80 FR 73104 - New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 226 (November 24, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 226 (November 24, 2015)
| Page Range | 73104-73105 | |
| FR Document | 2015-29902 |
[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)] [Rules and Regulations] [Pages 73104-73105] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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: http://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: http://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
![73104 Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Rules and Regulations
page 57523, column 2, beginning on line Accordingly, 21 CFR 510.600(c) is being Authority: 21 U.S.C. 321, 331, 351, 352,
26, remove ‘‘, excluding that airspace amended to add entries for this firm. 353, 360b, 371, 379e.
within Federal airways and within In accordance with the freedom of ■ 2. In § 510.600, in the table in
Canadian airspace’’. information provisions of 21 CFR part paragraph (c)(1), alphabetically add an
Issued in Fort Worth, TX, on November 10,
20 and 21 CFR 514.11(e)(2)(ii), a entry for ‘‘AquaBounty Technologies,
2015. summary of safety and effectiveness Inc.’’ and in the table in paragraph
Robert W. Beck,
data and information submitted to (c)(2), numerically add an entry for
support approval of this application ‘‘086053’’ to read as follows:
Manager, Operations Support Group, ATO
(FOI Summary) may be seen in the
Central Service Center.
Division of Dockets Management (HFA– § 510.600 Names, addresses, and drug
[FR Doc. 2015–29704 Filed 11–23–15; 8:45 am]
305), Food and Drug Administration, labeler codes of sponsors of approved
BILLING CODE 4910–13–P
5630 Fishers Lane, Rm. 1061, Rockville, applications.
MD 20852, between 9 a.m. and 4 p.m., * * * * *
Monday through Friday. (c) * * *
DEPARTMENT OF HEALTH AND The Agency has carefully considered (1) * * *
HUMAN SERVICES the potential environmental impact of
this action and has concluded that the Drug labeler
Food and Drug Administration Firm name and address
action will not have a significant impact code
on the human environment and that an
21 CFR Parts 510 and 528 environmental impact statement is not
* * * * *
[Docket No. FDA–2015–N–0002] required. FDA’s finding of no significant
AquaBounty Technologies,
impact (FONSI) and the evidence Inc., Two Clock Tower Pl.,
New Animal Drugs in Genetically supporting that finding, contained in an suite 395, Maynard, MA
Engineered Animals; opAFP–GHc2 environmental assessment (EA), may be 01754 ................................ 086053
Recombinant Deoxyribonucleic Acid seen in the Division of Dockets
Construct Management (address in the previous * * * * *
paragraph) between 9 a.m. and 4 p.m.,
AGENCY: Food and Drug Administration,
Monday through Friday. (2) * * *
HHS. Persons with access to the Internet
ACTION: Final rule. may obtain the FOI Summary, EA, and Drug Firm name
FONSI at the Center for Veterinary labeler code and address
SUMMARY: The Food and Drug
Administration (FDA, the Agency) is Medicine FOIA Electronic Reading
amending the animal drug regulations to Room: http://www.fda.gov/AboutFDA/ * * * * *
reflect the approval of a new animal CentersOffices/OfficeofFoods/CVM/ 086053 ......... AquaBounty Technologies,
drug application (NADA) filed by CVMFOIAElectronicReadingRoom/ Inc., Two Clock Tower Pl.,
AquaBounty Technologies, Inc. The default.htm. Patent information may be suite 395, Maynard, MA
NADA provides for use of a accessed in FDA’s publication, 01754 * * *
recombinant deoxyribonucleic acid Approved Animal Drug Products Online
(Green Book) at: http://www.fda.gov/ * * * * *
(rDNA) gene construct in a lineage of
genetically engineered Atlantic salmon. AnimalVeterinary/Products/Approved
AnimalDrugProducts/default.htm. PART 528—NEW ANIMAL DRUGS IN
DATES: This rule is effective November
This rule does not meet the definition GENETICALLY ENGINEERED
24, 2015.
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because ANIMALS
FOR FURTHER INFORMATION CONTACT: it is a rule of ‘‘particular applicability.’’
Larisa Rudenko, Center for Veterinary Therefore, it is not subject to the ■ 3. The authority citation for 21 CFR
Medicine (HFV–2), Food and Drug congressional review requirements in 5 part 528 continues to read as follows:
Administration, 7500 Standish Pl., U.S.C. 801–808.
Rockville, MD 20855, 240–276–8247, Authority: 21 U.S.C. 360b.
email: abig@fda.hhs.gov. List of Subjects ■ 4. Add § 528.1092 to read as follows:
SUPPLEMENTARY INFORMATION: 21 CFR Part 510
AquaBounty Technologies, Inc., Two § 528.1092 opAFP–GHc2 recombinant
Administrative practice and deoxyribonucleic acid construct.
Clock Tower Pl., suite 395, Maynard,
procedure, Animal drugs, Labeling, (a) Specifications. A single copy of the
MA 01754 filed NADA 141–454 for an
Reporting and recordkeeping a-form of the opAFP–GHc2 recombinant
opAFP–GHc2 rDNA construct at the a-
requirements. deoxyribonucleic acid (rDNA) construct
locus in the EO–1a lineage triploid,
hemizygous, all-female Atlantic salmon 21 CFR Part 528 at the a-locus in the EO–1 a lineage of
(Salmo salar) known as triploid, hemizygous, all-female Atlantic
Animal drugs.
AQUADVANTAGE Salmon. salmon (Salmo salar).
Therefore, under the Federal Food, (b) Sponsor. See No. 086053 in
Significantly more of these Atlantic Drug, and Cosmetic Act and under
salmon grow to at least 100 grams § 510.600 of this chapter.
authority delegated to the Commissioner (c) Indications for use. Significantly
within 2,700 Celsius degree-days than of Food and Drugs and redelegated to
their comparators. The NADA is more of these Atlantic salmon grow to
the Center for Veterinary Medicine, 21
mstockstill on DSK4VPTVN1PROD with RULES
approved as of November 19, 2015, and at least 100 grams within 2,700 Celsius
CFR parts 510 and 528 are amended as degree-days than their comparators.
the regulations are amended in 21 CFR follows:
part 528 to reflect the approval. (d) Limitations. These Atlantic salmon
In addition, AquaBounty PART 510—NEW ANIMAL DRUGS are produced as eyed-eggs and grown-
Technologies, Inc., is not currently out only in physically-contained,
listed in the animal drug regulations as ■ 1. The authority citation for 21 CFR freshwater culture facilities specified in
a sponsor of an approved application. part 510 continues to read as follows: an FDA-approved application.
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![Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Rules and Regulations 73105
Dated: November 19, 2015. email Ms. Regina Bergner, is fully or partially empty of cargo.
Bernadette Dunham, Environmental Standards Division (CG– Generally, the vessel will discharge
Director, Center for Veterinary Medicine. OES–3), Coast Guard; telephone 202– ballast water when it loads cargo, often
[FR Doc. 2015–29902 Filed 11–23–15; 8:45 am] 372–1431, email Regina.R.Bergner@ at another port of call. Vessels discharge
BILLING CODE 4164–01–P
uscg.mil. more than 80 million tons of ballast
SUPPLEMENTARY INFORMATION: water annually into U.S. waters.1
Many invasive species have been
Table of Contents for Preamble introduced into U.S. waters through
DEPARTMENT OF HOMELAND
SECURITY I. Abbreviations ballast water discharge because ballast
II. Background water often contains organisms
Coast Guard III. Basis and Purpose indigenous to the area where it was
A. Legal Authority loaded. These organisms can become
B. Purposes of This Regulatory Action invasive species when they are
33 CFR Part 151
IV. Regulatory History discharged in a new location, often with
[Docket No. USCG–2012–0924] V. Discussion of NPRM Comments and
Changes
damaging results.2
RIN 1625–AB68 A. Three Year Annual Reporting The Great Lakes provide many
Requirement for Vessels Operating examples of the damage invasive
Ballast Water Management Reporting Exclusively Within a Single COTP Zone species can inflict on an environment.
and Recordkeeping B. Revisions to the Ballast Water Reporting According to the U.S. Environmental
Form Protection Agency (EPA),3 no fewer
AGENCY: Coast Guard, DHS. C. Timing of Report Submission than 25 invasive species of fish have
ACTION: Final rule. D. Other Comments and Changes entered the Great Lakes. Invasive filter-
VI. Regulatory Analyses
SUMMARY: This final rule amends the A. Regulatory Planning and Review
feeders such as zebra mussels have
Coast Guard’s ballast water management 1. Require Vessels Operating in One COTP caused severe problems at power plants
reporting and recordkeeping Zone To Report BWM Practices and municipal water supplies, clogging
requirements. Upon the effective date of 2. Update Current Ballast Water Report intake screens, pipes, and cooling
this rule, the Coast Guard will require Requirements (33 CFR 151.2070) systems. Fast-growing invasive plants
vessels with ballast tanks operating 3. Allow Vessels To Submit Ballast Water have displaced native plant populations
Reports After Arrival to the Port or Place that support wildlife habitat and
exclusively on voyages between ports or
of Destination prevent erosion. The prevalence of these
places within a single Captain of the 4. Change the Format of Electronic Reports
Port Zone to submit an annual report of invasive plant species has also hindered
5. Summary of Economic Impacts of Final
their ballast water management Rule
commercial and recreational activities.
practices. This rule also simplifies and B. Small Entities Similar problems with invasive species
streamlines the ballast water report C. Assistance for Small Entities have occurred in U.S. waters throughout
form. Finally, this rule will allow most D. Collection of Information the country.4
vessels to submit ballast water reports E. Federalism
F. Unfunded Mandates Reform Act
III. Basis and Purpose
after arrival at a port or place of
G. Taking of Private Property A. Legal Authority
destination, instead of requiring
H. Civil Justice Reform
submission of such reports prior to I. Protection of Children The Non-Indigenous Aquatic
arrival. This rule will reduce the J. Indian Tribal Governments Nuisance Prevention and Control Act of
administrative burden on the regulated K. Energy Effects 1990 (NANPCA, Pub. L. 101–646), as
population, while still providing the L. Technical Standards amended by the National Invasive
Coast Guard with the information M. Environment Species Act of 1996 (NISA), (Pub. L.
necessary to analyze and understand 104–332), requires the Secretary of
I. Abbreviations
ballast water management practices. Homeland Security (Secretary) to
DATES: This final rule is effective BWM Ballast Water Management ensure, to the maximum extent
CFR Code of Federal Regulations
February 22, 2016, except for the practicable, that aquatic nuisance
COTP Captain of the Port
amendments to 33 CFR 151.2060(b) EPA Environmental Protection Agency species are not discharged into U.S.
through (f) and 151.2070, which contain EEZ Exclusive Economic Zone waters from vessels (16 U.S.C. 4701 et
collection of information requirements FR Federal Register seq.). These statutes also direct the
that have not yet been approved by the IMO International Maritime Organization Secretary to issue regulations and
Office of Management and Budget MISLE Marine Information for Safety and collect records regarding vessel
(OMB). The Coast Guard will publish a Law Enforcement ballasting practices as a means for
document in the Federal Register NANPCA Non-Indigenous Aquatic determining vessel compliance with the
announcing the effective date of those Nuisance Prevention and Control Act of
1990
sections. 1 See the American Association of Port
NBIC National Ballast Information
Authorities Web site at http://www.aapa-ports.org/
ADDRESSES: Comments and material Clearinghouse Issues/USGovRelDetail.cfm?itemnumber=880.
received from the public, as well as NISA National Invasive Species Act of 1996 2 For a list of examples of aquatic bio-invasions
documents mentioned in this preamble OMB Office of Management and Budget causing major impact internationally, see the
as being available in the docket, are part Pub. L. Public Law International Maritime Organization’s Web site at:
RFA Regulatory Flexibility Act
mstockstill on DSK4VPTVN1PROD with RULES
http://www.imo.org/OurWork/Environment/Ballast
of docket USCG–2012–0924 and are WaterManagement/Pages/AquaticInvasive
SANS Ship Arrival Notification System
available on the Internet by going to U.S.C. United States Code Species(AIS).aspx.
http://www.regulations.gov, inserting 3 See the EPA’s Web site at http://www.epa.gov/
USCG–2010–0924 in the ‘‘Keyword’’ II. Background glnpo/invasive.
4 The U.S. Geological Survey maintains an online
box, and then clicking ‘‘Search.’’ A vessel brings water into its ballast database of non-indigenous aquatic species at
FOR FURTHER INFORMATION CONTACT: If tanks to control or maintain trim, draft, http://nas.er.usgs.gov. The database is searchable by
you have questions on this rule, call or stability or stress of the vessel when it several variables, including by state and species.
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Document Created: 2015-12-14 14:08:40
Document Modified: 2015-12-14 14:08:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective November 24, 2015. | |
| Contact | Larisa Rudenko, Center for Veterinary Medicine (HFV-2), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8247, email: [email protected] | |
| FR Citation | 80 FR 73104 | |
| CFR Citation | 21
CFR
510 21 CFR 528 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Labeling and Reporting and Recordkeeping Requirements |
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