Document ID: FDA-2015-N-0002-0046
Agency: fda
Document Type: Rule
Title: New Animal Drugs in Genetically Engineered Animals; opAFP–GHc2
Recombinant Deoxyribonucleic Acid Construct
Posted Date: 2015-11-24T05:00Z

[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]

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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.

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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: 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
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                                * * * * *
AquaBounty Technologies, Inc., Two Clock Tower Pl.,              086053
 suite 395, Maynard, MA 01754..........................
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
         Drug  labeler code                 Firm name  and address
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                                * * * * *
086053..............................  AquaBounty Technologies, Inc., Two
                                       Clock Tower Pl., suite 395,
                                       Maynard, MA 01754 * * *
 
                                * * * * *
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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