[Federal Register: November 5, 2009 (Volume 74, Number 213)]
[Proposed Rules]
[Page 57277-57278]
[DOCID:fr05no09-18]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0889; Directorate Identifier 2009-NE-35-AD]
RIN 2120-AA64

Airworthiness Directives; Turbomeca Arriel 2B and 2B1 Turboshaft
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) issued by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Several events of uncoupling of the low-pressure (LP) fuel pump
impeller and the high-pressure (HP) fuel pump shaft have been
reported on Arriel 2 engines which do not incorporate Modification
TU 147. In most cases the ``low fuel pressure switch'' enlightened,
the pilot activated the aircraft booster pump in accordance with the
Flight Manual Instructions and landed safely with no other incident.
One case, on a single-engine helicopter, led to a sudden engine
power loss. The uncoupling of the LP fuel pump impeller and the HP
fuel pump shaft may lead to a limitation of engine power or, at
worst, an uncommanded in-flight shutdown. On a single-engine
helicopter, the result may be an emergency autorotation landing.

We are proposing this AD to prevent forced autorotation landing, or an
accident.

DATES: We must receive comments on this proposed AD by December 7,
2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Contact Turbomeca, 40220 Tarnos, France; telephone (33) 05 59 74 40
00, fax (33) 05 59 74 45 15, for the service information identified in
this proposed AD.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
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 Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: James Lawrence, Aerospace Engineer,
Engine Certification Office, FAA, Engine and Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0889;
Directorate Identifier 2009-NE-35-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 based on 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
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2009-0184, dated August 14, 2009 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Several events of uncoupling of the LP fuel pump impeller and
the HP fuel pump shaft have been reported on Arriel 2 engines which
do not incorporate Modification TU 147. In most cases the ``low fuel
pressure switch'' enlightened, the pilot activated the aircraft
booster pump in accordance with the Flight Manual Instructions and
landed safely with no other incident. One case, on a single-engine
helicopter, led to a sudden engine power loss. The uncoupling of the
LP fuel pump impeller and the HP fuel pump shaft may lead to a
limitation of engine power or, at worst, an uncommanded in-flight
shutdown. On a single-engine helicopter, the result may be an
emergency autorotation landing.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Turbomeca has issued Mandatory Service Bulletin No. A292 73 2830,
Version B, dated July 10, 2009. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of France,
and is approved for operation in the United States. Pursuant to our
bilateral agreement with France, they have notified us of the unsafe
condition described in the MCAI and service information referenced
above. We are proposing this AD because we evaluated all information
provided by EASA and determined the unsafe condition exists and is
likely to exist or develop on other products of the same type design.
This proposed AD would require the checking of the transmissible torque
between the LP pump impeller and the HP pump shaft, on HP/LP pump
metering units (HMUs) that do not incorporate Modification TU 147. This
proposed AD would also require replacing the HMU if it fails with an
HMU that has not incorporated Modification TU 147 but passes the check,
or with an HMU that incorporates Modification TU 147.

Differences Between This AD and the MCAI or Service Information

    The MCAI requires the checking of the transmissible torque between
the LP pump impeller and the HP pump shaft within 550 engine flight
hours from the effective date of the AD, but no later than June 30,
2010.

    This proposed AD would require the checking of the transmissible
torque between the LP pump impeller and the HP pump shaft within 550
engine flight hours from the effective date of the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 414 engines installed on helicopters of U.S.
registry. We also estimate that it would take about 2.5 work-hours per
engine to comply with this proposed AD. The average labor rate is $80
per work-hour. Replacement HMUs would cost about $12,000 per engine.
Based on these figures, if all of the HMUs were to fail the check, we
estimate the cost of the proposed AD on U.S. operators to be
$5,050,800.

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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Turbomeca: Docket No. FAA-2009-0889; Directorate Identifier 2009-NE-
35-AD.

Comments Due Date

    (a) We must receive comments by December 7, 2009.

Affected Airworthiness Directives (ADs)

    (b) None.

Applicability

    (c) This AD applies to Turbomeca Arriel 2B and 2B1 turboshaft
engines that have not incorporated Modification TU 147. These
engines are installed on, but not limited to, Eurocopter AS 350 B3
and EC 130 B4, and Chaughe Z11, helicopters.

Reason

    (d) This AD results from mandatory continuing airworthiness
information (MCAI) issued by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. We are issuing this AD to prevent forced autorotation
landing, or an accident.

Actions and Compliance

    (e) Unless already done, do the following actions.
    (1) Within 550 engine flight hours from the effective date of
this AD, check the transmissible torque between the low-pressure
(LP) pump impeller and the high-pressure (HP) pump shaft of the HP/
LP pump metering unit (HMU). Use paragraph 2 of the Instructions to
be Incorporated of Turbomeca Alert Service Bulletin No. A292 73
2830, Version B, dated July 10, 2009, to do the check.
    (2) If the check is compliant, apply the nominal tightening
torque to the screw of the LP pump impeller.
    (3) If the check is not compliant, replace the HP/LP pump
metering unit with a unit that has not incorporated Modification TU
147 but has passed the check, or with a unit that has incorporated
Modification TU 147.

FAA AD Differences

    (f) This AD differs from the MCAI and/or service information as
follows:
    (1) The MCAI requires the checking of the transmissible torque
between the LP pump impeller and the HP pump shaft within 550 engine
flight hours from the effective date of the AD, but no later than
June 30, 2010.
    (2) This AD requires the checking of the transmissible torque
between the LP pump impeller and the HP pump shaft within 550 engine
flight hours from the effective date of this AD.

Alternative Methods of Compliance (AMOCs)

    (g) The Manager, Engine Certification Office, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2009-0184, dated August 14, 2009, and Turbomeca Mandatory
Service Bulletin No. A292 73 2830, Version B, dated July 10, 2009,
for related information. Contact Turbomeca, 40220 Tarnos, France;
telephone (33) 05 59 74 40 00, fax (33) 05 59 74 45 15, for a copy
of this service information.
    (i) Contact James Lawrence, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax (781) 238-
7199, for more information about this AD.

    Issued in Burlington, Massachusetts, on October 27, 2009.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E9-26730 Filed 11-4-09; 8:45 am]

BILLING CODE 4910-13-P


July 19, 2018
                                CERTIFIED MAIL
Al Gonzalez
EH&S Coordinator
Meridian Manufacturing
2902 Expansion Blvd.
Storm Lake, IA 50588

Re:  Plant Number 11-01-029; Project Number 18-181; Issuance of Construction Permits.

Dear Mr. Gonzalez:

The Department has completed a review of the air construction permit application(s) submitted on May 3, 2018 and a determination has been made that the following permit(s) shall be issued:

                                Emission Unit
                              Description (EU ID)
                                     EP ID
                     Control Equipment Description (CE ID)
                                 Stack Testing
                                 Permit Number
Paint Booth (EU 1)
                                       1
                              Panel Filter (CE 1)
                                      No
                                  03-A-010-S2
Paint Booth (EU 1)
                                       2
                              Panel Filter (CE 2)
                                      No
                                  03-A-011-S2
Paint Booth (EU 2)
                                       3
                              Panel Filter (CE 3)
                                      No
                                  99-A-244-S6
Paint Booth (EU 2)
                                       4
                              Panel Filter (CE 4)
                                      No
                                  99-A-245-S6
Paint Booth (EU 3)
                                       5
                              Panel Filter (CE 5)
                                      No
                                  99-A-246-S6
Paint Booth (EU 3)
                                       6
                              Panel Filter (CE 6)
                                      No
                                  99-A-247-S6
Paint Kitchen (EU 6)
                                       8
                                      NA
                                      No
                                  00-A-965-S3
Paint Kitchen (EU 6)
                                       9
                                      NA
                                      No
                                  00-A-966-S3
Powder Coat Booth (EU 8)
                                      10
                             Fabric Filter (CE 10)
                                      No
                                  05-A-247-S1
Plasma Table (EU 23)
                                      23
                          Filters (CE 23A, 23B, 23C)
                                      No
                                  00-A-980-S3
Welding Area 1 (EU 30)
                                      30
                                      NA
                                      No
                                  05-A-566-S3
Welding Area 2 (EU 31)
                                      31
                                      NA
                                      No
                                  05-A-567-S3
Welding Area 3 (EU 32)
                                      32
                                      NA
                                      No
                                  05-A-568-S3
Welding Area 4 (EU 33)
                                      33
                                      NA
                                      No
                                  05-A-569-S3
Welding Area 5 (EU 34)
                                      34
                                      NA
                                      No
                                  09-A-686-S2

Your attention is directed toward the permit conditions within the permit(s) especially Condition 1 (Emission Limits), Condition 2 (Compliance Demonstration), and Condition 5 (Operating Requirements with Associated Recordkeeping and Monitoring).  Based upon the submitted application(s) the Department has made the following determinations:
 This facility is not subject to NSPS because there are no applicable subparts.
 This facility is subject to NESHAP subpart XXXXXX, National Emission Standards for Hazardous Air Pollutants: Area Source Standards for Nine Metal Fabrication and Finishing Source Categories. This facility is of the source category for Subpart MMMM  -  Surface Coating Miscellaneous Metal Parts and Products (40 CFR §63.3880- 40 CFR §63.3981) of the National Emission Standards for Hazardous Air Pollutants (NESHAP).  Only "major sources", as defined in 40 CFR § 63.2, are subject to this subpart. In this project, the facility was able to establish enforceable limits to become an area source of HAP per EPA's guidance document ("Reclassification of Major Sources as Area Sources Under Section 112 of the Clean Air Act", 1/25/18). Hence, the facility is an area source and not subject Subpart MMMM.
 This project makes this facility a minor stationary source for the Title V Operating Permit program. If you want to rescind your Title V permit please contact Weston Li at<PHONE_NUMBER> or Chris Kjellmark at<PHONE_NUMBER>.
 This facility is a minor source for Prevention of Significant Deterioration (PSD).
 Stack testing is not required for this project.  The Department maintains the right to require testing of any source of emissions in the future if needed [567 IAC 25.1(7)].

Per 561 IAC 7.4(1), the owner or operator shall file any written notice of appeal within thirty (30) days of receipt of the issued permit(s).  The written notice of appeal shall be filed with the Director of the Department with a copy to the Legal Services Bureau Chief at the following addresses:

Director
Iowa Department of Natural Resources
502 East 9[th] Street
Des Moines, IA  50319
Bureau Chief
Legal Services Bureau
Iowa Department of Natural Resources
502 East 9[th] Street
Des Moines, IA  50319

In addition to the permits you will find one (1) copy of each of the following attached to this letter: Start-up Notice, Start of Construction Notice, Response to Comments, and a list of definitions and acronyms.  When requesting a modification to any of the permits, use the permit number and your plant number for identification.  For future reference a status report of all construction permit applications submitted to the Department is available at www.iowadnr.gov/airpermitsearch.  If you have any general air quality construction permitting questions please call 1-877-AIR-IOWA.  If you have any questions about these permits, feel free to contact me by phone at<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>.

Sincerely,

Gary Smith
Environmental Engineer Senior
Air Quality Bureau, IDNR
C:

                       Air Quality Construction Permits
                                Common Acronyms
There are many terms and acronyms used in the air quality program.  This fact sheet has been developed to provide a brief explanation of some of those terms that could by listed within your air quality construction permit.  Please note that these acronyms may not be the exact definition of the term or acronym as contained within the regulations.

  acfm			Actual cubic feet per minute
  Applicant		The owner, company official or authorized agent
  BACT			Best Achievable Control Technology
  Btu			British thermal unit
  C			Degrees Celsius
  Condensable PM	Material that condenses and/or reacts upon cooling and dilution in the ambient air to form particulate matter immediately after discharge from the stack
  CO2e	Carbon dioxide equivalent which is the aggregate emissions of greenhouse gas (GHG) emissions based on global warming potentials
  Department		Iowa Department of Natural Resources
  dia.			Diameter
  F			Degrees Fahrenheit
  ft			Foot
  GHG	Greenhouse Gas which is defined as being the group of carbon dioxide (CO2), methane (CH4), nitrous oxide (N2O), hydrofluorocarbons (HFC), perfluorocarbons (PFC) and sulfur hexafluoride (SF6)
  g			grams
  g/dscm		Grams per dry standard cubic meter
  gr			Grains
  gr/dscf		Grains per dry standard cubic foot
  gr/scf			Grains per standard cubic foot
  HAP			Hazardous Air Pollutant(s)
  hp			horsepower
  hr			Hour
  LAER			Lowest Achievable Emission Rate
  lb			Pound
  lb/hr			Pounds per hour
  m			Meter
  MACT			Maximum Achievable Control Technology
  mg			Milligram
  MM			Million
  MSDS			Material Safety Data Sheet
  MW			Megawatt
  NA			Not Applicable
  PM2.5			Particulate Matter with an aerodynamic diameter equal to or less than 2.5 microns
  PM10			Particulate Matter with an aerodynamic diameter equal to or less than 10 microns
  PM  -  Federal 		Particulate Matter that does not include the condensable PM
  PM  -  State		Particulate Matter that includes condensable PM
  ppm			parts per million
  ppmv 			parts per million by volume
  ppmw			parts per million by weight
  RACT			Reasonably Achievable Control Technology
  scfm			Standard cubic feet per minute
  SDS			Safety Data Sheet
  SHAP			Single hazardous air pollutant
  THAP			Total hazardous air pollutants
  tons/yr		Tons per year
  yr			Year


[Federal Register Volume 82, Number 50 (Thursday, March 16, 2017)]
[Notices]
[Pages 14102-14103]
[FR Doc No: 2017-05260]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0006]

Agency Information Collection Activities; Revision of an Approved
Information Collection: Practices of Household Goods Brokers

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. FMCSA requests approval
to revise an ICR titled ``Practices of Household Brokers'' to no longer
include one-time costs previously incurred by brokers to come into
compliance with applicable Federal regulations, and to update other
wage related costs that have changed since the last approval. This ICR
is necessary to support the requirements of applicable Federal
regulations and FMCSA's responsibility to ensure consumer protection in
the transportation of household goods (HHG).

DATES: We must receive your comments on or before May 15, 2017.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Docket Number FMCSA-2017-0006 using any of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001 between 9 a.m. and 5
p.m. e.t., Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments and
additional information on the exemption process, see the Public
Participation heading below. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal Web site. If you want us to notify
you that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments online. Comments received after the
comment closing date will be included in the docket and will be
considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Monique Riddick, Commercial
Enforcement and Investigations Division, U.S. Department of
Transportation, Federal Motor Carrier Safety Administration, West
Building 6th Floor, 1200 New Jersey Avenue SE., Washington, DC 20590-
0001. Telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Background: FMCSA amended then-existing regulations for brokers in
response to Title IV, Subtitle B of the Safe, Accountable, Flexible,
Efficient, Transportation Equity Act: A Legacy for Users (SAFETEA-LU)
(Pub. L. 109-59) and a petition for rulemaking from the American Moving
and Storage Association (AMSA). The final rule titled, ``Brokers of
Household Goods Transportation by Motor Vehicles,'' (75 FR 72987, Nov.
29, 2010), amended 49 CFR part 371, by providing additional consumer
protection responsibilities for brokers of HHG. Specifically, section
4212 of SAFETEA-LU directs the Secretary to require HHG brokers to
provide individual shippers with the following information whenever a
broker has contact with a shipper or potential shipper:
    1. The broker's USDOT number.
    2. The FMCSA booklet titled ``Your Rights and Responsibilities When
You Move.''
    3. A list of all authorized motor carriers providing transportation
of HHG used by the broker and a statement that the broker is not a
motor carrier providing transportation of HHG.
    The collection of information required in the referenced final rule
assist shippers in their business dealings with interstate HHG brokers.
The information collected is used by prospective shippers to make
informed decisions about contracts, services ordered, executed, and
settled. The HHG broker is often the primary contact for individual
shippers and in the best position to educate shippers and prepare them
for a successful move. The information collected makes that possible.
It also combats deceptive business practices as the information helps
enforcement personnel better protect consumers by verifying that
shippers are receiving information to which they are entitled by
regulation.
    HHG brokers are required to provide individual shippers the ``Your
Rights and Responsibilities When You Move'' booklet and the ``Ready to
Move'' brochure. They have the option of providing paper copies or
presenting the information through a link on their Internet Web site.
The broker is required to document with signed receipts that the
individual shipper was provided those materials. HHG brokers are also
required to provide the list of HHG

motor carriers for which it would arrange transportation to move a
potential individual shipper's HHG, and that broker's identification
information:
    1. Assigned USDOT number; and
    2. Address.
    With this renewal, FMCSA makes minor revisions to the collection.
First, a program adjustment of 19,522 annual burden hours is the result
of the removal of first-year burden-hours that are no longer
applicable. We also provide an updated estimated number of household
goods brokers.
    Title: Practices of Household Goods Brokers.
    OMB Control Number: 2126-0048.
    Type of Request: Revision of a currently approved collection.
    Respondents: Brokers of Household Goods.
    Estimated Number of Respondents: 543 brokers.
    Estimated Time per Response: 0.25 hours per day x 240 workdays for
transactions per household goods broker; 20 hours per year per broker
for Web site/ad modifications; 10 hours per year per household goods
broker for creating a list of carriers; 0.5 hours per month x 12 months
per household goods broker for confirming required information; 0.083
hour per year x 36.8 explanations on average per household goods
broker; 4 hours per year x 5 agreements per household goods broker for
annual agreements through turnover; and 10 hours per year per household
goods broker for disclosure and records.
    Expiration Date: April 30, 2017.
    Frequency of Response: On occasion.
    Estimated Total Annual Burden: 70,000 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize or include your
comments in the request for OMB's clearance of this information
collection.

    Issued under the authority of 49 CFR 1.87 on: March 9, 2017.
Kelly Regal,
Associate Administrator, Office of Research and Information Technology.
[FR Doc. 2017-05260 Filed 3-15-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: May 18, 2006 (Volume 71, Number 96)]
[Notices]
[Page 28893-28897]
[DOCID:fr18my06-93]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53795; File No. SR-Phlx-2005-61]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing of Proposed Rule Change, and Amendment Nos. 1 and 2
Thereto, Relating to the Deletion of Certain Exchange Rules

May 12, 2006.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and 19b-4 thereunder,\2\ notice is hereby given that on
October 14, 2005, the Philadelphia Stock Exchange, Inc. (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by the Phlx. On March
10, 2006, the Exchange submitted Amendment No. 1 to the proposed rule
change.\3\ Phlx filed amendment No. 2 to the proposed rule change on
May 1, 2006.\4\ The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1, which replaced the original filing in its
entirety, made clarifying changes to the proposed rule change and
sought to retain Phlx Rules 229 Supplementary Material .07(c)(ii)
and 236.
    \4\ Amendment No. 2, which replaced the original filing and
Amendment No. 1 in their entirety, made general clarifying changes
to the proposed rule change and sought to retain Phlx Rule 219, as
well as Phlx Rules 229 Supplementary Material .07(c)(ii) and 236.
Phlx states that it plans to propose to delete Phlx Rules 219, 229
Supplementary Material .07(c)(ii), and 236 in a future proposed rule
change regarding a change to Phlx systems.
---------------------------------------------------------------------------

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

    The Phlx, pursuant to section 19(b)(1) of the Act \5\ and Rule 19b-
4 thereunder,\6\ proposes to delete Phlx Rules 129, 241-248, and 923.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(1).
    \6\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    The text of the proposed rule change, as amended, appears below.
Additions are italicized; deletions are [bracketed].
* * * * *
Rule 129 [Withdrawal of Orders] Reserved
[The withdrawal from the Floor of the Exchange of an order for the
purchase or sale of securities, or any part thereof, at the request of
another member of the Exchange, for the purpose of the purchase or sale
of the securities so withdrawn outside of the Exchange is prohibited.]
Rule 241 [Special Offerings] Reserved
    [Notwithstanding the provisions of other Rules, which might
otherwise apply, the Exchange may, subject to the conditions specified
in this Rule and to compliance with the provisions contained herein,
permit a ``Special Offering'' (as herein defined) to be made through
the facilities of the Exchange, provided that the Exchange (after
consulting and with the concurrence of a Governor who is active on the
Floor of the Exchange) shall have determined that the regular market on
the Exchange cannot, within a reasonable time and at a reasonable price
or prices, absorb the particular block of a security which is to be the
subject of such Special Offering. In making such determination the
following factors shall be taken into consideration, via:
    (a) Price range and the volume of transactions in such security on
the Floor of the Exchange during the preceding six months;
    (b) Attempts which have been made to dispose of the security in the
regular market on the Floor of the Exchange;
    (c) The apparent past and current interest in such security in such
regular market on the Floor; and
    (d) The number of shares or bonds and the current market value of
the block of such security proposed to be covered by such Special
Offering.
    Except in special circumstances a Special Offering will not be
permitted unless the offering involves at least 1,000 shares of stock
with an aggregate market value of not less than $25,000, or $15,000 par
value in bonds with an aggregate market value of not less than
$10,000.]
Rule 242 [Definition] Reserved
    [A Special Offering is defined as an offering (designated as a
fixed price offering) by one or more members or member organizations
acting for his or its own account or for the account of one or more
other persons, for the sale of a block of a security dealt in on the
Exchange through the facilities of the Exchange at a price not in
excess of the last sale of such security or the current offer of such
security in the regular market on the Floor of the Exchange, whichever
is the lower, but equal to or higher than the current bid for such
security in such market, whereby the offer or agrees to pay a special
commission to such members and member organizations as may accept all
or any part of such Offering for the account of his or its customers;
provided, that the security which is the

subject of such Offering is a security to which the exemption afforded
by Rule 240.10b-2(d)(1) issued by the Securities and Exchange
Commission, and such amendments thereto as have been or may be from
time to time adopted, is available at the time of such Offering.]
Rule 243 [Conditions] Reserved
    [No Special Offering, as provided in these Rules shall be made
unless each of the following conditions is complied with, via:
    (a) The person for whose account such Special Offering is to be
made shall at the time of such Offering be the owner of the entire
block of the security so to be offered, except that, for the purpose of
stabilizing, there also may be sold for such person's account, or for
the account of any member organization offering the block of security
on his behalf, as part of the Special Offering, an amount not to exceed
10% of the shares or bonds owned and originally offered in the Special
Offering by such person.
    (b) The person for whose account such Special Offering is to be
made shall include within the Offering all of the security which he
then intends to offer within a reasonable time, and there shall be
furnished to the Exchange before the Offering is made a written
statement by the offeror to that effect or a written statement by his
broker stating that the broker has been so advised by the offeror.
    (c) A Special Offering shall be automatically suspended as long as
an offering exists ``regular way'' at a price which would permit a
purchase at a lower net cost than in the Special Offering. Unless
otherwise specifically exempted by the Exchange, every Special Offering
shall remain open for a minimum period of 15 minutes, inclusive of any
period during which it is suspended by operation of the above
provision. A Special Offering which has not been completed in the 15
minute minimum period shall not be withdrawn before completion without
the approval of the Exchange.
    (d) The person for whose account such Special Offering is made
shall agree that during the period such offering is open, he will not
offer in the regular market on the floor of the Exchange any shares or
bonds of the security which is the subject of such Special Offering,
unless the prior permission of the Exchange is first obtained.
    (e) The special commission referred to in Rule 242 shall not exceed
$1 per share on purchases at a price of $50 or less per share, or 2% of
the purchase price on purchases at a price in excess of $50 per share.
In the case of bonds such commission shall not exceed 2\1/2\% of the
purchase price.
    (f) No member or member organization shall directly or indirectly
receive any part of the special commission referred to in Rule 242 in
connection with any purchase for his or its own account or the account
of a partner thereof or a stockholder therein or for the account of any
other member or member organization or partner thereof or stockholder
therein, made pursuant to a Special Offering.
    (g) A Special Offering shall not be made unless it can be accepted
in a lesser amount or amounts than the total of the securities offered.
    (h) A Special Offering shall be made for acceptance in round lots
or in odd lots, without preference, and in the case of an odd-lot
purchase no differential shall be added to the gross purchase price of
the Special Offering.
    (i) When buying orders in a Special Offering exceed the amount
available in the offering, the offered security will be allocated in
reasonably proportionate amounts.]
Rule 244 [When Effective] Reserved
    [A Special Offering, when approved, shall become effective upon
announcement by the Exchange on the tape of the terms and conditions of
such Offering.]
Rule 245 [Terms of Offering on Tape] Reserved
    [The terms of a Special Offering shall be printed on the tape
before it is effective, with a statement, if such be the fact, that
stabilizing transactions have been effected or are contemplated and
that it is intended to over allot as permitted by Rule 243(a).
Transactions effected pursuant to a Special Offering shall when
feasible be printed currently on the tape, and the tape shall show the
gross price and the special commission in a legend such as: ``SP OFF
100 XYZ 40 COM .50'', as well as the number of orders involved in such
transaction where more than one order is involved; and after the close
of the market, any unprinted remainder of such transactions executed
during the day shall be so printed. When the offering is terminated, an
announcement to that effect shall be printed on the tape; and when the
intention to stabilize is terminated, such fact shall be announced on
the tape, together with a statement that stabilizing transactions have
been effected, if such be the fact.]
Rule 246 [Odd Lots] Reserved
    [Transactions effected pursuant to a Special Offering shall not
elect the execution of any outstanding ``regular way'' odd-lot orders.]
Rule 247 [Authorization] Reserved
    [(a) A Special Offering may be approved and made only if the person
or persons for whose account it is proposed to be made shall have
specifically authorized such Offering and its terms.
Disclosure
    (b) A member organization effecting for the account of a customer a
purchase pursuant to a Special Offering shall confirm such transaction
to such customer at the offering price and shall not charge to or
collect from such customer any commission on account of such
transaction.
    The confirmation by a member organization to a buyer or seller in a
Special Offering shall state in full the terms and conditions of the
Special Offering. The confirmation to a buyer shall state at least:
    (1) That the purchase was part of a Special Offering;
    (2) That no commission is to be charged to the customer;
    (3) That the seller is to pay a special commission to the member
organization, if such be the fact;
    (4) The amount of such special commission;
    (5) The information printed on the tape regarding stabilizing
transactions or the intention to stabilize; and
    (6) The nature of the member organization's interest in the Special
Offering, if any, other than its interest as a recipient of the special
commission.
    (c) A member organization soliciting purchase orders for execution
pursuant to a Special Offering shall advise the person so solicited of
the terms and conditions of such Offering before effecting any
transaction for such person pursuant thereto. Such disclosure shall
include at least the items described in paragraphs (1) to (6) of Rule
247(b).
    (d) A member organization with an order for the purchase of a
security which is the subject of a Special Offering shall effect such
purchase in the regular market whenever a ``regular way'' offering is
available which would permit such purchase at a lower net cost than in
the Special Offering. Every order for purchase in a Special Offering
shall be accepted pursuant to the above condition.]
Rule 248 [Information Regarding Special Offerings] Reserved

    [It is not the purpose of these Rules to supersede the auction
market or supplant approved secondary distributions, but to provide
means for

the handling of blocks of securities dealt in on the Exchange, through
the facilities of the Exchange, where such blocks, under current
conditions, cannot readily be absorbed in the auction market within a
reasonable time and at a reasonable price.
    Rules 241-248 are intended primarily to provide for Special
Offerings on an agency basis by members or member organizations on
behalf of their non-member customers. However, the Rules do not
prohibit a Special Offering by a member or member organization for his
or its own account.
    .01 Preliminary Information Required.--The broker for the offeror
will be required to furnish the following information to the Exchange
prior to the announcement of the Special Offering on the tape:
    (a) Name of the security and ticker symbol.
    (b) Number of shares or bonds.
    (c) Special Offering price.
    (d) Special commission.
    (e) Name of the offeror.
    (f) Written assurance of the offeror, or of the broker upon advice
from the offeror, that the shares or bonds contained in the Offering
are all of the security which he then intends to offer within a
reasonable time, as required in Rule 243(b).
    (g) Assurance of agreement of offeror to terms of Offering.
    (h) Statement as to whether stabilizing operations will be engaged
in to facilitate Special Offering.
    (i) Statement as to whether the offeror or his agent intends, for
the purpose of stabilizing, to sell shares or bonds in the Special
Offering in excess of that owned and included in the original offer as
permitted by Rule 243(a).
    (j) Statement that the shares or bonds covered by the application
do or do not require registration under the Securities Act of 1933,
together with explanation thereof. This information should be given to
the Exchange as soon as possible in advance of the time it is proposed
to make the Special Offering. Announcement will not be made on the tape
of the Special Offering (and the Special Offering thus cannot become
effective) until the Exchange has the requisite information and has
approved it.
    .02 Ownership.--The offeror in a Special Offering must be the bona
fide owner of the entire block of security offered, net of any short
account the offeror may have in such security. Sales for the purpose of
stabilizing as permitted by Rule 243(a) are excepted.
    .03 ``Piecemeal.''--``All or None'' Offerings. ``Piecemeal'' or
successive offerings of the same security by the same offeror, and
offerings on an ``all-or-none'' basis, will not be permitted.
    .04 Minimum Period of Offering.--Rule 243(c) provides in part that
unless otherwise specifically exempted by the Exchange, every Special
Offering shall remain open for a minimum period of 15 minutes. An
exemption from this minimum requirement is specifically given to any
offering which has been announced on the Exchange ticker tape at least
one hour before the offering becomes effective. An offering so exempted
from the minimum 15 minute requirement shall not be closed without the
approval of the Exchange.
    .05 Other Offers by Offeror.--It should be noted that, under Rule
243(d), an offeror may not, while his Special Offering is open, offer
any shares or bonds of the same security in the regular auction market,
without prior permission of the Exchange.
    .06 Orders after Close.--Orders accumulated after the close shall
be completed on the Floor of the Exchange at the opening of the next
market session.
    .07 Handling of Special Offering Transactions.--Purchases against
Special Offerings must be completed on the Floor of the Exchange at the
post where the security is dealt in. The handling of the Floor end of
the business, on either the purchase or the offering side, may be
entrusted to a Floor broker or in the same manner as in the case of
regular commission orders. In reference to Rule 247 attention is
directed to the fact that in connection with a Special Offering, the
broker for the buyer is acting in an agency capacity and the agency
obligation to buy at the most advantageous cost to the customer shall
be observed.
    .08 Stabilizing.--The right to sell an amount not to exceed 10 per
cent of the number of shares or bonds owned and originally offered in
the Special Offering, for the purpose of stabilizing and as part of a
Special Offering, is subject to the prior approval of the Exchange.
Stabilizing operations in connection with Special Offerings must be
discussed in advance with the staff of the Exchange.
    .09 Stop Orders--Odd-lot Orders.--Transactions effected pursuant to
Special Offerings shall not elect stop-orders or open odd-lot orders
for execution in the regular market.
    .10 Confirmations.--The information to be furnished on
confirmations in conformity with Rule 247(b) may be inserted on the
face of an appropriate form of confirmation in type no smaller than
other surrounding type or it may appear on the back of such
confirmation in the same type, provided the face of the confirmation
contains the following legend in the type illustrated as follows:
``IMPORTANT--SEE REVERSE SIDE''
The information may also be attached and made a part of an appropriate
form of confirmation in type no smaller than 8 point.
    .11 Reports.--The applicant shall submit to the Exchange at the
close of each day a report of all transactions in the offered security
effected for the account of any person having an interest, as seller or
as agent, offering the block of the security on the seller's behalf, in
the Special Offering. Such reports shall cover the period beginning
with the date of commencement of the offering or the stabilizing,
whichever is earlier, and ending with the date on which the short
position has been covered or the Special Offering account has been
terminated, whichever is later.]
Rule 923 [Member Officers] Reserved
    [A member of the Exchange shall be an officer of the member
organization that is a corporation. He shall own and continue to own
such an interest in the voting stock of said corporation as shall be
acceptable to the Committee; provided that the Committee may waive such
requirement of voting stock ownership, if the voting stock ownership is
otherwise satisfactory to the Committee.]
* * * * *

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

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

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

1. Purpose
    The purpose of the proposed rule change, as amended, is to update
Phlx's rules to remove rules that, according to the Exchange, are no
longer applicable due to changes in the law or methods of business on
the Exchange.

Phlx Rule 129 Withdrawal of Orders

    Phlx Rule 129 prohibits the withdrawal of an order from the
Exchange, at the request of another member, for the purpose of the
purchase or sale of the securities outside of the Exchange. The
Exchange speculates that this rule was possibly adopted in the 1930's
or 1940's to keep orders presented on the Phlx market subject to the
regulatory protections available to them on the Exchange. Since that
time, the over the counter markets have become more sophisticated.
Currently, it is understood that members, in exercising their agency
duty to obtain best execution for orders entrusted to them, may remove
orders from the Exchange and seek execution in other venues. Therefore,
the Exchange believes that deletion of Phlx Rule 129 should assist
members in fulfilling their best execution obligations.

Phlx Rules 241-248 Rules for Special Offerings

    Phlx Rules 241-248 concern special offerings of securities on the
Exchange. In 1942, the Commission amended Rule 10b-2 under the Act \7\
to permit an exemption for special offerings under a plan filed with
the Commission by an exchange.\8\ Phlx's Plan, contained in Phlx Rules
241-248, permits special offerings, at a fixed price and for a fixed
period of time, on the Exchange where the quantity of stock involved
cannot be absorbed in the regular auction market within a reasonable
time and at a reasonable price. Phlx Rules 241-248 permit a person
making a special offering to pay a special commission to a broker for a
purchasing customer.
---------------------------------------------------------------------------

    \7\ 17 CFR 240.10b-2.
    \8\ Phlx filed its plan in 1943. See Securities Exchange Act
Release No. 3487 (September 23, 1943).
---------------------------------------------------------------------------

    Generally, Phlx Rules 241-248 specify a minimum share size of 1,000
shares, with a value of $25,000. According to the Exchange, by today's
standards, 1,000 shares of stock with a value of $25,000 is not a
quantity of stock that cannot readily be absorbed in the regular
auction market. Phlx Rules 241-248 predate Phlx crossing Rule 126,
which has special cross provisions for Trust Shares of 25,000 shares or
greater and all securities of 5,000 shares or greater, and PACE, which
is described in Phlx Rule 229 and sets minimum automatic execution
sizes for securities on the system of 599 shares, noting that
specialists may set higher levels.
    In proposing the rescission of Rule 10b-2, the Commission indicated
that it believed that the significant changes that have taken place in
the securities markets since Rule 10b-2's adoption, and the coverage of
other anti-fraud and anti-manipulation provisions of the federal
securities laws, such as Rules 10b-5 \9\ and 10b-6 \10\ under the Act,
made it appropriate to rescind Rule 10b-2. The Exchange now proposes to
delete Phlx Rules 241-248, the plan adopted in response to Rule 10b-2,
because it believes that these rules are obsolete as the Commission
rescinded Rule 10b-2 and the Exchange has not utilized Phlx Rules 241-
248 in the past twenty years.\11\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.10b-5.
    \10\ 17 CFR 240.10b-6.
    \11\ Similarly, the New York Stock Exchange (``NYSE'') rescinded
a rule (NYSE Rule 391) similar to Phlx Rules 241-248 in 1993 in
response to the Commission's rescission of Rule 10b-2. See
Securities Exchange Act Release No. 32822 (August 31, 1993), 58 FR
47484 (September 9, 1993) (SR-NYSE-93-20).
---------------------------------------------------------------------------

Phlx Rule 923 Member Officers

    Phlx Rule 923 requires members associated with member corporations
to be officers and voting stockholders of those member corporations,
noting that the Exchange may waive the voting stock requirement of the
rule. This rule was adopted at least fifty years ago, when most member
corporations were small regional companies. The purpose of this rule at
that time may have been to provide an additional means of obtaining
security for the debts of the member corporation by requiring that the
members who were trading the securities also be officers and/or owners
of the corporation. Today, the Phlx has other rule-based means to
require adequate financial security for the debts of member
corporations and for ensuring that member corporations are generally
financially solvent. Phlx Rule 909 requires member organizations to
provide and maintain security for any claims owed to the Exchange and
other members and member organizations.\12\ Phlx Rule 924 complements
Phlx Rule 909 by making the member organization liable for the fees,
fines, dues, penalties and other amounts imposed by the Exchange on its
members. This provision applies regardless of the officer or ownership
status of the member. Finally, Rule 15c3-1 under the Act \13\ requires
certain minimum net capital requirements for broker-dealers, which
include Exchange member corporations. Therefore, Phlx does not believe
that the requirement in Phlx Rule 923 serves to protect the Exchange
and believes deletion gives a member corporation maximum flexibility to
choose whom in their company to employ as members of the Exchange.
---------------------------------------------------------------------------

    \12\ Phlx notes that member corporations are a subset of member
organizations. Therefore, Phlx Rules 909 and 924 apply to member
corporations.
    \13\ 17 CFR 240.15c3-1.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal, as amended, is consistent
with section 6(b) of the Act,\14\ in general, and furthers the
objectives of section 6(b)(5) of the Act,\15\ in particular, in that it
is designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and to protect investors and the public interest by updating
the Exchange's rules.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change, as
amended, will impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.

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

    Written comments on the proposed rule change were neither solicited
nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which Phlx consents, the Commission will:
    (A) By order approve such proposed rule change, as amended, or
    (B) Institute proceedings to determine whether the proposed rule
change, as amended, should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml
); or

     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2005-61 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-Phlx-2005-61. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change, as
amended, that are filed with the Commission, and all written
communications relating to the proposed rule change, as amended,
between the Commission and any person, other than those that may be
withheld from the public in accordance with the provisions of 5 U.S.C.
552, will be available for inspection and copying in the Commission's
Public Reference Room. Copies of the filing also will be available for
inspection and copying at the principal office of the Phlx. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2005-61 and should be
submitted on or before June 8, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Lynn Taylor,
Assistant Secretary.
[FR Doc. E6-7566 Filed 5-17-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)]
[Notices]
[Pages 18571-18573]
[FR Doc No: 2018-08903]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0586]

Clinical Trial Imaging Endpoint Process Standards; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Clinical Trial
Imaging Endpoint Process Standards.'' This guidance assists sponsors in
optimizing the quality of imaging data obtained in clinical trials
intended to support approval of drugs and biological products. This
guidance

focuses on imaging acquisition, display, archiving, and interpretation
process standards that FDA regards as important when imaging is used to
assess a trial's primary endpoint or a component of that endpoint. This
guidance finalizes the draft guidance of the same name issued on March
5, 2015.

DATES: The announcement of the guidance is published in the Federal
Register on April 27, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-D-0586 for ``Clinical Trial Imaging Endpoint Process
Standards; Guidance for Industry.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Libero (Louis) Marzella, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5482, Silver Spring, MD 20993-0002, 301-
796-1414; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Clinical Trial Imaging Endpoint Process Standards.'' The
purpose of this guidance is to assist sponsors in optimizing the
quality of imaging data obtained in clinical trials intended to support
approval of drugs and biological products. It focuses on imaging
acquisition, display, archiving, and interpretation standards that FDA
regards as important when imaging is used to assess the trial's primary
endpoint or a component of that endpoint. The guidance describes the
minimum standards a sponsor should use to help ensure that clinical
trial imaging data are obtained in a manner that complies with a
trial's protocol, maintains imaging data quality, and provides a
verifiable record of the imaging process.
    This guidance addresses the background considerations for
determining the role of imaging in a clinical trial as well as the
major considerations in the development of an imaging charter that
describes the trial's imaging methods. The guidance specifically
addresses the technical components of a charter's description of the
image acquisition, image interpretation, and image data development
methods. This guidance finalizes the draft guidance issued on March 5,
2015 (80 FR 11998). Changes made to the draft guidance took into
consideration written and verbal comments received. In addition to
editorial changes primarily for clarification, changes also included
the following: clarifying the recommended role of a centralized image
interpretation process and the quality control process; streamlining
the description of the recommended approach to incidental findings and
to discordant image interpretations; and

highlighting further the interrelationship between a clinical protocol
and an imaging charter.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on clinical trial imaging endpoint process
standards. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: April 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08903 Filed 4-26-18; 8:45 am]
 BILLING CODE 4164-01-P