[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Notices]
[Pages 64321-64322]
[FR Doc No: 2019-25247]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4963]

Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Dermatologic and Ophthalmic
Drugs Advisory Committee. The general function of the committee is to
provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held on December 13, 2019, from 8 a.m. to 4
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2019-N-4963. The docket will close on December
12, 2019. Submit either electronic or written comments on this public
meeting by December 12, 2019. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before December 12, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of December 12, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before December 4, 2019, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments 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-2019-N-4963 for ``Dermatologic and Ophthalmic Drugs Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA 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 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 the 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.

FOR FURTHER INFORMATION CONTACT: Jay R. Fajiculay, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the

Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The committee will discuss biologics license application
(BLA) 761143, teprotumumab solution for intravenous use, submitted by
Horizon Pharma Ireland, Ltd., proposed for the treatment of active
thyroid eye disease.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before December 4, 2019, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 12:30 p.m. and 1:30 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before November 26, 2019. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by November 27, 2019.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Jay Fajiculay (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25247 Filed 11-20-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 100 (Tuesday, May 26, 2015)]
[Rules and Regulations]
[Pages 29941-29942]
[FR Doc No: 2015-12627]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Docket No. FAA-2014-0640; Airspace Docket No. 14-ACE-4]
RIN 2120-AA66

Modification of Restricted Areas R-4501A, R-4501B, R-4501C, R-
4501D, R-4501F, and R-4501H; Fort Leonard Wood, MO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies the designated altitudes of restricted
area R-4501B, Fort Leonard Wood, MO, by raising the restricted area
ceiling from 1,500 feet mean seal level (MSL) in the north and 2,200
feet MSL in the south to a single altitude of 4,300 feet MSL across the
entire restricted area. This action also adds exclusions to the
boundaries of R-4501C, R-4501F, and R-4501H to address overlapping
restricted areas. Finally, this action makes administrative changes to
the R-4501A and R-4501B titles and to R-4501A-D, R-4501F, and R-4501H
using agency information to standardize the format and information
describing these restricted areas of the Fort Leonard Wood restricted
area complex.

DATES: Effective date 0901 UTC, August 20, 2015.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy and
Regulations Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On September 25, 2014, the FAA published in the Federal Register a
notice of proposed rulemaking to modify the designated altitudes of
restricted area R-4501B to establish a single ceiling altitude, add
exclusions to the boundaries of R-4501C, R-4501F, and R-4501H to
address overlapping restricted areas, and make administrative changes
to the R-4501A and R-4501B titles and the R-4501A-D, R-4501F, and R-
4501H using agency information to standardize the format and
information describing these restricted areas (79 FR 57484). The R-4501
restricted area complex amendments support the military training
activities conducted at Fort Leonard Wood, MO.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal. No comments were
received.

The Rule

    The FAA is amending 14 CFR part 73 by amending the R-4501B
designated altitudes to establish a single ceiling altitude; adding
exclusions to the R-4501C, R-4501F, and R-4501H boundaries to prevent
overlapped restricted areas being active at the same time; and making
administrative changes to the R-4501A and R-4501B titles and the R-
4501A-D, R-4501F, and R-4501H using agency information to standardize
the format and information. The changes are described below.
    The R-4501B designated altitudes is changed from ``The area north
of a line between lat. 37[deg]42'51'' N., long. 92[deg]06'48'' W.; and
lat. 37[deg]42'53'' N., long. 92[deg]09'18'' W., surface to 1,500 feet
MSL. The area south of this line, surface to 2,200 feet MSL.'' to
``Surface to 4,300 feet MSL'' for the entire restricted area.
    The R-4501C, R-4501F, and R-4501H boundaries are changed by adding
exclusions to prevent overlapping restricted areas from being active in
the same airspace at the same time. R-4501C adds ``excluding R-4501B
when active''; R-4501F adds ``excluding R-4501A, R-4501B, and R-4501C
when active''; and R-4501H adds ``excluding R-4501B when active''.
    The R-4501A title is changed by removing the word ``West'' in the
title to read ``R-4501A Fort Leonard Wood, MO'' and the R-4501B title
is changed by removing the word ``East'' in the title to read ``R-4501B
Fort Leonard Wood, MO''. Additionally, the R-4501A, R-4501B, R-4501C,
and R-4501D using agency information is changed by prefacing the
existing using agency with ``U.S. Army.'' Lastly, the R-4501F and R-
4501H using agency is changed from ``U.S. Army, Headquarters U.S. Army
Training Center, Fort Leonard Wood, MO'' to ``U.S. Army, Commanding
General, Fort Leonard Wood, MO.'' These administrative changes
standardize the format and information describing the restricted areas
contained in the Fort Leonard Wood, MO, R-4501 complex.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that only affects air traffic
procedures and air navigation, it is certified that this rule, when
promulgated, does not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
because it modifies the restricted area airspace at Fort Leonard Wood,
MO, to enhance aviation safety and accommodate essential U.S. Army
training requirements.

Environmental Review

    This special use airspace action consists of minor adjustments to
boundaries and raising the altitude of portions of the airspace, which
is considered a minor adjustment to existing airspace in accordance
with FAA Order 1050.1E, Environmental Impacts: Policies and Procedures,
paragraph 401p(5). Since there will be no changes in type or number of
operations, the action is not expected to cause any significant
environmental impacts that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

Adoption of Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 73 as follows:

PART 73--SPECIAL USE AIRSPACE

0
1. The authority citation for part 73 continues to read as follows:

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

Sec.  73.45  [Amended]

0
2. Section 73.45 is amended as follows:

R-4501A Fort Leonard Wood West, MO [Removed]

R-4501B Fort Leonard Wood East, MO [Removed]

R-4501A Fort Leonard Wood, MO [New]

    Boundaries. Beginning at lat. 37[deg]41'06'' N., long.
92[deg]09'18'' W.; to lat. 37[deg]38'15'' N., long. 92[deg]09'18'' W.;
to lat. 37[deg]37'35'' N., long. 92[deg]10'38'' W.; to lat.
37[deg]36'15'' N., long. 92[deg]10'38'' W.; to lat. 37[deg]36'15'' N.,
long. 92[deg]15'22'' W.; to lat. 37[deg]39'28'' N., long.
92[deg]15'22'' W.; to lat. 37[deg]41'07'' N., long. 92[deg]14'24'' W.;
to the point of beginning.
    Designated altitudes. Surface to but not including 2,200 feet MSL.
    Time of designation. 0630-2100 Monday-Saturday; other times by
NOTAM issued at least 24 hours in advance.
    Controlling agency. FAA, Kansas City ARTCC.
    Using agency. U.S. Army, Commanding General, Fort Leonard Wood, MO.

R-4501B Fort Leonard Wood, MO [New]

    Boundaries. Beginning at lat. 37[deg]43'00'' N., long.
92[deg]06'56'' W.; to lat. 37[deg]42'11'' N., long. 92[deg]06'15'' W.;
to lat. 37[deg]39'07'' N., long. 92[deg]06'18'' W.; to lat.
37[deg]38'15'' N., long. 92[deg]09'18'' W.; to lat. 37[deg]43'02'' N.,
long. 92[deg]09'18'' W.; to the point of beginning.
    Designated altitudes. Surface to 4,300 feet MSL.
    Time of designation. 0630-2200 Monday-Saturday; other times by
NOTAM issued at least 24 hours in advance.
    Controlling agency. FAA, Kansas City ARTCC.
    Using agency. U.S. Army, Commanding General, Fort Leonard Wood, MO.

R-4501C Fort Leonard Wood, MO [Amended]

    Boundaries. Beginning at lat. 37[deg]41'00'' N., long.
92[deg]16'11'' W.; to lat. 37[deg]41'26'' N., long. 92[deg]10'16'' W.;
to lat. 37[deg]40'16'' N., long. 92[deg]07'06'' W.; to lat.
37[deg]38'20'' N., long. 92[deg]06'56'' W.; to lat. 37[deg]36'07'' N.,
long. 92[deg]10'28'' W.; to lat. 37[deg]35'22'' N., long.
92[deg]15'32'' W.; to the point of beginning, excluding R-4501B when
active.
    Designated altitudes. From 2,200 feet MSL to 5,000 feet MSL.
    Time of designation. 0900-2100 Monday; 0900-1600 Tuesday-Friday;
other times by NOTAM issued at least 24 hours in advance.
    Controlling agency. FAA, Kansas City ARTCC.
    Using agency. U.S. Army, Commanding General, Fort Leonard Wood, MO.

R-4501D Fort Leonard Wood, MO [Amended]

    Boundaries. Beginning at lat. 37[deg]41'00'' N., long.
92[deg]16'11'' W.; to lat. 37[deg]41'26'' N., long. 92[deg]10'16'' W.;
to lat. 37[deg]40'16'' N., long. 92[deg]07'06'' W.; to lat.
37[deg]38'20'' N., long. 92[deg]06'56'' W.; to lat. 37[deg]36'07'' N.,
long. 92[deg]10'28'' W.; to lat. 37[deg]35'22'' N., long.
92[deg]15'32'' W.; to the point of beginning.
    Designated altitudes. From 5,000 feet MSL to 12,000 feet MSL.
    Time of Designation. 0900-2100 Monday; 0900-1600 Tuesday-Friday;
other times by NOTAM issued at least 24 hours in advance.
    Controlling agency. FAA, Kansas City ARTCC.
    Using agency. U.S. Army, Commanding General, Fort Leonard Wood, MO.
* * * * *

R-4501F Fort Leonard Wood, MO [Amended]

    Boundaries. Beginning at lat. 37[deg]41'00'' N., long.
92[deg]09'05'' W.; to lat. 37[deg]41'00'' N., long. 92[deg]10'53'' W.;
to lat. 37[deg]43'02'' N., long. 92[deg]12'11'' W.; to lat.
37[deg]43'10'' N., long. 92[deg]08'46'' W.; to the point of beginning,
excluding R-4501A, R-4501B, and R-4501C when active.
    Designated altitudes. Surface to 3,200 feet MSL.
    Time of designation. 0700-1800 daily; other times by NOTAM issued
at least 24 hours in advance.
    Controlling agency. FAA, Kansas City ARTCC.
    Using agency. U.S. Army, Commanding General, Fort Leonard Wood, MO.

R-4501H Fort Leonard Wood, MO [Amended]

    Boundaries. Beginning at lat. 37[deg]42'50'' N., long.
92[deg]07'21'' W.; to lat. 37[deg]44'00'' N., long. 92[deg]07'16'' W.;
to lat. 37[deg]44'45'' N., long. 92[deg]05'41'' W.; to lat.
37[deg]44'50'' N., long. 92[deg]04'49'' W.; to lat. 37[deg]46'15'' N.,
long. 92[deg]05'31'' W.; to lat. 37[deg]47'45'' N., long.
92[deg]06'01'' W.; to lat. 37[deg]48'00'' N., long. 92[deg]06'01'' W.;
to lat. 37[deg]48'00'' N., long. 92[deg]02'41'' W.; thence south and
along the Big Piney River and Reservation boundary; to lat.
37[deg]42'30'' N., long. 92[deg]04'06'' W.; to lat. 37[deg]42'15'' N.,
long. 92[deg]06'06'' W.; to the point of beginning, excluding R-4501B
when active.
    Designated altitudes. Surface to 3,200 feet MSL.
    Time of designation. 1500-1600 Wednesday; other times by NOTAM.
    Controlling agency. FAA, Kansas City ARTCC.
    Using agency. U.S. Army, Commanding General, Fort Leonard Wood, MO.

    Issued in Washington, DC on May 15, 2015.
Gary A. Norek,
Manager, Airspace Policy and Regulations Group.
[FR Doc. 2015-12627 Filed 5-22-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50032-50033]
[FR Doc No: 2019-20645]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OA-2019-0296; FRL-9046-9]

Proposed Information Collection Request; Comment Request;
Procedures for Implementing the National Environmental Policy Act and
Assessing the Environmental Effects Abroad of EPA Actions (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Procedures for Implementing the
National Environmental Policy Act and Assessing the Environmental
Effects Abroad of EPA Actions'' (EPA ICR No. 2243.08, OMB Control No.
2020-0033) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. Before doing
so, the EPA is soliciting public comments on specific aspects of the
proposed information collection as described below. This is a proposed
extension of the ICR, which is currently approved through January 31,
2020. 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: Comments must be submitted on or before November 25, 2019.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OA-
2019-0296, online using www.regulations.gov (our preferred method) or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    The 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: Candi Schaedle, NEPA Compliance
Division, Office of Federal Activities, Mail Code 2203A, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about the EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. The
EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval. At that time, the EPA will issue another Federal
Register

notice to announce the submission of the ICR to OMB and the opportunity
to submit additional comments to OMB.
    Abstract: The National Environmental Policy Act of 1969 (NEPA), 42
U.S.C. 4321-4347 establishes a national policy for the environment. The
Council on Environmental Quality (CEQ) oversees the NEPA
implementation. CEQ's Regulations at 40 CFR parts 1500 through 1508 set
the standard for NEPA compliance. They also require agencies to
establish their own NEPA implementing procedures. The EPA's procedures
for implementing NEPA are found in 40 CFR part 6. Through this part,
the EPA adopted the CEQ Regulations and supplemented those regulations
for actions proposed by the EPA that are subject to NEPA requirements.
The EPA actions subject to NEPA include the award of wastewater
treatment construction grants under Title II of the Clean Water Act,
the EPA's issuance of new source National Pollutant Discharge
Elimination System (NPDES) permits under section 402 of the Clean Water
Act, certain research and development projects, development and
issuance of regulations, the EPA actions involving renovations or new
construction of EPA facilities, and certain grants awarded for projects
authorized by Congress through the agency's annual appropriations act.
The EPA is collecting information from certain applicants as part of
the process of complying with either NEPA or Executive Order 12114
(``Environmental Effects Abroad of Major Federal Actions''). The EPA's
NEPA regulations apply to actions of the EPA that are subject to NEPA
in order to ensure that environmental information is available to the
agency's decision-makers and the public before decisions are made and
before actions are taken. When the EPA conducts an environmental
assessment pursuant to its Executive Order 12114 procedures, the agency
generally follows its NEPA procedures. Compliance with the procedures
is the responsibility of the EPA's Responsible Officials, and for
applicant proposed actions applicants may be required to provide
environmental information to the EPA as part of the environmental
review process. For this ICR, applicant-proposed projects subject to
either NEPA or Executive Order 12114 (and that are not addressed in
other EPA programs' ICRs) are addressed through the NEPA process.
    Form Numbers: None.
    Respondents/Affected Entities: Entities potentially affected by
this action are certain grant or permit applicants who must submit
environmental information documentation to the EPA for their projects
to comply with NEPA or Executive Order 12114, including Wastewater
Treatment Construction Grants Program facilities, State and Tribal
Assistance Grant recipients, and new source National Pollutant
Discharge Elimination System permittees.
    Respondent's Obligation to Respond: Voluntary.
    Estimated Number of Respondents: 26 (total).
    Frequency of Response: On occasion.
    Total Estimated Burden: 4,720 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total Estimated Cost: $394,461 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is a decrease of 8,957 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to an adjustment change in the
size of the respondent universe.

    Dated: September 19, 2019.
Robert Tomiak,
Director, Office of Federal Activities.
[FR Doc. 2019-20645 Filed 9-23-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23321-23322]
[FR Doc No: 2016-09174]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4268-DR; Docket ID FEMA-2016-0001

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

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Mississippi (FEMA-4268-DR), dated March 25, 2016, and
related determinations.

DATES: Effective Date: April 5, 2016.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Mississippi is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of March 25, 2016.

    George and Pearl River Counties for Individual Assistance.

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

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-09174 Filed 4-19-16; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 24997-25000]
[FR Doc No: 2023-08686]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0795]

Agency Information Collection Activities; Proposed Collection;
Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer
Prescription Drug Advertising

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the proposed study entitled ``A Survey on
Quantitative Claims in Direct-to-Consumer Prescription Drug
Advertising.''

DATES: Either electronic or written comments on the collection of
information must be submitted by June 26, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 26, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

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

confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-0795 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; A Survey on Quantitative Claims
in Direct-to-Consumer Prescription Drug Advertising.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(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 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 of 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.

A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug
Advertising

OMB Control Number 0910-NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
    The mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the public health by helping to ensure that prescription
drug promotion is truthful, balanced, and accurately communicated so
that patients and healthcare providers can make informed decisions
about treatment options. OPDP's research program provides scientific
evidence to help ensure that our policies related to prescription drug
promotion will have the greatest benefit to public health. Toward that
end, we have consistently conducted research to evaluate the aspects of
prescription drug promotion that are most central to our mission,
focusing in particular on three main topic areas: advertising features,
including content and format; target populations; and research quality.
Through the evaluation of advertising features, we assess how elements
such as graphics, format, and the characteristics of the disease and
product impact the communication and understanding of prescription drug
risks and benefits. Focusing on target populations allows us to
evaluate how understanding of prescription drug risks and benefits may
vary as a function of audience. Our focus on research quality aims at
maximizing the quality of our research data through analytical
methodology development and investigation of sampling and response
issues. This study will inform the first topic area, advertising
features.
    Because we recognize that the strength of data and the confidence
in the robust nature of the findings are improved through the results
of multiple converging studies, we continue to develop evidence to
inform our thinking. We evaluate the results from our studies within
the broader context of research and findings from

other sources, and this larger body of knowledge collectively informs
our policies as well as our research program. Our research is
documented on our homepage at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links to the latest Federal Register
notices and peer-reviewed publications produced by our office.
    Direct-to-consumer (DTC) prescription drug advertising may make
quantitative claims about the drug's efficacy or risks (Ref. 1).
Although there is research and FDA guidance (``Presenting Quantitative
Efficacy and Risk Information in Direct-to-Consumer Promotional
Labeling and Advertisements,'' available at https://www.fda.gov/media/117573/download) that provides general guidelines for how to present
quantitative information, it is not fully understood how consumers will
interpret specific quantitative claims. We conducted a literature
review and found that while some types of quantitative information are
well-studied (e.g., relative frequencies), many questions remain on how
best to communicate certain quantitative information about prescription
drugs. For example, we do not have sufficient information about how
consumers interpret different claims describing medians (e.g., ``People
treated with Drug X lived for a median of 8 months'' alone or in
combination with a definition such as ``In people receiving Drug X,
this means that about half lived more than 8 months and about half
lived less than 8 months'' or ``A median is the middle number in a
group of numbers ordered from smallest to largest''). This study aims
to survey U.S. adults about their interpretation of specific
quantitative claims.
    We plan to use an address-based, mixed-mode methodology that will
direct one randomly chosen member of sampled households to complete a
20-minute online survey, with nonrespondents receiving a paper
questionnaire. The sample will be representative of the U.S.
population. A sample of U.S. households will be drawn from the U.S.
Postal Service Computerized Delivery Sequence File. Adults aged 18 or
over will be eligible for participation. Up to four contacts (mailings)
will be sent to respondents by U.S. mail. The contacts will include the
URL for the online survey and a unique survey login. This unique survey
login will be used to track completed surveys without the use of
personally identifying information. The contact method, based on recent
recommendations (Ref. 2), includes a prenotification letter (week 1), a
web survey invitation letter (soft launch in week 2, full launch in
week 3), a reminder postcard sent to nonresponders (week 5), and a
final mailing with the paper version of the survey sent to
nonresponders (Week 7). We estimate a 40-percent response rate, based
on recent experience with similar surveys. We estimate 1,100
respondents will complete the main study (see table 1).
    Based on previous research (Refs. 3, 4, and 5), we plan to include
a small prepaid incentive in the second mailing sent to the sampled
addresses as a gesture to encourage response and maintain data quality.
We expect that approximately 5 percent of the sampled addresses will be
postal nondeliverable returned letters from the first mailing
(prenotification letter), so the second mailing is estimated to go out
to the remaining addresses. We also will conduct an experiment to
assess the efficacy of using a promised post-paid incentive. Seventy-
five percent of the sample will be sent the promised incentive upon
completion of the survey, and the remaining 25 percent of the sample
will not be notified of or provided with any promised incentive. We
opted to split the sample 75-25 rather than 50-50 because the initial
evidence shows the benefits of including a promised incentive (Refs. 4,
6, and 7), and we aimed to maximize response rates.
    The survey contains questions about respondents' perceptions and
understanding of several quantitative claims drawn from DTC ads in the
marketplace. We will also measure other potentially important
variables, such as demographics and numeracy. The survey questions will
be informed by consumer feedback elicited in one-on-one interviews
(approved under OMB control number 0910-0847). The survey is available
upon request from [email protected].
    We will test whether any variables differed between modes (online
versus mail survey) and will account for any mode effects in our
analyses. We will examine the descriptive statistics for the survey
items (e.g., frequencies and percentages) and explore the relationship
between the survey items and demographic and health characteristics. We
will weight the data to account for different probability of selection
and nonresponse.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Number of
                 Activity                     Number of     responses per   Total  annual           Average burden  per response            Total hours
                                             respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Read prenotification letter..............           2,993               1           2,993  0.08 (5 min.)................................             239
Read web survey invitation letter \2\....           2,843               1           2,843  0.08 (5 min.)................................             227
Read reminder postcard...................           2,585               1           2,585  0.03 (2 min.)................................              78
Respond to survey (web and paper)........           1,100               1           1,100  0.33 (20 min.)...............................             363
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  ..............  ..............  ..............  .............................................             907
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The numbers assume around 5 percent postal nondeliverables from the prenotification letter and estimates nonrespondents for the subsequent mailings.

References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff, (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the

Federal Register, but websites are subject to change over time.

* 1. Sullivan, H.W., K.J. Aikin, and L.B. Squiers, ``Quantitative
Information on Oncology Prescription Drug Websites,'' Journal of
Cancer Education vol. 33, Issue 2, pp. 371-374, 2018. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5334459/).
2. Dillman, D.A., J.D. Smyth, and L.M. Christian, Internet, Phone,
Mail, and Mixed-Mode Surveys: The Tailored Design Method, 4th ed.,
John Wiley & Sons, Inc.: Hoboken, NJ, 2014.
* 3. Cheung, Y.T.D., X. Weng, M.P. Wang, et al., ``Effect of Prepaid
and Promised Financial Incentive on Follow-Up Survey Response in
Cigarette Smokers: A Randomized Controlled Trial,'' BMC Medical
Research Methodology, vol. 19, Article 138, 2019. (https://link.springer.com/article/10.1186/s12874-019-0786-9)
4. Mercer, A., A. Caporaso, D. Cantor, et al., ``How Much Gets You
How Much? Monetary Incentives and Response Rates in Household
Surveys,'' Public Opinion Quarterly, vol. 79, pp. 105-129, 2015.
5. Sun, H., J. Newsome, J. McNulty, et al., ``What Works, What
Doesn't? Three Studies Designed to Improve Survey Response,'' Field
Methods, vol. 32, Issue 3, pp. 235-252, 2020. (https://doi.org/10.1177/1525822X20915464).
6. Ellis, J., J. Charbonnier, C. Lowenstein, et al., ``Assessing the
Impacts of Different Incentives and Use of Postal Mail on Response
Rates,'' American Association for Public Opinion Research (AAPOR)
Conference, Chicago, IL, 2022, May.
* 7. Yu, S., H.E. Alper, A.M. Nguyen, et al., ``The Effectiveness of
a Monetary Incentive Offer on Survey Response Rates and Response
Completeness in a Longitudinal Study,'' BMC Medical Research
Methodology, vol. 17, Article 77, 2017. (https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-017-0353-1).

    Dated: April 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08686 Filed 4-24-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 72 (Monday, April 15, 2013)]
[Rules and Regulations]
[Pages 22189-22190]
[FR Doc No: 2013-08591]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-1294; Airspace Docket No. 11-ANM-28]
RIN 2120-AA66

Establishment of Area Navigation (RNAV) Routes; OR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes two new low-altitude RNAV routes,
designated T-302 and T-304, in the state of Oregon. The routes replace
segments of an existing VHF Omnidirectional Range (VOR) Federal airway
that will be removed due to the planned decommissioning of the
Portland, OR, VOR/DME in 2013. This action advances the implementation
of RNAV in the National Airspace System (NAS) and provides continued en
route navigation guidance in the affected airspace.

DATES: Effective date 0901 UTC, June 27, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy and ATC
Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    The FAA published in the Federal Register a notice of proposed
rulemaking (NPRM) to establish T-302 and T-304 in the state of Oregon
(78 FR 4354, January 22, 2013). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal. Two comments were received, both expressing support for
the proposal.

The Rule

    This action amends Title 14, Code of Federal Regulations (14 CFR)
part 71 by establishing RNAV routes T-302 and T-304 in Oregon. The new
low-altitude routes replace segments of a VOR Federal airway that will
be affected by the planned decommissioning of the Portland, OR, VOR/DME
in 2013. T-302 extends between the existing CUKIS, OR, fix and the
existing CUPRI, OR, fix. T-304 extends between the existing GLARA, OR,
fix and the existing HERBS, OR, fix. Additional waypoints are added
between the end-point fixes. This action enhances safety and
efficiency, expands the use of RNAV within the NAS, and provides for
continued en route navigation guidance in a portion of Seattle Air
Route Traffic Control Center's airspace.
    Area navigation routes are published in paragraph 6011 of FAA Order
7400.9W, dated August 8, 2012 and effective September 15, 2012, which
is incorporated by reference in 14 CFR 71.1. The area navigation routes
listed in this document will be published subsequently in the Order.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that only affects air traffic
procedures and air navigation, it is certified that this rule, when
promulgated, does not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies the route structure as required to preserve
the safe and efficient flow of air traffic.

Environmental Review

    The FAA has determined that this action is categorically excluded
from further environmental documentation according to FAA Order
1050.1E, Environmental Impacts: Policies and Procedures, in accordance
with paragraph 311a. The implementation of this action will not result
in any extraordinary circumstances in accordance with FAA Order 1050.1E
paragraph 304.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9W,
Airspace Designations and Reporting Points, dated August 8, 2012, and
effective September 15, 2012, is amended as follows:

Paragraph 6011 United States area navigation routes

* * * * *

T-302 CUKIS, OR to CUPRI, OR [New]

CUKIS, OR                        Fix                (45[deg]21'00'' N., long. 122[deg]21'49'' W.)
JJACE, OR                        WP                 (45[deg]09'52'' N., long. 122[deg]03'03'' W.)
JJETT, OR                        WP                 (44[deg]56'35'' N., long. 121[deg]40'56'' W.)
JERMM, OR                        WP                 (44[deg]46'05'' N., long. 121[deg]27'06'' W.)
CUPRI, OR                        Fix                (44[deg]37'04'' N., long. 121[deg]15'14'' W.)

T-304 GLARA, OR to HERBS, OR [New]

GLARA, OR                        Fix                (45[deg]16'40'' N., long. 122[deg]36'11'' W.)
PUTZZ, OR                        WP                 (45[deg]06'14'' N., long. 122[deg]07'19'' W.)
JJETT, OR                        WP                 (44[deg]56'35'' N., long. 121[deg]40'56'' W.)
WISSL, OR                        WP                 (44[deg]35'49'' N., long. 121[deg]24'59'' W.)
HERBS, OR                        Fix                (44[deg]25'07'' N., long. 121[deg]16'52'' W.)

    Issued in Washington, DC, on April 4, 2013.
Gary A. Norek,
Manager, Airspace Policy and ATC Procedures Group.
[FR Doc. 2013-08591 Filed 4-12-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 29, 2009 (Volume 74, Number 187)]
[Notices]
[Page 49906-49907]
[DOCID:fr29se09-89]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 17Ad-4(b) and (c), OMB Control No. 3235-0341, SEC File No.
270-264.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information provided for in Rule 17Ad-4(b) and (c) (17
CFR 240.17Ad-4(b) and (c)) of the Securities Exchange Act of 1934 (15
U.S.C. 78a et seq.).
    Rule 17Ad-4(b) and (c) is used to document when transfer agents are
exempt or no longer exempt from some of the Commission's transfer agent
rules. Depending on which federal government organization is the
transfer agent's appropriate regulatory agency (``ARA''), Rule 17Ad-
4(b)(3) requires an exempt transfer agent to either prepare and
maintain or file a document that certifies that the transfer agent
qualifies as exempt under Rule 17Ad-4(b)(1) or when the transfer agent
loses such exemption.
    The ARAs use the information contained in the notice to determine
whether a registered transfer agent qualifies for the exemption, to
determine when a registered transfer agent no longer qualifies for the
exemption, and to determine the extent that transfer agent is subject
to the Commission's rules.
    The Board of Governors of the Federal Reserve System (``the Fed'')
receives approximately two notices of exempt status and two notices of
loss of exempt status annually. The Federal Deposit Insurance
Corporation (``FDIC'') also receives approximately two notices of
exempt status and two notices of loss of exempt status annually. The
Commission and the Office of the Comptroller of the Currency (``OCC'')
do not require transfer agents to file a notice of exempt status or
loss of exempt status. Instead, transfer agents whose ARA is the
Commission or OCC need only to prepare and maintain these notices. The
Commission estimates that approximately ten notices of exempt status
and ten notices of loss of exempt status are prepared annually by
transfer agents whose ARA is the Commission. We estimate that the
transfer agents for whom the OCC is their ARA prepare and maintain
approximately five notices of exempt status and five notices of loss of
exempt status annually. Thus, a total of approximately thirty-eight
notices of exempt status and loss of exempt status are prepared and
maintained by transfer agents annually. Of these thirty-eight notices,
approximately eight are filed with an ARA. Any additional costs
associated with filing such notices would be limited primarily to
postage, which would be minimal. Since the Commission estimates that no
more than one-half hour is required to prepare each notice, the total
annual burden to transfer agents is approximately nineteen hours. The
average cost per hour is approximately $30. Therefore, the total cost
of compliance to the transfer agent industry is about $570.
    Please note that 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 control number.
    Comments should be directed to: (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by

sending an e-mail to<EMAIL_ADDRESS>and (ii) Charles
Boucher, Director/Chief Information Officer, Securities and Exchange
Commission, c/o Shirley Martinson, 6432 General Green Way, Alexandria,
VA 22312 or send an e-mail to<EMAIL_ADDRESS>Comments must be
submitted within 30 days of this notice.

    Dated: September 23, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-23494 Filed 9-28-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: August 30, 2006 (Volume 71, Number 168)]
[Proposed Rules]
[Page 51545-51546]
[DOCID:fr30au06-34]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[Docket Number EPA-R08-OAR-2006-0098; FRL-8215-2]
RIN 2008-AA00

Federal Implementation Plan for the Billings/Laurel, MT, Sulfur
Dioxide Area; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of the comment period.

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SUMMARY: EPA is extending the comment period for a proposed rule
published July 12, 2006 (71 FR 39259). In the July 12, 2006 document,
EPA proposed to promulgate a Federal Implementation Plan (FIP)
containing emission limits and compliance determining methods for
several sources located in Billings and Laurel, Montana. At the request
of several commenters, EPA is extending the comment period through
November 3, 2006.

DATES: Comments on the proposal must be received on or before November
3, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2006-0098, by one of the following methods:
     http://www.regulations.gov. Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>and<EMAIL_ADDRESS>
     Fax:<PHONE_NUMBER> (please alert the individual listed in
the section titled, FOR FURTHER INFORMATION CONTACT, if you are faxing
comments).
     Mail: Richard R. Long, Director, Air and Radiation
Program, Environmental Protection Agency (EPA), Region 8, Mailcode 8P-
AR, 999 18th Street, Suite 200, Denver, Colorado 80202-2466.
     Hand Delivery: Richard R. Long, Director, Air and
Radiation Program, Environmental Protection Agency (EPA), Region 8,
Mailcode 8P-AR, 999 18th Street, Suite 300, Denver, Colorado 80202-
2466. Such deliveries are only accepted Monday through Friday, 8 a.m.
to 4:55 p.m., excluding Federal holidays. Special arrangements should
be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-OAR-
2006-0098. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' systems, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA, without
going through http://www.regulations.gov your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
 For additional instructions on submitting

comments, go to Section I. General Information of the SUPPLEMENTARY
INFORMATION section of the July 12, 2006 document (71 FR 39259).

FOR FURTHER INFORMATION CONTACT: Laurie Ostrand, Air and Radiation
Program, Mailcode 8P-AR, Environmental Protection Agency (EPA), Region
8, 999 18th Street, Suite

200, Denver, Colorado 80202-2466,<PHONE_NUMBER>,
<EMAIL_ADDRESS>

    Dated: August 21, 2006.
Robert E. Roberts,
Regional Administrator, Region 8.
[FR Doc. E6-14452 Filed 8-29-06; 8:45 am]

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[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Proposed Rules]
[Pages 7005-7007]
[FR Doc No: 2012-3187]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

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

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

Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0101; Directorate Identifier 2010-SW-042-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter Deutschland GMBH Helicopters

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
Eurocopter Deutschland GMBH (ECD) Model MBB-BK 117 C-1 and C-2
helicopters. This proposed AD would require installing a placard that
corresponds to the maximum permissible flight altitude, amending the
Rotorcraft Flight Manual (RFM) to revise the maximum permissible
operating altitude, and inserting revised performance charts into the
RFM. The proposed AD would also require a repetitive maintenance ``MAX
N1 CHECK'' to determine the appropriate maximum altitudes. The AD would
also require, if the engine or a fuel control unit (FCU) or module 2 or
3 is replaced, repeating the maintenance ``MAX N1 CHECK.'' Finally, the
proposed AD specifies that modifying both engines would provide
terminating action for the proposed AD requirements. This proposed AD
is prompted by the failure of a ``few'' engines to reach the specified
one-engine-inoperative (OEI) rating at altitudes above 10,000 feet. The
proposed actions are intended to prevent flights at altitudes where the
full OEI engine power cannot be reached and subsequent loss of control
of the helicopter if an OEI operation is required.

DATES: We must receive comments on this proposed AD by April 10, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    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
economic evaluation, any comments received, and other information. The
street address for the Docket Operations Office (telephone 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.
    For service information identified in this proposed AD, contact
American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, Texas
75053-4005; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at http://www.eurocopter.com. You may review copies of the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Ed Cuevas, Aviation Safety Engineer,
Safety Management Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued AD No.:
2008-0061, dated March 27, 2008, to correct an unsafe condition for ECD
Model MBB-BK 117 C-1 and C-2 helicopters. EASA states that during
testing at maximum certification altitude, a few helicopters could not
reach the specified OEI power threshold. The cause was identified as an
engine acceleration limitation due to a lower delivered fuel flow than
the engine fuel flow demand needed to achieve the OEI rating at high
altitude. They state that this condition could occur at altitudes
exceeding 10,000 feet depending on the engine and FCU characteristics.

FAA's Determination

    We are proposing this AD because we evaluated all known relevant
information and determined that an unsafe condition exists and is
likely to exist or develop on other products of these same type
designs.

Related Service Information

    ECD has issued Alert Service Bulletin (ASB) No. ASB-MBB-BK117-60-
121, Revision 4, (ASB121) for Model MBB-BK 117 C-1 helicopters and ASB
MBB BK117 C-2-71A-003, Revision 3 (ASB003), for Model MBB-BK 117 C-2
helicopters. Both ASBs are dated December 11, 2007, and apply to
Turbomeca Arriel 1E2 engines. Both ASBs specify a ``MAX N1 CHECK'' for
helicopters with FCUs that have not been modified by Turbomeca

modification TU 358, for takeoffs, landings, and hovering in-ground
effect (IGE) or hovering out-of-ground effect (OGE) higher than 10,000
feet or flight above 13,000 feet. The ASBs specify limiting the maximum
permissible flight altitude if the OEI rating cannot be achieved. The
ASBs also specify the measures are no longer necessary when you modify
both engines (Modification TU 358). EASA classified these ASBs as
mandatory and issued AD No.: 2008-0061, dated March 27, 2008, to ensure
the continued airworthiness of these helicopters.

Proposed AD Requirements

    This proposed AD would require compliance with specified portions
of the manufacturer's service bulletin including installing a placard
that corresponds to the maximum permissible flight altitude, amending
the RFM to revise the maximum permissible operating altitude for both
the MBB-BK 117 C-1 and C-2 helicopters, and inserting revised
performance charts into the RFM for the C-1 model. This proposed AD
would also require maintenance ``MAX N1 CHECKs'' to determine the
modified maximum operational altitudes. This proposal would also
require, if the engine or an FCU or module 2 or 3 is replaced,
repeating the maintenance ``MAX N1 CHECK.'' Finally, this proposal
specifies that modifying both engines with Turbomeca Modification TU
358 is terminating action for the requirements of this proposed AD.
After the modification of both engines, you may remove the placards and
flight manual revisions required by this AD.

Differences Between This Proposed AD and the EASA AD

    We do not reference the effective date stated in the EASA AD
because it has passed. We have modified the initial placard wording to
make it clear that before performing the topping check, the ``operating
altitude'' for takeoff, landing, and hovering is a pressure altitude
(PA) of 10,000 feet, but flight up to a maximum 13,000 feet is
permitted as long as the helicopter stays at an airspeed above
effective translational lift. After the topping check is performed, the
``operating altitude'' limitation refers to all modes of flight.

Costs of Compliance

    We estimate that this proposed AD would affect 108 helicopters of
U.S. Registry.
    We estimate that operators may incur the following costs in order
to comply with this AD. It would take about 1 work-hour per helicopter
to affix a placard and insert the RFM pages at an average labor rate of
$85 per work-hour. We estimate 54 maintenance flight checks for higher
altitude operators would be required at $1,000 each. There are no parts
costs. Based on these figures, we estimate the total cost impact of the
proposed AD on U.S. operators to be $63,180.

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, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic 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
Airworthiness Directive (AD):

Eurocopter Deutschland GMBH: Docket No. FAA-2012-0101; Directorate
Identifier 2010-SW-042-AD.

(a) Applicability

    This AD applies to Eurocopter Deutschland GMBH (ECD) Model MBB-
BK 117 C-1 and C-2 helicopters with a Turbomeca Arriel 1E2 engine
installed, which has a Fuel Control Unit (FCU) that has not been
modified with Turbomeca Modification TU 358, certificated in any
category.

(b) Unsafe Condition

    This AD defines the unsafe condition as failure of engines to
reach the specified one-engine-inoperative (OEI) rating at altitudes
above 10,000 feet. This condition could result in high altitude
operations when full OEI engine power is not available and
subsequent loss of control of the helicopter if an OEI operation is
required.

(c) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance.

(d) Required Actions

    (1) For Model MBB-BK117 C-1 helicopters:
    (i) Before any flight operation at or above a pressure altitude
(PA) of 10,000 feet, unless accomplished previously:
    (A) Affix a placard to the instrument panel in plain view of the
pilot(s), which states: ``Maximum altitude for takeoff, landing, and
hovering is 10,000 ft PA. Maximum operating altitude above effective
translational lift is 13,000 ft PA,'' or comply with paragraph
(1)(iii) of this AD. The term ``hovering'' as used in this placard
includes both in-ground effect (IGE) and out-of-ground effect (OGE)
hovering.
    (B) Revise the Altitude Limitations section of the Rotorcraft
Flight Manual (RFM), in accordance with paragraph 2.9 on pages 9 and
10; paragraph B.2.1. on page 15; and paragraph C.2.3.2. on page 16
of Eurocopter Alert Service Bulletin No. ASB-MBB-BK117-60-121,
Revision 4, dated December 11, 2007 (ASB121).

    (C) Attach each revised page 11-1-7 (ASB121, page 11) through
11-1-10 (ASB121, page 14) to the unrevised same-numbered page in the
Performance section of the RFM.
    (ii) Within 50 hours time-in-service (TIS), unless accomplished
previously:
    (A) Revise the RFM as required by paragraph (1)(i)(B) and
(1)(i)(C) of this AD; and
    (B) Affix the placard as required by paragraph (1)(i)(A) of this
AD or comply with paragraph (1)(iii) of this AD.
    (iii) At intervals not to exceed 600 hours TIS:
    (A) Before operating between a 16,000 ft PA and 18,000 ft PA,
perform the ``MAX N1 CHECK'' by following the Accomplishment
Instructions, paragraph 2.B.1.1., of ASB121. If the OEI rating is
not reached, either affix a placard as required by paragraph
(1)(i)(A) or comply with paragraph (1)(iii)(B) or (1)(iii)(C) of
this AD.
    (B) Before operating between 13,000 ft PA and 16,000 ft PA,
perform the ``MAX N1 CHECK'' by following the Accomplishment
Instructions, paragraph 2.B.1.4., of ASB121.
    (1) If the OEI rating is reached, affix a placard to the
instrument panel in plain view of the pilot(s), which states:
``Maximum operating altitude is 16,000 ft PA.''
    (2) If the OEI rating is not reached, either affix a placard as
required by paragraph (1)(i)(A) of this AD or comply with paragraph
(1)(iii)(C) of this AD.
    (C) Before operating between 10,000 ft PA and 13,000 ft PA,
perform the ``MAX N1 CHECK'' by following the Accomplishment
Instructions, paragraph 2.B.1.7., of ASB121.
    (1) If the OEI rating is reached, affix a placard to the
instrument panel in plain view of the pilot(s), which states:
``Maximum operating altitude is 13,000 ft PA.''
    (2) If the OEI rating is not reached, affix a placard as
required by paragraph (1)(i)(A) of this AD.
    (2) For Model MBB-BK 117 C-2 helicopters:
    (i) Before any flight operation at or above a PA of 10,000 feet,
unless accomplished previously:
    (A) Affix a placard to the instrument panel in plain view of the
pilot(s), which states: ``Maximum altitude for takeoff, landing, and
hovering is 10,000 ft PA. Maximum operating altitude above effective
translational lift is 13,000 ft PA,'' or comply with paragraph
(2)(iii) of this AD. The term ``hovering'' as used in this placard
includes both IGE and OGE hovering.
    (B) Revise the Altitude Limitations section of the RFM in
accordance with paragraph A.2.3. on page 10 and paragraph 2.8. on
page 11 of Eurocopter ASB No. MBB BK117 C-2-71A-003, Revision 3,
dated December 11, 2007 (ASB003).
    (ii) Within 50 hours TIS, unless accomplished previously:
    (A) Revise the RFM as required by paragraph (2)(i)(B) of this
AD; and
    (B) Affix a placard as required by paragraph (2)(i)(A) of this
AD or comply with paragraph (2)(iii) of this AD.
    (iii) At intervals not to exceed 600 hours TIS:
    (A) Before operating between 16,000 ft PA and 18,000 ft PA,
perform the ``MAX N1 CHECK'' by following the Accomplishment
Instructions, paragraph 3.A.(1) (on pages 4 and 5), of ASB003. If
the OEI rating is not reached, either affix a placard as required by
paragraph (2)(i)(A) or comply with paragraph (2)(iii)(B) or
(2)(iii)(C) of this AD.
    (B) Before operating between 13,000 ft PA and 16,000 ft PA,
perform the ``MAX N1 CHECK'' by following the Accomplishment
Instructions, paragraph 3.A.(1) (on pages 5 and 6) of ASB003.
    (1) If the OEI rating is reached, affix a placard to the
instrument panel in plain view of the pilot(s), which states:
``Maximum operating altitude is 16,000 ft PA.''
    (2) If the OEI rating is not reached, either affix a placard as
required by paragraph (2)(i)(A) or comply with paragraph (2)(iii)(C)
of this AD.
    (C) Before operating between 10,000 ft PA and 13,000 ft PA,
perform the ``MAX N1 CHECK'' by following the Accomplishment
Instructions, paragraph 3.A.1. (on page 7) of ASB003.
    (1) If the OEI rating is reached, affix a placard to the
instrument panel in plain view of the pilot(s), which states:
``Maximum operating altitude is 13,000 ft PA.''
    (2) If the OEI rating is not reached, affix a placard as
required by paragraph (2)(i)(A) of this AD.
    (3) If an engine, FCU, engine module 2 or engine module 3 is
replaced, before any flight operation at or above a PA of 10,000
feet, comply with the requirements of paragraph (1) of this AD for
the Model MBB-BK 117 C-1 helicopter or paragraph (2) of this AD for
the Model MBB-BK 117 C-2 helicopter.
    (4) Modifying both engines with Turbomeca Modification TU 358 is
terminating action for the requirements of this AD. After modifying
both engines, remove from the RFM the revised altitude limitations
and the revised performance pages required by this AD.

(e) Alternative Methods of Compliance (AMOC)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Ed Cuevas, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 2601
Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For operations conducted under a Part 119 operating
certificate or under Part 91, Subpart K, we suggest that you notify
your principal inspector, or lacking a principal inspector, the
manager of the local flight standards district office or certificate
holding district office before operating any aircraft complying with
this AD through an AMOC.

(f) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (Germany) AD No.: 2008-0061, dated March 27, 2008.

(g) Subject

    Joint Aircraft Service Component (JASC) Code: 1100, Placards and
Markings.

    Issued in Fort Worth, Texas, on January 27, 2012.
Lance T. Gant,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2012-3187 Filed 2-9-12; 8:45 am]
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[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Page 36575]
[FR Doc No: 2014-15152]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Pilots
Convicted of Alcohol or Drug-Related Motor Vehicle Offenses or Subject
to State Motor Vehicle Administrative Procedure

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on April 14, 2014, vol. 79, no. 71, pages 20964-20965. The
requested information is needed to mitigate potential hazards presented
by airmen using alcohol or drugs in flight, to identify persons
possibly unsuitable for pilot certification.

DATES: Written comments should be submitted by July 28, 2014.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0543.
    Title: Pilots Convicted of Alcohol or Drug-Related Motor Vehicle
Offenses or Subject to State Motor Vehicle Administrative Procedure.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: Amendments to Parts 61 and 67 of the FAR implement
procedures enhance the safety of aviation commerce by identifying (i)
those persons who may prove unsuitable for airman certification as
indicated by an inability or unwillingness to comply with general
safety regulations and, (ii) those persons who have failed to report
violations of general safety regulations in concert with established
FAA requirements. The amendment to 14 CFR Part 61 requires airmen to
report to the FAA, within 60 days, all alcohol or drug related
convictions or administrative actions.
    Respondents: Approximately 1,185 pilots.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 10 minutes.
    Estimated Total Annual Burden: 197.5 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street NW., Washington, DC
20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC on June 23, 2014.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, ASP-110.
[FR Doc. 2014-15152 Filed 6-26-14; 8:45 am]
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