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  |"Holmstead, Jeff"<EMAIL_ADDRESS>
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<EMAIL_ADDRESS>"Rentz, Rebecca"<EMAIL_ADDRESS>
RobertJ Wayland/RTP/USEPA/US@EPA, Michael Horowitz/DC/USEPA/US@EPA  |
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  |10/18/2010 04:26 PM
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  |Re: Concerns about CPMS Requirement
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Hi Jeff,
Thanks for your note outlining the concerns about the CPMS requirement.
As discussed in the response to comment # 8.1 in the summary of comments and
responses for the final rule, we believe that these systems are available and
our cost information is based on quotes from vendors of these systems.  I have
copied an excerpt from the response below.  Our cost estimates for the final
rule included not only the equipment cost discussed in the response, but also
costs for operating and maintaining
the systems.   We believe that we have appropriately accounted for the
CPMS costs in our analysis.  Without more information on the basis for your
estimates, we cannot determine why they are different from EPA's estimates.
We believe that the continuous temperature monitoring is necessary to
demonstrate that the emission limitations are being met on a continuous basis.
The catalyst inlet temperature is an important determinate of catalytic
activity and resulting emissions reduction.

Excerpt from response to comment # 8.1:
"EPA disagrees with the commenters’ views that affordable, long-lasting, off-
the-grid systems to measure and record temperatures and pressure differential
at unmanned, remote locations do not exist. One instrument packager and vendor
suggested use of his firm’s off-theshelf, battery-operated components. Stand-
alone temperature measurements could be made and recorded using a single
channel data logger ($129), a temperature sensor ($40), and a copy of software
($99), while stand-alone pressure differential measurements could be made and
recorded using a multi-channel data logger ($485), a differential pressure
sensor ($220), and a copy of software ($89). As the battery life for such
systems is over 14 months and the data loggers can hold over 43,000 data
points – more than 14 months of 15 minute readings – each system could operate
unattended for more than a year. Assuming that an average source has 4
engines, equipment costs for a stand-alone temperature system would be under
$200 per point, while equipment costs for a stand-alone pressure differential
system would be under $370 per point. Of course, these equipment costs could
be further reduced by consolidating the number of data loggers. Given that
off-the-shelf equipment is available and that plant personnel are expected to
visit each remote site at least once per year, when the data loggers could be
downloaded or swapped out, we find no barriers for measuring and recording 15-
minute temperature and pressure differential data at remote sites."

Melanie King
Energy Strategies Group
Sector Policies and Programs Division
Office of Air Quality Planning and Standards U.S. Environmental Protection
Agency

Mail Code D243-01
RTP, NC  27711

Phone:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>
<EMAIL_ADDRESS>

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  |Melanie King/RTP/USEPA/US@EPA, "Rentz, Rebecca"<EMAIL_ADDRESS>
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  |10/15/2010 05:42 PM
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  |Concerns about CPMS Requirement
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Bob,

Sorry for the delay in getting back to you with more information about the
requirement for continuous parametric monitoring systems (CPMS) on 4SRB and
4SLB RICE > 500 hp.  As I mentioned, we had not really focused on this issue
before the rule came out because the table in the proposal seemed to suggest
that CPMS would not be required at area sources.

Over the last couple months, the Exterran folks have spent a lot of time and
effort (including meetings with CPMS vendors) trying to understand what this
requirement would actually mean for their fleet.  They didn’t want to go back
to you and Melanie unless it was a big issue for them, but they really believe
that the CPMS requirement for >500 hp engines at area sources will be much
more costly than EPA has estimated – quite a bit more expensive than actually
installing and operating catalytic controls on the engines.  They also point
out that the rule already includes 2 other compliance assurance mechanisms
that they believe will be more effective than CPMS, and that the CPMS
requirement won’t really accomplish anything in terms of reducing emissions.

It looks like the full cost of CPMS installation and operation is not
reflected in the Agency’s cost assessments for 4SRB and 4SLB > 500 hp at area
sources.  EPA has estimated that the cost of the CPMS requirement is about
$568 per engine.  Based on everything we have seen (including meetings to seek
pricing from vendors), the actual cost for Exterran to purchase and install
CPMS will be in the range of $6,000 - $8,000 per engine.  But this is not the
full cost – especially for engines at area sources, which are generally
located in remote areas.  On top of the initial cost, Exterran estimates that
the annual operating costs (primarily for gathering, reviewing and processing
the raw CPMS data) will be in the range of $9,000 - $13,000 per engine.  The
biggest part of this cost is for the time it will take to review the CPMS data
and match it up with operating events to explain the frequent temperature
variations that will occur at virtually all their engines.

Using our best estimates of the cost of CPMS requirement (including
installation and ongoing operation), we believe that the cost per ton of
formaldehyde reduced will be about 3 times higher than the estimates in the
final rule for both 4SLB and 4SRB > 500 hp at area sources.  Our estimate (and
we can provide you with a lot of backup data and analysis) is that it will
likely be more than $89,000 per ton of formaldehyde reduced for 4SLBs and
about $320,000 for 4SRBs.

Our technical folks also believe that CPMS is unlikely to achieve any
additional emission reductions because it is just one of three compliance
assurance provisions in the rule.  CPMS measures the catalyst inlet
temperature and is one indicator of catalyst performance but not the most
relevant one.  They believe that the required monthly measurement of
differential pressure across a catalyst is actually a better indicator for
catalyst performance because it will show whether a catalyst is plugged (as
indicated by high pressure differential) or has been blown out by an engine
backfire (as indicated by low pressure differential).  In addition to the
monthly measurement of pressure differential, the ZZZZ performance-testing
requirement is another compliance assurance mechanism.  Given the additional
cost and technical challenges associated with installing CPMS at area sources,
we really don’t believe that CMPS is warranted for these engines.

Although CPMS provides a near continuous measurement of inlet temperature,
operators will still need to go out and gather the data periodically and then
review it against past operating events.  Thus, CPMS will not identify
potential catalyst problems any sooner than the monthly measurement of
pressure differential.  In place of CPMS data collection (and associated
retroactive data review), we believe that regular temperature checks, together
with the required pressure readings and performance tests, makes much more
sense for the thousands of unmanned area sources.  This approach would ensure
regular on-the-spot checks and immediate maintenance actions, as opposed to
the retroactive data analysis that would be conducted for each semi-annual
report submittal.  Regular manual collection of temperature and pressure
differential would give a better indication of compliance by allowing the
operator to review both measures at the same time and then implement any
necessary maintenance actions immediately at the site.

Again, I am sorry we were not able to get this information to you sooner, but
we wanted to be sure that we really understood these issues before raising
them to you.  Please shoot me a message or give me a call
if you have any questions.<PHONE_NUMBER>.

Jeff


[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Proposed Rules]
[Pages 43459-43462]
[FR Doc No: 2022-15554]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0887; Project Identifier MCAI-2022-00051-T]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace LP (Type
Certificate Previously Held by Israel Aircraft Industries, Ltd.)
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Gulfstream Aerospace LP Model Gulfstream G150 airplanes.
This proposed AD was prompted by reports that wing flap fairing
debonding and corrosion were discovered at certain areas of the lower
skin on both wings. This proposed AD requires an inspection for
corrosion in certain areas of the wing skin fairings, additional
inspections if necessary, resealing the fairings with new fillet seal,
and applicable corrective actions, as specified in the Civil Aviation
Authority of Israel (CAAI) AD, which is proposed for incorporation by
reference. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by September
6, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Gulfstream
Aerospace Corporation, P.O. Box 2206, Mail Station D-25, Savannah, GA
31402-2206; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
[email protected]; internet https://www.gulfstream.com/customer-support. You may view this service information at the FAA,
Airworthiness Products

Section, Operational Safety Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0887; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, International Validation Branch, FAA, 2200 South
216th Street, Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0887; Project Identifier
MCAI-2022-00051-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dan
Rodina, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    The CAAI, which is the aviation authority for Israel, has issued AD
ISR I-57-2021-12-3, dated January 1, 2022 (CAAI AD ISR I-57-2021-12-3)
(also referred to after this as the Mandatory Continuing Airworthiness
Information, or the MCAI), to correct an unsafe condition for certain
Gulfstream Aerospace LP Model Gulfstream G150 airplanes.
    This proposed AD was prompted by reports that wing flap fairing
debonding and corrosion were discovered at the lower skin of rib 3 and
rib 11 on both wings. The FAA is proposing this AD to address flap
fairing debonding and moisture intrusion that might lead to lower wing
skin corrosion and cracking on both wings, and reduced structural
integrity of the wings. See the MCAI for additional background
information.

Related Service Information Under 1 CFR Part 51

    CAAI AD ISR I-57-2021-12-3, dated January 1, 2022, describes
procedures for an inspection for corrosion in the area of the wing skin
(or doubler if installed) under the rib 3 and rib 11 fairings, a
penetration or eddy current inspection for cracks if corrosion was
found, a measurement of the thickness of remaining wing skin (or
doubler) if no cracks were found, resealing of rib 3 and rib 11
fairings with new fillet seal, and applicable corrective actions.
Corrective actions include cleaning and removing corrosion, crack
repair, and repair of fairing installation locations with a certain
thickness reduction. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
and service information referenced above. The FAA is proposing this AD
because the FAA evaluated all the relevant information and determined
the unsafe condition described previously is likely to exist or develop
on other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD requires accomplishing the actions specified in
CAAI AD ISR I-57-2021-12-3 described previously, except for any
differences identified as exceptions in the regulatory text of this
proposed AD.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 87 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                 Labor cost                               Parts cost                  product        operators
----------------------------------------------------------------------------------------------------------------
29 work-hours x $85 per hour = $2,465.......  Minimal...........................          $2,465        $214,455
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition action that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need these on-condition actions:

                Estimated Costs of On-Condition Actions *
------------------------------------------------------------------------
          Labor cost              Parts cost        Cost per product
------------------------------------------------------------------------
Up to 10 work-hours x $85 per               $0  Up to $850.
 hour = $850.
------------------------------------------------------------------------
* The FAA has received no definitive data on which to base the cost
  estimates for the on-condition repairs specified in this proposed AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is 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

    The FAA 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) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Gulfstream Aerospace LP (Type Certificate Previously Held by Israel
Aircraft Industries, Ltd.): Docket No. FAA-2022-0887; Project
Identifier MCAI-2022-00051-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by September 6, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Gulfstream Aerospace LP Model Gulfstream G150
airplanes, certificated in any category, as identified in The Civil
Aviation Authority of Israel (CAAI) AD ISR I-57-2021-12-3, dated
January 1, 2022 (CAAI AD ISR I-57-2021-12-3).

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by reports that wing flap fairing debonding
and corrosion were discovered at lower skin of rib 3 and rib 11 on
both wings. The FAA is issuing this AD to address flap fairing
debonding and moisture intrusion that might lead to lower wing skin
corrosion and cracking on both wings, and reduced structural
integrity of the wings.

(f) Compliance

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

(g) Required Actions

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, CAAI AD ISR I-57-2021-12-3.

(h) Exceptions to Service Information Specifications

    (1) Where CAAI AD ISR I-57-2021-12-3 refers to its effective
date, this AD requires using the effective date of this AD.
    (2) Where the Compliance paragraph of CAAI AD ISR I-57-2021-12-3
requires compliance at a certain time, replace the text ``at the
next suitable planned maintenance inspection within the next 24
months from the effective date of this AD'' with ``within 24 months
after the effective date of this AD.''
    (3) Where the Action paragraph of CAAI AD ISR I-57-2021-12-3
refers to certain service information, replace the text ``Gulfstream
Service Bulletin No.150-57-197, dated January 01, 2022, or later
approved revision,'' with ``Gulfstream Service Bulletin No. 150-57-
197, Revision 1, dated June 16, 2022, or later approved revision.''
    (4) Where the service information specified in CAAI AD ISR I-57-
2021-12-3 specifies to report to Gulfstream if ``cracks were
discovered'' and ``for any fairing installation location with one or
more grid squares with thickness reduction of greater than 10%,''
for this AD, cracks and fairing installation locations with one or
more grid squares with thickness reduction of greater than 10% must
be repaired before further flight using a method approved by the
Manager, Large Aircraft Section, International Validation Branch,
FAA; or CAAI; or CAAI's authorized Designee. If approved by the
authorized Designee, the approval must include the Designee's
authorized signature.

(i) No Reporting Requirement

    Although the service information referenced in CAAI AD ISR I-57-
2021-12-3 specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (k)(2) of
this AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section,

International Validation Branch, FAA; or the Civil Aviation
Authority of Israel (CAAI); or the CAAI's authorized Designee. If
approved by the CAAI Designee, the approval must include the
Designee's authorized signature.

(k) Related Information

    (1) For CAAI AD ISR I-57-2021-12-3, dated January 01, 2022,
contact Civil Aviation Authority of Israel (CAAI), P.O. Box 1101,
Golan Street, Airport City, 70100, Israel; telephone 972-3-9774665;
fax 972-3-9774592; email [email protected]. You may find this CAAI AD
on the CAAI website at https://www.caa.gov.il. You may view this
material at the FAA, Airworthiness Products Section, Operational
Safety Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
This material may be found in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-
2022-0887.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected].

    Issued on July 15, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-15554 Filed 7-20-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Rules and Regulations]
[Pages 14584-14588]
[FR Doc No: 2018-06961]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 526, and 558

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship; Change of a Sponsor's Name and Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during October, November, and December 2017. FDA
is 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 changes
of sponsorship of applications and a change of a sponsor's name and
address.

DATES: This rule is effective April 5, 2018.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during October, November, and December
2017, 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 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 Dockets
Management Staff (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: https://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: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                       Table 1--Original and Supplemental NADAs and ANADAs Approved During
                                      October, November, and December 2017
----------------------------------------------------------------------------------------------------------------
                                                                                Effect of the
 Approval date   File No.       Sponsor        Product name        Species          action      Public documents
----------------------------------------------------------------------------------------------------------------
October 27,       141-467  Elanco US Inc.,   Avilamycin and    Chickens......  Original         FOI Summary; EA/
 2017.                      2500 Innovation   narasin Type C                    approval for     FONSI. \1\
                            Way,              medicated feeds.                  use of
                            Greenfield, IN                                      INTREPITY
                            46140.                                              (avilamycin)
                                                                                and MONTEBAN
                                                                                (narasin) Type
                                                                                A medicated
                                                                                articles to
                                                                                manufacture
                                                                                Type C
                                                                                medicated
                                                                                broiler
                                                                                chicken feeds
                                                                                for the
                                                                                prevention of
                                                                                mortality
                                                                                caused by
                                                                                necrotic
                                                                                enteritis
                                                                                associated
                                                                                with
                                                                                Clostridium
                                                                                perfringens,
                                                                                and the
                                                                                prevention of
                                                                                coccidiosis
                                                                                caused by
                                                                                Eimeria
                                                                                necatrix, E.
                                                                                tenella, E.
                                                                                acervulina, E.
                                                                                brunetti, E.
                                                                                mivati, and E.
                                                                                maxima.
October 27,       141-466  Elanco US Inc.,   Avilamycin,       Chickens......  Original         FOI Summary; EA/
 2017.                      2500 Innovation   narasin, and                      approval for     FONSI. \1\
                            Way,              nicarbazin Type                   use of
                            Greenfield, IN    C medicated                       INTREPITY
                            46140.            feeds.                            (avilamycin)
                                                                                and MAXIBAN
                                                                                (narasin and
                                                                                nicarbazin)
                                                                                Type A
                                                                                medicated
                                                                                articles to
                                                                                manufacture
                                                                                Type C
                                                                                medicated
                                                                                broiler
                                                                                chicken feeds
                                                                                for the
                                                                                prevention of
                                                                                mortality
                                                                                caused by
                                                                                necrotic
                                                                                enteritis
                                                                                associated
                                                                                with
                                                                                Clostridium
                                                                                perfringens,
                                                                                and the
                                                                                prevention of
                                                                                coccidiosis
                                                                                caused by
                                                                                Eimeria
                                                                                necatrix, E.
                                                                                tenella, E.
                                                                                acervulina, E.
                                                                                brunetti, E.
                                                                                mivati, and E.
                                                                                maxima.
November 9,       106-111  Zoetis Inc., 333  TELAZOL           Dogs..........  Supplemental     FOI Summary.
 2017.                      Portage St.,      (tiletamine and                   approval for
                            Kalamazoo, MI     zolazepam for                     intravenous
                            49007.            injection).                       administration
                                                                                in dogs for
                                                                                induction of
                                                                                anesthesia
                                                                                followed by
                                                                                maintenance
                                                                                with an
                                                                                inhalant
                                                                                anesthetic.
November 21,      200-473  Huvepharma EOOD,  TYLOVET (tylosin  Chickens......  Supplemental     FOI Summary.
 2017.                      5th Floor, 3A     tartrate)                         approval for
                            Nikolay Haytov    Soluble Powder.                   the control of
                            Str., 1113                                          mortality
                            Sofia, Bulgaria.                                    caused by
                                                                                necrotic
                                                                                enteritis
                                                                                associated
                                                                                with
                                                                                Clostridium
                                                                                perfringens in
                                                                                broiler
                                                                                chickens.
November 30,      097-505  Zoetis Inc., 333  Lincomycin Type   Swine.........  Supplemental     ................
 2017.                      Portage St.,      B and Type C                      approval for
                            Kalamazoo, MI     medicated feeds.                  use of
                            49007.                                              LINCOMIX
                                                                                (lincomycin)
                                                                                Type A
                                                                                medicated
                                                                                articles to
                                                                                manufacture
                                                                                Type B and
                                                                                Type C
                                                                                medicated
                                                                                swine feeds
                                                                                for reduction
                                                                                in the
                                                                                severity of
                                                                                the effects of
                                                                                respiratory
                                                                                disease
                                                                                associated
                                                                                with
                                                                                Mycoplasma
                                                                                hyopneumoniae.
December 11,      141-441  Virbac AH, Inc.,  IVERHART MAX      Dogs..........  Original         FOI Summary.
 2017.                      3200 Meacham      (ivermectin,                      approval of a
                            Blvd., Ft.        pyrantel                          soft chewable
                            Worth, TX 76137.  pamoate,                          tablet to
                                              praziquantel)                     prevent canine
                                              Soft Chew.                        heartworm
                                                                                disease by
                                                                                eliminating
                                                                                the tissue
                                                                                stage of
                                                                                heartworm
                                                                                larvae
                                                                                (Dirofilaria
                                                                                immitis) for a
                                                                                month (30
                                                                                days) after
                                                                                infection and
                                                                                for the
                                                                                treatment and
                                                                                control of
                                                                                roundworm
                                                                                (Toxocara
                                                                                canis,
                                                                                Toxascaris
                                                                                leonina),
                                                                                hookworm
                                                                                (Ancylostoma
                                                                                caninum,
                                                                                Uncinaria
                                                                                stenocephala,
                                                                                Ancylostoma
                                                                                braziliense),
                                                                                and tapeworm
                                                                                (Dipylidium
                                                                                caninum,
                                                                                Taenia
                                                                                pisiformis)
                                                                                infections.
December 12,      200-617  Pharmgate LLC,    Chlortetracyclin  Cattle........  Original         ................
 2017.                      1800 Sir Tyler    e and lasalocid                   approval for
                            Dr.,              Type B and Type                   use of DERACIN
                            Wilmington, NC    C medicated                       (chlortetracyc
                            28405.            feeds.                            line) and
                                                                                BOVATEC
                                                                                (lasalocid)
                                                                                Type A
                                                                                medicated
                                                                                articles to
                                                                                manufacture
                                                                                Type B and
                                                                                Type C
                                                                                medicated
                                                                                cattle feeds
                                                                                as a generic
                                                                                copy of NADA
                                                                                141-250.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact
  of this action and has made a finding of no significant impact (FONSI).

II. Changes of Sponsorship

    Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS
66211 has informed FDA that it has transferred ownership of, and all
rights and interest in, the following application to Elanco US, Inc.,
2500 Innovation Way, Greenfield, IN 46140:

------------------------------------------------------------------------
            File No.                   Product name       21 CFR section
------------------------------------------------------------------------
141-455........................  GALLIPRANT (grapiprant)        520.1084
                                  Tablets.
------------------------------------------------------------------------

    Strategic Veterinary Pharmaceuticals, Inc., 100 NW Airport Rd., St.
Joseph, MO 64503 has informed FDA that it has transferred ownership of,
and all rights and interest in, the following applications to HQ
Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ
07652:

------------------------------------------------------------------------
            File No.                   Product name       21 CFR section
------------------------------------------------------------------------
055-097........................  DRY-MAST (pen G               526.1696b
                                  procaine/
                                  dihydrostreptomycin
                                  sulfate) Infusion.
------------------------------------------------------------------------

    Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box
8500, Mankato, MN 56002-8500 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following
applications to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato,
MN 56001:

------------------------------------------------------------------------
            File No.                   Product name       21 CFR section
------------------------------------------------------------------------
141-187........................  CRYSTALYX IONO-LYX              558.311
                                  (lasalocid) Type C
                                  Medicated Protein
                                  Block.
------------------------------------------------------------------------

    Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. Box
8500, Mankato, MN 56002-8500 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following application
to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato, MN 56001:

------------------------------------------------------------------------
            File No.                   Product name       21 CFR section
------------------------------------------------------------------------
033-733........................  SWEETLIX BLOAT-GUARD           520.1840
                                  (poloxalene) Pressed
                                  Block.
------------------------------------------------------------------------

    Accordingly, the animal drug regulations are being amended to
reflect these changes of sponsorship. Following these withdrawals of
approval, neither Ridley Block Operations, Inc. nor Ridley U.S.
Holdings, Inc. is the sponsor of an approved application. Accordingly,
these firms will be removed from the list of sponsors of approved
applications in Sec.  510.600(c) (21 CFR 510.600(c)).

III. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document
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.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, and 526

    Animal drugs.

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, 21 CFR parts
510, 520, 522, 526, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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

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

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry
for ``Ridley Block Operations, Inc.'' and revise the entry for ``Ridley
U.S. Holdings, Inc.''; and in the table in paragraph (c)(2), remove the
entry for ``068287'' and revise the entry for ``067949''.
    The revisions read as follows:

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

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

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

                              * * * * * * *
Ridley USA, Inc., 111 W Cherry St., Suite 500,                   067949
 Mankato, MN 56001............................

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

    (2) * * *

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

                              * * * * * * *
067949........................................  Ridley USA, Inc., 111 W
                                                                       Cherry St., Suite 500,
                                                     Mankato, MN 56001.

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

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec.  520.1084   [Amended]

0
4. In Sec.  520.1084, in paragraph (b), remove ``086026'' and in its
place add ``058198''.

Sec.  520.1199   [Amended]

0
5. In Sec.  520.1199, in paragraph (a) introductory text, remove
``chewable tablet'' and in its place add ``chewable tablet or soft
chewable tablet''; and in paragraph (c)(2), remove ``Prevents'' and in
its place add ``To prevent''.

0
6. In Sec.  520.2640, revise paragraphs (b)(1) and (2) to read as
follows:

Sec.  520.2640   Tylosin.

* * * * *
    (b) * * *
    (1) Nos. 016592 and 058198 for use as in paragraph (e) of this
section.
    (2) No. 061623 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii),
(e)(2), (e)(3), and (e)(4) of this section.
* * * * *

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

0
7. The authority citation for part 522 continues to read as follows:

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

0
8. In Sec.  522.2470, revise paragraphs (b) and (c) to read as follows:

Sec.  522.2470   Tiletamine and zolazepam for injection.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) No. 054771 for use as in paragraph (c) of this section.
    (2) Nos. 026637 and 051311 for use as in paragraphs (c)(1)(i)(A),
(c)(1)(ii)(A), (c)(1)(iii) and (c)(2) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. Expressed as
milligrams of the drug combination:
    (A) An initial intramuscular dosage of 3 to 4.5 milligrams per
pound (mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of
body weight for minor procedures of short duration such as repair of
lacerations and wounds, castrations, and other procedures requiring
mild to moderate analgesia. Supplemental doses when required should be
less than the initial dose and the total dose given should not exceed
12 mg/lb of body weight. The maximum total safe dose is 13.6 mg/lb of
body weight.
    (B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg)
body weight to effect for induction of anesthesia followed by
maintenance with an inhalant anesthetic.
    (ii) Indications for use. (A) Intramuscular administration in dogs
for restraint and minor procedures of short duration (30 minutes
average) requiring mild to moderate analgesia.
    (B) Intravenous administration in dogs for induction of anesthesia
followed by maintenance with an inhalant anesthetic.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. An initial intramuscular dosage of 4.4 to 5.4
mg/lb of body weight is recommended for such procedures as dentistry,
treatment of abscesses, foreign body removal, and related types of
surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring
mild to moderate analgesia, such as repair of lacerations, castrations,
and other procedures of short duration. Initial dosages of 6.5 to 7.2
mg/lb of body weight are recommended for ovariohysterectomy and
onychectomy. When supplemental doses are required, such individual
supplemental doses should be given in increments that are less than the
initial dose and the total dose given (initial dose plus supplemental
doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb
of body weight.
    (ii) Indications for use. For restraint or for anesthesia combined
with muscle relaxation.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 526 continues to read as follows:

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

Sec.  526.1696b   [Amended]

0
10. In Sec.  526.1696b, in paragraph (b), remove ``054628'' and in its
place add ``042791''.

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

0
11. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
12. In Sec.  558.68, add paragraphs (e)(1)(iii) and (iv) to read as
follows:

Sec.  558.68  Avilamycin.

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

----------------------------------------------------------------------------------------------------------------
                                     Combination in
     Avilamycin in grams/ton           grams/ton       Indications for use        Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(iii) 13.6 to 40.9..............  Narasin,...........  Broiler chickens:    Feed as the sole ration       058198
                                  54 to 90...........   For the prevention   for 21 consecutive
                                                        of mortality         days to chickens that
                                                        caused by necrotic   are at risk of
                                                        enteritis            developing, but not
                                                        associated with      yet showing clinical
                                                        Clostridium          signs of, necrotic
                                                        perfringens; and     enteritis associated
                                                        for the prevention   with Clostridium
                                                        of coccidiosis       perfringens. To assure
                                                        caused by Eimeria    responsible
                                                        necatrix, E.         antimicrobial drug use
                                                        tenella, E.          in broiler chickens,
                                                        acervulina, E.       treatment
                                                        brunetti, E.         administration must
                                                        mivati, and E.       begin on or before 10
                                                        maxima.              days of age. Do not
                                                                             allow adult turkeys,
                                                                             horses, or other
                                                                             equines access to
                                                                             narasin formulations.
                                                                             Ingestion of narasin
                                                                             by these species has
                                                                             been fatal. Narasin as
                                                                             provided by No. 058198
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.
(iv) 13.6 to 40.9...............  Narasin............  Broiler chickens:    Feed as the sole ration       058198
                                  27 to 45;..........   For the prevention   for 21 consecutive
                                  nicarbazin.........   of mortality         days to chickens that
                                  27 to 45...........   caused by necrotic   are at risk of
                                                        enteritis            developing, but not
                                                        associated with      yet showing clinical
                                                        Clostridium          signs of, necrotic
                                                        perfringens; and     enteritis associated
                                                        for the prevention   with Clostridium
                                                        of coccidiosis       perfringens. To assure
                                                        caused by Eimeria    responsible
                                                        necatrix, E.         antimicrobial drug use
                                                        tenella, E.          in broiler chickens,
                                                        acervulina, E.       treatment
                                                        brunetti, E.         administration must
                                                        mivati, and E.       begin on or before 10
                                                        maxima.              days of age. Do not
                                                                             allow adult turkeys,
                                                                             horses, or other
                                                                             equines access to
                                                                             narasin formulations.
                                                                             Ingestion of narasin
                                                                             by these species has
                                                                             been fatal. Do not
                                                                             feed to laying hens.
                                                                             Withdraw 5 days before
                                                                             slaughter. Narasin and
                                                                             nicarbazin as provided
                                                                             by No. 058198 in Sec.
                                                                              510.600(c) of this
                                                                             chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec.  558.128   [Amended]

0
13. In Sec.  558.128, in paragraph (e)(4), in the ``Sponsor'' column,
numerically add ``069254'' to paragraphs (e)(4)(ii), (vii), (viii),
(ix), and (xviii) through (xxvi).

Sec.  558.311   [Amended]

0
14. In Sec.  558.311, in paragraph (b)(9) and in paragraph (e)(1)(xix),
in the ``Sponsor'' column, remove ``068287'' and in its place add
``067949''.

0
15. In Sec.  558.325 revise paragraph (e)(2)(xiv) to read as follows:

Sec.  558.325   Lincomycin.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in
      Lincomycin grams/ton            grams/ton        Indications for use        Limitations        Sponsors
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(xiv) 100 to 200...............  ..................  For reduction in the     Feed as sole                054771
                                                      severity of the          ration for 21
                                                      effects of respiratory   days.
                                                      disease associated
                                                      with Mycoplasma
                                                      hyopneumoniae.

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

* * * * *

    Dated: March 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06961 Filed 4-4-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 2, 2008 (Volume 73, Number 192)]
[Notices]
[Page 57387-57389]
[DOCID:fr02oc08-116]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-28408]

Notice of Applications for Deregistration under Section 8(f) of
the Investment Company Act of 1940

September 26, 2008.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
September, 2008. A copy of each application may be obtained for a fee
at the Commission's Public Reference Room, 100 F Street NE, Washington,
DC 20549-1520 (tel.<PHONE_NUMBER>). An order granting each application
will be issued unless the SEC orders a hearing. Interested persons may
request a hearing on any application by writing to the SEC's Secretary
at the address below and serving the relevant applicant with a copy of
the request, personally or by mail. Hearing requests should be received
by the SEC by 5:30 p.m. on October 21, 2008, and should be accompanied
by proof of service on the applicant, 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 Secretary, U.S. Securities and
Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

FOR FURTHER INFORMATION CONTACT: Diane L. Titus at<PHONE_NUMBER>, SEC,
Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

AIM Special Opportunities Funds [File No. 811-8697]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On April 19, 2007, applicant transferred its
assets to corresponding series of AIM Funds Group, based on net asset
value. Expenses of $320,500 incurred in connection with the
reorganization were paid by Invesco Aim Advisors, Inc., applicant's
investment adviser.
    Filing Dates: The application was filed on August 8, 2008, and
amended on September 19, 2008.
    Applicant's Address: 11 Greenway Plaza, Suite 100, Houston, TX
77046-1173.

Legg Mason Partners Appreciation Fund, Inc. [File No. 811-1940] Legg
Mason Partners Capital Fund, Inc. [File No. 811-2667] Legg Mason
Partners Aggressive Growth Fund, Inc. [File No. 811-3762] CitiFunds
Trust I [File No. 811-4006]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On April 16, 2007, each applicant
transferred its assets to a corresponding series of Legg Mason Partners
Equity Trust, based on net asset value. Expenses of approximately
$2,487,856, $521,422, $4,718,848 and $6,788, respectively, incurred in
connection with the reorganizations were paid by each applicant and
Legg Mason, Inc., the parent company of the investment adviser for each
applicant.
    Filing Date: The applications were filed on August 15, 2008.
    Applicants' Address: 55 Water St., New York, NY 10041.

Legg Mason Partners California Municipals Fund, Inc. [File No. 811-
3970] Legg Mason Partners Adjustable Rate Income Fund [File No. 811-
6663]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On April 16, 2007, each applicant
transferred its assets to corresponding series of Legg Mason Partners
Income Trust, based on net asset value. Expenses of approximately
$78,899 and $103,534, respectively, incurred in connection with the
reorganizations were paid by each applicant and Legg Mason Inc., the
parent company of the investment adviser for each applicant.
    Filing Date: The applications were filed on August 15, 2008.
    Applicants' Address: 55 Water St., New York, NY 10041.

Credit Suisse Short Duration Bond Fund [File No. 811-21032]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On July 30, 2008, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $8,200 incurred in connection with the liquidation were
paid by Credit Suisse Asset Management, LLC, applicant's investment
adviser. Applicant has retained $11,851 in cash for payment of
outstanding expenses.
    Filing Date: The application was filed on September 12, 2008.
    Applicant's Address: c/o Credit Suisse Asset Management, LLC,
Eleven Madison Ave., New York, NY 10010.

Dreyfus Florida Intermediate Municipal Bond Fund [File No. 811-6489]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On December 3, 2007, applicant transferred
its assets to Dreyfus Intermediate Municipal Bond Fund, Inc., based on
net asset value. Expenses of $56,540 incurred in connection with the
reorganization were paid by applicant and the acquiring fund.
    Filing Date: The application was filed on September 4, 2008.
    Applicant's Address: c/o The Dreyfus Corporation, 200 Park Ave.,
New York, NY 10166.

Dreyfus Florida Municipal Money Market Fund [File No. 811-7091]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 27, 2007, applicant transferred
its assets to Dreyfus Municipal Money Market Fund, Inc., based on net
asset value. Expenses of $47,480 incurred in connection with the
reorganization were paid by applicant and the acquiring fund.
    Filing Date: The application was filed on September 8, 2008.
     Applicant's Address: c/o The Dreyfus Corporation, 200 Park Ave.,
New York, NY 10166.

Dreyfus Insured Municipal Bond Fund, Inc. [File No. 811-4237]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On June 11, 2007, applicant transferred its
assets to Dreyfus Municipal Bond Fund, a series of Dreyfus Bond Funds,
Inc., based on net asset value. Expenses of $30,124 incurred in
connection with the reorganization were paid by The Dreyfus
Corporation, applicant's investment adviser.
    Filing Date: The application was filed on September 8, 2008.
     Applicant's Address: c/o The Dreyfus Corporation, 200 Park Ave.,
New York, NY 10166.

Dreyfus Massachusetts Intermediate Municipal Bond Fund [File No. 811-
6644]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On April 24, 2007, applicant transferred its
assets to Dreyfus Premier State Municipal Bond Fund--Massachusetts
Series--Class Z shares, based on net asset value. Expenses of $30,124
incurred in connection with the reorganization were paid by The Dreyfus
Corporation, applicant's investment adviser.
    Filing Date: The application was filed on September 4, 2008.
     Applicant's Address: c/o The Dreyfus Corporation, 200 Park Ave.,
New York, NY 10166.

Dreyfus New Jersey Intermediate Municipal Bond Fund [File No. 811-6643]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On June 7, 2007, applicant transferred its
assets to Dreyfus Premier New Jersey Municipal Bond Fund, Inc. (Class Z
shares), based on net asset value. Expenses of $30,124 incurred in
connection with the reorganization were paid by The Dreyfus
Corporation, applicant's investment adviser.
    Filing Date: The application was filed on September 4, 2008.
     Applicant's Address: c/o The Dreyfus Corporation, 200 Park Ave.,
New York, NY 10166.

Dreyfus New York Tax Exempt Intermediate Bond Fund [File No. 811-5161]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 28, 2007, applicant transferred
its assets to Dreyfus New York Tax Exempt Bond Fund, Inc., based on net
asset value. Expenses of $55,080 incurred in connection with the
reorganization were paid by applicant and the acquiring fund.
    Filing Date: The application was filed on September 8, 2008.
     Applicant's Address: c/o The Dreyfus Corporation, 200 Park Ave.,
New York, NY 10166.

Dreyfus Pennsylvania Intermediate Municipal Bond Fund [File No. 811-
7089]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 29, 2007, applicant transferred
its assets to Dreyfus Premier State Municipal Bond Fund--Pennsylvania
Series--Class Z shares, based on net asset value. Expenses of $53,460
incurred in connection with the reorganization were paid by applicant
and the acquiring fund.
    Filing Date: The application was filed on September 8, 2008.
     Applicant's Address: c/o The Dreyfus Corporation, 200 Park Ave.,
New York, NY 10166.

Dreyfus Premier GNMA Fund [File No. 811-4880]

    Summary: Applicant seeks an order declaring that it has ceased to
be an

investment company. On May 3, 2007, applicant transferred its assets to
Dreyfus Premier GNMA Fund, Inc., based on net asset value. Expenses of
$46,307 incurred in connection with the reorganization were paid by The
Dreyfus Corporation, applicant's investment adviser.
    Filing Date: The application was filed on September 4, 2008.
     Applicant's Address: c/o The Dreyfus Corporation, 200 Park Ave.,
New York, NY 10166.

Black Pearl Funds [File No. 811-21785]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On July 30, 2008, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $4,500 incurred in connection with the liquidation were
paid by Firsthand Capital Management, Inc., applicant's investment
adviser.
    Filing Date: The application was filed on August 29, 2008.
     Applicant's Address: Firsthand Capital Management, Inc., 125 South
Market St., Suite 1200, San Jose, CA 95113.

XTF Investors Trust [File No. 811-22002]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On March 10, 2008 and July 25, 2008,
applicant made liquidating distributions to its shareholders, based on
net asset value. Expenses of $3,440 incurred in connection with the
liquidation were paid by applicant and XTF Advisors, LLC, applicant's
investment adviser.
    Filing Date: The application was filed on August 29, 2008.
     Applicant's Address: c/o Gemini Fund Services, LLC, 450 Wireless
Blvd., Hauppauge, NY 11788.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-23198 Filed 10-1-08; 8:45 am]

BILLING CODE 8011-01-P