[Federal Register Volume 80, Number 7 (Monday, January 12, 2015)]
[Notices]
[Pages 1580-1581]
[FR Doc No: 2015-00251]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Passenger Facility Charge (PFC) Approvals and
Disapprovals

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Monthly Notice of PFC Approvals and Disapprovals. In December
2014, there were six applications approved. This notice also includes
information on one application, approved in October 2014, inadvertently
left off the October 2014 notice. Additionally, 17 approved amendments
to previously approved applications are listed.

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SUMMARY: The FAA publishes a monthly notice, as appropriate, of PFC
approvals and disapprovals under the provisions of the Aviation Safety
and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget
Reconciliation Act of 1990) (Pub. L. 101-508) and Part 158 of the
Federal Aviation Regulations (14 CFR part 158). This notice is
published pursuant to paragraph d of Sec.  158.29.

PFC Applications Approved

    Public Agency: City of Bangor, Maine.
    Application Number: 14-04-C-00-BGR.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $3,000,000.
    Earliest Charge Effective Date: June 1, 2015.
    Estimated Charge Expiration Date: May 1, 2018.
    Class of Air Carriers Not Required To Collect PFC's: On demand air
taxi commercial operators.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at Bangor International Airport.
    Brief Description of Projects Approved for Collection and Use:
    Terminal building renovations, phase 2.
    PFC application costs.
    Decision Date: October 29, 2014.

FOR FURTHER INFORMATION CONTACT: Priscilla Scott, New England Regional
Airports Division,<PHONE_NUMBER>.

    Public Agency: Louisville Regional Airport Authority, Louisville,
Kentucky.
    Application Number: 14-19-C-00-SDF.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $2,150,000.
    Earliest Charge Effective Date: January 1, 2016.
    Estimated Charge Expiration Date: May 1, 2016.
    Class of Air Carriers Not Required To Collect PFC's: Air taxi/
commercial operators filing FAA Form 1800-31 and operating at
Louisville International Airport (SDF).
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at SDF.
    Brief Description of Project Approved for Collection and Use:
Runway safety area 11-29.
    Decision Date: December 3, 2014.

FOR FURTHER INFORMATION CONTACT: Tommy DuPree, Memphis Airports
District Office,<PHONE_NUMBER>.

    Public Agency: Tri-Cities Airport Authority, Blountville,
Tennessee.
    Application Number: 15-06-C-00-TRI.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $1,866,027.
    Earliest Charge Effective Date: March 1, 2015.
    Estimated Charge Expiration Date: May 1, 2017.
    Class of Air Carriers Not Required To Collect PFC's: Air taxi/
commercial operators filing FAA Form 1800-31 and operating at Tri-
Cities Regional Airport (TRI).
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at TRI.
    Brief Description of Projects Approved for Collection and Use:
    Terminal road, phase 1.
    Access control/EOC.
    Terminal frontage improvements, phase 2.
    Passenger loading bridge--gate 6.
    Baggage claim system replacement.
    PFC consultant/development costs.
    Perimeter security fence.
    PFC administrative costs.
    Decision Date: December 3, 2014.

FOR FURTHER INFORMATION CONTACT: Cynthia Wills, Memphis Airports
District Office,<PHONE_NUMBER>.
    Public Agency: Evansville--Vanderburgh Airport Authority,
Evansville, Indiana.
    Application Number: 15-03-C-00-EVV.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $2,431,208.
    Earliest Charge Effective Date: May 1, 2015.
    Estimated Charge Expiration Date: November 1, 2018.
    Class of Air Carriers Not Required To Collect PFC's: Nonscheduled/
on-demand operators filing FAA Form 1800-31 and operating at Evansville
Regional Airport (EVV).
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at EVV.
    Brief Description of Project Approved for Collection and Use:
Passenger boarding bridges purchase and installation.
    Decision Date: December 5, 2014.

FOR FURTHER INFORMATION CONTACT: Michael Brown, Chicago Airports
District Office,<PHONE_NUMBER>.

    Public Agency: Massachusetts Port Authority, Boston Massachusetts.
    Application Number: 14-09-C-00-BOS.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $96,941,002.
    Earliest Charge Effective Date: May 1, 2023.
    Estimated Charge Expiration Date: October 1, 2024.
    Class of Air Carriers Not Required To Collect PFC'S: Non-scheduled/
on-demand air carriers.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at Boston Logan International Airport.
    Brief Description of Projects Approved for Collection and Use at a
$4.50 PFC Level:
    Rehabilitate runway 15R/33L.
    Rehabilitation of north Alpha and north Bravo taxiways.
    Runway 22R safety area improvements and replacement of 22R
engineered materials arresting system bed.
    Checked baggage inspection systems enhancements.
    Mitigation sound insulation program.
    Decision Date: December 10, 2014.

FOR FURTHER INFORMATION CONTACT: Priscilla Scott, New England Regional
Airports Division,<PHONE_NUMBER>.

    Public Agency: County of Pitkin, Aspen, Colorado.
    Application Number: 15-09-C-00-ASE.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved in this Decision: $3,155,000.
    Earliest Charge Effective Date: February 1, 2016.
    Estimated Charge Expiration Date: September 1, 2020.
    Class of Air Carriers Not Required To Collect PFC'S: None.
    Brief Description of Projects Approved for Collection and Use:
    Conduct environmental assessment (airfield geometry/
reconfiguration).
    Conduct environmental assessment (terminal area and east side
improvements).
    Acquire snow removal equipment (blower, plow, and broom).
    PFC administration fees.
    Decision Date: December 17, 2014.

FOR FURTHER INFORMATION CONTACT: Jesse Lyman, Denver Airports District
Office,<PHONE_NUMBER>.

    Public Agency: Shreveport Airport Authority, Shreveport, Louisiana.
    Application Number: 15-03-C-00-SHV.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved In This Decision: $6,248,208.
    Earliest Charge Effective Date: February 1, 2015.
    Estimated Charge Expiration Date: February 1, 2020.
    Class of Air Carriers Not Required To Collect PFC'S: On-demand air
taxi/commercial operations.
    Determination: Approved. Based on information contained in the
public agency's application, the FAA has determined that the approved
class accounts for less than 1 percent of the total annual enplanements
at Shreveport Regional Airport.
    Brief Description of Project Approved for Collection and Use:
Terminal renovations, phase 2.
    Decision Date: December 19, 2014.

FOR FURTHER INFORMATION CONTACT: Andy Velayos, Louisiana/New Mexico
Airports Development Office,<PHONE_NUMBER>.

    Amendments to PFC Approvals:

----------------------------------------------------------------------------------------------------------------
                                                                                Original         Amended
                                     Amendment       Original         Amended        estimated       estimated
   Amendment No.  city, state     approved  date   approved  net   approved  net   charge  exp.    charge  exp.
                                                   PFC  revenue    PFC  revenue        date            date
----------------------------------------------------------------------------------------------------------------
11-11-C-02-RNO, Reno, NV........        11/28/14     $33,933,876     $31,735,100        07/01/18        07/01/15
07-09-C-01-ATL, Atlanta, GA.....        12/17/14      38,058,462      30,722,380        01/01/20        01/01/20
05-05-C-08-EWR, Newark, NJ......        12/18/14     566,136,035     561,101,209        09/01/11        09/01/11
05-05-C-08-JFK, New York, NY....        12/18/14     646,919,140     641,165,883        07/01/11        07/01/11
05-05-C-08-LGA, New York, NY....        12/18/14     422,230,884     418,475,852        07/01/11        07/01/11
09-06-U-03-EWR, Newark, NJ......        12/18/14              NA              NA        09/01/11        09/01/11
09-06-U-03-JFK, New York, NY....        12/18/14              NA              NA        07/01/11        07/01/11
09-06-U-03-LGA, New York, NY....        12/18/14              NA              NA        07/01/11        07/01/11
10-07-C-01-EWR, Newark, NJ......        12/18/14     191,631,217     190,025,386        08/01/14        08/01/14
10-07-C-01-JFK, New York, NY....        12/18/14     255,794,990     253,651,480        06/01/14        06/01/14
10-07-C-01-LGA, New York, NY....        12/18/14     121,561,393     120,542,733        06/01/14        06/01/14
10-04-C-01-SWF, Newburgh, NY....        12/18/14       4,415,202       4,378,203        02/01/14        02/01/14
12-08-C-01-EWR, Newark, NJ......        12/18/14     121,393,042     121,393,042        10/01/17        10/01/17
12-08-C-01-JFK, New York, NY....        12/18/14     296,109,860     296,109,860        09/01/17        11/01/17
12-08-C-01-LGA, New York, NY....        12/18/14     150,655,394     150,655,394        09/01/17        11/01/17
12-05-C-01-SWF, Newburgh, NY....        12/18/14       3,372,027       3,372,027        02/01/18        02/01/18
11-11-C-01-CLE, Cleveland, OH...        12/19/14      36,577,300      72,641,519        02/01/21        09/01/23
----------------------------------------------------------------------------------------------------------------

    Issued in Washington, DC, on December 31, 2014.
Joe Hebert,
Manager, Financial Analysis and Passenger Facility Charge Branch.
[FR Doc. 2015-00251 Filed 1-9-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 137 (Wednesday, July 17, 2013)]
[Notices]
[Pages 42775-42776]
[FR Doc No: 2013-16926]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-00536; FRL-9391-8]

CGI Federal, Inc., and Custom Applications Management; Transfer
of Data

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces that pesticide related information
submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA), including information
that may have been claimed as Confidential Business Information (CBI)
by the submitter, will be transferred to CGI Federal, Inc., and its
subcontractor, Custom Applications Management, in accordance with the
CBI regulations. CGI Federal, Inc., and its subcontractor, Custom
Applications Management, have been awarded a contract to perform work
for OPP, and access to this information will enable CGI Federal, Inc.,
and its subcontractor, Custom Applications Management, to fulfill the
obligations of the contract.

DATES: CGI Federal, Inc., and its subcontractor, Custom Applications
Management, will be given access to this information on or before July
22, 2013.

FOR FURTHER INFORMATION CONTACT: Mario Steadman, Information Technology
and Resources Management Division (7502P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action applies to the public in general. As such, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, Custom Applications Management,
identified by docket identification (ID) number EPA-HQ-OPP-2013-00536
is available at http://www.regulations.gov or at the Office of
Pesticide Programs Regulatory Public Docket (OPP Docket) in the
Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg.,
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. Contractor Requirements

    Under Contract No. GS-35F-4797H, CGI Federal, Inc., and its
subcontractor, Custom Applications Management will perform. The
Contractor will develop applications, Web sites, Web pages, web-based
applications and databases, in accordance with EPA policies and related
Federal standards and procedures. The Contractor will provide

search engine enhancements and support. The Contractor shall manage the
full life-cycle of application and web projects efficiently and cost
effectively. The contractor shall provide requirement analysis, design,
development, testing, documentation, and implementation as defined. The
Contractor shall provide graphic and media support to those customers
who require it. The Contractor shall also provide graphic and media
support for the EPA Web Workgroup conferences.
    OPP has determined that access by CGI Federal, Inc., and its
subcontractor, Custom Applications Management, to information on all
pesticide chemicals is necessary for the performance of this contract.
    Some of this information may be entitled to confidential treatment.
The information has been submitted to EPA under FIFRA sections 3, 4, 6,
and 7 and under FFDCA sections 408 and 409.
    In accordance with the requirements of 40 CFR 2.307(h)(2), the
contract with CGI Federal, Inc., and its subcontractor, Custom
Applications Management, prohibits use of the information for any
purpose not specified in the contract; prohibits disclosure of the
information to a third party without prior written approval from the
Agency; and requires that each official and employee of the contractor
sign an agreement to protect the information from unauthorized release
and to handle it in accordance with the FIFRA Information Security
Manual. In addition, CGI Federal, Inc., and its subcontractor, Custom
Applications Management, are required to submit for EPA approval a
security plan under which any CBI will be secured and protected against
unauthorized release or compromise. No information will be provided to
CGI Federal, Inc., and its subcontractor, Custom Applications
Management, until the requirements in this document have been fully
satisfied. Records of information provided to CGI Federal, Inc., and
its subcontractor, Custom Applications Management, will be maintained
by EPA Project Officers for this contract. All information supplied to
CGI Federal, Inc., and its subcontractor, Custom Applications
Management, by EPA for use in connection with this contract will be
returned to EPA when CGI Federal, Inc., and its subcontractor, Custom
Applications Management, have completed their work.

List of Subjects

    Environmental protection, Business and industry, Government
contracts, Government property, Security measures.

    Dated: June 26, 2013.
Oscar Morales,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2013-16926 Filed 7-16-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 4, 2007 (Volume 72, Number 64)]
[Notices]
[Page 16343]
[DOCID:fr04ap07-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AC07-81-000]

Trans-Union Interstate Pipeline, L.P.; Notice of Filing

March 29, 2007.
    Take notice that on March 23, 2007, Trans-Union Interstate
Pipeline, L.P., submitted a request for a waiver of its requirement to
submit a 2006 FERC Form No. 2-A. The FERC Form No. 2-A is required
under section 260.2 of the Commission's regulations.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 or 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

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

TTY, call<PHONE_NUMBER>.
    Comment Date: April 19, 2007.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6202 Filed 4-3-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Rules and Regulations]
[Pages 55414-55415]
[FR Doc No: 2012-22194]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, and 556

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Enrofloxacin; Tylvalosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during July 2012. FDA is also informing the public of the
availability of summaries of the basis of approval and of environmental
review documents, where applicable.

DATES: This rule is effective September 10, 2012.

FOR FURTHER INFORMATION CONTACT:  George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect original and supplemental approval actions during July 2012,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday. Persons with access to the Internet may
obtain these documents at the Center for Veterinary Medicine FOIA
Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.

                                      Table 1--Original and Supplemental NADAs and ANADAs Approved During July 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               New animal drug
       NADA/ANADA              Sponsor          product name              Action            21 CFR section        FOIA summary           NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-336................  ECO LLC, 8209       AIVLOSIN            Original approval for             520.2645  yes..................  CE \1\
                          Hollister Ave.,     (tylvalosin         control of porcine                556.748
                          Las Vegas, NV       tartrate) Water     proliferative
                          89131.              Soluble Granules.   enteropathy (PPE)
                                                                  associated with
                                                                  Lawsonia
                                                                  intracellularis
                                                                  infection in groups of
                                                                  swine in buildings
                                                                  experiencing an
                                                                  outbreak of PPE.
141-068................  Bayer HealthCare    BAYTRIL 100         Supplement adding                  522.812  yes..................  CE \1\
                          LLC, Animal         (enrofloxacin)      control of bovine
                          Health Division,    Injectable          respiratory disease
                          P.O. Box 390,       Solution.           (BRD) in beef and non-
                          Shawnee Mission,                        lactating dairy cattle
                          KS 66201.                               at high risk of
                                                                  developing BRD
                                                                  associated with
                                                                  Mannheimia
                                                                  haemolytica,
                                                                  Pasteurella multocida,
                                                                  Histophilus somni and
                                                                  Mycoplasma bovis; and
                                                                  revising a food safety
                                                                  warning statement.

200-482................  Cross VetPharm      AMPROMED for        Original approval as a             520.100  yes..................  CE \1\
                          Group, Ltd.,        Calves              generic copy of NADA
                          Broomhill Rd.,      (amprolium) 9.6%    13-149.
                          Tallaght, Dublin    Oral Solution.
                          24, Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the
  human environment.

    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Parts 520 and 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520,
522, and 556 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

0
2. In Sec.  520.100, revise paragraph (b)(4) to read as follows:

Sec.  520.100  Amprolium.

* * * * *
    (b) * * *
    (4) No. 061623 for use of product described in paragraph (a)(1) of
this section as in paragraph (d)(2); and for use of product described
in paragraph (a)(2) of this section as in paragraphs (d)(1) and (d)(2)
of this section.
* * * * *

0
3. Add Sec.  520.2645 to read as follows:

Sec.  520.2645  Tylvalosin.

    (a) Specifications. Granules containing 62.5 percent tylvalosin (w/
w) as tylvalosin tartrate.
    (b) Sponsor. See No. 066916 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.748 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer 50 parts per
million tylvalosin in drinking water for 5 consecutive days.
    (2) Indications for use. For the control of porcine proliferative
enteropathy (PPE) associated with Lawsonia intracellularis infection in
groups of swine in buildings experiencing an outbreak of PPE.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
4. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

0
5. In 522.812, revise paragraphs (e)(2)(i), (e)(2)(ii)(A), and
(e)(2)(iii) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (e) * * *
    (2) * * *
    (i) Amount--(A) Single-dose therapy: For treatment of bovine
respiratory disease (BRD), administer 7.5 to 12.5 mg/kg of body weight
(3.4 to 5.7 mL per 100 pounds (/100 lb)) once by subcutaneous
injection. For control of BRD, administer 7.5 mg/kg of body weight (3.4
mL/100 lb) once by subcutaneous injection.
    (B) Multiple-day therapy: For treatment of BRD, administer 2.5 to
5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous
injection. Treatment should be repeated at 24-hour intervals for 3
days. Additional treatments may be given on days 4 and 5 to animals
that have shown clinical improvement but not total recovery.
    (ii) Indications for use--(A) Single-dose therapy: For the
treatment of BRD associated with Mannheimia haemolytica, Pasteurella
multocida, Histophilus somni, and Mycoplasma bovis in beef and non-
lactating dairy cattle; for the control of BRD in beef and non-
lactating dairy cattle at high risk of developing BRD associated with
M. haemolytica, P. multocida, H. somni and M. bovis.
* * * * *
    (iii) Limitations. Animals intended for human consumption must not
be slaughtered within 28 days from the last treatment. This product is
not approved for female dairy cattle 20 months of age or older,
including dry dairy cows. Use in these cattle may cause drug residues
in milk and/or in calves born to these cows. A withdrawal period has
not been established for this product in preruminating calves. Do not
use in calves to be processed for veal.
* * * * *

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
6. The authority citation for 21 CFR part 556 continues to read as
follows:

    Authority:  21 U.S.C. 342, 360b, 371.

0
7. Add Sec.  556.748 to read as follows:

Sec.  556.748  Tylvalosin.

    (a) Acceptable Daily Intake (ADI). The ADI for total residues of
tylvalosin is 47.7 micrograms per kilogram of body weight per day.
    (b) Tolerances. A tolerance for tylvalosin in edible tissues of
swine is not required.
    (c) Related conditions of use. See Sec.  520.2645 of this chapter.

    Dated: September 5, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-22194 Filed 9-7-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Notices]
[Page 43671]
[FR Doc No: 2018-18469]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC18-78-000.
    Applicants: Florida Power & Light Company.
    Description: Second Supplement to July 5, 2018 Response to June 5,
2018 Deficiency Letter of Florida Power & Light Company.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5084.
    Comments Due: 5 p.m. ET 9/11/18.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER18-1286-001.
    Applicants: FirstEnergy Solutions Corp.
    Description: Compliance filing: Notice of Transaction Closing and
Effective Date of Rate Schedule FERC No. 1 to be effective 7/31/2018.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5050.
    Comments Due: 5 p.m. ET 9/11/18.

    Docket Numbers: ER18-2264-000.
    Applicants: Macquarie Energy Trading LLC.
    Description: Baseline eTariff Filing: MBR Application to be
effective 10/21/2018.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5042.
    Comments Due: 5 p.m. ET 9/11/18.

    Docket Numbers: ER18-2265-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to First Revised
ISA No. 3255; Queue No. W4-073 to be effective 11/2/2016.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5043.
    Comments Due: 5 p.m. ET 9/11/18.

    Docket Numbers: ER18-2266-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1910R12 Southwestern Public
Service Company to be effective 8/1/2018.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5046.
    Comments Due: 5 p.m. ET 9/11/18.

    Docket Numbers: ER18-2267-000.
    Applicants: Entergy Texas, Inc.
    Description: Tariff Cancellation: ETI-Kirbyville Wholesale
Distribution Service Agreement to be effective 7/11/2018.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5047.
    Comments Due: 5 p.m. ET 9/11/18.

    Docket Numbers: ER18-2268-000.
    Applicants: Entergy Services, Inc.
    Description: Tariff Cancellation: Kirbyville-EES Local Balancing
Authority Agreement to be effective 7/11/2018.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5048.
    Comments Due: 5 p.m. ET 9/11/18.

    Docket Numbers: ER18-2269-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of ISA/SA
No. 4606; Queue No. AA1-046 to be effective 8/20/2018.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5064.
    Comments Due: 5 p.m. ET 9/11/18.

    Docket Numbers: ER18-2270-000.
    Applicants: Paulding Wind Farm III LLC.
    Description: Baseline eTariff Filing: Reactive Power Compensation
Filing to be effective 10/20/2018.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5069.
    Comments Due: 5 p.m. ET 9/11/18.

    Docket Numbers: ER18-2271-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2018-08-21_SA 3158 ATC-
Plymouth Project Commitment Agreement to be effective 10/21/2018.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5077.
    Comments Due: 5 p.m. ET 9/11/18.

    Docket Numbers: ER18-2272-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2018-08-21_SA 3144 Entergy
Texas-Liberty County-Entergy Texas MPFCA (J472 J483) to be effective 8/
7/2018.
    Filed Date: 8/21/18.
    Accession Number: 20180821-5093.
    Comments Due: 5 p.m. ET 9/11/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 21, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-18469 Filed 8-24-18; 8:45 am]
 BILLING CODE 6717-01-P


                                 Appendix G:
         Burden and Cost for Geologic Sequestration of Carbon Dioxide
                                 (Subpart RR)

Burden and Cost Estimate for Geologic Sequestration of Carbon Dioxide (Subpart RR)

The objective of this appendix is to summarize estimated burden and cost estimates for subpart RR of the Greenhouse Gas Reporting Program (GHGRP). More detail on the methodology, assumptions, and estimated costs, including costs for potential alternative cost scenarios, are presented in the docket.
Subpart RR monitoring and reporting costs are estimated here based on two types of potentially reporting facilities:
 Projects permitted under Class II of EPA's Underground Injection Control (UIC) program (for carbon dioxide enhanced oil recovery ("CO2-EOR") wells).
 Projects permitted under Class VI of EPA's UIC Program (assumed to be injecting into deep saline formations for purposes of the analysis).
The geologic and project characteristics of the "representative" facility for both the CO2-EOR case and the deep saline aquifer case are based on a typical CO2-EOR project in the Permian Basin of West Texas, where the majority of ongoing CO2-EOR operations in the U.S. exist.  This "representative" facility is comparable to that used in previous EPA subpart RR analyses.
Table 1 summarizes the subpart RR unit burden and cost estimates for CO2-EOR projects. Similarly, Table 2 summarizes the subpart RR unit burden and cost estimates for deep saline formation projects.
For purposes of this analysis, it was assumed that one deep saline formation project would report under subpart RR.  It was also assumed that 6 CO2-EOR projects would report under subpart RR, with 2 in year 1, 4 in year 2, and 6 in year 3.
Based on these estimated numbers of impacted facilities, estimates for the total burden and costs for subpart RR are presented in Table 3.
In summary, the major changes in the burden and cost estimates relative to previous estimates (i.e., EPA ICR No. 2300.10) are as follows:
 The number of projects assumed to hold Class VI well permits, and therefore which were also assumed to report under subpart RR, was updated.
 Costs were updated to account for more recent experience associated with CO2 storage projects sponsored by the U.S. Department of Energy.
 Additional CO2-EOR projects are assumed to report under subpart RR.

         Table 1. Unit Burden and Cost Estimates for CO2-EOR Projects

  Table 2. Unit Burden and Cost Estimates for Deep Saline Formation Projects

            Table 3. Total Burden and Cost Estimates for Subpart RR


[Federal Register: June 5, 2006 (Volume 71, Number 107)]
[Notices]
[Page 32338]
[DOCID:fr05jn06-47]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application for Surrender of License and Soliciting
Comments, Motions To Intervene, and Protests

May 30, 2006.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Surrender of License.
    b. Project No.: 11351-014.
    c. Date Filed: October 13, 2005.
    d. Applicant: Columbia Power & Water Systems.
    e. Name of Project: Old Columbia Dam Project.
    f. Location: The project is located on the Duck River, in Maury
County, Tennessee.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791-825r.
    h. Applicant Contact: Mr. James O. Clark, General Manager, Columbia
Power & Water Systems, P.O. Box 379, Columbia, TN 38402-0379, Phone:
(931) 388-4833 extension 7601.
    i. FERC Contact: Any questions on this notice should be addressed
to Mrs. Anumzziatta Purchiaroni at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>
    j. Deadline for filing comments and/or motions: June 30, 2006.
    k. Description of Request: The licensee states in the filing that
an economic evaluation was performed, and indicated that the
development of its 400-kW hydroelectric project was not feasible.
Therefore, it is surrendering its license.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. Information about this filing
may also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. You may
also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or e-mail<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. All documents (original and eight copies)
should be filed with: Magalie R. Salas, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. A
copy of any motion to intervene must also be served upon each
representative of the Applicant specified in the particular
application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.

Magalie R. Salas,
Secretary.
[FR Doc. E6-8668 Filed 6-2-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 60980-60981]
[FR Doc No: 2012-24571]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission hereby gives notice that
members of the Commission's staff may attend the following meetings
related to the transmission planning activities of the Mid-Continent
Area Power Pool (MAPP) and Southwest Power Pool (SPP):

MAPP-SPP Order 1000 Stakeholder Meeting--October 4, 2012

    The above-referenced meeting will be held at:

Crowne Plaza Hotel & Suites Minneapolis Airport, Three Appletree
Square, Bloomington, MN 55425.

    The above-referenced meeting is open to the public.

    Further information may be found at www.mapp.org.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:

Docket No. ER09-35-001, Tallgrass Transmission, LLC
Docket No. ER09-36-001, Prairie Wind Transmission, LLC
Docket No. ER09-548-001, ITC Great Plains, LLC
Docket No. ER09-659-002, Southwest Power Pool, Inc.
Docket No. ER11-4105-000, Southwest Power Pool, Inc.
Docket No. EL11-34-001, Midwest Independent Transmission System
Operator, Inc.
Docket No. ER12-1179-000, Southwest Power Pool, Inc.
Docket No. ER12-1401-000, Southwest Power Pool, Inc.
Docket No. ER12-1401-000, Southwest Power Pool, Inc.
Docket No. ER12-1415-000, Southwest Power Pool, Inc.
Docket No. ER12-1460-000, Southwest Power Pool, Inc.
Docket No. ER12-1610-000, Southwest Power Pool, Inc.
Docket No. ER12-1772-000, Southwest Power Pool, Inc.
Docket No. ER12-1779-000, Southwest Power Pool, Inc.
Docket No. ER12-2366-000, Southwest Power Pool, Inc.
Docket No. EL12-2-000, Southwest Power Pool, Inc.
Docket No. EL12-60-000, Southwest Power Pool, Inc., et al.
Docket No. ER12-2387, Southwest Power Pool Inc.

    For more information, contact Luciano Lima, Office of Energy
Markets Regulation, Federal Energy Regulatory Commission at (202) 288-
6738 or<EMAIL_ADDRESS>
    Dated: September 28, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-24571 Filed 10-4-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Rules and Regulations]
[Pages 24007-24010]
[FR Doc No: 2019-10993]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0350; Product Identifier 2019-CE-025-AD; Amendment
39-19634; AD 2019-08-13]
RIN 2120-AA64

Airworthiness Directives; Textron Aviation, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Textron Aviation, Inc. (type certificate previously held by Cessna
Aircraft Company) Models 525, 525A, and 525B airplanes with Tamarack
active load alleviation system (ATLAS) winglets installed in accordance
with Supplemental Type Certificate (STC) SA03842NY. This AD results
from mandatory continuing airworthiness information (MCAI) issued by
the aviation authority of another country to identify and correct an
unsafe condition on an aviation product. The MCAI describes the unsafe
condition as malfunction of the ATLAS. We are issuing this AD to
require actions to address the unsafe condition on these products.

DATES: This AD is effective May 24, 2019.
    We must receive comments on this AD by July 8, 2019.

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 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0350; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (telephone (800)
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Steven Dzierzynski, Aerospace
Engineer, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, New York 11590; telephone:<PHONE_NUMBER>; fax: (516) 794-
5531; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD No.: 2019-0086-E, dated April 19, 2019 (referred to after this as
``the MCAI''), to correct an unsafe condition for Textron Aviation,
Inc. Models 525, 525A, and 525B airplanes with Tamarack ATLAS winglets
installed in accordance with STC SA03842NY. The MCAI states:

    The active load alleviation system (ATLAS), when operational,
deflects the Tamarack active control surfaces (TACS) on the outboard
wings. Recently, occurrences have been reported in which ATLAS
appears to have malfunctioned, causing upset events where, in some
cases, the pilots had difficulty to recover the aeroplane to safe
flight. Investigation continues to determine the cause(s) for the
reported events.
    This condition, if not corrected, could lead to loss of control
of the aeroplane.
    To address this potential unsafe condition, Cranfield Aerospace
Solutions have issued the [service bulletin] SB, providing
instructions to pull and collar the ATLAS circuit breaker, to make
TACS immovable and to amend the applicable AFMS.
    For the reasons described above, this [EASA] AD requires the
Tamarack ATLAS to be deactivated and the TACS to be fixed in place.
This [EASA] AD also requires implementation of operational
limitations and repetitive pre-flight inspections by amending the
applicable AFMS. Finally, this [EASA] AD requires a modification of
the ATLAS, which would provide relief for the deactivation,
limitations and repetitive inspections as required by this AD.

    This [EASA] AD is an interim action and further AD action may
follow.
    The National Transportation Safety Board (NTSB) is investigating a
fatal accident involving a Model 525 airplane with the ATLAS STC
installed. The NTSB investigation focuses on the role the ATLAS may
have played in the accident. In addition to the accident, five
incidents of aircraft uncommanded roll events with the ATLAS activated
have been reported to EASA and the FAA. In each incident, the pilot was
able to recover from the event and land the aircraft safely. You may
examine the MCAI on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2019-0350.

FAA's Determination and Requirements of the 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 this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are issuing this AD because we
evaluated all information provided by the State of Design Authority and
determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.
    EASA has approved a master minimum equipment list (MMEL) for the
ATLAS, which allows operation of the airplane with the system disabled
for up to 10 flight hours with operating limitations. However, the FAA
has not approved an MMEL for the ATLAS. The EASA AD allows operation
for up to 100 flight hours with the system disabled and with the same
operating limitations as in the MMEL. However, this AD does not allow
operation with the ATLAS disabled.
    Instead, this AD prohibits all flight until a modification has been
incorporated in accordance with an FAA-approved method. Until a
modification method is developed and approved, this AD requires
revising the operating limitations in the AFM and fabricating and
installing a placard to prohibit further flight.

    The FAA finds the service information from the STC holder
(Cranfield Aerospace Solutions) does not contain adequate instructions
to safely disable the ATLAS. Those instructions include the use of
``speed tape'' around each Tamarack active camber surface (TACS) to
keep them faired in the neutral position during flight. Any
modifications mandated through AD action become changes to the type
design in the U.S. system. The FAA would need to ensure that the use of
speed tape complies with the applicable airworthiness regulations for
use on a movable surface to hold that surface in a fixed position. The
speed tape does not have sufficient testing and analysis to support the
type design change. This program would involve testing for
environmental effects, fatigue analysis, and analysis of hazards due to
potential failures of the tape. Without more analysis, the security of
the speed tape method to prevent movement of the TACS cannot be
assured, and loss of control of the airplane may occur with the ATLAS
disabled. An operator or Cranfield may provide substantiating data to
the FAA and request an alternative method of compliance using the
procedures in paragraph (g) of this AD.
    This AD specifies that the owner/operator (pilot) may revise the
AFM and may fabricate and install a placard prohibiting flight.
Revising an AFM is not considered a maintenance action and may be done
by a pilot holding at least a private pilot certificate. Allowing the
pilot to fabricate and install a placard is an exception to our
standard maintenance regulations. These actions must be recorded in the
aircraft maintenance records to show compliance with this AD.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because the
ATLAS, when operational, deflects the active control surfaces on the
outboard wings. The malfunction of the ATLAS may reduce the pilot's
ability to control the airplane. The service information provided by
the STC holder does not contain adequate instructions to mitigate the
unsafe condition. This unsafe condition could lead to loss of control
of the airplane with consequent loss of life. The severity of the risk
warrants compliance before further flight. Therefore, we find good
cause that notice and opportunity for prior public comment are
impracticable. In addition, for the reasons stated above, we find that
good cause exists for making this amendment effective upon publication.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2019-0350; Product
Identifier 2019-CE-025-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
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 AD.

Costs of Compliance

    We estimate that this AD affects 76 products of U.S. registry. We
also estimate that it will take about 2 work-hours per product to
revise the Operating Limitations section of the AFM and to fabricate
and install a placard. The average labor rate is $85 per work-hour. We
estimate the parts cost to fabricate the placard as $5.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $13,300, or $175 per product.
    This AD prohibits flight until the incorporation of an FAA-approved
modification. At this time, a modification does not exist; therefore,
we have no data to use for estimating the cost of the modification.
    As indicated earlier in this preamble, we specifically invite the
submission of comments and other data regarding the costs of 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 small airplanes, gliders,
balloons, airships, domestic business jet transport airplanes, and
associated appliances to the Director of the Policy and Innovation
Division.

Regulatory Findings

    We determined that 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 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.

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):

2019-08-13 Textron Aviation, Inc. (Type certificate previously held
by Cessna Aircraft Company): Amendment 39-19634; Docket No. FAA-
2019-0350; Product Identifier 2019-CE-025-AD.

(a) Effective Date

    This AD becomes effective May 24, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Textron Aviation, Inc. (type certificate
previously held by Cessna Aircraft Company) Models 525, 525A, and
525B airplanes, certificated in any category, with Tamarack active
load alleviation system (ATLAS) winglets installed in accordance
with Supplemental Type Certificate (STC) SA03842NY.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as malfunction of
the ATLAS, which could cause difficulty for the pilot to recover the
airplane to safe flight. We are issuing this AD to prevent failure
of the Tamarack ATLAS winglets, which may lead to the pilot's
inability to control the airplane.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) through (3) of this AD.
    (1) Before further flight after May 24, 2019 (the effective date
of this AD):
    (i) Revise the Operating Limitations section of the airplane
flight manual (AFM) to prohibit further flight. You may insert a
copy of this AD into the Operating Limitations section of the AFM to
comply with this requirement.
    (ii) Fabricate and install a placard in the cockpit of the
airplane, in plain view of the pilot, with the following text: ALL
FLIGHT IS PROHIBITED.
    (2) In addition to the provisions of 14 CFR 43.3 and 43.7, the
actions required by paragraph (f)(1) of this AD may be performed by
the owner/operator (pilot) holding at least a private pilot
certificate and must be entered into the aircraft records showing
compliance with this AD in accordance with 14 CFR 43.9(a)(1) through
(4) and 14 CFR 91.417(a)(2)(v). The record must be maintained as
required by 14 CFR 91.417. This authority is not applicable to
aircraft being operated under 14 CFR part 119.
    (3) You may remove the AFM revision and placard required by
paragraph (f)(1) of this AD after incorporating an FAA-approved
modification. To obtain FAA-approval, the modification method must
be approved by the Manager, New York ACO Branch, and the approval
letter must specifically refer to this AD. To contact the New York
ACO Branch, you may use the contact information found in paragraph
(g) of this AD.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, New York ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: Program Manager,
Continued Operational Safety FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 228-
7300; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>Before
using any approved AMOC on any airplane to which the AMOC applies,
notify your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.

(h) Special Flight Permit

    A special flight permit may be issued to allow 10 hours time-in-
service for non-passenger carrying flight under the operating
limitations in figure 1 to this paragraph of this AD.

[GRAPHIC] [TIFF OMITTED] TR24MY19.005

(i) Related Information

    Refer to MCAI European Aviation Safety Agency AD No.: 2019-0086-
E, dated April 19, 2019, for related information. You may examine
the MCAI on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2019-0350.

    Issued in Kansas City, Missouri, on May 20, 2019.
Melvin J. Johnson,
Aircraft Certification Service, Deputy Director, Policy and Innovation
Division, AIR-601.
[FR Doc. 2019-10993 Filed 5-22-19; 11:15 am]
 BILLING CODE 4910-13-P


[Federal Register: May 4, 2010 (Volume 75, Number 85)]
[Notices]
[Page 23777-23779]
[DOCID:fr04my10-92]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0190]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Infant Formula Requirements

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of

information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
regarding the manufacture of infant formula, including infant formula
labeling, quality control procedures, notification requirements, and
recordkeeping.

DATES:  Submit written or electronic comments on the collection of
information by July 6, 2010.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

 Infant Formula Requirements--21 CFR Parts 106 and 107 (OMB Control
Number 0910-0256)--Extension

    Statutory requirements for infant formula under the Federal Food,
Drug, and Cosmetic Act (the act) are intended to protect the health of
infants and include a number of reporting and recordkeeping
requirements. Among other things, section 412 of the act (21 U.S.C.
350a) requires manufacturers of infant formula to establish and adhere
to quality control procedures, notify FDA when a batch of infant
formula that has left the manufacturers' control may be adulterated or
misbranded, and keep records of distribution. FDA has issued
regulations to implement the act's requirements for infant formula in
parts 106 and 107 (21 CFR parts 106 and 107). FDA also regulates the
labeling of infant formula under the authority of section 403 of the
act (21 U.S.C. 343). Under the labeling regulations for infant formula
in part 107, the label of an infant formula must include nutrient
information and directions for use. The purpose of these labeling
requirements is to ensure that consumers have the information they need
to prepare and use infant formula appropriately. In a notice of
proposed rulemaking published in the Federal Register of July 9, 1996
(61 FR 36154), FDA proposed changes in the infant formula regulations,
including some of those listed in tables 1, 2, and 3 of this document.
The document included revised burden estimates for the proposed changes
and solicited public comment. In the interim, however, FDA is seeking
an extension of OMB approval for the current regulations so that it can
continue to collect information while the proposal is pending.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
   Federal Food, Drug, and Cosmetic Act or 21 CFR           No. of         Annual Frequency      Total Annual          Hours per
                       Section                            Respondents        per  Response         Responses           Response           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 412(d) of the act                                              5                  13                  65                  10                 650
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 106.120(b)                                                      1                   1                   1                   4                   4
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 107.50(b)(3) and (b)(4)                                         3                   2                   6                   4                  24
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 107.50(e)(2)                                                    1                   1                   1                   4                   4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                682
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
   21 CFR           No. of         Annual Frequency      Total Annual
   Section       Recordkeepers    per  Recordkeeping        Records        Hours per  Record      Total Hours
----------------------------------------------------------------------------------------------------------------
106.100                        5                  10                  50                 400              20,000
----------------------------------------------------------------------------------------------------------------
107.50                         3                  10                  30                 300               9,000
 (c)(3)
----------------------------------------------------------------------------------------------------------------

Total                                                                                29,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                Table 3.--Third Party Disclosure Requirements\1\
----------------------------------------------------------------------------------------------------------------
   21 CFR           No. of         Annual Frequency      Total Annual          Hours per
   Section        Respondents        of Disclosure        Disclosures         Disclosure          Total Hours
----------------------------------------------------------------------------------------------------------------
21 CFR                         5                  13                  65                   8                 520
 107.10(a)
 and 107.20
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information

    In compiling these estimates, FDA consulted its records of the
number of infant formula submissions received in the past. All infant
formula submissions to FDA may be provided in electronic format. The
hours per response reporting estimates are based on FDA's experience
with similar programs and information received from industry.
    FDA estimates that it will receive 13 reports from 5 manufacturers
annually under section 412(d) of the act, for a total annual response
of 65 reports. Each report is estimated to take 10 hours per response
for a total of 650 hours. FDA also estimates that it will receive one
notification under Sec.  106.120(b). The notification is expected to
take 4 hours per response, for a total of 4 hours.
    For exempt infant formula, FDA estimates that it will receive two
reports from three manufacturers annually under Sec.  107.50(b)(3) and
(b)(4), for a total annual response of six reports. Each report is
estimated to take 4 hours per response for a total of 24 hours. FDA
also estimates that it will receive one notification under Sec.
107.50(e)(2). The notification is expected to take 4 hours per
response, for a total of 4 hours.
    FDA estimates that 5 firms will expend approximately 20,000 hours
per year to fully satisfy the record keeping requirements in Sec.
106.100. It is estimated that 3 firms will expend approximately 9,000
hours per year to fully satisfy the record keeping requirements in
Sec.  107.50(c)(3).
    FDA estimates that compliance with the labeling requirements of
Sec. Sec.  107.10(a) and 107.20 will require 520 hours annually by 5
manufacturers.

    Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10360 Filed 5-3-10; 8:45 am]
BILLING CODE 4160-01-S