[Federal Register: May 18, 2006 (Volume 71, Number 96)]
[Rules and Regulations]
[Page 28777]
[DOCID:fr18my06-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R10-OAR-2006-0050; FRL-8171-4]

Approval and Promulgation of Air Quality Implementation Plans; La
Grande, OR; PM10 Maintenance Plan and Redesignation Request; Withdrawal
of Direct Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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SUMMARY: Due to an adverse comment, EPA is withdrawing the March 22,
2006 direct final rule (see 71 FR 14393) to approve a PM10
State Implementation Plan (SIP) maintenance plan revision for the La
Grande, Oregon nonattainment area and to redesignate the area from
nonattattainment to attainment for PM10. In the March 22,
2006 direct final rule, we stated that if we received adverse comments
by April 21, 2006, the direct final rule would be withdrawn and would
not take effect. EPA subsequently received adverse comment on that
direct final rule. EPA will address all comments received in a
subsequent final action based upon the proposed action also published
on March 22, 2006 (see 71 FR 14438). EPA will not institute a second
comment period on this document.

FOR FURTHER INFORMATION CONTACT: Donna Deneen, Environmental Protection
Agency, Region 10, 1200 Sixth Avenue (AWT-107), Seattle, WA 98101,
(206) 553-6706.

SUPPLEMENTARY INFORMATION: See the information provided in the direct
final rule located in the Rules and Regulations section of the March
22, 2006 Federal Register (71 FR 14393).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: May 9, 2006.
Julie M. Hagensen,
Acting Regional Administrator, Region 10.
[FR Doc. 06-4604 Filed 5-17-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: February 17, 2009 (Volume 74, Number 30)]
[Notices]
[Page 7462]
[DOCID:fr17fe09-118]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1817-DR; Docket ID FEMA-2008-0018]

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

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Washington (FEMA-1817-DR), datedJanuary 30, 2009, and
related determinations.

DATES: Effective Date: February 11, 2009.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Washington is hereby amended to include the Public
Assistance program in 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 January 30, 2009.

    Chelan, Columbia, Garfield, Jefferson, Klickitat, Lincoln,
Skamania, and Yakima Counties for Public Assistance.
    Clallam, Cowlitz, Grays Harbor, King, Kittitas, Lewis, Mason,
Pacific, Pierce, Skagit, Snohomish, Thurston, Wahkiakum, and Whatcom
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.

Nancy Ward,
Acting Administrator, Federal Emergency Management Agency.
 [FR Doc. E9-3327 Filed 2-13-09; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Proposed Rules]
[Pages 66629-66630]
[FR Doc No: 2022-23461]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-1224; Airspace Docket No. 22-ACE-18]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Marshalltown, IA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend the Class E airspace at
Marshalltown, IA. The FAA is proposing this action as the result of an
airspace review as part of the decommissioning of the Elmwood very high
frequency (VHF) omnidirectional range (VOR) as part of the VOR Minimal
Operational Network (MON) Program.

DATES: Comments must be received on or before December 19, 2022.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2022-1224/Airspace Docket No. 22-ACE-18 at the beginning of your
comments. You may also submit comments through the internet at
www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend the Class E airspace extending upward from 700 feet
above the surface at Marshalltown Municipal Airport, Marshalltown, IA,
to support instrument flight rule operations at this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2022-1224/
Airspace Docket No. 22-ACE-18.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments

received, and any final disposition in person in the Dockets Office
(see the ``ADDRESSES'' section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11G, Airspace
Designations and Reporting Points, dated August 19, 2022, and effective
September 15, 2022. FAA Order JO 7400.11G is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11G
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 by amending the
Class E airspace extending upward from 700 feet above the surface to
within a 6.5-mile (increased from a 6.4-mile) radius of Marshalltown
Municipal Airport, Marshalltown, IA; and removing the Elmwood VOR/DME
and associated extensions from the airspace legal description.
    This action is necessary due to an airspace review as part of the
decommissioning of the Elmwood VOR, which provided navigation
information for the instrument procedures this airport, as part of the
VOR MON Program.
    Class E airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11G, dated August 19, 2022, and effective September
15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

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

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

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

* * * * *

ACE IA E5 Marshalltown, IA [Amended]

Marshalltown Municipal Airport, IA
    (Lat. 42[deg]06'46'' N, long. 92[deg]55'04'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Marshalltown Municipal Airport.

    Issued in Fort Worth, Texas, on October 24, 2022.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2022-23461 Filed 11-3-22; 8:45 am]
BILLING CODE 4910-13-P


Memorandum To: 304( m) Record From: Tom Born Office of Water, Office of Science and Technology, Engineering and Analysis Division ( EAD)

Subject: 303( d) Impaired Waters Analysis: 303( d) Impairments Summary Table for Six 304( m) Industries The purpose of this memorandum is to place into the 304( m) docket the summary table that I created for the following six industries:

$ Petroleum Bulk Stations and Terminals  Organic Chemicals, Plastics, and Synthetic Fibers  Inorganic Chemicals  Nonferrous Metals Manufacturing $ Petroleum Refining  Coal Bed Methane Extraction.

The attached Excel table contains the following column headings for each of the six industries:

$ Total Facilities in Economic Census $ Total Facilities in PCS $ Facilities with PCS Loading Estimates $ Facilities Indexed to Receiving Waters $ Indexed Facilities on Impaired Waters $ Percent of Indexed Facilities on Impaired Waters $ Number of Major Facilities $ Number of Majors Indexed to Receiving Waters $ Number of Indexed Majors on Impaired Waters The table also contains statistics which summarize problems with the PCS data and indicate possible over counting and under counting that may occur in the impaired waters analysis.

( See attached file: 303d Impaired Waters Summary Table for 6 304m Industries 11 12 03. xls)


[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Notices]
[Pages 49528-49530]
[FR Doc No: 2019-20370]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-D-1647, FDA-2019-D-1649, FDA-2019-D-1651, and
FDA-2019-D-1652]

Safety and Performance Based Pathway Device-Specific Guidance;
Draft Guidances for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of several device-specific draft guidance documents
for the Safety and Performance Based Pathway--specifically, ``Spinal
Plating Systems--Performance Criteria for Safety and Performance Based
Pathway; Draft Guidance for Industry and Food and Drug Administration
Staff''; ``Cutaneous Electrode for Recording Purposes--Performance
Criteria for Safety and Performance Based Pathway; Draft Guidance for
Industry and Food and Drug Administration Staff''; ``Conventional Foley
Catheters--Performance Criteria for Safety and Performance Based
Pathway; Draft Guidance for Industry and Food and Drug Administration
Staff''; and ``Orthopedic Non-Spinal Metallic Bone Screws and Washers--
Performance Criteria for Safety and Performance Based Pathway; Draft
Guidance for Industry and Food and Drug Administration Staff.'' The
device-specific draft guidances identified in this notice were
developed in accordance with the finalized guidance entitled ``Safety
and Performance Based Pathway.'' These draft guidances are not final
nor are they in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidances by December 19, 2019 to ensure that the Agency considers your
comment on these draft guidance documents before it begins work on the
final version of the guidance documents.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include Docket No. FDA-
2019-D-1647 for ``Spinal Plating Systems--Performance Criteria for
Safety and Performance Based Pathway; Draft Guidance for Industry and
Food and Drug Administration Staff''; Docket No. FDA-2019-D-1649 for
``Cutaneous Electrode for Recording Purposes--Performance Criteria for
Safety and Performance Based Pathway; Draft Guidance for Industry and
Food and Drug Administration Staff''; Docket No. FDA-2019-D-1651 for
``Conventional Foley Catheters--Performance Criteria for Safety and
Performance Based Pathway; Draft Guidance for Industry and Food and
Drug Administration Staff''; and Docket No. FDA-2019-D-1652 for
``Orthopedic Non-Spinal Metallic Bone Screws and Washers--Performance
Criteria for Safety and Performance Based Pathway; Draft Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
will be placed in the dockets 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidances are available for download from
the internet. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidances. Submit written requests for a
single hard copy of the draft guidances entitled ``Spinal Plating
Systems--Performance Criteria for Safety and Performance Based Pathway;
Draft Guidance for Industry and Food and Drug Administration Staff,''
``Cutaneous Electrode for Recording Purposes--Performance Criteria for
Safety and Performance Based Pathway; Draft Guidance for Industry and
Food and Drug Administration Staff,'' ``Conventional Foley Catheters--
Performance Criteria for Safety and Performance Based Pathway; Draft
Guidance for Industry and Food and Drug Administration Staff,'' or
``Orthopedic Non-Spinal Metallic Bone Screws and Washers--Performance
Criteria for Safety and Performance Based Pathway; Draft Guidance for
Industry and Food and Drug Administration Staff'' to the Office of
Policy, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Jason Ryans, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    These device-specific draft guidances provide performance criteria
for premarket notification (510k) submissions to support the optional
Safety and Performance Based Pathway, as described in the guidance
entitled ``Safety and Performance Based Pathway.'' \1\ As described in
that guidance, substantial equivalence is rooted in comparisons between
new devices and predicate devices. However, the Federal Food, Drug, and
Cosmetic Act does not preclude FDA from using performance criteria to
facilitate this comparison. If a legally marketed device performs at
certain levels relevant to its safety and effectiveness, and a new
device meets those levels of performance for the same characteristics,
FDA could find the new device as safe and effective as the legally
marketed device. Instead of reviewing data from direct comparison
testing between the two devices, FDA could support a finding of
substantial equivalence with data demonstrating the new device meets
the level of performance of an appropriate predicate device(s). Under
this optional Safety and Performance Based Pathway, a submitter could
satisfy the requirement to compare its device with a legally marketed
device by, among other things, independently demonstrating that the
device's performance meets performance criteria as established in the
above-listed guidances, when finalized, rather than using direct
predicate comparison testing for some of the performance
characteristics.
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway.
---------------------------------------------------------------------------

II. Significance of Guidance

    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on
performance criteria for the ``Safety and Performance Based Pathway for
Spinal Plating Systems,'' ``Cutaneous Electrode for Recording
Purposes,'' ``Conventional Foley Catheters,'' and ``Orthopedic Non-

Spinal Metallic Bone Screws and Washers.'' They do not establish any
rights for any person and are not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. These guidances are not subject to
Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidances may
do so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. These draft
guidances are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of either ``Spinal Plating
Systems--Performance Criteria for Safety and Performance Based Pathway;
Draft Guidance for Industry and Food and Drug Administration Staff
(document number 19008),'' ``Cutaneous Electrode for Recording
Purposes--Performance Criteria for Safety and Performance Based
Pathway; Draft Guidance for Industry and Food and Drug Administration
Staff (document number 19014),'' ``Conventional Foley Catheters--
Performance Criteria for Safety and Performance Based Pathway; Draft
Guidance for Industry and Food and Drug Administration Staff (document
number 19010),'' or ``Orthopedic Non-Spinal Metallic Bone Screws and
Washers--Performance Criteria for Safety and Performance Based Pathway;
Draft Guidance for Industry and Food and Drug Administration Staff
(document number 19009)'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the documents.
Please use the document number and complete title to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    These draft guidance documents refer to previously approved
collections of information. These collections of information are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information have been approved by OMB as listed in the
following table:

------------------------------------------------------------------------
                                                           OMB  control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     Notification.
``Requests for Feedback on Medical  Q-Submissions.......       0910-0756
 Device Submissions: The Q-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
------------------------------------------------------------------------

    Dated: September 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20370 Filed 9-19-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 31, 2010 (Volume 75, Number 61)]
[Rules and Regulations]
[Page 16009]
[DOCID:fr31mr10-11]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2010-0167]

Drawbridge Operation Regulations; Acushnet River, New Bedford and
Fairhaven, MA, Event--Road Race

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Route 6 New Bedford Fairhaven Bridge across the Acushnet River, mile
0.0, between New Bedford and Fairhaven, Massachusetts. This temporary
deviation is necessary to facilitate a public event, the Greater New
Bedford Community Health Center 5K Road Race, by allowing the bridge to
remain in the closed position for two hours during the running of the
5K Road Race.

DATES: This deviation is effective from 10 a.m. through 12 p.m. on May
30, 2010.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2010-0167 and are available online
at http://www.regulations.gov, inserting USCG-2009-0001 in the
``Keyword'' and then clicking ``Search''. They are also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. John McDonald, Project Officer, First Coast Guard
District, telephone<PHONE_NUMBER><EMAIL_ADDRESS>If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    The Route 6 New Bedford Fairhaven Bridge, across the Acushnet River
at mile 0.0, between New Bedford and Fairhaven, Massachusetts, has a
vertical clearance in the closed position of 6 feet at mean high water
and 10 feet at mean low water. The Drawbridge Operation Regulations are
listed at 33 CFR 117.585. The bridge opens on the hour from 6 a.m.
through 10 a.m. and at a quarter past the hour between 11:15 a.m. and
6:15 p.m. The bridge opens on signal at all other times.
    The owner of the bridge, Massachusetts Department of
Transportation, requested this temporary deviation to facilitate a
public event, the Greater New Bedford Community Health Center 5K Road
Race.
    Under this deviation, the Route 6 New Bedford Fairhaven Bridge may
remain in the closed position between 10 a.m. and 12 p.m. on May 30,
2010. The 10 a.m. and 11:15 a.m. openings will be missed as a result of
this temporary deviation. Vessels able to pass under the closed draw
may do so at any time.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: March 16, 2010.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2010-7246 Filed 3-30-10; 8:45 am]
BILLING CODE 9110-04-P