[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41416-41417]
[FR Doc No: 2012-17077]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Food and Drug Administration/Xavier University Global Outsourcing
Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in
cosponsorship with Xavier University, is announcing a public conference
entitled ``FDA/Xavier University Global Outsourcing Conference.'' This
public conference for the pharmaceutical industry is in direct
alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes
presentations from key FDA officials, global regulators, and industry
experts. This conference drives collaboration on the topic of global
outsourcing compliance by bringing pharmaceutical/biotechnology
companies and contract partners to the same event to address the issues
that reside on both sides of the contract. Expert presentations address
the ``how to'' aspects of improving outsourced product quality through
topics such as FDA International Initiatives, FDA Inspection Trends,
Supply Chain Development, Quality Agreements, Supplier Qualification,
and many more. The experience level of our audience has fostered
engaged dialogue that has led to innovative initiatives.
    Dates and Times: The public conference will be held on September
24, 2012, from 8:30 a.m. to 5 p.m.; September 25, 2012, from 8:30 a.m.
to 5:30 p.m.; and September 26, 2012, from 8:30 a.m. to 12:45 p.m.
    Location: The public conference will be held on the campus of
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3073 or<PHONE_NUMBER>.
    Contact Persons:
    For information regarding this notice: Steven Eastham, Food and
Drug Administration, Cincinnati South Office, 36 East Seventh Street,
Cincinnati, OH 45202,<PHONE_NUMBER>, email<EMAIL_ADDRESS>    For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207,
513-745-3073, email<EMAIL_ADDRESS>    Registration: There is a registration fee. The conference
registration fees cover the cost of the presentations, training
materials, receptions, breakfasts, lunches, and dinners for the 2 \1/2\
days of the conference. Early registration ends August 5, 2012.
Standard registration ends September 2, 2012. Late registration occurs
September 3 to September 23, 2012. There will also be onsite
registration. The cost of registration is as follows:

                                         Table 1--Registration Fees \1\
----------------------------------------------------------------------------------------------------------------
                                           Fee on or before         Fee August  6th-       Fee September  3rd-
               Attendee                       August 5th             September 2nd            September 23rd
----------------------------------------------------------------------------------------------------------------
Industry.............................                     $995                   $1,295                   $1,495
Small Business (<100 employees)......                      800                      900                    1,000
Consultants..........................                      500                      600                      700
Startup Manufacturers/Academic.......                      200                      250                      300
Media/Government.....................                     Free                     Free                     Free
----------------------------------------------------------------------------------------------------------------
\1\ The fourth registration from the same company is free.

    The following forms of payment will be accepted: American Express,
Visa, Mastercard, and company checks.
    To register online for the public conference, please visit the
``Register Now'' link on the conference Web site at http://www.XavierGOC.com. FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.
    To register by mail, please send your name, title, firm name,
address, telephone and fax numbers, email, and payment information for
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory
Pkwy., Cincinnati, OH 45207. An email will be sent confirming your
registration.
    Attendees are responsible for their own accommodations. The
conference headquarters hotel is the Downtown Cincinnati Hilton
Netherlands Plaza, 35 West Fifth St., Cincinnati, OH 45202, 513-421-
9100. To make reservations online, please visit the ``Venue &
Logistics'' link at http://www.XavierGOC.com to make reservations. The
hotel is expected to sell out during this timeframe, so early
reservation in the conference room-block is encouraged.
    If you need special accommodations due to a disability, please
contact Marla Phillips (see Contact Persons) at least 7 days in advance
of the conference.

SUPPLEMENTARY INFORMATION: The public conference helps fulfill the
Department of Health and Human Services and FDA's important mission to
protect the public health. The conference will provide those engaged in
FDA-regulated outsourcing with information on the following topics:

 FDA International Initiatives
 European Union Regulator Perspective

 United States Pharmacopeia Chapter Development Impact
 Total Cost of Quality
 FDA New Inspectional Approach and Trends
 Supplier Selection and Due Diligence
 How to Operate in Different Regions of the World
 Establishing a Meaningful Supplier Qualification Program
 Supply Chain Development
 Finished Product Distribution Channel
 Enterprise Resource Planning
 Self Inspections & Corporate Audits
 Quality Agreements
 Business Process Management
 Global Standards Association Near Term Solutions
The conference includes:
 Deep Dive Lunch Sessions
 Live Polling Used by Speakers
 Case Studies
 Small Group Discussions
 Networking Lunch by Topic

    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The conference helps to achieve objectives set forth
in section 406 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115), which includes working closely with
stakeholders and maximizing the availability and clarity of information
to stakeholders and the public. The conference also is consistent with
the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.
104-121) by providing outreach activities by Government Agencies to
small businesses.

    Dated: July 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17077 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 17, 2009 (Volume 74, Number 220)]
[Notices]
[Page 59161-59162]
[DOCID:fr17no09-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[CP10-12-000]

Florida Gas Transmission Company, LLC; Notice of Request Under
Blanket Authorization

November 9, 2009.
    Take notice that on October 29, 2009, Florida Gas Transmission
Company, LLC (Florida Gas), filed in Docket No. CP10-12-000, a prior
notice request pursuant to Sections 157.205 and 157.208 of the
Commission's regulations under the Natural Gas Act (NGA), for
authorization to replace, upgrade, and relocate sections of its St.
Petersburg and Clearwater South Latersals, and Block Valve 24-10,
located in Pinellas County, Florida, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. Florida Gas and proposes to perform these activities under
its blanket certificate issued November 10, 1982, in Docket No. CP82-
553-000 [21 FERC ] 62,235 (1982)].
    Specifically, FGT proposes to relocate approximately 2.6 miles of
existing 10- and 12-inch sections of the St. Petersburg Lateral,
including upgrading a portion of the 10-inch section to a 12-inch
section; relocate, upgrade and replace BV 24-10; and relocate
approximately 444-feet of an existing 4-inch section of the Clearwater
South Lateral, all of which are located in Pinellas County, Florida.
The FGT pipeline modifications are required to accommodate Florida
Department of Transportation (``FDOT'') road improvement projects. FGT
estimates the cost of construction to be $19.5 million.
    The filing may be viewed on the Web at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    Any questions regarding this application may be directed to Stephen
Veatch, Senior Director of Certificates & Tariffs, Florida Gas
Transmission Company, LLC, 5444 Westheimer Road, Houston, Texas, 77056,
or call<PHONE_NUMBER>, or fax<PHONE_NUMBER>, or by e-mail
<EMAIL_ADDRESS>    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the NGA (18 CFR 157.205) a protest
to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for protest. If a protest is
filed and not withdrawn within 30 days after the time allowed for
filing a protest, the instant request shall be treated as an
application for authorization pursuant to Section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu

of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's web site (http://www.ferc.gov) under the ``e-Filing''
link. Persons unable to file electronically should submit an original
and 14 copies of the protest or intervention to the Federal Energy
regulatory Commission, 888 First Street, NE., Washington, DC 20426.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-27476 Filed 11-16-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 191 (Monday, October 3, 2016)]
[Notices]
[Page 68006]
[FR Doc No: 2016-23847]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-2653-000]

Cimarron Bend Wind Project I, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Cimarron Bend Wind Project I, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 17, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: September 27, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-23847 Filed 9-30-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40733-40735]
[FR Doc No: 2020-14569]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2019-0113]

Agency Information Collection Activities; Notice and Request for
Comment; Vehicle Information for the General Public

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments on a reinstatement of a
previously approved collection of information.

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SUMMARY: The National Highway Traffic Safety Administration (NHTSA)
seeks public comment about our intention to request the Office of
Management and Budget's approval on the reinstatement of a previously
approved information collection. Before a Federal agency can collect
certain information from the public, it must receive approval from the
Office of Management and Budget (OMB). Under procedures established by
the Paperwork Reduction Act of 1995, before seeking OMB approval,
Federal agencies must solicit public comment on proposed collections of
information, including extensions and reinstatement of previously
approved collections. This document describes one collection of
information concerning vehicle safety features for consumer information
purposes for which NHTSA intends to seek OMB approval (OMB Control
number 2127-0629).

DATES: Comments should be submitted on or before September 8, 2020.

ADDRESSES: You may submit comments [identified by Docket No. NHTSA-
2019-0113] through one of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments. Mail: Docket Management Facility; M-30, U.S. Department of
Transportation, West Building Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590 between 9 a.m.
and 5 p.m. Eastern Time, Monday through Friday, except Federal
holidays.
     Fax:<PHONE_NUMBER>.
    Regardless of how you submit your comments, please be sure to
mention the docket number of this document and identify the proposed
collection of information for which a comment is provided, by
referencing its OMB clearance number.
    Note: All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
Anyone is able to search the electronic form of all comments received
into any of our dockets by the name of the individual submitting the
comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: Complete copies of each request for
collection of information may be obtained at no charge from Ms. Johanna
Lowrie, U.S. Department of Transportation, NHTSA, Room W43-410, 1200
New Jersey Ave. SE, Washington, DC 20590. Ms. Lowrie's telephone number
is<PHONE_NUMBER>. Please identify the relevant collection of
information by referring to its OMB Control Number.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. In compliance with these requirements, NHTSA asks for
public comment on the following proposed collection of information:
    Title: Vehicle Information for the General Public.
    OMB Control Number: 2127-0629.
    Type of Request: Reinstatement of a previously approved collection.
    Type of Review Requested: Regular.
    Length of Approval Requested: Three Years.
    Abstract: NHTSA's mission is to save lives, prevent injury, and
reduce motor vehicle crashes. Consumer information programs are an
important tool for improving vehicle safety through market forces.
Pursuant to 49 U.S.C. 32302, the Secretary of Transportation (NHTSA by
delegation) is directed to provide to the public the following
information about passenger motor vehicles: Damage susceptibility;
crashworthiness, crash avoidance, and any other areas the Secretary
determines will improve safety of passenger motor vehicles; and the
degree of difficulty of diagnosis and repair of damage to, or failure
of, mechanical and electrical systems. For more than 40 years, under
its New Car Assessment Program (NCAP), NHTSA has been providing
consumers with vehicle safety information such as frontal and side
crash results, crash avoidance performance test results, rollover
propensity, and the availability of a wide array of safety features
provided on new model year vehicles. Additionally, the agency uses this
safety feature information when responding to consumer inquiries and
analyzing rulemaking petitions and the regulatory

impacts of Congressional Acts that require the agency to issue or
consider issuing new rules that would mandate certain vehicle safety
features.
    NHTSA has another information collection to obtain data related to
motor vehicle compliance with the agency's Federal motor vehicle safety
standards. Although the consumer information collection data (requested
by NCAP) is distinct and unique from the compliance data, respondents
to both collections are similar. Thus, the consumer information
collection is closely coordinated with the compliance collection to
enable responders to assemble the data more efficiently. The burden is
further reduced by sending electronic files to the respondents so that
they can enter the data and return it to the agency electronically.
    Affected Public: Manufacturers that sell passenger cars and light
truck vehicles (including sport utility vehicles, pickup trucks, and
vans) that have a Gross Vehicle Weight Rating (GVWR) of 10,000 pounds
or less in the United States.
    Estimated Number of Respondents: 21.
    Frequency: Annually.
    Number of Responses: 21.
    The consumer information collected will be used to disseminate
vehicle safely information via the agency's www.nhtsa.gov website, in
the ``Purchasing with Safety in Mind: What to look for when buying a
new vehicle'' brochure, and in other consumer publications, as well as
for internal agency analyses and responses to consumer inquiries.
    There are approximately 21 vehicle manufacturers that sell
passenger cars and light truck vehicles (including sport utility
vehicles, pickup trucks, and vans) in the United States with a Gross
Vehicle Weight Rating of 10,000 pounds or less, that NHTSA requests
annually to respond to this information request. These 21 vehicle
manufacturers produce an aggregate of approximately 400 vehicle models
each year. Estimates are based on an expected 5 hours to prepare the
request for each vehicle model. In addition, the estimate on total
annual burden hours for each task is based on a proportion of the job
function (e.g., 50 percent for data entry; 40 percent for technical
information validation; 10 percent for technical content approval).
    Estimated Total Annual Burden Hours: 2,000 hours.
    Number of vehicle models: 400.
    Number of hours per vehicle model: 5.
    Total annual burden hours: 2,000 = (5 hours/model x 400 models).

----------------------------------------------------------------------------------------------------------------
                                                                                Estimated total
                                                               Vehicle models   Estimated hours   annual burden
                                                                  per year        per  vehicle        hours
----------------------------------------------------------------------------------------------------------------
Preparation of Response.....................................              400                5            2,000
----------------------------------------------------------------------------------------------------------------

    A breakdown of the total annual burden hours (2,000) for this
collection of information by labor type is as follows:
    Burden hours for data entry = 2,000 hours x 50 percent = 1,000
hours.
    Burden hours for technical information validation = 2,000 hours x
40 percent = 800 hours.
    Burden hours for technical content approval = 2,000 hours x 10
percent = 200 hours.

------------------------------------------------------------------------
                                                Hours by labor type
                                         -------------------------------
                                           Percentage of     Number of
                                            total hours        hours
------------------------------------------------------------------------
Data Entry..............................              50           1,000
Technical Information Validation........              40             800
Technical Content Approval..............              10             200
------------------------------------------------------------------------

    Estimated Annual Labor Costs: $127,035.
    Cost associated with data entry = 1,000 hours x $36.51 \1\ per
hour/0.701 \2\ = $52,083.
---------------------------------------------------------------------------

    \1\ ``Motor Vehicle Manufacturing--May 2016 OES Industry-
Specific Occupational Employment and Wage Estimates.'' March 31,
2017. Business Operations Specialists, Occupation Code 13-1000; Mean
Hourly Wage = $36.51. https://www.bls.gov/oes/2016/may/naics4_336100.htm. Accessed Dec. 9, 2019.
    \2\ See Table 1 at https://www.bls.gov/news.release/pdf/ecec.pdf
for the total compensation rate for the employer for private
workers.
---------------------------------------------------------------------------

    Cost associated with technical information validation = 800 hours x
$50.27 \3\ per hour/0.701 = $57,369.
---------------------------------------------------------------------------

    \3\ ``Motor Vehicle Manufacturing--May 2016 OES Industry-
Specific Occupational Employment and Wage Estimates.'' March 31,
2017. Operations Specialties Managers, Occupation Code 11-3000; Mean
Hourly Wage = $50.27. https://www.bls.gov/oes/2016/may/naics4_336100.htm. Accessed Dec. 9, 2019.
---------------------------------------------------------------------------

    Cost associated with technical content approval = 200 hours x
$61.63 \4\ per hour/0.701 = $17,583.
---------------------------------------------------------------------------

    \4\ ``Motor Vehicle Manufacturing--May 2016 OES Industry-
Specific Occupational Employment and Wage Estimates.'' March 31,
2017. Advertising, Marketing, Promotions, Public Relations, and
Sales Managers, Occupation Code 11-2000; Mean Hourly Wage = $61.63.
https://www.bls.gov/oes/2016/may/naics4_336100.htm. Accessed Dec. 9,
2019.
---------------------------------------------------------------------------

    Cost associated with total annual burden hours is $127,035 =
($52,083 + $57,369 + $17,583).

----------------------------------------------------------------------------------------------------------------
                                                    Percent  of        Total
                                   Average wage        total       compensation    Annual hours    Annual labor
                                                   compensation        rate                            cost
----------------------------------------------------------------------------------------------------------------
Data Entry......................          $36.51            70.1          $52.08           1,000         $52,083
Vehicle Info. Validation........           50.27            70.1           71.71             800          57,369
Tech. Content Approval..........           61.63            70.1           87.92             200          17,583
                                 -------------------------------------------------------------------------------

    Estimated Annual Labor Cost   ..............  ..............  ..............  ..............         127,035
     for This Information
     Collection:................
----------------------------------------------------------------------------------------------------------------

    Public comments invited: The agency seeks comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department 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.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35; and delegation of authority at 49 CFR 1.95 and 501.8.

Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2020-14569 Filed 7-6-20; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Proposed Rules]
[Pages 31057-31061]
[FR Doc No: 2014-12613]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0291; Directorate Identifier 2013-NM-137-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede Airworthiness Directive (AD) 2004-03-
19, which applies to certain Airbus Model A320-111, -211, and -231
series airplanes. AD 2004-03-19 requires repetitive inspections for
cracking in the transition and pick-up angles in the lower part of the
center fuselage area, and corrective action if necessary. AD 2004-03-19
also provides for an optional terminating modification for the
repetitive inspection requirements. Since we issued AD 2004-03-19, we
have determined that the modification must be accomplished in order to
address the unsafe condition. This proposed AD would also require that
modification by installing washers between the transition pick-up angle
and the pin nuts, and doing related investigative and corrective
actions if necessary. This proposed AD would also add airplanes to the
applicability. We are proposing this AD to prevent fatigue cracking in
the transition and pick-up angles of the lower part of the center
fuselage, which could result in reduced structural integrity of the
wing-fuselage support and fuselage pressure vessel.

DATES: We must receive comments on this proposed AD by July 14, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

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-2014-
0291; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0291;
Directorate Identifier 2013-NM-137-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each

substantive verbal contact we receive about this proposed AD.

Discussion

    On January 30, 2004, we issued AD 2004-03-19, Amendment 39-13463
(69 FR 5922, February 9, 2004). AD 2004-03-19 requires actions intended
to address an unsafe condition on certain Airbus Model A320-111, -211,
and -231 series airplanes. (AD 2004-03-19 superseded AD 98-12-18,
Amendment 39-10573 (63 FR 31345, June 9, 1998)).
    Since we issued AD 2004-03-19, Amendment 39-13463 (69 FR 5922,
February 9, 2004), we have determined that the optional modification
specified in AD 2004-03-19 must be accomplished in order to address the
identified unsafe condition.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2013-0137, dated July 9, 2013 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    During the A320 fatigue test campaign, it has been determined
that fatigue damage could appear on the transition and pick-up angle
between Frame (FR) 35 and FR36.
    This condition, if not detected and corrected, could affect the
structural integrity of the aeroplane.
    To address this potential unsafe condition, DGAC [Direction
G[eacute]n[eacute]rale de l'Aviation Civile] France issued AD 2002-
183 [related to FAA AD 2004-03-19, Amendment 39-13463 (69 FR 5922,
February 9, 2004)], to require repetitive inspections of the center
fuselage pick-up angle between FR35 and FR36, below stringer 30,
left hand (LH) and right hand (RH) sides, and, depending on
findings, accomplishment of applicable corrective action(s).
    Since that [DGAC] AD [2002-183] was issued, a modification was
developed, which has been published through Airbus Service Bulletin
(SB) A320-53-1027 for in-service application, introducing additional
washers below the riveting, which constitutes terminating action for
the repetitive inspections.
    For the reasons described above, this [EASA] AD retains the
requirements of DGAC France AD 2002-183, which is superseded, and
requires modification of the transition and pick-up angle between
FR35 and FR36.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0291.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Change to Applicability

    We have added Airbus Model A320-212 airplanes to the applicability,
(paragraph (c) of this NPRM) because these airplanes are subject to the
same unsafe condition identified on Airbus Model A320-111, A320-211,
and A320-231 airplanes. We have also revised the applicability language
used in AD 2004-03-19, Amendment 39-13463 (69 FR 5922, February 9,
2004). This proposed AD applies to Airbus Model A320-111, -211, -212,
and -231 airplanes, all manufacturer serial numbers. We have added new
paragraph (n) in this proposed AD to specify that accomplishing Airbus
Modification 21202 in production terminates the requirements of this
AD.

Clarification of Modification Actions

    The optional modification specified in paragraph (e) of AD 2004-03-
19, Amendment 39-13463 (69 FR 5922, February 9, 2004), is proposed to
be required in paragraph (m) of this NPRM. The modification includes
rotating probe inspections for cracking of certain fastener holes and,
if any cracking is found, replacement or repair of certain parts. We
have included these inspections, as well as the replacement of
transition angles if cracking is found in the transition angles and
repair if cracking is found in the pick-up angles, in the description
of the modification in paragraph (m) of this NPRM.

Repair Approvals

    In many FAA transport ADs, when the service information specifies
to contact the manufacturer for further instructions if certain
discrepancies are found, we typically include in the AD a requirement
to accomplish the action using a method approved by either the FAA or
the State of Design Authority (or its delegated agent).
    We have recently been notified that certain laws in other countries
do not allow such delegation of authority, but some countries do
recognize design approval organizations. In addition, we have become
aware that some U.S. operators have used repair instructions that were
previously approved by a State of Design Authority or a Design Approval
Holder (DAH) as a method of compliance with this provision in FAA ADs.
Frequently, in these cases, the previously approved repair instructions
come from the airplane structural repair manual or the DAH repair
approval statements that were not specifically developed to address the
unsafe condition corrected by the AD. Using repair instructions that
were not specifically approved for a particular AD creates the
potential for doing repairs that were not developed to address the
unsafe condition identified by the MCAI AD, the FAA AD, or the
applicable service information, which could result in the unsafe
condition not being fully corrected.
    To prevent the use of repairs that were not specifically developed
to correct the unsafe condition, certain requirements of this proposed
AD would require that the repair approval specifically refer to the FAA
AD. This change is intended to clarify the method of compliance and to
provide operators with better visibility of repairs that are
specifically developed and approved to correct the unsafe condition. In
addition, we use the phrase ``its delegated agent, or the DAH with
State of Design Authority design organization approval, as applicable''
in this proposed AD to refer to a DAH authorized to approve certain
required repairs for this proposed AD.

Costs of Compliance

    We estimate that this proposed AD affects 482 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection [retained action from   9 work-hours x $85               $0  $765 per inspection  $18,360 per
 AD 2004-03-19, Amendment 39-       per hour = $765                      cycle.               inspection cycle
 13463 (69 FR 5922, February 9,     per inspection                                            (24 airplanes).
 2004)].                            cycle.
Inspection for Model A320-212      9 work-hours x $85                0  $765 per inspection  $32,130 per
 airplanes [new proposed action].   per hour = $765                      cycle.               inspection cycle
                                    per inspection                                            (42 airplanes).
                                    cycle.
Terminating modification [new      28 work-hours x $85           1,837  $4,217.............  $2,032,594.
 proposed action].                  per hour = $2,380.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. Amend Sec.  39.13 by removing airworthiness directive (AD) 2004-03-
19, Amendment 39-13463 (69 FR 5922, February 9, 2004), and adding the
following new AD:

Airbus: Docket No. FAA-2014-0291; Directorate Identifier 2013-NM-
137-AD.

(a) Comments Due Date

    We must receive comments by July 14, 2014.

(b) Affected ADs

    This AD supersedes AD 2004-03-19, Amendment 39-13463 (69 FR
5922, February 9, 2004).

(c) Applicability

    This AD applies to Airbus Model A320-111, -211, -212, and -231
airplanes, certificated in any category, all manufacturer serial
numbers.

(d) Subject

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

(e) Reason

    This AD was prompted by the determination that the modification
must be accomplished in order to address the unsafe condition. We
are issuing this AD to prevent fatigue cracking in the transition
and pick-up angles of the lower part of the center fuselage, which
could result in reduced structural integrity of the wing-fuselage
support and fuselage pressure vessel.

(f) Compliance

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

(g) Retained Detailed and Rotating Probe Inspections

    This paragraph restates the requirements of paragraph (b) of AD
2004-03-19, Amendment 39-13463 (69 FR 5922, February 9, 2004). For
Model A320-111, -211, and -231 airplanes on which the modification
specified in AD 98-12-18, Amendment 39-10573 (63 FR 31345, June 9,
1998), has not been done: Do the applicable inspections specified in
paragraphs (g)(1) and (g)(2) of this AD, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-53-1028,
Revision 01, dated February 12, 2002.
    (1) For airplanes on which the inspections required by AD 98-12-
18, Amendment 39-10573 (63 FR 31345, June 9, 1998), have been done:
Within 12,000 flight cycles after accomplishment of the last
inspection required by AD 98-12-18, do a detailed inspection of the
transition angle and a rotating probe inspection of the pick-up
angle in the lower part of the center fuselage area for cracking.
    (2) For airplanes on which the inspections required by AD 98-12-
18, Amendment 39-10573 (63 FR 31345, June 9, 1998), have not been
done: At the later of the times specified in paragraph (g)(2)(i) or
(g)(2)(ii) of this AD, do a detailed inspection of the transition
angle and a rotating probe inspection of the pick-up angle in the
lower part of the center fuselage area for cracking.
    (i) Before the accumulation of 10,400 total flight cycles, or
24,600 total flight hours, whichever is first.
    (ii) Before the accumulation of 16,000 total flight cycles, or
within 3,500 flight cycles after March 15, 2004 (the effective date
of AD 2004-03-19, Amendment 39-13463 (69 FR 5922, February 9, 2004),
whichever is first.

(h) Retained Repetitive Inspections

    This paragraph restates the requirements of paragraph (c) of AD
2004-03-19, Amendment 39-13463 (69 FR 5922, February 9, 2004). For
Model A320-111, -211, and -231 airplanes: Repeat the detailed and
rotating probe inspections specified in paragraphs (g)(1) and (g)(2)
of this AD at intervals not to exceed 10,400 flight cycles or 24,600
flight hours, whichever is first, until the modification specified
in paragraph (m) of this AD has been done.

(i) Retained Corrective Action for Paragraphs (g) and (h) of This AD

    This paragraph restates the requirements of paragraph (d) of AD
2004-03-19,

Amendment 39-13463 (69 FR 5922, February 9, 2004). For Model A320-
111, -211, and -231 airplanes: If any cracking is found during any
inspection required by paragraph (g) or (h) of this AD, prior to
further flight, either repair the cracking per the Accomplishment
Instructions of Airbus Service Bulletin A320-53-1028, Revision 01,
dated February 12, 2002; or do the modification specified in
paragraph (m) of this AD. Where Airbus Service Bulletin A320-53-
1028, Revision 01, dated February 12, 2002, specifies to contact the
manufacturer for repair instructions, prior to further flight,
repair the cracking in accordance with a method approved by the
Manager, International Branch, ANM-116 Transport Airplane
Directorate, FAA; or European Aviation Safety Agency (EASA) or the
Direction G[eacute]n[eacute]rale de l'Aviation Civile (or its
delegated agent). If the cracking is repaired, repeat the
inspections as required by paragraph (h) of this AD.

(j) New Detailed and Rotating Probe Inspections for Model A320-212
Airplanes

    For Model A320-212 airplanes on which the modification specified
in Airbus Service Bulletin A320-53-1027, has not been done as of the
effective date of this AD: Do the applicable inspections specified
in paragraph (j)(1) or (j)(2) of this AD, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-53-1028,
Revision 01, dated February 12, 2002.
    (1) For airplanes on which the inspections specified in Airbus
Service Bulletin A320-53-1028 have been done as of the effective
date of this AD: At the later of the times specified in paragraph
(j)(1)(i) or (j)(1)(ii) of this AD, do a detailed inspection of the
transition angle and a rotating probe inspection of the pick-up
angle in the lower part of the center fuselage area for cracking.
    (i) Within 10,400 flight cycles or 24,600 flight hours,
whichever occurs first after accomplishing the most recent
inspection specified in Airbus Service Bulletin A320-53-1028.
    (ii) Within 90 days after the effective date of this AD.
    (2) For airplanes on which the inspections specified in Airbus
Service Bulletin A320-53-1028 have not been done as of the effective
date of this AD: At the later of the times specified in paragraphs
(j)(2)(i) and (j)(2)(ii) of this AD, do a detailed inspection of the
transition angle and a rotating probe inspection of the pick-up
angle in the lower part of the center fuselage area for cracking.
    (i) Before the accumulation of 10,400 total flight cycles, or
24,600 total flight hours, whichever occurs first.
    (ii) Within 90 days after the effective date of this AD.

(k) New Repetitive Inspections for Model A320-212 Airplanes

    For Model A320-212 airplanes: Repeat the detailed and rotating
probe inspections specified in paragraphs (j)(1) and (j)(2) of this
AD at intervals not to exceed 10,400 flight cycles or 24,600 flight
hours, whichever occurs first, until the modification specified in
paragraph (m) of this AD has been done.

(l) New Corrective Action for Model A320-212 Airplanes

    For Model A320-212 airplanes: If any cracking is found during
any inspection required by paragraph (j) or (k) of this AD, before
further flight, do the actions specified in either paragraph (l)(1)
or (l)(2) of this AD.
    (1) Repair the crack in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A320-53-1028, Revision 01,
dated February 12, 2002, except where Airbus Service Bulletin A320-
53-1028, Revision 01, dated February 12, 2002, specifies to contact
the manufacturer, before further flight, repair using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or European Aviation Safety Agency
(EASA), or its delegated agent, or the design approval holder (DAH)
with EASA's design organization approval, as applicable. For a
repair method to be approved, the repair approval must specifically
refer to this AD. After the cracking is repaired, repeat the
inspections required by paragraph (k) of this AD.
    (2) Do the modification specified in paragraph (m) of this AD.

(m) New Terminating Modification for All Airplanes

    For all airplanes: Before the accumulation of 40,000 flight
cycles since first flight, or within 1,500 flight cycles after the
effective date of this AD, whichever occurs later, but not exceeding
48,000 flight cycles since first flight, modify by doing rotating
probe inspections for cracking of certain fastener holes, replacing
transition angles if any cracking is found in the transition angles,
repairing if any pick-up angles cracking is found, and installing
washers between the transition pick-up angle and the pin nuts; in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A320-53-1027, Revision 03, dated February 12, 2002, except
where Airbus Service Bulletin A320-53-1027, Revision 03, dated
February 12, 2001, specifies to contact Airbus, before further
flight, repair using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA, or
its delegated agent; or the DAH with EASA's design organization
approval, as applicable. For a repair method to be approved, the
repair approval must specifically refer to this AD. Accomplishment
of this modification terminates the repetitive inspections required
by paragraphs (h) and (k) of this AD.

(n) Terminating Modification

    For airplanes on which Airbus Modification 21202 has been
embodied in production: No actions are required by this AD.

(o) Credit for Previous Actions

    (1) This paragraph provides credit for the actions required by
paragraph (j) of this AD, if those actions were performed before the
effective date of this AD using Airbus Service Bulletin A320-53-
1028, dated March 1, 1994.
    (2) This paragraph provides credit for the action specified in
paragraph (m) of this AD, if that action was performed before the
effective date of this AD using Airbus Service Bulletin A320-53-
1027, dated March 1, 1994; Revision 1, dated September 5, 1994; or
Revision 2, dated June 8, 1995.

(p) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD. AMOCs
approved previously in accordance with AD 2004-03-19, Amendment 39-
13463 (69 FR 5922, February 9, 2004), are approved as AMOCs for the
corresponding provisions of this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer, use these actions if they
are FAA approved. Corrective actions are considered FAA-approved if
they were approved by the State of Design Authority (or its
delegated agent, or the DAH with a State of Design Authority's
design organization approval, as applicable). You are required to
ensure the product is airworthy before it is returned to service.

(q) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2013-0137, dated July 9, 2013,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2014-0291.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on May 15, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-12613 Filed 5-29-14; 8:45 am]
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[Federal Register: August 29, 2008 (Volume 73, Number 169)]
[Notices]
[Page 50958]
[DOCID:fr29au08-67]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. RP08-426-000; RP08-426-001]

El Paso Natural Gas Company; Notice of Technical Conference

August 22, 2008.
    On June 30, 2008, El Paso Natural Gas Company (El Paso) filed
revised tariff sheets pursuant to section 4 of the Natural Gas Act and
Part 154 of the Commission's regulations. In its filing, El Paso
proposes a number of new services, a rate increase for existing
services, and changes in certain terms and conditions of service. On
August 5, 2008, the Commission issued an order \1\ accepting and
suspending the tariff sheets, subject to refund and conditions,
establishing hearing procedures, and establishing a technical
conference. In that order, the Commission directed the Staff to convene
a technical conference to address the proposed services and terms and
conditions reflected in El Paso's filing.
---------------------------------------------------------------------------

    \1\ 124 FERC ] 61,124 (2008).
---------------------------------------------------------------------------

    Take notice that a technical conference to discuss issues raised by
El Paso's filing will be held on Thursday, September 11, 2008 at 9 a.m.
(EST) and Friday, September 12, 2008 at 9 a.m. (EST), in a room to be
designated at the offices of the Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. If necessary, the
conference will continue on Tuesday, October 21, 2008 at 9 a.m. (EST)
and Wednesday, October 22, 2008 at 9 a.m. (EST).
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    All parties and staff are permitted to attend. For further
information please contact April Ballou at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. E8-20046 Filed 8-28-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46066-46068]
[FR Doc No: 2017-21175]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5670]

Abbreviated New Drug Applications Submissions--Amendments To
Abbreviated New Drug Applications Under the Generic Drug User Fee Act;
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 guidance for industry entitled ``ANDA
Submissions--Amendments to Abbreviated New Drug Applications Under
GDUFA.'' This draft guidance is intended to explain to applicants how

the review goals established as part of the Generic Drug User Fee
Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to
abbreviated new drug applications (ANDAs) and prior approval
supplements (PASs) to FDA under the Federal Food, Drug, and Cosmetic
Act (FD&C Act). This draft guidance describes amendment classifications
and categories and explains how amendment submissions may affect an
application's review goal dates. The draft guidance also describes how
FDA will review amendments submitted to ANDAs and PASs received prior
to October 1, 2017, the effective date to implement the GDUFA II review
goals.

DATES: Submit either electronic or written comments on the draft
guidance by December 4, 2017 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-2017-D-5670 for ``ANDA Submissions--Amendments to Abbreviated New
Drug Applications Under GDUFA.'' 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: 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 Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002,
240-402-7930<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``ANDA Submissions--Amendments to Abbreviated New Drug
Applications Under GDUFA.'' This guidance is intended to assist
applicants preparing to submit amendments to ANDAs or PASs to FDA under
section 505(j) of the FD&C Act (21 U.S.C. 355(j)) by explaining how the
review goals established as part of GDUFA II apply to these
submissions. In accordance with the ``GDUFA Reauthorization Performance
Goals and Program Enhancements Fiscal Years 2018-2022'' (GDUFA II
Commitment Letter, available at: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf), FDA agreed to
certain review goals and procedures for the review of amendments
pending as of or received on or after the GDUFA II effective date.
    The GDUFA II Commitment Letter reflects significant changes in the
classification of and review goals for amendments to ANDAs and PASs
under the Generic Drug User Fee Amendments of 2012 (GDUFA I). Under
GDUFA I, amendments were classified into a complex tier system based on
the following factors:
     Whether the amendment was solicited (submitted in response
to a complete response letter) or unsolicited (submitted on the
applicant's own initiative).
     Whether the amendment was major or minor.
     The number of amendments submitted to the ANDA or PAS.
     Whether an inspection was necessary to support the
information contained in the amendment.
    GDUFA II simplified the amendment review goals and no longer
subjects them to a tier system; however, review

goals are still dependent on several factors. In general, under GDUFA
II, amendments will be designated as either standard or priority, will
be classified as major or minor, and will receive a goal date based on
the factors discussed in the draft guidance, including whether a
preapproval inspection is needed. When finalized, this draft guidance
will replace the December 2001 guidance for industry ``Major, Minor,
and Telephone Amendments to Abbreviated New Drug Applications.'' This
draft guidance supersedes the July 2014 draft guidance for industry
``ANDA Submissions--Amendments and Easily Correctable Deficiencies
Under GDUFA.''
    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 ``ANDA
Submissions--Amendments to Abbreviated New Drug Applications Under
GDUFA.'' 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 314.96 have been approved under
OMB control number 0910-0001.

III. Electronic Access

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

    Dated: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21175 Filed 10-2-17; 8:45 am]
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[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Pages 52771-52778]
[FR Doc No: 2014-21071]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-9635; 34-72948/August 29, 2014]

Order Making Fiscal Year 2015 Annual Adjustments to Registration
Fee Rates

I. Background

    The Commission collects fees under various provisions of the
securities laws. Section 6(b) of the Securities Act of 1933
(``Securities Act'') requires the Commission to collect fees from
issuers on the registration of securities.\1\ Section 13(e) of the
Securities Exchange Act of 1934 (``Exchange Act'') requires the
Commission to collect fees on specified repurchases of securities.\2\
Section 14(g) of the Exchange Act requires the Commission to collect
fees on proxy solicitations and statements in corporate control
transactions.\3\ These provisions require the Commission to make annual
adjustments to the fee rates applicable under these provisions.
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    \1\ 15 U.S.C. 77f(b).
    \2\ 15 U.S.C. 78m(e).
    \3\ 15 U.S.C. 78n(g).
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II. Fiscal Year 2015 Annual Adjustment to Fee Rates

    Section 6(b)(2) of the Securities Act requires the Commission to
make an annual adjustment to the fee rate applicable under Section
6(b).\4\ The annual adjustment to the fee rate under Section 6(b) of
the Securities Act also sets the annual adjustment to the fee rates
under Sections 13(e) and 14(g) of the Exchange Act.\5\
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    \4\ 15 U.S.C. 77f(b)(2). The annual adjustments are designed to
adjust the fee rate in a given fiscal year so that, when applied to
the aggregate maximum offering price at which securities are
proposed to be offered for the fiscal year, it is reasonably likely
to produce total fee collections under Section 6(b) equal to the
``target fee collection amount'' specified in Section 6(b)(6)(A) for
that fiscal year.
    \5\ 15 U.S.C. 78m(e)(4) and 15 U.S.C. 78n(g)(4).
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    Section 6(b)(2) sets forth the method for determining the annual
adjustment to the fee rate under Section 6(b) for fiscal year 2015.
Specifically, the Commission must adjust the fee rate under Section
6(b) to a ``rate that, when applied to the baseline estimate of the
aggregate maximum offering prices for [fiscal year 2015], is reasonably
likely to produce aggregate fee collections under [Section 6(b)] that
are equal to the target fee collection amount for [fiscal year 2015].''
That is, the adjusted rate is determined by dividing the ``target fee
collection amount'' for fiscal year 2015 by the ``baseline estimate of
the aggregate maximum offering prices'' for fiscal year 2015.
    Section 6(b)(6)(A) specifies that the ``target fee collection
amount'' for fiscal year 2015 is $515,000,000. Section 6(b)(6)(B)
defines the ``baseline estimate of the aggregate maximum offering
price'' for fiscal year 2015 as ``the baseline estimate of the
aggregate maximum offering price at which securities are proposed to be
offered pursuant to registration statements filed with the Commission
during [fiscal year 2015] as determined by the Commission, after
consultation with the Congressional Budget Office and the Office of
Management and Budget. . . .''

    To make the baseline estimate of the aggregate maximum offering
price for fiscal year 2015, the Commission used a methodology similar
to that developed in consultation with the Congressional Budget Office
(``CBO'') and Office of Management and Budget (``OMB'') to project the
aggregate offering price for purposes of the fiscal years 2011 through
2014 annual adjustments.\6\ Using this methodology, the Commission
determines the ``baseline estimate of the aggregate maximum offering
price'' for fiscal year 2015 to be $4,433,900,707,058.\7\ Based on this
estimate, the Commission calculates the fee rate for fiscal 2015 to be
$116.20 per million. This adjusted fee rate applies to Section 6(b) of
the Securities Act, as well as to Sections 13(e) and 14(g) of the
Exchange Act.
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    \6\ For the fiscal year 2011 estimate, the Commission used a
ten-year series of monthly observations ending in March 2011. For
fiscal years 2012-2015, the Commission used a ten-year series ending
in July of the applicable year.
    \7\ Appendix A explains how we determined the ``baseline
estimate of the aggregate maximum offering price'' for fiscal year
2015 using our methodology, and then shows the arithmetical process
of calculating the fiscal year 2015 annual adjustment based on that
estimate. The appendix includes the data used by the Commission in
making its ``baseline estimate of the aggregate maximum offering
price'' for fiscal year 2015.
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III. Effective Dates of the Annual Adjustments

    The fiscal year 2015 annual adjustments to the fee rates applicable
under Section 6(b) of the Securities Act and Sections 13(e) and 14(g)
of the Exchange Act will be effective on October 1, 2014.\8\
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    \8\ 15 U.S.C. 77f(b)(4), 15 U.S.C. 78m(e)(6) and 15 U.S.C.
78n(g)(6).
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IV. Conclusion

    Accordingly, pursuant to Section 6(b) of the Securities Act and
Sections 13(e) and 14(g) of the Exchange Act,\9\
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    \9\ 15 U.S.C. 77f(b), 78m(e) and 78n(g).
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    It is hereby ordered that the fee rates applicable under Section
6(b) of the Securities Act and Sections 13(e) and 14(g) of the Exchange
Act shall be $116.20 per million effective on October 1, 2014.

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.

Appendix A

    Congress has established a target amount of monies to be
collected from fees charged to issuers based on the value of their
registrations. This appendix provides the formula for determining
such fees, which the Commission adjusts annually. Congress has
mandated that the Commission determine these fees based on the
``aggregate maximum offering prices,'' which measures the aggregate
dollar amount of securities registered with the Commission over the
course of the year. In order to maximize the likelihood that the
amount of monies targeted by Congress will be collected, the fee
rate must be set to reflect projected aggregate maximum offering
prices. As a percentage, the fee rate equals the ratio of the target
amounts of monies to the projected aggregate maximum offering
prices.
    For 2015, the Commission has estimated the aggregate maximum
offering prices by projecting forward the trend established in the
previous decade. More specifically, an ARIMA model was used to
forecast the value of the aggregate maximum offering prices for
months subsequent to July 2014, the last month for which the
Commission has data on the aggregate maximum offering prices.
    The following sections describe this process in detail.

A. Baseline Estimate of the Aggregate Maximum Offering Prices for
Fiscal Year 2015.

    First, calculate the aggregate maximum offering prices (AMOP)
for each month in the sample (July 2004-July 2014). Next, calculate
the percentage change in the AMOP from month to month.
    Model the monthly percentage change in AMOP as a first order
moving average process. The moving average approach allows one to
model the effect that an exceptionally high (or low) observation of
AMOP tends to be followed by a more ``typical'' value of AMOP.
    Use the estimated moving average model to forecast the monthly
percent change in AMOP. These percent changes can then be applied to
obtain forecasts of the total dollar value of registrations. The
following is a more formal (mathematical) description of the
procedure:
    1. Begin with the monthly data for AMOP. The sample spans ten
years, from July 2004 to July 2014.
    2. Divide each month's AMOP (column C) by the number of trading
days in that month (column B) to obtain the average daily AMOP
(AAMOP, column D).
    3. For each month t, the natural logarithm of AAMOP is reported
in column E.
    4. Calculate the change in log(AAMOP) from the previous month as
[Delta]t = log (AAMOPt)-
log(AAMOPt-1). This approximates the percentage change.
    5. Estimate the first order moving average model
[Delta]t = [alpha] + [beta]et-1 +
et, where et denotes the forecast error for
month t. The forecast error is simply the difference between the
one-month ahead forecast and the actual realization of
[Delta]t. The forecast error is expressed as
et = [Delta]t-[alpha]-[beta]et-1.
The model can be estimated using standard commercially available
software. Using least squares, the estimated parameter values are
[alpha] = 0.0005277 and [beta] = -0.89215.
    6. For the month of August 2014 forecast
[Delta]t = 8/12 = [alpha] + [beta]e t = 7/12.
For all subsequent months, forecast [Delta]t = [alpha].
    7. Calculate forecasts of log(AAMOP). For example, the forecast
of log(AAMOP) for October 2014 is given by FLAAMOP
t = 10/12 = log(AAMOP t = 7/12) + [Delta]
t = 8/12 + [Delta] t = 9/12 + [Delta]
t = 10/12.
    8. Under the assumption that et is normally
distributed, the n-step ahead forecast of AAMOP is given by
exp(FLAAMOPt + [sigma]n\2\/2), where
[sigma]n denotes the standard error of the n-step ahead
forecast.
    9. For October 2014, this gives a forecast AAMOP of $17.470
billion (Column I), and a forecast AMOP of $401.8 billion (Column
J).
    10. Iterate this process through September 2015 to obtain a
baseline estimate of the aggregate maximum offering prices for
fiscal year 2015 of $4,433,900,707,058.

B. Using the Forecasts From A To Calculate the New Fee Rate.

    1. Using the data from Table A, estimate the aggregate maximum
offering prices between 10/01/14 and 9/30/15 to be
$4,433,900,707,058.
    2. The rate necessary to collect the target $515,000,000 in fee
revenues set by Congress is then calculated as: $515,000,000 /
$4,433,900,707,058 = 0.00011615.
    3. Round the result to the seventh decimal point, yielding a
rate of 0.0001162 (or $116.20 per million).

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BILLING CODE 8011-01-P
[FR Doc. 2014-21071 Filed 9-3-14; 8:45 am]
BILLING CODE 8011-01-C