[Federal Register Volume 87, Number 227 (Monday, November 28, 2022)]
[Notices]
[Pages 73021-73022]
[FR Doc No: 2022-25898]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0024; OMB No. 1660-0085]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Crisis Counseling Assistance and Training
Program

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: 30-Day notice of revision and request for comments.

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SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. This notice seeks comments
concerning the Crisis Counseling Assistance and Training Program, which
provides Federal funding in response to a state or Federally recognized
Tribe's request for Crisis Counseling services for a Presidentially
declared major disaster.

DATES: Comments must be submitted on or before December 28, 2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Information Management Division, 500 C Street SW, Washington, DC 20472,
email address [email protected] or
Ani Brown, EM Specialist, Recovery/Individual Assistance/Community
Services at [email protected] or<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Section 416 of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, (Pub. L. 93-288, as
amended and codified at 42 U.S.C. 5183) (``Act''), authorizes the
President to provide professional counseling services, including
financial assistance to states (which includes the fifty states, the
District of Columbia, and the U.S. territories), Federally recognized
Indian Tribal governments, local agencies or private mental health
organizations for professional counseling services, to survivors of
major disasters to relieve mental health problems caused or aggravated
by a major disaster or its aftermath. The implementing regulations for
Section 416 of the Stafford Act are at 44 CFR 206.171. Under 44 CFR
206.171 and by agreement, the U.S. Department of Health and Human
Services-Center for Mental Health Services (HHS-CMHS), which has
expertise in crisis counseling, coordinates with FEMA in administering
the Crisis Counseling Assistance and Training Program (CCP). FEMA and
HHS-CMHS provide program oversight, technical assistance, and training
to States and Federally recognized Tribes applying for CCP funding for
major disasters.
    FEMA is proposing to revise the collection by rewording the sub-
question from question 8 on the Crisis Counseling Assistance and
Training Program (CCP), Immediate Services

Program (ISP) Application, FEMA Form FF-104-FY-21-148 (formerly 003-0-
1) and from question 12 on the Crisis Counseling Assistance and
Training Program, Regular Services Program (RSP) Application, FEMA Form
FF-104-FY-21-149 (formerly 003-0-2). The rewording of these sub-
questions will allow for greater transparency of plans to ensure
accessibility to all eligible survivors.
    This proposed information collection previously published in the
Federal Register on August 24, 2022, at 87 FR 52018 with a 60 day
public comment period. FEMA received four comments. One comment agreed
with the changes being made and three comments were not germane to this
collection. The purpose of this notice is to notify the public that
FEMA will submit the information collection abstracted below to the
Office of Management and Budget for review and clearance.

Collection of Information

    Title: Crisis Counseling Assistance and Training Program.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0085.
    FEMA Forms: FEMA Form FF-104-FY-21-148 (formerly 003-0-1), Crisis
Counseling Assistance and Training Program, Immediate Services Program
Application; FEMA Form FF-104-FY-21-149 (formerly 003-0-2), Crisis
Counseling Assistance and Training Program, Regular Services Program
Application; ISP Final Report Narrative; Quarterly Report Narratives;
and Final RSP Report Narrative.
    Abstract: The Crisis Counseling Assistance and Training Program
(CCP) consists of two grant programs, the Immediate Services Program
(ISP) and the Regular Services Program (RSP). The ISP and RSP provide
supplemental funding to states and Federally recognized Tribes
following a Presidentially declared major disaster under the Stafford
Act. These grant programs provide funding for training and services,
including community outreach, public education, and counseling
techniques. States and Federally recognized Tribes are required to
submit an application that provides information on Needs Assessment,
Plan of Service, Program Management, and an accompanying Budget.
    Affected Public: State, local or Tribal Government.
    Estimated Number of Respondents: 90.
    Estimated Number of Responses: 108.
    Estimated Total Annual Burden Hours: 1,728.
    Estimated Total Annual Respondent Cost: $141,334.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $156,729.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
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; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) 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.

Millicent Brown Wilson,
Records Management Branch Chief, Office of the Chief Administrative
Officer, Mission Support, Federal Emergency Management Agency,
Department of Homeland Security.
[FR Doc. 2022-25898 Filed 11-25-22; 8:45 am]
BILLING CODE 9111-24-P


[Federal Register Volume 80, Number 204 (Thursday, October 22, 2015)]
[Notices]
[Pages 64053-64054]
[FR Doc No: 2015-26879]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Approval of Finding of No Significant Impact/Record of
Decision (FONSI/ROD) for the Proposed Replacement Airport (XWA) Serving
D-III Aircraft in Williston, North Dakota

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA is announcing approval of Finding of No Significant
Impact/Record of Decision for the proposed replacement airport (XWA)
serving D-III aircraft in Williston, North Dakota. The FAA approved the
FONSI/ROD on September 22, 2015.

SUPPLEMENTARY INFORMATION: The FONSI approved the Sponsor's proposed
action to develop aviation facilities that meet FAA airport design
standards and accommodate current and projected levels of aviation
activity for the Williston area. The need for the proposed action is to
provide aviation facilities necessary to meet the expected demand for
the forecasted growth of air traffic in Williston area consistent with
FAA airport design standards for ARC D-III aircraft, as well as provide
the capability for anticipated future operation of larger aircraft.
    The City of Williston proposes to decommission the existing Sloulin
Field International Airport (ISN) and construct, operate and maintain a
new airport located in Williston, North Dakota. The Airport will be
relocated approximately 6 miles north and 5 miles west of Williston.
The proposed new terminal building would be located approximately 2.5
miles from US Highway 2. The proposed new airport would be called the
Williston Basin

International Airport and the airport identifier changed to (XWA).
    The City of Williston proposes to relocate the Sloulin Field
International Airport to develop aviation facilities that meet FAA
airport design standards and accommodated current and projected levels
of aviation activity. They propose to construct two runways and related
aviation facilities that meet FAA airport design standards for Airport
Reference Code (ARC) D-III aircraft as well as acquire land for
compatible land use and expansion of facilities to future aviation
demands. Development of a replacement airport requires FAA approval of
an airport layout plan (ALP), the final EA and FONSI/ROD and approval
of funding from local agencies, North Dakota Aeronautics Commission
(NDAC), and the FAA. The proposed action would require the acquisition
of land for the construction of access roads, construction of runways,
taxiways, aprons and various airport structures, and the installation
of navigational aids to meet FAA design standards for ARC D-III
aircraft. The proposed action includes acquisition of land for
compatible land use, construction of facilities, and the closure and
sale of the existing Sloulin Field International Airport. The relocated
airport is anticipated to be constructed from 2015-2018, pending
funding availability.
    The FONSI/ROD indicates the project is consistent with existing
environmental policies and objectives as set forth in the National
Environmental Policy Act (NEPA) of 1969, as amended and will not
significantly affect the quality of the environment.
    In reaching this decision, the FAA has given careful consideration
to: (a) The role of Williston Airport plays in the national air
transportation system, (b) aviation safety, and (c) preferences of the
airport owner/operator, and (d) anticipated environmental impact.

DATES: This notice is effective October 22, 2015.

FOR FURTHER INFORMATION CONTACT: Ms. Lindsay Butler, Federal Aviation
Administration, Great Lakes Regional Office, 2300 East Devon Avenue,
Des Plaines, IL 60018. Telephone number:<PHONE_NUMBER>.

    Issued in Des Plaines, IL, on September 30, 2015.
Richard M. Kula,
Manager, Planning/Programming Branch, FAA Great Lakes Region.
[FR Doc. 2015-26879 Filed 10-21-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 27, 2007 (Volume 72, Number 38)]
[Notices]
[Page 8814-8816]
[DOCID:fr27fe07-145]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55296; File No. SR-Amex-2007-14]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to the Options Fee Schedule

February 14, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 30, 2007, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Amex. The Amex has filed the proposal pursuant to Section 19(b)(3)(A)
of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the
proposal effective upon filing with the Commission. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \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)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its options fee schedule (the ``Fee
Schedule'') to (i) reduce the daily maximum aggregate fee charged for
all dividend strategies, merger spreads and short stock interest
spreads to $100, (ii) reduce the monthly maximum aggregate fee charged
for such trades to $12,500, (iii) replace the term ``dividend spread''
with ``dividend strategies,'' (iv) extend the fee cap pilot program
until February 1, 2008, and (v) increase the licensing fee for the
Russell Index and Russell ETF Options (together the ``Russell Index
Options'') from $0.10 to $0.15 per contract side The text of the
proposed rule change is available at the Exchange, the Commission's
Public Reference Room, and http://www.amex.com.

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 Amex 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 Amex has prepared summaries, set forth
in sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose

Fee Cap Program

    Currently, specialists, registered options traders, non-member
market makers, firms, and member and non-member broker-dealers option
transaction, comparison and floor brokerage fees are limited to an
aggregate fee of $1,000 for all dividend spreads,\5\ merger spreads and
short stock interest spreads executed on the same trading day in the
same option class.\6\ In addition, such fees are also limited to
$50,000 per month per initiating firm. In order to attract additional
order flow to the Exchange, this proposal seeks to reduce the daily
aggregate to $100 and the monthly aggregate to $12,500. The Exchange
submits that the reduced fees may increase the trading opportunities
for its members as well as enable the Exchange to attract new business.
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    \5\ A ``dividend spread'' is any trade done within a defined
time frame in which a dividend arbitrage can be achieved between any
two (2) deep-in-the-money options.
    \6\ These fees are charged only to Exchange members.
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    This proposal will also amend the Fee Schedule to expand dividend
spreads to ``dividend strategies.'' Dividend strategies are
transactions done to achieve a dividend arbitrage involving the
purchase, sale and exercise of in-the-money options of the same class,
executed prior to the date on which the underlying stock goes ex-
dividend. The proposed amendment is similar to the definition currently
used by the Chicago Board Options Exchange (``CBOE'') as well as other
exchanges.\7\
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    \7\ See CBOE Fee Schedule and Philadelphia Stock Exchange Fee
Schedule.
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    The fee cap program is currently operated on a six (6) month pilot
basis. The proposal seeks to extend the pilot for an additional year,
through February 1, 2008. To date, the Exchange believes that the fee
cap program has been beneficial, and submits, that a one (1) year
extension is warranted.

Russell Index Option License Fee

    The proposal also seeks to increase the licensing fees for the
Russell Index Options. Currently, the licensing fees for the Russell
Index Options are $0.10 per contract side. The Exchange proposes to
increase this fee to $0.15 per contract side as a result of an increase
in the license agreement for the Russell Index Options.
    As detailed in the original filing regarding license fees for
Russell Index Options,\8\ the Exchange typically pays an index license
fee to a third party as a condition to the listing and trading of such
index options. In many cases, the Exchange is required to pay a
significant licensing fee to the index provider that may not be
reimbursed. In an effort to recoup the costs associated with certain
index licenses, the Exchange has established a per contract licensing
fee for the orders of specialists, registered options traders, firms,
non-member market makers and broker-dealers, that is collected on every
option transaction in designated products in which such market
participant is a party.\9\
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    \8\ See Securities Exchange Act Release No. 53968 (June 9,
2006), 71 FR 34971 (June 16, 2006) (SR-Amex-2006-56).
    \9\ See Securities Exchange Act Release No. 52493 (September 22,
2005), 70 FR 56941 (September 29, 2005) (SR-Amex-2005-087).
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    The purpose of the proposal is to charge a licensing fee of $0.15
per contract side for Russell Index Options for specialist, registered
options trader, firm, non-member market maker and broker-dealer orders
executed on the Exchange. In all cases, the fees are charged only to
Exchange members through whom the orders are placed.
    The proposal will allow the Exchange to recoup its costs in
connection with the index license fee for the trading of Russell Index
Options. The Exchange notes that the Amex in recent years has revised a
number of fees to better align Exchange fees with the actual cost of
delivering services and reduce Exchange subsidies of such services.
Implementation of this proposal is consistent with the reduction and/or
elimination of these subsidies.
    The Exchange asserts that the proposal is equitable as required by
Section 6(b)(4) of the Act.\10\ Further, the Exchange believes that
charging an options licensing fee, where applicable, to all market
participant orders except for customer orders is reasonable given the
competitive pressures in the industry.
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    \10\ 15 U.S.C. 78f(b)(4). Section 6(b)(4) of the Act states that
the rules of a national securities exchange provide for the
equitable allocation of reasonable dues, fees, and other charges
among its members and issuers and other persons using its
facilities.
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2. Statutory Basis
    The Exchange asserts that the proposal is equitable as required by
Section 6(b)(4) of the Act.

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing proposed rule change is subject to Section
19(b)(3)(A)(ii) of the Act \11\ and subparagraph (f)(2) of Rule 19b-4
thereunder \12\ because it establishes or changes a due, fee, or other
charge applicable only to a member imposed by the self-regulatory
organization. Accordingly, the proposal is effective upon the
Commission's receipt of the filing. At any time within 60 days of the
filing of the proposed rule change, the Commission may summarily
abrogate 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.
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    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \12\ 17 CFR 240.19b-4(f)(2).
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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 e-mail to<EMAIL_ADDRESS>Please include File Number SR-Amex-2007-14 on the

subject line.

Paper Comments

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

All submissions should refer to File Number SR-Amex-2007-14. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change 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 inspection and
copying in the Commission's Public Reference Room. Copies of the filing
also will be available for inspection and copying at the principal
office of the Amex. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-Amex-2007-14 and should be submitted on or before March 20, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-3285 Filed 2-26-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 165 (Monday, August 28, 2017)]
[Rules and Regulations]
[Pages 40672-40675]
[FR Doc No: 2017-17591]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0337; Product Identifier 2017-NM-006-AD; Amendment
39-19006; AD 2017-17-16]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 767 airplanes. This AD was prompted by a
report of cracking of the vertical stiffener in the nose wheel well.
This AD requires repetitive inspections of the nose wheel well bulkhead
stiffener for any cracking, and corrective actions if necessary. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective October 2, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 2,
2017.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call 425-
227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0337.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0337; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this final rule, the regulatory evaluation, any comments
received, and other information. The address for the Docket Office
(phone:<PHONE_NUMBER>) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Wayne Lockett, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW.,
Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 767 airplanes. The NPRM published in the Federal Register on May
16, 2017 (82 FR 22443). The NPRM was prompted by a report of cracking
of the vertical stiffener in the nose wheel well. The NPRM proposed to
require repetitive inspections of the nose wheel well bulkhead
stiffener for any cracking, and corrective actions if necessary. We are
issuing this AD to detect and correct such cracking, which could
adversely affect the structural integrity of the airplane and possibly
lead to cabin depressurization or a nose landing gear collapse.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment. United Airlines and The Boeing
Company supported the NPRM.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that accomplishing the supplemental
type certificate (STC) ST01920SE does not affect the actions specified
in the NPRM.
    We concur with the commenter. We have redesignated paragraph (c) of
the proposed AD (82 FR 22443, May 16, 2017) as paragraph (c)(1) and
added paragraph (c)(2) to this AD to state that installation of STC
ST01920SE does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST01920SE is
installed, a ``change in product'' alternative method of compliance
(AMOC) approval request is not necessary to comply with the
requirements of 14 CFR 39.17.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this final rule with the change described previously and minor
editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 767-53A0275, dated
January 5, 2017. The service information describes procedures for a
detailed inspection and a medium frequency eddy current inspection of
the nose wheel well bulkhead stiffener for any cracking, and corrective
actions if necessary. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 144 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection.....................  10 work-hour x $85 per               $0  $850 per            $122,400 per
                                  hour = $850 per                          inspection cycle.   inspection cycle.
                                  inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do certain repairs that would be
required based on the results of the inspection. We have no way of
determining the number of aircraft that might need this repair:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Repair.....................................  18 work-hour x $85 per hour =                    $0          $1,530
                                              $1,530.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for other repairs specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    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,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of 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 (AD):

2017-17-16 The Boeing Company: Amendment 39-19006; Docket No. FAA-
2017-0337; Product Identifier 2017-NM-006-AD.

(a) Effective Date

    This AD is effective October 2, 2017.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to The Boeing Company Model 767-200, -300, -
300F, and -400ER series airplanes, certificated in any category, as
identified in Boeing Alert Service Bulletin 767-53A0275, dated
January 5, 2017.
    (2) Installation of Supplemental Type Certificate (STC)
ST01920SE does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST01920SE
is installed, a ``change in product'' alternative method of
compliance (AMOC) approval request is not necessary to comply with
the requirements of 14 CFR 39.17.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by a report of cracking in the vertical
stiffener in the nose wheel well. We are issuing this AD to detect
and correct such cracking, which could adversely affect the
structural integrity of the airplane and possibly lead to cabin
depressurization or a nose landing gear collapse.

(f) Compliance

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

(g) Inspections

    At the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 767-53A0275, dated
January 5, 2017, except as specified in paragraph (h)(1) of this AD:
Do a detailed inspection and a medium frequency eddy current
inspection of the nose wheel well bulkhead stiffener for any
cracking, and do all applicable corrective actions, in accordance
with the Accomplishment Instructions of Boeing Alert Service
Bulletin 767-53A0275, dated January 5, 2017; except as specified in
paragraph (h)(2) of this AD. Do all corrective actions before
further flight. Repeat the inspections thereafter at the times
specified in paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 767-53A0275, dated January 5, 2017.

(h) Exceptions to the Service Information

    (1) Where Boeing Alert Service Bulletin 767-53A0275, dated
January 5, 2017, specifies a compliance time ``after the original
issue date of this service bulletin,'' this AD requires compliance
within the specified compliance time after the effective date of
this AD.
    (2) If any cracking is found and Boeing Alert Service Bulletin
767-53A0275, dated January 5, 2017, specifies to contact Boeing for
appropriate action and specifies that action as ``RC'' (Required for
Compliance): Before further flight repair using a method approved in
accordance with the procedures specified in paragraph (i) of this
AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (j) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO Branch, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) Except as required by paragraph (h)(2) of this AD: For
service information that contains steps that are labeled as RC, the
provisions of paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(j) Related Information

    For more information about this AD, contact Wayne Lockett,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 1601
Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:
425-917-6590; email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) 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) Boeing Alert Service Bulletin 767-53A0275, dated January 5,
2017.
    (ii) Reserved.
    (3) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
    (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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on August 11, 2017.
Dionne Palermo,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2017-17591 Filed 8-25-17; 8:45 am]
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[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Notices]
[Pages 32311-32312]
[FR Doc No: 2018-14867]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2173]

Long Term Follow-Up After Administration of Human Gene Therapy
Products; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Long Term Follow-Up
After Administration of Human Gene Therapy Products; Draft Guidance for
Industry.'' The draft guidance provides sponsors, who are developing a
human gene therapy (GT) product, recommendations regarding the design
of long term follow-up (LTFU) observational studies for the collection
of data on delayed adverse events following administration of a GT
product. The draft guidance, when finalized, is intended to supersede
the document entitled ``Guidance for Industry: Gene Therapy Clinical
Trials--Observing Participants for Delayed Adverse Events'' dated
November 2006. This draft guidance, when finalized, is also intended to
supplement the guidance entitled ``Testing of Retroviral Vector-Based
Human Gene Therapy Products for Replication Competent Retrovirus during
Product Manufacture and Patient Follow-up; Draft Guidance for
Industry.''

DATES: Submit either electronic or written comments on the draft
guidance by October 10, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for Written/Paper
Submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-2173 for ``Long Term Follow-Up After Administration of Human
Gene Therapy Products; Draft Guidance for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See

the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Long Term Follow-Up After Administration of Human Gene Therapy
Products; Draft Guidance for Industry.'' The draft guidance provides a
brief introduction of the product characteristics, patient-related
factors, and the preclinical and clinical data that should be
considered when assessing the need for LTFU observations for your GT
product. The draft guidance also describes the Agency's current
recommendations for the conduct of LTFU studies, specifically the
information/data to support a sponsor's rationale for the duration and
design of a LTFU protocol when clinical trials are initiated. Also
included in the draft guidance are GT product-specific clinical
considerations for monitoring subjects under a LTFU protocol and
recommendations on patient monitoring for licensed GT products. The
draft guidance, when finalized, is intended to supersede the guidance
entitled ``Guidance for Industry: Gene Therapy Clinical Trials--
Observing Participants for Delayed Adverse Events'' dated November
2006. The draft guidance, when finalized, is also intended to
supplement the guidance entitled ``Testing of Retroviral Vector-Based
Human Gene Therapy Products for Replication Competent Retrovirus during
Product Manufacture and Patient Follow-up; Draft Guidance for
Industry,'' published elsewhere in this issue of the Federal Register.
Also, elsewhere in this issue of the Federal Register, FDA is
announcing the availability of another draft guidance entitled
``Chemistry, Manufacturing, and Control Information for Human Gene
Therapy Investigational New Drug Applications; Draft Guidance for
Industry.''
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on long term
follow-up after administration of human gene therapy products. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 50 and 56 have been approved
under OMB control number 0910-0755; the collections of information in
21 CFR part 58 have been approved under OMB control number 0910-0119;
and the collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014.

III. Electronic Access

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

    Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14867 Filed 7-11-18; 8:45 am]
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