[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54128-54129]
[FR Doc No: 2018-23477]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2014-0713]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-NEW

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval for
the following collection of information: 1625-NEW, State Registration
Data. Our ICR describes the information we seek to collect from the
public. Review and comments by OIRA ensure we only impose paperwork
burdens commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
November 26, 2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2014-0713] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email: [email protected].
    (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention
Desk Officer for the Coast Guard.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: COMMANDANT (CG-612), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An

ICR is an application to OIRA seeking the approval, extension, or
renewal of a Coast Guard collection of information (Collection). The
ICR contains information describing the Collection's purpose, the
Collection's likely burden on the affected public, an explanation of
the necessity of the Collection, and other important information
describing the Collection. There is one ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. These comments
will help OIRA determine whether to approve the ICR referred to in this
Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2014-0713], and must be received by November 26,
2018.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-NEW.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day Notice (81 FR 85987, November 29,
2016) required by 44 U.S.C. 3506(c)(2). The Coast Guard previously
published a 60-day Notice for this ICR on October 7, 2014 (79 FR
60483). The comments from that Notice were addressed in the latest 60-
day Notice (81 FR 85987), November 29, 2016). The present 60-day Notice
elicited several questions from a single commenter.
    Comment (1) A commenter questioned the Coast Guard's response to
previously submitted comment (6) in which the Coast Guard noted a
reduced reporting burden with the revised form. The commenter noted
that the burden is not reduced since collecting aspects of vessels such
as hull material and engine type are already required under 33 CFR 174
even if statistics regarding these aspects are not required on form
CGHQ-3923.
    Answer: The burden of filling out the revised form is reduced. On
the previous version of CGHQ-3923, the Coast Guard required statistics
on over 150 data points whereas the proposed version of the form
requires only 69. The previous version requested information on five
variables (vessel type, hull material, length, engine type and use)
whereas the proposed version requires only three variables (vessel
type, length, primary operation). The Coast Guard expects a reduced
burden as the proposed form will require fewer queries and fewer data
point checks to complete it.
    Comment (2) A commenter questioned why aspects of vessels such as
hull material and engine type are necessary in 33 CFR 174 since they
are not required elements to be reported on form CGHQ-3923.
    Answer: Various aspects of vessels are required to be collected for
law enforcement purposes. Even though various vessel aspects such as
hull material and engine type are not on the proposed form CGHQ-3923,
they are used in accident, theft, and fraud investigations. Using
common terminology facilitates common understanding.
    Comment (3) A commenter noted that hull material and engine type
are of interest to sectors and should be on form CGHQ-3923 since
information on them cannot be obtained outside of CGHQ-3923.
    Answer: The Coast Guard works with various sectors including
government, industry, non-profits, and researchers. If a party
requested information other than what is available on CGHQ-3923, the
Coast Guard would direct the user to a more appropriate contact.
    Comment (4) A commenter provided a recommended version of CGHQ-3923
that is a medication of the previous CGHQ-3923. It includes additional
hull material entries, an additional engine type, and changes the names
of some categories.
    Answer: The Coast Guard thanks the commenter for the suggested form
but maintains a desire to have a simplified form for use by the States.
The Coast Guard has not used the hull material or engine information
collected previously. Because we have not used the data, we removed it
from the form so as to reduce the burden of data reporting on the
States.

Information Collection Request

    Title: State Registration Data.
    OMB Control Number: 1625-NEW.
    Summary: This file provides information on the collection of
registration data from the State reporting authorities.
    Need: 46 U.S.C. 12302 and 33 CFR 174.123 authorize the collection
of this information. Registration data is used for statistical
purposes.
    Forms: CGHQ-3923, State Registration Data.
    Respondents: 56 State reporting authorities respond.
    Frequency: Annually.
    Hour Burden Estimate: This is a new information collection; the
estimated annual burden is 42 hours a year.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter
35, as amended.

    Dated: 23 October 2018.
James D. Roppel,
U.S. Coast Guard, Acting Chief, Office of Information Management.
[FR Doc. 2018-23477 Filed 10-25-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Pages 13659-13660]
[FR Doc No: 2020-04754]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0256]

United States Food and Drug Administration and Health Canada
Joint Regional Consultation on the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a regional public meeting entitled ``U.S. Food and Drug Administration
and Health Canada Joint Regional Consultation on the International
Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH).'' The purpose of the public meeting is to provide
information and solicit public input on the current activities of the
ICH, as well as the upcoming ICH Assembly Meeting and the Expert
Working Group Meetings in Vancouver, Canada, scheduled for May 23
through 27, 2020. The topics to be addressed at the public meeting are
the current ICH guideline topics under development that will be
discussed at the forthcoming ICH Assembly Meeting in Vancouver.

DATES: The public meeting will be held on Friday, April 3, 2020, from
10 a.m. to 1 p.m. Submit either electronic or written comments on this
public meeting by Thursday, April 30, 2020. See the SUPPLEMENTARY
INFORMATION section for registration date and information.

ADDRESSES: The public meeting will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the
Great Room), Silver Spring, MD 20993-0002. The meeting will also be
broadcast on the web, allowing participants to join in person or via
the web. For those who will attend in person, the entrance for the
public meeting participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. For those who register to attend the public meeting
remotely via the webcast, a link to access the webcast will be emailed
1 week in advance of the meeting.
    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 May 20, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time on Thursday, April 30, 2020. 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-2020-N-0256 for ``U.S. Food and Drug Administration and Health
Canada Joint Regional Consultation on the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use; Public Meeting; 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.'' 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.

FOR FURTHER INFORMATION CONTACT: William Lewallen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993-0002, 301-
796-3810<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The ICH, formerly known as the International Conference on
Harmonisation, was established in 1990 as a joint regulatory/industry
project to improve, through harmonization, the efficiency of the
process for developing and registering new medicinal products in
Europe, Japan, and the United States without compromising the
regulatory requirements for safety and effectiveness. One of the goals
of harmonization is to identify and then reduce regional differences in
technical regulatory requirements for pharmaceutical products while
preserving a consistently high standard for drug efficacy, safety, and
quality.
    In 2015, the ICH was reformed to establish it as a true global
initiative and to expand beyond the previous ICH members. More
involvement from regulators around the world is expected, as they join
counterparts from Europe, Japan, the United States, Canada, and
Switzerland as ICH observers and regulatory members. Expanded
involvement is also anticipated from global regulated pharmaceutical
industry parties, joining as ICH observers and industry members. The
reforms built on a 25-year track record and have allowed ICH to
continue its successful delivery of harmonized guidelines for global
pharmaceutical development and their regulation.

II. Topics for Discussion at the Public Meeting

    The topics for discussion at this public meeting include the
current guidelines under development under the ICH. ICH guidelines are
developed following a five-step process.
    In step 1, experts from the different ICH regions work together to
prepare a consensus draft of the step 1 technical document. The step 1
technical document is submitted to the ICH Assembly to request
endorsement under step 2a of the process. Step 2b is a ``regulators
only'' step in which the ICH regulatory members review the step 2a
final technical document and take any actions, which might include
revisions that they deem necessary, to develop the draft ``guideline.''
Step 3 of the process begins with the public consultation process
conducted by each of the ICH regulatory members in their respective
regions, and this step concludes with completion and acceptance of any
revisions that need to be made to the step 2b draft guideline in
response to public comments. Adoption of the new guideline occurs in
step 4. Following adoption, the harmonized guideline moves to step 5,
the final step of the process when it is implemented by each of the
regulatory members in their respective regions. The ICH process has
achieved significant harmonization of the technical requirements for
the approval of pharmaceuticals for human use in the ICH regions since
1990. More information on the current ICH process and structure can be
found at the following website: https://www.ich.org.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting
must register online by April 2, 2020. To register for the public
meeting, please visit the following website: https://ich_regional_consultation_2020.eventbrite.com. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting in person must register by April 2, 2020, midnight Eastern
Time. Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public meeting will be provided beginning at 9:30 a.m.
    The agenda for the public meeting will be made available on the
internet at http://wcms-internet.fda.gov/drugs/news-events-human-drugs/health-canada-and-fda-joint-public-consultation-international-council-harmonisation-technical-0 approximately 2 weeks in advance of the
meeting.
    If you need special accommodations due to a disability, please
contact William Lewallen (see FOR FURTHER INFORMATION CONTACT) no later
than March 20, 2020.
    Persons attending FDA's meetings are advised that FDA is not
responsible for providing access to electrical outlets.
    Requests for Oral Presentations: If you wish to make a presentation
during the public comment session, please contact William Lewallen (see
FOR FURTHER INFORMATION CONTACT) no later than March 20, 2020.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations and request time for a
joint presentation. If selected for presentation, any presentation
materials must be emailed to William Lewallen (see FOR FURTHER
INFORMATION CONTACT) no later than April 2, 2020. No commercial or
promotional material will be permitted to be presented or distributed
at the public meeting. Signup for making a public comment will also be
available between 9 a.m. and 10 a.m. on the day of the meeting.
    Streaming Webcast of the Public Meeting: This public meeting will
also be webcast through the following link: https://collaboration.fda.gov/fdahealthcanada/. To register to attend via
webcast, please visit the following website: https://ich_regional_consultation_2020.eventbrite.com.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

    Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04754 Filed 3-6-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 13, 2007 (Volume 72, Number 48)]
[Notices]
[Page 11345]
[DOCID:fr13mr07-36]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP96-320-071]

Gulf South Pipeline Company, LP; Notice of Negotiated Rate Filing

March 7, 2007.
    Take notice that on March 1, 2007, Gulf South Pipeline Company, LP
(Gulf South) filed an amendment of negotiated rate contract between
Gulf South and South Alabama Gas District, Contract No. 30438, formerly
Contract Nos. 14505 and 29277.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

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

TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-4491 Filed 3-12-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: March 1, 2006 (Volume 71, Number 40)]
[Notices]
[Page 10505-10506]
[DOCID:fr01mr06-57]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0078; FRL-7762-2]

Notice of Filing of Pesticide Petitions for Establishment or
Amendment to Regulations for Residues of Pesticide Chemicals in or on
Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment or amendment of regulations for
residues of pesticide chemicals in or on various commodities.

DATES: Comments must be received on or before March 31, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0078. and pesticide petition number PP
6E7026, by one of the following methods:
     http://www.regulations.gov/. Follow the on-line

instructions for submitting comments.
     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2006-0078. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is<PHONE_NUMBER>. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0078. EPA's policy is that all comments received will be included
in the public 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 http://www.regulations.gov website is an ``anonymous access''

system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going at
regulations.gov, your e-mail address will be captured automatically and
included as part of the comment that is placed in the public docket and
made available on the Internet. If you submit an electronic comment,
EPA recommends that you include your name and other contact information
in the body of your comment and with any disk or CD ROM you submit. If
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
regulation.gov index.

Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in
regulations.gov or in hard copy at the Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1801
S. Bell St., Arlington, VA. The docket facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the docket facility is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division,
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington DC 20460-0001;<PHONE_NUMBER>;
e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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. What Action is the Agency Taking?

    EPA is printing a summary of a pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or amendment of regulations in
40 CFR part 180 for residues of pesticide chemicals in or on various
food commodities. EPA has determined that this pesticide petition
contains data or information regarding the elements set forth in FFDCA
section 408(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data support granting
of the pesticide petition. Additional data may be needed before EPA
rules on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner along with a description of the
analytical method available for the detection and measurement of the
pesticide chemical residues is available on EPA's Electronic Docket at
http://www.regulations.gov/. To locate this information on the home

page of EPA's Electronic Docket, select ``Quick Search'' and type the
OPP docket ID number. Once the search has located the docket, clicking
on the ``Docket ID'' will bring up a list of all documents in the
docket for the pesticide including the petition summary.

New Exemption from Tolerance

    PP 6E7026. BASF AG, 67056 Ludwigshafen, Germany, proposes to
establish an exemption from the requirement of a tolerance for residues
of a polymer, 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer, (CAS
Reg. No. 25189-83-7), in or on food commodities when used as an inert
ingredient . Because this petition is a request for an exemption from
the requirement of a tolerance without numerical limitations, no
analytical method is required.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: February 17, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E6-2895 Filed 2-28-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Notices]
[Pages 44708-44709]
[FR Doc No: 2021-17315]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-R10-OAR-2020-0724; FRL-8863-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Federal Implementation Plans Under the Clean
Air Act for Indian Reservations in Idaho, Oregon and Washington
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Federal Implementation Plans
under the Clean Air Act for Indian Reservations in Idaho, Oregon and
Washington (EPA ICR Number 2020.08, OMB Control Number 2060-0558), to
the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through August 31,
2021. Public comments were previously requested via the Federal
Register on February 12, 2021 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. 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.

DATES: Additional comments may be submitted on or before September 13,
2021.

ADDRESSES: Submit your comments to EPA, referencing Docket ID No. EPA-
R10-OAR-2020-0724, online using www.regulations.gov (our preferred
method), or by mail to: EPA Docket Center, Environmental Protection
Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC
20460. EPA's policy is that all comments received will be included in
the public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Sarah Frederick, Region 10 Air and
Radiation Division, telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: EPA promulgated Federal Implementation Plans (FIPs) under
the Clean Air Act for Indian reservations located in Idaho, Oregon, and
Washington in 40 CFR part 49 (70 FR 18074, April 8, 2005). The FIPs in
the final rule, also referred to as the Federal Air Rules for Indian
Reservations in Idaho, Oregon, and Washington (FARR), include
information collection requirements associated with the partial
delegation of administrative authority to a Tribe in 40 CFR 49.122; the
rule for limiting visible emissions at 40 CFR 49.124; fugitive
particulate matter rule in 40 CFR 49.126; the wood waste burner rule in
40 CFR 49.127; the rule for limiting sulfur in fuels in 40 CFR 49.130;
the rule for open burning in 40 CFR 49.131; the rules for general open
burning permits, agricultural burning permits, and forestry and
silvicultural burning permits in 40 CFR 49.132, 49.133, and 49.134; the
rule for emissions detrimental to human health and welfare in 40 CFR
49.135; the registration rule in 40 CFR 49.138; and the rule for non-
title V operating permits in 40 CFR 49.139. EPA uses this information
to manage the activities and sources of air pollution on the Indian
reservations in Idaho, Oregon, and Washington. EPA believes these
information collection requirements are appropriate because they will
enable EPA to develop and maintain accurate records of air pollution
sources and their emissions, track emissions trends and changes,
identify potential air quality problems, allow EPA to issue permits or
approvals, and ensure appropriate records are available to verify
compliance with these FIPs. The information collection requirements
listed above are all mandatory. Regulated entities can assert claims of
business confidentiality and EPA will address these claims in
accordance with the provisions of 40 CFR part 2, subpart B.

    Form Numbers:
EPA Form 7630-1 Nez Perce Reservation Air Quality Permit: Agricultural
Burn
EPA Form 7630-2 Nez Perce Reservation Air Quality Permit: Forestry Burn
EPA Form 7630-3 Nez Perce Reservation Air Quality Permit: Large Open
Burn
EPA Form 7630-4 Initial or Annual Source Registration
EPA Form 7630-5 Report of Change of Ownership
EPA Form 7630-6 Report of Closure

EPA Form 7630-7 Report of Relocation
EPA Form 7630-8 Small Burn Air Quality Permit Application
EPA Form 7630-9 Non-Title V Operating Permit Application Form
EPA Form 7630-10 Umatilla Indian Reservation: Agricultural Burn Permit
Application
EPA Form 7630-11 Umatilla Indian Reservation: Forestry Burn Permit
Application
EPA Form 7630-12 Umatilla Indian Reservation: Large Open Burn Permit
Application
EPA Form 5800-057 FARR Online Reporting System Initial or Annual Source
Registration

    Respondents/affected entities: Owners and operators of air emission
sources in all industry groups and tribal governments, located in the
identified Indian reservations.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 1,732 (total).
    Frequency of response: Annual or occasional.
    Total estimated burden: 3,601 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $286,888 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in the Estimates: There is decrease of 614 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is based on input from source
consultations, supersedence of the provisions of one rule (49.139), and
information we have learned about the source universe through
implementing the rules since the ICR was updated in 2018.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-17315 Filed 8-12-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Proposed Rules]
[Pages 68782-68783]
[FR Doc No: 2013-27366]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1904 and 1952

[Docket No. OSHA-2013-0023]
RIN 1218-AC49

Public Meeting on the Improve Tracking of Workplace Injuries and
Illnesses Proposed Rule

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice of public meeting.

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

SUMMARY: OSHA invites interested parties to attend an informal public
meeting on the Improve Tracking of Workplace Injuries and Illnesses
proposed rule. The purpose of the public meeting is to allow interested
persons to provide oral remarks regarding the proposed rule. The
proposed rule is a limited rulemaking to amend OSHA's recordkeeping
regulations to add requirements for the electronic submission of injury
and illness information employers are already required to keep.

DATES: The public meeting will be held on Thursday, January 9, 2014
from 9 a.m. to 4:30 p.m. at the U.S. Department of Labor in Washington,
DC. The deadline to request to attend the meeting as a speaker or an
observer is Friday, December 13, 2013.

ADDRESSES: Requests to attend the public meeting: Requests to attend
the public meeting, identified by docket number OSHA-2013-0023, or
regulatory information number (RIN) 1218-AC49, as a speaker or
observer, may be made by any of the methods below.
    a. Electronically: You may submit requests to attend the meeting
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting a
comment.
    b. Fax: If your request, including attachments, does not exceed
more than 10 pages, you may fax them to the OSHA Docket Office at (202)
693-1648; or
    c. Mail, hand delivery, express mail, messenger or courier service:
You may submit your request to attend the meeting, and any attachments,
to the OSHA Docket Office, Docket Number OSHA-2013-0023, U.S.
Department of Labor, Room N-2655, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone<PHONE_NUMBER> (OSHA's TTY number is
(877) 889-5627). Deliveries (hand, express mail, messenger and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Public Meeting: The public meeting will be held in the auditorium
of the U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210.
    Requests for special accommodations: Submit requests for special
accommodations to attend the public meeting to Frank Meilinger,
Director, OSHA Office of Communications, Room N-3647, U.S. Department
of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone:
(202) 693-1999; email<EMAIL_ADDRESS>    Instructions for submitting requests to attend the public meeting:
All requests to attend the public meeting must include the docket
number (Docket No. OSHA-2013-0023) or the RIN (1218-AC49) for this
rulemaking. Because of security-related procedures, submissions by
regular mail may result in significant delay. Please contact the OSHA
Docket Office for information about security procedures for making
submissions by hand delivery, express delivery, and messenger or
courier service.
    All requests to attend the meeting, including any personal
information you provide, are placed in the public docket without change
and may be made available online at http://www.regulations.gov.
Therefore, OSHA cautions you about submitting personal information such
as social security numbers and birthdates. For further information on
submitting requests to attend, plus additional information on the
rulemaking process, see Public Participation in the SUPPLEMENTARY
INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    a. Press inquiries: Contact Francis (Frank) Meilinger, Director,
OSHA Office of Communications, Room N-3647, U.S. Department of Labor,
200 Constitution Avenue NW., Washington, DC 20210; telephone: (202)
693-1999; email<EMAIL_ADDRESS>    b. General and technical information: Contact Dave Schmidt,
Director, Office of Statistical Analysis, OSHA Directorate of
Evaluation and Analysis, U.S. Department of Labor, 200 Constitution
Avenue NW., Room N-3507, Washington, DC 20210; telephone: (202) 693-
1886; email<EMAIL_ADDRESS>    c. Copies of this Federal Register notice: Electronic copies are
available at

http://www.regulations.gov. The Federal Register notice, as well as
news releases and other relevant information, also are available on the
OSHA Web page: http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 8, 2013, OSHA published the Improve Tracking of
Workplace Injuries and Illnesses proposed rule [See Vol. 78 FR 67254-
67283] OSHA proposes to amend its recordkeeping regulations to add
requirements for the electronic submission of injury and illness
information employers are already required to keep under Part 1904. The
proposed rule amends 29 CFR 1904.41 to add three new electronic
reporting requirements. The purpose of the rulemaking is to improve
workplace safety and health through the collection of useful,
accessible, establishment-specific injury and illness data to which
OSHA currently does not have direct, timely, and systematic access.
With the information acquired through the proposed rule, employers,
employees, employee representatives, the government, and researchers
will be better able to identify and abate workplace hazards. For
additional information on the proposed rule and other ways to submit
comments, see Vol. 78 FR 67254-67283.

II. Public Participation

    Recordkeeping requirements promulgated under the Occupational
Safety and Health Act of 1970 (OSH Act) are regulations, not standards.
Therefore, this rulemaking is governed by the notice and comments
requirements in the Administrative Procedure Act (APA) (5 U.S.C. 553)
rather than section 6 of the OSH Act (29 U.S.C. 655) and 29 CFR part
1911. Section 6(b)(3) of the OSH Act (29 U.S.C. 655(b)(3)) and 29 CFR
1911.11, both of which state the requirement for OSHA to hold an
informal public hearing on proposed rules, only apply to promulgating,
modifying or revoking occupational safety and health standards.
    Section 553 of the APA, which governs this proposal, does not
require a public hearing; instead, it states that the agency must
``give interested persons an opportunity to participate in the
rulemaking through submission of written data, views, or arguments with
or without opportunity for oral presentation'' (5 U.S.C. 553(c))
(emphasis added). To promulgate a proposed regulation, the APA requires
the agency to provide the terms of the proposed rule or a description
of these terms, specify the time during which the agency will receive
comments on the proposal, and give instructions regarding how to
participate in the rulemaking (5 U.S.C. 553(b)). The APA does not
specify a minimum period for submitting comments. In accordance with
the goals of Executive Order 12866, OSHA is providing 90 days for
public comment (E.O. 12866 section 6(a)(1)).
    Public Meeting: OSHA will hold a public meeting on the proposed
rule from 9 a.m. to 4:30 p.m. on Thursday, January 9, 2014 at the U.S.
Department of Labor in Washington, DC (see ADDRESSES section). If
necessary, the meeting may be extended to subsequent days. The purpose
of the public meeting is to allow interested persons to provide oral
remarks on the proposed rule, which is a limited rulemaking to amend
its recordkeeping regulations to add requirements for the electronic
submission of injury and illness information employers are already
required to keep under Part 1904. Although OSHA is not required to hold
a public meeting on proposed regulations, the Agency believes that the
public meeting will help facilitate the development of a clear and
complete rulemaking record. Consistent with this purpose, OSHA has the
discretion to limit the time of speakers whose presentation goes beyond
the scope of the proposed regulation.
    Requests for individuals to attend the meeting must be received by
Friday, December 13, 2013. The request must provide the following
information:
     Name, email address, and telephone number of each
individual who will attend the meeting;
     Name of the organization or establishment each attendee
represents, if any;
     Occupational title and position of each attendee, if any;
     If each attendee is planning to participate in-person or
via teleconference;
     Whether each attendee is planning to speak at the meeting;
and
     If planning to speak, the approximate time each attendee
wishes to speak, and the topics each attendee wishes to cover at the
meeting.
    OSHA will review each request to speak and determine whether the
information it contains warrants the amount of time the individual
requested. To ensure that each individual wishing to speak is allotted
time, speakers will be limited to a maximum of 10 minutes each. OSHA
may also limit the time allocated to any individual who fails to comply
substantially with the procedures for submitting a request to speak.
    At OSHA's discretion and as time permits, individuals who did not
submit a request to speak may be allowed time, not exceeding five
minutes, to make a brief oral statement at the end of the scheduled
presentations.
    OSHA will provide access to the public meeting via teleconference.
Attendees participating via teleconference can listen in, but will be
unable to speak during the meeting. The number of lines provided is
limited and will be available on a first come, first served basis to
those who indicate that they will be participating via teleconference
in their requests to attend the meeting. Additional teleconference
information, including dial-in number, will be provided in advance of
the meeting.
    OSHA will post the schedule of appearances for the public meeting,
as well as additional information about the meeting, on OSHA's Web
page: http://www.osha.gov. The meeting will be transcribed. The
transcription and all materials submitted during the public meeting
will be put in the public docket of the rulemaking (Docket No. OSHA-
2013-0023) at http://www.regulations.gov.

Authority and Signature

    This document was prepared under the direction of David Michaels,
Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and
Health, 200 Constitution Avenue NW., Washington, DC 20210. It is issued
under Sections 8 and 24 of the Occupational Safety and Health Act (29
U.S.C. 657, 673), Section 553 of the Administrative Procedure Act (5
U.S.C. 553), and Secretary of Labor's Order No. 41-2012 (77 FR 3912
(Jan. 25, 2012)).

    Signed at Washington, DC, November 8, 2013.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2013-27366 Filed 11-14-13; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Notices]
[Pages 38278-38279]
[FR Doc No: 2019-16796]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4447-DR; Docket ID FEMA-2019-0001]

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

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Ohio (FEMA-4447-DR), dated June 18, 2019, and related
determinations.

DATES: This amendment was issued July 17, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency

Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-
2833.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Ohio is hereby amended to include Public Assistance
for the following areas among those areas determined to have been
adversely affected by the event declared a major disaster by the
President in his declaration of June 18, 2019.

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

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-16796 Filed 8-5-19; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17135-17136]
[FR Doc No: 2011-7211]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0148]

Clarifying Edits to Existing Special Controls Guidance Documents;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of updated special controls guidance documents for class
II devices, which contain edits that reflect the Agency's effort to
clarify questions and confusion regarding its position on the binding
nature of special controls guidance documents. The revised language
does not change the Agency's position or view, but rather is intended
to clarify its position and remedy any possible confusion or
misunderstanding.

DATES: Submit either electronic or written comments on this document at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic
access to affected documents.
    Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5452, Silver Spring, MD 20993-0002, 301-
796-5678; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In December 2008, FDA revised the cover sheet and standard language
in newly issued special controls guidance documents to clarify the
effect of a guidance that has been established as a special control
(``special controls guidance''). In order to comply with the special
controls guidance, manufacturers must address each identified risk to
health presented in the guidance for the class II device by either
meeting the recommendations of the guidance or by some other means that
provides equivalent assurances of safety and effectiveness.
    FDA is now updating all pre-December 2008 special controls guidance
documents with the revised standard language. Revisions to the special
controls guidance documents include clarifying the statement of the
special controls guidance document's effect by replacing the standard
language with the following statement: ``The firm must show that its
device addresses the issues of safety and effectiveness identified in
this guidance, either by meeting the recommendations of this guidance
or by some other means that provides equivalent assurances of safety
and effectiveness.''
    Special controls guidance documents on the following topics have
been affected: \1\
---------------------------------------------------------------------------

    \1\ All guidance titles throughout this document reflect the
style of the published versions.
---------------------------------------------------------------------------

    1. Acute Upper Airway Obstruction Devices,
    2. Clitoral Engorgement Devices,
    3. Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA)
Premarket Notifications,
    4. Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-
Constrained Porous-Coated Uncemented Prosthesis,
    5. B-Type Natriuretic Peptide Premarket Notifications,
    6. Home Uterine Activity Monitors,
    7. Pharmacy Compounding Systems,
    8. Tissue Culture Media for Human ex vivo Tissue and Cell Culture
Processing Applications,
    9. Indwelling Blood Gas Analyzers,
    10. Ingestible Telemetric Gastrointestinal Capsule Imaging System,
    11. Premarket Notifications for Automated Differential Cell Counter
for Immature or Abnormal Blood Cells,
    12. Medical Washers and Medical Washer-Disinfectors,

    13. Endolymphatic Shunt Tube with Valve,
    14. Hip Joint Metal/Polymer Constrained Cemented or Uncemented
Prosthesis,
    15. Apnea Monitors,
    16. Polymethylmethacrylate (PMMA) Bone Cement,
    17. Cyclosporine and Tacrolimus Assays,
    18. Transcutaneous Air Conduction Hearing Aid System (TACHAS),
    19. Intraoral Devices for Snoring and/or Obstructive Sleep Apnea,
    20. Cutaneous Carbon Dioxide and Oxygen Monitors,
    21. Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer
Porous-Coated Uncemented Prostheses,
    22. Optical Impression Systems for Computer Assisted Design and
Manufacturing (CAD/CAM) of Dental Restorations,
    23. Resorbable Calcium Salt Bone Void Filler Device,
    24. Surgical Sutures,
    25. Breath Nitric Oxide Test,
    26. Breast Lesion Documentation System,
    27. Arrhythmia Detector and Alarm,
    28. Serological Reagents for the Laboratory Diagnosis of West Nile
Virus,
    29. Endotoxin Assay,
    30. Dental Sonography and Jaw Tracking Devices,
    31. Human Dura Mater (applicable to dura mater recovered before May
25, 2005),
    32. Hepatitis A Virus Serological Assays,
    33. Factor V Leiden DNA Mutation Detection Systems,
    34. Immunomagnetic Circulating Cancer Cell Selection and
Enumeration System,
    35. Root-form Dental Implants and Endosseous Dental Implant
Abutments,
    36. Dental Base Metal Alloys,
    37. Dental Noble Metal Alloys,
    38. Serological Assays for the Detection of Beta-Glucan,
    39. Sirolimus Test Systems,
    40. Newborn Screening Test Systems for Amino Acids, Free Carnitine,
and Acylcarnitines Using Tandem Mass Spectrometry,
    41. Implantable Radiofrequency Transponder System for Patient
Identification and Health Information,
    42. External Penile Rigidity Devices,
    43. Assisted Reproduction Laser Systems,
    44. Vascular and Neurovascular Embolization Devices,
    45. Drug Metabolizing Enzyme Genotyping System,
    46. Instrumentation for Clinical Multiplex Test Systems,
    47. Automated Fluorescence in situ Hybridization (FISH) Enumeration
Systems,
    48. Dental Bone Grafting Material Devices,
    49. RNA Preanalytical Systems (RNA Collection, Stabilization and
Purification Systems for RT-PCR used in Molecular Diagnostic Testing),
    50. Oral Rinse to Reduce the Adhesion of Dental Plaque,
    51. AFP-L3% Immunological Test Systems,
    52. CFTR Gene Mutation Detection System,
    53. Low Energy Ultrasound Wound Cleaner,
    54. Tinnitus Masker Devices,
    55. Labeling for Male Condoms Made of Natural Rubber Latex,
    56. Implantable Intra-Aneurysm Pressure Measurement System,
    57. Reagents for Detection of Specific Novel Influenza A Viruses,
    58. Topical Oxygen Chamber for Extremities,
    59. Olfactory Test Device,
    60. Fecal Calprotectin Immunological Test Systems,
    61. Absorbable Hemostatic Device,
    62. Quality Control Material for Cystic Fibrosis Nucleic Acid
Assays,
    63. Oxygen Pressure Regulators and Oxygen Conserving Devices,
    64. Herpes Simplex Virus Types 1 and 2 Serological Assays,
    65. Computerized Labor Monitoring Systems,
    66. Gene Expression Profiling Test System for Breast Cancer
Prognosis,
    67. Intervertebral Body Fusion Device,
    68. Filtering Facepiece Respirator for Use by the General Public in
Public Health Medical Emergencies,
    69. Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by
Recombinant DNA Technology,
    70. In Vitro Human Immunodeficiency Virus (HIV) Drug Resistance
Genotype Assay,
    71. Electrocardiograph Electrodes,
    72. Remote Medication Management System,
    73. Automated Blood Cell Separator Device Operating by Centrifugal
or Filtration Separation Principle,
    74. Plasmodium Species Antigen Detection Assays,
    75. Full Field Digital Mammography System,
    76. Certain Percutaneous Transluminal Coronary Angioplasty (PTCA)
Catheters,
    77. Tissue Adhesive for the Topical Approximation of Skin,
    78. Bone Sonometers,
    79. Tissue Expander,
    80. Cord Blood Processing System and Storage Container.

II. Electronic Access

    Persons interested in obtaining a copy of any revised special
controls guidance document may do so by using the Internet. A search
capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. To receive any affected CDRH guidance
you may either send an email request to<EMAIL_ADDRESS>to receive
an electronic copy of the document or send a fax request to 301-847-
8149 to receive a hard copy.
    For CBER guidances, you may send a request to the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. In addition, CBER guidance documents are available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.

    Authority:  21 U.S.C. 371(h).

    Dated: March 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-7211 Filed 3-25-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Proposed Rules]
[Page 67681]
[FR Doc No: 2015-27894]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2015-0546; A-1-FRL-9933-88-Region 1]

Approval and Promulgation of Air Quality Implementation Plans;
Connecticut; Volatile Organic Compound Emissions From Large Aboveground
Storage Tanks

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of Connecticut. The revision amends Regulations of Connecticut
State Agencies (RCSA) section 22a-174-20 to update the requirements for
controlling volatile organic compound (VOC) emissions from large
aboveground storage tanks. The intended effect of this action is to
approve these regulations into the Connecticut SIP. This action is
being taken in accordance with the Clean Air Act (CAA).

DATES: Written comments must be received on or before December 3, 2015.

ADDRESSES: Submit your comments identified by Docket ID Number EPA-R01-
OAR-2015-0546 for comments by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``Docket Identification Number EPA-R01-OAR-2015-0546,''
David Mackintosh, Air Quality Planning Unit, Office of Ecosystem
Protection, U.S. Environmental Protection Agency, EPA New England
Regional Office, 5 Post Office Square--Suite 100, (Mail code OEP05-2),
Boston, MA 02109-3912.
    5. Hand Delivery or Courier. Deliver your comments to: David
Mackintosh, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
5 Post Office Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109-
3912. Such deliveries are only accepted during the Regional Office's
normal hours of operation. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
legal holidays.
    Please see the direct final rule which is located in the Rules
Section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: David Mackintosh, Air Quality Planning
Unit, U.S. Environmental Protection Agency, New England Regional
Office, 5 Post Office Square--Suite 100, (Mail Code OEP05-02), Boston,
MA 02109-3912, telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.
    For additional information, see the direct final rule which is
located in the Rules Section of this Federal Register.

    Dated: August 27, 2015.
H. Curtis Spalding,
Regional Administrator, EPA New England.
[FR Doc. 2015-27894 Filed 11-2-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Notices]
[Pages 4796-4798]
[FR Doc No: 2014-01660]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71376; File No. SR-OCC-2013-807]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of No Objection To Advance Notice Filing Concerning the
Governance Committee Charter

January 23, 2014.
    On November 26, 2013, The Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission (``Commission'')
advance notice SR-OCC-2013-807 (``Advance Notice'') pursuant to Section
806(e)(1) of the Payment, Clearing, and Settlement Supervision Act of
2010 (``Clearing Supervision Act'' or ``Title VIII'') \1\ and Rule 19b-
4(n)(1)(i) under the Securities Exchange Act of 1934 (``Exchange
Act'').\2\ The Advance Notice was published for comment in the Federal
Register on December 20, 2013.\3\ The Commission did not receive any
comments on the Advance Notice publication. This publication serves as
a notice of no objection to the Advance Notice.
---------------------------------------------------------------------------

    \1\ 12 U.S.C. 5465(e)(1).
    \2\ 17 CFR 240.19b-4(n)(1)(i). OCC is a designated financial
market utility and is required to file advance notices with the
Commission. See 12 U.S.C. 5465(e). OCC also filed the proposal in
this Advance Notice as a proposed rule change under Section 19(b)(1)
of the Exchange Act and Rule 19b-4 thereunder, which was published
for comment in the Federal Register on December 16, 2013. 15 U.S.C.
78s(b)(1); 17 CFR 240.19b-4. See Release No. 34-71030 (Dec. 11,
2013), 78 FR 76182 (Dec. 16, 2013) (SR-OCC-2013-18).
    \3\ Release No. 34-71803 (Dec. 16, 2013), 78 FR 77181 (Dec. 20,
2013) (SR-OCC-2013-807) (``Notice'').
---------------------------------------------------------------------------

I. Description of the Advance Notice

    This advance notice concerns the Board of Director's (``Board'')
formation of a Governance Committee (``GC'') and its approval of the GC
Charter. As set forth in the GC Charter, the purpose of the GC is to
review the overall corporate governance of OCC and recommend
improvements to OCC's Board. The GC Charter describes the role the GC
plays

in assisting the Board in fulfilling its responsibilities, as described
in OCC's By-Laws and Rules, as well as specifying the policies and
procedures governing the membership and organization, scope of
authority, and specific functions and responsibilities of the GC. In
addition, the guidelines for the composition of the GC as well as the
policies regarding its meeting schedule, quorum rules, minute-keeping
and reporting requirements are set forth in the GC Charter and conform
to applicable requirements specified in OCC's By-Laws and Rules.
    The GC is composed of not fewer than five Directors with at least
one Public Director, one Exchange Director and one Member Director.
Management Directors will not be members of the GC. The Board will
designate a GC Chair and if the Chair is not present at a meeting, the
members who are present will designate a member to serve as the Acting
Chair. The GC will meet at least four times a year and a majority of
the GC members constitutes a quorum. The GC is permitted to call
executive sessions from which guests of the GC may be excluded, and GC
members are permitted to participate in all meetings by conference
telephone call or other means of communication that permit all meeting
participants to hear each other. The GC Chair, or the Chair's designee,
will report regularly to the Board on the GC's activities.
    The GC Charter sets forth certain functions and responsibilities
for the GC including, but not limited to, the following: Review the
composition of the Board as a whole, including the Board's balance of
participant and non-participant directors, business specialization,
technical skills, diversity and other desired qualifications; review
the Board's Charter for consistency with regulatory requirements,
transparency of the governance process and other sound governance
practice and recommend changes to the Board, where appropriate; review
the committee structure of the Board, including the GC, and recommend
changes to the Board, where appropriate; review OCC's policies and
procedures for identifying and reviewing Board nominee candidates,
including the criteria for Board nominees; develop and recommend to the
Board a periodic process of self-evaluation of the role and performance
of the Board, its committees and management in the governance of OCC;
review OCC's policies on conflicts of interest of directors, including
the OCC Directors Code of Conduct and recommend changes, where
appropriate; and, review OCC's new director orientation program as well
as OCC's training and education programs for Board members and
recommend changes, where appropriate. In addition to the foregoing, the
GC may undertake other and different activities, as appropriate, or as
may be delegated to it by the Board. In discharging its role, the GC
shall confer with management and other employees of OCC to the extent
the GC deems it necessary to do so to fulfill its duties.\4\
---------------------------------------------------------------------------

    \4\ The GC, subject to the approval of the Board, is permitted
to hire specialists or rely on outside advisors or specialists to
assist it in carrying out the GC's activities. The GC has the
authority to approve the fees and retention terms of such advisors
and specialists.
---------------------------------------------------------------------------

II. Discussion and Commission Findings

    Although Title VIII does not specify a standard of review for an
advance notice, the Commission believes that the stated purpose of
Title VIII is instructive.\5\ The stated purpose of Title VIII is to
mitigate systemic risk in the financial system and promote financial
stability by, among other things, promoting uniform risk management
standards for systemically-important financial market utilities
(``FMUs'') and strengthening the liquidity of systemically important
FMUs.\6\
---------------------------------------------------------------------------

    \5\ See 12 U.S.C. 5461(b).
    \6\ Id.
---------------------------------------------------------------------------

    Section 805(a)(2) of the Clearing Supervision Act \7\ authorizes
the Commission to prescribe risk management standards for the payment,
clearing, and settlement activities of designated clearing entities and
financial institutions engaged in designated activities for which it is
the supervisory agency or the appropriate financial regulator. Section
805(b) of the Clearing Supervision Act \8\ states that the objectives
and principles for the risk management standards prescribed under
Section 805(a) shall be to:
---------------------------------------------------------------------------

    \7\ 12 U.S.C. 5464(a)(2).
    \8\ 12 U.S.C. 5464(b).
---------------------------------------------------------------------------

     Promote robust risk management;
     Promote safety and soundness;
     Reduce systemic risks; and
     Support the stability of the broader financial system.
    The Commission has adopted risk management standards under Section
805(a)(2) of the Clearing Supervision Act \9\ (``Clearing Agency
Standards'').\10\ The Clearing Agency Standards became effective on
January 2, 2013 and require registered clearing agencies that perform
central counterparty (``CCP'') services to establish, implement,
maintain, and enforce written policies and procedures that are
reasonably designed to meet certain minimum requirements for their
operations and risk management practices on an ongoing basis.\11\ As
such, it is appropriate for the Commission to review advance notices
against these Clearing Agency Standards and the objectives and
principles of these risk management standards as described in Section
805(b) of the Clearing Supervision Act.\12\
---------------------------------------------------------------------------

    \9\ 12 U.S.C. 5464(a)(2).
    \10\ Rule 17Ad-22, 17 CFR 240.17Ad-22. Exchange Act Release No.
68080 (October 22, 2012), 77 FR 66220 (November 2, 2012) (S7-08-11).
    \11\ The Clearing Agency Standards are substantially similar to
the risk management standards established by the Board of Governors
of the Federal Reserve System (``Federal Reserve'') governing the
operations of designated DFMUs that are not clearing entities and
financial institutions engaged in designated activities for which
the Commission or the Commodity Futures Trading Commission is the
Supervisory Agency. See Financial Market Utilities, 77 FR 45907
(August 2, 2012).
    \12\ 12 U.S.C. 5464(b).
---------------------------------------------------------------------------

    OCC's GC, as described above, is tasked with reviewing the overall
corporate governance of OCC and making recommendations to the Board for
improvements. Consistent with Section 805(b) of the Clearing
Supervision Act,\13\ the Commission believes that OCC's GC should help
promote robust risk management and mitigate systemic risk by enhancing
the transparency of OCC's governance arrangements and providing a
vehicle for the review of OCC's governance structure, policies and
overall effectiveness and efficiency.
---------------------------------------------------------------------------

    \13\ See 12 U.S.C. 5464(b).
---------------------------------------------------------------------------

    Commission Rule 17Ad-22(d)(8),\14\ adopted as part of the Clearing
Agency Standards,\15\ requires that a registered clearing agency
establish, implement, maintain, and enforce written policies and
procedures reasonably designed to ''have governance arrangements that
are clear and transparent to fulfill the public interest requirements
in Section 17A of the Act applicable to clearing agencies, to support
the objectives of owners and participants, and to promote the
effectiveness of the clearing agency's risk management procedures.''
The Commission believes that the GC's review of OCC's governance
structure and any related recommendations that clarify OCC's governance
structure or further define governance responsibilities may help OCC
fulfill these requirements. Moreover, the Commission believes that the
GC may also aid in identifying any risks and inefficiencies in the
current governance structure and making recommendations to the full
Board to help mitigate those

risks and eliminate any such inefficiencies.
---------------------------------------------------------------------------

    \14\ 17 CFR 240.17Ad-22(d)(8).
    \15\ See supra note 10. Release No. 34-68080 (Oct. 22, 2012), 77
FR 66219 (November 2, 2012).
---------------------------------------------------------------------------

III. Conclusion

    It is therefore noticed, pursuant to Section 806(e)(1)(I) of the
Clearing Supervision Act,\16\ that the Commission does not object to
advance notice proposal (SR-OCC-2013-807) and that OCC is authorized to
implement the proposal as of the date of this notice or the date of an
order by the Commission approving a proposed rule change that reflects
rule changes that are consistent with this advance notice proposal (SR-
OCC-2013-18), whichever is later.
---------------------------------------------------------------------------

    \16\ 12 U.S.C. 5465(e)(1)(I).

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2014-01660 Filed 1-28-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Notices]
[Page 5842-5843]
[DOCID:fr04fe10-93]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Aviation Proceedings, Agreements Filed the Week Ending January
23, 2010

    The following Agreements were filed with the Department of
Transportation under the Sections 412 and 414 of the Federal Aviation
Act, as amended (49 U.S.C. 1382 and 1384) and procedures governing
proceedings to enforce these provisions. Answers may be filed within 21
days after the filing of the application.

    Docket Number: DOT-OST-2010-0019.
    Date Filed: January 20, 2010.
    Parties: Members of the International Air Transport Association.
    Subject: Mail Vote 618, TC3 Special Passenger Amending Resolution
010L, between Japan and Korea (Rep. of), (Memo 1353), Intended
effective date: 15 February 2010/1 April 2010.

Barbara J. Hairston,
Supervisory Dockets Officer, Docket Operations, Alternate Federal
Register Liaison.
[FR Doc. 2010-2397 Filed 2-3-10; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29789-29790]
[FR Doc No: 2015-12517]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Fifteenth Meeting: RTCA NextGen Advisory Committee (NAC)

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Fifteenth Meeting Notice of RTCA NextGen Advisory Committee.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
fifteenth meeting of the RTCA NextGen Advisory Committee.

DATES: The meeting will be held June 5, 2015 from 9 a.m. to 3 p.m.

ADDRESSES:  The meeting will be held at RTCA Headquarters, NBAA/Colson
Conference Rooms 1150, 18th Street NW., Suite 910, Washington, DC
20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org. Andy
Cebula, NAC Secretary can also be contacted at<EMAIL_ADDRESS>or 202-
330-0652.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a) (2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 224. The agenda will
include the following:

June 5th

 Opening of Meeting/Introduction of NAC Members--Chairman
Richard Anderson, Chief Executive Officer, Delta Air Lines, Inc.
 Official Statement of Designated Federal Official--The
Honorable Mike Whitaker, FAA Deputy Administrator
 Review and Approval of February 26, 2015 Meeting Summary
 Chairman's Report--Chairman Anderson
 FAA Report--Mr. Whitaker
 NextGen Integration Working Group (NIWG) Reports--Surface,
Performance Based Navigation, Multiple Runway Operations, DataComm
 Harmonization of DataComm
 NACSC Metrics AdHoc Group Report
 NAC ADS-B AdHoc Group Report
 FAA Response to RTCA ``Blueprint for Success to Implementing
Performance Based Navigation'' Recommendation
 Summary of meeting and next steps--DFO and NAC Chairman
Closing Comments
 Other business
 Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on May 19th 2015.
Mohannad Dawoud,
Management Analyst, NextGen, Program Oversight and Administration,
Federal Aviation Administration.
[FR Doc. 2015-12517 Filed 5-19-15; 4:15 pm]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Rules and Regulations]
[Pages 12439-12440]
[FR Doc No: 2020-04387]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2020-0057]
RIN 1625-AA00

Safety Zone; Monongahela River Mile 28.0 to Mile 30.0,
Pittsburgh, PA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
mile 28.0 to mile 30.0 of the Monongahela River. This action is
necessary to provide for the safety of life on these navigable waters
near Mitchell Power Plant, Pittsburgh, PA, during an electrical
conducter pull from March 2, 2020 through March 20, 2020. This
rulemaking would prohibit persons and vessels from being in the safety
zone unless authorized by the Captain of the Port Pittsburgh or a
designated representative.

DATES: This rule is effective without actual notice from March 3, 2020
through March 20, 2020. For the purposes of enforcement, actual notice
will be used from March 2, 2020 until March 3, 2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2020-0057 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 MST2 Trevor Vannatta, Waterways Management U.S. Coast
Guard; telephone<PHONE_NUMBER>, 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

    On November 12, 2019, the Duquesne Light Company notified the Coast
Guard that it will be conducting an electrical conducter pull on March
2, 2020, in order to replace an existing electrical conductor with a
new higher ampacity electrical conductor. In response, on February 3,
2020, the Coast Guard published a notice of proposed rulemaking (NPRM)
titled ``Safety Zone; Monongahela River Mile 28.0 to Mile 30.0,
Pittsburgh, PA'', (85 FR 5911, Feb. 3, 2020). That NPRM comment period
does not close until March 4, 2020. The Coast Guard is unable to delay
implementing this final rule to await the close of the comment period
becuase the start date of the electrical conductor pull is March 2,
2020.
    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 immediate action is needed to
mitigate potential safety hazards associated with the process of
pulling the new cables across the Monongahela River. It is
impracticable to publish an NPRM and consider the comments before
issuing this final rule because we must establish this safety zone by
March 2, 2020, when the electrical pulling is scheduled to start.
    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 because immediate action is needed to
protect vessels and persons during the replacement of old powerlines
crossing the Monongahela River beginning on March 2, 2020.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Pittsburgh (COTP) has determined that
potential hazards associated with the replacement of powerlines between
March 2, 2020 through March 20, 2020 will be a safety concern for
anyone between Mile 28.0-30.0 on the Monongahela River. The purpose of
this rule is to ensure safety of vessels and the navigable waters in
the safety zone before, during, and after the scheduled work.

IV. Discussion of Comments, Changes, and the Rule

    This rule establishes a safety zone from March 2, 2020 through
March 20, 2020. The safety zone will cover all navigable waters from
mile 28.0 to mile 30.0 on the Monongahela River near Pittsburgh, PA.
The duration of the zone is intended to ensure the safety of vessels
and these navigable waters before, during, and after a scheduled
maintenance activity. No vessel or person would be permitted to enter
the safety zone without obtaining permission from the COTP or a
designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the safety zone. The safety zone will impact
a 2-mile stretch of the Monongahela River for 19 days, and vessel
traffic would be able to safely transit around this safety zone.
Moreover, the Coast Guard would issue a Broadcast Notice to Mariners
via VHF-FM marine channel 16 about the zone, and the rule would allow
vessels to seek permission to enter the zone.

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 received 0 comments
from the Small Business Administration on this rulemaking. 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
IV.A above, thisrule would 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.

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, 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 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 a
safety zone lasting from March 2, 2020 through March 20, 2020 from mile
28.0 to mile 30.0 on the Monongahela River near Pittsburgh, PA. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

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.T08-0057 to read as follows:

Sec.  165.T08-0057  Safety Zone; Monongahela, Mile 28.0 to Mile 30.0,
Pittsburgh, PA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Monongahela River from mile 28.0 to mile 30.0.
    (b) Effective period. This section is effective from March 2, 2020
through March 20, 2020.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry of persons and vessels into this zone is prohibited
unless authorized by the Captain of the Port Marine Safety Unit
Pittsburgh (COTP) or a designated representative.
    (2) Persons or vessels requiring entry into or passage through the
zone must request permission from the COTP or a designated
representative. The COTP's representative may be contacted at 412-221-
0807.
    (3) All persons and vessels shall comply with the instructions of
the COTP or a designated representative. Designated COTP
representatives include United States Coast Guard commissioned,
warrant, and petty officer.
    (d) Information broadcasts. The Captain COTP or a designated
representative will inform the public through Local Notice to Mariners
(LNMs), Broadcast Notices to Mariners (BNMs), and/or Marine Safety
Information Bulletins (MSIBs), as appropriate.

    Dated: February 27, 2020.
A.W. Demo,
Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit
Pittsburgh.
[FR Doc. 2020-04387 Filed 3-2-20; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: November 8, 2005 (Volume 70, Number 215)]
[Notices]
[Page 67765]
[DOCID:fr08no05-67]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Pub. L. 94-409, that the Securities and
Exchange Commission will hold the following meeting during the week of
November 7, 2005:
    A Closed Meeting will be held on Thursday, November 10, 2005 at 10
a.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(5), (6), (7), (9)(B), and (10) and 17 CFR
200.402(a)(5), (6), (7), 9(ii) and (10) permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Glassman, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
November 10, 2005 will be:
    Formal orders of investigations;
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings of an
enforcement nature;
    Opinion; and a
    Regulatory matter bearing enforcement implications.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: November 3, 2005.
Jonathan G. Katz,
Secretary.
[FR Doc. 05-22292 Filed 11-3-05; 4:11 pm]

BILLING CODE 8010-01-P