                                 TELEPHONE LOG

Name of Caller: 	John Sunda, SAIC

Date: 	October 27, 2011

Company Name: 	Sontek/YSI

Street Address:	9940 Summers Ridge Road

City/State/ZIP:	San Diego, CA 92121

Person Contacted:	Joel Edelman

Title:	Applications Engineer

Contact Info:		1-858-546-8327 Ext 135

Called to inquire about use and cost of acoustic measuring devices for flow velocity measurement at industrial cooling water intakes.

He said that the costs of an Acoustic Doppler Velocimeter will vary depending on instrumentation features such as real-time versus recording but would generally costs between $9,000 to $11,000 or more for each unit. I asked about equipment lifetime and he said that there are no moving parts and it would mostly be dependent on the environment but that at a minimum it should last more than10 years.

I asked about mounting set ups and he said it depended on the requirements could be as simple as a set up of one or more units that could fixed or moved around or a sophisticated system where the probe can automatically move across the face of the screen.


[Federal Register: August 29, 2008 (Volume 73, Number 169)]
[Notices]
[Page 50981]
[DOCID:fr29au08-93]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1780-DR]

Texas; Amendment No. 4 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Texas (FEMA-1780-DR), dated July 24, 2008, and related
determinations.

DATES: Effective Date: August 13, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Texas is hereby amended to include the following area
among those areas determined to have been adversely affected by the
catastrophe declared a major disaster by the President in his
declaration of July 24, 2008.

    Jim Hogg County for Public Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-20070 Filed 8-28-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Pages 27860-27861]
[FR Doc No: E9-13629]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

 Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System or Relief From the
Requirements of Title 49 Code of Federal Regulations Part 236

    Pursuant to Title 49 Code of Federal Regulations (CFR) Part 235 and
49 U.S.C. 20502(a), the following railroad has petitioned the Federal
Railroad Administration (FRA) seeking approval for the discontinuance
or modification of the signal system or relief from the requirements of
49 CFR Part 236, as detailed below.
    Docket Number: FRA-2009-0046.
    Applicant: Paducah & Louisville Railway, Inc., Mr. C.D. Edwards,
General Supervisor of Signals and Structures, 1400 Bell Avenue,
Paducah, Kentucky 42003.
    The Paducah & Louisville Railway, Inc. (P&L) seeks approval of the
proposed discontinuance and removal of signal locations between
Milepost (MP) J 22.0 and MP J 45.0, and replacing with new signal and
track circuitry.
    The locations are between West Point, Kentucky, MP J 22.0 and North
Cecilia, Kentucky, MP J 45.0. The proposal consists of retiring nine
back-to-back signal locations between MP J 22 and MP J 45, and
replacing with six back-to-back signal locations. Electro Code II track
circuitry is to be replaced with Electro Code 5 track circuitry.
    The signals to be removed are: J234, J235; J262, J261; NBH, J283;
J308, SBH; J238, J239; J356, J355; J382, J381; J408, J407; and J432,
J433. The signals to be installed are: J250, J251; NBH, J283; J308,
SBH; J346, J345; J382, J381; and J420, J421.
    The reason given for the proposed changes is to improve safety of
train operation and reduce the cost of testing, and maintenance.
    Any interested party desiring to protest the granting of an
application shall set forth specifically the grounds upon which the
protest is made, and include a concise statement of the interest of the
party in the proceeding. Additionally, one copy of the protest shall be
furnished to the applicant at the address listed above.
    FRA expects to be able to determine these matters without an oral
hearing. However, if a specific request for an oral hearing is
accompanied by a showing that the party is unable to adequately present
his or her position by written statements, an application may be set
for public hearing.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.

    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0046) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC on June 5, 2009.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E9-13629 Filed 6-10-09; 8:45 am]
BILLING CODE 4910-06-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCE

September 7, 2007

MEMORANDUM

SUBJECT:	Review of Butoxypolypropylene glycol (BPG) Incident Reports

		DP Barcode 338971, PC Code 011901, Decision # 377963

FROM:	Ruth H. Allen, PhD, MPH, Epidemiologist

 		Chemistry and Exposure Branch

		Health Effects Division (7509P)

		Monica Hawkins, M.P.H., Environmental Health Scientist

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

		Hans Allender, Ph.D., Statistician

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

THRU:	David J. Miller, Chief

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

TO:		Matthew Lloyd, Industrial Hygienist,

		Reregistration Review Branch (RRB) 1

		Health Effects Division (HED) (7509P)

CC:		Cathryn O’Connell,  Chemical Review Manager, RRB2

		 and

		Tom Myers, Team Leader, RRB2

		Special Review and Reregistration Division (SRRD), (7509-P)

USE PROFILE

Butoxypolypropylene glycol PC Code 011901 (BPG) is an insecticide
typically used as a fly repellant in areas that contain animals or as a
direct pet treatment.  It is not formulated in single active ingredient
products, but is often formulated with other active ingredients into a
variety of pesticide products.  Many BPG products also contain with
Pyrethrins (botanicals)/ Pyrethroids (synthetics) and Piperonyl butoxide
(PY/PBO) or other active ingredients (e.g., synthetic pyrethroids). BPG
containing products are registered for use as direct pet treatments,
including horses and in or around large animal premises, e.g., barns. A
number of BPG registered products were voluntarily cancelled in the last
10 years.

BACKGROUND

To generate this review, the Office of Pesticide Programs (OPP)
consulted the following databases for the poisoning incidents on the
active ingredient BPG.  Because BPG is formulated with other active
ingredients, it is not possible to isolate reported pesticide poisoning
incidents attributable to BPG exposure only.  However, upon request, HED
reviewed the respective incident data systems to qualitatively address
the frequency and severity of the health effects attributed to BPG
containing products.  This report contains several sections and case
summaries:

1 - Cases reported in the Poison Control Center Database from 1993 to
2005. (None)

2 - Cases reported in the Incident Data System from 1999 to the present.
(3)

3 - Cases reported in NPIC 1999 to present (2)

4 - Recommendations

While each of the pesticide poisoning incident datasets were consulted
in the preparation of this report (See Attachment 1), only those
datasets which allowed provision of some qualitative or anecdotal
information are included in this incident summary report.

INCIDENT REVIEW RESULTS

A brief description of each database used for this incident review is
presented here.

1.	  SEQ CHAPTER \h \r 1 Poison Control Center Data – 1993-2005

Since BPG is not used alone, there are no individual incidents in the
American Association of Poison Control Center (AAPCC) single chemical
database. The PCC database on mixtures is not accessible at this time.
ITRMD staff did perform a review  of the PCC’s Poisondex listing of
pesticide products (Fall 2006) for product mixtures containing BPG.
Twelve BPG containing products are represented in both the PCC database
for mixtures and the EPA indident data system (IDS).  While HED is
unable at this time to access the PCC mixtures database and provide a
quantitative analysis of poisoning incidents for different population
sub-groups, one can conclude from this cross-comparison that some of the
products involved in pesticide exposure incidents reported to the EPA
IDS system are also reported to the AAPCC database.  Qualitatively, we
can surmise that there are pesticide incidents reported to AAPCC as a
result of BPG exposure.

2. 	Incident Data Systems (IDS) (1992 to present)

A review of the Incident Data System (IDS) for the active ingredient BPG
revealed 7 incidents attributed to the chemical.  Most of these
incidents took place between 1996 to 2000 and involved domestic animals,
including lack of efficacy reports, deaths of dogs, and major animal
toxic poisoning requiring emergency medical treatment.

Since the year 2000, there are a few notable human incidents reported in
IDS.  These incidents reflect BPG’s use in a formulation including
other active ingredient (a mixture) but are included here because the
incident reports relay instances of serious neurotoxic outcomes.  When
reviewing IDS reported incidents, it should be noted that cases are not
necessarily medically confirmed and therefore may be anecdotal in nature
and also that case reports may be missing pertinent details concerning
the exposure circumstances. Some of the products included in this IDS
review may be cancelled or no longer in use at this time (August 2007).

I 016329-001 (HB-Human Major Incident). In 2002, a woman in Oklahoma was
hospitalized after using Pyranha fly spray on horses (4/30/2002).
Observers reported that her face was distorted and her words were
slurred. She reported leg problems, tremors and, memory problems.
Relevant medical summary on this case was submitted to EPA and reviewed
including a medical toxicology report, medical diagnosis reports, and
lawsuit details.  The medical toxicologists conclusion was that the
patient, a professional horse trainer, developed a complex neurotoxic
movement disorder following sensitization to Pyranha that contains 0.3%
pyrethrins, 0.4% PY/PBO and 33% BPG. According to her medical
toxicologist, she can no longer work at her profession and is at risk of
developing environmental Parkinson’s disease.

I 013785-001 and -002 (HB- Human Major Incidents). In 2003, one alleged
case of wrongful death in Florida attributed to the BPG containing
product Pyranha.  The IDS includes one report of a wrongful death
lawsuit (registrant notified 12/17/02, EPA notified 2/26/03).  A female
was exposed while in a barn when an automatic sprinkler system
containing dilute product containing PY/PBO and BPG was released.  The
exposure event took place in 1983; the individual died in 2000.

b) In another instance, the IDS report includes another case of personal
injury suffered by a woman in Oklahoma (registrant notified 1/24/03, EPA
notified 2 26 03).  The report includes details of  paralysis and
apparent convulsions attributed to BPG product exposure
(unsubstantiated).  This case was reported to IDS as part of a planned
litigation.  No further details were given. This incident is distinct
from the Oklahoma reported incident above (I 016329-001).

3. 	National Pesticide Information Center NPIC)

Two NPIC information call cases were review and both cases were ranked
“unlikely” by NPIC.

One case involved suspected poisoning of a pet (dog).   The owner
applied “Mosquito Beater” (naphthalene and BPG), around an outdoor
firepit area.  The pet was potentially exposed over a 2-hour period in
which the pet was allowed to roam unattended in the area containing the
pesticide-treated area.  No immediate, acute effects were observed by
the owner, however at a later time point (not specified in the report)
the dog began displaying symptoms of distress (lack of eating).
Veterinarian conditionally diagnosed dog with pancreatic cancer or
pancreatitis.  The caller inquired as to whether the exposure to
pesticide product could be a contributing factor.  The NPIC classified
this incident as unlikely related to the suspected exposure.

In a second case, a man repored use of “Mosquito Beater”
(naphthalene and BPG) and later experienced adverse symptoms.  The
residential applicator reported wearing no gloves or other protective
equipment and did not recall inhaling pesticide dust particiles at the
time of application.  Reported symptoms were vague and included
abdominal stiffness and possible vertigo.  The NPIC classified this
incident as unlikely to be related to BPG product exposure.

4. Recommendations

Because BPG is formulated with other active ingredients, HED cannot form
conclusions about the incidents attributable to BPG exposure singly.
HED does not currently have the ability to evaluate pesticide
ingredients that are formulated as mixtures.  In the future, HED may
have the capacity to quantitatively address pesticide poisoning
incidents attributed to mixtures.

Attachment 1

1) Poison Control Centers – OPP purchases American Association of
Poison Control Center (AAPCC) data covering the years 1993 through 2005
for all reported pesticides incidents.  The last acquisition of data
covering 2004 and 2005 took place in late 2006. Most of the national
Poison Control Centers (PCCs) participate in a national data collection
system called the National Poison Center System (NPCS), previously
called The Toxic Exposure Surveillance System (TESS).

PCC reports includes 61 centers at hospital and universities that
provide coverage to 100% of the United States population.  Datasets
incorporate an extensive quality assurance process including a
standardized computer-based data collection system.  Some PCCs cover
multiple States; others cover a metropolitan area, or an entire State.
PCCs provide emergency health care information through telephone
consultation for individual consumers and health care providers
concerning suspected poisonings involving drugs, household products and,
pesticides.  Data collection to aid pesticide regulatory programs is
secondary to this service.

An elaborate, computer assisted protocol is followed to generate
exposure reports.  Specially trained medical staff record suspected
pesticide poisoning exposures as confirmed, possible, probable, or
definite.  Approximately 50% of database reports include medical
follow-up, in those cases clinical outcomes are determined, i.e., cases
resolved by phone consultation with PCC specialist.  Specialists may
record that patients are seen in health care facility, patients
hospitalized, or patients admitted to Intensive Care Unit (ICU).  PCCs
receive calls 24 hours a day, 7-days a week throughout the entire year,
and they handle non-occupational and occupational calls.  Discussions
are underway to improve collection of OPP-specific occupational data.
Because mainly consumers initiate PCC calls, this database is not
currently a complete source of occupational poisoning incidents.

2) OPP Incident Data System (IDS) This database includes reports of
incidents from various sources, including mandatory Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA) Section 6 (a) (2) reports from
registrants, other federal and state health and environmental agencies
and individual consumers.  The IDS has been in existence since 1992.
Reports submitted to the Incident Data System represent anecdotal
reports or allegations only, unless otherwise stated in this report.
Typically, OPP does not draw conclusions implicating the pesticide as a
cause of any of the reported health effects.  Nevertheless, sometimes
with enough cases and/or documentation, patterns and risk mitigation
measures may be suggested.

3) California Department of Pesticide Regulation - California has
collected uniform data on suspected pesticide poisonings since 1982.
Physicians are required, by state statute, to report to their local
health officer all occurrences of illness suspected of being related to
exposure to pesticides.  The majority of the incidents involve workers,
i.e., pesticide applicators or farm workers.  Information on exposure
(worker activity), type of illness (systemic, eye, skin, eye/skin and
respiratory), likelihood of a causal relationship, and number of days
off work and in the hospital are provided.

4) National Institute of Occupational Safety and Health/ Sentinel Event
Notification System for Occupational Risks (NIOSH/SENSOR) performs
standardized surveillance in twelve states from 1998 through 2006.
States included in this reporting system are Arizona, California,
Florida, Iowa, Louisiana, Michigan, North Carolina, New York, New
Mexico, Oregon, Texas, and Washington. A number of other States can and
do report, periodically and on request for special circumstances,
because they participate in the NIOSH/ SENSOR network as part of the
Council of State and Territorial Epidemiologists (CSTE).  Reporting is
variable from state-to-state because of the dissimilar cooperation from
different sources of reporting (e.g., workers compensation, Poison
Control Centers, emergency departments and hospitals, enforcement
investigations, private physicians, etc.).  Therefore, OPP does not
characterize these reports as estimating the total magnitude of
poisoning for a State.  The focus of NIOSH/SENSOR database is on
occupationally related cases. However, the information collected on each
case is standardized and categorized according to the certainty of the
information collected and the severity of the case. Detailed exposure
circumstances may be available if the State provided follow-up case
reports, as in serious cases ending in death.

National Pesticide Information Center (NPIC)

NPIC is a hotline and pesticide health effects information service for
the public and health professionals. The service is maintained at Oregon
State University under contract to US EPA, See the NPIC web site at
<http://www.npic.orst.edu>.

6)	Agricultural Health Study (AHS)

AHS is a long-term prospective epidemiology study of 90,000 certified
pesticide applicators and their spouses from Iowa (IA) and North
Carolina (NC). Both cancers and non-cancer endpoints are being followed
with repeated interviews on lifetime, last 5 years, and current
pesticide use and other farming characteristics. Results for various
disease patterns and for individual chemicals are published and posted
at   HYPERLINK "http://www.aghealth.org"  http://www.aghealth.org .

7)	National Health and Nutrition Examination Survey Data (NHANES)

BPG was not included in NHANES 3 and NHANES 99+.

8) 	Literature Study Summary

A Pub Med search was conducted for any human clinical case reports or
health effects for this chemical. There were no recent results.

 PAGE

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[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52083-52084]
[FR Doc No: 2019-21335]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 8046-004]

Big Wood Canal Company; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, Protests,
Recommendations, and Terms and Conditions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Amendment of Conduit Exemption.
    b. Project No.: 8046-004.
    c. Date Filed: August 22, 2019, and supplemented on September 20,
2019.
    d. Applicant: Big Wood Canal Company.
    e. Name of Project: Sagebrush Hydroelectric Project.
    f. Location: The project is located on the South Gooding Main Canal
in Lincoln County, near Gooding, Idaho. The project occupies federal
lands administered by the U.S. Bureau of Land Management.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Nicholas E. Josten, GeoSense LLC, 2742
Saint Charles Ave., Idaho Falls, ID 83404,<PHONE_NUMBER>.
    i. FERC Contact: Linda Stewart,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing responsive documents: Due to the small size
of the proposed project, as well as the resource agency consultation
letters filed with the application, the 60-day timeframe specified in
18 CFR 4.34(b) for filing all comments, motions to intervene, protests,
recommendations, terms and conditions, and prescriptions is shortened
to 30 days from the issuance date of this notice. All reply comments
must be filed with the Commission within 45 days from the issuance date
of this notice.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426. The first page of any filing
should include docket number P-8046-004.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, it must also serve a
copy of the document on that resource agency.
    k. Description of Request: Big Wood Canal Company (exemptee)
proposes to construct a new powerhouse and remove the existing
powerhouse. Specifically, the exemptee proposes to construct a new
powerhouse containing a single 475-kilowatt (kW) turbine generating
unit. The new powerhouse would be located immediately downstream of the
existing intake structure, which would be retained. The exemptee also
proposes to remove the approximately 400-foot-long existing, buried
penstock and the existing powerhouse, which contains three turbine
generating units with a total installed capacity of 315 kW. The
exemptee would also excavate, along the route of the existing buried
penstock, an approximately 350-foot-long open tailrace channel to
return water to the South Gooding Main Canal.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE, Room 2A, Washington, DC
20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number, P-8046, in the docket number
field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of
new filings and

issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or email<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
and .214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
deadline date for the particular application.
    n. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'',
``MOTION TO INTERVENE,'' ``REPLY COMMENTS,'' ``RECOMMENDATIONS,''
``TERMS AND CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the
heading, the name of the applicant and the project number of the
application to which the filing responds; (3) furnish the name,
address, and telephone number of the person protesting or intervening;
and (4) otherwise comply with the requirements of 18 CFR 385.2001
through 385.2005. All comments, motions to intervene, or protests must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: September 25, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-21335 Filed 9-30-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 176 (Tuesday, September 11, 2012)]
[Notices]
[Page 55894]
[FR Doc No: 2012-22252]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Thirteenth Meeting: RTCA Special Committee 223, Airport Surface
Wireless Communications

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

ACTION: Meeting Notice of RTCA Special Committee 223, Airport Surface
Wireless Communications.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
thirteenth meeting of the RTCA Special Committee 223, Airport Surface
Wireless Communications.

DATES: The meeting will be held October 2-3, 2012, from 9 a.m.-5 p.m.

ADDRESSES: The meeting will be held at the secured facilities at RTCA,
Inc., 1150 18th Street NW., Suite 910, Washington, DC, 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th
Street, NW., Suite 910, Washington, DC, 20036, or by telephone at (202)
330-0652/(202) 833-9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 223. The agenda will
include the following:

October 2, 2012

 Welcome/Introductions/Administrative Remarks
 Agenda Overview
 Review/Approve Prior Plenary Meeting Summary
     RTCA Paper No. 170-12/SC223-027 and Action Item Status
 General Presentations of Interest

Tuesday Afternoon--General Presentations Continued

MOPS Working Group Breakout Session

Wednesday, October 3, 2012

Wednesday Morning--MOPS Working Group Breakout Session\

Wednesday Afternoon--Reconvene Plenary

 Establish Agenda, Date, and Place for RTCA Plenary Meeting
14
 Review of Meeting Summary Report
 Adjourn by 1500
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on September 4, 2012.
Kathy Hitt,
Management Analyst, Business Operations Group, Federal Aviation
Administration.
[FR Doc. 2012-22252 Filed 9-10-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Notices]
[Pages 6144-6145]
[FR Doc No: 2015-02107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74173; File No. SR-BATS-2015-06]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Amend
the Fees Applicable to Securities Listed on BATS Exchange, Inc.
pursuant to Rule 14.13

January 29, 2015.
    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 January 22, 2015, BATS Exchange, Inc. (the ``Exchange'' or ``BATS'')
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 prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend the fees applicable to
securities listed on the Exchange pursuant to BATS Rule 14.13. Changes
to the Exchange's fees pursuant to this proposal are effective upon
filing. Changes to the fee schedule pursuant to this proposal are
effective upon filing.
    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com/, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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 parts of such
statements.

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

1. Purpose
    On August 30, 2011, the Exchange received approval of rules
applicable to the qualification, listing, and delisting of companies on
the Exchange,\3\ which it modified on February 8, 2012 in order to
adopt pricing for the listing of exchange traded products (``ETPs'')\4\
on the Exchange,\5\ which it subsequently modified again on June 4,
2014,\6\ and October 16, 2014.\7\ The Exchange proposes to modify Rule
14.13, entitled ``Company Listing Fees,'' to modify how the Exchange
administers the billing of the application fee applicable to the
listing of ETPs to more closely align with the Exchange's typical
billing cycle, which is administered on a monthly basis. Currently, the
issuer of an ETP is required to pay the $5,000 application fee to the
Exchange with the application to list the ETP on the Exchange. The
Exchange is proposing to amend the language in Rule 14.13(b)(1)(C) such
that the application fee for ETPs becomes billable to the issuer for
the month during which the ETP is first listed on the Exchange. As
proposed, instead of requiring the Exchange to take payment without
issuing any bill, the Exchange would bill application fees to issuers
on a monthly basis, which is in line with how the Exchange applies most
other aspects of its billing. The Exchange notes that it is not
proposing to amend the $5,000 application fee for ETPs.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 65225 (August 30,
2011) 76 FR 55148 (September 6, 2011) (SR-BATS-2011-018).
    \4\ As defined in BATS Rule 11.8(e)(1)(A), the term ``ETP''
means any security listed pursuant to Exchange Rule 14.11.
    \5\ See Securities Exchange Act Release No. 66422 (February 17,
2012) 77 FR 11179 (February 24, 2012) (SR-BATS-2012-010).
    \6\ See Securities Exchange Act Release No. 72377 (June 12,
2014) 79 FR 34822 (June 18, 2014) (SR-BATS-2014-024).
    \7\ See Securities Exchange Act Release No. 73414 (October 23,
2014) 79 FR 64434 (October 29, 2014) (SR-BATS-2014-050)
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that

are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6 of the Act.\8\ Specifically, the
Exchange believes that the proposed rule change is consistent with
Section 6(b)(4) and 6(b)(5) of the Act,\9\ in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
issuers and it does not unfairly discriminate between customers,
issuers, brokers or dealers.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed changes are a reasonable,
equitable, and non-discriminatory allocation of fees to issuers because
the proposal is designed only to amend the timing and method with which
issuers are billed for the application fee for ETPs and not to make any
changes to the amount of the $5,000 application fee. Further, the
proposal will benefit all ETP issuers because it will allow them to pay
their application fee at a later date than they are required to pay the
application fee today. The Exchange also notes that the proposed
changes will apply equally to all issuers that list ETPs on the
Exchange. Based on the foregoing, the Exchange believes that the
proposed amendment to the billing associated with application fees for
ETPs is a reasonable, equitable, and non-discriminatory allocation of
fees to issuers.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. With
respect to the proposed new billing method for the application fee
related to ETPs, the Exchange does not believe that the changes burden
competition, but instead, enhance competition, as it is intended to
increase the competitiveness of the Exchange's listings program by
allowing the Exchange to offer ETPs the ability to pay their
application fees after an ETP is already listed and trading on the
Exchange instead of requiring the issuer to pay the application fee
upon submission of their application. As such, the proposal is a
competitive proposal that is intended to make the Exchange a more
attractive venue for ETP listings, which will, in turn, benefit the
Exchange and all other BATS-listed ETPs.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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) of the Act\10\ and paragraph (f) of Rule 19b-4
thereunder.\11\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
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.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 email to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2015-06 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BATS-2015-06. This file
number should be included on the subject line if email 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices 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 available
publicly. All submissions should refer to File Number SR-BATS-2015-06,
and should be submitted on or before February 25, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-02107 Filed 2-3-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Notices]
[Page 14888]
[FR Doc No: 2017-05782]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC17-5-000]

Commission Information Collection Activities (FERC-588), Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the information collection FERC-
588 (Emergency Natural Gas Transportation, Sale and Exchange
Transactions) and will be submitting FERC-588 to the Office of
Management and Budget (OMB) for review of the information collection
requirements.

DATES: Comments in consideration of the collection of information are
due May 22, 2017.

ADDRESSES: You may submit comments identified by Docket No. IC17-5-000
by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-588, Emergency Natural Gas Transportation, Sale and
Exchange Transactions.
    OMB Control No.: 1902-0144.
    Type of Request: Three-year extension of the FERC-588 information
collection requirements with no changes to the reporting requirements.
    Abstract: The FERC-588 is used by the Commission to implement the
statutory provisions of sections 7(c) of the Natural Gas Act (NGA)
(Pub. L. 75-688) (15 U.S.C. 717-717w) and provisions of the Natural Gas
Policy Act of 1978 (NGPA), 15 U.S.C. 3301-3432. Under the NGA, a
natural gas company must obtain Commission approval to engage in the
transportation, sale or exchange of natural gas in interstate commerce.
However, section 7(c) exempts from certificate requirements ``temporary
acts or operations for which the issuance of a certificate will not be
required in the public interest.'' The NGPA also provides for non-
certificated interstate transactions involving intrastate pipelines and
local distribution companies.
    A temporary operation, or emergency, is defined as any situation in
which an actual or expected shortage of gas supply would require an
interstate pipeline company, intrastate pipeline, or local distribution
company, or Hinshaw pipeline to curtail deliveries of gas or provide
less than the projected level of service to the customer. The natural
gas companies which provide the temporary assistance to the companies
which are having the ``emergency'' must file the necessary information
described in Part 284, Subpart I of the Commission's Regulations with
the Commission, so that it may determine if their assisting
transaction/operation qualifies for exemption. The assisting company
may or may not be under the Commission's jurisdiction and if their
assisting actions qualify for the exemption, they will not become
subject to the Commission's jurisdiction for such actions.
    A report within forty-eight hours of the commencement of the
transportation, sale or exchange, a request to extend the sixty-day
term of the emergency transportation, if needed, and a termination
report are required. The data required to be filed for the forty-eight
hour report is specified by 18 CFR 284.270.
    Type of Respondents: Natural Gas Pipelines.
    Estimate of Annual Burden: \1\ The Commission estimates the Public
Reporting Burden for this information collection as:
---------------------------------------------------------------------------

    \1\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.

                                     FERC-588--Emergency Natural Gas Transportation, Sale and Exchange Transactions
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Annual number
                                     Number of     of responses    Total number   Average burden & cost per  Total annual burden hours &     Cost per
                                    respondents   per respondent   of responses          response \2\             total annual Cost       respondent ($)
                                             (1)             (2)     (1) * (2) =  (4)......................  (3) * (4) = (5)............       (5) / (1)
                                                                             (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Natural Gas Pipelines...........              10               3              30  10 hrs.; $765.00.........  300 hrs $22,950.00.........         2295.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
\2\ The estimates for cost per response are derived using the 2017 FERC average salary plus benefits of $158,754/year (or $76.50/hour). Commission staff
  finds that the work done for this information collection is typically done by wage categories similar to those at FERC.

    Comments:Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: March 17, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-05782 Filed 3-22-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Page 54279]
[FR Doc No: 2015-22650]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2694-042]

Duke Energy Carolinas, LLC; Notice of Application for Temporary
Variance and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Temporary Variance from license Article 401
    b. Project No.: 2694-042
    c. Date Filed: June 9, 2015
    d. Applicant: Duke Energy Carolinas, LLC
    e. Name of Project: Queens Creek Hydroelectric Project
    f. Location: The project is located on Queens Creek, near the Town
of Topton in Macon County, North Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r)
    h. Applicant Contact: Jeffrey G. Lineberger, Director, Water
Strategy and Hydro Licensing, Duke Energy Carolinas, LLC, 526 South
Church Street, Mail Code: EC12Y/PO Box 1006, Charlotte, NC, 28201-1006;
telephone:<PHONE_NUMBER>.
    i. FERC Contact: Kurt Powers, telephone:<PHONE_NUMBER>, and email
address<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protests
is 15 days from the issuance date of this notice by the Commission.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail a copy to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426. Please include
the project number (P-2694-042) on any comments or motions filed.
    k. Description of Request: The licensee is requesting a temporary
variance to the reservoir elevation range for Queens Creek Lake
required by Article 401 of the project license. Article 401 requires
the licensee to maintain Queens Creek Lake within one foot above and
two feet below the reservoir's normal full operating pool level of
3,017.0 feet mean sea level (msl) (or 2,895.0 feet Nantahala Datum
(ND)). The licensee requests to begin lowering Queens Creek Lake on
October 1, 2015, to reach a target reservoir elevation of approximately
2,985.2 feet msl by November 1, 2015. The drawdown would allow the
licensee to make required repairs to the headgate screens and draft
tube for the Queens Creek Hydroelectric Station. The drawdown would
also provide safe access for divers to install a bulkhead to allow the
licensee to drain and replace leaking penstock piping components and
valves. Once the reservoir level reaches the target elevation of
2,985.2 feet msl the bulkhead would be installed, closing the intake
structure, and the lake would begin refilling to the normal range
required by Article 401. The licensee would maintain a minimum flow of
one cubic feet per second in the bypassed reach during the drawdown and
repairs; which the licensee plans to complete by November 30, 2015.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the document. A copy is also
available for inspection and reproduction at the address in item (h)
above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the amendment application.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: September 2, 2015.
Kimberly Bose,
Secretary.
[FR Doc. 2015-22650 Filed 9-8-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43210-43214]
[FR Doc No: 2013-17324]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0845]

Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug
Applications and 77 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 52 new drug applications (NDAs) and 77 abbreviated new drug
applications (ANDAs) from multiple applicants. The holders of the
applications notified the Agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.

DATES: Effective August 19, 2013.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in

table 1 in this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications under the process in Sec.  314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

                                 Table 1
------------------------------------------------------------------------
      Application No.                 Drug                Applicant
------------------------------------------------------------------------
NDA 011620.................  Cardiografin           Bracco Diagnostics,
                              (diatrizoate           107 College Rd.
                              meglumine USP, 85%)    East, Princeton, NJ
                              Injection.             08540.
NDA 012828.................  Travase (sutilains)    Abbott Laboratories,
                              Ointment.              PA 77/Bldg. AP30-
                                                     1E, 200 Abbott Park
                                                     Rd., Abbott Park,
                                                     IL 60064-6157.
NDA 014215.................  Celestone              Merck Sharp & Dohme
                              (betamethasone) Oral   Corp., One Merck
                              Solution.              Dr., P.O. Box 100,
                                                     Whitehouse Station,
                                                     NJ 08889.
NDA 014685.................  Aventyl                Ranbaxy Inc., U.S.
                              (nortriptyline         Agent for Ranbaxy
                              hydrochloride (HCl)    Laboratories
                              Oral Solution, 10      Limited, 600
                              milligrams (mg)/5      College Rd. East,
                              milliliters (mL).      Princeton, NJ
                                                     08540.
NDA 014860.................  Aralen Phosphate       Sanofi-Aventis U.S.,
                              (chloroquine           LLC, 55 Corporate
                              phosphate) with        Dr., Bridgewater,
                              primaquine phosphate   NJ 08807-0890.
                              Tablets.
NDA 016017.................  Cloroquine-Primaquine  Do.
                              (chloroquine
                              phosphate and
                              primaquine
                              phosphate) Tablets.
NDA 016019.................  Questran Resin         Bristol-Myers Squibb
                              (cholestyramine        Co., P.O. Box 4000,
                              resin).                Princeton, NJ 08543-
                                                     4000.
NDA 016640.................  Questran Powder        Do.
                              (cholestyramine for
                              oral suspension).
NDA 016721.................  Dalmane (flurazepam    Valeant
                              HCl) Capsules.         Pharmaceuticals
                                                     North America, LLC,
                                                     700 Route 202/206
                                                     North, Bridgewater,
                                                     NJ 08807.
NDA 016732.................  Talwin 50              Sanofi-Aventis U.S.,
                              (pentazocine HCl       LLC.
                              USP), Tablets, 50 mg.
NDA 016891.................  Talwin Compound        Do.
                              (pentazocine HCl USP
                              and aspirin USP),
                              Equivalent to (EQ)
                              12.5 mg (base) and
                              325 mg.
NDA 016927.................  Demulen 1/50-21        G.D. Searle, LLC, c/
                              (ethynodiol            o Pfizer Inc., 235
                              diacetate/ethinyl      East 42nd St., New
                              estradiol) Tablets.    York, NY 10017.
NDA 016936.................  Demulen 1/50-28        Do.
                              (ethynodiol
                              diacetate/ethinyl
                              estradiol) Tablets.
NDA 017557.................  Danocrine (danazol)    Sanofi-Aventis U.S.,
                              Capsules.              LLC.
NDA 017633.................  Glycine Irrigation     Hospira, Inc., 275
                              USP, 1.5%.             North Field Dr.,
                                                     Lake Forest, IL
                                                     60045.
NDA 017821.................  Flexeril               Janssen Research &
                              (cyclobenzaprine       Development, LLC,
                              HCl) Tablets, 5 mg     1125 Trenton-
                              and 10 mg.             Harbourton Rd.,
                                                     Titusville, NJ
                                                     08560.
NDA 017850.................  Klotrix (potassium     Bristol-Myers Squibb
                              chloride) Extended-    Co.
                              Release Tablets.
NDA 017857.................  Stadol (butorphanol    Do.
                              tartrate USP)
                              Injection.
NDA 018160.................  Demulen 1/35-28        G.D. Searle, LLC, c/
                              (ethynodiol            o Pfizer Inc.
                              diacetate/ethinyl
                              estradiol) Tablets.
NDA 018168.................  Demulen 1/35-21        Do.
                              (ethynodiol
                              diacetate/ethinyl
                              estradiol) Tablets.
ANDA 018398................  Dopamine HCl           Baxter Healthcare
                              Injection USP, 40 mg/  Corp., 25212 W.
                              mL and 80 mg/mL.       Illinois Route 120,
                                                     Round Lake, IL
                                                     60073.
NDA 018458.................  Talacen (pentazocine   Sanofi-Aventis U.S.,
                              HCl USP and            LLC.
                              acetaminophen USP),
                              Tablets, EQ 25 mg
                              (base) and 650 mg.
ANDA 018581................  Sodium Nitroprusside   Baxter Healthcare
                              for Injection USP,     Corp.
                              50 mg/vial.
NDA 018733.................  Talwin Nx              Sanofi-Aventis U.S.,
                              (pentazocine HCl and   LLC.
                              naloxone HCl)
                              Tablets, 50 mg and
                              0.5 mg.
NDA 018981.................  Enkaid (encainide      Bristol-Myers Squibb
                              HCl) Capsules.         Co.
NDA 019057.................  Hytrin (terazosin      Abbott Laboratories.
                              HCl) Tablets, 1 mg,
                              2 mg, 5 mg, and 10
                              mg.
NDA 019436.................  Primacor (milrinone    Sanofi-Aventis U.S.,
                              lactate) Injection,    LLC.
                              EQ 1 mg (base)/mL.
NDA 019507.................  Kerlone (betaxolol     Do.
                              HCl) Tablets, 10 mg
                              and 20 mg.
NDA 019578.................  Mefloquine HCl         U.S. Army Office of
                              Tablets, 250 mg.       the Surgeon
                                                     General, Department
                                                     of the Army, 1430
                                                     Veterans Dr., Fort
                                                     Detrick, MD 21702-
                                                     5009.
NDA 019669.................  Questran Light,        Bristol-Myers Squibb
                              Questran II, and       Co.
                              Questran Sugar Free
                              (cholestyramine for
                              oral suspension).
NDA 019807.................  Kerledex (betaxolol    Sanofi-Aventis U.S.,
                              HCl and                LLC.
                              chlorthalidone)
                              Tablets.
NDA 019977.................  Oramorph SR (morphine  Xanodyne
                              sulfate) Sustained-    Pharmaceuticals,
                              Release Tablets, 15    Inc., One
                              mg, 30 mg, 60 mg,      Riverfront Pl.,
                              and 100 mg.            Newport, KY 41071.
NDA 020036.................  Aredia (pamidronate    Novartis
                              disodium) for          Pharmacueticals
                              injection, 30 mg, 60   Corp., One Health
                              mg, and 90 mg.         Plaza, East
                                                     Hanover, NJ 07936-
                                                     1080.
NDA 020038.................  Fludara (fludarabine   Genzyme Corp., 500
                              phosphate) for         Kendall St.,
                              Injection, 50 mg/      Cambridge, MA
                              vial.                  02142.
NDA 020056.................  Atropine Sulfate       U.S. Army Office of
                              Aerosol for            the Surgeon
                              Inhalation.            General.
NDA 020070.................  Cognex (tacrine HCl)   Shionogi Inc., 300
                              Capsules, 10 mg, 20    Campus Dr., Florham
                              mg, 30 mg, and 40 mg.  Park, NJ 07932.
NDA 020095.................  Zantac (ranitidine     GlaxoSmithKline,
                              HCl) Geldose           P.O. Box 13398, 5
                              Capsules.              Moore Dr., Research
                                                     Triangle Park, NC
                                                     27709.
NDA 020151.................  Effexor (venlafaxine   Wyeth
                              HCl) Tablets, 12.5     Pharmaceuticals,
                              mg, 25 mg, 37.5 mg,    Inc., 235 East 42nd
                              50 mg, 75 mg, and      St., New York, NY
                              100 mg.                10017.
NDA 020239.................  Kytril (granisetron    Hoffman-La Roche,
                              HCl) Injection, EQ 1   Inc., c/o
                              mg (base)/mL and 0.1   Genentech, Inc., 1
                              mg (base)/mL, 1 mg     DNA Way, South San
                              (base)/mL, and 3 mg    Francisco, CA
                              (base)/mL.             94080.

NDA 020305.................  Kytril (granisetron    Do.
                              HCl) Tablets, EQ 1
                              mg (base), EQ 2 mg
                              (base).
NDA 020336.................  DynaCirc CR            GlaxoSmithKline,
                              (isradipine)           2301 Renaissance
                              Controlled-Release     Blvd., King of
                              Tablets.               Prussia, PA 19406.
NDA 020343.................  Primacor (milrinone    Sanofi-Aventis U.S.,
                              lactate) Injection.    LLC.
NDA 020347.................  Hytrin (terazosin      Abbott Laboratories.
                              HCl) Capsules, 1 mg,
                              2 mg, 5, mg, and 10
                              mg.
NDA 020441.................  Pulmicort Turbuhaler   AstraZeneca, 1800
                              (budesonide)           Concord Pike, P.O.
                              Inhalation Powder.     Box 8355,
                                                     Wilmington, DE
                                                     19803-8355.
NDA 020484.................  Innohep (tinzaparin    LEO Pharma A/S, c/o
                              sodium) Injection.     Parexel
                                                     International
                                                     Corp., 4600 East-
                                                     West Highway, Suite
                                                     350, Bethesda, MD
                                                     20814.
NDA 020611.................  Dovonex                LEO Pharma A/S, c/o
                              (calcipotriene)        LEO Pharma Inc., 1
                              Topical Solution,      Sylvan Way,
                              0.005%.                Parsippany, NJ
                                                     07054.
NDA 020680.................  Norvir (ritonavir)     Abbott Laboratories.
                              Capsules, 100 mg.
NDA 021238.................  Kytril (granisetron    Hoffman-La Roche,
                              HCl) Oral Solution,    Inc., c/o
                              2 mg/10 mL.            Genentech, Inc.
NDA 021320.................  Plenaxis (abarelix)    Specialty European
                              Injection, 100 mg/     Pharma Limited, c/o
                              vial.                  Strategic
                                                     Bioscience Corp.,
                                                     93 Birch Hill Rd.,
                                                     Stow, MA 01775.
NDA 021744.................  Proquin XR             Depomed Inc., 1360
                              (ciprofloxacin HCl)    O'Brien Dr., Menlo
                              Tablets, 500 mg.       Park, CA 94025.
NDA 022021.................  Altace (ramipril)      King Pharmaceuticals
                              Tablets, 1.25 mg,      Inc., c/o Pfizer
                              2.5 mg, 5 mg, and 10   Inc., 235 East 42nd
                              mg.                    St., New York, NY
                                                     10017.
NDA 022026.................  Amlodipine Besylate    Synthon
                              Orally                 Pharmaceuticals,
                              Disintegrating         Inc., 9000
                              Tablets, 2.5 mg, 5     Development Dr.,
                              mg, and 10 mg.         P.O. Box 110487,
                                                     Research Triangle
                                                     Park, NC 27709.
NDA 022456.................  Omeprazole, Sodium     Santarus, Inc., 3721
                              Bicarbonate, and       Valley Centre Dr.,
                              Magnesium Hydroxide    Suite 400, San
                              Tablets.               Diego, CA 92130.
ANDA 040015................  Neosar                 Teva Parenteral
                              (cyclophosphamide)     Medicines, Inc., 19
                              for Injection, 100     Hughes, Irvine, CA
                              mg, 200 mg, 500 mg,    92618.
                              1 gram (gm), and 2
                              gm vials.
ANDA 040079................  Thiamine HCl           Hospira, Inc.
                              Injection USP, 100
                              mg/mL.
ANDA 040131................  Edrophonium Chloride   Do.
                              Injection, 10 mg/mL.
ANDA 040162................  Prochlorperazine       IVAX
                              Maleate Tablets USP,   Pharmaceuticals,
                              5 mg and 10 mg.        Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, 400 Chestnut
                                                     Ridge Rd.,
                                                     Woodcliff Lake, NJ
                                                     07677.
ANDA 040272................  Oxycodone and          Duramed
                              Acetaminophen          Pharmaceuticals,
                              Tablets USP, 5 mg/     Inc., Subsidiary of
                              325 mg.                Barr Laboratories,
                                                     Inc., Indirect
                                                     Wholly Owned
                                                     Subsidiary of Teva
                                                     Pharmaceuticals
                                                     USA, 400 Chestnut
                                                     Ridge Rd.,
                                                     Woodcliff Lake, NJ
                                                     07677.
ANDA 040332................  Leucovorin Calcium     Teva Parenteral
                              Injection USP, 10 mg   Medicines, Inc.
                              (base).
ANDA 040364................  Prednisolone Syrup,    Nesher
                              15 mg/5 mL.            Pharmaceuticals
                                                     (USA) LLC, 13910
                                                     Saint Charles Rock
                                                     Rd., Bridgton, MO
                                                     63044.
ANDA 040373................  Hydralazine HCl        Teva Parenteral
                              Injection USP, 20 mg/  Medicines, Inc.
                              mL.
ANDA 040423................  Prednisolone Syrup, 5  Nesher
                              mg/5 mL.               Pharmaceuticals
                                                     (USA) LLC.
ANDA 040505................  Prochlorperazine       Teva Parenteral
                              Edisylate Injection    Medicines, Inc.
                              USP, 5 mg/mL.
ANDA 040641................  Methylprednisolone     Bedford
                              Sodium Succinate for   Laboratories, 300
                              Injection USP, 125     Northfield Rd.,
                              mg/vial, 500 mg/       Bedford, OH 44146.
                              vial, and 1 gm/vial.
ANDA 040662................  Methylprednisolone     Do.
                              Sodium Succinate for
                              Injection USP, 40 mg/
                              vial.
ANDA 040709................  Methylprednisolone     Do.
                              Sodium Succinate for
                              Injection USP, 500
                              mg/vial and 1 gm/
                              vial.
ANDA 040795................  Benzonatate Capsules   Nesher
                              USP, 100 mg and 200    Pharmaceuticals
                              mg.                    (USA) LLC.
ANDA 040909................  Sodium Polystyrene     Citrus Pharma, LLC,
                              Sulfonate Powder for   3940 Quebec Ave.
                              Suspension, 454 gm/    North, Minneapolis,
                              bottle.                MN 55427.
NDA 050261.................  Declomycin             CorePharma, LLC, 215
                              (demeclocycline HCl)   Wood Ave.,
                              Tablets, 75 mg, 150    Middllesex, NJ
                              mg, and 300 mg.        08846-2554.
ANDA 060003................  V-Cillin K (pencillin  Eli Lilly and Co.,
                              V potassium tablets    Lilly Corporate
                              USP), 125 mg, 250      Center,
                              mg, and 500 mg.        Indianapolis, IN
                                                     46285.
ANDA 060517................  Fugizone               Bristol-Myers Squibb
                              (amphotericin B) for   Co.
                              Injection.
ANDA 060575................  Mycostatin (nystatin)  Do.
                              Cream, 100,000 units/
                              gm.
ANDA 061901................  Kantrex (kanamycin     Sandoz Inc., 2555 W.
                              sulfate injection      Midway Blvd.,
                              USP) Injection,75 mg/  Broomfield, CO
                              2 mL, 500 mg/2 mL,     80038-0446.
                              and 1 gm/3 mL.
ANDA 062008................  Nebcin (tobramycin     Eli Lilly and Co.
                              for injection USP).
ANDA 062311................  Amikin (amikacin       Brisol-Myers Squibb
                              sulfate injection      Co.
                              USP), 50 mg/mL and
                              250 mg/mL.
ANDA 062707................  Nebcin (tobramycin     Eli Lilly and Co.
                              for injection USP).
ANDA 063041................  Clindamycin Injection  Teva Parenteral
                              USP.                   Medicines, Inc.
ANDA 063080................  Tobramycin Injection   Hospira, Inc.
                              USP.
ANDA 063149................  Gentamicin Injection   Teva Parenteral
                              USP, 10 mg/mL.         Medicines, Inc.
ANDA 063282................  Clindamycin Phosphate  Do.
                              Injection, EQ 150 mg
                              (base)/mL.
ANDA 063253................  Erythromycin           Do.
                              Lactobionate for
                              Injection USP, 500
                              mg (base)/vial and 1
                              gm (base)/vial.
ANDA 064021................  Tobramycin Sulfate     Bristol-Myers Squibb
                              Injection.             Co.
                             Amphotericin B for     Teva Parenteral
                              Injection USP, 50 mg/  Medicines, Inc.
                              vial.
ANDA 064212................  Daunorubicin HCl for   Do.
                              Injection USP, 20 mg
                              (base)/vial and 50
                              mg (base)/vial.

ANDA 065037................  Idarubicin HCl for     Do.
                              Injection USP, 5 mg/
                              vial, 10 mg/vial,
                              and 20 mg/vial.
ANDA 065321................  Nystatin Topical       Nesher
                              Powder USP, 100,000    Pharmaceuticals
                              units/gm.              (USA) LLC.
ANDA 065433................  Mycophenolate Mofetil  Zydus
                              Capsules, 250 mg.      Pharmaceuticals
                                                     (USA) Inc., 73
                                                     Route 31 North,
                                                     Pennington, NJ
                                                     08534.
ANDA 065477................  Mycophenolate Mofetil  Do.
                              Tablets, 500 mg.
ANDA 070159................  Tolazamide Tablets     Par Pharmaceutical,
                              USP, 100 mg.           Inc., One Ram Ridge
                                                     Rd., Spring Valley,
                                                     NY 10977.
ANDA 070160................  Tolazamide Tablets     Do.
                              USP, 250 mg.
ANDA 070161................  Tolazamide Tablets     Do.
                              USP, 500 mg.
ANDA 070431................  Valproic Acid          Do.
                              Capsules, 250 mg.
ANDA 070577................  Verapamil HCl          Hospira, Inc.
                              Injection USP, 2.5
                              mg/mL.
ANDA 070818................  Ibuprofen Tablets      Ohm Laboratories, c/
                              USP, 400 mg.           o Ranbaxy Inc., 600
                                                     College Rd. East,
                                                     Princeton, NJ
                                                     08540.
ANDA 070980................  Potassium Chloride     Nesher
                              Extended-Release       Pharmaceuticals
                              Capsules USP, 10       (USA) LLC.
                              milliequivalents.
ANDA 071200................  Disopyramide           Do.
                              Phosphate Extended-
                              Release Capsules
                              USP, 150 mg.
ANDA 071726................  Metaproterenol         Nephron
                              Sulfate Inhalation     Pharmaceuticals
                              Solution, 0.6%.        Corp., 4121 South
                                                     West 34th St.,
                                                     Orlando, FL 32811.
ANDA 071855................  Metaproterenol         Do.
                              Sulfate Inhalation
                              Solution, 0.4%.
ANDA 072273................  Albuterol Inhalation   Armstrong
                              Aerosol\1\.            Pharmaceuticals,
                                                     Inc. 25 John Rd.,
                                                     Canton, MA 02021.
ANDA 072437................  Fenoprofen Calcium     Par Pharmaceuticals,
                              Capsules USP, 200 mg.  Inc.
ANDA 072974................  Methyldopate HCl       Teva Parenteral
                              Injection USP.         Medicines, Inc.
ANDA 073000................  Dopamine HCl           Do.
                              Injection USP, 80 mg/
                              mL.
ANDA 073117................  Metoclopramine         Hospira, Inc.
                              Injection USP, 5 mg/
                              mL.
ANDA 073465................  Sodium Nitroprusside   Teva Parenteral
                              Injection, 25 mg/mL.   Medicines, Inc.
ANDA 073617................  Pentamidine            Baxter Healthcare
                              Isethionate for        Corp.
                              Injection, 300 mg/
                              vial.
ANDA 073683................  Cyclobenzaprine HCl    Sandoz Inc.
                              Tablets, 10 mg.
ANDA 074013................  Pindolol Tablets USP,  Mylan
                              5 mg.                  Pharmaceuticals,
                                                     Inc., 781 Chestnut
                                                     Ridge Rd., P.O. Box
                                                     4310, Morgantown,
                                                     WV 26505-4310.
ANDA 074018................  Pindolol Tablets USP,  Do.
                              10 mg.
ANDA 074105................  Naproxen Tablets USP,  DAVA
                              250 mg, 375 mg, and    Pharmaceuticals,
                              500 mg.                Inc., Parker Plaza,
                                                     400 Kelby St., 10th
                                                     Floor, Fort Lee, NJ
                                                     07024.
ANDA 074147................  Metoclopramide         Hospira, Inc.
                              Injection USP, 5 mg/
                              mL.
ANDA 074206................  Dobutamine Injection   Teva Parenteral
                              USP, 250 mg (base)/    Medicines, Inc.
                              20 mL.
ANDA 074252................  Cimetidine HCl         Do.
                              Injection, EQ 300 mg
                              (base)/2 mL.
ANDA 074519................  Captopril Tablets,     Sandoz Inc.
                              12.5 mg, 25 mg, 50
                              mg, and 100 mg.
ANDA 074613................  Bumetanide Injection   Teva Parenteral
                              USP, 0.25 mg/mL.       Medicines, Inc.
ANDA 074616................  Inamrinone Lactate     Hospira, Inc.
                              Injection, 5 mg/mL.
ANDA 074629................  Iopamidol Injection    Baxter Healthcare
                              USP, 41%, 51%, 61%,    Corp.
                              and 76%.
ANDA 074637................  Iopamidol Injection    Hospira, Inc.
                              USP, 61%.
ANDA 074753................  Atracurium Besylate    Baxter Healthcare
                              Injection USP, 10 mg/  Corp.
                              mL (preserved).
ANDA 074768................  Atracurium Besylate    Do.
                              Injection USP, 10 mg/
                              mL (preservative
                              free).
ANDA 074784................  Atracurium Besylate    Teva Parenteral
                              Injection USP, 10 mg/  Medicines, Inc.
                              mL.
ANDA 074795................  Fluphenazine           Do.
                              Decanoate Injection
                              USP, 25 mg/mL.
ANDA 074969................  Acyclovir for          Do.
                              Injection USP, 500
                              mg/vial and 1,000 mg/
                              vial.
ANDA 075004................  Diltiazem HCl          Hospira, Inc.
                              Injection, 5 mg/mL.
ANDA 075005................  Iopamidol Injection    Do.
                              USP, 51%, 61%, and
                              76%.
ANDA 075012................  Etodolac Tablets USP,  Mylan
                              400 mg and 500 mg.     Pharmaceuticals,
                                                     Inc.
ANDA 075071................  Etodolac Capsules,     Do.
                              200 mg and 300 mg.
ANDA 075119................  Buspirone HCl Tablet   Egis Pharmaceuticals
                              USP, 5 mg, 10 mg,      PLC, c/o GlobePharm
                              and 15 mg.             Inc., 313 Pine St.,
                                                     Suite 204,
                                                     Deerfield, IL
                                                     60015.
NDA 075166.................  Isosorbide             SkyePharma AG, c/o
                              Mononitrate Extended-  Compliance
                              Release Tablets, 60    Resources, LLC,
                              mg.                    7100 Farmington
                                                     Lane, Hillsborough,
                                                     NC 27278.
ANDA 075328................  Pemoline Tablets,      Vintage
                              18.75 mg, 37.5 mg,     Pharmaceuticals,
                              and 75 mg.             120 Vintage Dr.,
                                                     Huntsville, AL
                                                     35811.
ANDA 075392................  Propofol Injectable    Teva Parenteral
                              Emulsion, 10 mg/mL.    Medicines, Inc.
------------------------------------------------------------------------
\1\ This product included an oral pressurized metered-dose inhaler that
  contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
  longer be used as a propellant for any albuterol metered-dose inhalers
  (see 70 FR 17168, April 4, 2005).

    Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in table 1 in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective August 19, 2013. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that
are in inventory on the date that this notice becomes effective (see

DATES) may continue to be dispensed until the inventories have been
depleted or the drug products have reached their expiration dates or
otherwise become violative, whichever occurs first.

    Dated: July 15, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-17324 Filed 7-18-13; 8:45 am]
BILLING CODE 4160-01-P