Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 79623 

64 FR 36361, July 6, 1999, 72 FR 50112, 

August 30, 2007, 74 FR 41713, August 

18, 2009, 76 FR 45270, July 28, 2011, 

and 84 FR 22854, May 20, 2019) is 

amended to reflect the reorganization of 

CVM OM and ONADE. 

The reorganization of OM merged the 

Budget Planning and Evaluation Staff 

(BPES) and the Program and Resource 

Management Staff (PRMS) and retitled 

the PRMS to the Financial Management 

Staff (FMS) and abolished BPES. The 

reorganization retitled ONADE to the 

Office of New Animal Product 

Evaluation (ONAPE), established the 

Regulatory Counsel Staff and the 

Administrative Staff, established 

branches within the Division of Food 

Animal Drugs, the Division of 

Companion Animal Drugs, the Division 

of Human Food Safety, the Division of 

Manufacturing Technologies, the 

Division of Business Information 

Science and Management, the Division 

of Animal Bioengineering and Cellular 

Therapies (DABCT), and the Division of 

Scientific Support (DSS). The 

reorganization retitled DABCT to the 

Division of Biotechnology and retitled 

DSS to the Division of Statistical and 

Biological Sciences. The reorganization 

established the Office of Generic Animal 

Drugs (OGAD), established the Business 

Management and Operations Staff and 

the Division of Manufacturing 

Technologies (DMT) under OGAD, 

realigned the Division of Generic 

Animal Drugs (DGAD) from ONADE to 

OGAD, and established branches under 

DGAD and DMT. 

DCGB. ORGANIZATION. CVM’s OM 

is headed by the Associate Director for 

Management, and includes the 

following: 

Financial Management Staff (DCGB1) 

Human Capital Management Staff 

(DCGB2) 

Talent Development Staff (DCGB3) 

Business Informatics Staff (DCGB5) 

DCGC. ORGANIZATION. CVM’s 

ONAPE is headed by the Director, and 

includes the following: 

Office of New Animal Product 

Evaluation (DCGC) 

Regulatory Counsel Staff (DCGC1) 

Administrative Staff (DCGC2) 

Division of Food Animal Drugs 

(DCGCA) 

Food Animal Branch 1 (DCGCA1) 

Food Animal Branch 2 (DCGCA2) 

Division of Companion Animal Drugs 

(DCGCC) 

Companion Animal Branch 1 (DCGCC1) 

Companion Animal Branch 2 (DCGCC2) 

Companion Animal Branch 3 (DCGCC3) 

Division of Human Food Safety 

(DCGCD) 

Human Food Safety Branch 1 (DCGCD1) 

Human Food Safety Branch 2 (DCGCD2) 

Division of Manufacturing Technologies 

(DCGCE) 

Feed and Topical Branch (DCGCE1) 

Sterile Drugs Branch (DCGCE2) 

Biotherapeutics Branch (DCGCE3) 

Chemotherapeutics Branch (DCGCE4) 

Drug Substance Branch (DCGCE5) 

Division of Statistical and Biological 

Sciences (DCGCF) 

Environmental Branch (DCGCF1) 

Biostatistics Branch 1 (DCGCF2) 

Biostatistics Branch 2 (DCGCF3) 

Clinical Pharmacology Branch 

(DCGCF4) 

Division of Business Information 

Science and Management (DCGCH) 

Business Informatics Branch (DCGCH1) 

Quality Assurance Branch (DCGCH2) 

Project Management Branch (DCGCH3) 

Division of Biotechnology (DCGCI) 

Animal Biotechnology Branch (DCGCI1) 

Biologic Products Branch (DCGCI2) 

DCGG. ORGANIZATION. CVM’s 

OGAD is headed by the Director, and 

includes the following: 

Office of Generic Animal Drugs (DCGG) 

Business Management and Operations 

Staff (DCGG1) 

Division of Generic Animal Drugs 

(DCGGA) 

Generics Review Branch 1 (DCGGA1) 

Generics Review Branch 2 (DCGGA2) 

Generics Review Branch 3 (DCGGA3) 

Generics Review Branch 4 (DCGGA4) 

Generics Review Branch 5 (DCGGA5) 

Division of Manufacturing Technologies 

(DCGGB) 

Generic Drug Manufacturing Branch 1 

(DCGGB1) 

Generic Drug Manufacturing Branch 2 

(DCGGB2) 

Generic Drug Manufacturing Branch 3 

(DCGGB3) 

Generic Drug Substances and Facilities 

Assessment Branch (DCGGB4) 

II. Delegations of Authority 

Pending further delegation, directives, 

or orders by the Commissioner of Food 

and Drugs, all delegations and 

redelegations of authority made to 

officials and employees of affected 

organizational components will 

continue in them or their successors 

pending further redelegations, provided 

they are consistent with this 

reorganization. 

III. Electronic Access 

This reorganization is reflected in 

FDA’s Staff Manual Guide (SMG). 

Persons interested in seeing the 

complete SMG can find it on FDA’s 

website at: https://www.fda.gov/ 

AboutFDA/ReportsManualsForms/ 

StaffManualGuides/default.htm. 

(Authority: 44 U.S.C. 3101) 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2024–22147 Filed 9–26–24; 11:15 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–2672] 

Amended Environmental Assessment 

for Production of AquAdvantage 

Salmon at the Bay Fortune and Rollo 

Bay Facilities on Prince Edward Island, 

Canada; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

document entitled ‘‘Amended 

Environmental Assessment for 

Production of AquAdvantage Salmon at 

the Bay Fortune and Rollo Bay Facilities 

on Prince Edward Island, Canada.’’ This 

amended environmental assessment 

(EA) has been prepared by FDA in 

support of the approved new animal 

drug application (NADA 141–454) 

concerning AquAdvantage Salmon 

(AAS), in response to an order by the 

U.S. District Court, Northern District of 

California. 

FOR FURTHER INFORMATION CONTACT: 

Holly Zahner, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0834, 

holly.zahner@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the availability of a 

document entitled ‘‘Amended 

Environmental Assessment for 

Production of AquAdvantage Salmon at 

the Bay Fortune and Rollo Bay Facilities 

on Prince Edward Island, Canada.’’ This 

amended EA has been prepared by FDA 

in support of the approved application 

(NADA 141–454) concerning AAS, in 

response to an order by the U.S. District 

Court, Northern District of California, 

issued on November 5, 2020; Inst. for 

Fisheries Res. v. United States Food and 

Drug Adm’n, 499 F. Supp. 3d 657, 660 

(N.D. Cal. 2020) and is available in the 

docket. 

On November 19, 2015, FDA 

approved NADA 141–454 concerning 

AAS, owned by AquaBounty 

Technologies (ABT). AAS are triploid, 

hemizygous, all-female Atlantic salmon 


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79624 Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 

(Salmo salar) bearing a single copy of 

the a-form of the opAFP–GHc2 

recombinant DNA (rDNA) construct at 

the a-locus in the E.O.-1a lineage. AAS 

is designed to exhibit a rapid-growth 

phenotype. The November 19, 2015, 

NADA approval allowed for the AAS to 

be produced at a facility on Prince 

Edward Island (PEI), Canada, and grown 

at a facility in Panama (that has 

subsequently closed) and allowed for 

sale of food harvested from AAS in the 

United States. 

As part of the NADA review process 

under the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321, et seq.) 

and consistent with the mandates in the 

National Environmental Policy Act of 

1969 (NEPA) (42 U.S.C. 4321, et seq.) 

and FDA’s environmental impact 

considerations regulations (21 CFR part 

25), FDA’s Center for Veterinary 

Medicine prepared an EA dated 

November 12, 2015, for the original 

approval of the rDNA construct as 

integrated in the genome of AAS. Based 

on the 2015 EA and the specific 

conditions that were established in the 

NADA, FDA determined the action 

would not individually or cumulatively 

have a significant effect on the quality 

of the human environment in the United 

States. Therefore, FDA prepared a 

finding of no significant impact 

(FONSI). Based on the findings in the 

2015 EA, FDA also made a ‘‘no effect’’ 

determination under the Endangered 

Species Act (ESA) (16 U.S.C. 1531, et 

seq.), concluding that AAS, when 

produced and reared under the 

conditions in the application, and as 

described in the 2015 EA, would not 

jeopardize the continued existence of 

U.S. populations of threatened or 

endangered Atlantic salmon or result in 

the destruction or adverse modification 

of their critical habitat. 

Subsequently, several organizations 

filed suit in the U.S. District Court, 

Northern District of California, 

challenging, among other things, FDA’s 

evaluations under NEPA and the ESA 

for the 2015 NADA approval. On 

November 5, 2020, the Court found that 

‘‘FDA did not . . . meaningfully analyze 

what might happen to normal salmon in 

the event the engineered salmon did 

survive and establish themselves in the 

wild. Even if this scenario was unlikely, 

the FDA was still required to assess the 

consequences of it coming to pass.’’ The 

Court ordered FDA to complete the 

analysis and reconsider its ‘‘no effect’’ 

determination under the ESA together 

with a revised NEPA evaluation. See 

Inst. for Fisheries Res. v. United States 

Food and Drug Adm’n, 499 F. Supp. 3d 

657, 660 (N.D. Cal. 2020). However, the 

Court did not vacate the approval; the 

approval remains in effect. 

To address the November 5, 2020, 

Court opinion, we prepared a draft 

amended EA, titled ‘‘Draft Amended 

Environmental Assessment for 

Production of AquAdvantage Salmon at 

the Bay Fortune and Rollo Bay Facilities 

on Prince Edward Island, Canada.’’ We 

requested that the public review that 

draft amended EA and submit 

comments to the docket (87 FR 69032, 

November 17, 2022). We also held a 

virtual public meeting on December 15, 

2022, at which we solicited comment on 

the draft amended EA (87 FR 69030, 

November 17, 2022). 

In that draft amended EA, we 

expanded our assessment beyond that in 

the 2015 EA to include an exhaustive 

analysis of the likelihood and severity of 

harms that could occur if AAS and 

AquAdvantage broodstock (collectively 

referred to in the amended EA as ABT 

Salmon) are assumed to be present in 

the U.S. aquatic environment. We 

outlined the pathways necessary for 

ABT Salmon to escape confinement 

from the PEI facilities and migrate to 

and establish a persistent population in 

the United States. We also evaluated the 

potential pathways for disease 

(including pathogen and parasite) 

transmission from ABT Salmon and 

from the production of ABT Salmon at 

facilities on PEI to wild fish 

populations. In addition, we identified 

and evaluated the potential harms 

(consequences) to the U.S. environment 

and the endangered Atlantic salmon of 

the Gulf of Maine Distinct Population 

Segment if these highly unlikely 

scenarios were to occur. Finally, we 

revisited whether there is a potential for 

significant impacts on the U.S. 

environment under NEPA, and whether 

the action could result in effects on 

threatened and endangered Atlantic 

salmon and their critical habitat in the 

United States under the ESA. 

We note that the information and 

analyses in the draft amended EA 

reflected comments and input received 

from the National Marine Fisheries 

Service and the Fish and Wildlife 

Service during an ESA technical 

assistance review. 

We received 1,728 comment 

submissions on the draft amended EA. 

Please refer to ‘‘Summary Responses to 

Public Comments on the November 

2022 AAS Draft Amended 

Environmental Assessment’’ (https://

www.fda.gov/media/181568/download?

attachment) for a summary and FDA 

review of these comments. 

FDA is announcing the availability of 

an EA entitled ‘‘Amended 

Environmental Assessment for 

Production of AquAdvantage Salmon at 

the Bay Fortune and Rollo Bay Facilities 

on Prince Edward Island, Canada.’’ This 

document can be found at https://

animaldrugsatfda.fda.gov/adafda/ 

views/#/home/previewsearch/141- 

454#eaid. 

We have also prepared and are 

making available a FONSI and, based on 

the findings in the EA, have made a ‘‘no 

effect’’ determination under the ESA, 

concluding that AAS, when produced 

and reared under the conditions as 

described in the EA, will not jeopardize 

the continued existence of U.S. 

populations of threatened or endangered 

Atlantic salmon or result in the 

destruction or adverse modification of 

their critical habitat. This document can 

be found at https://animaldrugsatfda.

fda.gov/adafda/views/#/home/ 

previewsearch/141-454#eaid. 

Dated: September 24, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22308 Filed 9–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–4115] 

Clarification of Radiation Control 

Regulations for Manufacturers of 

Diagnostic X-Ray Equipment; 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Clarification of 

Radiation Control Regulations for 

Manufacturers of Diagnostic X-Ray 

Equipment.’’ This guidance provides 

clarification to industry and FDA staff of 

the Federal regulations that relate to 

diagnostic x-ray equipment. These 

regulations pertain to the recordkeeping, 

reporting, manufacturing, importing, 

and installation of an ‘‘electronic 

product’’ as defined in FDA regulations. 

This guidance supersedes FDA’s 1989 

guidance entitled ‘‘Clarification of 

Radiation Control Regulations for 

Diagnostic X-Ray Equipment.’’ 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 30, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 


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