Statement of Organization, Functions, and Delegations of Authority, 79622-79623 [2024-22147]
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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.
ddrumheller on DSK120RN23PROD with NOTICES1
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.
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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 30day 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 résumé 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.
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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
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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.
SUMMARY:
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,
E:\FR\FM\30SEN1.SGM
30SEN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices
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)
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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.
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79623
(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.
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
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79622-79623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22147]
-----------------------------------------------------------------------
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,
[[Page 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
