[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Pages 8151-8153]
[FR Doc No: 2019-03574]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2017-0020; Notice 2]

Volkswagen Group of America, Inc., Grant of Petition for Decision
of Inconsequential Noncompliance

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

ACTION: Grant of petition.

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SUMMARY: Volkswagen Group of America, Inc. (Volkswagen), has determined
that certain model year (MY) 2012-2017 Volkswagen motor vehicles do not
fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No.
126, Electronic Stability Control Systems for Light Vehicles.
Volkswagen filed a noncompliance report dated March 1, 2017, and later
revised it on December 21, 2017. Volkswagen also petitioned NHTSA on
March 2, 2017, and amended the petition on December 21, 2017, for a
decision that the subject noncompliance is inconsequential as it
relates to motor vehicle safety. This document announces the grant of
this petition.

FOR FURTHER INFORMATION CONTACT: Vince Williams, Office of Vehicle
Safety Compliance, NHTSA, telephone<PHONE_NUMBER>, facsimile (202)
366-3081.

SUPPLEMENTARY INFORMATION:
    I. Overview: Volkswagen, has determined that certain MY 2012-2017
Volkswagen motor vehicles do not fully comply with paragraph S5.3.3 of

FMVSS No. 126, Electronic Stability Control Systems for Light Vehicles
(49 CFR 571.126). Volkswagen filed a noncompliance report dated March
1, 2017, and later revised it on December 21, 2017, pursuant to 49 CFR
part 573, Defect and Noncompliance Responsibility and Reports.
Volkswagen also petitioned NHTSA on March 2, 2017, and amended the
petition on December 21, 2017, for an exemption from the notification
and remedy requirements of 49 U.S.C. chapter 301 on the basis that this
noncompliance is inconsequential as it relates to motor vehicle safety,
pursuant to 49 U.S.C. 30118(d) and 30120(h) and 49 CFR part 556.
    Notice of receipt of the petition was published with a 30-day
public comment period, on May 18, 2017, in the Federal Register (82 FR
22869). No comments were received. To view the petition and all
supporting documents, log onto the Federal Docket Management System
(FDMS) website at: https://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2017-0020.''
    II. Vehicles Involved: Approximately 53,911 MY 2013-2017 Volkswagen
CC motor vehicles, manufactured between January 19, 2012, and November
28, 2016, and approximately 176,547 MY 2012-2017 Volkswagen Tiguan
motor vehicles, manufactured between January 9, 2012, and February 28,
2017, are potentially involved.
    Volkswagen revised its noncompliance report and amended its
petition on December 21, 2017, to include approximately 12,541 MY 2015-
2017 Audi Q3 motor vehicles, manufactured between April 16, 2014, and
June 25, 2015, thus, bringing the new total of potentially affected
vehicles to 242,999.
    III. Noncompliance: Volkswagen explains that during an electronic
stability control (ESC) malfunction in the subject vehicles, the ESC
system malfunction telltale illuminates as required by FMVSS No. 126
unless the steering angle sensor is the source of the malfunction. In
the instance of a steering angle sensor malfunction, the ESC system
malfunction telltale does not re-illuminate immediately after the
vehicle ignition is reactivated, as required by paragraph S5.3.3 of
FMVSS No. 126. Specifically, the ESC system malfunction telltale will
only re-illuminate after the vehicle reaches a speed of 1.2 mph and
will remain continuously illuminated thereafter as required by FMVSS
No. 126 for the rest of the ignition cycle regardless of vehicle speed.
    IV. Rule Requirements: Paragraph S5.3.3 of FMVSS No. 126, includes
the requirements that, subject to the exceptions not relevant to this
petition, the ESC malfunction telltale must illuminate when an ESC
malfunction exists and must remain continuously illuminated as long as
the malfunction exists whenever the ignition locking system is in the
``On'' position.
    V. Summary of Volkswagen's Petition: Volkswagen stated that the
condition described above is inconsequential as it relates to motor
vehicle safety because the warning (ESC system malfunction telltale)
immediately re-illuminates when the vehicle starts to move and reaches
2 km/h or 1.2 mph.
    Furthermore, Volkswagen explained that the condition is limited to
an ESC system fault caused by the steering angle sensor. For all other
potential ESC system faults, the ESC system malfunction telltale
illuminates as required with the next ignition key in the ``On''
(``Run'') position.
    Volkswagen concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    Volkswagen's petition analyses and supporting documents are
available by logging onto the Federal Docket Management System (FDMS)
website at https://www.regulations.gov and following the online search
instructions to locate the docket number listed in the heading of this
notice.
    NHTSA's Analysis: NHTSA has reviewed Volkswagen's analyses that the
subject noncompliance is inconsequential to motor vehicle safety.
Specifically, in the instance of a steering angle sensor malfunction,
the ESC system malfunction telltale does not re-illuminate immediately
after the vehicle ignition is reactivated as required by paragraph
S5.3.3 of FMVSS No. 126.
    Volkswagen explained that the ESC system malfunction telltale does
not re-illuminate when the ignition is reactivated as required,
however, it does illuminate immediately when the vehicle starts to move
and reaches 2 km/h or 1.2 mph. Volkswagen stated that this specific
condition is limited only to a malfunction caused by the steering angle
sensor and that for all other potential ESC system malfunctions, the
telltale illuminates as required when the ignition locking system is in
the ``On'' (``Run'') position.
    On March 28, 2017, and November 16, 2017, NHTSA contacted
Volkswagen to request additional information regarding the behavior of
the ESC system malfunction telltale. In response to those requests,
Volkswagen explained that these vehicles were originally designed with
the 2km/h (1.2 mph) threshold to prevent nuisance ESC system
malfunction telltale activations during steering component workshop
troubleshooting and repairs. Volkswagen clarified that during
subsequent ignition cycles, the ESC system malfunction telltale on
these vehicles illuminates after the vehicle speed reaches 2 km/h or
1.2 mph and stays illuminated for the entire ignition cycle regardless
of vehicle speed (i.e., even if the vehicle speeds falls back down
below 2 km/h or 1.2 mph). Volkswagen added that these vehicles are also
equipped with a separate Electronic Power Steering (EPS) warning light,
on the dashboard in clear view of the driver, that illuminates when the
steering angle sensor malfunctions, and is illuminated during the
period of time the ESC malfunction telltale is required to illuminate
but does not.
    The agency believes that the subject noncompliance poses no
significant risk to motor vehicle safety as discussed below. If the
vehicle is in operation when a steering angle sensor malfunction first
occurs, the ESC malfunction telltale will illuminate and stay
illuminated as required by the standard until the vehicle's ignition is
turned off. It is only upon re-activation of the ignition system that
the malfunction telltale does not re-illuminate immediately but then
does so very quickly when the vehicle begins to move. After the
telltale does re-illuminate, it remains illuminated, regardless of
vehicle speed, until the malfunction is corrected or the ignition is
deactivated once again. The ESC malfunction telltale will not
illuminate for very short periods of time, between when the ignition is
activated and the vehicle reaches a speed of 2 km/h. If this condition
ever occurs, it will take place for a very short duration of time at
very low speeds, conditions under which a vehicle loss of control due
to instabilities that require the ESC system to activate will not
occur.
    Finally, Volkswagen did mention that these vehicles are also
equipped with a separate EPS warning light that when activated is on
the dashboard in clear view of the driver. The symbol used for the EPS
telltale is a vehicle's steering wheel. This telltale will illuminate
when the steering angle sensor malfunctions, and is illuminated during

the period-of-time the ESC malfunction telltale is required to
illuminate but does not.
    NHTSA's Decision: In consideration of the foregoing, NHTSA finds
that Volkswagen has met its burden of persuasion that the FMVSS No. 126
noncompliance is inconsequential as it relates to motor vehicle safety.
Accordingly, Volkswagen's petition is hereby granted and Volkswagen is
consequently exempted from the obligation to provide notification of,
and a free remedy for, that noncompliance under 49 U.S.C. 30118 and
30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the subject vehicles that Volkswagen no longer
controlled at the time it determined that the noncompliance existed.
However, the granting of this petition does not relieve vehicle
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after
Volkswagen notified them that the subject noncompliance existed.

    Authority:  49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Michael A. Cole,
Acting Director, Office of Vehicle Safety Compliance.
[FR Doc. 2019-03574 Filed 3-5-19; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Rules and Regulations]
[Page 60721]
[FR Doc No: 2011-25220]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2011-N-0003]

New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental abbreviated new
animal drug application (ANADA) filed by Ivy Laboratories, Division of
Ivy Animal Health, Inc. The supplemental ANADA provides for use of
increased dose levels of melengestrol acetate and monensin in two-way,
combination drug Type C medicated feeds for heifers fed in confinement
for slaughter.

DATES: This rule is effective September 30, 2011.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a
supplement to ANADA 200-422 for use of HEIFERMAX 500 (melengestrol
acetate) and RUMENSIN (monensin, USP) single-ingredient Type A
medicated articles to make two-way, combination drug Type C medicated
feeds for heifers fed in confinement for slaughter. The supplemental
ANADA provides for use of increased dose levels of melengestrol acetate
and monensin. The supplemental application is approved as of July 1,
2011, and the regulations in 21 CFR 558.342 are amended to reflect the
approval and minor revisions.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application 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.
    The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    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 in 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 part 558 is
amended as follows:

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

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

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

0
2. In Sec.  558.342, in the table in paragraph (e)(1), remove and
reserve paragraphs (e)(1)(v) and (e)(1)(vi); in paragraph (e)(1)(x), in
the ``Sponsor'' column, add ``021641''; and revise paragraph (d)(2) to
read as follows:

Sec.  558.342  Melengestrol.

* * * * *
    (d) * * *
    (2) A physically stable melengestrol acetate liquid Type B or C
feed will not be subject to the requirements for mixing directions
prescribed in paragraph (d)(1) of this section provided it has a pH of
4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a
viscosity of not less than 300 centipoises per second for 3 months.
* * * * *

    Dated: September 20, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2011-25220 Filed 9-29-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34353-34354]
[FR Doc No: 2016-12657]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Advisory Committee; Science Advisory Board to the National Center
for Toxicological Research; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Science Advisory Board to the National Center for
Toxicological Research (NCTR) by the Commissioner of Food and Drugs
(the Commissioner). The Commissioner has determined that it is in the
public interest to renew the Science Advisory Board to the National
Center for Toxicological Research for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until June
2, 2018.

DATES: Authority for the Science Advisory Board to the National Center
for Toxicological Research will expire on June 2, 2016, unless the
Commissioner formally determines that renewal is in the public
interest.

FOR FURTHER INFORMATION CONTACT: Donna L. Mendrick, National Center for
Toxicological Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301-
796-8892<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Science Advisory Board to the National Center for
Toxicological Research. The committee is a discretionary Federal
advisory committee established to provide advice to the Commissioner.
The Science Advisory Board to the National Center for Toxicological
Research advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drugs for human use and, as required, any other product for which FDA
has regulatory responsibility. The Board advises the Director, NCTR, in
establishing, implementing, and evaluation the research programs that
assist the Commissioner of Food and Drugs in fulfilling his regulatory
responsibilities. The Board provides an extra-agency review in ensuring
that the research programs at NCTR are scientifically sound and
pertinent.
    The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of toxicological research. Members will be invited to serve for
overlapping terms of up to 4 years. Almost all non-Federal members of
this committee serve as Special Government Employees. The core of
voting members may include one technically qualified member, selected
by the Commissioner or designee, who is identified with consumer
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons.
    Further information regarding the most recent charter and other
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ToxicologicalResearch/ucm148166.htm or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no change has been made to the
committee name or description of duties, no amendment will be made to
21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 24, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-12657 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 30, 2010 (Volume 75, Number 125)]
[Notices]
[Page 37786]
[DOCID:fr30jn10-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-31-000]

 DCP Guadalupe Pipeline, LLC; Notice of Baseline Filing

June 23, 2010.
    Take notice that on June 10, 2010, DCP Guadalupe Pipeline, LLC
submitted a baseline filing of its Storage Statement of Operating
Conditions for services provided under Section 311 of the Natural Gas
Policy Act of 1978 (``NGPA'').
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern time on Friday, July 2, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-15838 Filed 6-29-10; 8:45 am]
BILLING CODE 6717-01-P


September 8, 2004 Mr. James I. Palmer, Jr. Regional Administrator U. S EPA, Region 4 61 Forsyth Street Atlanta, Georgia 30303 RE: PM2.5 Non attainment Designations Dear Mr. Palmer:

In your June 29, 2004 letter, you provided North Carolina with EPA's response to our state's PM2.5 non attainment boundary recommendations. North Carolina has been a leader among states with regard to improving air quality and remains committed to the continued improvement of air quality and the protection of its citizens. The non attainment boundary recommendations made by EPA include several counties that North Carolina continues to believe should be designated attainment for PM2.5. Below, I state why North Carolina believes that these counties should be designated attainment. I also urge you to consider again the discussion and technical documents presented in our initial February 2004 submissions. In addition, please find attached our PM2.5 Designation Response Technical Support Document.

In the Greensboro/ Winston Salem/ High Point area, EPA recommends that the entire counties of Stokes, Guilford, Davidson, Forsyth and Randolph be designated non attainment. North Carolina originally recommended Davidson County only as the PM2.5 non attainment boundary. We continue to believe that only Davidson County should be designated as nonattainment

North Carolina believes that Stokes County should be designated attainment for the following reasons. While Stokes County contains the Belews Creek power plant, an analysis of forward trajectories indicates that emissions from Belews Creek do not frequently impact the PM2.5 monitor in Davidson County. There are also PM2.5 monitors currently attaining the standard in Forsyth County that lie between Stokes County and the non attaining monitor in Davidson County. Even if the Belews Creek facility is affecting the Lexington area, significant NOx controls have already been installed on the plant. Selective catalytic reduction systems have already been installed on units 1 and 2 at the Belews Creek facility, and additional burner technology has been added at unit 2. This NOx control technology began operation in 2003 and 2004. Consequently, the NOx emissions will decrease from 43,567 tons per year to 7,022 tons per year and new SO2 controls will be installed over the next several years as a result of the Clean Smokestacks Act. SO2 emissions from Belews Creek will be reduced by nearly 90% in the next several years as these controls become fully operational. Mr. James I. Palmer, Jr. September 8, 2004 Page 2 of 4 Also, Stokes County is an extremely rural county, and therefore has very little mobile emissions. North Carolina believes that the current and future controls on the Belews Creek facility, the apparent small impact of Belews Creek on Davidson County, and the rural nature of the county support designating Stokes County in attainment for PM2.5. If EPA continues to believe that Stokes County should be designated non attainment because of Belews Creek, North Carolina recommends that only the Sauratown Township where the Belews Creek power plant is located be designated non attainment.

North Carolina believes that Randolph County should be designated attainment for several reasons. The EPA L Factor ranking for Randolph County is the lowest of the counties recommended by EPA to be designated non attainment. Randolph County is also predominately downwind of Davidson County during the summer months when PM2.5 concentrations are the highest and therefore emissions from Randolph County would not be expected to contribute significantly to PM2.5 concentrations in Davidson County during those months. The majority of emissions within Randolph County are mobile emissions and less than 5% of the workforce commutes into Davidson County. Furthermore, the mobile source emissions will be addressed by federal rules such as heavy duty engine standards and low sulfur diesel.

Guilford and Forsyth counties each contain PM2.5 monitors that are attaining the standard based on current design values. The counties also lie to the north and northeast of Davidson County, which makes Guilford and Forsyth counties predominately downwind of Davidson County during the summer months when PM2.5 is the highest. The majority of emissions from these counties are mobile, and therefore these counties and surrounding counties will benefit from federal rules addressing mobile emissions as well as the expanded North Carolina motor vehicle inspection program. They will also benefit from local measures aimed at reducing mobile emissions as part of the Early Action Compact ( EAC) effort in the Triad area.

North Carolina has an analysis that shows PM2.5 concentration and its relationship to population density in the Triad area. The Lexington monitor does not behave the same as surrounding monitors when considering the population around the monitoring site. The analysis suggests that the higher concentrations of PM2.5 in Davidson County are the result of local factors rather than broader population related regional influences and therefore the addition of counties beyond just Davidson County will not help the monitor attain the standard. Please see appendix for details.

Finally, with regard to the Lexington monitor, there has been a downward trend in the PM2.5 concentrations since 1999. We believe that this in considerable part reflects some reductions in the emission of pollutants in certain upwind states over that period. EPA itself has already concluded that these out of state sources contribute significantly to elevated PM2.5 in North Carolina. We expect that the downward trend should continue at this site as more emissions reductions are expected due to implementation of the Clean Smokestacks Act, NOx SIP call rules, federal heavy duty engine standards and new fuel standards. We anticipate further improvement in Lexington monitor air quality will result from positive action by EPA on North Carolina's section 126 petition, as well as actual promulgation of the proposed Clean Air Mr. James I. Palmer, Jr. September 8, 2004 Page 3 of 4 Interstate Rule, both of which will further reduce the contribution from upwind, out of state sources to the Lexington area's non attainment and maintenance problems.

For the reasons stated herein, North Carolina believes that only Davidson County should be designated non attainment, while Stokes, Randolph, Guilford and Forsyth counties should be designated as attainment for PM2.5.

With regard to the non attaining monitor in Hickory, North Carolina continues to oppose a non attainment designation for any area beyond the metropolitan planning organization boundary of Catawba County. There is little to be gained by including the partial counties of Burke and Caldwell in the non attainment area for the Hickory region for several reasons. Catawba County emissions are significantly higher than both Burke and Caldwell counties in the L Factor analysis. The bulk of emissions from these counties is from the mobile sector and therefore will benefit from state and federal rules addressing mobile emissions. There would be little to no additional opportunity to reduce mobile emissions by designating Burke and Caldwell counties as non attainment.

A non attainment designation for PM2.5 would place significant additional burdens on Burke and Caldwell counties since these counties are already participating in an EAC for ozone. These counties are making progressive strides to reduce emissions as part of the EAC effort and North Carolina feels that a designation of non attainment for these counties would do little to reduce PM2.5 in Catawba County. North Carolina believes the recommendation to designate only Catawba County as non attainment is appropriate, while Burke, Caldwell and the non MPO parts of Catawba counties should be designated as attainment for PM2.5.

Furthermore, on the basis of air quality data for 2004 gathered to date, North Carolina believes there is a significant probability that the Hickory monitor will attain the standard based on complete 2002 2004 data. We expect that it will be possible to maintain this attainment status as more emissions reductions are expected due to implementation of the Clean Smokestacks Act, NOx SIP call rules, federal heavy duty engine standards and new fuel standards. We are also anticipating needed reductions from upwind out of state sources from the proposed Clean Air Interstate Rule, North Carolina's section 126 petition and other initiatives, which will help Davidson County as well. EPA already has concluded that these out of state sources contribute significantly to elevated PM2.5 in North Carolina.

North Carolina therefore suggests that EPA designate the Hickory area as " unclassifiable", if the designation is made before December 31, 2004. The designation for this area as attainment can then be finalized in February 2004 using the 2002 2004 data, assuming that it in fact shows what we anticipate. Alternatively, if the designation is made after December 31, 2004, the designation should be based on the 2002 2004 data. This approach would conserve significant federal, state and local resources by avoiding the need for the redesignation demonstration, as well as transportation conformity, in an area that is already attaining the PM2.5 standard. Mr. James I. Palmer, Jr. September 8, 2004 Page 4 of 4 Finally, on June 21, 2004, I wrote to the Administrator to register our concerns regarding the recently introduced emissions weighted approach for nonattainment boundary delineation. I reiterate those comments here. In particular, the emissions weighted analysis fails to account for prevailing wind directions during the periods when PM2.5 values are higher, assumes incorrectly that emissions impact a monitor equally throughout the year, fails to consider distance between emissions and the monitors, and fails to recognize any effects from the significant reductions resulting from North Carolina's Clean Smokestacks Act. The most glaring demonstration of the weakness of the emissions weighted approach is that some counties EPA intends to designate as nonattainment under this approach actually are in attainment according to monitors located in those counties. Moreover, this emissions weighted analysis was introduced late and so could not be addressed by the Governors in their initial recommendations. This runs counter to the statefederal interactive process prescribed by law. For these reasons, the State believes that the use of the emissions weighted approach is arbitrary and should not influence the final delineation of nonattainment area boundaries.

North Carolina is proud to be a leader in the improvement of air quality and is committed to the continued improvement of air quality within its borders. We have invested significant resources in understanding the nature of our air quality issues and feel confident that our recommendation to designate only Davidson and Catawba counties is sufficient for the state and EPA to continue the work toward protecting the health of our citizens. We know that you and your colleagues will give these comments careful attention as EPA evaluates and makes the final decisions on PM2.5 boundaries later this year. We appreciate that careful attention because we also appreciate the nature and extent of the challenge EPA faces in making these decisions across the nation.

Sincerely,

William G. Ross, Jr.

Attachment: PM2.5 Designation Response Technical Support Document cc: Secretary Lyndo Tippett ( w/ o attachment) Secretary James Fain ( w/ o attachment) Keith Overcash ( w/ o attachment)


[Federal Register: January 23, 2009 (Volume 74, Number 14)]
[Notices]
[Page 4272-4274]
[DOCID:fr23ja09-112]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59243; File No. SR-Phlx-2008-86]

 Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
to Amending the Phlx Fee Schedule

January 13, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 30, 2008, NASDAQ OMX PHLX, Inc. (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been substantially prepared by the Exchange. Phlx has
designated this proposal as one establishing or changing a member due,
fee, or other charge imposed under Section 19(b)(3)(A)(ii) of the Act
\3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to

solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange, pursuant to Section 19(b)(1) of the Act \5\ and Rule
19b-4 thereunder,\6\ proposes to amend its Summary of Equity Option,
and MNX, NDX, RUT and RMN Charges (``Summary of Equity Option''),
Summary of Index Option Charges, $60,000 ``Firm Related'' Equity Option
and Index Option Cap, and Summary of U.S. Dollar-Settled Foreign
Currency Option Charges fee schedules. Specifically, the Exchange
proposes to: (1) Consolidate the comparison and transaction charges on
its fee schedules into one charge, (2) assess a customer execution
charge of $0.12 per contract side on options on the Russell 2000 [reg]
Index (the ``Full Value Russell Index'' or ``RUT''), and options on the
one-tenth value Russell 2000[supreg] Index \7\ (the ``Reduced Value
Russell Index'' or ``RMN'') on the Summary of Equity Option fee
schedule; and (3) create a Broker-Dealer transaction charge on the
Summary of Index Option Charges and Summary of U.S. Dollar-Settled
Foreign Currency Option Charges fee schedules.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(1).
    \6\ 17 CFR 240.19b-4.
    \7\ Russell 2000[supreg] is a trademark and service mark of the
Frank Russell Company, used under license. Neither Frank Russell
Company's publication of the Russell Indexes nor its licensing of
its trademarks for use in connection with securities or other
financial products derived from a Russell Index in any way suggests
or implies a representation or opinion by Frank Russell Company as
to the attractiveness of investment in any securities or other
financial products based upon or derived from any Russell Index.
Frank Russell Company is not the issuer of any such securities or
other financial products and makes no express or implied warranties
of merchantability or fitness for any particular purpose with
respect to any Russell Index or any data included or reflected
therein, nor as to results to be obtained by any person or any
entity from the use of the Russell Index or any data included or
reflected therein.
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    The Exchange also proposes to delete from the Summary of Equity
Option fee schedule the Specialist Deficit (Shortfall) fee and the
14,000 contract cap that is applied to Registered Options Traders
(``ROTs'') transaction and comparison charges and Specialist
transaction charges when contra-party to a non-AUTOM delivered customer
order.
    The Exchange also proposes to delete from its Summary of Equity
Option fee schedule unnecessary footnotes \8\ and to delete from its
Summary of Index Option Charges and Summary of U.S. Dollar-Settled
Foreign Currency Option Charges fee schedules unnecessary text (marked
with ``**'') relating to rebate request forms for Firm/Proprietary
transaction charges.
---------------------------------------------------------------------------

    \8\ The Commission also notes that the remaining footnotes have
been re-numbered.
---------------------------------------------------------------------------

    Additionally, the Exchange proposes to increase the Firm Related
\9\ equity option and index option cap from $60,000 per month to
$65,000 per month and to exclude the current U.S. dollar-settled
foreign currency option transaction and comparison charges from this
cap.
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    \9\ See, e.g., Securities Exchange Act Release Nos. 54981
(December 20, 2006), 71 FR 78251 (December 28, 2006) (SR-Phlx-2006-
86); 53287 (February 14, 2006), 71 FR 9186 (February 22, 2006) (SR-
Phlx-2006-10) and 56437 (September 13, 2007), 72 FR 53616 (September
19, 2007) (SR-Phlx-2007-65).
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    While changes to the fee schedule pursuant to this proposal are
effective upon filing, the Exchange has designated these changes to be
operative for transactions settling on or after January 2, 2009.\10\
---------------------------------------------------------------------------

    \10\ This filing was inadvertently filed as a Stock Clearing
Corporation of Philadelphia filing instead of a NASDAQ OMX PHLX
filing. As a result of refiling, Exhibit 5 now reflects amendments
that were made in SR-Phlx-2008-85. The Commission notes that SR-
Phlx-2008-85 has since been withdrawn and re-filed as SR-Phlx-2008-
87.
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    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    Generally, the purpose of the proposed rule change is to update the
Exchange's fee schedules by adopting new fees and deleting fees and
text that are no longer deemed necessary.
    Currently, the Exchange separately itemizes comparison and
transaction charges. The Exchange proposes to eliminate the comparison
fee as a separate line item and instead imbed the fee in the existing
transaction charge. This change will not change the actual amount being
charged to Exchange members, but should simplify the fee schedules so
that total transaction costs are more easily understood.\11\
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    \11\ This proposal is similar to a proposal filed by the
International Securities Exchange, LLC (``ISE'') whereby ISE
eliminated its comparison fee as a separate line item and imbedded
the fee into the execution fee. See Securities Exchange Act Release
No. 58139 (July 10, 2008), 73 FR 41142 (July 17, 2008) (SR-ISE-2008-
54).
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    The purpose of creating a separate Broker-Dealer transaction charge
on the Summary of Index Option Charges and Summary of U.S. Dollar-
Settled Foreign Currency Option Charges fee schedules is to raise
revenue and to specifically set forth the Broker-Dealer transaction
charges, which are currently included in the customer transaction
charges. Previously, Broker-Dealers and customers were each charged a
$.40 transaction fee and a $.04 comparison fee for a combined charge of
$.44. The Exchange proposes to raise revenue by increasing the total
fee charged to Broker-Dealers by $.01. This new rate of $.45 for
Broker-Dealers is the same charge that Broker-Dealer incur with respect
to equity options.\12\ The Exchange believes that separating the
Broker-Dealer transaction charges from the customer transaction charges
should help to more readily identify the applicable transaction
charges.
---------------------------------------------------------------------------

    \12\ See e-mail from Angela S. Dunn, Counsel, Phlx, to Richard
Holley III, Senior Special Counsel, Commission, dated January 8,
2009.
---------------------------------------------------------------------------

    The purpose of assessing a customer an equity option transaction
charge of $0.12 per contract side for customer executions in RUT and
RMN is to raise revenue, while remaining competitive in the
marketplace.\13\
---------------------------------------------------------------------------

    \13\ The Exchange currently assesses an equity option
transaction charge of $0.12 per contract for customer executions
options on the one-tenth of the value of the Nasdaq 100 Index (the
``Mini Nasdaq 100 Index'' or ``MNX'') and options on the full value
of the Nasdaq 100 Index (the ``Full-size Nasdaq 100 Index'' or
``NDX''). See Securities Exchange Act Release No. 58049 (June 27,
2008), 73 FR 38286 (July 3, 2008) (SR-Phlx-2008-46).
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    The Exchange proposes to delete the language that is marked with
``**'' on both the Summary of Index Option Charges and the Summary of
U.S. Dollar-Settled Foreign Currency Option Charges in order to delete
obsolete language. The Exchange is able to identify Firm/Proprietary
Orders electronically and therefore submitting a rebate request form is
no longer necessary.
    The purpose of deleting language, which relates to identifying
certain trademarks, from footnotes that appear in the Summary of Equity
Option fee schedule is to remove unnecessary and/or outdated language
from the fee schedule. Although the Exchange

intends to continue trading the MNX, NDX, RUT and RMN products, it does
not believe that, at this time, the language in the related footnotes
should be included on the Summary of Equity Option fee schedule.
    The Exchange has decided for business purposes to exclude the
current U. S. dollar-settled foreign currency option transaction and
comparison charges from the $60,000 Firm-Related Equity Option and
Index Option Cap calculation. The Exchange believes that it can
continue to attract this business without offering the cap, which
should also help to raise revenue.
2. Statutory Basis
    The Exchange believes that its proposal to amend its schedule of
fees is consistent with Section 6(b) of the Act \14\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \15\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among Exchange members. By amending the Exchange's
fee schedule and adding nominal fees and deleting fees and text the
Exchange no longer deems necessary, the Exchange believes that members
and member organizations should benefit from the proposals described
herein.
---------------------------------------------------------------------------

    \14\15 U.S.C. 78f(b).
    \15\15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

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

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \16\ and paragraph (f)(2) of Rule 19b-4 \17\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \17\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2008-86 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2008-86. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-Phlx-2008-86 and should be
submitted on or before February 13, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-1297 Filed 1-22-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Page 31355]
[FR Doc No: 2021-12246]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92119; File No. SR-NASDAQ-2020-082]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Designation of a Longer Period for Commission Action on
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change, as Modified by Amendment No. 1, To Offer Certain Listed
Companies Access to a Complimentary Board Recruiting Solution To Help
Advance Diversity on Company Boards

June 7, 2021.
    On December 1, 2020, The Nasdaq Stock Market LLC (``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
offer certain listed companies access to a complimentary board
recruiting solution to help advance diversity on company boards. The
proposed rule change was published for comment in the Federal Register
on December 10, 2020.\3\ On January 19, 2021, pursuant to Section
19(b)(2) of the Act,\4\ the Commission designated a longer period
within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ On February 26, 2021, the
Exchange filed Amendment No. 1 to the proposed rule change, which
replaced and superseded the proposed rule change as originally filed.
On March 10, 2021, the Commission published notice of Amendment No. 1
and instituted proceedings pursuant to Section 19(b)(2)(B) of the Act
\6\ to determine whether to approve or disapprove the proposed rule
change, as modified by Amendment No. 1.\7\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 90571 (December 4,
2020), 85 FR 79556. Comments received on the proposed rule change
are available on the Commission's website at: https://www.sec.gov/comments/sr-nasdaq-2020-082/srnasdaq2020082.htm.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 90952, 86 FR 7148
(January 26, 2021). The Commission designated March 10, 2021 as the
date by which the Commission shall approve or disapprove, or
institute proceedings to determine whether to disapprove, the
proposed rule change.
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 91286, 86 FR 14484
(March 16, 2021).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \8\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for notice and comment in the
Federal Register on December 10, 2020. June 8, 2021 is 180 days from
that date, and August 7, 2021 is 240 days from that date.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider the proposed
rule change and the comment letters. Accordingly, the Commission,
pursuant to Section 19(b)(2) of the Act,\9\ designates August 7, 2021
as the date by which the Commission shall either approve or disapprove
the proposed rule change (File No. SR-NASDAQ-2020-082), as modified by
Amendment No. 1.
---------------------------------------------------------------------------

    \9\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(57).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-12246 Filed 6-10-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33757-33758]
[FR Doc No: 2014-13757]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-P-0136 (Formerly Docket No. 2006P-0496) and Docket
No. FDA-2007-P-0353 (Formerly Docket No. 2007P-0034)]

Determination That AZO GANTANOL (Phenazopyridine Hydrochloride,
Sulfamethoxazole) Tablet, 100 Milligrams/500 Milligrams, and AZO
GANTRISIN (Phenazopyridine Hydrochloride, Sulfisoxazole) Tablet, 50
Milligrams/500 Milligrams, Were Not Withdrawn From Sale for Reasons of
Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its
determination that AZO GANTANOL (phenazopyridine hydrochloride (HCl)
and sulfamethoxazole) Tablet, 100 milligrams (mg)/500 mg, and AZO
GANTRISIN (phenazopyridine HCl and sulfisoxazole) Tablet, 50 mg/500 mg,
were not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for phenazopyridine HCl and sulfamethoxazole
tablet, 100 mg/500 mg, and phenazopyridine HCl and sulfisoxazole
tablet, 50 mg/500 mg, if all other legal and regulatory requirements
are met.

FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of

the drug that was previously approved. Sponsors of ANDAs do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA). The only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to FDA's approval of an ANDA that refers to the
listed drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an
ANDA that does not refer to a listed drug.
    AZO GANTANOL is the subject of NDA 013294, held by Roche and
approved on April 8, 1965. AZO GANTRISIN is the subject of NDA 019358,
held by Roche and initially approved on August 31, 1990. Under the Drug
Efficacy Study Implementation (DESI), FDA concluded that a fixed
combination drug product containing 500 mg of sulfamethoxazole and 100
mg of phenazopyridine HCl, and certain other sulfonamide/
phenazopyridine combinations, are effective for indications described
in a Federal Register notice published on July 29, 1983 (DESI 12056, 48
FR 34516). Consistent with that determination, both AZO GANTANOL and
AZO GANTRISIN are indicated for the initial treatment of uncomplicated
urinary tract infections caused by susceptible strains of Escherichia
coli, Klebsiella species, Enterobacter species, Proteus mirabilis,
Proteus vulgaris, and Staphylococcus aureus when relief of symptoms of
pain, burning, or urgency is needed during the first 2 days of therapy.
    In a letter dated May 29, 1998, Roche requested that FDA withdraw
approval of NDA 013294 for AZO GANTANOL (phenazopyridine HCl and
sulfamethoxazole) Tablet, 100 mg/500 mg. In the Federal Register of
September 25, 1998 (63 FR 51359), FDA announced that it was withdrawing
approval of NDA 013294 effective September 25, 1998.
    In a letter dated March 23, 1998, Roche requested that FDA withdraw
approval of NDA 019358 for AZO GANTRISIN (phenazopyridine HCl and
sulfisoxazole) Tablet, 50 mg/500 mg. In the Federal Register of May 12,
1998 (63 FR 26191), FDA announced that it was withdrawing approval of
NDA 019358 effective June 11, 1998.
    Vintage Pharmaceuticals, LLC, submitted a citizen petition dated
December 1, 2006 (Docket No. FDA-2006-P-0136), under 21 CFR 10.30,
requesting that FDA determine whether AZO GANTANOL and AZO GANTRISIN
were withdrawn from sale for reasons of safety or effectiveness.
JRRapoza Associates, Inc., submitted a citizen petition dated January
17, 2007 (Docket No. FDA-2007-P-0353), under 21 CFR 10.30, also
requesting that FDA determine whether AZO GANTANOL and AZO GANTRISIN
were withdrawn from sale for reasons of safety or effectiveness.
    FDA has reviewed its records and, under Sec.  314.161, has
determined that AZO GANTANOL (phenazopyridine HCl and sulfamethoxazole)
Tablet, 100 mg/500 mg, and AZO GANTRISIN (phenazopyridine HCl and
sulfisoxazole) Tablet, 50 mg/500 mg, were not withdrawn from sale for
reasons of safety or effectiveness. We have also independently
evaluated relevant literature and have found no information that would
indicate that these products were withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list AZO GANTANOL
(phenazopyridine HCl and sulfamethoxazole) Tablet, 100 mg/500 mg, and
AZO GANTRISIN (phenazopyridine HCl and sulfisoxazole) Tablet, 50 mg/500
mg, in the ``Discontinued Drug Product List'' section of the Orange
Book. The ``Discontinued Drug Product List'' delineates, among other
things, drug products that have been discontinued from marketing for
reasons other than safety or effectiveness. ANDAs that refer to either
AZO GANTANOL (phenazopyridine HCl and sulfamethoxazole) Tablet, 100 mg/
500 mg, or AZO GANTRISIN (phenazopyridine HCl and sulfisoxazole)
Tablet, 50 mg/500 mg, may be approved by the Agency if all other legal
and regulatory requirements for the approval of ANDAs are met. If FDA
determines that the labeling for either drug product should be revised
to meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: June 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13757 Filed 6-11-14; 8:45 am]
BILLING CODE 4164-01-P