[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46172-46173]
[FR Doc No: 2018-19741]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3308]

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

AGENCY: Food and Drug Administration, HHS.

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

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

DATES: The meeting will be held on October 10, 2018, from 8 a.m. to 1
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-3308. The docket will close on October
9, 2018. Submit either electronic or written comments on this public
meeting by October 9, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before October 9, 2018. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of October 9, 2018. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before October 1, 2018, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-3308 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff.

If you do not wish your name and contact information be made publicly
available, you can provide this information on the cover sheet and not
in the body of your comments and you must identify the information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email: [email protected]; or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The committee will discuss biologics license application
761088 for CT-P10, a proposed biosimilar to Genentech, Inc.'s RITUXAN
(rituximab), submitted by Celltrion, Inc. The proposed indications
(uses) for this product are for the treatment of adult patients with
(1) relapsed or refractory, low-grade or follicular, CD20-positive, B-
cell Non-Hodgkin's Lymphoma (NHL) as a single agent; (2) previously
untreated follicular, CD20-positive, B-cell NHL in combination with
first-line chemotherapy and, in patients achieving a complete or
partial response to CT-P10 in combination with chemotherapy, as single-
agent maintenance therapy; and (3) non-progressing (including stable
disease), low-grade, CD20-positive, B-cell NHL as a single agent after
first-line cyclophosphamide, vincristine, and prednisone.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before October 1, 2018, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 noon. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before September 24, 2018. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by September 25, 2018.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Lauren D. Tesh (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19741 Filed 9-11-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95582-95584]
[FR Doc No: 2016-31294]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RD16-6-000]

Proposed Consolidated Information Collection Activities [FERC-
725A(1B) and FERC-725Z]; Comment Request

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Comment request.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Collection (Commission or
FERC) is submitting FERC-725A(1B) (Mandatory Reliability Standards for
the Bulk Power System) and FERC-725AZ (Mandatory Reliability Standards:
IRO Reliability Standards), in Docket No. RD16-6 to the Office of
Management and Budget (OMB) for review of the information collection
requirements. Any interested person may file comments directly with OMB
and should address a copy of those comments to the Commission as
explained below. The Commission issued a Notice in the Federal Register
(81 FR 66952, 9/29/2016) requesting public comments. FERC received no
comments in response to FERC-725A(1B) or FERC-725Z and is making this
notation in the submittal to OMB.

DATES: Comments on the collection of information are due by January 27,
2017.

ADDRESSES: Comments filed with OMB, identified by RD16-6-000, FERC-725Z
(OMB Control No. 1902-0276), and FERC-725A(1B) (OMB Control No. TBD),
should be sent via email to the Office of Information and Regulatory
Affairs<EMAIL_ADDRESS>Attention: Federal Energy Regulatory
Commission Desk Officer. The Desk Officer may also be reached via
telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Commission, in
Docket No. RD16-6, by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>by telephone at<PHONE_NUMBER>, and by fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION:

    Authority: 44 U.S.C. 3507(a)(1)(D).

    Title: FERC-725A(1B), (Mandatory Reliability Standards for the Bulk
Power System).
    OMB Control No.: TBD.
    Type of Request: Three-year extension of FERC-725A(1B) information
collection requirement with no changes to the reporting requirements.
    Abstract: Under section 215 of the Federal Power Act (FPA),\1\ the
Commission proposes to approve Reliability Standards TOP-010-1 (Real-
time Reliability Monitoring and Analysis Capabilities) and IRO-018-1
(Reliability Coordinator Real-time Reliability Monitoring and Analysis
Capabilities), submitted by North American Electric Corporation (NERC).
In this order, the Reliability Standards build on monitoring, real-time
assessments and support effective situational awareness. The
Reliability Standards accomplish this by requiring applicable entities
to: (1) Provide notification to operators of real-time monitoring alarm
failures; (2) provide operators with indications of the quality of
information being provided by their monitoring and analysis
capabilities; and (3) address deficiencies in the quality of
information being provided by their monitoring and analysis
capabilities.
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    \1\ Section 215 was added by the Energy Policy Act of 2005,
Public Law 109-58, 119 Stat. 594 (2005) (codified at 16 U.S.C.
824o).
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    FERC-725A(1B) address situational awareness objectives by providing
for operator awareness when key alarming tools are not performing as
intended. These collections will improve real-time situational
awareness capabilities and enhance reliable operations by requiring
reliability coordinators, transmission operators, and balancing
authorities to provide operators with an improved awareness of system
conditions analysis capabilities, including alarm availability, so that
operators may take appropriate steps to ensure reliability. These
functions include planning, operations, data sharing, monitoring, and
analysis.
    Type of Respondents: Balancing Authority (BA),Transmission
Operations (TOP) and Reliability Coordinators (RC).
    Estimate of Annual Burden \2\: The Commission estimates the annual
public reporting burden for the information collection as:
---------------------------------------------------------------------------

    \2\ Burden is the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. For further
explanation of what is included in the information collection
burden, reference 5 Code of Federal Regulations 1320.3.

                                            FERC-725A(1B), Changes Due to TOP-010-1 in Docket No. RD16-6-000
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Number of     Annual number                   Average burden &     Total annual
             Entity                Requirements &     respondents    of responses    Total number   cost per response    burden hours &      Cost per
                                       period             \3\       per respondent   of Responses          \4\         total annual cost  respondent ($)
                                                               (1)             (2)     (1) * (2) =  (4)..............  (3) * (4) = (5)..       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
BA \5\.........................  Year 1                        100               1             100  70 hrs.;           7,000 hrs.;             $4,494.00
                                  Implementation                                                     $4,494.00.         $449,400.00.
                                  (one-time
                                  reporting).

                                 Starting in Year              100               1             100  42 hrs.;           4,200 hrs.;              2,696.40
                                  2 (annual                                                          $2,696.40.         $269,640.00.
                                  reporting).
TOP \6\........................  Year 1                        171               1             171  70 hrs.;           11,970 hrs.;             4,494.00
                                  implementation                                                     $4,494.00.         $768,474.00.
                                  (one-time
                                  reporting).
                                 Starting in Year              171               1             171  40 hrs. $2,568.00  6,840 hrs.;              2,568.00
                                  2 (annual                                                                             $439,128.00.
                                  reporting).
BA/TOP.........................  Annual Record                 271               1             271  2 hrs.; $75.38...  542 hrs.;                   75.38
                                  Retention.                                                                            $20,427.98.
                                                   -----------------------------------------------------------------------------------------------------
    Total burden hours per year  .................  ..............  ..............  ..............  .................  19,512 hrs.        ..............
                                                                                $1,238,301.98
                                                                                (Year 1); 11,582
                                                                                hrs. $729,195.98
                                                                                per year,
                                                                                (starting in
                                                                                Year 2).
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Title: FERC-725Z, Mandatory Reliability Standards: IRO Reliability
Standards.
---------------------------------------------------------------------------

    \3\ The number of respondents is the number of entities in which
a change in burden from the current standards to the proposed
exists, not the total number of entities from the current or
proposed standards that are applicable.
    \4\ The estimated hourly costs (salary plus benefits) are based
on Bureau of Labor Statistics (BLS) information, as of May 2015 (at
http://www.bls.gov/oes/current/naics2_22.htm, with updated benefits
information for March 2016 at http://www.bls.gov/news.release/ecec.nr0.htm), for an electrical engineer (code 17-2071, $64.20/
hour), and for information and record clerks record keeper (code 43-
4199, $37.69/hour). The hourly figure for engineers is used for
reporting; the hourly figure for information and record clerks is
used for document retention.
    \5\ Balancing Authority (BA). The following Requirements and
associated measures apply to balancing authorities: Requirement R1:
A revised data specification and writing the required operating
process/operating procedure; and Requirement R2: Quality monitoring
logs and the data errors and corrective action logs.
    \6\ Transmission Operations (TOP). The following Requirements
and associated measures apply to transmission operators: Requirement
R1: A revised data specification and writing the required operating
process/operating procedure; and Requirement R3: Alarm process
monitor performance logs to maintain performance logs and corrective
action plans.
---------------------------------------------------------------------------

    OMB Control No.: 1902-0276.
    Type of Request: Three-year extension of FERC-725Z information
collections requirement with no changes to the reporting requirements.
    Abstract: FERC-725Z requires reliability coordinators to have an
alarm process monitor that provides notification to system operators
when the failure of a real-time monitoring alarm processor has
occurred. Proposed Reliability Standard TOP-010-1, Requirement R4
contains an identical requirement applicable to transmission operators
and balancing authorities. This collection will improve real-time
situational awareness capabilities and enhance reliable operations by
requiring reliability coordinators, transmission operators, and
balancing authorities to provide operators with an improved awareness
of system conditions analysis capabilities, including alarm
availability, so that operators may take appropriate steps to ensure
reliability. These functions include planning, operations, data
sharing, monitoring, and analysis.
    Type of Respondents: Balancing Authority and Transmission
Operations.
    Estimate of Annual Burden: The Commission estimates the annual
public reporting burden for the information collection as:

                                                FERC-725Z, Changes Due to Reliability Standard IRO-018-1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Number of     Annual number                   Average burden &     Total annual
             Entity                Requirements &     respondents    of responses    Total number   cost per response    burden hours &      Cost per
                                       period             \7\       per respondent   of responses          \8\         total annual cost  respondent ($)
                                                               (1)             (2)     (1) * (2) =  (4)..............  (3) * (4) = (5)..       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
RC \9\.........................  Year 1                         11               1              11  60 hrs.;           660 hrs.;               $3,852.00
                                  Implementation                                                     $3,852.00.         $42,372.00.
                                  (reporting).
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection;

and (4) ways to minimize the burden of the collection of information on
those who are to respond, including the use of automated collection
techniques or other forms of information technology.
---------------------------------------------------------------------------

    \7\ The number of respondents is the estimated number of
entities for which there is a change in burden from the current
standards to the proposed standards, not the total number of
entities from the current or proposed standards that are applicable.
    \8\ The estimated hourly costs (salary plus benefits) are based
on Bureau of Labor Statistics (BLS) information, as of May 2015 (at
http://www.bls.gov/oes/current/naics2_22.htm, with updated benefits
information for March 2016 at http://www.bls.gov/news.release/ecec.nr0.htm), for an electrical engineer (code 17-2071, $64.20/
hour), and for information and record clerks (code 43-4199, $37.69/
hour). The hourly figure for engineers is used for reporting; the
hourly figure for information and record clerks is used for document
retention.
    \9\ Reliability Coordinator (RC). The following Requirements and
the associated measures apply to RCs: Requirement R1: A revised data
specification and writing the required operating Process/Operating
Procedure; Requirement R2: Quality monitoring logs and the data
errors and corrective action logs; and Requirement R3: Alarm process
monitor performance logs.
    \10\ There is a DLO for Docket No. RD16-6-001, Revisions to the
Violation Risk Factors for Reliability Standards, approving the
directed changes to VRF designations in IRO-018-1 and TOP-010-1.

    Dated: December 20, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-31294 Filed 12-27-16; 8:45 am]
 BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION IX AIR DIVISION

Technical Support Document

for

EPA’s Notice of Proposed Rulemaking and Direct Final Rule

for the

California State Implementation Plan

South Coast Air Quality Management District

Rule 1122, Solvent Degreasers

Prepared by: Francisco Dóñez

October 2005

AGENCY NAME:		South Coast Air Quality Management District (SCAQMD)

SUBMITTED RULE:	Rule 1122, Solvent Degreasers

				Adopted: October 1, 2004

				Submitted: January 13, 2005

				Complete: February 16, 2005

PREVIOUS RULE		No other versions of Rule 1122 have been submitted to

SUBMITTALS:		EPA as a revision to the State Implementation Plan (SIP).

SIP-APPROVED RULE:	Rule 1122, Solvent Degreasers

				Adopted: July 11, 1997

				Submitted: September 8, 1997

				Approved: April 2, 1999 (64 FR 15922)

RULE SUMMARY

SCAQMD Rule 1122 applies to all persons who own or operate batch-loaded
cold cleaners, open-top vapour degreasers, all types of conveyorized
degreasers, and air-tight and airless cleaning systems that carry out
solvent degreasing operations with a solvent containing Volatile Organic
Compounds (VOCs) or with a NESHAP halogenated solvent.  The most recent
rule amendments reflect the findings of a technology assessment to
evaluate an exemption for certain small degreasers.

Revisions to Rule 1122

Submitted Rule 1122 makes the following changes to the SIP-approved
rule.  Unless otherwise noted, section references apply to the version
of the rule submitted on January 13, 2005.

Section (k)(1)(C) extends the sunset date for the existing exemption
for small-sized degreasers to June 1, 2005.

Section (k)(1)(D) exempts from the rule small degreasers, used in
specific cleaning applications, that are vented to an emission
collection and control system.

Section (k)(1)(E) contains a limited exemption for small degreasers used
only for cleaning electronic components designed to travel over 100
miles above the earth’s surface.

Section (k)(1)(F) provides a permanent exemption for small degreasers
used for research and development/quality assurance programs.

Section (k)(2)(H) extends the exemption for the cleaning of photocurable
resins from stereolithography equipment and models to December 31. 2008.

Section (h)(7) lists compliance test methods for determining the
efficiency of a VOC emission collection and control system.

Additional minor rule language clarifications.

RULE EVALUATION

Generally, SIP rules must be enforceable (see section 110(a) of the
CAA), must require Reasonably Available Control Technology (RACT) for
major sources in ozone nonattainment areas (see section 182(a)(2)(A)),
and must not relax existing requirements (see sections 110(l) and 193).
The SCAQMD regulates an extreme ozone nonattainment area (see 40 CFR
part 81) and Rule 1122 must fulfill RACT.

Documents used to evaluate the rule include the following: EPA’s
Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations (May 25, 1988, the “Bluebook”); and EPA Region IX’s
Guidance Document for Correcting Common VOC and Other Rule Deficiencies
(August 21, 2001, the “Little Bluebook”).

Submitted Rule 1122 is consistent with these documents and EPA SIP
approval criteria.  The revised rule contains more stringent criteria
for exempting small degreasers from the rule.  Except for some narrowly
defined applications, small degreasers may only be exempted if they are
vented to a VOC emission control system.  The rule fulfills RACT and all
other requirements mentioned above.

Net Effect on Emissions

No emissions reductions are expected from this rule revision.  According
to the SCAQMD, the VOC emissions associated with the small degreaser
exemptions will continue to be 25 pounds per day.

RECOMMENDED ACTION

I recommend full approval of submitted Rule 1122 under Section 110(k) of
the Clean Air Act to replace the SIP-approved version of Rule 1122.

ATTACHMENTS

SCAQMD Rule 1122, Solvent Degreasers, adopted October 1, 2004.

SCAQMD Rule 1122, Solvent Degreasers, adopted September 8, 1997.

U.S. EPA. Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations. May 25, 1988 (the "Bluebook," cover only).

U.S. EPA Region IX. Guidance Document for Correcting Common VOC & Other
Rule Deficiencies. August 21, 2001 (the "Little Bluebook," cover only).

 PAGE

 PAGE   3


[Federal Register: April 12, 2010 (Volume 75, Number 69)]
[Notices]
[Page 18507-18508]
[DOCID:fr12ap10-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0164]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals:
Comparative Metabolism Studies in Laboratory Animals (VICH GL47);
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (206) entitled
``Draft Guidance for Industry on Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals:
Comparative Metabolism Studies in Laboratory Animals,'' VICH GL47. This
draft guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This draft
VICH guidance document is intended to provide recommendations for
internationally harmonized procedures to identify the metabolites of
veterinary food animal drugs in laboratory animals used for
toxicological testing for the purpose of comparison to the residues of
the drugs in food animals.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by May 12, 2010.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your request.
    Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
(206) entitled ``Draft Guidance for Industry on Studies to
Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in
Food-Producing Animals: Comparative Metabolism Studies in Laboratory
Animals,'' VICH GL47. In recent years, many important initiatives have
been undertaken by regulatory authorities and industry associations to
promote the international harmonization of regulatory requirements. FDA
has participated in efforts to enhance harmonization and has expressed
its commitment to seek scientifically based harmonized technical
procedures for the development of pharmaceutical products. One of the
goals of harmonization is to identify and then reduce differences in
technical requirements for drug development among regulatory agencies
in different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Approval of Pharmaceuticals
for Human Use for several years to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the European Union (EU), Japan, and the United States.
The VICH is a parallel initiative for veterinary medicinal products.
The VICH is concerned with developing harmonized technical requirements
for the approval of veterinary medicinal products in the EU, Japan, and
the United States, and includes input from both regulatory and industry
representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission, European Medicines Evaluation Agency,
European Federation of Animal Health, Committee on Veterinary Medicinal
Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal
Health Institute, the Japanese Veterinary Pharmaceutical Association,
the Japanese Association of Veterinary Biologics, and the Japanese
Ministry of Agriculture, Forestry, and Fisheries.
    Four observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, and one
representative from the industry of Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also participates in the VICH Steering Committee
meetings.

II. Draft Guidance on Studies to Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Animals

    The VICH Steering Committee held a meeting on November 5, 2009, and
agreed that the draft guidance document entitled ``Draft Guidance for
Industry on Studies to Evaluate the Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing Animals: Comparative Metabolism
Studies in Laboratory Animals,'' VICH GL47 should be made available for
public comment. This draft VICH guidance document is one of a series
developed to facilitate the mutual acceptance of residue chemistry data
for veterinary drugs used in food-producing animals. This guidance was
prepared after consideration of the current requirements for evaluating
veterinary drug residues in the EU, Japan, United States, Australia,
New Zealand and Canada.
    The objective of this guidance is to provide recommendations for
internationally harmonized procedures to identify the metabolites of
veterinary food animal drugs in laboratory animals used for
toxicological testing for the purpose of comparison to the residues of
the drugs in food animals. The purpose of comparative metabolism
studies is to determine if laboratory animals used for toxicological
testing have been exposed to the metabolites that humans will be
exposed to as residues in products of food animal origin.
    The human food safety evaluation of veterinary drug residues
assures that food derived from treated animals is

safe for human consumption. As part of the data collection process,
studies are conducted to characterize the metabolites to which
laboratory animals are auto-exposed during the toxicological testing of
the veterinary drug. The purpose of these studies is to determine
whether the metabolites that people will consume from tissues of target
food animals are also produced by metabolism in the laboratory animals
used for the safety testing.
    FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.

III. Significance of Guidance

    This draft guidance, developed under the VICH process, has been
revised to conform to FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents must not
include mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
    The draft guidance, when finalized, will represent the agency's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in sections 1-3 of this guidance have been
approved under OMB control no. 0910-0032.

V. 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.

VI. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/default.htm or http://
www.regulations.gov.

    Dated: April 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8229 Filed 4-9-10; 8:45 am]
BILLING CODE 4160-01-S


SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY STANDARDS OF PERFORMANCE FOR NSPS SUBPART AAA, NEW RESIDENTIAL WOOD HEATERS 1. Identification of the Information Collection 1( a) Title of the Information Collection ICR for 40 CFR 60.530 thru 60.539( b), New Source Performance Standards for New Residential Wood Heaters ( Subpart AAA).

1( b) Short Characterization/ Abstract The wood heater NSPS [ 40 CFR 60.530 thru 60.539( b), New Source Performance Standards for New Residential Wood Heaters ( Subpart AAA)] was proposed on February 18, 1987, and promulgated on February 26, 1988. These standards apply to each wood heater manufactured on or after July 1, 1988, or sold at retail on or after July 1, 1990. Wood heaters manufactured on or after July 1, 1990, or sold at retail on or after July 1, 1992, must meet more stringent emission standards. Approximately 50 manufacturers, 3,500 retailers, and 4 certification laboratories are currently subject to the regulations. No increase is expected in those estimates over the next 3 years. Particulate matter ( PM) is the pollutant regulated under the standards.

Two features of this rulemaking unique to the NSPS program require emphasis at the outset. First, these standards were negotiated by representatives of groups affected by the NSPS, including those groups which are burdened by the information collection activities. None of these activities were judged to be unreasonable by these representatives. Some of these provisions were recommended by the affected groups as a means of promoting an efficient and smooth running certification and enforcement program. Second, these regulations established a certification program instead of the usual NSPS requirement that each affected facility demonstrates compliance through new source review and testing. Under this certification program a single wood heater is tested to demonstrate compliance for an entire model line, which could consist of thousands of stoves. The certification approach significantly reduces the compliance burden, including information collection, for the manufacturers of wood heaters. Because of the potential risks to the environment from the intentional or accidental 2 misuse of the certification approach, there were, however, several safeguards included, some of which entail reporting and recordkeeping. Under this regulation, wood heater manufacturers, testing laboratories, and retailers are required to submit reports to EPA and/ or to maintain records for demonstrating compliance with the NSPS.

The information supplied by the manufacturer to the Agency is used to ( 1) ensure that best demonstrated technology ( BDT) is being applied to reduce emissions from wood heaters; ( 2) ensure that the wood heater tested for certification purposes is in compliance with the applicable emission standards ( 3) provide assurance that nontested production model heaters have emission performance characteristics similar to tested models; and ( 4) provide an indicator of continued compliance.

Information supplied to the Agency by testing laboratories is used to grant or deny laboratory accreditation, and assist in enforcement and compliance activities. Information requested by the Agency from manufacturers is used to determine compliance with requirements that are based upon volume of production.

The number of total affected entities ( i. e., respondents) is 54. The total number of annual responses is 3,093. The total annual labor costs are 7,653 person hours. The total annual capital and Operation/ Maintenance costs are estimated to be $ 1,500,573.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 111 of the Clean Air Act, as amended, to establish standards of performance for new stationary sources that reflect:

. . . application of the best technological system of continuous emissions reduction which ( taking into consideration the cost of achieving such emissions reduction, or any nonair quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated [ Section 111( a)( l)].

The Agency refers to this charge as selecting the best demonstrated technology ( BDT). Section 111 also requires that the Administrator review and, if appropriate, revise such standards every four years.

In addition, Section 114( a) states that the Administrator may require any owner or operator subject to any requirement of this Act to: 3 . . . ( A) establish and maintain such records; ( B) make such reports; ( C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; ( D) sample such emissions ( in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; ( F) submit compliance certifications in accordance with section 114( a)( 3); and ( G) provide such other information as the Administrator may reasonably require.

In the Administrator's judgment, particulate matter emissions from new residential wood heaters cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, the NSPS was promulgated for this source category at 40 CFR Part 60, Subpart AAA.

2( b) Practical Utility/ Utility of the Data The control of pollution from new residential wood heaters ( i. e., stoves) relies on the reduction of particulate matter emissions by proper wood heater design. A representative unit each certified model line is tested for particulate emissions. The manufacturer also conducts periodic quality assurance inspections to ensure that only complying stoves are sold to the general public.

The required notifications are used to inform the Agency or delegated authority when a new model line is expected to be tested. The reviewing authority may then observe the testing operation, if necessary. Emission test reports are needed as these are the Agency's record of a model line's initial capability to comply with the emission standard, and serve as a record of the operating conditions under which compliance was achieved.

Adequate recordkeeping, and reporting is necessary to ensure compliance with these standards, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The recordkeeping and reporting requested is required under 40 CFR Part 60, Subpart AAA. 4 3( a) Nonduplication Duplication in the reporting requirements under the regulations is minimal. Provisions have been made in the regulations to allow emission tests performed for Oregon certification to also apply for national certification. The only other federal paperwork burden which affects wood heaters is the Consumer Product Safety Commission's ( CPSC) requirement ( 16 CFR 1406) that certain solid fuel fired heating appliances be accompanied by safety warnings and installation instructions on permanent labeling and in owner's manuals. Although the standards also require certain labeling and owner's manual contents, the required disclosures and data can be combined with the CPSC required label and owner's manual contents. This provision was agreed upon by the negotiating committee to avoid duplication.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on 3/ 31/ 2000.

3( c) Consultations No comments were received on the burden published in the Federal Register.

3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the required standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting noncomplying wood heaters would decrease.

3( e) General Guidelines This section discusses the special circumstances where the regulations exceed two of the nine Paperwork Reduction Act guidelines. 5 These two items are as follows:

( a) Requiring respondents to prepare a written response to an information collection request in less than 30 days after its receipt.

Accredited laboratories are required to report to the Agency within 24 hours whenever a manufacturer which has notified the laboratory that it intends to apply for alternative certification for a model line fails to submit on schedule a representative unit of that model line for certification testing. This requirement is designed to limit circumvention by manufacturers who self certify, but who then fail to submit on schedule the self certified model for testing at an accredited laboratory. The one day reporting requirement will enable the Agency to effectively police the manufacture and sale of self certified wood heaters.

( b) Requiring respondents to retain records, other than health, medical, or tax records, for more than 3 years.

Manufacturers and laboratories are required to retain certification records for 5 years, and to retain wood heater units tested for certification as long as the certification is in effect. Each wood heater model line is certified for a 5 year period, and records must be maintained to answer any enforcement questions that arise during that period.

Manufacturers are also required to maintain sales records for 5 years. This information is useful for determining compliance with requirements based on volume production. The information is also useful for allowing dissemination of emission control and maintenance information to commercial owners, and assisting State and local officials in developing emission control strategies for nonattainment areas.

3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979). 6 3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The appropriate SIC codes for the respondents affected by this collection activity are 3433, 3631, and 8734. The corresponding, respective, NAICS codes are 333414, 335221 and 541380.

4( b) INFORMATION REQUESTED ( i) Data All data in this ICR that is recorded and/ or reported is required by 40 CFR 60.530 thru 60.539( b), New Source Performance Standards for New Residential Wood Heaters ( Subpart AAA).

Manufacturers, testing laboratories and retailers/ distributors of new residential wood heaters must make the following reports:

Reports for NSPS Subpart AAA The reporting requirements for NSPS Subpart AAA were uniquely designed for the manufacturers, testing laboratories and retailers/ distributors of new residential wood heaters. A special table is attached that describes the requirements in detail. See Table A, Respondent Reporting and Recordkeeping New Residential Wood Heaters  NSPS Subpart AAA. See Table A Manufacturers, testing laboratories and retailers/ distributors of new residential wood heaters must keep the following records: 7 Recordkeeping for NSPS Subpart AAA The recordkeeping requirements for NSPS Subpart AAA were uniquely designed for the manufacturers, testing laboratories and retailers/ distributors of new residential wood heaters. A special table is attached that describes the requirements in detail. See Table A, Respondent Reporting and Recordkeeping New Residential Wood Heaters  NSPS Subpart AAA. See Table A ( ii) Respondent Activities Respondent Activities Read instructions.

Manufacturers must obtain a certificate of compliance for each model line of wood heater to be manufactured/ sold and conduct quality assurance activities.

Laboratories must install, calibrate, maintain, and operate the appropriate equipment and demonstrate their proficiency at performing the required tests ( emission, burn rate and air tofuel ratio).

Retailers/ distributors must maintain sale records of used wood heaters.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable instructions and requirements. Respondent Activities 8 Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

The means of collecting the required information does not employ the use any special automated, mechanical, or technical collection techniques.

The reports that are submitted by the manufacturer to EPA are either very voluminous ( e. g., the application for model line certificate) or performed infrequently. Therefore, the electronic submission of such reports is not considered economically viable.

5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts various activities in connection with the acquisition, analysis, storage, and distribution of the required information as follows:

Agency Activities The Agency activities for NSPS Subpart AAA are in response to a uniquely designed rule. A special table is attached that describes the requirements in detail. See Table B, Agency Activities, New Residential Wood Heaters  NSPS Subpart AAA. See Table B 5( b) Collection Methodology and Management All reports are sent directly to the Agency. Data obtained during periodic visits by Agency personnel from records maintained by the respondents are tabulated and published for internal Agency use in compliance and enforcement programs.

Information contained in the reports is systematically filed at the Agency headquarters. Portions of the data are entered into a special database program maintained exclusively by the Agency for later retrieval, study and essential reports. 9 Public access to the wood heater database can be obtained by writing to the Agency. Reports of wood heaters currently certified are commonly requested by retailers and the general public.

Records required by this NSPS must be retained by the owner or operator for five years.

5( c) Small Entity Flexibility Virtually all of the manufacturers, laboratories, and commercial owners affected by this proposed regulation are considered small businesses based on the definition used by the Small Business Administration. Special efforts taken by the Agency to minimize burden to these respondents are summarized elsewhere in this supporting statement.

Since this rule was developed through the regulatorynegotiation process, industry representatives directly participated in the writing of the rule and agreed to make all of the required reports and keep the appropriate records as specified in the rule.

Additional efforts were taken by the Agency to reduce the burden imposed on the smallest businesses affected by this regulation. Provisions were included which allow delayed compliance of up to one year for those manufacturers producing fewer than 2,000 wood heaters per year. In addition, less frequent quality assurance emission audits were required for those manufacturers that produce fewer than 2,500 wood heaters within a model line. The wood heater standards also allow small manufacturers to purchase a certified design from another manufacturer. In this case, no certification testing is required. This provision has significantly reduced the burden associated with certification process for small manufacturers of wood heaters.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 2: Industry Burden.

6. Estimating the Burden and Cost of the Collection Table 2 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for each of the subparts included in this ICR. The 10 individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified.

The information collection, under this rule, is consistent and compatible, to the maximum extent practicable, with the respondents existing reporting or recordkeeping practices. There are no new rule requirements, since the last ICR, that would require the respondent to adjust their existing recordkeeping or reporting from previously applicable instructions or requirements that burden must be included. Responses to this information collection are mandatory.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated at 7,653 ( rounded) person hours. These hours are based on Agency studies and background documents from the development of the standards or test methods, Agency knowledge and experience with the NSPS program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This is an NSPS rule that focuses on model line certification using specific emission testing protocol which requires technically trained personnel. The other requirements in the rule, with a few minor exceptions, would also employ technically oriented personnel. Therefore, this ICR uses a single, technical labor rate.

The technical labor rate used is derived from the United States Department of Commerce Bureau of Labor Statistics, March 1999, Table 10: Employment Costs for Private Industry by Occupational and Industry Group. The rate is from column 1: Total compensation and is $ 26.16 per hour. This wage rate has been loaded by adding 110% overhead which yields a final labor rate of $ 54.94 per hour. 11 ( ii) Estimating Capital and Operations and Maintenance Costs The total annualized capital/ startup costs are $ 527,978 ( rounded). The cost are taken from Table 2 and, for manufacturers, consist of the Certification Test ($ 498,750.00), and the Application For Certification($ 29,228.08) and, for the laboratories, consist of the Proficiency Test  Accreditation ($ 7,416.90) and Notice of Proficiency Test ($ 54.94).

The annual O& M costs consist of all the remaining costs listed in Table2 and total $ 972,595 ( rounded). It should be noted that the manufacturer's O& M costs reflects the dollar amount paid by the manufacturer to the testing laboratory to perform certification test( with no associated hourly costs). On the other hand, the O& M costs to the testing laboratory reflect those hourly costs necessary to comply with specific rule provisions regarding accrediation and the maintenance of certification test records.

The overall burden cost to industry is similar to that reported in the previous ICR ($ 1,347,984). Two minor items that were previously listed under capital/ startup cost have been redesignated as O & M costs. The overall burden cost increase is attributed entirely to the higher technical labor rate used in this IRC.

( iii) Capital/ Start up vs. O& M Costs There are no new respondents and their associated capital start up costs for this ICR. The O& M costs have been previously reported.

( iv) Summary This rule is involves the certification of wood heater model lines rather than the installation of control equipment and the use of continuous monitors. For reporting purposes on the OMB 83 I form, the figures generated under item 6( b)( i) are reported as Capital/ Startup and O& M costs [ item 6( b)( 2)].

Therefore, the Capital/ Start up costs for this ICR are $ 527,978. This cost is shown on the OMB 83 I form in block 14a: Total annualized capital/ startup costs. The numbers in block 14 of the OMB 83 I form are truncated to show the cost in thousands of dollars.

The total Operating and Maintenance ( O& M) Costs for this ICR are $ 972,595. This cost is shown on the OMB 83 I form in block 12 14b: Total annual costs ( O& M). The numbers in block 14 of the OMB 83 I form are truncated to show the cost in thousands of dollars.

The total respondent costs have been calculated on the addition of the capital start up costs and the annual operations and maintenance costs. The average annual cost for capital and operations and maintenance costs to industry over the next three years of the ICR is estimated to be $ 1,500,573. This cost is shown on the OMB 83 I form in block 14 letter c: Total annualized cost requested. The numbers in block 14 of the OMB 83 I form are truncated to show the cost in thousands of dollars.

6( c) Estimating Agency Burden and Cost The only Federal costs are user costs associated with analysis of the reported information. Publication and distribution of the information are part of the AIRS program. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The average annual Federal Government cost during the 3 years of the ICR is estimated to be $ 194,452 ( from Table 1: Agency Burden Costs). This cost is based on an average wage of a ( GS 10 step 1 employee rate, ($ 17.09 hr + 110% overhead = $ 35.89. This rate is from OPM's 2000 General Schedule, excluding locality pay, basic rates.

6( d) Estimating the Respondent Universe and Total Burden and Costs Respondent Universe Regulation Title ( A) No. New Sources per Year ( B) No. of Initial Reports for New Sources ( C) No. of Existing Sources ( D) No. of Reports for Existing Sources ( E) Total Annual Responses Wood Heater NSPS Zero Zero 54 3,093 3,093 The number of total respondents is 54. This number is the sum of numbers in columns A and C of the Respondent Universe table. It is shown on the OMB 83 I form in block 13a. This is the number of existing sources plus the number of sources 13 anticipated in one year.

The total annual responses is 3,093. This number is in column E of the Respondent Universe table. It is shown on the OMB 83 I form in block 13b. The total annual labor costs are 7,653. This number is shown on the OMB 83 I form in block 13c. Details upon which this estimate is based appear in Table 2: Industry Burden.

The total annual capital and O& M costs to the regulated entity are $ 1,500,573. This number is shown on the OMB 83 I form in block 14c. These costs are detailed in sections 6( b)( i)( iii) of this ICR.

6( e) Bottom Line Burden Hours And Cost Tables The bottom line burden hours and cost tables are attached as Table 1: Agency Burden, and Table 2: Industry Burden.

6( f) Reasons for Change in Burden The wood heater has been fairly stagnate over the past three years and the number of affected sources remains approximately the same. Therefore, the rather modest burden cost increase is attributed entirely to the higher technical labor rate used in this IRC. 6( g) Burden Statement Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested 14 methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, Office of Environmental Information ( OEI), U. S. Environmental Protection Agency, Mail code 2822, 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number 1176.06 and OMB control number 2060 0161 in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


[Federal Register: August 7, 2007 (Volume 72, Number 151)]
[Notices]
[Page 44130]
[DOCID:fr07au07-36]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-537-000]

Northern Natural Gas Company; Notice of Proposed Changes in FERC
Gas Tariff

July 31, 2007.
    Take notice that on July 27, 2007, Northern Natural Gas Company
(Northern), tendered for filing in its FERC Gas Tariff, Fifth Revised
Volume No. 1 the following tariff sheets, to be effective August 27,
2007:

44 Revised Sheet No. 66A
First Revised Sheet No. 66B.03
Tenth Revised Sheet No. 66D

    Northern states that it is filing the above-referenced tariff
sheets to submit a Rate Schedule PDD service agreement for Commission
acceptance as a non-conforming and negotiated rate agreement.
    Northern further states that copies of the filing have been mailed
to each of its customers and interested state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

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

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-15278 Filed 8-6-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 116 (Friday, June 16, 2023)]
[Rules and Regulations]
[Pages 39350-39352]
[FR Doc No: 2023-12956]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-0502; Airspace Docket No. 23-ASO-09]
RIN 2120-AA66

Amendment of Class E Airspace; Augusta, GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This amends Class E airspace extending upward from 700 feet
above the surface in Augusta, GA, as the result of new procedures
developed for the Augusta University Medical Center and Children's
Hospital of Georgia Heliport. This action establishes Class E airspace
extending upward from 700 feet above the surface within a 6-mile radius
of the Augusta University Medical Center and Children's Hospital of
Georgia. The FAA will also update the geographical coordinates for the
Emory non-directional beacon (NDB) in the Augusta Class E5 legal
description to align with information located in the FAA's database.

DATES: Effective date 0901 UTC, October 5, 2023. 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: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours a day, 365 days a year.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation

Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jennifer Ledford, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; 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
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it amends airspace for Augusta University Medical Center
and Children's Hospital of Georgia Heliport, Augusta, GA, to support
IFR operations in the area.

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA 2023-0502 in the Federal Register (88 FR 18264: March 28, 2023),
amending Class E airspace extending upward from 700 feet above the
surface at the Augusta University Medical Center and Children's
Hospital of Georgia Heliport. One comment was received concerning
whether the airspace would be exclusive to medical aircraft or if it
would be open to the public. The controlled airspace surrounding
Augusta University Medical Center and Children's Hospital was
established to provide for the safety and management of instrument
flight rules operations in the area, as a new instrument approach
procedure was recently developed for the heliport. All aircraft
operating within the Class E airspace must adhere to the requirements
set forth in 14 CFR 91.127.

Differences From the NPRM

    Subsequent to the publication of the Notice of Proposed Rulemaking,
the FAA found that the geographical coordinates for the Emory NDB did
not align with the information found in FAA's database. This action
updates the Emory NDB geographical coordinates.

Incorporation by Reference

    Class E airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11, Airspace Designations and Reporting Points, which
is incorporated by reference in 14 CFR 71.1 annually. This document
amends the current version of that order, FAA Order JO 7400.11G, dated
August 19, 2022, and effective September 15, 2022. FAA Order JO
7400.11G is publicly available as listed in the ADDRESSES section of
this document. These amendments will be published in the next FAA Order
JO 7400.11 update.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by amending Class E airspace
extending upward from 700 feet above the surface in Augusta, GA, by
establishing Class E airspace extending upward from the surface within
a 6-mile radius of the Augusta University Medical Center and Children's
Hospital of Georgia. This airspace will allow medical transport
helicopters to fly during inclement weather and will be included in the
Augusta, GA, Class E5 legal description. In addition, this action will
update the Emory NDB geographical coordinates in the Augusta, GA, Class
E5 legal description to align with the information found in the FAA's
database.

Regulatory Notices and Analyses

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

Environmental Review

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

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

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

0
1. The authority citation for 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
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

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

* * * * *

ASO GA E5 Augusta, GA [Amended]

Augusta Regional Airport at Bush Field, GA
    (Lat 33[deg]22'12'' N, long 81[deg]57'52'' W)
Daniel Field
    (Lat 33[deg]28'00'' N, long 82[deg]02'22'' W)
Augusta University Medical Center and Children's Hospital of Georgia
    (Lat 33[deg]28'17'' N, long 81[deg]59'17'' W)
Emory NDB
    (Lat 33[deg]27'46'' N, long 81[deg]59'49'' W)

    That airspace extending upward from 700 feet above the surface
within an 8.6-mile radius of Augusta Regional Airport at Bush Field
and within 3.2 miles on either side of the 168[deg] bearing from the
airport extending from the 8.6-mile radius to 12.5 miles south of
the airport, and within a 7-mile radius of Daniel Field, and a 6-
mile radius of Augusta University Medical Center and Children's
Hospital of Georgia, and within 8 miles west and 4 miles east of the
349[deg] bearing from the Emory NDB extending from the 7-mile radius
of Daniel Field and the 6-mile radius of Augusta University Medical
Center and Children's Hospital of Georgia to 16 miles north of the
Emory NDB.
* * * * *

    Issued in College Park, GA, on June 12, 2023.
Andreese C. Davis,
Manager Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2023-12956 Filed 6-15-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Rules and Regulations]
[Pages 38871-38873]
[FR Doc No: 2019-16960]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0672]
RIN 1625-AA00

Safety Zone; St. Norbert College Fireworks, Fox River, De Pere,
WI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain navigable waters of the Fox River in De Pere, WI for the St.
Norbert College Fireworks event. This temporary safety zone is
necessary to protect spectators, mariners, vessels, and property from
potential hazards associated with a fireworks display. Entry of vessels
or persons into this zone is prohibited unless specifically authorized
by the Captain of the Port Lake Michigan.

DATES: This rule is effective from 7:30 p.m. through 9 p.m. on August
25, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0672 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Petty Officer Kyle Weitzell, Sector Lake Michigan
Waterways Management Division, U.S. Coast Guard; telephone 414-747-
7148, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard did not receive the
final details of this fireworks display in sufficient time to publish
an NPRM. Delaying the effective date of this rule to wait for a commend
period to run would be both impracticable and contrary to the public
interest because it would inhibit the Coast Guard's ability to protect
the public, mariners, vessels, and property from the hazards associated
with this event which is scheduled on August 25, 2019.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to public interest
because waiting for an NPRM and final publication would inhibit the
Coast Guard's ability to protect spectators and vessels from the
potential safety hazards associated with a fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Lake
Michigan has determined that potential hazards associated with the St.
Norbert College Fireworks display on August 25, 2019, will be a safety
concern for anyone within a 500-foot radius of a vessel used to launch
fireworks in the Fox River in De Pere, WI at coordinates 44[deg]26'55''
N, 088[deg]03'50'' W. This rule is needed to protect personnel,
vessels, and the marine environment in the navigable waters within the
safety zone during the fireworks display.

IV. Discussion of the Rule

    This rule establishes a safety zone from 7:30 p.m. through 9 p.m.
on August 25, 2019 for the waters of the Fox River in De Pere, WI at
coordinates 44[deg]26'55'' N, 088[deg]03'50'' W. The duration of the
zone is intended to protect personnel, vessels, and the marine
environment in these navigable waters from falling embers and fireworks
debris during the St. Norbert College Fireworks display. The duration
of the zone is intended to ensure the safety of vessels and these
navigable waters before, during, and after the fireworks display. Entry
into, transiting, or anchoring within the safety zone is prohibited
unless authorized by the COTP or a designated on-scene representative.
The COTP or a

designated on-scene representative may be contacted via VHF Channel 16.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the
characteristics of the safety zone. The safety zone created by this
rule will be relatively small and is designed to minimize its impact on
navigable waters. This rule will prohibit entry into certain navigable
waters in the Fox River, Du Pere, WI not to exceed one and one half
hour in duration. Thus, restrictions on vessel movement within that
particular area are expected to be minimal. Under certain conditions,
moreover, vessels may still transit through the safety zone when
permitted by the Captain of the Port Lake Michigan.

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 rule
will 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
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 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
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves establishment of a safety zone. It is
categorically excluded from further review under paragraph L60(a) in
Table 3-1 of U.S. Coast Guard Environmental Planning Implementing
Procedures. A Record of Environmental Consideration supporting this
determination will be available in the docket where indicated under
ADDRESSES once it is completed.

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.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 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. 0170.1.

0
2. Add Sec.  165.T09-0672 to read as follows:

Sec.  165.T09-0672  Safety Zone; St. Norbert College Fireworks, Fox
River, De Pere, WI.

    (a) Location. All navigable waters of the Fox River in De Pere, WI
within 500 feet of a vessel used to launch fireworks at coordinates
44[deg]26'55'' N, 088[deg]03'50'' W.
    (b) Enforcement Period. The regulated area described in paragraph
(a) will be enforced from 7:30 p.m. through 9 p.m. on August 25, 2019.
    (c) Regulations. (1) In accordance with the general regulations in
section Sec.  165.23, entry into, transiting, or anchoring within this
safety zone is prohibited unless authorized by the Captain of the Port
Lake Michigan (COTP) or a designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or a designated on-scene representative.
    (3) The ``on-scene representative'' of the COTP is any Coast Guard
commissioned, warrant or petty officer who has been designated by the
COTP to act on his or her behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or an on-scene representative to obtain
permission to do so. The COTP or an on-scene representative may be
contacted via VHF Channel 16. Vessel operators given permission to
enter or operate in the safety zone must comply with all directions
given to them by the COTP or an on-scene representative.

    Dated: August 2, 2019.
L.M. Lusk,
Commander, U.S. Coast Guard, Acting Captain of the Port Sector Lake
Michigan.
[FR Doc. 2019-16960 Filed 8-7-19; 8:45 am]
BILLING CODE 9110-04-P