Statement of Organization, Functions, and Delegations of Authority, 105052-105054 [2024-30334]
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Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices
photos, quotes, and findings from the
photo elicitation data collection,
alongside related findings from the
NextGen descriptive studies. The
exhibit will provide illustrative
examples of how well-being has been
influenced by program participation
according to NextGen participants and
staff. The exhibit will also include
human-centered design activities that
engage members of NextGen
communities (where programs being
evaluated for the NextGen Project were
implemented) and researchers in
descriptive study and photo elicitation
findings by collecting data on their
reflections on the exhibit. The WellBeing Storytelling Exhibit is also
intended to improve understanding and
future dissemination of study findings,
and to pilot the method and product of
a storytelling exhibit as a culturally
responsive evaluation strategy. The data
collection instruments for this project
include photo elicitation submission
forms for participants and staff, photo
elicitation interview guides for
participants and staff, and human-
centered design activities at the photo
exhibits.
Respondents: Program participants
and frontline staff enrolled in the
NextGen Project; NextGen community
members including community
partners, employers, policymakers,
funders, and NextGen participants and
staff; and human services researchers
and practitioners. All NextGen
participants will be able to opt out of
the data collection activities.
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request
period)
Instrument
Avg. burden
per response
(in hours)
Total/annual
burden
(in hours)
Photo elicitation submission form—Participants ..............................................
Photo elicitation submission form—Staff .........................................................
Photo elicitation interview discussion guide—Participants ..............................
Photo elicitation interview discussion guide—Staff .........................................
Human-centered design activities at the exhibit ..............................................
40
40
40
40
60
1
1
1
1
1
0.50
0.50
1.00
1.00
0.25
20
20
40
40
15
Estimated total annual burden hours: ......................................................
........................
........................
........................
135
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Section 413 of the Social
Security Act, as amended by the FY
2017 Consolidated Appropriations Act,
2017 (Pub. L. 115–31).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–30709 Filed 12–23–24; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
(total over
request
period)
BILLING CODE 4184–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
10 OCC Regional Offices and integrates
regional work in central office planning.
Administration for Children and
Families
Linda Hitt,
Director, Office of the Executive Secretariat.
[FR Doc. 2024–30650 Filed 12–23–24; 8:45 am]
Office of Child Care; Statement of
Organization, Functions, and
Delegations of Authority; Correction
Administration for Children
and Families, HHS.
ACTION: Notice; correction.
AGENCY:
The Administration for
Children and Families (ACF) published
a document in the Federal Register on
December 4, 2024, concerning minor
adjustments made to the organization of
the Office of Child Care (OCC) in adding
a Regional Operations Division. The
document contained an incorrect code.
FOR FURTHER INFORMATION CONTACT:
Anne-Marie Twohie, Deputy Director,
Office of Child Care, 330 C Street SW,
Washington, DC 20201, (240) 935–1159.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Correction
In the Federal Register on December
4, 2024, in FR Doc. 2024–28368 at 89 FR
96255 in the second full paragraph of
the third column, correct F to read:
F. Regional Operations Division
(KVAD): The Regional Operations
Division is responsible for providing
oversight, direction, and guidance to the
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA), Center for Drug
Evaluation and Research’s (CDER),
Office of Surveillance and Epidemiology
(OSE) and Office of New Drugs (OND)
has modified their organizational
structure. The new organizational
structure was approved by the Secretary
of Health and Human Services on
November 20, 2014.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jennifer Wade, Acting Director, Division
of Reorganizations and Delegations of
Authority, Office of Budget, Office of
Finance, Budget, and Acquisitions,
Food and Drug Administration, 10903
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Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices
New Hampshire Ave., Silver Spring, MD
20993, 240–731–0192.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
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,
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
revised to reflect the Food and Drug
Administration’s reorganization of
CDER’s OSE and OND.
The purpose of this reorganization is
to strengthen OSE and OND’s ability to
support FDA’s mission and streamline
its operations.
Within OSE, the newly elevated
Office of Regulatory Science (ORS) will
provide scientific and technical
leadership in pharmacovigilance
informatics, regulatory informatics
systems, and science operations,
including securing access to necessary
data sources for drug product
surveillance operations and overseeing
applied research studies. While the
newly elevated Office of Regulatory
Operations (ORO) will manage strategic
and operational projects associated with
drug safety, particularly with drug
safety reviews. The Executive
Operations Staff (EOS) will liaise with
stakeholders through the Center and the
FDA as well as with external groups as
appropriate to activities within OSE,
coordinate executive operations of
Office leadership, and support
organizational development activities
for OSE staff.
Within OND, this overall
reorganization proposal addresses key
priorities for the country as exhibited by
their direct connection to multiple acts
of Congress or declarations from the
executive branch, including the OverThe-Counter (OTC) Monograph Reform,
Biosimilars User Fee Act III (BsUFA III),
Opioids Public Health Emergency
Declaration, and the SUPPORT Act.
Through this reorganization the FDA
will be best organized and positions to
address the critical workload, policy
and oversight demands expected in the
space of biosimilars, OTC drug
products, rare disease drug
development, and opioids.
The FDA’s CDER has been
restructured as follows:
DCDE ORGANIZATION. The CDER’s
OSE is headed by the Director, OSE and
includes the following:
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19:37 Dec 23, 2024
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Office of Surveillance and Epidemiology
(DCDE)
Program Management and Analysis Staff
(DCDE3)
Executive Operations Staff (DCDE5)
Office of Medication Error Prevention
and Risk Management (DCDEA)
Division of Medication Error Prevention
and Analysis (DCDEAA)
Division of Risk Management (DCDEAB)
Office of Pharmacovigilance and
Epidemiology (DCDEB)
Division of Epidemiology I (DCDEBA)
Division of Epidemiology I (DCDEBB)
Division of Pharmacovigilance I
(DCDEBC)
Division of Pharmacovigilance I
(DCDEBD)
Office of Regulatory Science (DCDEC)
Division of Regulatory Science and
Applied Research (DCDECA)
Division of Pharmacovigilance
Informatics and Operations
Management (DCDECB)
Office of Regulatory Operations
(DCDED)
Division of Regulatory Project
Management I (DCDEDA)
Division of Regulatory Project
Management II (DCDEDB)
DCDG ORGANIZATION. The CDER’s
OND is headed by the Director, OND
and includes the following
organizational units:
Office of Neuroscience (DCDGA)
Division of Neurology I (DCDGAB)
Division of Neurology II (DCDGAC)
Division of Psychiatry (DCDGAD)
Division of Pharmacology/Toxicology
for Neuroscience (DCDGAF)
Office of Cardiology, Hematology,
Endocrinology, & Nephrology
(DCDGB)
Division of Metabolism & Endocrinology
Products (DCDGBA)
Division of Pulmonary, Allergy &
Rheumatology Products (DCDGBB)
Division of Anesthesia, Analgesia &
Addiction Products (DCDGBC)
Office of Immunology & Inflammation
(DCDGC)
Division of Gastroenterology & Urologic
Products (DCDGCA)
Division of Bones, Reproductive &
Urologic Products (DCDGCB)
Division of Dermatology & Dental
Products (DCDGCC)
Office of Infectious Diseases (DCDGD)
Division of Anti-Infective Products
(DCDGDA)
Division of Anti-Viral Products
(DCDGDB)
Division of Transplant &
Ophthalmology Products (DCDGDC)
Office of Rare Diseases, Pediatrics,
Urology & Reproductive Medicine
(DCDGE)
Division of Pediatrics and Maternal
Health (DCDGEC)
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105053
Division of Pharmacology/Toxicology of
Rare Diseases, Pediatrics, Urologic
and Reproductive Medicine
(DCDGED)
Division of Urology, Obstetrics, and
Gynecology (DCDGEF)
Division of Rare Diseases (DCDGEG)
Division of Medical Genetics (DCDGEH)
Office of Oncologic Diseases (DCDGF)
Office of Therapeutic Biologics &
Biosimilars (DCDGG)
Division of Policy (DCDGGA)
Division of Scientific Review (DCDGGB)
Office of Administrative Operations
(DCDGH)
Administrative Analysis Staff
(DCDGH1)
Administrative Operations Staff 1
(DCDGH2)
Administrative Operations Staff 2
(DCDGH3)
Administrative Operations Staff 3
(DCDGH4)
Administrative Operations Staff 4
(DCDGH5)
Administrative Operations Staff 5
(DCDGH6)
Financial Services Staff (DCDGH7)
Office of Nonprescription Drugs
(DCDGI)
Nonprescription Drugs Pharmacology
Toxicology Staff (DCDGI1)
Division of Nonprescription Drugs I
(DCDGIA)
Division of Nonprescription Drugs II
(DCDGIB)
Division of Nonprescription Drugs III
(DCDGIC)
Division of Pharmacology/Toxicology
for Nonprescription Drugs (DCDGID)
Office of Specialty Medicine (DCDGJ)
Division of Ophthalmology (DCDGJA)
Division of Imaging & Radiation
Medicine (DCDGJB)
Office of New Drug Policy (DCDGK)
Division of Clinical Policy (DCDGKA)
Division of Regulatory Policy (DCDGKB)
Office of Regulatory Operations
(DCDGL)
Division of Regulatory Operation for
Infectious Disease (DCDGLA)
Division of Regulatory Operations for
Oncologic Disease (DCDGLB)
Division of Regulatory Operations for
Nonprescription Drugs (DCDGLC)
Division of Regulatory Operations for
Neuroscience (DCDGLD)
Division of Regulatory Operations for
Cardiology, Hematology,
Endocrinology & Nephrology
(DCDGLE)
Division of Regulatory Operations for
Immunology & Inflammation
(DCDGLF)
Division of Regulatory Operations for
Rare Diseases, Pediatrics, Urology &
Reproductive Medicine (DCDGLG)
Division of Regulatory Operations for
Specialty Medicine (DCDGLH)
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Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices
Division of Regulatory Operations for
Pain, Anesthesia, and Addiction
Medicine (DCDGLI)
Office of Program Operations (DCDGM)
Executive Operations Staff (DCDGM1)
Business Process & Analysis Staff
(DCDGM2)
Learning & Talent Development Staff
(DCDGM3)
Program Development, Implementation
& Management Staff (DCDGM4)
Office of Drug Evaluation Science
(DCDGN)
Division of Clinical Outcome
Assessment (DCDGNA)
Division of Biomedical Informatics,
Research & Biomarker Development
(DCDGNB)
Office of Pain, Anesthesia, and
Addiction Medicine (DCDGO)
Division of Anesthesia and Pain
Medicine (DCDGOA)
Division of Substance Use Disorder
Medicine (DCDGOB)
Division of Pharmacology/Toxicology
for Pain, Anesthesia, and Addiction
Medicine (DCDGOC)
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 Staff Manual Guide 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 of Health and Human Services.
[FR Doc. 2024–30334 Filed 12–23–24; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5353]
Privacy Act of 1974; System of
Records
Food and Drug Administration,
Department of Health and Human
Services.
AGENCY:
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ACTION:
Notice of a modified system of
records.
In accordance with the
requirements of the Privacy Act of 1974,
as amended, the Department of Health
and Human Services (HHS) is modifying
an existing departmentwide system of
records, ‘‘Federal Advisory Committee
Membership Files,’’ System No. 09–90–
0059. The modifications include, among
other things, adding records about any
prospective guest speakers at Federal
advisory committee meetings who
disclose financial interests and
professional relationships related to the
matter they will be speaking on, and
changing the name of the system of
records to ‘‘Federal Advisory
Committee/Subgroup Member,
Subscriber/Registrant, and Guest
Speaker Records.’’
DATES: In accordance with 5 U.S.C.
552a(e)(4) and (11), the modified system
of records is effective December 26,
2024. The new and revised routine uses
will be effective January 27, 2025.
Submit any comments by January 27,
2025.
ADDRESSES: The public should submit
written comments, by mail or email, to
Beth Kramer, HHS Privacy Act Officer,
at 200 Independence Ave. SW, Suite
729H, Washington, DC 20201, or
Beth.Kramer@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
General questions about the modified
system of records should be submitted
by mail, email, or telephone to Beth
Kramer, HHS Privacy Act Officer, at 200
Independence Ave. SW, Suite 729H,
Washington, DC 20201, or
Beth.Kramer@hhs.gov or 202–690–6941.
SUPPLEMENTARY INFORMATION: This
departmentwide system of records
currently covers records retrieved by
personal identifier about: (1) members
and prospective members of HHS
advisory committees established under
the Federal Advisory Committee Act
(FACA) and (2) members of the public
who have requested to be included in
mailing lists in order to receive
publications or notices of information
issued or posted by a particular HHS
Federal advisory committee. The system
of records notice (SORN) is being
revised to add three additional
categories of individuals and records,
i.e.: (1) records about any members of
working groups or subcommittees (i.e.,
subgroups) of an HHS Federal advisory
committee who are not appointed as
members of the committee, which are
similar to the committee member
records currently covered in the SORN,
(2) records about individuals who
register to attend HHS Federal advisory
SUMMARY:
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committee meetings, which are similar
to the subscriber records currently
covered in the SORN, and (3) records
about prospective guest speakers at HHS
Federal advisory committee meetings,
which are described in section I., below;
and to make other modifications. All
modifications are summarized in
section II., below.
I. Background on Guest Speaker
Records
A ‘‘guest speaker’’ is an individual
whose professional background or other
qualifications are checked and/or who is
screened for possible conflicts of
interest (financial interests and
professional relationships) related to a
matter the guest speaker wishes to speak
on at an HHS Federal advisory
committee meeting, so that the agency
can decide whether to invite the
individual to speak and can publicly
acknowledge the speaker’s relevant
qualifications and interests at the start
of the meeting, to enable the committee
members to objectively evaluate the
speaker’s presentation. The term ‘‘guest
speaker’’ as used in SORN 09–90–0059
does not include agency employees
speaking at an HHS Federal advisory
committee meeting in an official,
governmental capacity and individual
participants in the public hearing
portion of an advisory committee
meeting. A guest speaker is either a nonFederal government employee (nonFGE) or a special government employee
(SGEs) acting in a non-official, nongovernmental capacity.
Only certain HHS components, such
as the Food and Drug Administration
(FDA), screen guest speakers for
potential conflicts of interest (all FDA
advisory committees must conduct
conflict screening of potential guest
speakers). Such screening promotes
transparency and openness in the
advisory committee process and
supports compliance with the
requirement in 5 U.S.C. 1004(b)(3) and
41 CFR 102–3.105(g) to prevent
committees’ advice and
recommendations from being influenced
by special interests. For FDA, such
screening also supports compliance
with the requirement in FDA
regulations at 21 CFR 14.60(b)(2) to
document in meeting minutes the
‘‘names and affiliations or interests of
public participants.’’
Guest speakers who are screened for
conflicts are not required to complete a
Federal confidential financial disclosure
form. The invitation extended to them
to participate as a guest speaker in an
HHS Federal advisory committee
meeting may be conditioned on their
voluntary disclosure of potential
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]]>Agencies
[Federal Register Volume 89, Number 247 (Thursday, December 26, 2024)]
[Notices]
[Pages 105052-105054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30334]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA), Center for Drug
Evaluation and Research's (CDER), Office of Surveillance and
Epidemiology (OSE) and Office of New Drugs (OND) has modified their
organizational structure. The new organizational structure was approved
by the Secretary of Health and Human Services on November 20, 2014.
FOR FURTHER INFORMATION CONTACT: Jennifer Wade, Acting Director,
Division of Reorganizations and Delegations of Authority, Office of
Budget, Office of Finance, Budget, and Acquisitions, Food and Drug
Administration, 10903
[[Page 105053]]
New Hampshire Ave., Silver Spring, MD 20993, 240-731-0192.
SUPPLEMENTARY INFORMATION:
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, 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 revised to reflect the Food and
Drug Administration's reorganization of CDER's OSE and OND.
The purpose of this reorganization is to strengthen OSE and OND's
ability to support FDA's mission and streamline its operations.
Within OSE, the newly elevated Office of Regulatory Science (ORS)
will provide scientific and technical leadership in pharmacovigilance
informatics, regulatory informatics systems, and science operations,
including securing access to necessary data sources for drug product
surveillance operations and overseeing applied research studies. While
the newly elevated Office of Regulatory Operations (ORO) will manage
strategic and operational projects associated with drug safety,
particularly with drug safety reviews. The Executive Operations Staff
(EOS) will liaise with stakeholders through the Center and the FDA as
well as with external groups as appropriate to activities within OSE,
coordinate executive operations of Office leadership, and support
organizational development activities for OSE staff.
Within OND, this overall reorganization proposal addresses key
priorities for the country as exhibited by their direct connection to
multiple acts of Congress or declarations from the executive branch,
including the Over-The-Counter (OTC) Monograph Reform, Biosimilars User
Fee Act III (BsUFA III), Opioids Public Health Emergency Declaration,
and the SUPPORT Act. Through this reorganization the FDA will be best
organized and positions to address the critical workload, policy and
oversight demands expected in the space of biosimilars, OTC drug
products, rare disease drug development, and opioids.
The FDA's CDER has been restructured as follows:
DCDE ORGANIZATION. The CDER's OSE is headed by the Director, OSE
and includes the following:
Office of Surveillance and Epidemiology (DCDE)
Program Management and Analysis Staff (DCDE3)
Executive Operations Staff (DCDE5)
Office of Medication Error Prevention and Risk Management (DCDEA)
Division of Medication Error Prevention and Analysis (DCDEAA)
Division of Risk Management (DCDEAB)
Office of Pharmacovigilance and Epidemiology (DCDEB)
Division of Epidemiology I (DCDEBA)
Division of Epidemiology I (DCDEBB)
Division of Pharmacovigilance I (DCDEBC)
Division of Pharmacovigilance I (DCDEBD)
Office of Regulatory Science (DCDEC)
Division of Regulatory Science and Applied Research (DCDECA)
Division of Pharmacovigilance Informatics and Operations Management
(DCDECB)
Office of Regulatory Operations (DCDED)
Division of Regulatory Project Management I (DCDEDA)
Division of Regulatory Project Management II (DCDEDB)
DCDG ORGANIZATION. The CDER's OND is headed by the Director, OND
and includes the following organizational units:
Office of Neuroscience (DCDGA)
Division of Neurology I (DCDGAB)
Division of Neurology II (DCDGAC)
Division of Psychiatry (DCDGAD)
Division of Pharmacology/Toxicology for Neuroscience (DCDGAF)
Office of Cardiology, Hematology, Endocrinology, & Nephrology (DCDGB)
Division of Metabolism & Endocrinology Products (DCDGBA)
Division of Pulmonary, Allergy & Rheumatology Products (DCDGBB)
Division of Anesthesia, Analgesia & Addiction Products (DCDGBC)
Office of Immunology & Inflammation (DCDGC)
Division of Gastroenterology & Urologic Products (DCDGCA)
Division of Bones, Reproductive & Urologic Products (DCDGCB)
Division of Dermatology & Dental Products (DCDGCC)
Office of Infectious Diseases (DCDGD)
Division of Anti-Infective Products (DCDGDA)
Division of Anti-Viral Products (DCDGDB)
Division of Transplant & Ophthalmology Products (DCDGDC)
Office of Rare Diseases, Pediatrics, Urology & Reproductive Medicine
(DCDGE)
Division of Pediatrics and Maternal Health (DCDGEC)
Division of Pharmacology/Toxicology of Rare Diseases, Pediatrics,
Urologic and Reproductive Medicine (DCDGED)
Division of Urology, Obstetrics, and Gynecology (DCDGEF)
Division of Rare Diseases (DCDGEG)
Division of Medical Genetics (DCDGEH)
Office of Oncologic Diseases (DCDGF)
Office of Therapeutic Biologics & Biosimilars (DCDGG)
Division of Policy (DCDGGA)
Division of Scientific Review (DCDGGB)
Office of Administrative Operations (DCDGH)
Administrative Analysis Staff (DCDGH1)
Administrative Operations Staff 1 (DCDGH2)
Administrative Operations Staff 2 (DCDGH3)
Administrative Operations Staff 3 (DCDGH4)
Administrative Operations Staff 4 (DCDGH5)
Administrative Operations Staff 5 (DCDGH6)
Financial Services Staff (DCDGH7)
Office of Nonprescription Drugs (DCDGI)
Nonprescription Drugs Pharmacology Toxicology Staff (DCDGI1)
Division of Nonprescription Drugs I (DCDGIA)
Division of Nonprescription Drugs II (DCDGIB)
Division of Nonprescription Drugs III (DCDGIC)
Division of Pharmacology/Toxicology for Nonprescription Drugs (DCDGID)
Office of Specialty Medicine (DCDGJ)
Division of Ophthalmology (DCDGJA)
Division of Imaging & Radiation Medicine (DCDGJB)
Office of New Drug Policy (DCDGK)
Division of Clinical Policy (DCDGKA)
Division of Regulatory Policy (DCDGKB)
Office of Regulatory Operations (DCDGL)
Division of Regulatory Operation for Infectious Disease (DCDGLA)
Division of Regulatory Operations for Oncologic Disease (DCDGLB)
Division of Regulatory Operations for Nonprescription Drugs (DCDGLC)
Division of Regulatory Operations for Neuroscience (DCDGLD)
Division of Regulatory Operations for Cardiology, Hematology,
Endocrinology & Nephrology (DCDGLE)
Division of Regulatory Operations for Immunology & Inflammation
(DCDGLF)
Division of Regulatory Operations for Rare Diseases, Pediatrics,
Urology & Reproductive Medicine (DCDGLG)
Division of Regulatory Operations for Specialty Medicine (DCDGLH)
[[Page 105054]]
Division of Regulatory Operations for Pain, Anesthesia, and Addiction
Medicine (DCDGLI)
Office of Program Operations (DCDGM)
Executive Operations Staff (DCDGM1)
Business Process & Analysis Staff (DCDGM2)
Learning & Talent Development Staff (DCDGM3)
Program Development, Implementation & Management Staff (DCDGM4)
Office of Drug Evaluation Science (DCDGN)
Division of Clinical Outcome Assessment (DCDGNA)
Division of Biomedical Informatics, Research & Biomarker Development
(DCDGNB)
Office of Pain, Anesthesia, and Addiction Medicine (DCDGO)
Division of Anesthesia and Pain Medicine (DCDGOA)
Division of Substance Use Disorder Medicine (DCDGOB)
Division of Pharmacology/Toxicology for Pain, Anesthesia, and Addiction
Medicine (DCDGOC)
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 Staff Manual Guide 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 of Health and Human Services.
[FR Doc. 2024-30334 Filed 12-23-24; 8:45 am]
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