[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Rules and Regulations]
[Page 67372-67374]
[DOCID:fr14no08-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0854; Directorate Identifier 2008-CE-050-AD;
Amendment 39-15718; AD 2008-22-21]
RIN 2120-AA64

Airworthiness Directives; Allied Ag Cat Productions, Inc. Model
G-164 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA adopts a new airworthiness directive (AD) to supersede
AD 78-08-09, which applies to certain Allied Ag Cat Productions, Inc.
(formerly Grumman-American) (Allied Ag Cat) Models G-164, G-164A, and
G-164B airplanes. AD 78-08-09 currently requires repetitively
inspecting the interior and the exterior of the main tubular spar of
the rudder assembly for corrosion, taking necessary corrective action
if corrosion is found, and applying corrosion protection. Since we
issued AD 78-08-09, the rudder main tubular spar failed on a later
production airplane. Consequently, this AD retains the actions required
in AD 78-08-09 and expands the applicability to include all G-164
series airplanes. We are issuing this AD to detect and correct
corrosion in the rudder main tubular spar, which could result in
failure of the weld to the main spar tube. This failure could lead to
loss of directional control.

DATES: This AD becomes effective on December 19, 2008.
    On December 19, 2008, the Director of the Federal Register approved
the incorporation by reference of certain publications listed in this
AD.

ADDRESSES: To get the service information identified in this AD,
contact Allied Ag Cat Productions, Inc., 301 West Walnut Street, P.O.
Box 482, Walnut Ridge, Arkansas 72479; telephone:<PHONE_NUMBER>.
    To view the AD docket, go to U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue, SE., Washington, DC 20590, or on the Internet at
http://www.regulations.gov. The docket number is FAA-2008-0854;
Directorate Identifier 2008-CE-050-AD.

FOR FURTHER INFORMATION CONTACT: Andy McAnaul, Aerospace Engineer,
10100 Reunion Pl., Ste. 650, San Antonio, Texas 78216; telephone: (210)
308-3365; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    On August 1, 2008, we issued a proposal to amend part 39 of the
Federal Aviation Regulations (14 CFR part 39) to include an AD that
would apply to certain Allied Ag Cat Models G-164, G-164A, and G-164B
airplanes. This proposal was published in the Federal Register as a
notice of proposed rulemaking (NPRM) on August 7, 2008 (73 FR 45900).
The NPRM proposed to supersede AD 78-08-09 with a new AD that would
retain the actions required in AD 78-08-09 and expand the applicability
to include all G-164 series airplanes.

Comments

    We provided the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
and FAA's response to each comment:

Comment Issue No. 1: AD Is Supported

    Ronald I. Gustin, Craig T. Fountain, and Ken J. Kuther all state
that they support the AD action as proposed in the NPRM.
    Ronald Gustin states that of the 13 Ag Cat airplanes inspected by
mechanics at Gustin Aviation, which was prompted by the NPRM, 4
airplanes had severe corrosion of the rudder main spar tube that
required repair; 2 airplanes had light rust; and 7 airplanes were
corrosion free. Craig T. Fountain and Ken J. Kuther, who collectively
own four of the airplanes inspected by Gustin Aviation, confirm the
reported corrosion found and also support the proposed AD action.
    The commenters support the NPRM.
    We are not changing the final rule AD action based on these
comments.

Comment Issue No. 2: Extend Comment Period

    Bryan D. Hauschild states that he is planning to recover the rudder
on his airplane during the off-season, which is November through March.
He states that at that time he would be able to get a good look at the
area in question.
    Mr. Hauschild requests to extend the comment period for the NPRM so
that his airplane is not pulled from its seasonal service at this time.
    We do not agree with the commenter. We believe that the fleet
service history and severity of corrosion reported on Ag Cat rudders
requires AD action. Extending the comment period in order to delay the
effective date of this AD

would create an unacceptable safety risk.
    We are not changing the final rule AD action based on this comment.

Conclusion

    We have carefully reviewed the available data and determined that
air safety and the public interest require adopting the AD as proposed
except for minor editorial corrections. We have determined that these
minor corrections:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Costs of Compliance

    We estimate that this AD affects 2,700 airplanes in the U.S.
registry.
    We estimate the following costs to do the inspections:

----------------------------------------------------------------------------------------------------------------
                                                                                Total cost per   Total cost on
                  Labor cost                              Parts cost                airplane      U.S. operators
----------------------------------------------------------------------------------------------------------------
4 work-hours x $80 per hour = $320...........  Not applicable.................            $320         $864,000
----------------------------------------------------------------------------------------------------------------

    We have no way of determining the cost of repairs, parts
replacement, or the number of airplanes that may require repair or
parts replacement based on the result of the proposed inspections.

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 AD.

Regulatory Findings

    We have 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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a summary of the costs to comply with this AD (and
other information as included in the Regulatory Evaluation) and placed
it in the AD Docket. You may get a copy of this summary by sending a
request to us at the address listed under ADDRESSES. Include ``Docket
No. FAA-2008-0854; Directorate Identifier 2008-CE-050-AD'' in your
request.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the Federal Aviation Administration amends part 39 of the Federal
Aviation Regulations (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 removing Airworthiness Directive (AD)
78-08-09, Amendment 39-3191, and adding the following new AD:

2008-22-21 Allied Ag Cat Productions, Inc.: Amendment 39-15718;
Docket No. FAA-2008-0854; Directorate Identifier 2008-CE-050-AD.

Effective Date

    (a) This AD becomes effective on December 19, 2008.

Affected ADs

    (b) This AD supersedes AD 78-08-09, Amendment 39-3191.

Applicability

    (c) This AD applies to the following airplane models, all serial
numbers, that are certificated in any category:

------------------------------------------------------------------------
                                 Models
-------------------------------------------------------------------------
G-164, G-164A, G-164B, G-164B with 73'' wing gap, G-164B-15T, G-164B-
 34T, G-164B-20T, G-164C, G-164D, and G-164D with 73'' wing gap.
------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from a report of the rudder main tubular
spar failing on a later production airplane. We are issuing this AD
to detect and correct corrosion in the rudder main tubular spar,
which could result in failure of the weld to the main spar tube.
This failure could lead to loss of directional control.

Compliance

    (e) To address this problem, you must do the following, unless
already done:

------------------------------------------------------------------------
             Actions                  Compliance          Procedures
------------------------------------------------------------------------
(1) Drill an access hole and do   (i) For airplanes   Following Steps 1
 a visual inspection using a       previously          through 3 of
 borescope of the lower end        affected by AD 78-  Grumman American
 internal cavity of the rudder     08-09: Initially    Aviation
 main spar tube for corrosion      inspect within      Corporation Ag-
 and do a visual inspection of     the next 60         Cat Service
 the exterior of the rudder main   months after the    Bulletin No. 61,
 spar tube for corrosion.          last inspection     dated June 6,
                                   required in AD 78-  1977.
                                   08-09 or within
                                   the next 30 days
                                   after December
                                   19, 2008 (the
                                   effective date of
                                   this AD),
                                   whichever occurs
                                   later.
                                   Repetitively
                                   inspect
                                   thereafter at
                                   intervals not to
                                   exceed 60
                                   calendar months.

                                  (ii) For airplanes  ..................
                                   not previously
                                   affected by AD 78-
                                   08-09: Initially
                                   inspect within
                                   the next 30 days
                                   after the
                                   effective date of
                                   this AD.
                                   Repetitively
                                   inspect
                                   thereafter at
                                   intervals not to
                                   exceed 60
                                   calendar months.
(2) If corrosion is found during  Before further      As specified in
 any inspection required in        flight after any    Steps 5 and 6 of
 paragraph (e)(1) of this AD,      inspection in       Grumman American
 repair in accordance with         which corrosion     Aviation
 Advisory Circular 43.13-1B, Chg   is found.           Corporation Ag-
 1, dated September 27, 2001, or                       Cat Service
 replace the damaged part(s).                          Bulletin No. 61,
                                                       dated June 6,
                                                       1977, and
                                                       following
                                                       Advisory Circular
                                                       43.13-1B, Chg 1,
                                                       dated September
                                                       27, 2001, which
                                                       can be found at
                                                       http://
                                                       rgl.faa.gov/.
(3) After each inspection,        Before further      As specified in
 repair, or replacement required   flight after any    Step 4 of Grumman
 in this AD, corrosion protect     inspection          American Aviation
 the spar tube internal cavity     required in         Corporation Ag-
 by filling with warm, raw         paragraph (e)(1)    Cat Service
 linseed oil, Paralketone, or      of this AD and      Bulletin No. 61,
 CRC3 (LPS Heavy Duty Rust         after any repair    dated June 6,
 Inhibitor Type 3), or suitable    or replacement      1977.
 equivalent protector for alloy    required in
 steel, and allow to drain. Seal   paragraph (e)(2)
 access hole with Scotch           of this AD.
 caulking compound, a suitable
 silicone based sealant, or
 equivalent.
(4) Verify rigging check of the   Before further      (i) Following Ag-
 rudder.                           flight after any    Cat Maintenance
                                   inspection          Manual pages 6-14
                                   required in         through 6-16,
                                   paragraph (e)(1)    copyright 1978;
                                   of this AD and      or
                                   after any repair   (ii) Following Ag-
                                   or replacement      Cat G-164D
                                   required in         Maintenance
                                   paragraph (e)(2)    Manual pages 6-24
                                   of this AD.         and 6-29,
                                                       copyright 1995.
(5) Only install a rudder that    As of the next 30   Not applicable.
 has been inspected as specified   days after
 in paragraph (e)(1) of this AD,   December 19, 2008
 is free of corrosion, and has     (the effective
 had the corrosion protection      date of this AD).
 applied and sealed as specified
 in paragraph (e)(3) of this AD.
------------------------------------------------------------------------

Alternative Methods of Compliance (AMOCs)

    (f) The Manager, Fort Worth Airplane Certification Office, 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: Andy
McAnaul, Aerospace Engineer, ASW-150, FAA San Antonio MIDO-43, 10100
Reunion Place, Suite 650, San Antonio, Texas 78216, phone: (210)
308-3365; fax:<PHONE_NUMBER>. 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.
    (g) AMOCs approved for AD 78-08-09 are not approved for this AD.

Material Incorporated by Reference

    (h) You must use Grumman American Aviation Corporation Ag-Cat
Service Bulletin No. 61, dated June 6, 1977, and Ag-Cat Maintenance
Manual pages 6-14 through 6-16, copyright 1978; or Ag-Cat G-164D
Maintenance Manual pages 6-24 and 6-29, copyright 1995, to do the
actions required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Allied Ag Cat Productions, Inc., 301 West Walnut Street, P.O. Box
482, Walnut Ridge, Arkansas 72479; telephone:<PHONE_NUMBER>.
    (3) You may review copies at the FAA, Central Region, Office of
the Regional Counsel, 901 Locust, Kansas City, Missouri 64106; or at
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/code_
of_federal_regulations/ibr_locations.html.

    Issued in Kansas City, Missouri, on October 23, 2008.
John Colomy,
Acting, Small Airplane Directorate, Aircraft Certification Service.
 [FR Doc. E8-25766 Filed 11-13-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 53 (Friday, March 18, 2011)]
[Notices]
[Page 14969]
[FR Doc No: 2011-6414]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OARM-2011-0189; FRL-9282-8]

Public Availability of Environmental Protection Agency FY 2010
Service Contract Inventory

AGENCY: Environmental Protection Agency.

ACTION: Notice of public availability of FY 2010 Service Contract
inventories.

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SUMMARY: In accordance with Section 743 of Division C of the
Consolidated Appropriations Act of 2010 (Pub. L. 111-117),
Environmental Protection Agency is publishing this notice to advise the
public of the availability of the FY 2010 Service Contract inventory.
This inventory provides information on service contract actions over
$25,000 that were made in FY 2010. The information is organized by
function to show how contracted resources are distributed throughout
the agency. The inventory has been developed in accordance with
guidance issued on November 5, 2010 by the Office of Management and
Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance
is available at http://www.whitehouse.gov/sites/default/files/omb/procurement/memo/service-contract-inventories-guidance-11052010.pdf.
Environmental Protection Agency has posted its inventory and a summary
of the inventory on the EPA's homepage at the following link: http://www.epa.gov/oam/inventories/inventories.htm.

FOR FURTHER INFORMATION CONTACT: Questions regarding the service
contract inventory should be directed to Linear Cherry in the Office of
Acquisition Management, Headquarters Procurement Operations Division
(3803R), Business Analysis Support Staff, Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

How can I get copies of this docket and other related information?

    1. EPA has established a docket for this action under Docket ID No.
EPA-HQ-OARM-2011-0189. Publicly available docket materials are
available either electronically through http://www.regulations.gov or
in hard copy at the FY 2010 Service Contract Inventory Docket in the
EPA Docket Center, (EPA/DC) EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA Docket Center 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
(202) 566-1744, and the telephone number for the FY 2010 Service
Contract Inventory Docket is<PHONE_NUMBER>.
    2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

    Dated: March 11, 2011.
John R. Bashista,
Director, Office of Acquisition Management.
[FR Doc. 2011-6414 Filed 3-17-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 25, 2011 (Volume 76, Number 101)]
[Proposed Rules]
[Page 30295-30297]
[DOCID:fr25my11-15]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0530; Directorate Identifier 2011-CE-012-AD]
RIN 2120-AA64

Airworthiness Directives; SOCATA Model TBM 700 Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    A TBM 700 operator reported a case of elevator trim tab actuator
jamming once the trim tab arrived to stop.
    The investigations conducted by the trim tab actuator
manufacturer have shown that there was a discrepancy with PRECILEC
manufacturing process of elevator trim tab actuator which caused
this event. It has been determined as well that this discrepancy is
limited to a batch of Serial Numbers (S/N).
    If not detected and corrected, a jammed trim tab could lead to
unusual control forces, resulting in lower controllability,
particularly if combined with adverse flight conditions at landing.

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by July 11, 2011.

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.
    For service information identified in this proposed AD, contact
SOCATA--Direction des Services--65921 Tarbes Cedex 9--France; telephone
+33 (0) 62 41 7300, fax +33 (0) 62 41 76 54, or for North America:
SOCATA NORTH AMERICA, 7501 South Airport Road, North Perry Airport
(HWO), Pembroke Pines, Florida 33023; telephone:<PHONE_NUMBER>; fax:
(954) 964-4141; e-mail<EMAIL_ADDRESS>Internet: http://
mysocata.com. You may review copies of the referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, Missouri 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; 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: Albert Mercado, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; 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-2011-0530;
Directorate Identifier 2011-CE-012-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 because of those comments.
    We will post all comments we receive, without change, to http://
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

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD No.: 2011-0060, dated March 29, 2011 (Correction: March 30, 2011)
(referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI states:

    A TBM 700 operator reported a case of elevator trim tab actuator
jamming once the trim tab arrived to stop.
    The investigations conducted by the trim tab actuator
manufacturer have shown that there was a discrepancy with PRECILEC
manufacturing process of elevator trim tab actuator which caused
this event. It has been determined as well that this discrepancy is
limited to a batch of Serial Numbers (S/N).
    If not detected and corrected, a jammed trim tab could lead to
unusual control forces, resulting in lower controllability,
particularly if combined with adverse flight conditions at landing.
    For the reasons described above, this AD requires the inspection
of the elevators trim tab actuator P/N<PHONE_NUMBER> for identification
of S/N and, in case of findings, the replacement of the affected
ones with serviceable units.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    DAHER-SOCATA has issued Mandatory Service Bulletin SB 70-190-27,
dated January 2011. The actions described in this service information
are intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of the 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 this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    We estimate that this proposed AD will affect 377 products of U.S.
registry. We also estimate that it would take about 1 work-hour per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour. Required parts would cost
about $0 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $32,045, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 7 work-hours and require parts costing $0, for a cost of
$595 per product. We have no way of determining the number of products
that may need these actions.
    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

SOCATA: Docket No. FAA-2011-0530; Directorate Identifier 2011-CE-
012-AD.

Comments Due Date

    (a) We must receive comments by July 11, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to SOCATA Model TBM 700 airplanes, serial
numbers 1 through 530, certificated in any category.

Subject

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

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    A TBM 700 operator reported a case of elevator trim tab actuator
jamming once the trim tab arrived to stop.
    The investigations conducted by the trim tab actuator
manufacturer have shown that there was a discrepancy with PRECILEC
manufacturing process of elevator trim tab actuator which caused
this event. It has been determined as well that this discrepancy is
limited to a batch of Serial Numbers (S/N).
    If not detected and corrected, a jammed trim tab could lead to
unusual control forces, resulting in lower controllability,
particularly if combined with adverse flight conditions at landing.
    For the reasons described above, this AD requires the inspection
of the elevators trim tab actuator P/N<PHONE_NUMBER> for identification
of S/N and, in case of findings, the replacement of the affected
ones with serviceable units.

Actions and Compliance

    (f) Unless already done, do the following actions:

    (1) Within 12 months after the effective date of this AD,
identify the serial number (S/N) of Left Hand and Right Hand
PRECILEC elevator trim tab actuators following DAHER-SOCATA
Mandatory Service Bulletin SB 70-190-27, dated January 2011.
    (2) If, as a result of the inspection required by paragraph
(f)(1) of this AD you find any affected elevator trim tab actuator
as listed in DAHER-SOCATA Mandatory Service Bulletin SB 70-190-27,
dated January 2011, installed on an airplane, before further flight,
replace it with a serviceable part following DAHER-SOCATA Mandatory
Service Bulletin SB 70-190-27, dated January 2011.
    (3) After the effective date of this AD, do not install on an
airplane any PRECILEC elevator trim tab actuator part number
6071017251 with an S/N listed in DAHER-SOCATA Mandatory Service
Bulletin SB 70-190-27, dated January 2011, unless it has been
repaired in accordance with DAHER-SOCATA Mandatory Service Bulletin
SB 70-190-27, dated January 2011.

    Note 1: Trim tab actuators repaired by a service center are
identified with screw green colored locking varnish as shown in
figure 2 of DAHER-SOCATA Mandatory Service Bulletin SB 70-190-27,
dated January 2011.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, 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: Albert Mercado, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. 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.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a Federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2011-0060, dated March 29, 2011 (Correction: March 30, 2011); and
DAHER-SOCATA Mandatory Service Bulletin SB 70-190-27, dated January
2011, for related information. For service information related to
this AD, contact SOCATA--Direction des Services--65921 Tarbes Cedex
9--France; telephone +33 (0) 62 41 7300, fax +33 (0) 62 41 76 54, or
for North America: SOCATA NORTH AMERICA, 7501 South Airport Road,
North Perry Airport (HWO), Pembroke Pines, Florida 33023; telephone:
(954) 893-1400; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Internet: http://mysocata.com. You may
review copies of the referenced service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on May 18, 2011.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2011-12967 Filed 5-24-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Page 13130]
[FR Doc No: 2023-04271]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0094]

Joint Meeting of the Nonprescription Drugs Advisory Committee and
the Anesthetic and Analgesic Drug Products Advisory Committee;
Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The meeting of the Nonprescription Drugs Advisory Committee
and the Anesthetic and Analgesic Drug Products Advisory Committee
scheduled for March 20, 2023, is cancelled. This meeting was announced
in the Federal Register of January 30, 2023. The meeting is no longer
needed.

FOR FURTHER INFORMATION CONTACT: Moon Choi, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
[email protected], or FDA Advisory Committee Information Line, 1-800-
741-8138<PHONE_NUMBER> in the Washington, DC area), and follow the
prompts to the desired center or product area. Please call the
Information Line for up-to-date information on this meeting, which was
announced in the Federal Register of January 30, 2023 (88 FR 5893).

    Dated: February 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04271 Filed 3-1-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Rules and Regulations]
[Pages 13226-13232]
[FR Doc No: 2015-05644]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 556, and 558

[Docket No. FDA-2014-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

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 November and December 2014. FDA is also informing the
public of the availability of summaries of the basis of approval and of
environmental review documents, where applicable. The animal drug
regulations are also being amended to reflect a change of sponsorship
of eight NADAs and nine ANADAs, and to make correcting amendments for a
drug labeler code.

DATES: This rule is effective March 13, 2015.

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 approval actions for NADAs and ANADAs during November and
December 2014, 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 CVM FOIA Electronic
Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and
patent information may be accessed in FDA's publication, Approved
Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
    In addition, Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE
68144, has transferred ownership of, and all rights and interest in,
the following approved applications to Pharmgate LLC, 161 North
Franklin Turnpike, Suite 2C, Ramsey, NJ 07446:

------------------------------------------------------------------------
      File No.                 Product name               21 CFR Cite
------------------------------------------------------------------------
065-480............  Chlortetracycline Soluble Powder  520.441.
138-934............  PENNCHLOR SP (chlortetracycline,  558.145.
                      sulfamethazine, penicillin)
                      Type A medicated articles.
138-935............  PENNCHLOR (chlortetracycline)     558.128.
                      Type A medicated articles.
138-938............  PENNOX (oxytetracycline) Type A   558.450.
                      medicated articles.
138-939............  NEO-OXY (neomycin sulfate and     558.455.
                      oxytetracycline) Type A
                      medicated articles.
140-680............  TYLAN (tylosin phosphate) Type A  558.625.
                      medicated articles.
140-681............  TYLAN Sulfa-G (tylosin phosphate  558.630.
                      and sulfamethazine) Type A
                      medicated articles.
141-137............  PENITRACIN (bacitracin            Not codified.
                      methylenedisalicylate) 50 Type
                      A medicated article.
200-026............  PENNOX 343 (oxytetracycline)....  520.1660d.
200-154............  PENNOX 200 (oxytetracycline)....  558.450.
200-295............  PENNCHLOR 64 (chlortetracycline)  558.128.
200-314............  PENNCHLOR S (chlortetracycline).  558.140.
200-354............  PENNCHLOR (chlortetracycline)/    558.355.
                      COBAN (monensin).
200-356............  PENNCHLOR (chlortetracycline)/    558.600.
                      DENAGARD (tiamulin).

200-357............  PENNCHLOR (chlortetracycline)/    558.550.
                      BIO-COX (salinomycin).
200-358............  PENNCHLOR (chlortetracycline)/    558.76.
                      BMD (bacitracin MD).
200-359............  PENNCHLOR (chlortetracycline)/    558.195.
                      DECCOX (decoquinate).
------------------------------------------------------------------------

    At this time, the regulations are being amended to reflect these
changes of sponsorship. Following these changes of sponsorship,
Pharmgate LLC will now be the sponsor of an approved application while
Pennfield Oil Co. will no longer be the sponsor of an approved
application. Also, Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader
Wadi Seer, Amman, Jordan 11118, has informed FDA that it has changed
its name to Hikma International Pharmaceuticals LLC. Accordingly, Sec.
510.600 (21 CFR 510.600) is being amended to reflect these changes. In
addition, FDA is amending Sec.  510.600 and several sections of part
520 to reflect a correct drug labeler code for Akorn Animal Health,
Inc. FDA is also amending the regulations in 21 CFR parts 520, 522,
556, and 558 to redesignate several sections to reflect alphabetical
order and to make minor technical amendments. These corrections and
technical amendments are being made to improve the accuracy of the
animal drug regulations.

                             Table 1--Original and Supplemental NADAs and ANADAs Approved During November and December 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      New animal drug  product                                        21 CFR        FOIA         NEPA
      NADA/  ANADA                 Sponsor                      name                          Action                 Sections     Summary       Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-575................  Putney, Inc., One Monument  Carprofen Chewable         Original approval as a generic         520.309          yes   CE \1\ \2\
                          Sq., suite 400, Portland,   Tablets.                   copy of NADA 141-111.
                          ME 04101.
141-232................  Zoetis Inc., 333 Portage    SIMPLICEF (cefpodoxime     Supplemental approval of chewable      520.370          yes   CE \1\ \3\
                          St., Kalamazoo, MI 49007.   proxetil) Chewable         tablet dosage form for dogs.
                                                      Tablets.
200-512................  Zoetis Inc., 333 Portage    TRIAMULOX (tiamulin        Original approval as a generic        520.2455          yes   CE \1\ \2\
                          St., Kalamazoo, MI 49007.   hydrogen fumarate)         copy of NADA 140-916.
                                                      Liquid Concentrate.
200-573................  Putney, Inc., One Monument  Dexmedetomidine HCl......  Original approval as a generic         522.558          yes   CE \1\ \2\
                          Sq., suite 400, Portland,  (dexmedetomidine            copy of NADA 141-267.
                          ME 04101.                   hydrochloride).
                                                     Injectable Solution......
141-068................  Bayer HealthCare LLC,       BAYTRIL 100                Supplemental approval adding           522.812          yes    CE\1\ \4\
                          Animal Health Division,     (enrofloxacin).            administration by intramuscular
                          P.O. Box 390, Shawnee      Injectable Solution......   injection in swine and an
                          Mission, KS 66201.                                     indication for control of
                                                                                colibacillosis in groups or pens
                                                                                of weaned pigs.
141-349................  Zoetis Inc., 333 Portage    DRAXXIN 25...............  Supplemental approval for             522.2630          yes   CE \1\ \4\
                          St., Kalamazoo, MI 49007.  (tulathromycin)..........   treatment of bovine respiratory
                                                     Injectable Solution......   disease (BRD) in suckling
                                                                                calves, dairy calves, and veal
                                                                                calves.
141-437................  Novartis Animal Health US,  OSURNIA..................  Original approval for the              524.955          yes   CE \1\ \3\
                          Inc., 3200 Northline       (florfenicol,               treatment of otitis externa in
                          Ave., suite 300,            terbinafine,               dogs.
                          Greensboro, NC 27408.       betamethasone acetate)
                                                      Otic Gel.
034-267................  Intervet, Inc., 556 Morris  GENTOCIN DURAFILM........  Supplemental approval of             524.1044i          yes   CE \1\ \3\
                          Ave., Summit, NJ 07901.    (gentamicin sulfate and     additional safety information.
                                                      betamethasone).
                                                     Ophthalmic Solution......
141-034................  Huvepharma AD, 5th Floor,   GAINPRO..................  Supplemental approval of a free-        558.95          yes   CE \1\ \2\
                          3A Nikolay Haytov Str.,    (bambermycins)...........   choice Type C medicated loose
                          1113 Sophia, Bulgaria.     Type A medicated article.   mineral feed without selenium
                                                                                for pasture cattle.
200-510 \5\............  Pharmgate LLC, 161 North    DERACIN..................  Original approval as a generic         558.128          yes   CE \1\ \2\
                          Franklin Turnpike, suite   (chlortetracycline)......   copy of NADA 048-761.
                          2C, Ramsey, NJ 07446.      Type A medicated articles
141-258................  Intervet, Inc., 556 Morris  ZILMAX (zilpaterol         Supplemental approval to provide       558.665          yes   CE \1\ \2\
                          Ave., Summit, NJ 07901.     hydrochloride) Type A      for component feeding of Type C
                                                      medicated article.         medicated feeds.

141-276 \5\............  Intervet, Inc., 556 Morris  ZILMAX (zilpaterol         Supplemental approval to provide       558.665          yes   CE \1\ \6\
                          Ave., Summit, NJ 07901.     hydrochloride) plus        for component feeding of
                                                      RUMENSIN (monensin) plus   combination drug Type C
                                                      TYLAN (tylosin             medicated feeds.
                                                      phosphate) Type C
                                                      medicated feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined 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 have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(d)(5).
\5\ This application is affected by guidance for industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on
  Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI
  #209,'' December 2013.
\6\ CE granted under 21 CFR 25.33(a)(2).

    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 Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

    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 510,
520, 522, 524, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. Amend Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1), in the entry for ``Akorn Animal
Health, Inc.'', in the ''Drug labeler code'' column, remove ``053599'',
and in its place add ``059399'';
0
b. In the table in paragraph (c)(1), in the entry for ``Hikma
Pharmaceuticals LLC'', in the ``Firm name and address'' column, remove
``Hikma Pharmaceuticals LLC'', and in its place add ``Hikma
International Pharmaceuticals LLC'';
0
c. In the table in paragraph (c)(1), remove the entry for ``Pennfield
Oil Co.'' and add an entry, in alphabetical order, for ``Pharmgate
LLC'';
0
d. In the table in paragraph (c)(2), remove the entries for ``000008'',
``048164'', and ``053599'' and add entries, in numerical order, for
``059399'' and ``069254''; and
0
e. In the table in paragraph (c)(2), in the entry for ``059115'', in
the ``Firm name and address'' column, remove ``Hikma Pharmaceuticals
LLC'', and in its place add ``Hikma International Pharmaceuticals
LLC''.
    The additions and revisions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Pharmgate LLC, 161 North Franklin Turnpike, suite 2C,             069254
 Ramsey, NJ 07446.......................................

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
059399......................  Akorn Animal Health, Inc., 1925 West Field
                               Ct., suite 300, Lake Forest, IL 60045

                              * * * * * * *
069254......................  Pharmgate LLC, 161 North Franklin
                               Turnpike, suite 2C, Ramsey, NJ 07446

                              * * * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec. Sec.  520.310 and 520.312   [Redesignated as Sec. Sec.  520.301
and 520.302]

0
4. Redesignate Sec. Sec.  520.310 and 520.312 as Sec. Sec.  520.301 and
520.302, respectively.

Sec.  520.309  [Redesignated as Sec.  520.304 and Amended]

0
5. Redesignate Sec.  520.309 as Sec.  520.304 and revise newly
redesignated Sec.  520.304 by adding paragraph (b)(3) to read as
follows:

Sec.  520.304  Carprofen.

* * * * *
    (b) * * *
    (3) No. 026637 for use of product described in paragraph (a)(2) of
this section as in paragraph (d) of this section.
* * * * *

0
6. In Sec.  520.370, revise paragraphs (a) and (b) and in paragraph
(c)(2), remove ``intermedius'' and in its place add
``pseudintermedius'' to read as follows:

Sec.  520.370  Cefpodoxime tablets.

    (a) Specifications. (1) Each tablet contains cefpodoxime proxetil
equivalent to 100 or 200 milligrams (mg) cefpodoxime.
    (2) Each chewable tablet contains cefpodoxime proxetil equivalent
to 100 or 200 mg cefpodoxime.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for
uses as follows:
    (1) No. 026637 for use of product in paragraph (a)(1) of this
section as in paragraph (c) of this section.
    (2) No. 054771 for use of products in paragraph (a) of this section
as in paragraph (c) of this section.
* * * * *

Sec.  520.441  [Amended]

0
7. In Sec.  520.441, in paragraph (b)(1), remove ``048164'' and in its
place add ``069254''.

0
8. Amend Sec.  520.1660d as follows:
0
a. In paragraph (b)(6), remove ``048164'' and in its place add
``069254''.
0
b. In paragraphs (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and
(d)(1)(ii)(C)(3), revise the last sentence.
    The revisions read as follows:

Sec.  520.1660d  Oxytetracycline powder.

* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (A) * * *
    (3) * * * Zero-day withdrawal for those products sponsored by Nos.
054771, 057561, 061133, and 069254.
    (B) * * *
    (3) * * * Zero-day withdrawal for those products sponsored by Nos.
054771, 057561, 061133, and 069254.
    (C) * * *
    (3) * * * Zero-day withdrawal for those products sponsored by Nos.
054771, 057561, 061133, and 069254.
* * * * *

0
9. In Sec.  520.2455, revise paragraphs (b)(3) and (c) to read as
follows:

Sec.  520.2455  Tiamulin.

* * * * *
    (b) * * *
    (3) No. 054771 for the product described in paragraph (a)(3) of
this section.
    (c) Related tolerances. See Sec.  556.732 of this chapter.
* * * * *

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

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

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

Sec.  522.246  [Amended]

0
11. In Sec.  522.246, in paragraph (b)(3), remove ``053599'' and in its
place add ``059399''.

0
12. In Sec.  522.558, revise paragraphs (a) and (b) to read as follows:

Sec.  522.558  Dexmedetomidine.

    (a) Specifications. Each milliliter of solution contains:
    (1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or
    (2) 0.5 mg dexmedetomidine hydrochloride.
    (b) Sponsors. See sponsors in in Sec.  510.600(c) of this chapter
for use as in paragraph (c) of this section:
    (1) No. 026637 for use of product described in paragraph (a)(2) of
this section;
    (2) No. 052483 for use of products described in paragraph (a) of
this section.
* * * * *

0
13. Amend Sec.  522.812 as follows:
0
a. Revise paragraph (b)(2);
0
b. Remove paragraph (e)(3)(i);
0
c. Redesignate paragraphs (e)(3)(ii) and (e)(3)(iii) as paragraphs
(e)(3)(i) and (e)(3)(ii), respectively; and
0
d. Revise newly redesignated paragraph (e)(3)(i).
    The revisions read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (2) No. 055529 for use of product described in paragraph (a)(1) of
this section as in paragraph (e)(1) of this section, and use of product
described in paragraph (a)(2) of this section as in paragraphs
(e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i)(B), and (e)(3)(ii)
of this section.
* * * * *
    (e) * * *
    (3) * * *
    (i) Amounts and indications for use. (A) Administer, either by
intramuscular or subcutaneous (behind the ear) injection, a single dose
of 7.5 mg/kg of body weight for the treatment and control of swine
respiratory disease (SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis,
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma
hyopneumoniae.
    (B) Administer, by subcutaneous (behind the ear) injection, a
single dose of 7.5 mg/kg of body weight for the treatment and control
of swine respiratory disease (SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and
Streptococcus suis.
    (C) Administer, either by intramuscular or subcutaneous (behind the
ear) injection, a single dose of 7.5 mg/kg of body weight for the
control of colibacillosis in groups or pens of weaned pigs where
colibacillosis associated with Escherichia coli has been diagnosed.
* * * * *

0
14. In Sec.  522.1222, revise paragraph (b) to read as follows:

Sec.  522.1222  Ketamine.

* * * * *

    (b) Sponsors. See Nos. 000859, 026637, 054628, 054771, 059399, and
063286 in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  522.2474  [Amended]

0
15. In Sec.  522.2474, in paragraph (b), remove ``053599'' and in its
place add ``059399''.

0
16. In Sec.  522.2630, revise paragraphs (b)(1), (b)(2), (d)(1)(ii)(A),
(d)(1)(ii)(B), and (d)(1)(iii) to read as follows:

Sec.  522.2630  Tulathromycin.

* * * * *
    (b) * * *
    (1) Product described as in paragraph (a)(1) of this section for
use as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2)
of this section.
    (2) Product described as in paragraph (a)(2) of this section for
use as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and
(d)(2) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (A) Beef and non-lactating dairy cattle. For the treatment of
bovine respiratory disease (BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma
bovis. For the control of respiratory disease in cattle at high risk of
developing BRD associated with M. haemolytica, P. multocida, H. somni,
and M. bovis. For the treatment of infectious bovine
keratoconjunctivitis (IBK) associated with Moraxella bovis. For the
treatment of bovine foot rot (interdigital necrobacillosis) associated
with Fusobacterium necrophorum and Porphyromonas levii.
    (B) Suckling calves, dairy calves, and veal calves. For the
treatment of bovine respiratory disease (BRD) associated with
Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and
Mycoplasma bovis.
    (iii) Limitations. (A) Cattle intended for human consumption must
not be slaughtered within 18 days from the last treatment. Do not use
in female dairy cattle 20 months of age or older. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
    (B) Calves intended for human consumption must not be slaughtered
within 22 days from the last treatment. Not for use in ruminating
cattle. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
* * * * *

Sec.  522.2662  [Amended]

0
17. In Sec.  522.2662, in paragraph (b)(4), remove ``053599'' and in
its place add ``059399''.

Sec.  522.2670  [Amended]

0
18. In Sec.  522.2670, in paragraph (b)(1), remove ``053599'' and in
its place add ``059399''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
19. The authority citation for 21 CFR part 524 continues to read as
follows:

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

0
20. Add Sec.  524.955 to read as follows:

Sec.  524.955  Florfenicol, terbinafine, and betamethasone acetate otic
gel.

    (a) Specifications. Each milliliter of gel contains 10 milligrams
(mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer one dose (1
tube) per affected ear(s) and repeat administration in 7 days.
    (2) Indications for use. For the treatment of otitis externa in
dogs associated with susceptible strains of bacteria (Staphylococcus
pseudintermedius) and yeast (Malassezia pachydermatis).
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

0
21. In Sec.  524.1044i, revise paragraph (c)(2) to read as follows:

Sec.  524.1044i  Gentamicin and betamethasone ophthalmic solution.

* * * * *
    (c) * * *
    (2) Indications for use. For treatment of external eye infections
and inflammation.
* * * * *

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

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

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

Sec.  556.738  [Redesignated as Sec.  556.732]

0
23. Redesignate Sec.  556.738 as Sec.  556.732.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
24. The authority citation for 21 CFR part 558 continues to read as
follows:

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

Sec.  558.76  [Amended]

0
25. In Sec.  558.76, in paragraph (d)(1)(iv), in the ``Limitations''
and ``Sponsor'' columns, remove ``048164'' and in its place add
``069254''.

0
26. In Sec.  558.95, add paragraph (d)(4)(v) to read as follows:

Sec.  558.95  Bambermycins.

* * * * *
    (d) * * *
    (4) * * *
    (v) Used as a free-choice Type C medicated loose mineral feed for
pasture cattle (slaughter, stocker, and feeder cattle; and dairy and
beef replacement heifers) as follows:
    (A) Specifications.

------------------------------------------------------------------------
                                        International
             Ingredient                   feed No.           Percent
------------------------------------------------------------------------
Deflorinated phosphate (20.5%                 6-01-080             42.50
 calcium, 18.5% phosphorus).........
Sodium chloride (salt)..............          6-04-152             20.10
Calcium carbonate (38% calcium).....          6-01-069             15.45
Corn distillers dried grains w/               5-28-236              9.57
 solubles...........................
Magnesium oxide.....................          6-02-756              5.15
Vitamin and trace mineral premix *..  ................              3.72
Mineral oil.........................  ................              1.00
Yeast (primary dehydrated yeast)....          7-05-533              0.75
Bambermycins Type A article (10 g/    ................              0.60
 lb)................................
Iron oxide..........................          6-02-431              0.50
Magnesium sulfate (67%).............          6-02-758              0.32
Copper sulfate......................          6-01-720              0.18

Potassium sulfate (0.33%)...........          6-06-098              0.16
------------------------------------------------------------------------
* Content of vitamin/trace mineral premix may be varied. However, they
  should be comparable to those used for other free-choice feeds.
  Formulation modifications require FDA approval prior to marketing.
  Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
  Policy Guides Sec. 651.100 (CPG 7125.18).

    (B) Amount per ton. 120 grams.
    (C) Indications for use. For increased rate of weight gain.
    (D) Limitations. For free-choice feeding to pasture cattle
(slaughter, stocker, and feeder cattle; and dairy and beef replacement
heifers). Feed a non-medicated commercial mineral product for 6 weeks
to stabilize consumption between 2.66 and 10.66 ounces per head per
day. Feed continuously to provide 10 to 40 milligrams bambermycins per
head per day. Daily bambermycins intakes in excess of 20 mg/head/day
have not been shown to be more effective than 20 mg/head/day.
* * * * *

0
27. Amend Sec.  558.128 as follows:
0
a. In paragraph (b)(1), remove ``Nos. 054771, 048164, and 066104'' and
in its place add ``Nos. 054771, 066104, and 069254'';
0
b. In paragraphs (e)(4)(ii) and (iv), in the ``Limitations'' column,
remove ``048164'' wherever it occurs and in its place add ``069254'';
0
c. In paragraphs (e)(1)(i), (ii), and (iii), (e)(2)(i), (ii), (iii),
and (iv), (e)(3)(i), (ii), (iii), and (iv), (e)(4)(i), (ii), (iv),
(vii), and (viii), and (e)(5)(i) and (ii), in the ``Sponsor'' column,
remove ``048164'' wherever it occurs and in its place in numerical
order add ``069254''; and
0
d. Revise paragraphs (e)(1)(iv), (e)(4)(v), and (e)(4)(ix).
    The revisions read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
        Chlortetracycline amount             Indications for use               Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(iv) 500 g/ton.........................  Chickens: For the           1. Feed for 5 d. To sponsor         054771,
                                          reduction of mortality      No. 054771 under NADA 048-761      069254.
                                          due to E. coli infections   and No. 069254 under ANADA
                                          susceptible to              200-510: zero withdrawal time.
                                          chlortetracycline.
                                                                     2. Feed for 5 d; withdraw 24 h      012286,
                                                                      prior to slaughter; do not         054771,
                                                                      feed to chickens producing         066104,
                                                                      eggs for human consumption.        069254.
----------------------------------------------------------------------------------------------------------------

* * * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
        Chlortetracycline amount             Indications for use               Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(v) 500 to 4,000 g/ton.................  Calves, beef and            Feed continuously for not more       054771
                                          nonlactating dairy          than 5 days to provide 10 mg/       069254
                                          cattle; treatment of        lb body weight per day. To
                                          bacterial enteritis         sponsor No. 054771 under NADA
                                          caused by E. coli and       046-699: 24-h withdrawal time.
                                          bacterial pneumonia        To sponsor No. 054771 under
                                          caused by P. multocida      NADA 048-761 and No. 069254
                                          susceptible to              under ANADA 200-510: Zero
                                          chlortetracycline.          withdrawal time.

                                                  * * * * * * *
(ix) 350 mg/head/day...................  1. Beef cattle: For         Withdraw 48 h prior to              012286,
                                          control of bacterial        slaughter. To sponsor No.          054771,
                                          pneumonia associated with   054771 under NADA 046-699: 48-     066104,
                                          shipping fever complex      h withdrawal time. To sponsor      069254.
                                          caused by Pasteurella       No. 054771 under NADA 048-761
                                          spp. susceptible to         and No. 069254 under ANADA
                                          chlortetracycline.          200-510: Zero withdrawal time.
                                         2. Beef cattle (under 700   Withdraw 48 h prior to              012286,
                                          lb): For control of         slaughter. To sponsor No.          054771,
                                          active infection of         054771 under NADA 046-699: 48-     066104,
                                          anaplasmosis caused by A.   h withdrawal time. To sponsor      069254.
                                          marginale susceptible to    No. 054771 under NADA 048-761
                                          chlortetracycline.          and No. 069254 under ANADA
                                                                      200-510: zero withdrawal time.
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec.  558.140  [Amended]

0
28. In Sec.  558.140, in paragraph (b)(1), remove ``048164'' and in its
place add ``069254''.

Sec.  558.145  [Amended]

0
29. In Sec.  558.145, in paragraph (a)(2), remove ``048164'' and in its
place add ``069254''.

Sec.  558.195  [Amended]

0
30. In Sec.  558.195, in paragraph (e)(2)(iv), in the ``Limitations''
and ``Sponsor'' columns, remove ``048164'' and in its place add
``069254''.

Sec.  558.355  [Amended]

0
31. In Sec.  558.355, in paragraph (f)(1)(xiv)(b), remove ``048164''
and in its place add ``069254''.

Sec.  558.450  [Amended]

0
32. Amend Sec.  558.450 as follows:
0
a. In paragraph (a)(2), remove ``048164'' and in its place add
``069254'';
0
b. In paragraphs (d)(2)(iii), (d)(2)(iv), and (d)(4)(ii), in the
``Limitations'' column, remove ``048164'' wherever it occurs and in its
place add ``069254''; and
0
c. In paragraphs (d)(1)(i), (ii), (iii), and (iv), (d)(2)(i), (ii),
(iii), and (iv), (d)(3)(i) and (ii), (d)(4)(i), (ii), (iii), (iv), and
(v), and (d)(5)(i), (ii), and (iii), in the ``Sponsor'' column, remove
``048164'' and in its place add ``069254''.

Sec.  558.455  [Amended]

0
33. Amend Sec.  558.455 as follows:
0
a. In paragraph (b), remove ``Nos. 048164 and 066104'' and in its place
add ``Nos. 066104 and 069254''; and
0
b. In paragraphs (e)(1)(i), (ii), (iii), and (iv), (e)(2)(i), (ii),
(iii), and (iv), (e)(3)(i) and (ii), and (e)(4)(i), (ii), (iii), (iv),
(v), and (vi), in the ``Sponsor'' column, remove ``048164'' and in its
place in numerical order add ``069254''.

Sec.  558.550  [Amended]

0
34. In Sec.  558.550, in paragraphs (b)(3) and (d)(1)(xvi)(c), remove
``048164'' and in its place add ``069254''.

Sec.  558.600  [Redesignated as Sec.  558.612 and Amended]

0
35. Redesignate Sec.  558.600 as Sec.  558.612 and amend newly
redesignated Sec.  558.612 as follows:
0
a. In paragraph (c), remove ``Sec.  556.738'' and in its place add
``Sec.  556.732''; and
0
b. In paragraph (e)(1)(iii), in the ``Limitations'' and ``Sponsor''
columns, remove ``048164'' and in its place in numerical order add
``069254''.

Sec.  558.615  [Redesignated as Sec.  558.600]

0
36. Redesignate Sec.  558.615 as Sec.  558.600.

Sec.  558.625  [Amended]

0
37. In Sec.  558.625, in paragraph (b)(5), remove ``048164'' and in its
place add ``069254''.

Sec.  558.630  [Amended]

0
38. In Sec.  558.630, in paragraph (b)(2), remove ``No. 054771'' and in
its place add ``Nos. 054771 and 069254''.

0
39. Amend Sec.  558.665 as follows:
0
a. Revise paragraphs (d)(1) and (e)(1);
0
b. Redesignate paragraph (d)(2) as paragraph (d)(4); and
0
c. Add paragraphs (d)(2), (d)(3), (e)(7), and (e)(8).
    The revisions and additions read as follows:

Sec.  558.665  Zilpaterol.

* * * * *
    (d) * * *
    (1) Labeling shall bear the following caution statements:
``Zilpaterol hydrochloride is not for use in animals intended for
breeding. Do not allow horses or other equines access to feed
containing zilpaterol. Do not use in veal calves.''
    (2) Labeling of Type A medicated articles and Type B medicated
feeds used to manufacture complete Type C medicated feeds shall bear
the caution statements in paragraph (d)(3) of this section.
    (3) Labeling of complete Type C medicated feeds shall bear the
following caution statements: ``Not to be fed to cattle in excess of 90
mg zilpaterol/head/day in complete feed. If pen consumption of complete
feed exceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol
should not be fed in complete feed.''
* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination grams/
     Zilpaterol in grams/ton              ton            Indications for use        Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 6.8.........................  ...................  Cattle fed in            Feed continuously         000061
                                                        confinement for          as the sole ration
                                                        slaughter: For           during the last 20
                                                        increased rate of        to 40 days on feed
                                                        weight gain, improved    to provide 60 to
                                                        feed efficiency, and     90 mg/head/day.
                                                        increased carcass        Withdrawal period:
                                                        leanness in cattle fed   3 days.
                                                        in confinement for
                                                        slaughter during the
                                                        last 20 to 40 days on
                                                        feed.

                                                  * * * * * * *
(7) 6.8 to 24...................  ...................  Cattle fed in            Feed continuously         000061
                                                        confinement for          to cattle during
                                                        slaughter: For           the last 20 to 40
                                                        increased rate of        days on feed to
                                                        weight gain, improved    provide 60 mg
                                                        feed efficiency, and     zilpaterol
                                                        increased carcass        hydrochloride per
                                                        leanness in cattle fed   head per day.
                                                        in confinement for       Withdrawal period:
                                                        slaughter during the     3 days.
                                                        last 20 to 40 days on
                                                        feed.
(8) 6.8 to 24...................  Monensin 10 to 40,   Cattle fed in            Feed continuously         000061
                                   plus tylosin 8 to    confinement for          to cattle during
                                   10.                  slaughter: For           the last 20 to 40
                                                        increased rate of        days on feed to
                                                        weight gain, improved    provide 60 mg
                                                        feed efficiency, and     zilpaterol
                                                        increased carcass        hydrochloride per
                                                        leanness in cattle fed   head per day. See
                                                        in confinement for       paragraphs Sec.
                                                        slaughter during the     Sec.   558.355(d)
                                                        last 20 to 40 days on    and 558.625(c).
                                                        feed; for prevention     Monensin and
                                                        and control of           tylosin as
                                                        coccidiosis due to       provided by No.
                                                        Eimeria bovis and E.     000986 in Sec.
                                                        zuernii; and for         510.600(c) of this
                                                        reduction of incidence   chapter.
                                                        of liver abscesses       Withdrawal period:
                                                        caused by                3 days.
                                                        Fusobacterium
                                                        necrophorum and
                                                        Arcanobacterium
                                                        (Actinomyces) pyogenes.
----------------------------------------------------------------------------------------------------------------

    Dated: March 9, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-05644 Filed 3-12-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72058-72059]
[FR Doc No: 2016-25223]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2406]

Emerging Issues and Cross-Cutting Scientific Advances;
Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

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

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to receive input on emerging issues and cross-cutting
scientific advances that may impact FDA preparedness and inter-Agency
activities. Interested parties are invited to submit comments regarding
emerging technologies and cross-cutting scientific advances of
importance to FDA. The focus is on areas that may impact FDA in 5 or
more years.

DATES: Submit either electronic or written comments by October 21,
2019.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-2406 for ``Emerging Issues and Cross-Cutting Scientific
Advances.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Donna Mendrick, National Center for
Toxicological Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Michael Morgan, Office of Regulatory
Science and Innovation, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public
health by assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our Nation's
food supply, cosmetics, and products that emit radiation. FDA is tasked
with advancing the public health by helping to speed innovations that
protect the public health. FDA also has responsibility for regulating
the manufacturing, marketing, and distribution of tobacco products, to
protect the public health, and to reduce tobacco use by minors.
Finally, FDA plays a significant role in the Nation's counterterrorism
capability. FDA fulfills this responsibility by ensuring the security
of the food supply, and by fostering development of medical products
used to respond to deliberate and naturally emerging public health
threats.
    FDA's ability to achieve its mission relies on awareness of, and
proactive preparedness for, emerging issues and scientific advances,
which will impact the development of regulated products well in advance
of formal FDA regulatory submissions (e.g., 5-10 years). To realize
this goal requires long-range horizon scanning by a cadre of scientific
leaders from FDA, other government Agencies, interested stakeholders,
and the public. Emerging sciences, such as synthetic biology, are
expected to impact FDA regulated products in the relatively near term.
The goal of this initiative is to identify issues and advances that
will impact the Agency in the longer term and thus may be in their
infancy.
    FDA formed the Emerging Sciences Working Group to provide an FDA-
wide science-based forum to identify and

communicate scientific regulatory approaches, in order to prepare for
anticipated high impact emerging science and technology. Additionally,
the Emerging Sciences Working Group informs and advises Agency and FDA
Center leadership on critical and cross-cutting issues likely to impact
regulatory policy development.
    The Emerging Sciences Working Group is seeking input from the
public to identify emerging science and technology. Results from long
range horizon scanning will assist FDA regarding emerging issues and
cross-cutting scientific advances, which may impact FDA preparedness in
the future.

    Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25223 Filed 10-18-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 31, 2007 (Volume 72, Number 249)]
[Notices]
[Page 74372-74373]
[DOCID:fr31de07-96]

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

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 28080; 812-13453]

The UBS Funds, et al.; Notice of Application

December 19, 2007.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from rule 12d1-2(a)
under the Act.

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

    Summary of Application: Applicants request an order to permit funds
of funds relying on rule 12d1-2 under the Act to invest in certain
financial instruments.
    Applicants: The UBS Funds, SMA Relationship Trust, UBS Investment
Trust, UBS Index Trust, UBS Series Trust, and UBS Relationship Funds
(collectively, the ``Trusts''); UBS Global Asset Management (Americas)
Inc. (the ``Advisor''); and UBS Global Asset Management (US) Inc.
(``UBS Global AM (US)'').
    Filing Dates: The application was filed on November 23, 2007, and
amended on December 14, 2007.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on January 15, 2008 and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, Commission, 100 F Street, NE., Washington, DC
20549-1090; Applicants, c/o Mark F. Kemper, UBS Global Asset Management
(Americas) Inc., One North Wacker Drive, Chicago, IL 60606.

FOR FURTHER INFORMATION CONTACT: Lewis Reich, Senior Counsel, at (202)
551-6919, or Nadya B. Roytblat, Assistant Director, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Branch, 100 F Street, NE., Washington, DC
20549-0104 (telephone<PHONE_NUMBER>).

Applicants' Representations

    1. Each Trust organized as a Delaware statutory trust or a
Massachusetts business trust and is registered under the Act as an
open-end management investment company. The Trusts offer separate
series (``Funds'') that may invest in other registered investment
companies in reliance on section 12(d)(1)(G) of the Act and rule 12d1-2
under the Act (``Underlying Funds'').\1\ Applicants propose that the
Funds be permitted to invest in futures contracts, options on futures
contracts, swap agreements, derivatives, and other financial
instruments that may not be securities within the meaning of section
2(a)(36) of the Act (``Other Investments'') in addition to the
Underlying Funds.\2\
---------------------------------------------------------------------------

    \1\ Applicants request that the relief apply to all existing and
future series of the Trusts and all other management investment
companies and their series registered under the Act that are in the
same group of investment companies, as defined in section
12(d)(1)(G) of the Act, as the Trusts. All Funds that currently
intend to rely on the order have been named as applicants. Any other
existing or future entity that relies on the order in the future
will do so only in accordance with the terms and conditions in the
application.
    \2\ As part of its strategy to invest in securities, Other
Investments and Underlying Funds, an Applicant Fund also may,
pursuant to rule 12d1-2 under the Act, invest in securities issued
by another registered investment company that is not in the same
group of investment companies as the Fund (a ``Non-Group Fund'')
consistent with section 12(d)(1)(A) or 12(d)(1)(F) of the Act.
---------------------------------------------------------------------------

    2. The Advisor is a Delaware corporation and an indirect, wholly-
owned subsidiary of UBS AG, an internationally diversified organization
with operations in many aspects of the financial services industry. The
Advisor is registered as an investment adviser under the Investment
Advisers Act of 1940 and serves as investment adviser to the Funds. UBS
Global AM (US), also a Delaware corporation and an indirect, wholly-
owned subsidiary of UBS AG, is registered as a broker-dealer under the
Securities Exchange Act of 1934 Act (``Exchange Act'') and serves as
the principal underwriter to The UBS Funds, SMA Relationship Trust, UBS
Investment Trust, UBS Index Trust, and UBS Series Trust.

Applicants' Legal Analysis

    Section 12(d)(1)(A) of the Act provides that no registered
investment company (``acquiring company'') may acquire securities of
another investment company (``acquired company'') if such securities
represent more than 3% of the acquired company's outstanding voting
stock or more than 5% of the acquiring company's total assets, or if
such securities, together with the securities of other investment
companies, represent more than 10% of the acquiring company's total
assets. Section 12(d)(1)(B) of the Act provides that no registered
open-end investment company may sell its securities to

another investment company if the sale will cause the acquiring company
to own more than 3% of the acquired company's voting stock, or cause
more than 10% of the acquired company's voting stock to be owned by
investment companies.
    1. Section 12(d)(1)(G) of the Act provides that section 12(d)(1)
will not apply to securities of an acquired company purchased by an
acquiring company if: (i) The acquiring company and acquired company
are part of the same group of investment companies; (ii) the acquiring
company holds only securities of acquired companies that are part of
the same group of investment companies, government securities, and
short-term paper; (iii) the aggregate sales loads and distribution-
related fees of the acquiring company and the acquired company are not
excessive under rules adopted pursuant to section 22(b) or section
22(c) of the Act by a securities association registered under section
15A of the Exchange Act or by the Commission; and (iv) the acquired
company has a policy that prohibits it from acquiring securities of
registered open-end management investment companies or registered unit
investment trusts in reliance on section 12(d)(1)(F) or (G) of the Act.
    2. Rule 12d1-2 under the Act permits a registered open-end
investment company or a registered unit investment trust that relies on
section 12(d)(1)(G) of the Act to acquire, in addition to securities
issued by another registered investment company in the same group of
investment companies, government securities, and short-term paper: (1)
Securities issued by an investment company that is not in the same
group of investment companies, when the acquisition is in reliance on
section 12(d)(1)(A) or 12(d)(1)(F) of the Act; (2) securities (other
than securities issued by an investment company); and (3) securities
issued by a money market fund, when the investment is in reliance on
rule 12d1-1 under the Act. For the purposes of rule 12d1-2,
``securities'' means any security as defined in section 2(a)(36) of the
Act.
    3. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction from any provisions of the Act, or
from any rule under the Act, if such exemption is necessary or
appropriate in the public interest and consistent with the protection
of investors and the purposes fairly intended by the policies and
provisions of the Act.
    4. Applicants state that the proposed arrangement would comply with
the provisions of rule 12d1-2 under the Act, but for the fact that the
Funds may invest a portion of their assets in Other Investments.
Applicants request an order under section 6(c) of the Act for an
exemption from rule 12d1-2(a) to allow the Funds to invest in Other
Investments. Applicants assert that permitting the Funds to invest in
Other Investments as described in the application would not raise any
of the concerns that the requirements of section 12(d)(1) were designed
to address.

Applicants' Conditions

    Applicants agree that the order granting the requested relief will
be subject to the following conditions:
    1. Prior to approving any investment advisory agreement under
section 15 of the Act, the board of trustees of the appropriate Fund,
including a majority of the trustees who are not ``interested
persons,'' as defined in section 2(a)(19) of the Act, will find that
the advisory fees, if any, charged under the agreement are based on
services provided that are in addition to, rather than duplicative of,
services provided pursuant to the advisory agreement of any Underlying
Fund or any Non-Group Fund in which the Fund may invest. Such findings,
and the basis upon which the findings are made, will be recorded fully
in the minute books of the appropriate Fund.
    2. Applicants will comply with all provisions of rule 12d1-2 under
the Act, except for paragraph (a)(2), to the extent that it restricts
any Fund from investing in Other Investments as described in the
application.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-25378 Filed 12-28-07; 8:45 am]

BILLING CODE 8011-01-P