[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Notices]
[Pages 31368-31371]
[FR Doc No: 2012-12775]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0429]

Guidance on Meetings With Industry and Investigators on the
Research and Development of Tobacco Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Meetings with
Industry and Investigators on the Research and Development of Tobacco
Products.'' This guidance describes FDA's current policies and
recommendations with respect to Agency meetings with tobacco
manufacturers, importers, researchers, and/or investigators relating to
their plans to conduct research to inform the regulation of tobacco
products, or support the development or marketing of tobacco products.
The guidance is intended to assist persons seeking a meeting with FDA
to discuss the research and development of tobacco products. This
guidance does not pertain to other types of meetings or meeting
requests with Center for Tobacco Products (CTP) staff.

DATES: Submit either electronic or written comments on this guidance at
any time. Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 (the PRA) by July 24, 2012 (see section
III. Paperwork Reduction Act of 1995 in this document).

ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Meetings with Industry and Investigators on the Research and
Development of Tobacco Products'' to the Center for Tobacco Products,
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850-3229. Send one self-addressed adhesive label to assist that
office in processing your request or include a fax number to which the
guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments, including comments on the
proposed collection of information, to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the guidance: Gerie
Voss, Center for Tobacco Products, 9200 Corporate Blvd., Rockville, MD
20850,

1-877-287-1373<EMAIL_ADDRESS>    With regard to the proposed collection of information: Daniel
Gittleson, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-5156<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Meetings with Industry and Investigators on the Research and
Development of Tobacco Products.'' This guidance is intended to assist
tobacco manufacturers, importers, researchers, and investigators, and
their representatives who seek meetings with staff of FDA's CTP
relating to their plans to conduct research to inform the regulation of
tobacco products or support the development or marketing of tobacco
products. This guidance does not pertain to other types of meetings or
meeting requests with CTP staff.
    The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) offers tobacco product manufacturers
several pathways to obtain an order from FDA to authorize the marketing
of a tobacco product before it may be introduced or delivered into
interstate commerce. To provide assistance with these pathways to
market particular products, FDA will meet with tobacco product
manufacturers, importers, researchers, and investigators (or their
representatives) where appropriate.
    This guidance is intended to assist persons who seek guidance
relating to their research to inform the regulation of tobacco
products, or to support the development or marketing of tobacco
products. In the guidance, the Agency discusses, among other things:
     What information FDA recommends persons include in such a
meeting request,
     How and when to submit such a request, and
     What information FDA recommends persons submit prior to
such a meeting.

II. Significance of Guidance

    FDA is issuing this guidance as a level 2 guidance consistent with
FDA's good guidance practices regulations (21 CFR 10.115). The guidance
represents the Agency's current thinking on ``Meetings with Industry
and Investigators on the Research and Development of Tobacco
Products.'' It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Paperwork Reduction Act of 1995

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information that they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal Agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing this notice of the proposed collection of information
set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden on the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry: Meetings With Industry and Investigators on the
Research and Development of Tobacco Products

    This guidance is intended to assist persons seeking to have a
meeting with FDA on the research and development of tobacco products.
This guidance document discusses, among other things: What information
FDA recommends that persons include in a meeting request, how and when
to submit a request, and what information FDA recommends that persons
submit prior to the meeting.
    This guidance describes two collections of information: (1) The
submission of a meeting request containing certain information and (2)
the submission of an information package in advance of the meeting. The
purpose of this proposed information collection is to allow FDA to
conduct meetings with tobacco manufacturers, importers, researchers,
and investigators in an effective and efficient manner.
A. Meeting Requests
    Section IV.E of the guidance sets forth FDA's recommendations for
materials to be included in a request for a meeting with FDA to discuss
the research and development of tobacco products. Under the guidance,
FDA recommends that the following information be included in the
meeting request:
    1. Product name and FDA-assigned Submission Tracking Number (if
applicable);
    2. Product category (e.g., cigarettes, smokeless tobacco, etc.) (if
applicable);
    3. Product use (indicate for consumer use or for further
manufacturing);
    4. Contact information for individual or company requesting the
meeting;
    5. The type of meeting being requested;
    6. A brief statement of the purpose of the meeting, which could
include a discussion of the types of studies or data to be discussed at
the meeting, the general nature of the primary questions to be asked,
and where the meeting fits in the overall product development plans;
    7. A draft list of the specific objectives/outcomes expected from
the meeting;
    8. A preliminary proposed agenda, including estimated amounts of
time needed for each agenda item and designated speaker(s);
    9. A draft list of specific questions, grouped by discipline;
    10. A list of all individuals (including titles and
responsibilities) who will attend the meeting on behalf of the tobacco
product manufacturer, importer, researcher, or investigator;
    11. The approximate date on which supporting documentation (i.e.,
the meeting information package) likely will be received by FDA; and
    12. Suggested dates and times for the meeting (note that generally
a meeting will be scheduled for approximately 1 to 1.5 hours).
    This information will be used by the Agency to: (1) Determine the
utility of the meeting, (2) identify Agency staff necessary to discuss
proposed agenda items, and (3) schedule the meeting.
B. Information Packages
    An individual submitting a meeting information package to FDA in
advance of a meeting should provide summary information relevant to the
product and supplementary information pertaining to any issue raised by
the individual or

FDA to be discussed at the meeting. As stated in section IV.K of the
guidance, FDA recommends that meeting information packages generally
include updated information from the meeting request (see items 1
through 8 in section III.A of this document) and:
    1. Chemistry, manufacturing, and control data summary (as
applicable);
    2. Preclinical data summary (as applicable);
    3. Clinical data summary (as applicable);
    4. Behavioral and product use data summary (as applicable);
    5. User and nonuser perception data summary (as applicable); and
    6. Investigational plans for studies and surveillance of the
tobacco product, including a summary of proposed study protocols
containing the following information (as applicable):
    a. Study objective(s),
    b. Study hypotheses,
    c. Study design,
    d. Study population (inclusion/exclusion criteria, comparison
group(s)),
    e. Human subject protection information, including Institutional
Review Board information,
    f. Primary and secondary endpoints (definition and success
criteria),
    g. Sample size calculation,
    h. Data collection procedures,
    i. Duration of followup and baseline and followup assessments, and
    j. Data analysis plan(s).
    The purpose of the information package is to provide Agency staff
the opportunity to adequately prepare for the meeting, including the
review of relevant data concerning the product. In the Agency's
experience, reviewing such information is critical to achieving a
productive meeting. For the information that was previously submitted
in the meeting request, the information package should provide updated
information that reflects the most current and accurate information
available.
C. Description of Respondents
    The respondents to this collection of information are
manufacturers, importers, researchers, and investigators of tobacco
products who seek to meet with FDA to discuss their plans regarding the
development or marketing of a tobacco product.
    FDA estimates the burden of this collection of information as
follows:

                                   Table 1--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
Meeting requests and information     Number of     responses per   Total annual    per response     Total hours
            packages                respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
                                                Meeting Requests
----------------------------------------------------------------------------------------------------------------
Combining and sending meeting                 67               1              67              10             670
 request letters for
 manufacturers, importers, and
 researchers....................
----------------------------------------------------------------------------------------------------------------
                                          Meeting Information Packages
----------------------------------------------------------------------------------------------------------------
Combining and submitting meeting              67               1              67              18           1,206
 information packages for
 manufacturers, importers, and
 researchers....................
                                 -------------------------------------------------------------------------------
    Collection Totals...........  ..............  ..............  ..............  ..............           1,876
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's estimate of the number of respondents for meeting requests in
table 1 of this document is based on the number of meeting requests to
be received over the next 3 years. In the first year of this
collection, FDA estimates that 50 preapplication meetings will be
requested. In year 2, FDA estimates that 100 meetings will be
requested, especially as applications and reports for substantial
equivalence, etc., are received and acted upon. Once the public knows
more about submitting these applications in year 3, the request for
meetings is expected to drop back to the year 1 rate of 50 per year.
Thus, FDA estimates the number of manufacturers, importers,
researchers, and investigators who are expected to submit meeting
request requests in table 1 of this document to be 67 (50 year 1
requests + 100 year 2 requests + 50 year 3 requests divided by 3). The
hours per response, which is the estimated number of hours that a
respondent would spend preparing the information recommended by this
guidance to be submitted with a meeting request is estimated to be
approximately 10 hours each, and the total burden hours are 670 hours
(10 hours preparation/mailing times 67 average respondents per year).
Based on FDA's experience, the Agency expects it will take respondents
this amount of time to prepare, gather, copy, and submit brief
statements about the product and a description of the purpose and
details of the meeting.
    FDA's estimate of the number of respondents for compiling meeting
information packages in table 1 of this document is based on 67
respondents each preparing copies of their information package and
submitting them to FDA, for a total of 1,206 hours annually. The hours
per response, which is the estimated number of hours that a respondent
would spend preparing the information package as recommended by the
guidance, is estimated to be approximately 18 hours per information
package. Based on FDA's experience, the Agency expects that it will
take respondents 1,206 hours of time (67 respondents times 18 hours) to
gather, copy, and submit brief statements about the product, a
description of the details of the anticipated meeting, and data and
information that generally would already have been generated for the
planned research and/or product development.
    The total number of burden hours for this collection of information
is 1,876 hours (67 hours to prepare and submit meeting requests and
1,206 hours to prepare and submit information packages).

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division

of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain an electronic
version of this guidance document at http://www.regulations.gov or
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12775 Filed 5-24-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 80 (Tuesday, April 26, 2016)]
[Notices]
[Page 24609]
[FR Doc No: 2016-09546]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2015-0808; FRL-9945-30-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Hazardous Waste Specific Unit Requirements,
and Special Waste Processes and Types (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Hazardous Waste Specific Unit
Requirements, and Special Waste Processes and Types (Renewal)'' (EPA
ICR No. 1572.11, OMB Control No. 2050-0050) to the Office of Management
and Budget (OMB) for review and approval in accordance with the
Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed
extension of the ICR, which is currently approved through April 30,
2016. Public comments were previously requested via the Federal
Register (81 FR 1420) on January 12, 2016 during a 60-day comment
period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An Agency may not conduct or
sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before May 26, 2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
RCRA-2015-0808, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Norma Abdul-Malik, Office of Resource
Conservation and Recovery (5303P), Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number:
703-308-8753; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Supporting documents which explain in detail the information that
the EPA will be collecting are available in the public docket for this
ICR. The docket can be viewed online at www.regulations.gov or in
person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The telephone number for the Docket Center is
202-566-1744. For additional information about EPA's public docket,
visit http://www.epa.gov/dockets.
    Abstract: This ICR provides a discussion of all of the information
collection requirements associated with specific unit standards
applicable to owners and operators of facilities that treat, store, or
dispose of hazardous wastes as defined by 40 CFR part 261. It includes
a detailed description of the data items and respondent activities
associated with each requirement and with each hazardous waste
management unit at a facility. The specific units and processes
included in this ICR are: Tank systems, Surface impoundments, Waste
piles, Land treatment, Landfills, Incinerators, Thermal treatment,
Chemical, physical, and biological treatment, Miscellaneous (subpart
X), Drip pads, Process vents, Equipment leaks, Containment buildings,
and Recovery/recycling.
    With each information collection covered in this ICR, the EPA is
aiding the goal of complying with its statutory mandate under RCRA to
develop standards for hazardous waste treatment, storage, and disposal
facilities, to protect human health and the environment. Without the
information collection, the agency cannot assure that the facilities
are designed and operated properly.
    Form Numbers: None.
    Respondents/affected entities: Hazardous waste facilities; State,
Local, or Tribal governments.
    Respondent's obligation to respond: Mandatory (40 CFR 261, 264,
265, and 266).
    Estimated number of respondents: 4,543 (total).
    Frequency of response: On occasion.
    Total estimated burden: 654,097 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $25,535,215 (per year), includes $3,682,707
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is an increase of 17,085 hours in
the total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is mainly due to an increase in the
number of tank systems reporting in RCRAInfo.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2016-09546 Filed 4-25-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: November 13, 2009 (Volume 74, Number 218)]
[Notices]
[Page 58620]
[DOCID:fr13no09-43]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2618-020]

Domtar Maine LLC; Notice of Application Ready for Environmental
Analysis and Soliciting Comments, Recommendations, Terms and
Conditions, and Prescriptions

November 5, 2009.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New License.
    b. Project No.: 2618-020.
    c. Date filed: March 19, 2009.
    d. Applicant: Domtar Maine LLC.
    e. Name of Project: West Branch Project.
    f. Location: On Grand Lake Stream, a tributary of the St. Croix
River in Penobscot, Washington and Hancock Counties, Maine.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Scott Beal, Domtar Maine LLC, 144 Main
Street, Baileyville, Maine 04694,<PHONE_NUMBER>.
    i. FERC Contact: John Costello<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions is 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Comments, recommendations, terms and conditions, and prescriptions
may be filed electronically via the Internet in lieu of paper. The
Commission strongly encourages electronic filings. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
(http://www.ferc.gov/docs-filing/ferconline.asp) under the ``e-filing''
link. For a simpler method of submitting text only comments, click on
``Quick Comment.''
    k. This application has been accepted, and is ready for
environmental analysis at this time.
    l. The existing West Branch Project includes two developments
(Sysladobsis and West Grand) comprising two dams and a dike. There are
no generating facilities located at the project. The 23,500 acre
impounded waters are comprised of West Grand, Junior, Pocumcus, Pug,
Bottle, Norway, and Scraggly lakes.
    The Sysladobsis development includes the 250-foot-long by 9-foot-
high Sysladobsis Dam (the furthest upstream), an earth embankment
structure with a timber gate and fish facility. The dam impounds the
5,400-acres Sysladobsis Lake and discharges directly into the West
Grand development.
    The West Grand development includes the 487-foot-long West Grand
Dam which has a 105.9-foot-long gate structure with five waste gates. A
vertical slot design upstream fish passage facility is located adjacent
to the dam's waste gate No. 1.
    The approximately 535-foot-long by 15-foot-high Farm Cove Dike is
located approximately 3.5 miles west of the main outlet dam to West
Grand Lake. The dike comprises a 10-foot-wide by 30-foot-long fishway.
The dike has no gates or other flow controls; the only flow passing
capability is through the fishway.
    No new construction is planned.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    All filings must: (1) bear in all capital letters the title
``COMMENTS,'' ``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS''; (2) set forth in the heading, the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b), and 385.2010.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-27294 Filed 11-12-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Notices]
[Pages 23799-23800]
[FR Doc No: 2012-9553]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0040]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of applications for exemptions; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 10 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. If granted, the exemptions would enable these
individuals to qualify as drivers of commercial motor vehicles (CMVs)
in interstate commerce without meeting the Federal vision requirement.

DATES: Comments must be received on or before May 21, 2012.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2012-0040 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     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: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. 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
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption.'' FMCSA can renew exemptions at the end of each
2-year period. The 10 individuals listed in this notice have each
requested such an exemption from the vision requirement in 49 CFR
391.41(b)(10), which applies to drivers of CMVs in interstate commerce.
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.

Qualifications of Applicants

Rudolph P. Bisschop

    Mr. Bisschop, age 55, has had amblyopia in his left eye since
childhood. The best corrected visual acuity in his right eye is 20/30,
and in his left eye, 20/80. Following an examination in 2011, his
ophthalmologist noted, ``In my medical opinion, you have sufficient
stable vision to perform all of the driving tasks required to operate a
commercial motor vehicle.'' Mr. Bisschop reported that he has driven
tractor-trailer combinations for 30 years, accumulating 1.9 million
miles. He holds a Class A CDL from Massachusetts. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Richard Doroba

    Mr. Doroba, 46, has had amblyopia in his right eye since birth. The
best corrected visual acuity in his right eye is 20/200, and in his
left eye, 20/20. Following an examination in 2011, his optometrist
noted, ``Mr. Doroba, in my medical opinion, has sufficient vision to
perform the driving tasks required of a commercial vehicle operator.''
Mr. Doroba reported that he has driven tractor-trailer combinations for
25 years, accumulating 1.5 million miles. He holds a Class A CDL from
Illinois. His driving record for the last 3 years shows one crash for
which he was cited for speeding too fast for conditions and no
convictions for moving violations in a CMV.

Dennis E. Fisher

    Mr. Fisher, 55, has a history of macular degeneration in his right
eye due to branch vein occlusion. The best corrected visual acuity in
his right eye is 20/80, and in his left eye, 20/30. Following an
examination in 2011, his ophthalmologist noted, ``Has sufficient vision
to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Fisher reported that he has driven tractor-trailer
combinations for 31 years, accumulating 3.6 million miles. He holds a
Class A CDL from New York. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Charles W. Gajefski

    Mr. Gajefski, 53, has had a retinal scar in his right eye since
childhood. The best corrected visual acuity in his right eye is 20/200,
and in his left eye, 20/15. Following an examination in 2011, his
optometrist noted, ``It is my professional opinion that Charles is
capable of safely performing the driving tasks necessary to operate a
commercial vehicle.'' Mr. Gajefski reported that he has driven tractor-
trailer combinations for 2 years, accumulating 400,000 miles. He holds
a Class A CDL from Colorado. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Steven M. Martin

    Mr. Martin, 45, has had amblyopia in his right eye since birth. The
best corrected visual acuity in his right eye is 20/2000, and in his
left eye, 20/20. Following an examination in 2011, his optometrist
noted, ``In my medical

opinion, Mr. Martin has sufficient vision to operate a commercial motor
vehicle.'' Mr. Martin reported that he has driven straight trucks for
28 years, accumulating 84,000 miles and tractor-trailer combinations
for 14 years, accumulating 196,000 miles. He holds a Class A CDL from
Illinois. His driving record for the last 3 years shows no crashes but
one conviction for speeding in a CMV. He exceeded the speed limit by 16
mph.

Charles A. Padgett

    Mr. Padgett, 53, has had staphyloma in his right eye since birth.
The best corrected visual acuity in his right eye is count-finger
vision, and in his left eye, 20/20. Following an examination in 2011,
his optometrist noted, ``I do believe he has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Padgett reported that he has driven straight trucks for 9 years,
accumulating 468,000 miles and tractor-trailer combinations for 6
years, accumulating 240,000 miles. He holds a Class A CDL from Florida.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Joseph L. Ruff.

    Mr. Ruff, 51, has had coat's disease in his right eye since birth.
The visual acuity in his right eye is light perception, and in his left
eye, 20/15. Following an examination in 2011, his ophthalmologist
noted, ``I feel that he has sufficient vision to perform driving tasks
required to operate a commercial motor vehicle.'' Mr. Ruff reported
that he has driven straight trucks for 4 years, accumulating 52,000
miles. He holds a Class C operator's license from Georgia. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Tommy Thomas

    Mr. Thomas, 52, has a prosthetic right eye due to a traumatic
injury sustained in 1971. The visual acuity in his right eye is no
light perception, and in his left eye, 20/20. Following an examination
in 2011, his ophthalmologist noted, ``The patient has been advised of
monocular precautions and is cleared to drive a commercial vehicle at
this time.'' Mr. Thomas reported that he has driven tractor-trailer
combinations for 3 years, accumulating 195,000 miles. He holds a Class
A CDL from California. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Malcolm J. Tilghman, Sr.

    Mr. Tilghman, 51, has had amblyopia in his right eye since birth.
The best corrected visual acuity in his right eye is 20/400, and in his
left eye, 20/20. Following an examination in 2011, his optometrist
noted, ``In this case I certify that vision in Mr. Tilghman's left eye
qualifies him to operate a commercial motor vehicle.'' Mr. Tilghman
reported that he has driven straight trucks for 3 years, accumulating
687,500 miles and buses for 10 years, accumulating 100,000 miles. He
holds a Class B CDL from Delaware. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

William S. Willis, Jr.

    Mr. Willis, 74, has had amblyopia in his right eye since birth. The
best corrected visual acuity in his right eye is 20/200, and in his
left eye, 20/25. Following an examination in 2011, his ophthalmologist
noted, ``Has significant vision to operate commercial vehicle.'' Mr.
Willis reported that he has driven straight trucks for 57 years,
accumulating 798,000 miles and tractor-trailer combinations for 30
years, accumulating 180,000 miles. He holds a Class A CDL from
Maryland. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. The Agency will consider all comments
received before the close of business May 21, 2012. Comments will be
available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable.
    In addition to late comments, FMCSA will also continue to file, in
the public docket, relevant information that becomes available after
the comment closing date. Interested persons should monitor the public
docket for new material.

    Issued on: April 16, 2012.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2012-9553 Filed 4-19-12; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 78, Number 140 (Monday, July 22, 2013)]
[Notices]
[Page 43963]
[FR Doc No: 2013-17565]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Sixty-Second Meeting: RTCA Special Committee 135, Environmental
Conditions and Test Procedures for Airborne Equipment

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

ACTION: Meeting Notice of RTCA Special Committee 135, Environmental
Conditions and Test Procedures for Airborne Equipment.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
Sixty-Second meeting of the RTCA Special Committee 135, Environmental
Conditions and Test Procedures for Airborne Equipment.

DATES: The meeting will be held November 13-15 from 9:00 a.m. to 5:00
p.m.

ADDRESSES: The meeting will be held at EUROCAE Headquarters, 102 Rue
Etienne Dolet, 92230 Malakoff, France.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 330-
0652/(202) 833-9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org or Sophie Bousquet<EMAIL_ADDRESS>202-330-0663.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 135. The agenda will
include the following:

November 13-15, 2013

 Introductions and Administrative Remarks
 Approval of the Agenda
 Approval of the Minutes of Plenary 61
 Review User Guide Drafts
     Section 4
     Section 5
     Section 7
     Section 8
     Section 9
     Section 10
     Section 11
     Section 15
     Section 16
     Section 20
     Section 21
     Section 22
     Section 23
     Section 26
 Review Open Proposals
 Review User Guide Schedule
 Other Business
 Adjourn
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on July 12, 2013.
Paige Williams,
Management Analyst, NextGen, Business Operations Group, Federal
Aviation Administration.
[FR Doc. 2013-17565 Filed 7-19-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Pages 2266-2268]
[FR Doc No: 2016-00641]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76864; File No. SR-BATS-2015-122]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Rules
27.1, Definitions, and 27.4, Temporary Rule Governing Phase-Out of P
and P/A Orders

January 11, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 28, 2015, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal to authorize the BATS Options Market
(``BATS Options'') to delete its rule entitled ``Temporary Rule
Governing Phase-Out of P and P/A Orders'' and amend any references in
the rules to the Plan for the Purpose of Creating and Operating an
Intermarket Linkage (``Linkage Plan''). \5\
---------------------------------------------------------------------------

    \5\ See Chapter XXVII, Intermarket Linkage Rules, Rule 27.4.,
Temporary Rule Governing Phase-Out of P and P/A Orders.
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange 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. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts 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 is to eliminate existing
references to the Linkage Plan and also replace any references to the
Linkage Plan with references to the Options Order Protection and
Locked/Crossed Market Plan (``Plan'') in order to clarify the current
rules in effect.
    On February 4, 2010, the Exchange filed the Plan, joining all other
approved options exchanges in adopting the Plan.\6\ The Plan required
each options exchange to adopt rules implementing various requirements
specified in the Plan. The Plan replaced the former Linkage Plan. The
Linkage Plan required Participating Exchanges \7\ to operate a
standalone system or ``Linkage'' for sending order-flow between
exchanges to limit trade-throughs.\8\ The Options Clearing Corporation
(``OCC'') operated the Linkage system (the ``System'').\9\ The Exchange
adopted various rules in connection with the Plan to avoid trade-
throughs and locked markets, among other things.\10\ The Exchange
currently offers private routing directly to away markets.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release Nos. 61546 (February 19,
2010), 75 FR 8762 (February 25, 2010) (Notice of Filing and
Immediate Effectiveness of Amendment to the Options Order Protection
and Locked/Crossed Markets Plan to Add the BATS Exchange, Inc. as a
Participant).
    \7\ The term ``Participating Exchanges'' refers to all options
exchanges that had been approved to participate in the Linkage Plan.
    \8\ See footnote 6.
    \9\ See footnote 6.
    \10\ See footnote 6.
---------------------------------------------------------------------------

    The Exchange adopted a temporary rule entitled ``Temporary Rule
Governing Phase-Out of P and P/A Orders'' (``Temporary Rule''),\11\ in
order to facilitate the participation of certain Participating
Exchanges who may require the use of Principal Acting as Agent Orders
(``P/A Orders'') \12\ and

Principal Orders (``P'') \13\ after implementation of the Plan. Certain
Participating Exchanges required a temporary transition period during
which they continued to utilize these order types that existed under
the Linkage Plan. The Exchange proposed substantially similar rules
with that of the other Participating Exchanges to accommodate the
possibility of continued use of P/A Orders and P Orders. At this time
all Participating Exchanges have discontinued use of the Linkage Plan.
The Exchange proposes at this time to delete this Temporary Rule
because it is no longer necessary in light of the discontinued use of
the Linkage Plan. Additionally, the Exchange proposes to amend Section
17, Definitions, in Chapter XXVII, Intermarket Linkage Rules, to
redefine ``Plan'' to comport with the Plan.
---------------------------------------------------------------------------

    \11\ See Chapter XXVII, Intermarket Linkage Rules, Rule 27.4,
``Temporary Rule Governing Phase-Out of P and P/A Orders''.
    \12\ A P/A Order is an order for the principal account of a
Primary Market Maker (or equivalent entity on another Eligible
Exchange that is authorized to represent Public Customer orders),
reflecting the terms of a related unexecuted Public Customer order
for which the Primary Market Maker is acting as agent. See Chapter
XXVII, Rule 27.4(d)(4)(A).
    \13\ A Principal Order is an order for the principal account of
a market maker (or equivalent entity on another Eligible Exchange)
and is not a P/A Order. See Chapter XXVII, Rule 27.4(d)(4)(B).
---------------------------------------------------------------------------

    In addition to the changes set forth above, the Exchange proposes
to add the letter ``(a)'' to Rule 27.1 to conform with the typical
numbering used in Exchange rules.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\14\ In particular,
the proposal is consistent with Section 6(b)(5) of the Act \15\ because
it is designed to prevent fraudulent and manipulative acts and
practices, 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,
in general, to protect investors and the public interest by proposing
the elimination of the Temporary Rule, which reflects usage of the
former Linkage Plan that has been replaced by the Plan. The Exchange
believes that elimination of the reference to the Temporary Rule will
help to avoid potential confusion by Members and other market
participants because the Linkage Plan is and has been in full effect
for some time, and, therefore, the Temporary Rule is outdated and
unnecessary.
---------------------------------------------------------------------------

    \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 will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposal will simply
eliminate the Temporary Rule, which is outdated and no longer necessary
for the reasons described above. Accordingly, the Exchange does not
believe that the proposal has any competitive effect.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \16\ and Rule 19b-4(f)(6) thereunder.\17\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6)
thereunder.\18\
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \17\ 17 CFR 240.19b-4(f)(6).
    \18\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of the Exchange's intent to file
the proposed rule change, along with a brief description and text of
the proposed rule change, at least five business days prior to the
date of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Exchange has satisfied this
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange has asked the Commission to waive the
30-day operative delay so that the Exchange may eliminate its Temporary
Rule, which has been replaced by the Plan. The Commission believes that
removal of the obsolete rule could avoid potential confusion by Members
and other market participants. Based on the foregoing, the Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest.\19\ The Commission
hereby grants the Exchange's request and designates the proposal
operative upon filing.
---------------------------------------------------------------------------

    \19\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or 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 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 email to<EMAIL_ADDRESS>Please include
File No. SR-BATS-2015-122 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File No. SR-BATS-2015-122. This file
number should be included on the subject line if email 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 that are
filed with the Commission, and all written communications relating to
the

proposed rule change 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing will also be available
for inspection and copying at the principal office of the Exchange. 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 No. SR-BATS-2015-122 and should be
submitted on or before February 5, 2016.
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-00641 Filed 1-14-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Rules and Regulations]
[Pages 24899-24902]
[FR Doc No: 2023-08629]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0665; Project Identifier MCAI-2022-00625-R;
Amendment 39-22405; AD 2023-07-03]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Leonardo S.p.a. Model AB412 and AB412 EP helicopters. This AD was
prompted by a report of a fatigue crack in a left-hand (LH) fin spar
cap. This AD requires cleaning and repetitively inspecting certain
part-numbered LH fin spar caps, and repetitively inspecting the
exterior of the fin skin and, depending on the results, accomplishing
corrective action. This AD also prohibits certain corrective actions as
a terminating action for the repetitive inspections unless the
corrective actions have been approved as a terminating action, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is incorporated by reference. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective May 10, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 10,
2023.
    The FAA must receive comments on this AD by June 9, 2023.

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 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.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0665; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the EASA AD, any comments received,
and other information. The street address for Docket Operations is
listed above.
    Material Incorporated by Reference:
     For EASA material that is incorporated by reference (IBR)
in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; phone: +49 221 8999 000; email: [email protected]; internet:
easa.europa.eu. You may find this IBR material on the EASA website at
ad.easa.europa.eu.
     You may view this service information at the FAA, Office
of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2023-0665.
    Other Related Service Information: For Leonardo Helicopters service
information identified in this final rule, contact Leonardo S.p.A.
Helicopters, Emanuele Bufano, Head of Airworthiness, Viale G. Agusta
520, 21017 C. Costa di Samarate (Va) Italy; telephone (+39) 0331-
225074; fax (+39) 0331-229046; or at
customerportal.leonardocompany.com/en-US/. This service information is
also available at the FAA contact information under Material
Incorporated by Reference above.

FOR FURTHER INFORMATION CONTACT: Gregory Koenig, Aerospace Engineer,
Airframe & Administrative Services Section, Chicago ACO Branch,
Compliance & Airworthiness Division, FAA, 2300 E Devon Ave., Des
Plaines, IL 60018; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2023-0665; Project Identifier MCAI-
2022-00625-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate

the submitted comments as CBI. Please mark each page of your submission
containing CBI as ``PROPIN.'' The FAA will treat such marked
submissions as confidential under the FOIA, and they will not be placed
in the public docket of this AD. Submissions containing CBI should be
sent to Gregory Koenig, Aerospace Engineer, Airframe & Administrative
Services Section, Chicago ACO Branch, Compliance & Airworthiness
Division, FAA, 2300 E Devon Ave., Des Plaines, IL 60018; telephone
(847) 294-7127; email [email protected]. Any commentary that the
FAA receives which is not specifically designated as CBI will be placed
in the public docket for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2022-0084, dated May 11, 2022 (EASA
AD 2022-0084), to correct an unsafe condition for Leonardo S.p.A. Model
AB212, AB412, and AB412EP helicopters, all serial numbers.
    This AD was prompted by a report of a fatigue crack in a LH fin
spar cap. The FAA is issuing this AD to detect a crack, a loose or
missing rivet, damage, or distortion. The unsafe condition, if not
addressed, could result in stress concentrations at the edge of the
rivet hole, possibly resulting in reduced structural integrity of the
fin spar and subsequent loss of control of the helicopter. See EASA AD
2022-0084 for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0084 requires cleaning and repetitively inspecting
certain part-numbered LH fin spar caps for a crack, loose rivet, and
other damage, and repetitively inspecting the exterior of the fin skin
in the area in contact with the fin spar cap for a crack, loose rivet,
and distortion. If any discrepancy is detected, EASA AD 2022-0084 also
requires contacting Leonardo S.p.A. for approved repair instructions
and accomplishing the repair. Additionally, EASA AD 2022-0084 prohibits
certain corrective actions as terminating action for the repetitive
inspections, unless stated otherwise in the repair instructions.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in ADDRESSES.

Other Related Service Information

    The FAA also reviewed Leonardo Helicopters Service Bulletin No.
412-168, dated May 19, 2021, which specifies procedures to clean
certain parts, and using a 10x magnifying glass and a bright light,
inspect both flanges of the LH fin spar cap part number 212-030-447-117
for cracks, loose rivets, and other damage. This service information
also specifies procedures to inspect the exterior of the fin skin in
the area in contact with the fin spar cap for cracks, loose rivets, and
distortion, and if any cracks or damage are found, to contact Leonardo
Helicopters and send a compliance form to
[email protected].

FAA's Determination

    These products have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in its AD. The FAA is issuing this AD after
determining that the unsafe condition described previously is likely to
exist or develop on other products of these same type designs.

AD Requirements

    This AD requires accomplishing the actions specified in EASA AD
2022-0084, described previously, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this AD and except as discussed under ``Differences Between this AD and
the EASA AD.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result,
EASA AD 2022-0084 will be incorporated by reference in this FAA final
rule. This AD would, therefore, require compliance with EASA AD 2022-
0084 in its entirety through that incorporation, except for any
differences identified as exceptions in the regulatory text of this AD.
Using common terms that are the same as the heading of a particular
section in EASA AD 2022-0084 does not mean that operators need comply
only with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in EASA AD 2022-0084. Service information
referenced in EASA AD 2022-0084 for compliance will be available at
regulations.gov under Docket No. FAA-2023-0665.

Differences Between This AD and the EASA AD

    EASA AD 2022-0084 applies to Model AB212 helicopters, whereas this
AD does not because that model is not FAA type-certificated. If there
is any discrepancy as defined in the service bulletin, EASA AD 2022-
0084 requires contacting Leonardo S.p.A. for approved repair
instructions and accomplishing the repair, whereas this AD requires
accomplishing the corrective actions in accordance with a method
approved by the FAA, EASA, or Leonardo S.p.a. Helicopters' Design
Organization Approval instead.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    There are currently no domestic operators of these products.
Accordingly, notice and opportunity for prior public comment are
unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the
foregoing reasons, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    There are no costs of compliance with this AD because there are no
helicopters

with these type certificates on the U.S. Registry.

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.
    The FAA is 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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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:

2023-07-03 Leonardo S.p.a.: Amendment 39-22405; Docket No. FAA-2023-
0665; Project Identifier MCAI-2022-00625-R.

(a) Effective Date

    This airworthiness directive (AD) is effective May 10, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Leonardo S.p.a. Model AB412 and AB412 EP
helicopters, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code: 5302, Rotorcraft
Tail Boom.

(e) Unsafe Condition

    This AD was prompted by a report of a fatigue crack in a left-
hand (LH) fin spar cap. The FAA is issuing this AD to detect a
crack, a loose or missing rivet, damage, or distortion. The unsafe
condition, if not addressed, could result in stress concentrations
at the edge of the rivet hole, possibly resulting in reduced
structural integrity of the fin spar and subsequent loss of control
of the helicopter.

(f) Compliance

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

(g) Required Actions

    Except as specified in paragraphs (h) and (i) of this AD: Comply
with all required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency AD 2022-0084,
dated May 11, 2022 (EASA AD 2022-0084).

(h) Exceptions to EASA AD 2022-0084

    (1) Where EASA AD 2022-0084 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2022-0084 refers to flight hours, this AD
requires using hours time-in-service.
    (3) Where the service information referenced in paragraph (1) of
EASA AD 2022-0084 specifies to ``inspect both flanges of the left
hand fin spar cap between F.S. 50 and F.S. 71 using 10x magnifying
glass and a bright light for cracks, loose rivets, and other
damage;'' for this AD, replace that text with, ``inspect both
flanges of the left hand fin spar cap between F.S. 50 and F.S. 71
using a 10X or higher power magnifying glass and a flashlight for a
crack, a loose or missing rivet, and other damage, which may be
indicated by fretting around the rivet.''
    (4) Instead of complying with paragraph (2) of EASA AD 2022-
0084, comply with the following; ``During any inspection as required
by paragraph (1) of EASA AD 2022-0084, for this AD, if there is a
crack, a loose or missing rivet, other damage, or distortion, before
further flight, accomplish the corrective action in accordance with
a method approved by the Manager, General Aviation & Rotorcraft
Section, International Validation Branch, FAA; or EASA; or Leonardo
S.p.a. Helicopters' Design Organization Approval (DOA). If approved
by the DOA, the approval must include the DOA-authorized
signature.''
    (5) This AD does not adopt the ``Remarks'' section of EASA AD
2022-0084.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2022-0084
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation 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 International Validation Branch, send
it to the attention of the person identified in paragraph (k) 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.

(k) Related Information

    For more information about this AD, contact Gregory Koenig,
Aerospace Engineer, Airframe & Administrative Services Section,
Chicago ACO Branch, Compliance & Airworthiness Division, FAA, 2300 E
Devon Ave., Des Plaines, IL 60018; telephone<PHONE_NUMBER>; email
[email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0084,
dated May 11, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0084, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; phone: +49 221 8999 000; email:
[email protected]; internet: easa.europa.eu. You may find this
material on the EASA website at ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 3, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-08629 Filed 4-24-23; 8:45 am]
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[Federal Register: October 13, 2006 (Volume 71, Number 198)]
[Notices]
[Page 60502]
[DOCID:fr13oc06-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-619-001]

Transcontinental Gas Pipe Line Corporation; Notice of Corrected
Tariff Sheet

October 5, 2006.
    Take notice that on October 4, 2006, Transcontinental Gas Pipe Line
Corporation (Transco) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, Substitute Ninth Revised Sheet No.
30 to be effective November 1, 2006.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

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

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-16977 Filed 10-12-06; 8:45 am]

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