This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Food and Drug Administration, HHS.
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.
This rule is effective November 24, 2015.
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.
AquaBounty Technologies, Inc., Two Clock Tower Pl., suite 395, Maynard, MA 01754 filed NADA 141-454 for an opAFP-GHc2 rDNA construct at the α-locus in the EO-1α 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.
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:
1. The authority citation for 21 CFR part 510 continues to read as follows:
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:
(c) * * *
(1) * * *
| Firm name and address | Drug labeler code |
|---|---|
| * * * * * | |
| AquaBounty Technologies, Inc., Two Clock Tower Pl., suite 395, Maynard, MA 01754 | 086053 |
| * * * * * | |
(2) * * *
| Drug labeler code | Firm name and address |
|---|---|
| * * * * * | |
| 086053 | AquaBounty Technologies, Inc., Two Clock Tower Pl., suite 395, Maynard, MA 01754 * * * |
| * * * * * | |
3. The authority citation for 21 CFR part 528 continues to read as follows:
4. Add § 528.1092 to read as follows:
(a) Specifications. A single copy of the α-form of the opAFP-GHc2 recombinant deoxyribonucleic acid (rDNA) construct at the α-locus in the EO-1 α 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 grown-out only in physically-contained, freshwater culture facilities specified in an FDA-approved application.
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