New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct, 73104-73105 [2015-29902]
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73104
Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Rules and Regulations
page 57523, column 2, beginning on line
26, remove ‘‘, excluding that airspace
within Federal airways and within
Canadian airspace’’.
Issued in Fort Worth, TX, on November 10,
2015.
Robert W. Beck,
Manager, Operations Support Group, ATO
Central Service Center.
[FR Doc. 2015–29704 Filed 11–23–15; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 528
[Docket No. FDA–2015–N–0002]
New Animal Drugs in Genetically
Engineered Animals; opAFP–GHc2
Recombinant Deoxyribonucleic Acid
Construct
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, the Agency) is
amending the animal drug regulations to
reflect the approval of a new animal
drug application (NADA) filed by
AquaBounty Technologies, Inc. The
NADA provides for use of a
recombinant deoxyribonucleic acid
(rDNA) gene construct in a lineage of
genetically engineered Atlantic salmon.
DATES: This rule is effective November
24, 2015.
FOR FURTHER INFORMATION CONTACT:
Larisa Rudenko, Center for Veterinary
Medicine (HFV–2), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8247,
email: abig@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
AquaBounty Technologies, Inc., Two
Clock Tower Pl., suite 395, Maynard,
MA 01754 filed NADA 141–454 for an
opAFP–GHc2 rDNA construct at the alocus in the EO–1a lineage triploid,
hemizygous, all-female Atlantic salmon
(Salmo salar) known as
AQUADVANTAGE Salmon.
Significantly more of these Atlantic
salmon grow to at least 100 grams
within 2,700 Celsius degree-days than
their comparators. The NADA is
approved as of November 19, 2015, and
the regulations are amended in 21 CFR
part 528 to reflect the approval.
In addition, AquaBounty
Technologies, Inc., is not currently
listed in the animal drug regulations as
a sponsor of an approved application.
mstockstill on DSK4VPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
23:14 Nov 23, 2015
Jkt 238001
Accordingly, 21 CFR 510.600(c) is being
amended to add entries for this firm.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
(FOI Summary) may be seen in the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday.
The Agency has carefully considered
the potential environmental impact of
this action and has concluded that the
action will not have a significant impact
on the human environment and that an
environmental impact statement is not
required. FDA’s finding of no significant
impact (FONSI) and the evidence
supporting that finding, contained in an
environmental assessment (EA), may be
seen in the Division of Dockets
Management (address in the previous
paragraph) between 9 a.m. and 4 p.m.,
Monday through Friday.
Persons with access to the Internet
may obtain the FOI Summary, EA, and
FONSI at the Center for Veterinary
Medicine FOIA Electronic Reading
Room: https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Patent information may be
accessed in FDA’s publication,
Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/
AnimalVeterinary/Products/Approved
AnimalDrugProducts/default.htm.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
21 CFR Part 528
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510 and 528 are amended as
follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Frm 00018
Fmt 4700
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘AquaBounty Technologies,
Inc.’’ and in the table in paragraph
(c)(2), numerically add an entry for
‘‘086053’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
Sfmt 4700
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
AquaBounty Technologies,
Inc., Two Clock Tower Pl.,
suite 395, Maynard, MA
01754 ................................
*
*
*
Drug labeler
code
*
*
086053
*
*
(2) * * *
Drug
labeler code
Firm name
and address
*
*
086053 .........
*
*
*
*
*
AquaBounty Technologies,
Inc., Two Clock Tower Pl.,
suite 395, Maynard, MA
01754 * * *
*
*
*
PART 528—NEW ANIMAL DRUGS IN
GENETICALLY ENGINEERED
ANIMALS
3. The authority citation for 21 CFR
part 528 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
PO 00000
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
4. Add § 528.1092 to read as follows:
§ 528.1092 opAFP–GHc2 recombinant
deoxyribonucleic acid construct.
(a) Specifications. A single copy of the
a-form of the opAFP–GHc2 recombinant
deoxyribonucleic acid (rDNA) construct
at the a-locus in the EO–1 a lineage of
triploid, hemizygous, all-female Atlantic
salmon (Salmo salar).
(b) Sponsor. See No. 086053 in
§ 510.600 of this chapter.
(c) Indications for use. Significantly
more of these Atlantic salmon grow to
at least 100 grams within 2,700 Celsius
degree-days than their comparators.
(d) Limitations. These Atlantic salmon
are produced as eyed-eggs and grownout only in physically-contained,
freshwater culture facilities specified in
an FDA-approved application.
E:\FR\FM\24NOR1.SGM
24NOR1
Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Rules and Regulations
Dated: November 19, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
email Ms. Regina Bergner,
Environmental Standards Division (CG–
OES–3), Coast Guard; telephone 202–
372–1431, email Regina.R.Bergner@
uscg.mil.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–29902 Filed 11–23–15; 8:45 am]
BILLING CODE 4164–01–P
Table of Contents for Preamble
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 151
[Docket No. USCG–2012–0924]
RIN 1625–AB68
Ballast Water Management Reporting
and Recordkeeping
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
This final rule amends the
Coast Guard’s ballast water management
reporting and recordkeeping
requirements. Upon the effective date of
this rule, the Coast Guard will require
vessels with ballast tanks operating
exclusively on voyages between ports or
places within a single Captain of the
Port Zone to submit an annual report of
their ballast water management
practices. This rule also simplifies and
streamlines the ballast water report
form. Finally, this rule will allow most
vessels to submit ballast water reports
after arrival at a port or place of
destination, instead of requiring
submission of such reports prior to
arrival. This rule will reduce the
administrative burden on the regulated
population, while still providing the
Coast Guard with the information
necessary to analyze and understand
ballast water management practices.
DATES: This final rule is effective
February 22, 2016, except for the
amendments to 33 CFR 151.2060(b)
through (f) and 151.2070, which contain
collection of information requirements
that have not yet been approved by the
Office of Management and Budget
(OMB). The Coast Guard will publish a
document in the Federal Register
announcing the effective date of those
sections.
SUMMARY:
Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of docket USCG–2012–0924 and are
available on the Internet by going to
https://www.regulations.gov, inserting
USCG–2010–0924 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
mstockstill on DSK4VPTVN1PROD with RULES
ADDRESSES:
VerDate Sep<11>2014
23:14 Nov 23, 2015
Jkt 238001
I. Abbreviations
II. Background
III. Basis and Purpose
A. Legal Authority
B. Purposes of This Regulatory Action
IV. Regulatory History
V. Discussion of NPRM Comments and
Changes
A. Three Year Annual Reporting
Requirement for Vessels Operating
Exclusively Within a Single COTP Zone
B. Revisions to the Ballast Water Reporting
Form
C. Timing of Report Submission
D. Other Comments and Changes
VI. Regulatory Analyses
A. Regulatory Planning and Review
1. Require Vessels Operating in One COTP
Zone To Report BWM Practices
2. Update Current Ballast Water Report
Requirements (33 CFR 151.2070)
3. Allow Vessels To Submit Ballast Water
Reports After Arrival to the Port or Place
of Destination
4. Change the Format of Electronic Reports
5. Summary of Economic Impacts of Final
Rule
B. Small Entities
C. Assistance for Small Entities
D. Collection of Information
E. Federalism
F. Unfunded Mandates Reform Act
G. Taking of Private Property
H. Civil Justice Reform
I. Protection of Children
J. Indian Tribal Governments
K. Energy Effects
L. Technical Standards
M. Environment
I. Abbreviations
BWM Ballast Water Management
CFR Code of Federal Regulations
COTP Captain of the Port
EPA Environmental Protection Agency
EEZ Exclusive Economic Zone
FR Federal Register
IMO International Maritime Organization
MISLE Marine Information for Safety and
Law Enforcement
NANPCA Non-Indigenous Aquatic
Nuisance Prevention and Control Act of
1990
NBIC National Ballast Information
Clearinghouse
NISA National Invasive Species Act of 1996
OMB Office of Management and Budget
Pub. L. Public Law
RFA Regulatory Flexibility Act
SANS Ship Arrival Notification System
U.S.C. United States Code
II. Background
A vessel brings water into its ballast
tanks to control or maintain trim, draft,
stability or stress of the vessel when it
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
73105
is fully or partially empty of cargo.
Generally, the vessel will discharge
ballast water when it loads cargo, often
at another port of call. Vessels discharge
more than 80 million tons of ballast
water annually into U.S. waters.1
Many invasive species have been
introduced into U.S. waters through
ballast water discharge because ballast
water often contains organisms
indigenous to the area where it was
loaded. These organisms can become
invasive species when they are
discharged in a new location, often with
damaging results.2
The Great Lakes provide many
examples of the damage invasive
species can inflict on an environment.
According to the U.S. Environmental
Protection Agency (EPA),3 no fewer
than 25 invasive species of fish have
entered the Great Lakes. Invasive filterfeeders such as zebra mussels have
caused severe problems at power plants
and municipal water supplies, clogging
intake screens, pipes, and cooling
systems. Fast-growing invasive plants
have displaced native plant populations
that support wildlife habitat and
prevent erosion. The prevalence of these
invasive plant species has also hindered
commercial and recreational activities.
Similar problems with invasive species
have occurred in U.S. waters throughout
the country.4
III. Basis and Purpose
A. Legal Authority
The Non-Indigenous Aquatic
Nuisance Prevention and Control Act of
1990 (NANPCA, Pub. L. 101–646), as
amended by the National Invasive
Species Act of 1996 (NISA), (Pub. L.
104–332), requires the Secretary of
Homeland Security (Secretary) to
ensure, to the maximum extent
practicable, that aquatic nuisance
species are not discharged into U.S.
waters from vessels (16 U.S.C. 4701 et
seq.). These statutes also direct the
Secretary to issue regulations and
collect records regarding vessel
ballasting practices as a means for
determining vessel compliance with the
1 See the American Association of Port
Authorities Web site at https://www.aapa-ports.org/
Issues/USGovRelDetail.cfm?itemnumber=880.
2 For a list of examples of aquatic bio-invasions
causing major impact internationally, see the
International Maritime Organization’s Web site at:
https://www.imo.org/OurWork/Environment/Ballast
WaterManagement/Pages/AquaticInvasive
Species(AIS).aspx.
3 See the EPA’s Web site at https://www.epa.gov/
glnpo/invasive.
4 The U.S. Geological Survey maintains an online
database of non-indigenous aquatic species at
https://nas.er.usgs.gov. The database is searchable by
several variables, including by state and species.
E:\FR\FM\24NOR1.SGM
24NOR1
]]>Agencies
[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Rules and Regulations]
[Pages 73104-73105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29902]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 528
[Docket No. FDA-2015-N-0002]
New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2
Recombinant Deoxyribonucleic Acid Construct
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency) is amending
the animal drug regulations to reflect the approval of a new animal
drug application (NADA) filed by AquaBounty Technologies, Inc. The NADA
provides for use of a recombinant deoxyribonucleic acid (rDNA) gene
construct in a lineage of genetically engineered Atlantic salmon.
DATES: This rule is effective November 24, 2015.
FOR FURTHER INFORMATION CONTACT: Larisa Rudenko, Center for Veterinary
Medicine (HFV-2), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8247, email: abig@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: AquaBounty Technologies, Inc., Two Clock
Tower Pl., suite 395, Maynard, MA 01754 filed NADA 141-454 for an
opAFP-GHc2 rDNA construct at the [alpha]-locus in the EO-1[alpha]
lineage triploid, hemizygous, all-female Atlantic salmon (Salmo salar)
known as AQUADVANTAGE Salmon. Significantly more of these Atlantic
salmon grow to at least 100 grams within 2,700 Celsius degree-days than
their comparators. The NADA is approved as of November 19, 2015, and
the regulations are amended in 21 CFR part 528 to reflect the approval.
In addition, AquaBounty Technologies, Inc., is not currently listed
in the animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
firm.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application (FOI Summary) may be seen in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday.
The Agency has carefully considered the potential environmental
impact of this action and has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact (FONSI) and the evidence supporting that finding, contained in
an environmental assessment (EA), may be seen in the Division of
Dockets Management (address in the previous paragraph) between 9 a.m.
and 4 p.m., Monday through Friday.
Persons with access to the Internet may obtain the FOI Summary, EA,
and FONSI at the Center for Veterinary Medicine FOIA Electronic Reading
Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. 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.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 528
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and
528 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``AquaBounty Technologies, Inc.'' and in the table in
paragraph (c)(2), numerically add an entry for ``086053'' to read as
follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
AquaBounty Technologies, Inc., Two Clock Tower Pl., 086053
suite 395, Maynard, MA 01754..........................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
086053.............................. AquaBounty Technologies, Inc., Two
Clock Tower Pl., suite 395,
Maynard, MA 01754 * * *
* * * * *
------------------------------------------------------------------------
PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS
0
3. The authority citation for 21 CFR part 528 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. Add Sec. 528.1092 to read as follows:
Sec. 528.1092 opAFP-GHc2 recombinant deoxyribonucleic acid construct.
(a) Specifications. A single copy of the [alpha]-form of the opAFP-
GHc2 recombinant deoxyribonucleic acid (rDNA) construct at the [alpha]-
locus in the EO-1 [alpha] lineage of triploid, hemizygous, all-female
Atlantic salmon (Salmo salar).
(b) Sponsor. See No. 086053 in Sec. 510.600 of this chapter.
(c) Indications for use. Significantly more of these Atlantic
salmon grow to at least 100 grams within 2,700 Celsius degree-days than
their comparators.
(d) Limitations. These Atlantic salmon are produced as eyed-eggs
and grown-out only in physically-contained, freshwater culture
facilities specified in an FDA-approved application.
[[Page 73105]]
Dated: November 19, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-29902 Filed 11-23-15; 8:45 am]
BILLING CODE 4164-01-P
