an alternate tonnage measured under 46 U.S.C. 14302 as prescribed by
the Secretary under 46 U.S.C. 14104 that regularly carries goods,
supplies, individuals in addition to the crew, or equipment in support
of exploration, exploitation, or production of offshore mineral or
energy resources.
    Oil spill response vessel means a vessel that is designated in its
certificate of inspection as such a vessel, or that is adapted to
respond to a discharge of oil or a hazardous material.
* * * * *
    Passenger vessel means a vessel of at least 100 gross tons as
measured under 46 U.S.C. 14502, or an alternate tonnage measured under
46 U.S.C. 14302 as prescribed by the Secretary under 46 U.S.C. 14104--
    (1) Carrying more than 12 passengers, including at least one
passenger for hire;
    (2) That is chartered and carrying more than 12 passengers; or
    (3) That is a submersible vessel carrying at least one passenger
for hire.
* * * * *
    Recreational vessel means a vessel being manufactured or operated

primarily for pleasure; or leased, rented, or chartered to another for
the latter's pleasure.
* * * * *
    Towing vessel means a commercial vessel engaged in or intending to
engage in pulling, pushing, or hauling alongside, or any combination of
pulling, pushing, or hauling alongside.
* * * * *
    7. In redesignated Sec.  160.203:
    a. Revise paragraph (a);
    b. Remove paragraph (b);
    c. Redesignate paragraphs (c) and (d) as paragraphs (b) and (c);
and
    d. In redesignated paragraph (c), following the two places where
the term ``NOA'' is used, add the phrase ``or NOD''.
    The revision reads as follows:

Sec.  160.203  Applicability.

    (a) This subpart applies to U.S. vessels in commercial service and
all foreign vessels that are bound for or departing from ports or
places of the United States.
* * * * *
    8. In redesignated Sec.  160.204, lift the suspension of paragraphs
(d) and (e), and revise Sec.  160.204 to read as follows:

Sec.  160.204  Exemptions.

    (a) Except for reporting notice of hazardous conditions, the
following vessels are exempt from requirements in this subpart:
    (1) A passenger or offshore supply vessel when employed in the
exploration for or in the removal of oil, gas, or mineral resources on
the continental shelf.
    (2) An oil spill response vessel (OSRV) when engaged in actual
spill response operations or during spill response exercises.
    (3) A vessel required by 33 CFR 165.830 or 165.921 to report to the
Inland River Vessel Movement Center (IRVMC).
    (4) The following vessels neither carrying certain dangerous cargo
nor controlling another vessel carrying certain dangerous cargo:
    (i) A foreign vessel 300 gross tons or less not engaged in
commercial service.
    (ii) A vessel operating exclusively within a single Captain of the
Port Zone. Captain of the Port zones are defined in 33 CFR part 3.
    (iii) A U.S. towing vessel and a U.S. barge operating solely
between ports or places of the continental United States.
    (iv) A public vessel.
    (v) Except for a tank vessel, a U.S. vessel operating solely
between ports or places of the United States on the Great Lakes.
    (vi) A U.S. vessel 300 gross tons or less, engaged in commercial
service not coming from a foreign port or place.
    (b) A vessel less than 500 gross tons need not submit the
International Safety Management (ISM) Code Notice (Entry 7 in Table
160.206 of Sec.  160.206).
    (c) A U.S. vessel need not submit the International Ship and Port
Facility Security (ISPS) Code Notice information (Entry 8 in Table
160.206 of Sec.  160.206).
    9. Add Sec.  160.205 to read as follows:

Sec.  160.205  Notices of arrival and departure.

    The owner, agent, master, operator, or person in charge of a vessel
must submit notices of arrival and notices of departure consistent with
the requirements in this subpart.
    10. In Sec.  160.206, lift the suspension of item (8) in table in
paragraph (a) and revise Sec.  160.206 to read as follows:

Sec.  160.206  Information required in a NOA.

    (a) Information required. With the exceptions noted in paragraph
(b) of this section, each NOA must contain all of the information items
specified in Table 160.206. Vessel owners and operators should protect
any personal information they gather in preparing notices for
transmittal to the National Vessel Movement Center (NVMC) so as to
prevent unauthorized disclosure of that information.

                                      Table 160.206--NOA Information Items
----------------------------------------------------------------------------------------------------------------
                                                      Vessels neither carrying CDC     Vessels carrying CDC or
                Required information                     nor controlling another     controlling another vessel
                                                           vessel carrying CDC              carrying CDC
----------------------------------------------------------------------------------------------------------------
(1) Vessel Information:
    (i) Name........................................                            X                             X
    (ii) Name of the registered owner...............                            X                             X
    (iii) Country of registry.......................                            X                             X
    (iv) Call sign..................................                            X                             X
    (v) International Maritime Organization (IMO)                               X                             X
     international number or, if vessel does not
     have an assigned IMO international number,
     substitute with official number................
    (vi) Name of the operator.......................                            X                             X
    (vii) Name of charterer.........................                            X                             X
    (viii) Name of classification society...........                            X                             X
    (ix) Maritime Mobile Service Identity (MMSI)                                X                             X
     number, if applicable; and.....................
    (x) Whether the vessel is 300 gross tons or less                            X                             X
     (yes or no)....................................
(2) Voyage Information:
    (i) Names of last five foreign ports or places                              X                             X
     visited........................................
    (ii) Dates of arrival and departure for last                                X                             X
     five foreign ports or places visited...........
    (iii) For the port or place of the United States                            X                             X
     to be visited, list the name of the receiving
     facility, the port or place, the city, and the
     state..........................................
    (iv) For the port or place of the United States                             X                             X
     to be visited, the estimated date and time of
     arrival........................................
    (v) For the port or place in the United States                              X                             X
     to be visited, the estimated date and time of
     departure......................................
    (vi) The location (port or place and country) or                            X                             X
     position (latitude and longitude or waterway
     and mile marker) of the vessel at the time of
     reporting......................................
    (vii) The name and telephone number of a 24-hour                            X                             X
     point of contact...............................
    (viii) Whether the vessel's voyage time is less                             X                             X
     than 24 hours (yes or no)......................
    (ix) Last Port of Call..........................                            X                             X
    (x) Dates of arrival and departure for last port                            X                             X
     or place visited; and..........................
    (xi) The estimated date and time of arrival to                              X                             X
     the entrance of the port, if applicable. List
     sea buoy, pilot station, or COLREGS demarcation
     line...........................................

(3) Cargo Information:
    (i) A general description of cargo, other than                              X                             X
     CDC, onboard the vessel (e.g., grain,
     container, oil, etc.)..........................
    (ii) Name of each CDC carried, including cargo    ............................                            X
     UN number, if applicable; and..................
    (iii) Amount of each CDC carried................  ............................                            X
(4) Information for each Crewmember Onboard:
    (i) Full name...................................                            X                             X
    (ii) Date of birth..............................                            X                             X
    (iii) Nationality...............................                            X                             X
    (iv) Passport* or mariner's document number                                 X                             X
     (type of identification and number)............
    (v) Passport country of issuance*; and..........                            X                             X
    (vi) Passport date of expiration*...............                            X                             X
    (vii) Position or duties on the vessel; and.....                            X                             X
    (viii) Where the crewmember embarked (list port                             X                             X
     or place and country)..........................
(5) Information for each Person Onboard in Addition
 to Crew:
    (i) Full name...................................                            X                             X
    (ii) Date of birth..............................                            X                             X
    (iii) Nationality...............................                            X                             X
    (iv) Passport number*...........................                            X                             X
    (v) Passport country of issuance*...............                            X                             X
    (vi) Passport date of expiration;* and..........                            X                             X
    (vii) Where the person embarked (list port or                               X                             X
     place and country).............................
(6) Operational condition of equipment required by                              X                             X
 33 CFR part 164 of this chapter (see note to
 table):
(7) International Safety Management (ISM) Code
 Notice:
    (i) The date of issuance for the company's                                  X                             X
     Document of Compliance certificate that covers
     the vessel.....................................
    (ii) The date of issuance for the vessel's                                  X                             X
     Safety Management Certificate; and.............
    (iii) The name of the Flag Administration, or                               X                             X
     the recognized organization(s) representing the
     vessel Flag Administration, that issued those
     certificates...................................
(8) International Ship and Port Facility Security
 Code (ISPS) Notice:
    (i) The date of issuance for the vessel's                                   X                             X
     International Ship Security Certificate (ISSC),
     if any.........................................
    (ii) Whether the ISSC, if any, is an initial                                X                             X
     Interim ISSC, subsequent and consecutive
     Interim ISSC, or final ISSC....................
    (iii) Declaration that the approved ship                                    X                             X
     security plan, if any, is being implemented....
    (iv) If a subsequent and consecutive Interim                                X                             X
     ISSC, the reasons therefore....................
    (v) The name and 24-hour contact information for                            X                             X
     the Company Security Officer; and..............
    (vi) The name of the Flag Administration, or the                            X                             X
     recognized security organization(s)
     representing the vessel Flag Administration
     that issued the ISSC...........................
----------------------------------------------------------------------------------------------------------------

    Note to Table 160.206. For items with an asterisk (*), see
paragraph (b) of this section. Submitting a response for item 6 does
not serve as notice to the District Commander, Captain of the Port, or
Vessel Traffic Center, under 33 CFR 164.53 that navigation equipment is
not operating properly.
    (b) Exceptions. If a crewmember or person on board other than a
crewmember is not required to carry a passport for travel, then
passport information required in Table 160.206 by items (4)(iv) through
(vi), and (5) (iv) through (vi), need not be provided for that person.
    11. Add Sec.  160.207 to read as follows:

Sec.  160.207  Information required in a NOD.

    (a) Information required. With the exceptions noted in paragraph
(b) of this section, each NOD must contain all of the information items
specified in Table 160.207. Vessel owners and operators should protect
any personal information they gather in preparing notices for
transmittal to the NVMC so as to prevent unauthorized disclosure of
that information.

                                      Table 160.207--NOD Information Items
----------------------------------------------------------------------------------------------------------------
                                                      Vessels neither carrying CDC   Vessels either carrying CDC
                Required information                     nor controlling another       or  controlling another
                                                           vessel carrying CDC          vessel  carrying CDC
----------------------------------------------------------------------------------------------------------------
(1) Vessel Information:
    (i) Name........................................                            X                             X
    (ii) Name of the registered owner...............                            X                             X

    (iii) Country of registry.......................                            X                             X
    (iv) Call sign..................................                            X                             X
    (v) International Maritime Organization (IMO)                               X                             X
     international number or, if vessel does not
     have an assigned IMO international number,
     substitute with official number................
    (vi) Name of the operator.......................                            X                             X
    (vii) Name of charterer.........................                            X                             X
    (viii) Name of classification society; and......                            X                             X
    (ix) Maritime Mobile Service Identity (MMSI)                                X                             X
     number.........................................
(2) Voyage Information:
    (i) The name of departing port or place of the                              X                             X
     United States, the estimated date and time of
     departure......................................
    (ii) Next port or place of call (including                                  X                             X
     foreign), the estimated date and time of
     arrival; and...................................
    (iii) The name and telephone number of a 24-hour                            X                             X
     point of contact...............................
(3) Cargo Information:
    (i) A general description of cargo, other than                              X                             X
     CDC, onboard the vessel (e.g., grain,
     container, oil, etc.)..........................
    (ii) Name of each CDC carried, including cargo    ............................                            X
     UN number, if applicable; and..................
    (iii) Amount of each CDC carried................  ............................                            X
(4) Information for each Crewmember Onboard:
    (i) Full name...................................                            X                             X
    (ii) Date of birth..............................                            X                             X
    (iii) Nationality...............................                            X                             X
    (iv) Passport* or mariner's document number                                 X                             X
     (type of identification and number)............
    (v) Passport country of issuance*...............                            X                             X
    (vi) Passport date of expiration*...............                            X                             X
    (vii) Position or duties on the vessel; and.....                            X                             X
    (viii) Where the crewmember embarked (list port                             X                             X
     or place and country)..........................
(5) Information for each Person Onboard in Addition
 to Crew:
    (i) Full name...................................                            X                             X
    (ii) Date of birth..............................                            X                             X
    (iii) Nationality...............................                            X                             X
    (iv) Passport number*...........................                            X                             X
    (v) Passport country of issuance*...............                            X                             X
    (vi) Passport date of expiration* and...........                            X                             X
    (vii) Where the person embarked (list port or                               X                             X
     place and country).............................
----------------------------------------------------------------------------------------------------------------

    Note to Table 160.207. For items with an asterisk (*), see
paragraph (b) of this section.
    (b) Exceptions. If a crewmember or person on board other than a
crewmember is not required to carry a passport for travel, then
passport information required in Table 160.207 by items (4)(iv) through
(vi), and (5) (iv) through (vi), need not be provided for that person.
    12. In Sec.  160.208, revise the section heading and paragraphs (a)
and (c) to read as follows:

Sec.  160.208   Updates to a submitted NOA or NOD.

    (a) Unless otherwise specified in this section, whenever events
cause submitted NOA and NOD information to become inaccurate, vessels
must submit an update within the times required in Sec. Sec.  160.212
and 160.213.
* * * * *
    (c) When reporting updates, revise and resubmit the NOA or NOD.
    13. In Sec.  160.210, lift the suspensions on the last sentence of
paragraph (b), the last sentence of paragraph (c), and paragraph (d);
and revise Sec.  160.210 to read as follows:

Sec.  160.210   Methods for submitting a NOA or a NOD.

    (a) National Vessel Movement Center (NVMC). Vessels must submit NOA
and NOD information required by Sec. Sec.  160.206 and 160.207 to the
NVMC, by electronic Notice of Arrival and Departure (eNOAD) using
methods specified at: http://www.nvmc.uscg.gov.
    (b) Saint Lawrence Seaway. Those vessels transiting the Saint
Lawrence Seaway inbound, bound for a port or place in the United
States, may meet the submission requirements of paragraph (a) of this
section by submitting the required information to the Saint Lawrence
Seaway Development Corporation and the Saint Lawrence Seaway Management
Corporation of Canada via eNOAD using methods specified at: http://
www.nvmc.uscg.gov.
    14. In Sec.  160.212, lift the suspension of paragraph (c), and
revise Sec.  160.212 to read as follows:

Sec.  160.212   When to submit a NOA.

    (a) Submission of a NOA. (1) Except as set out in paragraph (a)(2)
and (a)(3) of this section, all vessels must submit NOAs within the
times required in paragraph (a)(4) of this section.
    (2) Towing vessels, when in control of a vessel carrying CDC and
operating solely between ports or places of the continental United
States, must submit a NOA before departure but at least 12

hours before arriving at the port or place of destination.
    (3) U.S. vessels 300 gross tons or less, arriving from a foreign
port or place, and whose voyage time is less than 24 hours must submit
a NOA at least 60 minutes before departure from the foreign port or
place.

------------------------------------------------------------------------
 (4) If your voyage time is--         Then you must submit a NOA--
------------------------------------------------------------------------
(i) 96-hours or more; or.....  At least 96-hours before arriving at the
                                port or place of destination; or
(ii) Less than 96-hours......  Before departure but at least 24-hours
                                before arriving at the port or place of
                                destination.
------------------------------------------------------------------------

    (b) Submission of updates to a NOA. (1) Except as set out in
paragraphs (b)(2) and (b)(3) of this section, vessels must submit
updates in NOA information within the times required in paragraph
(b)(4) of this section.
    (2) Towing vessels, when in control of a vessel carrying CDC and
operating solely between ports or places in the continental United
States, must submit updates to a NOA as soon as practicable but at
least 6 hours before entering the port or place of destination.
    (3) U.S. vessels 300 gross tons or less, arriving from a foreign
port or place, whose voyage time is--
    (i) Less than 24 hours but greater than 6 hours, must submit
updates to a NOA as soon as practicable, but at least 6 hours before
entering the port or place of destination.
    (ii) Less than or equal to 6 hours, must submit updates to a NOA as
soon as practicable, but at least 60 minutes before departure from the
foreign port or place.
    (4) Times for submitting updates to NOAs are as follows:

------------------------------------------------------------------------
If your remaining voyage time
             is--               Then you must submit updates to a NOA--
------------------------------------------------------------------------
(i) 96-hours or more.........  As soon as practicable, but at least 24-
                                hours before arriving at the port or
                                place of destination.
(ii) Less than 96-hours but    As soon as practicable, but at least 24-
 not less than 24-hours;        hours before arriving at the port or
 or..........                   place of destination; or
(iii) Less than 24-            As soon as practicable, but at least 12-
 hours.......                   hours before arriving at the port or
                                place of destination.
------------------------------------------------------------------------

    15. Add Sec.  160.213 to read as follows:

Sec.  160.213   When to submit a NOD.

    (a) Submission of a NOD. All vessels must submit a NOD no later
than 60 minutes before departure.
    (b) Submission of updates to a NOD. Vessels must submit updates in
NOD information as soon as practicable but no later than 12 hours after
departure.

Sec.  160.215   [Redesignated as Sec.  160.216]

    16. Redesignate Sec.  160.215 as Sec.  160.216, and add a new Sec.
160.215 to read as follows:

Sec.  160.215   Force majeure.

    When a vessel is bound for a port or place of the United States
under force majeure, it must comply with the requirements in this
section, but not other sections of this subpart. The vessel must report
the following information to the nearest Captain of the Port as soon as
practicable:
    (a) The vessel master's intentions;
    (b) Any hazardous conditions as defined in Sec.  160.202; and
    (c) If the vessel is carrying certain dangerous cargo or
controlling a vessel carrying certain dangerous cargo, the amount and
name of each CDC carried, including cargo UN number if applicable.

PART 161--VESSEL TRAFFIC MANAGEMENT

    17. The authority citation for part 161 continues to read as
follows:

    Authority: 33 U.S.C. 1223, 1231; 46 U.S.C. 70114, 70117; Public
Law 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    18. In Sec.  161.2, revise the term ``VTS User'' to read as
follows:

Sec.  161.2   Definitions.

* * * * *
    VTS User means a vessel, or an owner, operator, charterer, master,
or person directing the movement of a vessel within a VTS area, that
is:
    (1) Subject to the Vessel Bridge-to-Bridge Radiotelephone Act;
    (2) Required to participate in a VMRS; or
    (3) Equipped with a Coast Guard type-approved Automatic
Identification System (AIS).
* * * * *
    19. In Sec.  161.5, revise paragraph (b) to read as follows:

Sec.  161.5   Deviations from the rules.

* * * * *
    (b) Requests to deviate from any provision in this part due to
circumstances that develop during a transit or immediately preceding a
transit may be made to the appropriate Vessel Traffic Center (VTC).
Requests to deviate must be made as far in advance as practicable. Upon
receipt of the request, the VTC may authorize a deviation if it is
determined that, based on vessel handling characteristics, traffic
density, radar contacts, environmental conditions and other relevant
information, such a deviation provides a level of safety equivalent to
that provided by the required measure or is a maneuver considered
necessary for safe navigation under the circumstances.

Sec.  161.12   [Amended]

    20. In Sec.  161.12(d)(5), remove the section reference ``Sec.
160.204'' and add, in its place, the section reference ``Sec.
160.202''.
    21. In Sec.  161.19, revise paragraph (f) to read as follows:

Sec.  161.19   Sailing Plan

* * * * *
    (f) Dangerous cargo on board or in its tow, as defined in Sec.
160.202 of this chapter.

PART 164--NAVIGATION SAFETY REGULATIONS

    22. The authority citation for part 164 is revised to read as
follows:

    Authority: 33 U.S.C. 1222(5), 1223, 1231; 46 U.S.C. 2103, 3703;
Department of Homeland Security Delegation No. 0170.1. Sec. 164.13
also issued under 46 U.S.C. 8502. Sec. 164.46 also issued under 46
U.S.C. 70114 and sec. 102 of Public Law 107-295. Sec. 164.61 also
issued under 46 U.S.C. 6101.

    23. In Sec.  164.02, revise the introductory text of paragraph (a)
to read as follows:

Sec.  164.02  Applicability exception for foreign vessels.

    (a) Except for Sec.  164.46(c), none of the requirements of this
part apply to vessels that:
* * * * *

    24. Revise Sec.  164.03 to read as follows:

Sec.  164.03   Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that
specified in this section, the Coast Guard must publish notice of
change in the Federal Register and the material must be available to
the public. All approved material is available for inspection at the
National Archives and Records Administration (NARA). For more
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html. Also, it is available for inspection at the Coast
Guard, Office of Navigation Systems (CG-5413), 2100 Second Street SW.,
Washington, DC 20593-0001, and is available from the sources listed
below.
    (b) American Petroleum Institute (API), 1220 L Street, NW.,
Washington, DC 20005.
    (1) API Specification 9A, Specification for Wire Rope, Section 3,
Properties and Tests for Wire and Wire Rope, May 28, 1984, IBR approved
for Sec.  164.74.
    (2) [Reserved].
    (c) American Society for Testing and Materials (ASTM), 100 Bar
Harbor Drive, West Conshohocken, PA 19428-2959.
    (1) ASTM D4268-93, Standard Test Method for Testing Fiber Ropes,
IBR approved for Sec.  164.74.
    (2) [Reserved].
    (d) Cordage Institute, 350 Lincoln Street, Hingham, MA 02043.
    (1) CIA-3, Standard Test Methods for Fiber Roper Including Standard
Terminations, Revised, June 1980, IBR approved for 164.74.
    (2) [Reserved].
    (e) International Maritime Organization (IMO), 4 Albert Embankment,
London SE1 7SR, U.K.
    (1) IMO Resolution A342(IX), Recommendation on Performance
Standards for Automatic Pilots, November 12, 1975, IBR approved for
Sec.  164.13.
    (2) IMO Resolution A.917(22), Guidelines for the Onboard
Operational Use of Shipborne Automatic Identification System (AIS),
January 25, 2002, IBR approved for Sec.  164.46.
    (3) Resolution MSC.74(69), Annex 3, Recommendation on Performance
Standards for a Universal Shipborne Automatic Identification System
(AIS), May 12, 1998, IBR approved for Sec.  164.46.
    (4) SN/Circ. 227, Guidelines for the Installation of a Shipborne
Automatic Identification System (AIS), January 6, 2003, IBR approved
for Sec.  164.46.
    (5) SN/Circ.244, Guidance on the Use of the UN/LOCODE in the
Destination Field in AIS Messages, December 15, 2004, IBR approved for
Sec.  164.46.
    (6) SN/Circ.245, Amendments to the Guidelines for the Installation
of a Shipborne Automatic Identification System (AIS)(SN/Circ.227),
March 2, 2005, IBR approved for Sec.  164.46.
    (7) SOLAS, International Convention for the Safety of Life at Sea,
1974, and 1988 Protocol relating thereto, 2000 Amendments, effective
January and July 2002, (SOLAS 2000 Amendments), IBR approved for Sec.
164.46.
    (8) Conference resolution 1, Adoption of amendments to the Annex to
the International Convention for the Safety of Life at Sea, 1974, and
amendments to Chapter V of SOLAS 1974, adopted on December 12, 2002,
IBR approved for Sec.  164.46.
    (9) SN/Circ.236, Guidance on the Application of AIS Binary
Applications, May 20, 2004, IBR approved for Sec.  164.46.
    (f) Radio Technical Commission for Maritime Services (RTCM), 655
Fifteenth Street, NW., Suite 300, Washington, DC 20005.
    (1) RTCM Paper 12-78/DO-100, Minimum Performance Standards, Loran C
Receiving Equipment, 1977, IBR approved for Sec.  164.41.
    (2) RTCM Paper 71-95/SC112-STD, RTCM Recommended Standards for
Marine Radar Equipment Installed on Ships of Less Than 300 Tons Gross
Tonnage, Version 1.1, October 10, 1995, IBR approved for Sec.  164.72.
    (3) RTCM Paper 191-93/SC112-X, RTCM Recommended Standards for
Maritime Radar Equipment Installed on Ships of 300 Tons Gross Tonnage
and Upwards, Version 1.2, December 20, 1993, IBR approved for Sec.
164.72.

Sec.  164.43   [Removed]

    25. Remove Sec.  164.43.
    26. Revise Sec.  164.46 to read as follows:

Sec.  164.46   Automatic Identification System.

    (a) Definitions. As used in this section--
    Automatic Identification Systems or AIS means a maritime navigation
safety communications system standardized by the International
Telecommunication Union (ITU), adopted by the International Maritime
Organization (IMO), that--
    (1) Provides vessel information, including the vessel's identity,
type, position, course, speed, navigational status and other safety-
related information automatically to appropriately equipped shore
stations, other ships, and aircraft;
    (2) Receives automatically such information from similarly fitted
ships; monitors and tracks ships; and
    (3) Exchanges data with shore-based facilities.
    Gross tonnage means tonnage as defined under the International
Convention on Tonnage Measurement of Ships, 1969.
    International voyage means a voyage from a country to which the
present International Convention for the Safety of Life at Sea (SOLAS),
1974 applies to a port outside such country, or conversely.
    Properly installed, operational means an Automatic Identification
System (AIS) that is installed and operated using the guidelines set
forth by the International Maritime Organization (IMO) Safety of
Navigation Circulars (SN/Circ.) 227, 236, 244, and 245, and Resolution
A.917(22)(Incorporated by reference, see Sec.  164.03).
    (b) AIS carriage. The following vessels must have onboard a
properly installed, operational, Coast Guard type-approved Automatic
Identification System (AIS):
    (1) A self-propelled vessel of 65 feet or more in length, engaged
in commercial service;
    (2) A towing vessel of 26 feet or more in length and more than 600
horsepower, engaged in commercial towing;
    (3) A self-propelled vessel carrying 50 or more passengers, engaged
in commercial service;
    (4) A vessel carrying more than 12 passengers for hire and capable
of speeds in excess of 30 knots;
    (5) A dredge or floating plant engaged in or near a commercial
channel or shipping fairway in operations likely to restrict or affect
navigation of other vessels except for an unmanned or intermittently
manned floating plant under the control of a dredge; and
    (6) A self-propelled vessel carrying or engaged in the movement of
certain dangerous cargoes as defined in Sec.  160.202 of this
subchapter.

    Note to paragraph (b): Except for those vessels denoted in
paragraph (c) of this section, use of Coast Guard type-approved AIS
Class B is permissible, however, not well-suited, on vessels that
are highly maneuverable, navigate at high speed, or routinely
operate on or near very congested waterways or in close-quarter
situations with other AIS equipped vessels.

    (c) SOLAS provisions. The following self-propelled vessels must
comply with International Convention for Safety of Life at Sea (SOLAS),
as amended, Chapter V, regulation <IP_ADDRESS>, 19.2.4 (AIS Class A), and
<IP_ADDRESS> or <IP_ADDRESS> as applicable (Incorporated by reference, see
Sec.  164.03):

    (1) A vessel of 500 gross tonnage or more;
    (2) A vessel of 300 gross tonnage or more, on an international
voyage; and
    (3) A vessel of 150 gross tonnage or more, when carrying more than
12 passengers on an international voyage.
    (d) Operations. The requirements in this paragraph are applicable
to any vessel equipped with AIS.
    (1) Use of AIS does not relieve the vessel of the requirements to
sound whistle signals or display lights or shapes in accordance with
the International Regulations for Preventing Collisions at Sea, 1972
(72 COLREGS), 28 U.S.T. 3459, T.I.A.S. 8587, or Inland Navigation
Rules, 33 U.S.C. 2001 through 2073; nor of the radio requirements of
the Vessel Bridge-to-Bridge Radiotelephone Act, 33 U.S.C. 1201-1208,
part 26 of this chapter, and 47 CFR part 80.
    (2) AIS must be maintained in effective operating conditions which
includes the:
    (i) Ability to reinitialize the AIS should the need arise (this
could require access and knowledge of the AIS power source and
password);
    (ii) Ability to access AIS information from the primary conning
position of the vessel;
    (iii) Accurate broadcast of a properly assigned Maritime Mobile
Service Identity (MMSI) number;
    (iv) Accurate input and upkeep of all AIS data and system updates;
and
    (v) Continual operation of AIS, and its associated devices (e.g.,
GPS, gyro, converters), at all times the vessel is underway, at anchor,
or moored in or near a commercial channel or shipping fairway in
operations likely to restrict or affect navigation of other vessels,
except--
    (A) When use of AIS would compromise the safety or security of the
vessel or a security incident is imminent.
    (B) The AIS should be returned to continuous operation as soon as
the compromise has been mitigated or the security incident has passed.
At that time, those vessels denoted in paragraph (b), must report to
the nearest U.S. Captain of the Port or Vessel Traffic Center, and
record in the ship's official log, the AIS operational interruption and
the reason for the interruption.
    (3) AIS messaging must be conducted in English and solely to
exchange or communicate navigation safety information (for example,
SECURITE). Although not prohibited, it should not be relied upon as the
primary means for broadcasting distress or urgent communications (for
example, MAYDAY or PAN PAN). (47 CFR 80.1109, Distress, urgency, and
safety communications).

    Note to paragraph (d): AIS devices must be able to broadcast
vessel position, course, and speed, and may require the input of an
external positioning device (e.g., DGPS) to do so. Although of great
benefit, the integration of existing, or installation of, other
external devices or displays (e.g., transmitting heading device,
gyro, rate of turn indicator, ECDIS/ECS, and radar) is highly
recommended but is not currently required except as denoted in Sec.
164.46(c).

    (e) Watchkeeping. AIS is primarily intended for use of the master
or person in charge of the vessel, or the person designated by the
master or person in charge to pilot or direct the movement of the
vessel, who must maintain a periodic watch for AIS information.
    (f) Portable AIS. The use of a portable AIS is permissible only to
the extent that electromagnetic interference does not affect the proper
function of existing navigation and communication equipment on board
and such that only one AIS unit may be in operation at any one time.
    (g) Pilot Port. The AIS Pilot Port, on any vessel subject to
pilotage, must be readily available and easily accessible from the
primary conning position of the vessel and within at least 3 feet of a
120-volt 50/60 Hz AC power receptacle.
    (h) Exceptions. Only those vessels that operate solely within a
very confined area (e.g., less than a one nautical-mile radius,
shipyard, fleeting area), or on short and fixed schedules (e.g., a
bank-to-bank river ferry service), or that otherwise are not likely to
encounter another AIS equipped vessel, may request a yearly deviation
from this section as set forth in Sec.  164.55.
    (i) Implementation date. Those vessels identified in paragraph (b)
of this section that were not previously subject to AIS carriage must
install AIS no later than [date of the first day of the seventh month
after publication of the final rule to be inserted].

Sec.  164.53   [Amended]

    27. In Sec.  164.53(b), following the word ``vessel's'', add the
phrase ``automatic identification system (AIS),''.

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    28. The authority citation for part 165 is revised to read as
follows:

    Authority: 33 U.S.C. 1226, 1231; 50 U.S.C. 191, 195; 33 CFR
1.05-1(g), 6.04-1, 6.04-6, and 160.5; Department of Homeland
Security Delegation No. 0170.1.

Sec.  165.1704   [Amended]

    29. In Sec.  165.1704, in paragraph (c)(4), following the
punctuation mark ``;'', add the word ``and''; in paragraph (c)(5),
following the term ``6 knots'', remove ``; and'' and add, in their
place, the punctuation mark ``.''; and remove paragraph (c)(6).

    Dated: December 2, 2008.
Thad W. Allen,
Admiral, U.S. Coast Guard Commandant.
[FR Doc. E8-29698 Filed 12-11-08; 4:15 pm]

BILLING CODE 4910-15-P


[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Proposed Rules]
[Pages 6477-6480]
[FR Doc No: 2018-03026]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0078; Product Identifier 2017-NM-107-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2017-01-
02, which applies to certain The Boeing Company Model 787-8 and 787-9
airplanes. AD 2017-01-02 requires an inspection for discrepant inboard
and outboard trailing edge flap rotary actuators. Since we issued AD
2017-01-02, we have determined that it is necessary to revise the
applicability to include additional airplanes, and to reduce the number
of affected actuators. This proposed AD would continue to require an
inspection of the inboard and outboard trailing edge flap rotary
actuator for any discrepant rotary actuator, and corrective actions if
necessary. We are proposing this AD to address the unsafe condition on
these products.

DATES: We must receive comments on this proposed AD by April 2, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-

30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view this service information at the FAA, Transport Standards Branch,
1601 Lind Avenue SW, Renton, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available on
the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2018-0078.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0078; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Douglas Tsuji, Senior Aerospace
Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 1601
Lind Avenue SW, Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax: 425-
917-6590; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0078;
Product Identifier 2017-NM-107-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued AD 2017-01-02, Amendment 39-18769 (82 FR 4775, January
17, 2017) (``AD 2017-01-02''), for certain The Boeing Company Model
787-8 and 787-9 airplanes. AD 2017-01-02 requires an inspection for
discrepant inboard and outboard trailing edge flap rotary actuators. AD
2017-01-02 resulted from a report that indicated that some rotary
actuators of the inboard and outboard trailing edge flap may have been
assembled with an incorrect no-back brake rotor-stator stack sequence
during manufacturing. We issued AD 2017-01-02 to detect and replace
incorrectly assembled rotary actuators, which could cause accelerated
unit wear that will eventually reduce braking performance. This
degradation could lead to loss of no-back brake function and reduced
controllability of the airplane.

Actions Since AD 2017-01-02 Was Issued

    Since we issued AD 2017-01-02, we have determined that it is
necessary to revise the applicability to include additional airplanes,
and to reduce the number of affected actuators.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin B787-81205-SB270032-00,
Issue 003, dated July 28, 2017. The service information describes
procedures for an inspection of the inboard and outboard trailing edge
flap rotary actuator for any discrepant rotary actuator, and corrective
actions if necessary. The related investigative action includes a
functional test of the trailing edge flap no-back brake. The corrective
actions include replacement of the discrepant rotary actuator with a
non-discrepant rotary actuator. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would retain all requirements of AD 2017-01-02 and
add airplanes to the applicability. This proposed AD would require
accomplishing the actions specified in the service information
described previously. For information on the procedures and compliance
times, see this service information at http://www.regulations.gov by
searching for and locating Docket No. FAA-2018-0078.
    The phrase ``related investigative actions'' is used in this
proposed AD. Related investigative actions are follow-on actions that
(1) are related to the primary action, and (2) further investigate the
nature of any condition found. Related investigative actions in an AD
could include, for example, inspections.
    The phrase ``corrective actions'' is used in this proposed AD.
Corrective actions correct or address any condition found. Corrective
actions in an AD could include, for example, repairs.

Differences Between This Proposed AD and the Service Information

    To support operations, many operators have put processes in place
that, given certain conditions, allow them to rotate or transfer parts
or equipment within their fleets to different aircraft than what is
defined in the manufacturer's type design. We have determined that the
parts or equipment subject to the unsafe condition may have been
rotated or transferred in this manner, due to similarity with parts or
equipment not subject to the unsafe condition. Therefore, the
applicability of this proposed AD is for all The Boeing Company Model
787 series airplanes.
    The effectivity specified in Boeing Alert Service Bulletin B787-
81205-SB270032-00, Issue 001, dated November 3, 2015, consists of only
certain Boeing Model 787-8 and 787-9 airplanes. In this proposed AD,
the actions required by paragraphs (g) and (h) of this AD would be
accomplished on any The Boeing Company Model 787 series airplane with
an original Certificate of Airworthiness or an original Export
Certificate of Airworthiness dated on or before the effective date of
the final rule. Expanding the applicability of this proposed AD
addresses the rotability issue of the trailing edge flap rotary
actuators. We have confirmed with the manufacturer that the
accomplishment instructions in the following service information are
applicable to the expanded group of airplanes:

     Boeing Alert Service Bulletin B787-81205-SB270032-00,
Issue 001, dated November 3, 2015.
     Boeing Alert Service Bulletin B787-81205-SB270032-00,
Issue 002, dated November 3, 2016.
     Boeing Alert Service Bulletin B787-81205-SB270032-00,
Issue 003, dated July 28, 2017.
    The Boeing Company Model 787 series airplanes with an original
Certificate of Airworthiness or an original Export Certificate of
Airworthiness dated after the effective date of the final rule are not
required to complete the actions specified in paragraphs (g) and (h) of
this AD, but must comply with the parts installation prohibition in
paragraph (i) of this AD.

Costs of Compliance

    We estimate that this proposed AD affects 89 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspection............................  5 work-hours x $85 per                $0            $425         $37,825
                                         hour = $425.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary on-condition
actions that would be required based on the results of the proposed
inspection. We have no way of determining the number of aircraft or the
number of rotary actuators (up to 8 per shipset) that might need these
on-condition actions:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
              Action                     Labor cost         Parts cost               Cost per product
----------------------------------------------------------------------------------------------------------------
Check to determine flight cycles    1 work-hour x $85                 $0  $85 per rotary actuator.
 on the rotary actuator.             per hour = $85.
Functional Test per rotary          2 work-hours x $85                 0  $170 per rotary actuator.
 actuator.                           per hour = $170.
Replacement per rotary actuator...  2 work-hours x $85                 0  $170 per rotary actuator.
                                     per hour = $170.
System Test after rotary actuator   24 work-hours x $85                0  $2,040 per airplane.
 replacement(s) per airplane.        per hour = $2,040.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2017-01-02, Amendment 39-18769 (82 FR 4775, January 17, 2017), and
adding the following new AD:

The Boeing Company: Docket No. FAA-2018-0078; Product Identifier
2017-NM-107-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by April 2,
2018.

(b) Affected ADs

    This AD replaces AD 2017-01-02, Amendment 39-18769 (82 FR 4775,
January 17, 2017) (``AD 2017-01-02'').

(c) Applicability

    This AD applies to all The Boeing Company Model 787 series
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
control systems.

(e) Unsafe Condition

    This AD was prompted by a report indicating that some inboard
and outboard trailing edge flap rotary actuators may have been
assembled with an incorrect no-back brake rotor-stator stack
sequence during manufacturing. We are issuing this AD to detect and
replace incorrectly assembled rotary actuators, which could cause
accelerated unit wear that will eventually reduce braking
performance. This degradation could lead to loss of no-back brake
function and reduced controllability of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Inspection and Other Actions

    For The Boeing Company Model 787-8 and 787-9 airplanes
identified in Boeing Alert Service Bulletin B787-81205-SB270032-00,
Issue 001, dated November 3, 2015: Within 60 months after February
21, 2017 (the effective date of AD 2017-01-02), do an inspection of
the inboard and outboard trailing edge flap rotary actuator for any
discrepant rotary actuator, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin B787-81205-SB270032-
00, Issue 001, dated November 3, 2015; or Boeing Alert Service
Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017. If
any discrepant rotary actuator is found, within 60 months after
February 21, 2017, do the actions specified in paragraph (g)(1) or
(g)(2) of this AD, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin B787-81205-SB270032-
00, Issue 001, dated November 3, 2015; or Boeing Alert Service
Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017.
After the effective date of this AD only Boeing Alert Service
Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017, may
be used.
    (1) Replace the discrepant rotary actuator.
    (2) Check the maintenance records to determine the flight cycles
of each discrepant rotary actuator and, within 60 months after
February 21, 2017 (the effective date of AD 2017-01-02), do all
applicable related investigative and corrective actions.

(h) New Requirements: Inspection, Related Investigative and Corrective
Actions

    For airplanes not identified in Boeing Alert Service Bulletin
B787-81205-SB270032-00, Issue 001, dated November 3, 2015, which
have an Original Certificate of Airworthiness or Export Certificate
of Airworthiness with a date on or before the effective date of this
AD: Within 60 months after the effective date of this AD, do an
inspection of the inboard and outboard trailing edge flap rotary
actuator for any discrepant rotary actuator, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin B787-
81205-SB270032-00, Issue 003, dated July 28, 2017. If any discrepant
rotary actuator is found, within 60 months after the effective date
of this AD, do the actions specified in paragraph (h)(1) or (h)(2)
of this AD, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003,
dated July 28, 2017.
    (1) Replace the discrepant rotary actuator.
    (2) Check the maintenance records to determine the flight cycles
of each discrepant rotary actuator and, within 60 months after the
effective date of this AD, do all applicable related investigative
and corrective actions.

(i) Parts Installation Limitation

    As of the effective date of this AD, no person may install, on
any airplane, a rotary actuator with a part number and serial number
identified in Appendix A of Boeing Alert Service Bulletin B787-
81205-SB270032-00, Issue 003, dated July 28, 2017, unless the
actuator has been permanently marked in accordance with Task 2 of
Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003,
dated July 28, 2017, with ``B787-81205-SB270032-00 INCORPORATED.''

(j) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Boeing Alert Service Bulletin B787-
81205-SB270032-00, Issue 002, dated November 3, 2016.
    (2) This paragraph provides credit for the actions specified in
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD using Boeing Alert Service Bulletin B787-
81205-SB270032-00, Issue 001, dated November 3, 2015, or Boeing
Alert Service Bulletin B787-81205-SB270032-00, Issue 002, dated
November 3, 2016.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (l)(1) of this AD. Information may be
emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO Branch, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) AMOCs approved previously for AD 2017-01-02 are approved as
AMOCs for the corresponding provisions of this AD.
    (5) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(k)(5)(i) and (k)(5)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(l) Related Information

    (1) For more information about this AD, contact Douglas Tsuji,
Senior Aerospace Engineer, Systems and Equipment Section, FAA,
Seattle ACO Branch, 1601 Lind Avenue SW, Renton, WA 98057-3356;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 1601 Lind Avenue
SW, Renton, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on January 30, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-03026 Filed 2-13-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 112 (Friday, June 10, 2022)]
[Proposed Rules]
[Pages 35472-35473]
[FR Doc No: 2022-12509]

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

Coast Guard

33 CFR Part 117

[Docket No. USCG-2022-0222]
RIN 1625-AA09

Drawbridge Operation Regulation; Okeechobee Waterway, Stuart, FL

AGENCY: Coast Guard, DHS.

ACTION: Supplemental notification of inquiry, request for comments.

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

SUMMARY: The Coast Guard is seeking information and comments on
proposing a change to the drawbridge operating regulations for the
Florida East Coast (FEC) Railroad Bridge, mile 7.4, and the SR 707
(Dixie Hwy) Bridge, mile 7.5, across the Okeechobee Waterway (OWW), at
Stuart, Florida. In anticipation of passenger rail service across the
FEC Railroad Bridge, the Coast Guard recognizes a change to the
drawbridge operating schedules may be necessary to meet the reasonable
needs of the maritime community and railway traffic. We invite your
comments on this proposed rulemaking.

DATES: Comments and related material must reach the Coast Guard on or
before July 25, 2022.

ADDRESSES:  You may submit comments identified by docket number USCG-
2022-0222 using Federal Decision Making Portal at https://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Ms. Jennifer Zercher, Bridge Management Specialist,
Seventh Coast Guard District, telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive Order
FR Federal Register
Sec.  Section Symbol
U.S.C. United States Code
FEC Florida East Coast
SR State Route
WAMS Waterways Analysis and Management System
OWW Okeechobee Waterway
HWY Highway
NOI Notification of Inquiry

II. Background, Purpose and Purpose

    On May 3, 2022, the Coast Guard published a notification of inquiry
(NOI) in the Federal Register (87 FR 26145) to solicit public comments
on proposing a change to the drawbridge operating regulations for the
Florida East Coast (FEC) Railroad Bridge, mile 7.4, and the SR 707
(Dixie Hwy) Bridge, mile 7.5, across the Okeechobee Waterway (OWW), at
Stuart, Florida. Comments and related material were to reach the Coast
Guard on or before July 5, 2022. As of May 27, 2022, 16 comments were
received. These comments will be addressed with the Supplemental NOI
comments.
    On May 26, 2022, the Honorable Brian Mast requested the NOI be
``recalled, rewritten, and republished'' based on concerns the NOI
failed to address all recommendations included in the 2018 Waterways
Analysis and Management System (WAMS) study. The Coast Guard will
publish an ex parte communications memorandum via the Federal Register
using docket number USCG-2022-0222.
    This Supplemental NOI is being provided to clarify the Coast
Guard's intent in gathering information under this NOI. The Coast Guard
is seeking information regarding usage and equitable access to the
waterway under the FEC Railroad Bridge, mile 7.4, and the SR 707 (Dixie
Hwy) Bridge, mile 7.5, across the OWW, at Stuart, Florida. For
drawbridge operating regulations, the Coast Guard interprets
``equitable'' usage as access to the waterway which meets the
reasonable needs of navigation while balancing the needs of competing
modes of transportation.

III. Discussion on Comments and Changes

    As noted above, a request was made to recall, rewrite, and
republish the NOI based on an apparent lack of objectivity regarding
the Coast Guard's intent as to mariners' access to the waterway. The
Coast Guard has updated the summary and revised question six of the
original NOI to avoid perceived bias by the Coast Guard. A Supplemental
NOI will be published in the Federal Register.

IV. Information Requested

    To aid us in further developing a proposed rule, we seek responses
from waterway users to the following questions:
    (1) Do you currently transit through the FEC Railroad Bridge
crossing the Okeechobee Waterway, mile 7.4, at Stuart, Florida?
    (2) How often do you transit this waterway?
    (3) If railway traffic impedes your navigation of this area, how
long are you normally delayed?
    (4) How would you propose to regulate the balance of railway and
maritime traffic in this area?
    (5) What challenges have you experienced when transiting this area
due to these bridges and/or railway activity?
    (6) At what frequency and duration should the drawbridge openings
occur in order to meet the needs of navigation?
    (7) Should the SR 707 (Dixie Hwy) Bridge opening schedule mirror
the operating schedule of the FEC Railroad Bridge?

V. Public Participation and Request for Comments

    We encourage you to submit comments in response to this notice of
inquiry through the Federal Decision Making Portal at https://www.regulations.gov. To do so, go to

https://www.regulations.gov, type USCG-2022-0222 in the search box and
click ``Search.'' Next, look for this document in the Search Results
column, and click on it. Then click on the Comment option. In your
submission, please include the docket number for this notice of inquiry
and provide a reason for each suggestion or recommendation. 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.
    To view documents mentioned in this proposed rule as being
available in the docket, find the docket as described in the previous
paragraph, and then select ``Supporting & Related Material'' in the
Document Type column. Public comments will also be placed in our online
docket and can be viewed by following instructions on the https://www.regulations.gov Frequently Asked Questions web page. We review all
comments received, but we may choose not to post off-topic,
inappropriate, or duplicate comments that we receive. Additionally, if
you go to the online docket and sign up for email alerts, you will be
notified when comments are posted or a final rule is published.
    We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have
provided. For more about privacy and submissions in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020).
    We may hold a public meeting, if necessary, to receive oral
comments on this Notice of Inquiry and will announce the date, time,
and location in a separate document published in the Federal Register.
If you signed up for docket email alerts mentioned in the paragraph
above, you will receive an email notice when the public meeting notice
is published and placed in the docket.
    This document is issued under authority of 5 U.S.C. 552 (a) and 33
U.S.C. 499.

    Dated: June 6, 2022.
Jeffrey K. Randall,
Captain, U.S. Coast Guard, Acting Commander, Seventh Coast Guard
District.
[FR Doc. 2022-12509 Filed 6-9-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 82 (Monday, May 1, 2017)]
[Proposed Rules]
[Pages 20288-20290]
[FR Doc No: 2017-08708]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 82, No. 82 / Monday, May 1, 2017 / Proposed
Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0330; Directorate Identifier 2017-NM-016-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 737-300, -400, and -500 series
airplanes. This proposed AD would require repetitive inspections for
cracking in the skin lap splice at the lower fastener row, and repair
if necessary. This AD was prompted by an evaluation by the design
approval holder (DAH) indicating that the lower skin at the skin lap
splice lower fastener row is subject to widespread fatigue damage
(WFD). We are proposing this AD to address the unsafe condition on
these products.

DATES: We must receive comments on this proposed AD by June 15, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110 SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may
view this referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. Boeing
Alert Service Bulletin 737-53A1365, dated January 23, 2017, is also
available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0330.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0330; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: James Guo, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone:
562-627-5357; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2017-0330;
Directorate Identifier 2017-NM-016-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Fatigue damage can occur locally, in small areas or structural
design details, or globally, in widespread areas. Multiple-site damage
is widespread damage that occurs in a large structural element such as
a single rivet line of a lap splice joining two large skin panels.
Widespread damage can also occur in multiple elements such as adjacent
frames or stringers. Multiple-site damage and multiple-element damage
cracks are typically too small initially to be reliably detected with
normal inspection methods. Without intervention, these cracks will
grow, and eventually compromise the structural integrity of the
airplane. This condition is known as WFD. It is associated with general
degradation of large areas of structure with similar structural details
and stress levels. As an airplane ages, WFD will likely occur, and will
certainly occur if the airplane is operated long enough without any
intervention.
    The FAA's WFD final rule (75 FR 69746, November 15, 2010) became
effective on January 14, 2011. The WFD rule requires certain actions to
prevent structural failure due to WFD throughout the operational life
of certain existing transport category airplanes and all of these
airplanes that will be certificated in the future. For existing and
future airplanes subject to the WFD rule, the rule requires that DAHs
establish a limit of validity (LOV) of the engineering data that
support the structural maintenance program. Operators affected by the
WFD rule may not fly an airplane beyond its LOV, unless an extended LOV
is approved.
    The WFD rule (75 FR 69746, November 15, 2010) does not require
identifying and developing maintenance actions if the DAHs can show
that such actions are not necessary to prevent WFD before the airplane
reaches the LOV. Many LOVs, however, do depend on accomplishment of
future maintenance actions. As stated in the WFD rule, any maintenance
actions necessary to reach the LOV will be mandated by airworthiness
directives through separate rulemaking actions.

    In the context of WFD, this action is necessary to enable DAHs to
propose LOVs that allow operators the longest operational lives for
their airplanes, and still ensure that WFD will not occur. This
approach allows for an implementation strategy that provides
flexibility to DAHs in determining the timing of service information
development (with FAA approval), while providing operators with
certainty regarding the LOV applicable to their airplanes.
    We received a report indicating that, during window belt
replacements, cracking was found in the lower skin at the stringer S-14
lap splice lower row between station (STA) 360 and STA 540, and between
STA 727 and STA 908, on a Model 737-300 airplane. An additional 51
airplanes were inspected and 22 crack indications were reported on
airplanes with 42,358 to 48,188 total flight cycles and 53,490 to
58,796 total flight hours. We are issuing this AD to detect and correct
cracks in the lower skin which, if not detected, could link up,
resulting in reduced structural integrity of the airplane and
consequent uncontrolled decompression of the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-53A1365, dated
January 23, 2017. The service information describes procedures for eddy
current inspections for cracking at the skin lap splice in the lower
fastener row, and repair if necessary. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between this Proposed AD and the Service
Information.'' For information on the procedures and compliance times,
see this service information at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0330.

Differences Between This Proposed AD and the Service Information

    Boeing Alert Service Bulletin 737-53A1365, dated January 23, 2017,
specifies to contact the manufacturer for certain instructions, but
this proposed AD would require using repair methods, modification
deviations, and alteration deviations in one of the following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) whom we have
authorized to make those findings.

Costs of Compliance

    We estimate that this proposed AD affects 126 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
          Action                   Labor cost        Parts cost      Cost per product     Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Inspection................  84 work-hours x $85 per          $0  $7,140 per inspection    $899,640 per
                             hour = $7,140 per                    cycle.                   inspection cycle.
                             inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2017-0330; Directorate Identifier
2017-NM-016-AD.

(a) Comments Due Date

    We must receive comments by June 15, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 737-300, -400, -500
airplanes, certificated in any category, as identified in Boeing
Alert Service Bulletin 737-53A1365, dated January 23, 2017.

(d) Subject

    Air Transport Association (ATA) of America Code 53; Fuselage.

(e) Unsafe Condition

    This AD was prompted by an evaluation by the design approval
holder indicating that the lower skin at the skin lap splice lower
fastener row is subject to widespread fatigue damage. We are issuing
this AD to detect and correct cracks in the lower skin, which, if
not detected, could link up, resulting in reduced structural
integrity of the airplane and consequent uncontrolled decompression
of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Repetitive Inspections

    Except as provided by paragraph (i) of this AD, at the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 737-53A1365, dated January 23, 2017:
Do external eddy current inspections at stringer S-14 on the left
and right sides of the airplane (S-14L and S-14R) for any crack in
the skin lap splice at the lower fastener row, in accordance with
the Accomplishment Instructions of Boeing Alert Service Bulletin
737-53A1365, dated January 23, 2017. Repeat the inspections
thereafter at the applicable times specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1365, dated
January 23, 2017.

(h) Repair

    If any crack is found during any inspection required by
paragraph (g) of this AD, repair before further flight using a
method approved in accordance with the procedures specified in
paragraph (j) of this AD. Although Boeing Alert Service Bulletin
737-53A1365, dated January 23, 2017, specifies to contact Boeing for
appropriate action and specifies that action as ``RC'' (Required for
Compliance), this AD requires repair as specified in this paragraph.

(i) Exceptions to Service Information Specifications

    (1) Where Boeing Alert Service Bulletin 737-53A1365, dated
January 23, 2017, specifies a compliance time ``after the original
issue date of this service bulletin,'' this AD requires compliance
within the specified compliance time after the effective date of
this AD.
    (2) The Condition column of Table 1 and Table 2 of paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 737-53A1365,
dated January 23, 2017, refers to total flight cycles ``at the
original issue date of this service bulletin.'' This AD, however,
applies to the airplanes with the specified total flight cycles as
of the effective date of this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the ACO, send it to the attention of the
person identified in paragraph (k)(1) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) Except as required by paragraph (h) of this AD: For service
information that contains steps that are labeled as Required for
Compliance (RC), the provisions of paragraphs (j)(4)(i) and
(j)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(k) Related Information

    (1) For more information about this AD, contact James Guo,
Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-
5357; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on April 24, 2017.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-08708 Filed 4-28-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: August 11, 2010 (Volume 75, Number 154)]
[Notices]
[Page 48696-48697]
[DOCID:fr11au10-70]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0198]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
September 10, 2010.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0120.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Premarket Notification--(OMB Control Number 0910-0120)--Extension

    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360(k)) and the implementing regulation under part 807
(21 CFR part 807, subpart E) requires a person who intends to market a
medical device to submit a premarket notification submission to FDA at
least 90 days before proposing to begin the introduction, or delivery
for introduction into interstate commerce, for commercial distribution
of a device intended for human use. Based on the information provided
in the notification, FDA must determine whether the new device is
substantially equivalent to a legally marketed device, as defined in
Sec.  807.92(a)(3). If the device is determined to be not substantially
equivalent to a legally marketed device, it must have an approved
premarket approval application (PMA), Product Development Protocol,
Humanitarian Device Exemption (HDE), Petition for Evaluation of
Automatic Class III Designation (de novo) or be reclassified

into class I or class II before being marketed. FDA makes the final
decision of whether a device is substantially equivalent or not
equivalent.
    Section 807.81 states when a premarket notification is required. A
premarket notification is required to be submitted by a person who is:
     Introducing a device to the market for the first time;
     Introducing a device into commercial distribution for the
first time by a person who is required to register; and
     Introducing or reintroducing a device which is
significantly changed or modified in design, components, method of
manufacturer, or the intended use that could affect the safety and
effectiveness of the device.
    Section 807.87 specifies information required in a premarket
notification submission.
    Section 204 of the Food and Drug Administration Modernization Act
(FDAMA) amended section 514 of the act (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions including premarket
notifications or other requirements. FDA has published and updated the
list of recognized standards regularly since enactment of FDAMA and has
allowed 510(k) submitters to certify conformance to recognized
standards to meet the requirements of Sec.  807.87. FDA Form FDA 3654,
the 510(k) Standards Data Form, standardizes the format for submitting
information on consensus standards that a 510(k) submitter chooses to
use as a portion of their premarket notification submission (The Form
FDA 3654 is not for declarations of conformance to a recognized
standard). FDA believes that use of this form will simplify the 510(k)
preparation and review process for 510(k).
    Form FDA 3514, a summary coversheet form, assists respondents in
categorizing administrative 510(k) information for submission to FDA.
This form also assists respondents in categorizing information for
other FDA medical device programs such as PMAs, investigational device
exemptions, and HDEs. Under Sec.  807.87(h), each 510(k) submitter must
include in the 510(k) either a summary of the information in the 510(k)
as required by Sec.  807.92 (510(k) summary) or a statement certifying
that the submitter will make available upon request the information in
the 510(k) with certain exceptions as per Sec.  807.93 (510(k)
statement). If the 510(k) submitter includes a 510(k) statement in the
510(k) submission, Sec.  807.93 requires that the official
correspondent of the firm make available within 30 days of a request,
all information included in the submitted premarket notification on
safety and effectiveness. This information will be provided to any
person within 30 days of a request if the device described in the
510(k) submission is determined to be substantially equivalent. The
information provided will be a duplicate of the 510(k) submission
including any safety and effectiveness information, but excluding all
patient identifiers and trade secret and commercial confidential
information. According to Sec.  807.90, submitters may request
information on their 510(k) review status 90 days after the initial
log-in date of the 510(k). Thereafter, the submitter may request status
reports every 30 days following the initial status request. To obtain a
510(k) status report, the submitter should complete the status request
form, Form FDA 3541, and fax it to the Center for Devices and
Radiological Health office identified on the form. The most likely
respondents to this information collection will be specification
developers and medical device manufacturers.
    In the Federal Register of May 5, 2010 (75 FR 24708), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            No. of         Annual Frequency      Total Annual          Hours per
         21 CFR  Section             Form  Number         Respondents        per Response          Responses           Response           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807 subpart E                     ..................               3,800                   1               3,800               79                300,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.87                                 FDA Form 3514               1,956                   1               1,956                0.5                  978
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.90 (a)(3)                          FDA Form 3541                 218                   1                 218                0.25                  55
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.87(d) and (f)                      FDA Form 3654               1,500                   1               1,500               10                 15,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.92 and 807.93                 ..................               2,000                  10               2,000               10                 20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                336,233
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19746 Filed 8-10-10; 8:45 am]
BILLING CODE 4160-01-S