Strategic Economic and Community Development, 53457-53458 [2015-21898]
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53457
Rules and Regulations
Federal Register
Vol. 80, No. 172
Friday, September 4, 2015
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
7 CFR Part 301
[Docket No. APHIS–2014–0023]
Gypsy Moth Generally Infested Areas;
Additions in Minnesota, Virginia, West
Virginia, and Wisconsin
Animal and Plant Health
Inspection Service, USDA.
ACTION: Affirmation of interim rule as
final rule.
AGENCY:
We are adopting as a final
rule, without change, an interim rule
that amended the gypsy moth
regulations by adding areas in
Minnesota, Virginia, West Virginia, and
Wisconsin to the list of generally
infested areas based on the detection of
infestations of gypsy moth in those
areas. As a result of the interim rule, the
interstate movement of regulated
articles from those areas was restricted.
The interim rule was necessary to
prevent the artificial spread of the gypsy
moth to noninfested areas of the United
States.
DATES: Effective on September 4, 2015,
we are adopting as a final rule the
interim rule published at 80 FR 12916–
12917 on March 12, 2015.
FOR FURTHER INFORMATION CONTACT: Mr.
Paul Chaloux, National Policy Manager,
Emerald Ash Borer Program and Gypsy
Moth Program, Plant Protection and
Quarantine, APHIS, 4700 River Road
Unit 137, Riverdale, MD 20737; (301)
851–2064.
SUPPLEMENTARY INFORMATION: The gypsy
moth, Lymantria dispar (Linnaeus), is a
destructive pest of forest, shade, and
commercial trees such as nursery stock
and Christmas trees. The gypsy moth
regulations (contained in 7 CFR 301.45
through 301.45–12 and referred to
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SUMMARY:
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below as the regulations) restrict the
interstate movement of regulated
articles from generally infested areas to
prevent the artificial spread of the gypsy
moth.
In an interim rule 1 effective and
published in the Federal Register on
March 12, 2015 (80 FR 12916–12917,
Docket No. APHIS–2014–0023), we
amended the regulations in § 301.45–
3(a) by adding the following areas to the
list of generally infested areas: Cook and
Lake Counties in Minnesota; Tazewell
County in Virginia; McDowell, Mercer,
Raleigh, Summers, and Wyoming
Counties in West Virginia; and Iowa
County in Wisconsin. As a result of the
interim rule, the interstate movement of
regulated articles from these areas was
restricted.
Comments on the interim rule were
required to be received on or before May
11, 2015. We received two comments by
that date. The comments were from the
National Plant Board and an individual.
Both commenters supported the interim
rule. Therefore, for the reasons given in
the interim rule, we are adopting the
interim rule as a final rule without
change.
This action also affirms the
information contained in the interim
rule concerning Executive Order 12866
and the Regulatory Flexibility Act,
Executive Orders 12372 and 12988, and
the Paperwork Reduction Act.
Further, for this action, the Office of
Management and Budget has waived its
review under Executive Order 12866.
List of Subjects in 7 CFR Part 301
Agricultural commodities, Plant
diseases and pests, Quarantine,
Reporting and recordkeeping
requirements, Transportation.
PART 301—DOMESTIC QUARANTINE
NOTICES
Accordingly, we are adopting as a
final rule, without change, the interim
rule that amended 7 CFR part 301 and
that was published at 80 FR 12916–
12917 on March 12, 2015.
■
1 To view the interim rule and the comments we
received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2014-0023.
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Done in Washington, DC, this 31st day of
August 2015.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2015–21998 Filed 9–3–15; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Rural Business-Cooperative Service
Rural Housing Service
Rural Utilities Service
Farm Service Agency
7 CFR Part 1980
RIN 0570–AA94
Strategic Economic and Community
Development
Rural Business-Cooperative
Service, Rural Housing Service, Rural
Utilities Service, Farm Service Agency,
U.S. Department of Agriculture (USDA).
ACTION: Interim rule with public
comment; reopening of public comment
period.
AGENCY:
Through this action, the Rural
Housing Service, the Rural BusinessCooperative Service, the Rural Utilities
Service, and the Farm Service Agency
are reopening the comment period for
the interim rule, published on May 20,
2015 ‘‘Strategic Economic and
Community Development’’.
DATES: Comments on the interim rule
that was published on May 20, 2015 (80
FR 28807) and effective June 19, 2015,
must be received by September 18,
2015.
SUMMARY:
Submit your comments on
this rule by any of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Submit written comments via
the U.S. Postal Service to the Branch
Chief, Regulations and Paperwork
Management Branch, U.S. Department
of Agriculture, STOP 0742, 1400
Independence Avenue SW.,
Washington, DC 20250–0742.
• Hand Delivery/Courier: Submit
written comments via Federal Express
Mail, or other courier service requiring
ADDRESSES:
E:\FR\FM\04SER1.SGM
04SER1
53458
Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Rules and Regulations
a street address, to the Branch Chief,
Regulations and Paperwork
Management Branch, U.S. Department
of Agriculture, 300 7th Street SW., 7th
Floor, Washington, DC 20024.
All written comments will be
available for public inspection during
regular work hours at the 300 7th Street,
SW., 7th Floor address listed above.
Dated: August 26, 2015.
Lisa Mensah,
Under Secretary, Rural Development.
Dated: August 27, 2015.
Michael Scuse,
Under Secretary, Farm and Foreign
Agricultural Services.
[FR Doc. 2015–21898 Filed 9–3–15; 8:45 am]
BILLING CODE 3410–XY–P
FOR FURTHER INFORMATION CONTACT:
Farah Ahmad, Rural BusinessCooperative Service, U.S. Department of
Agriculture, Stop 3254, 1400
Independence Avenue SW.,
Washington, DC 20250–0783,
Telephone: 202–245–1169. Email:
Farah.Ahmad@wdc.usda.gov.
On July
20, 2015, the Rural Housing Service, the
Rural Business-Cooperative Service, the
Rural Utilities Service, and the Farm
Service Agency published an interim
rule with comment in the Federal
Register (80 FR 28807), ‘‘Strategic
Economic and Community
Development.’’ The interim rule
identified that public comments were to
be submitted by August 18, 2015.
Unfortunately, the Web site
Regulations.gov inadvertently closed the
comment period on July 20, 2015,
which was the closing date for
comments on the information collection
request. To compensate for closing the
comment period early via the
Regulations.gov Web site, this action
provides commenters additional time to
submit comments on the interim rule.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 524, and 558
[Docket No. FDA–2015–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications
AGENCY:
This rule is effective September
4, 2015.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during May and June 2015, as
listed in table 1. In addition, FDA is
informing the public of the availability,
where applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852, between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with
access to the Internet may obtain these
documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/
Products/
ApprovedAnimalDrugProducts/
default.htm.
DATES:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
application-related actions for new
animal drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs) during May and
June 2015. FDA is also informing the
public of the availability of summaries
of the basis of approval and of
environmental review documents,
where applicable. The animal drug
regulations are also being amended to
reflect a nonsubstantive change. This
technical amendment is being made to
improve the accuracy of the regulations.
SUMMARY:
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2015
Sponsor
New animal drug
product name
Action
141–417 .........................
Bayer HealthCare LLC,
Animal Health Division, P.O. Box 390,
Shawnee Mission, KS
66201.
CORAXIS (moxidectin)
Topical Solution for
Dogs.
141–188 .........................
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NADA/ANADA
Merial Inc., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–
4640.
MARQUIS (ponazuril)
Oral Paste.
141–262 .........................
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
CERENIA (maropitant
citrate) Tablets.
Original approval for the
prevention of heartworm disease, and
for the treatment and
control of intestinal
hookworm,
roundworm and
whipworm infections
in dogs.
Supplemental approval
of a revised dosage
that includes a loading dose on the first
day of treatment.
Supplemental approval
extending duration of
daily administration
until resolution of
acute vomiting.
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21 CFR
sections
FOIA
summary
NEPA
review
524.1450
CE.1 2
520.1855
yes .......
CE.1 2
520.1315
04SER1
yes .......
yes .......
CE.1 2
]]>Agencies
[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)]
[Rules and Regulations]
[Pages 53457-53458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21898]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Rural Business-Cooperative Service
Rural Housing Service
Rural Utilities Service
Farm Service Agency
7 CFR Part 1980
RIN 0570-AA94
Strategic Economic and Community Development
AGENCY: Rural Business-Cooperative Service, Rural Housing Service,
Rural Utilities Service, Farm Service Agency, U.S. Department of
Agriculture (USDA).
ACTION: Interim rule with public comment; reopening of public comment
period.
-----------------------------------------------------------------------
SUMMARY: Through this action, the Rural Housing Service, the Rural
Business-Cooperative Service, the Rural Utilities Service, and the Farm
Service Agency are reopening the comment period for the interim rule,
published on May 20, 2015 ``Strategic Economic and Community
Development''.
DATES: Comments on the interim rule that was published on May 20, 2015
(80 FR 28807) and effective June 19, 2015, must be received by
September 18, 2015.
ADDRESSES: Submit your comments on this rule by any of the following
methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Submit written comments via the U.S. Postal Service
to the Branch Chief, Regulations and Paperwork Management Branch, U.S.
Department of Agriculture, STOP 0742, 1400 Independence Avenue SW.,
Washington, DC 20250-0742.
Hand Delivery/Courier: Submit written comments via Federal
Express Mail, or other courier service requiring
[[Page 53458]]
a street address, to the Branch Chief, Regulations and Paperwork
Management Branch, U.S. Department of Agriculture, 300 7th Street SW.,
7th Floor, Washington, DC 20024.
All written comments will be available for public inspection during
regular work hours at the 300 7th Street, SW., 7th Floor address listed
above.
FOR FURTHER INFORMATION CONTACT: Farah Ahmad, Rural Business-
Cooperative Service, U.S. Department of Agriculture, Stop 3254, 1400
Independence Avenue SW., Washington, DC 20250-0783, Telephone: 202-245-
1169. Email: Farah.Ahmad@wdc.usda.gov.
SUPPLEMENTARY INFORMATION: On July 20, 2015, the Rural Housing Service,
the Rural Business-Cooperative Service, the Rural Utilities Service,
and the Farm Service Agency published an interim rule with comment in
the Federal Register (80 FR 28807), ``Strategic Economic and Community
Development.'' The interim rule identified that public comments were to
be submitted by August 18, 2015. Unfortunately, the Web site
Regulations.gov inadvertently closed the comment period on July 20,
2015, which was the closing date for comments on the information
collection request. To compensate for closing the comment period early
via the Regulations.gov Web site, this action provides commenters
additional time to submit comments on the interim rule.
Dated: August 26, 2015.
Lisa Mensah,
Under Secretary, Rural Development.
Dated: August 27, 2015.
Michael Scuse,
Under Secretary, Farm and Foreign Agricultural Services.
[FR Doc. 2015-21898 Filed 9-3-15; 8:45 am]
BILLING CODE 3410-XY-P
