TX,
to Cedar Creek, TX; and From Texarkana, AR, to Kinston, NC. The FAA is
removing the segments from Marvell, AR, to Charlotte, NC. This change
configures V-54 into three parts: From Waco, TX, to Cedar Creek, TX;
From Texarkana, AR, to Little Rock, AR; and From Sandhills, NC, to
Kinston, NC.
    V-140: V-140 currently consists of two parts: From Panhandle, TX,
to London, KY; and from Bluefield, WV, to Casanova, VA. The NPRM
proposed removing the Walnut Ridge, AR, Dyersburg, TN, and Hazard, KY,
navigation aids from V-140. A separate docket action removed the
Kingfisher, OK, (IFI) VORTAC from the route. This rule retains the
Walnut Ridge VORTAC as part of V-140. As a result, V-140 consists of
the following four parts: From Panhandle, TX, to Burns Flat, OK; From
Tulsa, OK, to Walnut Ridge, AR; From Nashville, TN, to London, KY; and
From Bluefield, WV, to Casanova, VA
    V-278: V-278 currently consists of two parts: From Texico, NM, to
Plainview, TX; and from Bowie, TX, to Vulcan, AL. The NPRM proposed to
remove the segments from Monticello, AR, to Vulcan, AL. This rule
removes Monticello, AR from the route, but retains the segments from
Greenville, MS to Vulcan, AL. The first part of V-278 (from Texico to
Plainview) remains unchanged. The second part of the route is amended
as follows: From Bowie, TX; Bonham, TX; Paris, TX; Texarkana, AR; to
INT Texarkana 088[deg] and Eldorado, AR 034[deg] radials; From
Greenville, MS; Sidon, MS; Bigbee, MS; to Vulcan, AL.
    V-305: V-305 currently extends from El Dorado, AR, to Kokomo, IN.
The NPRM proposed to remove Walnut Ridge, AR, and Malden, MO, from the
route. This rule removes Malden, MO, but retains the segments from
Little Rock, AR, to Walnut Ridge, AR. As amended, V-305 consists of two
separate parts: From Eldorado, AR, to Walnut Ridge, AR; and From
Cunningham, KY, to Kokomo, IN.
    V-397: V-397 currently extends from Monroe, LA, to Marvell, AR. The
FAA is removing the entire route.
    Full route descriptions of the above routes are listed in ``The
Amendment'' section of this rule.
    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.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (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 only affects air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action of amending five VOR
Federal airways, and removing one airway, in the southeastern United
States qualifies for categorical exclusion under the National
Environmental Policy Act (42 U.S.C. 4321 et seq.) and its implementing
regulations at 40 CFR part 1500, and in accordance with FAA Order
1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-
6.5a, which categorically excludes from further environmental impact
review rulemaking actions that designate or modify classes of airspace
areas, airways, routes, and reporting points (see 14 CFR part 71,
Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic
Service Routes; and Reporting Points); and paragraph 5-6.5b, which
categorically excludes from further environmental impact review
``Actions regarding establishment of jet routes and Federal airways
(see 14 CFR 71.15, Designation of jet routes and VOR Federal airways) .
. .''. As such, this action is not expected to cause any potentially
significant environmental impacts. In accordance with FAA Order
1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA
has reviewed this action for factors and circumstances in which a
normally categorically excluded action may have a significant
environmental impact requiring further analysis. The FAA has determined
no extraordinary circumstances exist that warrant preparation of an
environmental assessment or environmental impact study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 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 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 JO
7400.11F Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-47 [Amended]

    From Cunningham, KY; to Pocket City, IN. From Cincinnati, KY;
Rosewood, OH; to Flag City, OH.
* * * * *

V-54 [Amended]

    From Waco, TX; to Cedar Creek, TX. From Texarkana, AR; INT
Texarkana 052[deg] and

Little Rock, AR, 235[deg] radials; to Little Rock. From Sandhills,
NC; INT Sandhills 146[deg] and Fayetteville, NC, 267[deg] radials;
Fayetteville; to Kinston, NC.
* * * * *

V-140 [Amended]

    From Panhandle, TX; to Burns Flat, OK. From Tulsa, OK;
Razorback, AR; Harrison, AR; to Walnut Ridge, AR; From Nashville,
TN; Livingston, TN; to London, KY. From Bluefield, WV; INT Bluefield
071[deg] and Montebello, VA, 250[deg] radials; Montebello; to
Casanova, VA.
* * * * *

V-278 [Amended]

    From Texico, NM; to Plainview, TX. From Bowie, TX; Bonham, TX;
Paris, TX; Texarkana, AR; to INT Texarkana 088[deg] and El Dorado,
AR 034[deg] radials; From Greenville, MS; Sidon, MS; Bigbee. MS; to
Vulcan, AL.
* * * * *

V-305 [Amended]

    From El Dorado, AR; Little Rock, AR; to Walnut Ridge, AR; From
Cunningham, KY; Pocket City, IN; INT Pocket City 046[deg] and
Hoosier, IN, 205[deg] radials; Hoosier; INT Hoosier 025[deg] and
Brickyard, IN, 185[deg] radials; Brickyard; INT Brickyard 038[deg]
and Kokomo, IN, 182[deg] radials; to Kokomo.
* * * * *

V-397 [Removed]

* * * * *

    Issued in Washington, DC, on May 3, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-09923 Filed 5-11-22; 8:45 am]
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