[Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)]
[Notices]
[Page 52224]
[FR Doc No: 2013-20576]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission held a Closed Meeting on Friday, August 16,
2013 at 12:30 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries attended the Closed Meeting.
Certain staff members who had an interest in the matter also were
present.
    The General Counsel of the Commission, or her designee, certified
that, in her opinion, one or more of the exemptions set forth in 5
U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3),
(5), (7), 9(ii) and (10), permitted consideration of the scheduled
matter at the Closed Meeting.
    Commissioner Gallagher, as duty officer, voted to consider the item
listed for the Closed Meeting in a closed session, and determined that
no earlier notice thereof was possible.
    The subject matter of the Closed Meeting was: Settlement of
injunctive actions.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: August 19, 2013.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-20576 Filed 8-20-13; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Pages 38963-38964]
[FR Doc No: 2019-16949]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF19-5-000]

Bonneville Power Administration; Notice of Filing

    Take notice that on July 29, 2019, Bonneville Power Administration
submitted tariff filing per: Bonneville Power Administration Proposed
FY2020-2021 Wholesale Power and Transmission Rate Adjustment filing to
be effective October 1, 2019.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 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
website that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 28, 2019.

    Dated: August 2, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-16949 Filed 8-7-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52765-52766]
[FR Doc No: 2022-18540]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10100-01-OA]

Request for Nominations of Candidates for the National
Environmental Education Advisory Council (NEEAC)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) or Agency
Office of Public Engagement and Environmental Education is soliciting
applications for environmental education professionals for
consideration to serve on the National Environmental Education Advisory
Council (NEEAC). There are multiple vacancies on the Advisory Council
that must be filled. Additional avenues and resources may be utilized
in the solicitation of applications. ``In accordance with Executive
Order 14035

(June 25, 2021), EPA values and welcomes opportunities to increase
diversity, equity, inclusion and accessibility on its federal advisory
committees. EPA's federal advisory committees have a workforce that
reflects the diversity of the American people.''

DATES: Nominations should be submitted by September 19, 2022 per the
instructions below.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this Notice and Request for Nominations
may contact Mr. Javier Araujo, Designated Federal Officer (DFO), Office
of Environmental Education (OEE), by telephone at<PHONE_NUMBER> or via
email at [email protected]. General information concerning the
NEEAC can be found on the following website: https://www.epa.gov/education/national-environmental-education-advisory-council-neeac.

SUPPLEMENTARY INFORMATION:

Background

    The National Environmental Education Act requires that the council
be comprised of (11) members appointed by the Administrator of the EPA.
Members represent a balance of perspectives, professional
qualifications, and experience. The Act specifies that members must
represent the following sectors: primary and secondary education (one
of whom shall be a classroom teacher), two members; colleges and
universities, two members; business and industry, two members; non-
profit organizations, two members; state departments of education and
natural resources, two members; and one member to represent senior
Americans. Members are chosen to represent various geographic regions
of the country, and the Council strives for a diverse representation.
The professional backgrounds of Council members should include
education, science, policy, or other appropriate disciplines. Each
member of the Council shall hold office for a one (1) to three (3) year
period.
    Members are expected to participate in up to two (2 in person
meetings per year and monthly or more virtual conference calls per
year. The anticipated time commitment may be between 15 and 40 hours
per month.
    Positions on the National Environmental Education Advisory Council
(NEEAC) are being offered without compensation. However, if selected,
you will be provided with per diem as well as travel expense coverage
for in person scheduled meetings.

Request for Nominations

    The NEEAC staff office seeks candidates with demonstrated
experience and or knowledge in any of the following environmental
education issue areas: (a) Integrating environmental education into
state and local education reform and improvement; (b) state, local and
tribal level capacity building for environmental education: (c) cross-
sector partnerships to foster environmental education; (d) leveraging
resources for environmental education; (e) design and implementation of
environmental education research; (f) evaluation methodology;
professional development for teachers and other education
professionals; and targeting under-represented audiences, including
low-income, multi-cultural, senior citizens and other adults. Specific
experience in environmental justice and climate change are essential.

Process and Deadline for Submitting Nominations

    Any interested and qualified individuals may be considered for
appointment on the National Environmental Education Advisory Council.
In order to apply, the following four items should be submitted in
electronic format to the Designated Federal Officer, Javier Araujo,
[email protected] and contain the following: (1) Contact
information including name, address, phone, and an email address (2) a
curriculum vitae or resume (3) Please include the specific area of
expertise in environmental education and the sector or slot the
applicant is applying for in the subject line of your submission (4) A
one page commentary on the applicant's philosophy regarding the need
for, development, implementation and or management of environmental
education.
    Nominations should be submitted by September 19, 2022.
    Submit nominations electronically to Javier Araujo, Designated
Federal Officer, National Environmental Education Advisory Council,
U.S. Environmental Protection Agency, email: [email protected]

FOR FURTHER INFORMATION CONTACT: For information regarding this Request
for Nominations, please contact Mr. Javier Araujo, Designated Federal
Officer, [email protected],<PHONE_NUMBER>, U.S. EPA, Office of
Environmental Education, William Jefferson Clinton North Room 1426,
1200 Pennsylvania Avenue NW, Washington, DC 20460.
    General Information concerning NEEAC can be found on the EPA
website at: https://www.epa.gov/education/national-environmental-education-advisory-council-neeac.
    The short list candidates will be required to fill out the
Confidential Disclosure Form for Special Government Employees serving
Federal Advisory Committees at the U.S. Environmental Protection
Agency. (EPA form 3110-48). This confidential form allows government
officials to determine whether there is a statutory conflict between
that person's public responsibilities (which include membership on a
Federal Advisory Committee) and private interests and activities and
the appearance of a lack of impartiality as defined by Federal
regulation. The form may be viewed and downloaded from the following
URL address: http://intranet.epa.gov/ogc/ethics/EPA3110-48ver3.pdf.
Please note this form is not an application form.

Rosemary Enobakhare,
Associate Administrator, Office of Public Engagement and Environmental
Education.
[FR Doc. 2022-18540 Filed 8-26-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Notices]
[Pages 64927-64929]
[FR Doc No: 2018-27345]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0312]

Hours of Service of Drivers: American Bakers Association and
International Dairy Foods Association; Application for Exemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of application for exemption; request for comments.

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SUMMARY: FMCSA announces that it has received a joint application from
the American Bakers Association (ABA) and the International Dairy Foods
Association (IDFA) requesting an exemption from the hours-of-service
(HOS) regulations for drivers engaged in the delivery of baked goods
and milk products during periods and in geographic areas reasonably
anticipated to be impacted by an impending natural disaster or
emergency situation. ABA/IDFA requests a 5-year exemption from 49 CFR
part 395 for their drivers engaged in the delivery of essential food
staples to extend their driving hours to help communities prepare for
anticipated disaster conditions, such as extreme weather events,
natural disasters, and other emergencies. The applicants state that the
exemption would achieve a level of safety equivalent to, or greater
than, the level that would be achieved absent the proposed exemption.
FMCSA requests public comment on ABA/IDFA's application for exemption.

DATES: Comments must be received on or before January 17, 2019.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2018-0312 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. See the
Public Participation and Request for Comments section below for further
information.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m.
E.T., Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line FDMS is available 24 hours each
day, 365 days each year.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: For information concerning this
notice, please contact Mr. Richard Clemente, Transportation Specialist,
FMCSA Driver and Carrier Operations Division; Telephone: (202) 366-
2722; Email<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, contact Docket Services, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2018-0312), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov and put
the docket number, ``FMCSA-2018-0312'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope. FMCSA will consider all comments and material received
during the comment period and may grant or not grant this application
based on your comments.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain Federal Motor Carrier Safety Regulations
(FMCSRs). FMCSA must publish a notice of each exemption request in the
Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request.
    The Agency reviews safety analyses and public comments submitted,
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305).

The decision of the Agency must be published in the Federal Register
(49 CFR 381.315(b)) with the reasons for denying or granting the
application and, if granted, the name of the person or class of persons
receiving the exemption, and the regulatory provision from which the
exemption is granted. The notice must also specify the effective period
(up to 5 years) and explain the terms and conditions of the exemption.
The exemption may be renewed (49 CFR 381.300(b)).

III. Request for Exemption

    The American Bakers Association (ABA) represents the wholesale
baking industry. ABA advocates on behalf of more than 1,000 baking
facilities and company suppliers. Their members produce bread, rolls,
crackers, bagels, sweet goods, tortillas, and many other baked
products. ABA advises that the average number of drivers and commercial
motor vehicles (CMVs) per company is approximately 1,050, ranging from
70 to 5,500.
    The International Dairy Foods Association (IDFA) represents the
dairy manufacturing and marketing industry. Their members range from
large multinational organizations to single-plant companies, and
together they represent more than 85 percent of the milk, cultured
products, cheese, ice cream and frozen desserts produced and marketed
in the U.S. and sold throughout the world. IDFA states that, based on
statistics for the fluid milk industry, the sector has approximately
15,500 drivers and 18,000 trucks (both tractor-trailers and smaller
delivery trucks). The industry believes that approximately 450,000,000
miles are driven each year in milk and dairy product deliveries.
    ABA/IDFA requests an exemption from the provisions of 49 CFR 395.3,
``Maximum driving time for property-carrying vehicles'' for their
drivers delivering ``essential food staples,'' particularly baked goods
and milk products, in advance of anticipated natural disasters or other
emergency conditions. The requested exemption would only cover the
period of time in advance of, during, and shortly after the emergency
condition, where the HOS rules can be an unintended barrier to
efficient disaster preparations and operations.
    The applicants proposed that the exemption apply during periods of
disaster preparation in anticipation of disaster conditions, to be
defined based on the existing definition of ``Emergency'' in 49 CFR
390.5, but modified to encompass conditions that are reasonably
anticipated. The exemption would apply from the time that a natural
disaster or emergency is reasonably anticipated until a reasonable time
after the disaster has resolved. ABA/IDFA states that, although some
element of reasonable judgement is necessarily inherent in this
proposed approach, a definition that is tied to an official Declaration
of Emergency would defeat the public purpose of a disaster preparation
exemption by forcing suppliers to wait until an official declaration of
emergency by the President, State governors, or FMCSA, which would
often leave insufficient lead time for disaster preparation.
Accordingly, the requested exemption should allow suppliers to use
reasonable judgment based on early warning announcements, such as
hazardous weather announcements.
    ABA/IDFA advises that disaster preparation is not limited to
hurricanes, as serious storms such as ice storms, heavy rains, or
strong frontal patterns that spawn tornadoes can also wreak levels of
havoc in certain regions throughout the country. The need of consumers
for essential food staples significantly increases in advance of and
during emergency conditions, and emergency preparations are often
exacerbated by a rush on retail establishments prior to announced
emergency events.
    The increased demand for essential food staples prior to threatened
natural disasters and other emergencies requires changes to delivery
logistics, schedules, and HOS for at least a 72-hour period prior to an
anticipated disaster event, as it is critical to move a large volume of
supplies into the disaster-affected area, and supplies often must be
sourced from regional distribution centers, other manufacturing
facilities that are able to increase production, or in the case of
widespread disasters, distribution systems in other regions. Disaster
preparations significantly and abruptly increase the need for driving
time, delivery routes and drivers, due to heavy traffic on roads,
challenging driving conditions, use of alternative or evacuation
routes, and disruptions such as downed trees and traffic accidents.
Furthermore, emergency conditions may create situations in which rest
breaks on normal schedules are infeasible or dangerous due to road or
parking conditions.
    According to ABA/IDFA, the best way to prepare for anticipated
disasters or emergencies is to increase delivery runs ahead of the
impending situation. Because facilities in a disaster area that produce
fresh bread and milk may be without power, flooded, or otherwise
impacted by the disaster, it is often necessary to source replacement
deliveries from more distant production facilities in other regions.
Suppliers often have the ability to increase production well ahead of
emergency situations, and will begin advancing product into the market
72 hours or more ahead of the anticipated stock depletion. Experience
has shown the applicants that the HOS restrictions often become a
limiting factor at the expense of effective emergency preparations.
Perhaps the most critical factor, due to a national shortage of
licensed commercial drivers, there are simply no additional drivers or
contract carriers available to supplement normal driver ranks due to
the spiking demand ahead of and during disasters. Accordingly, the only
way to prepare for disasters is to increase routes and driving times of
regular drivers in the suppliers' distribution network.
    In summary, this exemption woulld allow suppliers of essential food
staples to adapt delivery schedules to allow communities to prepare for
anticipated disaster conditions, such as extreme weather events,
natural disasters, and other emergencies that disrupt delivery
schedules and require increased driving hours. The exemption would help
avoid shortages of essential food staples at retail stores and food
establishments that could otherwise result if deliveries are restricted
by the generally applicable HOS rules in 49 CFR 395.3. ABA/IDFA states
that without an exemption to the HOS provisions, retail stores and food
establishments are more likely to run out of product, leaving consumers
lacking essential food staples during emergency conditions.

IV. Method To Ensure an Equivalent or Greater Level of Safety

    By providing the flexibility for bakery and milk product delivery
drivers to adjust HOS during disaster conditions, suppliers will be
able to supply essential food staples with greater efficiency and
safety by allowing experienced drivers and employers to modify delivery
routes and schedules to accommodate the safe delivery of emergency
supplies.
    As detailed in their application, ABA/IDFA believes the ability to
utilize the judgment of experienced, well-trained and qualified drivers
during weather events will promote safety. The nature of retail
unloading, and familiar routes, reduces concerns regarding driver
fatigue and safety. Many retail stores are open only during set hours,
which provides natural limits to the use of the exemption.The ability
to take breaks and end the day according to the

conditions of the road and traffic during the weather event will allow
drivers to take their time and use caution as appropriate under the
conditions at that time, rather than feeling pressure to comply with
the HOS rules that are most appropriate for normal driving conditions.
ABA/IDFA further adds that the exemption perhaps most importantly will
allow families to stock supplies at their regular neighborhood stores
and avoid the need for residents to drive unnecessarily looking for
emergency supplies of essential food staples in advance of or during a
disaster situation.
    Regarding an equivalent level of safety, ABA/IDFA details the
following in their application regarding HOS compliance following the
exemption from 49 CFR 395.3: A weather ``trigger'' would start a 72-
hour HOS exemption period leading up to an anticipated storm, which
creates two possible scenarios following the exemption period: (1)
FMCSA grants a wide-scale HOS exemption period for the impacted area or
a State government declares a state of emergency and suspends the HOS
requirements, or (2) the storms impact on the region is too
insignificant to warrant an HOS exemption on either the State or
Federal level. In the case of the first scenario, the HOS requirements
for that period are already suspended and concerns of equivalent safety
will have already been considered in existing regulations In the second
scenario, the applicants propose an equivalent level of safety as
follows: (1) For the 11 hour driving time limit, for every 2 hours a
driver surpasses this limit, an additional hour will be added to the
original 10-hour rest limit to be completed between runs following the
exemption period; and (2) for the 60/70 hour limits, should a driver
surpass these normal limits during the exemption period, two additional
hours will be added to the original 34-hour off duty period required
following the exemption period. In order to verify compliance, the
hours would continue to be documented through the use of electronic
logging devices pursuant to the current rules in 49 CFR part 395,
subpart B. The requested exemption is for 5 years. A copy of ABA/IDFA's
application for exemption is available for review in the docket for
this notice.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-27345 Filed 12-17-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Notices]
[Page 6639-6640]
[DOCID:fr10fe09-82]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0112]

Determination of Regulatory Review Period for Purposes of Patent
Extension; VETMEDIN

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for VETMEDIN and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that animal drug product.

ADDRESSES: Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360b(j)) became effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the animal drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for an animal drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(4)(B).
    FDA recently approved for marketing the animal drug product
VETMEDIN (pimobendan). VETMEDIN is indicated for the management of the
signs of mild, moderate, or severe (modified NYHA Class II, III, or IV)
congestive heart failure in dogs due to atrioventricular valvular
insufficiency or dilated cardiomyopathy. VETMEDIN is indicated for use
with concurrent therapy for congestive heart failure (e.g., furosemide,
etc.) as appropriate on a case-by-case basis. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for VETMEDIN (U.S. Patent No. 5,364,646) from
Dr. Karl Thomae GmbH, and the Patent and Trademark Office requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated May 6, 2008, FDA advised the Patent
and Trademark Office that this animal drug product had undergone a
regulatory review period and that the approval of VETMEDIN represented
the first permitted commercial marketing or use of the product. Shortly
thereafter,

the Patent and Trademark Office requested that FDA determine the
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
VETMEDIN is 2,751 days. Of this time, 2,715 days occurred during the
testing phase of the regulatory review period, while 36 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 512(j) of the act (21 U.S.C.
360b(j)) became effective: October 20, 1999. The applicant claims April
8, 1999, as the date the investigational new animal drug application
(INAD) became effective. However, the date that a major health or
environmental effects test is begun or the date on which the agency
acknowledges the filing of a notice of claimed investigational
exemption for a new animal drug, whichever is earlier, is the effective
date for the INAD. According to FDA records, October 20, 1999, is the
effective date for the INAD.
    2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the act: March 26, 2007.
FDA has verified the applicant's claim that the new animal drug
application (NADA) for VETMEDIN (NADA 141-273) was initially submitted
on March 26, 2007.
    3. The date the application was approved: April 30, 2007. FDA has
verified the applicant's claim that NADA 141-273 was approved on April
30, 2007.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,492 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by April 13, 2009. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by August 10,
2009. To meet its burden, the petition must contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30. Comments and petitions should be submitted to the
Division of Dockets Management. Three copies of any mailed information
are to be submitted, except that individuals may submit one copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Comments and petitions may be seen in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: February 2, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-2684 Filed 2-9-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: November 30, 2010 (Volume 75, Number 229)]
[Notices]
[Page 74127]
[DOCID:fr30no10-148]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Proposed Modification of the Philadelphia, PA Class B Airspace
Area; Public Meetings

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of meetings.

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SUMMARY: This notice announces six fact-finding informal airspace
meetings to solicit information from airspace users and others,
concerning a proposal to revise the Class B airspace area at
Philadelphia, PA. The purpose of these meetings is to provide
interested parties an opportunity to present views, recommendations,
and comments on the proposal. All comments received during these
meetings will be considered prior to any issuance of a notice of
proposed rulemaking.

Times and Dates: The informal airspace meetings will be held on
Tuesday, February 15, 2011; Wednesday, February 16, 2011; Thursday,
February 17, 2011; Tuesday, February 22, 2011; Wednesday, February 23,
2011; and Thursday, February 24, 2011. FAA presentations will begin at
4 p.m. and again at 7 p.m. on each meeting date. Comments must be
received on or before March 26, 2011.

ADDRESSES: (1) The meeting on Tuesday, February 15, 2011, will be held
at New Castle Airport, 151 North Dupont Highway, New Castle, DE 19720;
(2) The meeting on Wednesday, February 16, 2011, will be held at New
Garden Airport, 1235 Newark Road, Toughkenamon, PA 19374; (3) The
meeting on Thursday, February 17, 2011, will be held at Wings Field
Terminal Building, 1501 Narcissa Road, Blue Bell, PA 19422; (4) The
meeting on Tuesday, February 22, 2011, will also be held at Wings Field
Terminal Building, 1501 Narcissa Road, Blue Bell, PA 19422; (5) The
meeting on Wednesday, February 23, 2011, will be held at Flying W
Airport, 60 Fostertown Road, Medford, NJ 08055; and (6) The meeting on
Thursday, February 24, 2011, will be held at Freefall Adventures
Skydive School, 300 Dahlia Avenue, Williamstown, NJ 08094.
    Comments: Send comments on the proposal to: Mark D. Ward, Manager,
Operations Support Group, Eastern Service Area, Air Traffic
Organization, Federal Aviation Administration, P.O. Box 20636, Atlanta,
GA 30320.

FOR FURTHER INFORMATION CONTACT: Gail Swider, Support Manager,
Philadelphia ATCT/TRACON, 15 Hog Island Road, Philadelphia, PA 19153;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Meeting Procedures

    (a) Doors open 30 minutes prior to the beginning of each meeting.
The meetings will be informal in nature and will be conducted by one or
more representatives of the FAA Eastern Service Center. A
representative from the FAA will present an informal briefing on the
planned modification to the Class B airspace area at Philadelphia, PA.
Following the presentation, there will be time for questions and
presentations by attendees, although a time limit may be imposed. Only
comments concerning the plan to modify the Class B airspace area at
Philadelphia, PA, will be accepted.
    (b) The meetings will be open to all persons on a space-available
basis. There will be no admission fee or other charge to attend and
participate.
    (c) Any person wishing to make a presentation to the FAA panel will
be asked to sign in and estimate the amount of time needed for such
presentation. This will permit the panel to allocate an appropriate
amount of time for each presenter. These meetings will not be adjourned
until everyone on the list has had an opportunity to address the panel.
    (d) Position papers or other handout material relating to the
substance of these meetings will be accepted. Participants wishing to
submit handout material should present an original and two copies to
the presiding officer. There should be additional copies of each
handout available for other attendees.
    (e) These meetings will not be formally recorded. However, a
summary of comments made at the meeting will be filed in the docket.

Agenda for the Meetings

--Sign-in
--Presentation of Meeting Procedures
--FAA presentation on the proposed Class B airspace area modifications
--Solicitation of public comments
--Closing Comments.

    Issued in Washington, DC, on November 24, 2010.
Edith V. Parish,
Manager, Airspace and Rules Group.
[FR Doc. 2010-30085 Filed 11-29-10; 8:45 am]
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