Statement of Organization, Functions, and Delegations of Authority, 94 [2021-28385]
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Federal Register / Vol. 87, No. 1 / Monday, January 3, 2022 / Notices
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for a particular device panel.
The interested organizations are not
bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
IV. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nomination
must include a current, complete
re´sume´ or curriculum vitae for each
nominee including current business
address and telephone number, email
address if available, and a signed copy
of the Acknowledgement and Consent
form available at the FDA Advisory
Committee Membership Nomination
Portal (see ADDRESSES) within 30 days of
publication of this document (see
DATES). Nominations must also specify
the advisory panel for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the particular device panels listed in the
table. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process).
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
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.
khammond on DSKJM1Z7X2PROD with NOTICES
Dated: December 27, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–28453 Filed 12–30–21; 8:45 am]
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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), Office of the
Commissioner (OC), Office of the Chief
Scientist (OCS) has modified their
organizational structure. The new
organizational structure was approved
by the Deputy Secretary of Health and
Human Services and effective on
November 24, 2021.
FOR FURTHER INFORMATION CONTACT:
Yashika Rahaman, Director, Office of
Planning, Evaluation and Risk
Management, Office of Finance, Budget,
Acquisitions and Planning, FDA, 4041
Powder Mill Road, 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,
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
Office of the Chief Scientist.
The FDA Office of the Commissioner,
Office of the Chief Scientist (OCS), is
realigning the FDA Technology Transfer
Program (FDATT), from the Office of
Regulatory Science and Innovation
(ORSI), OCS, to the OCS Immediate
Office (OCS–IO). This realignment of
the FDATT program and resources
intends to further enhance the
effectiveness of FDA’s partnership
programs by increasing the FDA-wide
its efforts to (1) facilitate the
implementation of authorizing
legislation for federal technology
transfer, (2) ensure compliance with
relevant legal and regulatory
requirements, and (3) establish/maintain
related policies and processes. The
realignment will also increase OCS’s
effectiveness in driving regulatory
science research through external
partnerships and would demonstrate
FDA’s commitment to strengthening its
partnership and collaboration
capabilities, which are key contributors
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
to sustaining FDA’s ability to see and be
at the forefront of biomedical
advancements in carrying out its public
health mission. Additionally, OCS is
abolishing the Division of Science
Innovation & Critical Path from its
Office of Regulatory Science and
Innovation (ORSI). ORSI’s programs
have evolved away from the need for
this division. This proposed, formal
abolishment of the division will serve as
a corrective action to align ORSI’s
organizational structure with its current
programmatic responsibilities that fulfill
its functions. The Food and Drug
Administration’s Office of the Chief
Scientist has been restructured as
follows:
DCCF. ORGANIZATION. The Office
of the Chief Scientist is headed by the
FDA Chief Scientist, and includes the
following:
Office of the Chief Scientist (DCP)
Advisory Committee Oversight and
Management Staff (DCP1)
FDA Technology Transfer Program Staff
(DCP2)
Office of Counter-Terrorism and
Emerging Threats (DCPA)
Office of Laboratory Safety (DCPB)
Office of Regulatory Science and
Innovation (DCPC)
Office of Scientific Integrity (DCPD)
Office of Scientific Professional
Development (DCPE)
National Center for Toxicological
Research (DCPF)
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/Reports
ManualsForms/StaffManualGuides/
default.htm.
Authority: 44 U.S.C. 3101.
Dated: October 22, 2021.
Andrea Palm,
Deputy Secretary of Health and Human
Services.
[FR Doc. 2021–28385 Filed 12–30–21; 8:45 am]
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03JAN1
Agencies
[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Page 94]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28385]
-----------------------------------------------------------------------
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), Office of the
Commissioner (OC), Office of the Chief Scientist (OCS) has modified
their organizational structure. The new organizational structure was
approved by the Deputy Secretary of Health and Human Services and
effective on November 24, 2021.
FOR FURTHER INFORMATION CONTACT: Yashika Rahaman, Director, Office of
Planning, Evaluation and Risk Management, Office of Finance, Budget,
Acquisitions and Planning, FDA, 4041 Powder Mill Road, 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, 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 Office of the Chief Scientist.
The FDA Office of the Commissioner, Office of the Chief Scientist
(OCS), is realigning the FDA Technology Transfer Program (FDATT), from
the Office of Regulatory Science and Innovation (ORSI), OCS, to the OCS
Immediate Office (OCS-IO). This realignment of the FDATT program and
resources intends to further enhance the effectiveness of FDA's
partnership programs by increasing the FDA-wide its efforts to (1)
facilitate the implementation of authorizing legislation for federal
technology transfer, (2) ensure compliance with relevant legal and
regulatory requirements, and (3) establish/maintain related policies
and processes. The realignment will also increase OCS's effectiveness
in driving regulatory science research through external partnerships
and would demonstrate FDA's commitment to strengthening its partnership
and collaboration capabilities, which are key contributors to
sustaining FDA's ability to see and be at the forefront of biomedical
advancements in carrying out its public health mission. Additionally,
OCS is abolishing the Division of Science Innovation & Critical Path
from its Office of Regulatory Science and Innovation (ORSI). ORSI's
programs have evolved away from the need for this division. This
proposed, formal abolishment of the division will serve as a corrective
action to align ORSI's organizational structure with its current
programmatic responsibilities that fulfill its functions. The Food and
Drug Administration's Office of the Chief Scientist has been
restructured as follows:
DCCF. ORGANIZATION. The Office of the Chief Scientist is headed by
the FDA Chief Scientist, and includes the following:
Office of the Chief Scientist (DCP)
Advisory Committee Oversight and Management Staff (DCP1)
FDA Technology Transfer Program Staff (DCP2)
Office of Counter-Terrorism and Emerging Threats (DCPA)
Office of Laboratory Safety (DCPB)
Office of Regulatory Science and Innovation (DCPC)
Office of Scientific Integrity (DCPD)
Office of Scientific Professional Development (DCPE)
National Center for Toxicological Research (DCPF)
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.
Dated: October 22, 2021.
Andrea Palm,
Deputy Secretary of Health and Human Services.
[FR Doc. 2021-28385 Filed 12-30-21; 8:45 am]
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