79622 Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 

panel, according to its specialty area: (1) 

advises on the classification or 

reclassification of devices into one of 

three regulatory categories and advises 

on any possible risks to health 

associated with the use of devices; (2) 

advises on formulation of product 

development protocols; (3) reviews 

premarket approval applications for 

medical devices; (4) reviews guidelines 

and guidance documents; (5) 

recommends exemption of certain 

devices from the application of portions 

of the Federal Food, Drug, and Cosmetic 

Act; (6) advises on the necessity to ban 

a device; and (7) responds to requests 

from the Agency to review and make 

recommendations on specific issues or 

problems concerning the safety and 

effectiveness of devices. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, may also 

make appropriate recommendations to 

the Commissioner on issues relating to 

the design of clinical studies regarding 

the safety and effectiveness of marketed 

and investigational devices. 

The Medical Devices Dispute 

Resolution Panel provides advice to the 

Commissioner on complex or contested 

scientific issues between FDA and 

medical device sponsors, applicants, or 

manufacturers relating to specific 

products, marketing applications, 

regulatory decisions and actions by 

FDA, and Agency guidance and 

policies. The Panel makes 

recommendations on issues that are 

lacking resolution, are highly complex 

in nature, or result from challenges to 

regular advisory panel proceedings or 

Agency decisions or actions. 

II. Criteria for Members 

Persons nominated for membership as 

consumer representatives on 

committees or panels should meet the 

following criteria: (1) demonstrate an 

affiliation with and/or active 

participation in consumer or 

community-based organizations, (2) be 

able to analyze technical data, (3) 

understand research design, (4) discuss 

benefits and risks, and (5) evaluate the 

safety and efficacy of products under 

review. The consumer representative 

should be able to represent the 

consumer perspective on issues and 

actions before the advisory committee; 

serve as a liaison between the 

committee and interested consumers, 

associations, coalitions, and consumer 

organizations; and facilitate dialogue 

with the advisory committees on 

scientific issues that affect consumers. 

III. Selection Procedures 

Selection of members representing 

consumer interests is conducted 

through procedures that include the use 

of organizations representing the public 

interest and public advocacy groups. 

These organizations recommend 

nominees for the Agency’s selection. 

Representatives from the consumer 

health branches of Federal, State, and 

local governments also may participate 

in the selection process. Any consumer 

organization interested in participating 

in the selection of an appropriate voting 

or nonvoting member to represent 

consumer interests should send a letter 

stating that interest to FDA (see 

ADDRESSES) within 30 days of 

publication of this document. 

Within 45 days of the end of this 30- 

day period, FDA will compile a list of 

consumer organizations that will 

participate in the selection process and 

will forward to each such organization 

a ballot listing at least two qualified 

nominees selected by the Agency based 

on the nominations received, together 

with each nominee’s current curriculum 

vitae or resume. Ballots are to be filled 

out and returned to FDA within 30 days. 

The nominee receiving the highest 

number of votes ordinarily will be 

selected to serve as the member 

representing consumer interests for that 

particular advisory committee or panel. 

IV. Nomination Procedures 

Any interested person or organization 

may nominate one or more qualified 

persons to represent consumer interests 

on the Agency’s advisory committees or 

panels. Self-nominations are also 

accepted. Nominations must include a 

current, complete re ́sume ́ or curriculum 

vitae for each nominee and a signed 

copy of the Acknowledgement and 

Consent form available at the FDA 

Advisory Nomination Portal (see 

ADDRESSES), and a list of consumer or 

community-based organizations for 

which the candidate can demonstrate 

active participation. 

Nominations must also specify the 

advisory committee(s) or panel(s) for 

which the nominee is recommended. In 

addition, nominations must also 

acknowledge that the nominee is aware 

of the nomination unless selfnominated. FDA will ask potential 

candidates to provide detailed 

information concerning such matters as 

financial holdings, employment, and 

research grants and/or contracts to 

permit evaluation of possible sources of 

conflicts of interest. Members will be 

invited to serve for terms of up to 4 

years. 

FDA will review all nominations 

received within the specified 

timeframes and prepare a ballot 

containing the names of qualified 

nominees. Names not selected will 

remain on a list of eligible nominees 

and be reviewed periodically by FDA to 

determine continued interest. After 

selecting qualified nominees for the 

ballot, FDA will provide those 

consumer organizations that are 

participating in the selection process 

with the opportunity to vote on the 

listed nominees. Only organizations 

vote in the selection process. Persons 

who nominate themselves to serve as 

voting or nonvoting consumer 

representatives will not participate in 

the selection process. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 24, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22292 Filed 9–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA), Center for 

Veterinary Medicine’s (CVM), Office of 

Management (OM) and Office of New 

Animal Drug Evaluation (ONADE) have 

modified their organizational structures. 

The new organizational structures were 

approved by the Secretary of Health and 

Human Services on July 22, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Yashika Rahaman, Director, Office of 

Planning, Evaluation, and Risk 

Management, Office of Finance, Budget, 

Acquisitions, and Planning, Food and 

Drug Administration, 4041 Powder Mill 

Rd., Beltsville, MD 20705–4304, 301– 

796–3843. 

I. Introduction 

Part D, Chapter D–B, (Food and Drug 

Administration), the Statement of 

Organization, Functions and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, 60 FR 56606, November 9, 1995, 


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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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