[Federal Register Volume 78, Number 15 (Wednesday, January 23, 2013)]
[Notices]
[Page 4844]
[FR Doc No: 2013-01287]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2165-049]

Alabama Power Company; Notice Rejecting Request for Rehearing

    On March 31, 2010, the Commission issued a new license to Alabama
Power Company (Alabama Power) for the continued operation and
maintenance of the Warrior River Hydroelectric Project No. 2165,
located on the Black Warrior River and on the Sipsey Fork of the Black
Warrior River, in Cullman, Walker, Winston, and Tuscaloosa Counties,
Alabama.\1\ The Smith Lake Improvement and Stakeholders Association
(Lake Association) filed a timely request for rehearing of the order,
and on November 15, 2012, the Commission issued an order denying
rehearing and providing clarification of the March 31 Order. \2\ On
December 17, 2012, the Lake Association filed a timely request for
rehearing of the November 15 Order.
---------------------------------------------------------------------------

    \1\ Alabama Power Co., 130 FERC ] 62,271 (2010) (March 31
Order).
    \2\ Alabama Power Co., 141 FERC ] 61,127 (2012) (November 15
Order).
---------------------------------------------------------------------------

    Rehearing of an order on rehearing lies when the later order
modifies the result reached in the original order in a manner that
gives rise to a wholly new objection.\3\ The November 15 Order does not
modify the result of the March 31 Order. Further, the arguments Lake
Association makes in its rehearing request were considered and denied
in the November 15 Order. Therefore, the request for rehearing by the
Lake Association is rejected.
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    \3\ See, e.g., Union Electric Company d/b/a AmerenUE, 114 FERC ]
61,230, at 61,745-46 (2006); Duke Power, 114 FERC ] 61,148, at P 1
(2006); Gustavus Electric Co., 111 FERC ] 61,424, at P 3 (2005);
Symbiotic, L.L.C., 99 FERC ] 61,064, at 61,300 (2002); and
PacifiCorp, 99 FERC ] 61,015, at 61,052 (2002). See also Southern
Natural Gas Co. v. FERC, 877 F.2d 1066, 1073 (DC Cir. 1999) (citing
Tennessee Gas Pipeline v. FERC, 871 F.2d 1109-10 (D.C. Cir. 1988)).
---------------------------------------------------------------------------

    This notice constitutes final agency action. Requests for rehearing
by the Commission of this rejection must be filed within 30 days of the
date of issuance of this notice pursuant to section 313(a) of the
Federal Power Act, 16 U.S.C. 825l (2006), and section 385.713 of the
Commission's regulations, 18 CFR 385.713 (2012).

    Dated: January 16, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-01287 Filed 1-22-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4620-4622]
[FR Doc No: 2022-01738]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4428]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medicated Feed Mill License Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of medicated feed mill license reporting.

DATES: Submit either electronic or written comments on the collection
of information by March 29, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 29, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 29, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-4428 for ``Medicated Feed Mill License Application.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including

the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medicated Feed Mill License Application--21 CFR Part 515

OMB Control Number 0910-0337--Extension

    Feed manufacturers that seek to manufacture a Type B or Type C
medicated feed using Category II, Type A medicated articles or
manufacture certain liquid and free-choice feed using Category I, Type
A medicated articles that must follow proprietary formulas or
specifications, are required to obtain a facility license under section
512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360b). Our regulations in part 515 (21 CFR part 515) establish the
procedures associated with applying for a facility license. We require
that a manufacturer seeking a facility license submit a completed
medicated feed mill license application using Form FDA 3448 (21 CFR
515.10(b)). We use the information submitted to establish that the
applicant has made the certifications required by section 512 of the
FD&C Act, to register the mill, and to schedule a preapproval
inspection.
    We require the submission of a supplemental medicated feed mill
license application for a change in facility ownership or a change in
facility address (Sec.  515.11(b) (21 CFR 515.11(b))). If a licensed
facility is no longer manufacturing medicated animal feed under Sec.
515.23 (21 CFR 515.23), a manufacturer may request voluntary revocation
of a medicated feed mill license. An applicant also has the right to
file a request for hearing under Sec.  515.30(c) (21 CFR 515.30(c)) to
give reasons why a medicated feed mill license should not be refused or
revoked.
    Under Sec.  510.305 (21 CFR 510.305) we require each applicant to
maintain in a single accessible location: (a) A copy of the approved
medicated feed mill license (Form FDA 3448) on the premises of the
manufacturing establishment; and (b) Approved or index listed labeling
for each Type B and/or Type C feed being manufactured on the premises
of the manufacturing establishment or the facility where the feed
labels are generated.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
         21 CFR section and activity              Number of     responses per   Total annual          Average burden  per response          Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicated Feed Mill License Application using               5               1               5  0.25 (15 minutes)........................            1.25
 Form FDA 3448 (515.10(b)).
Supplemental Feed Mill License Application                 14               1              14  0.25 (15 minutes)........................             3.5
 using Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed Mill                15               1              15  0.25 (15 minutes)........................            3.75
 License (515.23).
Filing a Request for a Hearing on Medicated                 1               1               1  4........................................               4
 Feed Mill License (515.30(c)).
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................            12.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
         21 CFR section and activity              Number of      records per    Total annual       Average burden  per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of Records for Approved Labeling              795               1             795  0.03 (2 minutes).........................              24
 for Each ``Type B'' and ``Type C'' Feed
 (510.305).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an
overall decrease of 17 hours and a corresponding decrease of 105
responses/records. We attribute this adjustment to a decrease in the
number of submissions we received over the last few years.

    Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01738 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 11, 2007 (Volume 72, Number 132)]
[Notices]
[Page 37770-37771]
[DOCID:fr11jy07-92]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0134; FRL-8121-8]

Aliphatic Alcohols Reregistration Eligibility Decision; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's Reregistration
Eligibility Decision (RED) for the pesticide aliphatic alcohols, and
opens a public comment period on this document. The Agency's risk
assessments and other related documents also are available in the
aliphatic alcohols Docket. The aliphatic alcohols subject to this RED
include 1-hexanol, 1-octanol, 1-decanol and 1-dodecanol, and are used
as a growth regulator for tobacco sucker control, and as a Lepidopteran
pheromone in apple and pear orchards. EPA has reviewed aliphatic
alcohols through a modified, 1-phase, low risk process with a public
comment period following the publication of the RED. Through this
process, EPA is ensuring that all pesticides meet current health and
safety standards.

DATES: Comments must be received on or before September 10, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0134, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0134. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. 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, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either in the
electronic docket at http://www.regulations.gov, or, if only available

in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kevin Costello, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in 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 procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. 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.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    Under section 4 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to
ensure that they meet current scientific and regulatory standards. EPA
has completed a Reregistration Eligibility Decision (RED) for the
pesticide, aliphatic alcohols under section 4(g)(2)(A) of FIFRA. The
aliphatic alcohols subject to this RED include 1-hexanol, 1-octanol, 1-
decanol and 1-dodecanol, and are used as a growth regulator for tobacco
sucker control, and as a Lepidopteran pheromone in apple and pear
orchards. EPA has determined that the data base to support
reregistration is substantially complete and that products containing
aliphatic alcohols are eligible for reregistration, provided the label
amendments described in the RED are implemented. Upon submission of any
required product specific data under section 4(g)(2)(B) and any
necessary changes to the registration and labeling (either to address
concerns identified in the RED or as a result of product specific
data), EPA will make a final reregistration decision under section
4(g)(2)(C) for products containing aliphatic alcohols.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14,
2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, EPA is tailoring its public participation process to be
commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
Due to its uses, low human health and ecological risks, and other
factors, the aliphatic alcohols were reviewed through a modified, 1-
phase, low risk process.
    The reregistration program is being conducted under Congressionally
mandated time frames, and EPA recognizes the need both to make timely
decisions and to involve the public. The Agency is issuing the
aliphatic alcohols RED for public comment. This comment period is
intended to provide an opportunity for public input and a mechanism for
initiating any necessary amendments to the RED. All comments should be
submitted using the methods in ADDRESSES, and must be received by EPA
on or before the closing date. These comments will become part of the
Agency Docket for aliphatic alcohols. Comments received after the close
of the comment period will be marked ``late.'' EPA is not required to
consider these late comments.
    The Agency will carefully consider all comments received by the
closing date and will provide a Response to Comments Memorandum in the
Docket and regulations.gov. If any comment significantly affects the
document, EPA also will publish an amendment to the RED in the Federal
Register. In the absence of substantive comments requiring changes, the
aliphatic alcohols RED will be implemented as it is now presented.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA as amended directs that, after submission
of all data concerning a pesticide active ingredient, the Administrator
shall determine whether pesticides containing such active ingredient
are eligible for reregistration, before calling in product specific
data on individual end-use products and either reregistering products
or taking other ``appropriate regulatory action.''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 2, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-13332 Filed 7-10-07; 8:45 am]

BILLING CODE 6560-50-S


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on July 16, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 2003-15645

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  AEROVIAS de MEXICO, S.A. de C.V.
                               Date Filed:  July 10, 2003

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to conduct scheduled, combination service between Guadalajara,
Mexico, and Las Vegas, Nevada.

If renewal, date and citation of last action:  New authority.

Applicant representative(s):  William C. Evans,<PHONE_NUMBER>        DOT
analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.			       			                        Action date:
July 16, 2003

Effective dates of authority granted:  July 16, 2003, through July 16,
2004.

Basis for approval:  United States-Mexico Air Transport Services
Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated: Standard exemption
conditions.

Special conditions/Remarks:

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
_______________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/re潰瑲彳癡慩楴湯愮灳

4


[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Proposed Rules]
[Pages 55974-55976]
[FR Doc No: 2022-19777]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0731]
RIN 1625-AA00

Safety Zone; Mission Bay Closure, San Diego, CA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for certain waters of Mission Bay. The safety zone is needed to
protect personnel, vessels, and the marine environment from potential
hazards created by the California Department of Fish and Wildlife
(CDFW) Oil Spill Prevention and Response (OSPR) Sensitive Site Strategy
Evaluation Program (SSSEP) boom deployment exercise. Entry of vessels
or persons into this zone is prohibited unless specifically authorized
by the Captain of the Port Sector San Diego. We invite your comments on
this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before October 13, 2022.

ADDRESSES: You may submit comments identified by docket number USCG-
2022-0731 using the Federal Decision Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LTJG Shera Kim, Waterways
Management, U.S. Coast guard Sector San Diego, Coast Guard; telephone
619-278-7656, 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, Purpose, and Legal Basis

    On November 15, 2022, the Coast Guard will be working in
conjunction with the California Department of Fish and Wildlife and
local Oil Spill Response Organization to conduct boom deployment
exercises from 9 a.m. to 12 p.m. Contractors will bring up to 12000-
feet of floating oil boom aboard a workboat and deploy Area Contingency
Plan (ACP)-6 Geographic Response Strategies (GRS). The Captain of the
Port San Diego (COTP) has determined that potential hazards associated
with the boom deployment exercise would be a safety concern for anyone
within a 100-yard radius of the boom. The COTP is proposing to
establish a safety zone from 9 a.m. to noon on November 15, 2022.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within a 100-yard radius of the boom before,
during, and after the scheduled event. The Coast Guard is proposing
this rulemaking under authority in 46 U.S.C. 70034 (previously 33
U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone from 9 a.m. until
noon on November 15, 2022. The safety zone would cover all navigable
waters within 100 yards of a boom in Mission Bay located across the
entrance channel from the shoreline north of Mariners Cove inlet to a
point south of Mission Bay Drive bridge on the Quivira Basin shoreline.
The duration of the zone is intended to ensure the safety of vessels
and these navigable waters before, during, and after the scheduled 9
a.m. until noon boom deployment exercise. No vessel or person would be
permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative. The regulatory text we are
proposing appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed 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. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the

Office of Management and Budget (OMB).
    This regulatory action determination is based on safety zone being
of a limited three hour duration, limited to a relatively small
geographic area, and the presence of safety hazards in the area
encompassing the Mission Bay Entrance.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

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 proposed rule would not
result in such an expenditure, we do discuss the potential effects of
this proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination 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 proposed rule involves a safety
zone lasting 3 hours that would prohibit entry within 100 yards of the
boom. Normally such actions are categorically excluded from further
review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1. We seek any comments or information that
may lead to the discovery of a significant environmental impact from
this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email 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.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2022-0731 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

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 is
proposing to amend 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:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T11-0731 to read as follows:

Sec.  165.T11-0731   Safety Zone; Mission Bay, San Diego, CA.

    (a) Location. The following area is a safety zone: Mission Bay
located across the entrance channel from the shoreline north of
Mariners Cove inlet to a point south of Mission Bay Drive bridge on the
Quivira Basin shoreline.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Sector San Diego (COTP) in the enforcement of the
safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF Channel 16. Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (d) Enforcement period. This section will be enforced from 9 a.m.
until noon on November 15, 2022.

    Dated: September 7, 2022.
J.W. Spitler,
Captain, U.S. Coast Guard, Captain of the Port Sector San Diego.
[FR Doc. 2022-19777 Filed 9-12-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53867-53868]
[FR Doc No: 2018-23322]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-46-000]

Notice of Schedule for Environmental Review of the Adelphia
Gateway Project: Adelphia Gateway, LLC

    On January 12, 2018, Adelphia Gateway, LLC (Adelphia) filed an
application in Docket No. CP18-46-000 requesting a Certificate of
Public Convenience and Necessity pursuant to Section 7(c) of the
Natural Gas Act to construct and operate certain natural gas pipeline
facilities, as well as acquire and convert an existing oil pipeline
(southern segment) and an existing dual-phase oil and natural gas
pipeline (northern segment) to natural gas only. On August 31, 2018,
Adelphia filed an amendment to the application proposing to increase
its proposed capacity on the northern segment, but would not result in
any changes to the proposed facilities. The proposed project is located
in both Pennsylvania and Delaware and is known as the Adelphia Gateway
Project (Project). As amended, the Project would provide about 250 and
350 million standard cubic feet of natural gas per day on the existing
18-inch-diameter and 20-inch-diameter portions of the northern segment,
respectively. The Project would also provide 250 million standard cubic
feet of natural gas per day on the existing 18-inch-diameter southern
segment to the greater Philadelphia industrial region with potential to
serve additional markets in the northeast.
    On January 23, 2018, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA--January 4, 2019
90-day Federal Authorization Decision Deadline--April 4, 2019

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    Adelphia Gateway proposes to acquire and convert the above
referenced northern and southern segments and four existing meter
stations to natural gas only, and construct and operate about 4.7 miles
of new 16-inch-diameter natural gas pipeline, five meter stations with
eight interconnects, seven blowdown assemblies, two mainline valves,
and appurtenant facilities in Delaware, Bucks, Chester, Montgomery, and
Northampton Counties, Pennsylvania, and New Castle County, Delaware.
Additionally, Adelphia proposes to construct two new 5,625 horsepower
compressor stations in Delaware and Bucks Counties, Pennsylvania.

Background

    On May 1, 2018, the Commission issued a Notice of Intent to Prepare
an Environmental Assessment for the proposed Adelphia Gateway Project,
Request for Comments on Environmental Issues, and Notice of Public
Scoping Sessions (NOI). The NOI was sent to affected landowners;
federal, state, and local government agencies; elected officials;
Native American tribes; other interested parties; and local libraries
and newspapers. In response to the NOI and during Project scoping, the
Commission received comments from the U.S. Environmental Protection
Agency, Pennsylvania Department of Transportation, local and state
governments, non-governmental organizations, and more than 360 comment
letters from residents. The primary issues raised by the commenters
relate to safety and health concerns for residents and nearby
communities, as well as concerns related to environmental impacts
associated with the repurposing of the existing system to transport
natural gas and construction of new natural gas infrastructure. Project
stakeholders also generally expressed Project concerns about the
following:
     Noise, safety, air quality, and visual impacts of the
proposed compressor stations;
     effects on local communities, nearby properties, and
property rights and values;
     direct harm to local communities, cultural and historical
interests, and open space;
     water quality impacts, including erosion and stormwater
runoff, and impacts on drinking water supplies;
     contaminated groundwater and soil;
     traffic impacts;
     impacts on tourism; and
     climate change.
    All substantive comments will be addressed in the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP18-46), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at [email protected]. The eLibrary link on the FERC
website also provides access to the texts of formal documents issued by
the Commission, such as orders, notices, and rule makings.

    Dated: October 19, 2018.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2018-23322 Filed 10-24-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 233 (Wednesday, December 8, 2021)]
[Rules and Regulations]
[Pages 69581-69582]
[FR Doc No: 2021-26481]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0557; Airspace Docket No. 21-AWP-2]
RIN 2120-AA66

Establishment of Class E Airspace; Rogers Field, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action establishes Class E airspace extending upward from
700 feet above the surface of the earth at Rogers Field, Chester, CA.
This action would accommodate a new area navigation (RNAV) procedure
and ensure the safety and management of instrument flight rule (IFR)
operations within the National Airspace System.

DATES: Effective 0901 UTC, March 24, 2022. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
part 51, subject to the annual revision of FAA Order JO 7400.11 and
publication of conforming amendments.

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

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority

described in Subtitle VII, part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would establish Class E airspace extending upward from
700 feet above ground level to support IFR operations at Rogers Field,
Chester, CA.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (86 FR 43456; August 9, 2021) for Docket No. FAA-2021-0557 to
establish Class E airspace at Rogers Field, Chester, CA. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. One comment in
support of the action was received.
    Class E airspace designations are published in paragraphs 6005 of
FAA Order JO 7400.11F, dated August 10, 2021, and effective September
15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

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

The Rule

    The FAA is amending 14 CFR part 71 by establishing Class E airspace
extending upward from 700 feet above the surface of the earth at Rogers
Field, Chester, CA.
    The Class E airspace will be established extending upward from 700
feet above ground level (AGL) within a 4-mile radius of the airport. In
addition, airspace extending upward from 700 feet AGL will be
established within an area 2 miles each side of the approach course to
runway 34, extending 3.3 miles south from the 4-mile radius parallel to
the extended center line of runway 16, then proceeding southeast 7
miles on a course of 131[deg]. This will form a dog leg that provides
controlled airspace for aircraft as they descend below 1500 feet AGL on
approach to runway 34. The airspace extending upward from 700 feet AGL
will also include an area 2 miles each side of the 330[deg] bearing
from the airport extending from the 4-mile radius northwest to 5.5
miles from the airport. This area will provide controlled airspace for
the departure and missed approach procedures.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

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

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant the preparation of an
environmental assessment.

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 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

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

* * * * *

AWP CA E5 Chester, CA [NEW]

Rogers Field Airport, CA
    (Lat. 40[deg]16'57'' N, long. 121[deg]14'28'' W)

    That airspace extending upward from 700 feet within a 4-mile
radius of the airport and that area bounded by a line beginning at
the point the 202[deg] bearing intersects the 4-mile radius to lat.
40[deg]08'35.96'' N, long. 121[deg]15'41.59'' W; to lat.
40[deg]3'58.22'' N, long. 121[deg]08'45.53'' W; to lat.
40[deg]07'0.09'' N, long. 121[deg]05'18.56'' W; to lat.
40[deg]10'9.68'' N, long. 121[deg]9'57.89'' W; to lat.
40[deg]11'32.19'' N, long. 121[deg]10'51.97'' W; to the point the
144[deg] bearing intersects the 4-mile radius thence clockwise along
the 4-mile radius to the point of beginning, and that airspace 2
miles each side of the 330[deg] bearing extending from the 4-mile
radius to 5.5 miles northwest of the airport.

    Issued in Des Moines, Washington, on November 30, 2021.
B.G. Chew,
Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2021-26481 Filed 12-7-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 206 (Monday, October 26, 2015)]
[Notices]
[Pages 65277-65279]
[FR Doc No: 2015-27072]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76201; File No. SR-MIAX-2015-59]

Self-Regulatory Organizations: Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Exchange Rule 404

October 20, 2015.
    Pursuant to the provisions of 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 October 15, 2015, Miami International
Securities Exchange LLC (``MIAX'' or ``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') a proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by the Exchange. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange is filing a proposal to amend Exchange Rule 404 to
replace the name ``Google Inc.'' with ``Alphabet Inc.''
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange is proposing to amend Interpretations and Policies .08
to MIAX Rule 404, entitled Mini Option Contracts, to replace the name
``Google Inc.'' with ``Alphabet Inc.'' Google Inc. (``Google'')
recently announced plans to reorganize and create a new public holding
company, which will be called Alphabet Inc. (``Alphabet''). As a result
of the holding company reorganization, each share of Class A Common
Stock (``GOOGL''), on which the Exchange has the ability to list as a
Mini Option, will automatically convert into an equivalent
corresponding share of Alphabet Inc. stock. The symbol ``GOOGL''
remains unchanged.
    The Exchange is proposing to make this change to Interpretations
and Policies .08 to enable the Exchange to list and trade Mini Options
on Google, now Alphabet, Class A shares. The Exchange is proposing to
make this change because, on October 5, 2015 Google reorganized and as
a result underwent a name change.
    The purpose of this change is to ensure that Interpretations and
Policies .08 to Exchange Rule 404 reflects the Exchange's intention to
be able to list and trade Mini Options on only an exhaustive list of
underlying securities outlined in Interpretations and Policies .08 to
Rule 404. As a result, the proposed change will help avoid confusion.
2. Statutory Basis
    MIAX believes that its proposed rule change is consistent with
section 6(b) of the Act \3\ in general, and furthers the objectives of
section 6(b)(5) of the Act \4\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanisms of a
free and open market and a national market system and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In particular, the proposed rule change to change the name Google
to Alphabet to reflect the new ownership structure is consistent with
the Act because the proposed change is merely updating the current name
associated with the stock symbol GOOGL. The proposed change will allow
for continued benefit to investors by enabling the Exchange to provide
them with additional investment alternatives.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. In particular, the proposed
rule change to change the name Google to Alphabet to reflect the new
ownership structure is consistent with the Act because the proposed
change is merely updating the current name associated with the stock
symbol GOOGL. The proposed change will allow for continued benefit to
investors by enabling the Exchange to provide them with additional
investment alternatives.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \5\ and Rule 19b-4(f)(6) \6\
thereunder.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or 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-MIAX-2015-59 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-MIAX-2015-59. 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 filing also will be available
for inspection and copying at the principal

office of the Exchange. 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-MIAX-2015-59, and should be submitted on or before November 16,
2015.

     For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority. \7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-27072 Filed 10-23-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Page 41971]
[FR Doc No: 2020-15025]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP20-68-000; CP20-70-000]

Enable Gas Transmission, LLC; Enable Gulf Run Transmission, LLC;
Notice of Revised Schedule for Environmental Review of The Gulf Run and
Line CP Modifications Project

    This notice identifies the Federal Energy Regulatory Commission
staff's revised schedule for the completion of the environmental
assessment (EA) for Enable Gas Transmission, LLC and Enable Gulf Run
Transmission, LLC (collectively, Enable) Gulf Run and Line CP
Modifications Project. The first notice of schedule, issued on April
28, 2020, identified July 31, 2020 as the EA issuance date. However,
Enable filed supplemental information on June 23, 2020 related to
certain modifications to its project. In addition, the U.S. Army Corps
of Engineers (USACE) recently requested cooperating agency status for
the project to ensure that the EA addresses the USACE National
Environmental Policy Act requirements for processing Enable's June 4,
2020 USACE application for a Clean Water Act Section 404 Individual
Permit for the project. This change is in response to the court
vacatur, in April 2020, of the Nationwide Permit 12 Program. As a
result, Commission staff has revised the schedule for issuance of the
EA.

Schedule for Environmental Review

Issuance of the EA October 29, 2020
90-day Federal Authorization Decision Deadline January 27, 2021

    If a schedule change becomes necessary, an additional notice will
be provided so that the relevant agencies are kept informed of the
project's progress.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the eLibrary link, enter the
``Docket Number'' excluding the last three digits (i.e., CP20-68 or -
70), select a date range, and follow the instructions. For assistance
with access to eLibrary, the helpline can be reached at<PHONE_NUMBER>,
TTY<PHONE_NUMBER>, or at<EMAIL_ADDRESS>The eLibrary link
on the FERC website also provides access to the texts of formal
documents issued by the Commission, such as orders, notices, and rule
makings.

    Dated: July 7, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-15025 Filed 7-10-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Pages 52766-52767]
[FR Doc No: 2012-21387]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67725; File No. 4-652]

Technology and Trading Roundtable

AGENCY: Securities and Exchange Commission.

ACTION: Notice of roundtable discussion; request for comment.

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

SUMMARY: The Securities and Exchange Commission will host a one day
roundtable entitled ``Technology and Trading: Promoting Stability in
Today's Markets'' to discuss ways to promote stability in markets that
rely on highly automated systems. The roundtable will focus on the
relationship between the operational stability and integrity of our
securities market and the ways in which market participants design,
implement, and manage complex and inter-connected trading technologies.
    The roundtable discussion will be held in the multi-purpose room of
the Securities and Exchange Commission headquarters at 100 F Street
NE., in Washington, DC on September 14, 2012 from 10 a.m. to
approximately 4 p.m. The public is invited to observe the roundtable
discussion. Seating will be available on a first-come, first-served
basis. The roundtable discussion also will be available via webcast on
the Commission's Web site at www.sec.gov.
    The roundtable will consist of two panels. The morning panel will
focus on error prevention--where technology experts will discuss
current best practices and practical constraints for creating,
deploying, and operating mission-critical systems, including those that
are used to automatically generate and route orders, match trades,
confirm transactions, and disseminate data. The afternoon panel will
focus on error response--where panelists will discuss how the market
might employ independent filters, objective tests, and other real-time
processes or crisis-management procedures to detect, limit, and
possibly terminate erroneous market activities when they do occur,
thereby limiting the impact of such errors.

DATES: The roundtable discussion will take place on September 14, 2012.
The Commission will accept comments

regarding issues addressed at the roundtable until October 5, 2012.

ADDRESSES: Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/other.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number 4-652 on the subject line.

Paper Comments

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

All submission should refer to File Number 4-652. This file number
should be included on the subject line if email is used. To help us
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/other.shtml). Comments are
also 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 a.m. and 3 p.m. All
comments received will be posted without change; we do not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.

FOR FURTHER INFORMATION CONTACT: Arisa Tinaves, Special Counsel, at
(202) 551-5676, Division of Trading and Markets, Securities and
Exchange Commission, 100 F Street NE., Washington, DC 20549-7010.

    By the Commission.
     Dated: August 24, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-21387 Filed 8-29-12; 8:45 am]
BILLING CODE 8011-01-P


                    UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

                                   	  Issued by the Department of
Transportation on May 29, 2002

		       NOTICE OF ACTION TAKEN -- DOCKET OST-2002-12193

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of     American Airlines, Inc.           filed    4/25/02
for:

XX  U.S-South Africa third-country code-share authorization to provide:

American requests a U.S.-South Africa third-country code-share
authorization to be designated in order to operate code-share services
with Crossair Ltd d/b/a Swiss in the U.S.-South Africa market.  American
initially plans to serve the market between the United States and
Johannesburg via Zurich with its partner Swiss operating the service.

Applicant rep.:   Carl B. Nelson, Jr.<PHONE_NUMBER>    DOT analyst:
Gerald Caolo,<PHONE_NUMBER>

DISPOSITION

XX  Granted  (see remarks below)

The above action was effective when taken:   May 29, 2002, and will
remain in effect indefinitely

Action taken by:  Paul L. Gretch, Director

		  Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and South Africa.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions and limitations indicated:  XX  Holder’s
certificates of public convenience and necessity

	   XX  Statement of authorization dated April 23, 2002, in Docket
2002-12001, authorizing

   American/Crossair code-share operations, and conditions therein

________________________________________________________________________
_____________

Remarks:  Under Annex 1 of the 1999 U.S.-South Africa Air Transport
Agreement, up to four U.S. carriers may operate cooperative service
arrangements with third-country airlines in the U.S.-South Africa
market.  Three of these authorizations have been granted to Delta,
United, and Northwest and thus, one is available for American's proposed
service.

________________________________________________________________________
_____________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our

action was consistent with Department policy; (2) grant of the authority
was consistent with the public interest; and (3) grant of the authority
would not constitute a major regulatory action under the Energy Policy
and Conservation Act of 1975.  To the extent not granted, we denied all
requests in the referenced Docket.  We may amend, modify, or revoke the
authority granted in this Notice at any time without hearing at our
discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

 American and Crossair Ltd. d/b/a Swiss were granted a blanket statement
of authorization to engage in reciprocal code-share services by Notice
of Action Taken dated April 23, 2002, in Docket OST-2002-12001.

 PAGE

 PAGE   2


220 U. S. ENVIRONMENTAL PROTECTION AGENCY 1 2 Transcript of Hearing to Take Comment on 3 Two Proposed Rules 4

1. Revisions to the National Ambient Air Quality 5 Standards for Particulate Matter 6 and 7 2. Revisions to Ambient Air Monitoring Regulations 8    9 DATE: Wednesday, March 8, 2006 ( Afternoon and Evening 10 Sessions) 11 HELD AT: 12 13 Holiday Inn 14 4th and Arch Streets 15 Philadelphia, Pennsylvania 16 HELD BEFORE:

17 JOHN BACHMANN, CHAIR Associate Director of Science/ Policy and Programs 18 JUDY KATZ 19 Director of the Air Protection Division 20 PHIL LORANG Office of Air Quality Planning and Standards' 21 Ambient Air Monitoring Group 22 BETH HASSET SIPPLE Office of Air Quality Planning and Standards' 23 Ambient Standards Group 24 REPORTED BY:


[Federal Register: June 16, 2010 (Volume 75, Number 115)]
[Notices]
[Page 34203-34204]
[DOCID:fr16jn10-122]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Indiana Transportation Museum

[Waiver Petition Docket Number FRA-2010-0021]

    The Indiana Transportation Museum (ITMZ) seeks a waiver of
compliance from certain provisions of the Railroad Freight Car Safety
Standards, 49 CFR 215.303, which requires stenciling of restricted
cars. ITMZ owns four cabooses. They are car numbers: Monon 81528, C & O
90876, NKP 405, and W & LR 770 that are older than 50 years, and
therefore, restricted by the provision of 49 CFR 215.203(a). ITMZ is
seeking special approval to continue to use these cars under proceeding
according to 49 CFR 215.203(b).
    ITMZ claims that it operates and maintains the subject cars. These
cars are in good operating condition. These cars do not carry a load,
travel at a maximum speed of 25 miles per hour, and will not be
interchanged. All these cars are operated in captive service on the
railroad which runs between Tipton, Indiana, to downtown Indianapolis,
Indiana, and owned by the Hoosier Heritage Port Authority. These cars
are preserved in historically accurate condition. Stenciling the cars
because of their restricted equipment status would interfere with the
historically integrity.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2010-0021) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, if submitted on behalf of 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) or at
http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on June 10, 2010.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2010-14474 Filed 6-15-10; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Rules and Regulations]
[Pages 20583-20585]
[FR Doc No: E9-10244]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. FDA-2009-N-0100]

Revision of the Requirements for Publication of License
Revocation

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is clarifying the
regulatory procedures for notifying the public about the revocation of
a biologics license to be consistent with current practices. FDA is
amending the regulations in accordance with the agency's direct final
rule procedures. Elsewhere in this issue of the Federal Register, we
are publishing a companion proposed rule under FDA's usual procedures
for notice and comment rulemaking to provide a procedural framework to
finalize the rule in the event that we receive any significant adverse
comments on the direct final rule. If we receive any significant
adverse comments that warrant terminating the direct final rule, we
will consider such comments on the proposed rule in developing the
final rule.

DATES: This rule is effective September 17, 2009. Submit written or
electronic comments on or before July 20, 2009. If FDA receives no
significant adverse comments within the specified comment period, the
agency will publish a document confirming the effective date of the
final rule in the Federal Register within 30 days after the comment
period on this direct final rule ends. If timely significant adverse
comments are received, the agency will publish a document in the
Federal Register withdrawing this direct final rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0100, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to  http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 25, 1977 (42 FR 4680), FDA
issued a final rule revising, among other things, the procedures under
part 601 (21 CFR part 601) for issuing, revoking, and suspending
biologics licenses, and publishing license revocations. FDA revised
these procedures in order to simplify and codify existing practices,
establish new requirements where appropriate, and ensure that practices
and procedures would be consistently applied throughout the agency.

    A provision under the January 25, 1977, final rule provided that a
``Notice of revocation of a license, with statement of the cause
therefor, shall be issued by the Commissioner and published in the
Federal Register'' (Sec.  601.8). FDA interprets this requirement to
apply only to a license which the Commissioner of Food and Drugs (the
Commissioner) has found grounds to revoke under Sec.  601.5(b). FDA has
not routinely published, in the Federal Register, a notice of
revocation of a biologics license resulting from a manufacturer's
voluntary request for revocation for reasons unrelated to a finding by
the Commissioner that reasonable grounds to revoke the license exist
under Sec.  601.5(b). Examples of situations in which a manufacturer
might voluntarily request that a license be revoked include economic
loss, change in product marketing strategy, lack of public need,
corporate reorganization, or the emergence of innovative replacement
products. FDA does not consider the revocation of licenses in such
circumstances to require publication in the Federal Register. However,
FDA may publish a notice of revocation for licenses revoked at the
voluntary request of a manufacturer in situations where such notice is
in the interest of public health.

II. Highlights of the Direct Final Rule

    FDA is amending Sec.  601.8 to read: ``The Commissioner, following
revocation of a biologics license under 21 CFR 601.5(b), will publish a
notice in the Federal Register with a statement of the specific grounds
for the revocation.''
    This amendment revises the existing regulation to clarify that FDA
will publish a notice of license revocation in cases where the
Commissioner has made a finding that reasonable grounds for revocation
exist under Sec.  601.5(b). This amendment also clarifies that the
phrase ``with statement of the cause therefor,'' (Sec.  601.8) refers
to the specific grounds for revocation enumerated in Sec.  601.5(b).
The rule, as amended, does not affect other regulations or procedures
for notification of license revocation. The rule does not alter
existing FDA practices for publishing notices of voluntary withdrawal,
including notices of voluntary withdrawal of new drug applications.

III. Legal Authority

    FDA is issuing this regulation under the biological products
provisions of the Public Health Service Act (42 U.S.C. 262 and 264) and
the drugs and general administrative provisions of the Federal Food,
Drug, and Cosmetic Act (sections 201, 301, 501, 502, 503, 505, 510,
701, and 704) (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371, and
374). Under these provisions of the Public Health Service Act and the
Federal Food, Drug, and Cosmetic Act, we have the authority to issue
and enforce regulations designed to ensure that biological products are
safe, pure, and potent; and prevent the introduction, transmission, and
spread of communicable disease.

IV. Rulemaking Action

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA
described the agency's procedures for when and how we will employ
direct final rulemaking. We have determined that this rule is
appropriate for direct final rulemaking because it includes only
noncontroversial amendments, and we anticipate no significant adverse
comments. Consistent with our procedures on direct final rulemaking,
FDA is publishing, elsewhere in this issue of the Federal Register, a
companion proposed rule to amend Sec.  601.8. The companion proposed
rule provides a procedural framework within which the rule may be
finalized in the event that the direct final rule is withdrawn due to
any significant adverse comments. The comment period for the direct
final rule runs concurrently with the companion proposed rule. Any
comments received in response to the companion proposed rule will be
considered as comments regarding the direct final rule.
    A significant adverse comment is defined as a comment that explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change. In determining whether an adverse comment is
significant and warrants terminating a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the Administrative Procedure Act (APA) (5 U.S.C.
553). Comments that are frivolous, insubstantial, or outside the scope
of the rule will not be considered significant or adverse under this
procedure.
    A comment recommending a regulation change in addition to that in
this rule will not be considered a significant adverse comment unless
the comment states why the rule would be ineffective without the
additional change. In addition, if a significant adverse comment
applies to an amendment, paragraph, or section of this rule that can be
severed from the remainder of the rule, we may adopt as final those
provisions of the rule that are not the subject of a significant
adverse comment.
    If any significant adverse comments are received during the comment
period, FDA will publish, before the effective date of the direct final
rule, a document withdrawing the direct final rule. If we withdraw the
direct final rule, any comments received will be applied to the
companion proposed rule and will be considered in developing a final
rule using the usual notice-and-comment procedures under the APA (5
U.S.C. 552a et seq).
    If FDA receives no significant adverse comments during the
specified comment period, FDA intends to publish a document confirming
the effective date within 30 days after the comment period ends.
Additional information about direct rulemaking procedures is set forth
in a guidance published in the Federal Register of November 21, 1997
(62 FR 62466).

V. Analysis of Impacts

A. Review Under Executive Order 12866, the Regulatory Flexibility Act,
and the Unfunded Mandates Reform Act of 1995

    FDA has examined the impacts of the direct final rule under
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this direct final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the direct final rule makes current
regulations consistent with existing FDA practices and procedures, the
agency certifies that this direct final rule will not have a
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may

result in the expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100,000,000 or more
(adjusted annually for inflation) in any one year.'' The current
threshold after adjustment for inflation is $130 million, using the
most current (2007) Implicit Price Deflator for the Gross Domestic
Product. FDA does not expect this final rule to result in any 1-year
expenditure that would meet or exceed this amount.

B. Environmental Impact

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

C. Federalism

    FDA has analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the direct final rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the agency has concluded that the rule does not contain policies that
have federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

VI. Paperwork Reduction Act of 1995

    This direct final rule contains no collections of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VII. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

List of Subjects in 21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential
business information.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 601 is amended as follows:

PART 601--LICENSING

0
1. The authority citation for 21 CFR part 601 continues to read as
follows:

    Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353,
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C.
216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322
(21 U.S.C. 355 note).

0
2. Revise Sec.  601.8 to read as follows:

Sec.  601.8  Publication of revocation.

    The Commissioner, following revocation of a biologics license under
21 CFR 601.5(b), will publish a notice in the Federal Register with a
statement of the specific grounds for the revocation.

    Dated: March 25, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10244 Filed 5-4-09; 8:45 am]
BILLING CODE 4160-01-S