[Federal Register Volume 81, Number 130 (Thursday, July 7, 2016)]
[Notices]
[Pages 44357-44358]
[FR Doc No: 2016-16032]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78205; File No. SR-ICC-2016-009]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Filing of Proposed Rule Change To Revise the ICC Treasury Operations
Policies and Procedures

June 30, 2016.
    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 15, 2016, ICE Clear Credit LLC (``ICC'') 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 primarily by ICC. 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The purpose of proposed rule change is to revise the ICC Treasury
Operations Policies and Procedures to provide for the use of a
committed foreign exchange (``FX'') facility, to make changes to the
investment guidelines as well as additional clean-up changes, and to
provide additional clarification regarding the calculation of
collateral haircuts. These revisions do not require any changes to the
ICC Clearing Rules.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, ICC 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. ICC has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of these statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    ICC proposes changes to the ICC Treasury Operations Policies and
Procedures to provide for the use of a committed FX facility, to make
changes to the investment guidelines as well as additional clean-up
changes, and to provide additional clarification regarding the
calculation of collateral haircuts. ICC believes such revisions will
facilitate the prompt and accurate clearance and settlement of
securities transactions and derivative agreements, contracts, and
transactions for which it is responsible. The proposed revisions are
described in detail as follows.
    ICC has revised its Treasury Operations Policies and Procedures to
provide for the use of a committed FX facility. ICC has established a
committed FX facility which provides for same day settled spot FX
transactions. The facility allows ICC to use available United States
Dollars (``USD'') to convert into Euro to meet a Euro liquidity need,
for example in the unlikely event of a Clearing Participant default
when Euro is needed for liquidity but only USD is available. In
addition, the policy has been revised to document that the FX facility
will be tested twice a year.
    Additionally, ICC has revised its Treasury Operations Policies and
Procedures to make changes to the ICC Treasury Department investment
guidelines for operating capital and guaranty fund and margin cash. ICC
has updated the list of permitted investments to add short term US
Treasury securities (with a final maturity of no greater than 98 days)
and remove Money Market Mutual Funds. ICC has also updated its
investment policy for operating capital to include Treasury/agency
reverse repurchase (``repo'') agreements. ICC has updated the
governance section of the operating capital investment policy to note
that the Risk Committee will review any proposed changes to the policy
and make recommendations to the Board. Further, ICC has removed
reference to an obsolete financial report.
    ICC also has made additional clean-up changes throughout the
Treasury Operations Policies and Procedures. Specifically, ICC has
removed outdated language stating that ICC treasury services are
provided by The Clearing Corporation. Further, throughout the document,
ICC changed references to the ``Director of Operations'' to the ``Chief
Operating Officer,'' to correctly reflect the officer title. ICC
removed reference to specific reverse repo counterparties to reflect
the addition of multiple reverse repo counterparties. Further, ICC
notes that it has arrangements in place to settle tri-party and
bilateral reverse repo transactions, both of which settle delivery vs.
payment (``DVP''). As a result, ICC has clarified references throughout
the policy from ``DVP reverse repo'' to more specifically refer to
``bilateral reverse repo.'' ICC removed reference to the titles of
specific agreements that it may enter to effect reverse repo
transactions and added general language to encompass all agreements
that may be required. ICC removed information regarding the monitoring
of available liquidity resources and added reference to the ICC
Liquidity Risk Management Framework. ICC clarified that its committed
repo facility may be used to convert sovereign debt into cash and that
the facility will be tested twice per calendar year. ICC removed
outdated information under the ``ICE Clear Credit Banking
Relationships'' section of the policy and added language stating that
ICC endeavors to maintain banking relationships with highly
creditworthy and reliable bank institutions that provide operational
and strategic support with respect to holding margin and Guaranty Fund
cash and collateral. ICC also removed references to specific banking
counterparties, as ICC's banking relationships have expanded to include
multiple counterparties. ICC replaced the specific names with a generic
reference, to capture all counterparties utilized by ICC. ICC also
updated certain SWIFT banking information throughout the policy.
Further, ICC updated the list of applications used by the Treasury
Department to perform daily operations.
    Finally, ICC revised its Treasury Operations Policies and
Procedures to provide additional clarification regarding the
calculation of collateral haircuts when yield rates are less than or
equal to one basis point. This change documents current ICC practices
as related to collateral haircut calculation; there is no change to the
collateral haircut methodology.

    Section 17A(b)(3)(F) of the Act \3\ requires, among other things,
that the rules of a clearing agency be designed to promote the prompt
and accurate clearance and settlement of securities transactions and,
to the extent applicable, derivative agreements, contracts, and
transactions and to comply with the provisions of the Act and the rules
and regulations thereunder. ICC believes that the proposed revisions to
the ICC Treasury Operations Policies and Procedures are consistent with
the requirements of the Act and the rules and regulations thereunder
applicable to ICC, in particular, to section 17A(b)(3)(F),\4\ because
ICC believes that the proposed rule changes will facilitate the prompt
and accurate settlement of swaps and security-based swaps, and
contribute to the safeguarding of securities and funds associated with
swap and security-based swap transactions which are in the custody or
control of ICC or for which it is responsible.\5\ The changes to
provide for the use of a committed FX facility will enhance ICC's
liquidity resources, and the changes to the investment guidelines
ensure the reliable investment of assets in ICC's control with minimal
risk. The additional clean-up changes ensure that the documentation of
ICC's treasury arrangements remains up-to-date, clear, and transparent.
Similarly, the additional clarification regarding the calculation of
collateral haircuts promotes transparency of ICC's risk management
practices as related to collateral haircuts. As such, the proposed rule
changes will facilitate the prompt and accurate settlement of swaps and
contribute to the safeguarding of customer funds and securities within
the control of ICC within the meaning of section 17A(b)(3)(F) \6\ of
the Act.
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    \3\ 15 U.S.C. 78q-1(b)(3)(F).
    \4\ Id.
    \5\ The Commission has modified the text prepared by ICC as
agreed upon by ICC.
    \6\ Id.
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    In addition, the proposed revisions to the ICC Treasury Operations
Policies and Procedures are consistent with the relevant requirements
of Rule 17Ad-22.\7\ In particular, the use of a committed FX facility
further ensures that ICC maintains sufficient financial resources at
all times to meet the requirements set forth in Rule 17Ad-22(b)(3).\8\
Additionally, the changes to the investment guidelines result in
investment arrangements with minimal credit, market and liquidity
risks. Such changes are therefore reasonably designed to meet the
requirements of Rule 17Ad-22(d)(3).\9\ Finally, the additional clean-up
changes and clarification regarding the calculation of collateral
haircuts ensure ICC's governance arrangements remain clear and
transparent, consistent with the requirements of Rule 17AD-
22(d)(8).\10\
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    \7\ 17 CFR 240.17Ad-22.
    \8\ 17 CFR 240.17Ad-22(b)(3).
    \9\ 17 CFR 240.17Ad-22(d)(3).
    \10\ 17 CFR 240.17Ad-22(d)(8).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    ICC does not believe the proposed revisions would have any impact,
or impose any burden, on competition. The revisions to ICC's Treasury
Operations Policies and Procedures to provide for the use of a
committed FX facility, to make changes to the investment guidelines as
well as additional clean-up changes, and to provide additional
clarification regarding the calculation of collateral haircuts apply
uniformly across all CPs. Therefore, ICC does not believe the proposed
revisions impose any burden on competition that is inappropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments relating to the proposed rule changes have not
been solicited or received. ICC will notify the Commission of any
written comments received by ICC.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

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-ICC-2016-009 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-ICC-2016-009. 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 Web site (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 Web site 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 such filings will also be available
for inspection and copying at the principal office of ICE Clear Credit
and on ICE Clear Credit's Web site at https://www.theice.com/clear-credit/regulation.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-ICC-2016-009
and should be submitted on or before July 28, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-16032 Filed 7-6-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: July 28, 2008 (Volume 73, Number 145)]
[Notices]
[Page 43817-43818]
[DOCID:fr28jy08-132]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2008-0137]

Qualification of Drivers; Exemption Applications; Diabetes

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt fifty-six individuals
from its rule prohibiting persons with insulin-treated diabetes
mellitus (ITDM) from operating commercial motor vehicles (CMVs) in
interstate commerce. The exemptions will enable these individuals to
operate CMVs in interstate commerce.

DATES: The exemptions are effective July 28, 2008. The exemptions
expire on July 28, 2010.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room W64-224,
Department of Transportation, 1200 New Jersey Avenue, SE., Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's complete Privacy Act Statement in the
Federal Register (65 FR 19476, Apr. 11, 2000). This statement is also
available at http://Docketsinfo.dot.gov.

Background

    On June 11, 2008, FMCSA published a notice announcing receipt of
applications for exemption from the Federal diabetes standard from
fifty-six individuals, and requested comments from the public (73 FR
33144). The public comment period closed on July 10, 2008, and no
comments were received.
    FMCSA has evaluated the eligibility of the fifty-six applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current standard for diabetes in 1970
because several risk studies indicated that diabetic drivers had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The 2003

Notice (68 FR 52442) in conjunction with the November 8, 2005 (70 FR
67777), Federal Register Notice provides the current protocol for
allowing such drivers to operate CMVs in interstate commerce.
    These fifty-six applicants have had ITDM over a range of 1 to 33
years. These applicants report no hypoglycemic reaction that resulted
in loss of consciousness or seizure, that required the assistance of
another person, or that resulted in impaired cognitive function without
warning symptoms in the past 5 years (with one year of stability
following any such episode). In each case, an endocrinologist has
verified that the driver has demonstrated willingness to properly
monitor and manage his or her diabetes, received education related to
diabetes management, and is on a stable insulin regimen. Each driver
reported no other disqualifying conditions, including diabetes-related
complications. Each meets the vision standard at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the June 11, 2008, Federal Register
Notice (73 FR 33144). Therefore, they will not be repeated in this
notice.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. The exemption allows the applicants
to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision and
reviewed the treating endocrinologist's medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that exempting these applicants from the
diabetes standard in 49 CFR 391.41(b)(3) is likely to achieve a level
of safety equal to that existing without the exemption.

Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submits to FMCSA a quarterly monitoring
checklist completed by the treating endocrinologist as well as an
annual checklist with a comprehensive medical evaluation; (2) that each
individual reports to FMCSA within 2 business days of occurrence, all
episodes of severe hypoglycemia, significant complications, or
inability to manage diabetes; also, any involvement in an accident or
any other adverse event in a CMV or personal vehicle, whether or not
they are related to an episode of hypoglycemia; (3) that each
individual provide a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (4) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file, or keep a copy in his/her driver's qualification
file if he/she is self-employed. The driver must also have a copy of
the certification when driving, for presentation to a duly authorized
Federal, State, or local enforcement official.

Discussion of Comments

    FMCSA received no comments in this proceeding.

Conclusion

    After considering the comments to the docket, and based upon its
evaluation of the fifty-six exemption applications, FMCSA exempts,
Timothy R. Abraham, Mark A. Arndt, David D. Canady, William M. Camp,
Scott A. Cary, Eugene W. Clark, Jr., Jeffrey D. Crabtree, David C.
Crawford, David W. Dawley, Adam F. Demeter, Henry D. Dyer, Stephen E.
Foltz, Randall A. Ford, Larry A. Fritz, Clayton L. Funk, Bruce A. Gay,
Jarret L. Gerber, Frederick G. Gillespie, Jose L. Gonzales, Kevin
Gumbrell, Danny E. Helton, Robert G. Hemeon, Marcus L. Jackson, Richard
S. Jackson, William J. Jackson, Alan L. Johnson, Nathan S. Kelley,
Angela M. King, Scott M. Lowry, Ramon A. Mateo, Robert L. Mills, Jr.,
Richard Murphy, Edward F. Murray, Peter H. Palen, Jr., Travis L.
Ploman, Nicholas W. Pomnitz, Thomas G. Riley, Jr., Melvin D. Robertson,
Robert A. Roskamp, Brandon M. Ross, Ulysses A. Santiago, Jr., Jeremy S.
Samiec, Patrick D. Schiller, Bruce D. Schmoyer, Joseph E. Sobiech, John
J. Sorce, Donald J. Stabler, Ronald L. Stigall, Cory C. Struble, James
L. Swedenburg, Jr., Lawrence M. Tanner, Robert D. Tarkington, Richard
L. Thistle, Travis A. Udulutch, Joshua C. Webb, and Robert C. Whitney,
from the ITDM standard in 49 CFR 391.41(b)(3), subject to the
conditions listed under ``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid for two years unless revoked earlier by FMCSA. The exemption
will be revoked if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315. If the exemption is
still effective at the end of the 2-year period, the person may apply
to FMCSA for a renewal under procedures in effect at that time.

    Issued on: July 18, 2008.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
 [FR Doc. E8-17190 Filed 7-25-08; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Notices]
[Page 60852]
[FR Doc No: 2014-23961]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-1609]

Determination That LUPRON DEPOT (Leuprolide Acetate for Depot
Suspension), Injectable 3.75 Milligrams/Vial Was Not Withdrawn From
Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75
milligrams (mg)/vial, was not withdrawn from sale for reasons of safety
or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for LUPRON DEPOT (leuprolide
acetate for depot suspension), Injectable 3.75 mg/vial, if all other
legal and regulatory requirements are met. However, in considering
whether to file an ANDA for leuprolide acetate for depot suspension,
future applicants are advised that they may not be able to obtain
LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75
mg/vial, for bioequivalence testing because the product has not been
commercially available for a number of years. An ANDA applicant who is
unable to obtain LUPRON DEPOT (leuprolide acetate for depot
suspension), Injectable 3.75 mg/vial, for bioequivalence testing should
contact the Office of Generic Drugs for a determination of what is
necessary to show bioavailability and the same therapeutic effect.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products with Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161). FDA may not approve an ANDA that does not refer
to a listed drug.
    LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable
3.75 mg/vial, is the subject of NDA2001, held by Abbvie Endocrine, Inc.
(Abbvie), and initially approved on October 22, 1990. LUPRON DEPOT is
indicated for management of endometriosis, including pain relief and
reduction of endometriotic lesions. LUPRON DEPOT, concomitantly with
iron therapy, is also indicated for the preoperative hematologic
improvement of patients with anemia caused by uterine leiomyomata.
    In a report dated December 15, 1999, Abbvie notified FDA that
LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75
mg/vial, was being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
    Terri Nataline, on behalf of Lachman Consultant Services, Inc.,
submitted a citizen petition dated November 25, 2013 (Docket No. FDA-
2013-P-1609), under 21 CFR 10.30, requesting, in part, that the Agency
determine whether LUPRON DEPOT, Injectable 3.75 mg/vial, was withdrawn
from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that LUPRON DEPOT, Injectable 3.75 mg/vial, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that LUPRON DEPOT,
Injectable 3.75 mg/vial, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of LUPRON DEPOT, Injectable 3.75 mg/vial,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have reviewed the
available evidence and determined that the products were not withdrawn
from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list LUPRON DEPOT,
Injectable 3.75 mg/vial, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to LUPRON DEPOT, Injectable 3.75 mg/
vial, may be approved by the Agency as long as they meet all other
legal and regulatory requirements for the approval of ANDAs. If FDA
determines that labeling for these drug products should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23961 Filed 10-7-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Rules and Regulations]
[Pages 21883-21885]
[FR Doc No: 2018-10044]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0387]
RIN 1625-AA00

Safety Zone; Barge PFE-LB444, San Joaquin River, Blackslough
Landing, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the San Joaquin River due to an unstable, partially
submerged barge with hull number PFE-LB444. The temporary safety zone
is needed to protect personnel, vessels, and the marine environment
from potential hazards created by the barge and associated recovery
efforts. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by the Captain of the Port San
Francisco.

DATES: This rule is effective without actual notice from May 11, 2018
until May 31, 2018. For the purposes of enforcement, actual notice will
be used from May 7, 2018 until May 11, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0387 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Junior Grade Emily K. Rowan, U.S. Coast Guard
Sector San Francisco; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because of the emergent nature of the
situation. Notice and comment procedures would be impracticable because
immediate action is needed protect personnel, vessels, and the marine
environment from potential hazards associated with the barge and
associated recovery efforts.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For the reasons stated above,
delaying the effective date of the rule would be impracticable.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Department
of Homeland Security Delegation No. 0170.1, which collectively
authorize the Coast Guard to establish safety zones. The Captain of the
Port San Francisco (COTP) has determined that potential hazards
associated with the barge and associated recovery efforts will be a
safety concern for anyone within a 90-yard radius of the barge. This
rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the safety zone.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from May 7, 2018
through May 31, 2018. The safety zone will cover all navigable waters
within 90 yards of the unstable barge and associated recovery efforts
centered in approximate position 37[deg] 59' 41.88'' N, 121[deg] 25'
8.88'' W (NAD 83). The effect of the temporary safety zone is intended
to protect personnel, vessels, and the marine environment in these
navigable waters from potential hazards associated with the barge and
associated recovery efforts. No vessel or person will be permitted to
enter the safety zone without obtaining permission from the COTP or a
designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the limited
duration and narrowly tailored geographic area of the safety zone.
Although this rule restricts access to the waters encompassed by the
safety zone, the effect of this rule will not be significant because
the local waterway users will be notified via

public Broadcast Notice to Mariners to ensure the safety zone will
result in minimum impact. The entities most likely to be affected are
waterfront facilities, commercial vessels, and pleasure craft engaged
in recreational activities.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule may affect the following entities, some of which may be
small entities: owners and operators of waterfront facilities,
commercial vessels, and pleasure craft engaged in recreational
activities and sightseeing, if these facilities or vessels are in the
vicinity of the safety zone at times when this zone is being enforced.
This rule will not have a significant economic impact on a substantial
number of small entities for the following reasons: (i) this rule will
encompass only a small portion of the waterway for a limited period of
time, and (ii) the maritime public will be advised in advance of these
safety zones via Broadcast Notice to Mariners.
    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 rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, which guides the Coast Guard in complying
with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-
4370f), and have determined that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This rule involves safety zones of
limited size and duration. It is categorically excluded from further
review under Categorical Exclusion L60(d) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental
Consideration supporting this determination will be prepared and
submitted after issuance or publication in accordance with DHS
Instruction Manual 023-01-001-01, Rev. 01.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T11-924 to read as follows:

Sec.  165.T11-924   Safety Zone; Barge PFE-LB444, San Joaquin River,
Blackslough Landing, CA.

    (a) Location. The following area is a safety zone: all navigable
waters within 90 yards of the unstable, partially submerged barge and
associated recovery efforts centered in approximate position 37[deg]
59' 41.88'' N, 121[deg] 25' 8.88'' W (NAD 83).
    (b) Enforcement period. The zone described in paragraph (a) of this
section will be enforced from May 7, 2018 through May 31, 2018. The
Captain of the Port San Francisco (COTP) will notify the maritime
community of periods during which these zones will be enforced via
Broadcast Notice to Mariners in accordance with Sec.  165.7.
    (c) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer

on a Coast Guard vessel or a Federal, State, or local officer
designated by or assisting the COTP in the enforcement of the safety
zone.
    (d) Regulations. (1) Under the general regulations in subpart C of
this part, entry into, transiting or anchoring within this safety zone
is prohibited unless authorized by the COTP or the COTP's designated
representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or a designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or a designated representative to obtain
permission to do so. Vessel operators given permission to enter or
operate in the safety zone must comply with all directions given to
them by the COTP or a designated representative. Persons and vessels
may request permission to enter the safety zones on VHF-23A or through
the 24-hour Command Center at telephone<PHONE_NUMBER>.

    Dated: May 7, 2018.
Anthony J. Ceraolo,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
[FR Doc. 2018-10044 Filed 5-10-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Notices]
[Pages 65700-65701]
[FR Doc No: 2012-26578]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2012-0026]

Notice of Request for Comments on the Scope of Future Revisions
to ``Criteria for Preparation and Evaluation of Radiological Emergency
Response Plans and Preparedness in Support of Nuclear Power Plants''
(NUREG-0654/FEMA-REP-1, Rev. 1)

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency (FEMA) is soliciting
comments from stakeholders and interested members of the public on the
scope of future revisions to ``Criteria for Preparation and Evaluation
of Radiological Emergency Response Plans and Preparedness in Support of
Nuclear Power Plants,'' (NUREG-0654/FEMA-REP-1, Rev. 1). In association
with this request for comments, FEMA and the Nuclear Regulatory
Commission (NRC) held two public meetings on August 22, 2012 and
September 13, 2012.

DATES: Written comments must be submitted to FEMA by January 31, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. FEMA-2012-
0026, by one of the following methods:
    [ssquf] Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
    [ssquf] Mail/Hand Delivery/Courier: FEMA, Regulatory Affairs
Division, Office of Chief Counsel, 500 C Street SW., Room 840,
Washington, DC 20472-3100.
    Instructions: Direct your comments to Docket ID No. FEMA-2012-0026.
All submissions received must include the agency name and docket ID.
Regardless of the method used for submitting comments or material, all
submissions will be posted, without change, to the Federal e-Rulemaking
Portal at http://www.regulations.gov, and will include any personal
information you provide. Therefore, submitting this information makes
it public. Please be aware that anyone is able to search the electronic
form of all comments received into any of our dockets by the name of
the individual who submitted the comment (or signed the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may want to review the Federal Docket Management System of records
notice published in the Federal Register on March 24, 2005 (70 FR
15086).
    Do not submit comments that include trade secrets, confidential
commercial or financial information to the public regulatory docket.
Comments containing this type of information should be appropriately
marked as containing such information and submitted by mail to the
address specified in the ADDRESSES section of this notice. If FEMA
receives a request to examine or copy this information, FEMA will treat
it as any other request under the Freedom of Information Act (FOIA), 5
U.S.C. 552, and the Department of Homeland Security (DHS)'s FOIA
regulation found in 6 Code of Federal Regulations (CFR) Part 5 and
FEMA's regulations found in 44 CFR Part 5.
    Docket: For access to the docket to read background documents or
comments received, go to the Federal eRulemaking Portal at http://www.regulations.gov, click on ``Advanced Search,'' then enter ``FEMA-
2012-0026'' in the ``By Docket ID'' box, then select ``FEMA'' under
``By Agency,'' and then click ``Search.'' Submitted comments may also
be inspected at FEMA, Office of Chief Counsel, Room 835, 500 C Street
SW., Washington, DC 20472.

FOR FURTHER INFORMATION CONTACT: Vanessa Quinn, Radiological Emergency
Preparedness Branch Chief, Radiological Emergency Preparedness Branch,
Technological Hazards Division, National Preparedness Directorate,
Federal Emergency Management Agency; Phone Number:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FEMA, working with the Nuclear Regulatory
Commission (NRC), is soliciting comments from stakeholders and
interested members of the public on the scope of future revisions to
``Criteria for Preparation and Evaluation of Radiological Emergency
Response Plans and Preparedness in Support of Nuclear Power Plants,''
NUREG-0654/FEMA-REP-1, Rev. 1. The document is available online at
http://www.regulations.gov (Docket ID FEMA-2012-0026).
    NUREG-0654/FEMA-REP-1, Rev.1 is a joint FEMA/NRC policy document
that provides guidance on the sixteen Planning Standards referenced in
FEMA's regulations at 44 CFR 350.5 and the NRC's regulations at 10 CFR
part 50. Both agencies use these Planning Standards to evaluate the
adequacy of the emergency plans of commercial nuclear power plant
owners and operators (NRC), and the emergency plans and preparedness of
State and local governments within the Emergency Planning Zones
surrounding commercial nuclear power plants (FEMA).
    Since the publication of NUREG-0654/FEMA-REP-1, Rev.1 in November
1980, four supplementary documents and one addendum have been issued
that update and modify specific planning and procedural elements. These
documents are available online at http://www.regulations.gov (Docket ID
FEMA-2012-0026). FEMA and the NRC are considering revising NUREG-0654/
FEMA-REP-1, Rev.1 to address stakeholder interest and the various
emergency planning and preparedness lessons learned since its initial
publication.
    FEMA and the NRC held two public meetings on August 22, 2012 and

September 13, 2012. (77 FR 46766, August 6, 2012). The purpose of these
public meetings was to: (1) Solicit input from stakeholders and
interested members of the public on the scope of future revisions to
NUREG-0654/FEMA-REP-1, Rev.1; (2) describe the proposed timeline for
the revisions to NUREG-0654/FEMA-REP-1, Rev.1; and (3) promote
transparency, public participation, and collaboration during the NUREG-
0654/FEMA-REP-1, Rev.1 revision process. All of the presentation
material and meeting notes are available to review online at http://www.regulations.gov (Docket ID FEMA-2012-0026).
    Through this Notice, we are soliciting comments from stakeholders
and interested members of the public on the scope of future revisions
to NUREG-0654/FEMA-REP-1, Rev.1. While not limited to these specific
areas, we are soliciting comments on the following issues related to
NUREG-0654/FEMA-REP-1, Rev.1 revision:
     Format and Terminology: various e-formats, clean-up edits,
and web-based software.
     Policy and Legal Frameworks: National Response Frameworks,
National Incident Management System (NIMS), emergency preparedness (EP)
rulemaking issues, NRC Commission papers, lessons learned from the
Fukushima-Daiichi nuclear power plant accident, and Presidential Policy
Directive 8 (PPD-8).
     Engineering: evacuation time estimates (ETEs), Alert and
Notification Systems (ANS), State-of-the-Art Reactor Consequence
Analyses (SOARCA), Joint Information Centers (JICs), Joint Information
Systems (JIS), messaging (including risk communication), social media,
expanding emergency planning zones (EPZs).
     Health Physics: protective action recommendations (PARs),
radiological laboratories, monitoring/decontamination, dose assessment,
recovery/re-entry/return, portal monitors, potassium iodide (KI), and
monitoring and decontamination of household pets.
     Operational: letters of agreement (LOAs), mobilization,
memorandums of understandings (MOUs), staffing, authorities, protective
action decisions (PADs).
     Training and Implementation: implementation timeline,
deadlines, updating courses, credentialing.
     Assessments: exercises, plan reviews, inspections, call-in
drills, report-in drills.
     Miscellaneous: additional items that are not defined in
any of the specified category areas.

    Dated: October 23, 2012.
Timothy W. Manning,
Deputy Administrator, Protection and National Preparedness, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2012-26578 Filed 10-29-12; 8:45 am]
BILLING CODE 9110-21-P


[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Rules and Regulations]
[Pages 28852-28853]
[FR Doc No: 2020-10157]

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

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0002; Airspace Docket No. 19-ACE-10]
RIN 2120-AA66

Amendment of VOR Federal Airways V-125, V-178, V-313, and V-429
in the Vicinity of Cape Girardeau, MO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends VHF Omnidirectional Range (VOR) Federal
airways V-125, V-178, V-313, and V-429 in the vicinity of Cape
Girardeau, MO. The modifications are necessary due to the planned
decommissioning of the VOR portion of the Cape Girardeau, MO, VOR/
Distance Measuring Equipment (VOR/DME) navigation aid (NAVAID), which
provides navigation guidance for portions of the affected airways. The
Cape Girardeau VOR is being decommissioned as part of the FAA's VOR
Minimum Operational Network (MON) program.

DATES: Effective date 0901 UTC, July 16, 2020. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11D, 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>. The Order is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of FAA Order 7400.11D at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, 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.

History

    The FAA published a notice of proposed rulemaking (NPRM) for Docket
No. FAA-2020-0002 in the Federal Register (85 FR 3299; January 21,
2020), amending VOR Federal airways V-125, V-178, V-313, and V-429 in
the vicinity of Cape Girardeau, MO, due to the planned decommissioning
of the VOR portion of the Cape Girardeau, MO, VOR/DME. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal. No comments were received.
    Subsequent to the NPRM, the FAA published a rule for Docket No.
FAA-2020-0008 in the Federal Register (85 FR 26601; May 5, 2020),
amending VOR Federal airway V-178 by removing the airway segment
between the Cunningham, KY, VOR/DME and the New Hope, KY, VOR/DME. The
airway amendment, effective July 16, 2020, is included in this rule.
    VOR Federal airways are published in paragraph 6010(a) of FAA Order
7400.11D dated August 8, 2019, and effective September 15, 2019, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal airways
listed in this document will be subsequently published in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The FAA is amending Title 14 Code of Federal Regulations (14 CFR)
part 71 by modifying VOR Federal airways V-125, V-178, V-313, and V-
429. The planned decommissioning of the VOR portion of the Cape
Girardeau, MO, VOR/DME NAVAID has made this action necessary. The VOR
Federal airway changes are outlined below.
    V-125: V-125 extends between the Cape Girardeau, MO, VOR/DME and
the St Louis, MO, VOR/Tactical Air Navigation (VORTAC). The NIKEL fix
in the airway description is amended to describe it as the intersection
of the Farmington, MO, VORTAC 046[deg] and Marion, IL, VOR/DME 282[deg]
radials. Additionally, the airway segment overlying the Cape Girardeau,
MO, VOR/DME between the Cape Girardeau, MO, VOR/DME and the
intersection of the Farmington, MO, VORTAC 046[deg] and Marion, IL,
VOR/DME 282[deg] radials (NIKEL fix) is removed. The unaffected portion
of the existing airway remain as charted.
    V-178: V-178 extends between the Hallsville, MO, VORTAC and the
Cunningham, KY, VOR/DME; and between the New Hope, KY, VOR/DME and the
Bluefield, WV, VOR/DME. The airway segment overlying the Cape
Girardeau, MO, VOR/DME between the Farmington, MO, VORTAC and the
Cunningham, KY, VOR/DME is removed. The unaffected portions of the
existing airway remain as charted.
    V-313: V-313 extends between the Malden, MO, VORTAC and the
Pontiac, IL, VOR/DME. The airway segment overlying the Cape Girardeau,
MO, VOR/DME between the Malden, MO, VORTAC and the Centralia, IL,
VORTAC is removed. The unaffected portions of the existing airway
remain as charted.
    V-429: V-429 extends between the Cape Girardeau, MO, VOR/DME and
the Bible Grove, IL, VORTAC; and between the Champaign, IL, VORTAC and
the Joliet, IL, VOR/DME. The airway segment overlying the Cape
Girardeau, MO, VOR/DME between the Cape Girardeau, MO, VOR/DME and the
Marion, IL, VOR/DME is removed. The unaffected portions of the existing
airway remain as charted.
    All radials in the route descriptions below are stated in True
degrees.

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 modifying VOR Federal
airways V-125, V-178, V-313, and V-429, due to the planned
decommissioning of the VOR portion of the Cape Girardeau, MO, VOR/DME
NAVAID, qualifies for categorical exclusion under the National
Environmental Policy Act 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). As such, this action is not expected to result in 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
that 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).

Adoption of 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 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019 and
effective September 15, 2019, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-125 [Amended]

    From INT Farmington, MO, 046[deg] and Marion, IL, 282[deg]
radials; to St Louis, MO.
* * * * *

V-178 [Amended]

    From Hallsville, MO; INT Hallsville l83[deg] and Vichy, MO,
32l[deg] radials; Vichy; to Farmington, MO. From New Hope, KY;
Lexington, KY; to Bluefield, WV.
* * * * *

V-313 [Amended]

    From Centralia, IL; Adders, IL; to Pontiac, IL.
* * * * *

V-429 [Amended]

    From Marion, IL; INT Marion 011[deg] and Bible Grove, IL,
207[deg] radials; to Bible Grove. From Champaign, IL; Roberts, IL;
to Joliet, IL.
* * * * *

    Issued in Washington, DC.
Scott M. Rosenbloom,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2020-10157 Filed 5-13-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: December 20, 2010 (Volume 75, Number 243)]
[Rules and Regulations]
[Page 79304-79308]
[DOCID:fr20de10-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 262

[EPA-HQ-RCRA-2003-0012; FRL-9240-5]

Technical Corrections to the Standards Applicable to Generators
of Hazardous Waste; Alternative Requirements for Hazardous Waste
Determination and Accumulation of Unwanted Material at Laboratories
Owned by Colleges and Universities and Other Eligible Academic Entities
Formally Affiliated With Colleges and Universities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action for six technical
corrections to an alternative set of hazardous waste generator
requirements known as the ``Academic Laboratories rule'' or ``Subpart
K'' which is applicable to laboratories owned by eligible academic
entities. These changes correct errors published in the Academic
Laboratories Final rule, including omissions and redundancies, as well
as remove an obsolete reference to the Performance Track program, which
has been terminated. These technical corrections will improve the
clarity of the Academic Laboratories rule.

DATES: This rule is effective on March 7, 2011 without further notice,
unless EPA receives adverse comment by January 19, 2011. If EPA
receives adverse comment, we will publish a timely withdrawal in the
Federal Register informing the public that the specific amendments in
this Direct Final rule for which the Agency received adverse comment
will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2003-0012 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: RCRA Docket, Environmental Protection Agency,
Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC 20460. 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-HQ-2003-
0012. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://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 http://
www.regulations.gov or e-mail. The http://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 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. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/
dockets.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the RCRA Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
RCRA Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kristin Fitzgerald, Office of Resource
Conservation and Recovery, (5304P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460;<PHONE_NUMBER>;
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Why is EPA using a direct final rule?

    EPA is publishing this rule without a prior Proposed rule because
we view this as a noncontroversial action and anticipate no adverse
comment since the changes are minor and consistent with the preamble
language from the Final rule of December 1, 2008 (73 FR 72912).
However, in the ``Proposed Rules'' section of today's Federal Register,
we are publishing a separate document that will serve as the Proposed
rule to amend 40 CFR Part 262, Subpart K if adverse comments are
received on this Direct Final rule. We will not institute a second
comment period on this action. Any parties interested in commenting
must do so at this time. For further information about commenting on
this rule, see the ADDRESSES section of this document.
    If EPA receives adverse comment, we will publish a timely
withdrawal in the Federal Register to notify the public that those
specific amendments in this Direct Final rule for which the Agency
received adverse comment will not take effect, and the reason for such
withdrawal. We would address all public comments in a subsequent Final
rule based on the Proposed rule.

Does this action apply to me?

    This Direct Final rule amends Subpart K of 40 CFR part 262.
Entities potentially affected by this action are any of the following
which generate hazardous waste in laboratories: (1) Colleges and
universities; (2) non-profit research institutes that are either owned
by or have a formal written affiliation agreement with a college or
university; and (3) teaching hospitals that are either owned by or have
a formal written affiliation agreement with a college or university.

                     NAICS Codes of Entities Potentially Affected by this Direct Final Rule
----------------------------------------------------------------------------------------------------------------
                               NAICS codes                                       Description of NAICS code
----------------------------------------------------------------------------------------------------------------
Colleges & Universities:
    6112, 61121, 611210.................................................  Junior Colleges.
    6113, 61131, 611310.................................................  Colleges, Universities, and
                                                                           Professional Schools.
    6115, 61151.........................................................  Technical and Trade Schools.
    611519..............................................................  Other Technical and Trade Schools.
    61161, 611610.......................................................  Fine Arts Schools.
Teaching Hospitals:
    54194, 541940.......................................................  Veterinary Services (Animal
                                                                           Hospitals).
    622.................................................................  Hospitals.
    6221, 62211, 622110.................................................  General Medical and Surgical
                                                                           Hospitals.
    6222, 62221, 622210.................................................  Psychiatric and Substance Abuse
                                                                           Hospitals.
    6223, 62231, 622310.................................................  Specialty (except Psychiatric and
                                                                           Substance Abuse) Hospitals.
Non-profit Research Institutes:
    5417, 54171, 541710.................................................  Research and Development in the
                                                                           Physical, Engineering, and Life
                                                                           Sciences.
    54172, 541720.......................................................  Research and Development in the Social
                                                                           Sciences and Humanities.
----------------------------------------------------------------------------------------------------------------

What should I consider as I prepare my comments for EPA?

    A. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information on a disk
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
as CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in

accordance with the procedures set forth in 40 CFR part 2.
    B. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible.
     Make sure to submit your comments by the comment period
deadline identified.

Preamble Outline

I. Statutory Authority
II. Explanation of Changes
III. State Authorization
    A. Applicability of Rules in Authorized States
    B. Effect on State Authorization
IV. Statutory and Executive Order Reviews
    A. Regulatory Flexibility Act
    B. Congressional Review Act

I. Statutory Authority

    These regulations are promulgated under the authority of Sec. Sec.
2002, 3001, 3002, and 3004 of the Solid Waste Disposal Act (SWDA) of
1970, as amended by the Resource Conservation and Recovery Act (RCRA)
of 1976, as amended by the Hazardous and Solid Waste Amendments of 1984
(HSWA), 42 U.S.C. 6921, 6922, 6923, and 6924.

II. Explanation of Changes

    In today's Direct Final rule, there are six technical corrections
to the final Academic Laboratories rule (also referred to as Subpart
K), which was published in the Federal Register on December 1, 2008 (73
FR 72912).
    The first two corrections in today's Direct Final rule are to the
definition of ``central accumulation area,'' which is in the section of
the Academic Laboratories Final rule entitled Definitions for this
subpart (Sec.  262.200). First, in the Academic Laboratories Final
rule, the definition of ``central accumulation area'' included a
reference to the RCRA hazardous waste generator regulations for what
are typically called ``large quantity generators.'' The regulatory
reference that was included in the Academic Laboratories Final rule was
Sec.  262.34(a). However, large quantity generators are also subject to
Sec.  262.34(b), if they accumulate hazardous waste for more than 90
days. In the Academic Laboratories Final rule, we inadvertently omitted
that additional regulatory reference for large quantity generators;
therefore, we are adding it in today's Direct Final rule.
    Second, the definition of ``central accumulation area'' included a
reference to the RCRA hazardous waste generator regulations for
Performance Track members (specifically Sec.  262.34(j) and (k)) in
order to indicate that eligible academic entities that were Performance
Track members were eligible to use the Academic Laboratories rule.
However, after the Academic Laboratories rule became final, EPA's
Performance Track program was terminated (74 FR 22742). Therefore, we
are removing the parenthetical statement from the definition of
``central accumulation area'' that references the generator regulations
specifically for Performance Track members, since the reference is now
moot.
    The third correction in today's Direct Final rule is in the section
of the Academic Laboratories Final rule entitled Labeling and
management standards for containers of unwanted material in the
laboratory (Sec.  262.206). The regulatory text of the Final rule
requires that containers of unwanted material be kept closed at all
times, with three exceptions. One of the exceptions to the ``closed
container rule'' is when adding, removing or consolidating unwanted
material (Sec.  262.206(b)(3)(i)). In this instance, we use the term
``consolidating'' to mean combining the contents of several containers
into a single container. This is often also referred to as ``bulking.''
    In the preamble to the Final rule (see page 72937), we used the
term ``consolidation'' in a different sense. In this instance, we used
the term ``consolidation'' to mean moving containers of unwanted
material from one laboratory to another laboratory, such that
containers from multiple laboratories can be collected or
``consolidated'' to accumulate in one laboratory. Under this use of the
term, the contents of the containers remain in their original
containers, but the location of the containers changes. To eliminate
confusion caused by using the same term in two different ways, in Sec.
262.206(b)(3)(i), we are changing the term ``consolidating'' to
``bulking.''
    The fourth correction in today's Direct Final rule is in the
section of the Academic Laboratories Final rule entitled ``Making the
hazardous waste determination at an on-site interim status or permitted
treatment, storage or disposal facility'' (Sec.  262.212). Under
paragraph (e)(1) of that section, if an unwanted material is a
hazardous waste, an eligible academic entity must ``Write the words
``hazardous waste'' on the container label that is affixed or attached
to the container * * *'' In a parenthetical following the quoted text,
we inadvertently included the phrase ``(or on the label that is affixed
or attached to the container, if that is preferred).'' This
parenthetical is repetitive of the text immediately preceding it in
paragraph (e)(1); therefore we are amending paragraph Sec.
262.212(e)(1) to eliminate the redundant parenthetical phrase.
    The last two corrections in today's Direct Final rule are in the
``Laboratory management plan'' (LMP) section of the Academic
Laboratories rule (Sec.  262.214). Specifically, eligible academic
entities that choose to opt into Subpart K are required to have a
written LMP with two parts, and a total of nine elements. Part I of the
LMP must contain two elements, while Part II of the LMP must contain
seven elements.
    The fifth correction in today's Direct Final rule is in the first
element of Part I of the LMP (Sec.  262.214(a)(1)). The preamble to the
Academic Laboratories Final rule makes it clear that we intended the
first element of Part I of the LMP to include just two items, but the
regulatory language inadvertently made it seem like those two items
were just part of the requirement, rather than the entire requirement.
Therefore, in Sec.  262.214(a)(1), we are replacing the word
``including'' with the words ``as follows'' in order to make clear our
intent. In fact, it is in the first element of Part II of the LMP
(Sec.  262.214(b)(1)) that eligible academic entities must include
their best intended practices for container labeling and management
that go beyond the two items required in the first element of Part I.
    The sixth correction in today's Direct Final rule is in the first
element of Part II of the LMP (Sec.  262.214(b)(1)). When the Academic
Laboratories rule was proposed (71 FR 29712), EPA did not specifically
address in-line containers in the container management standards in
Sec.  262.206(b). In the Final rule, we added Sec.
262.206(b)(3)(iii)(A) to the container management standards, which
specifically addresses the management of in-line containers by allowing
venting

of a container when it is necessary for the proper operation of
laboratory equipment, such as with in-line collection of unwanted
materials from high performance liquid chromatographs.
    When Sec.  262.206(b)(3)(iii)(A) was added, we neglected to
eliminate the redundant requirement that addresses in-line containers
in the first element of Part II of the LMP regulations (Sec.
262.214(b)(1)). Therefore, we are eliminating the redundant language
today.

III. State Authorization

A. Applicability of Rules in Authorized States

    Under Sec.  3006 of RCRA, EPA may authorize a qualified State to
administer its own hazardous waste program within the State in lieu of
the Federal program. Following authorization, EPA retains enforcement
authority under Sec. Sec.  3008, 3013, and 7003 of RCRA, although
authorized States have primary enforcement responsibility. The
standards and requirements for State authorization are found at 40 CFR
part 271.
    Prior to enactment of the Hazardous and Solid Waste Amendments of
1984 (HSWA), a State with final RCRA authorization administered its
hazardous waste program entirely in lieu of EPA administering the
Federal program in that State. The Federal requirements no longer
applied in the authorized State, and EPA could not issue permits for
any facilities in that State, since only the State was authorized to
issue RCRA permits. When new, more stringent Federal requirements were
promulgated, the State was obligated to enact equivalent authorities
within specified time frames. However, the new Federal requirements did
not take effect in an authorized State until the State adopted the
Federal requirements as State law.
    In contrast, under RCRA Sec.  3006(g) (42 U.S.C. 6926(g)), which
was added by HSWA, new requirements and prohibitions imposed under HSWA
authority take effect in authorized States at the same time that they
take effect in unauthorized States. EPA is directed by the statute to
implement these requirements and prohibitions in authorized States,
including the issuance of permits, until the State is granted
authorization to do so. While States must still adopt HSWA-related
provisions as State law to retain final authorization, EPA implements
the HSWA provisions in authorized States until the States do so.
    Authorized States are required to modify their program only when
EPA enacts Federal requirements that are more stringent or broader in
scope than the existing Federal requirements. RCRA Sec.  3009 allows
the States to impose standards more stringent than those in the Federal
program (see also 40 CFR 271.1). Therefore, authorized States may, but
are not required to, adopt Federal HSWA and non-HSWA regulations that
are considered (1) less stringent or (2) neither more nor less
stringent than previous Federal regulations.

B. Effect on State Authorization

    These amendments are promulgated under non-HSWA RCRA authority.
These non-HSWA amendments will be applicable on the effective date only
in those States that do not have final authorization of their base RCRA
programs. Authorized States are required to modify their programs only
when EPA promulgates Federal regulations that are more stringent or
broader in scope than the authorized State regulations. For those
changes that are less stringent or reduce the scope of the Federal
program, States are not required to modify their program. This is a
result of Sec.  3009 of RCRA, which allows States to impose more
stringent regulations than the Federal program. Today's amendments are
considered to be neither more nor less stringent than the current
standards. Therefore, authorized States, while not required to modify
their programs to adopt the technical corrections discussed above, are
strongly urged to adopt these technical corrections to avoid any
confusion or misunderstanding by the regulated community and the
public.

IV. Statutory and Executive Order Reviews

    As explained above, this action makes technical corrections to the
text of the Academic Laboratories rule but does not make any
substantive change to the requirements of that rule. 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: Regulatory Planning and Review (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.);
     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: Federalism (64 FR 43255, August 10, 1999);
     Does not have Tribal implications as specified by
Executive Order 13175: Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 9, 2000), because, as the rule does
not make any substantive changes, it will not impose substantial direct
costs on Tribal governments or preempt Tribal law;
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045: Protection
of Children from Environmental Health and Safety Risks (62 FR 19885,
April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211: Actions that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001);
     Does not involve technical standards; thus the
requirements of Sec.  12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272) do not apply; and
     Is one for which the EPA lacks the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).

A. Regulatory Flexibility Act

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

    After considering the economic impact of today's Direct Final rule
on small entities, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
This action does not create any new regulatory requirements, but rather
makes technical corrections to Subpart K of the hazardous waste
generator regulations. Although this Direct Final rule will not have a
significant economic impact on a substantial number of small entities,
EPA nonetheless has tried to reduce the impact of this rule on small
entities.

B. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. section 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).

List of Subjects in 40 CFR Part 262

    Environmental protection, Exports, Hazardous materials
transportation, Hazardous waste, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements.

    Dated: December 13, 2010.
Mathy Stanislaus,
Assistant Administrator, Office of Solid Waste and Emergency Response.
    For the reasons set out in the preamble, Part 262 of title 40,
chapter I of the Code of Federal Regulations is amended as follows:

PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE

0
1. The authority citation for part 262 continues to read as follows:

    Authority:  42 U.S.C. 6906, 6912, 6922-6925, 6937, and 6938.

Subpart K--Alternative Requirements for Hazardous Waste
Determination and Accumulation of Unwanted Material for
Laboratories Owned by Eligible Academic Entities

0
2. Amend Sec.  262.200 to revise the definition of ``central
accumulation area'' to read as follows:

Sec.  262.200  Definitions for this subpart.

* * * * *
    Central accumulation area means an on-site hazardous waste
accumulation area subject to either Sec.  262.34(a)-(b) of this part
(large quantity generators) or Sec.  262.34(d)-(f) of this part (small
quantity generators). A central accumulation area at an eligible
academic entity that chooses to be subject to this subpart must also
comply with Sec.  262.211 when accumulating unwanted material and/or
hazardous waste.
* * * * *

0
3. Amend Sec.  262.206 to revise paragraph (b)(3)(i), to read as
follows:

Sec.  262.206  Labeling and management standards for containers of
unwanted material in the laboratory.

* * * * *
    (b) * * *
    (3) * * *
    (i) When adding, removing or bulking unwanted material, or
* * * * *

0
4. Amend Sec.  262.212 to revise paragraph (e)(1), to read as follows:

Sec.  262.212  Making the hazardous waste determination at an on-site
interim status or permitted treatment, storage or disposal facility.

* * * * *
    (e) * * *
    (1) Write the words ``hazardous waste'' on the container label that
is affixed or attached to the container within 4 calendar days of
arriving at the on-site interim status or permitted treatment, storage
or disposal facility and before the hazardous waste may be removed from
the on-site interim status or permitted treatment, storage or disposal
facility, and
* * * * *

0
5. Amend Sec.  262.214 to revise paragraphs (a)(1) introductory text
and (b)(1), to read as follows:

Sec.  262.214  Laboratory management plan.

* * * * *
    (a) * * *
    (1) Describe procedures for container labeling in accordance with
Sec.  262.206(a), as follows:
* * * * *
    (b) * * *
    (1) Describe its intended best practices for container labeling and
management (see the required standards at Sec.  262.206).
* * * * *
[FR Doc. 2010-31746 Filed 12-17-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Notices]
[Pages 80106-80107]
[FR Doc No: 2010-31958]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2010-59]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before January 10, 2011.

ADDRESSES: You may send comments identified by Docket Number FAA-2010-
1226 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: David Staples<PHONE_NUMBER>, Keira
Jones<PHONE_NUMBER>, or Tyneka Thomas<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue,
SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on December 16, 2010.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2010-1226.
    Petitioner: Skywarrior, Inc.
    Section of 14 CFR Affected: 14 CFR 141.5(e), 141.27(b), 141.45,
141.55(c)(1), and 141.81.
    Description of Relief Sought: Skywarrior, Inc. is requesting relief
from the requirement concerning renewal of the school's provisional
pilot school certificate and ratings. Additionally, the petitioner
requests relief from the ground training facilities requirements given
the school's use of online training material, as well as the ground
training instructor requirement given the use of non-FAA certificated
or part 141 school supervised military instructors. The petitioner also
requests relief from the requirement to graduate at least 10 different
people from the school's approved training course in order to maintain
a part 141 pilot school certificate and associated ratings.

[FR Doc. 2010-31958 Filed 12-20-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Page 30480]
[FR Doc No: 2015-12917]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4210-DR; Docket ID FEMA-2015-0002]

West Virginia; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster for the
State of West Virginia (FEMA-4210-DR), dated March 31, 2015, and
related determinations.

DATES: Effective date: May 8, 2015.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this declared disaster is now March 3, 2015, through and
including March 14, 2015.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-12917 Filed 5-27-15; 8:45 am]
 BILLING CODE 9111-23-P