Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee, 93-94 [2021-28453]
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Federal Register / Vol. 87, No. 1 / Monday, January 3, 2022 / Notices
Dated December 27, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–28397 Filed 12–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0008]
Request for Nominations on Public
Advisory Panels of the Medical
Devices Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on certain panels of the Medical
Devices Advisory Committee (MDAC or
Committee) in the Center for Devices
and Radiological Health (CDRH) notify
FDA in writing. FDA is also requesting
nominations for nonvoting industry
representatives to serve on certain
device panels of the MDAC in the
CDRH. A nominee may either be selfnominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current and
upcoming vacancies effective with this
notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
SUMMARY:
the FDA by February 2, 2022 (see
sections I and II of this document for
further details). Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
February 2, 2022.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Margaret
Ames (see FOR FURTHER INFORMATION
CONTACT). All nominations for
nonvoting industry representatives
should be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5213, Silver Spring,
MD 20993, 301–796–5960, email:
margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency is requesting nominations for
nonvoting industry representatives to
the panels listed in the table in this
document.
I. Medical Devices Advisory Committee
The Committee reviews and evaluates
data on the safety and effectiveness of
marketed and investigational devices
and makes recommendations for their
regulation. The panels engage in a
number of activities to fulfill the
functions the Federal Food, Drug, and
Cosmetic Act (FD&C Act) envisions for
device advisory panels. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, advises
the Commissioner of Food and Drugs
(the Commissioner) regarding
recommended classification or
reclassification of devices into one of
three regulatory categories; advises on
any possible risks to health associated
with the use of devices; advises on
formulation of product development
protocols; reviews premarket approval
applications for medical devices;
reviews guidelines and guidance
documents; recommends exemption of
certain devices from the application of
portions of the FD&C Act; advises on the
necessity to ban a device; and 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
Committee also provides
recommendations to the Commissioner
or designee on complexity
categorization of in vitro diagnostics
under the Clinical Laboratory
Improvement Amendments of 1988.
Panels
Function
Circulatory System Devices Panel .....................................
Reviews and evaluate data concerning the safety and effectiveness of marketed and
investigational devices for use in the circulatory and vascular systems and makes
appropriate recommendations to the Commissioner of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of marketed
and investigational devices for use in obstetrics and gynecology and makes appropriate recommendations to the Commissioner of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of marketed
and investigational diagnostic or therapeutic radiological and nuclear medicine devices and makes appropriate recommendations to the Commissioner of Food and
Drugs.
Obstetrics and Gynecology Devices Panel .......................
Radiological Devices Panel ...............................................
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93
II. Qualifications
III. Selection Procedure
Persons nominated for the device
panels should be full-time employees of
firms that manufacture products that
would come before the panel, or
consulting firms that represent
manufacturers, or have similar
appropriate ties to industry.
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
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of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
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94
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
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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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[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Pages 93-94]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28453]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
Request for Nominations on Public Advisory Panels of the Medical
Devices Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on certain panels of the
Medical Devices Advisory Committee (MDAC or Committee) in the Center
for Devices and Radiological Health (CDRH) notify FDA in writing. FDA
is also requesting nominations for nonvoting industry representatives
to serve on certain device panels of the MDAC in the CDRH. A nominee
may either be self-nominated or nominated by an organization to serve
as a nonvoting industry representative. Nominations will be accepted
for current and upcoming vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to the FDA by
February 2, 2022 (see sections I and II of this document for further
details). Concurrently, nomination materials for prospective candidates
should be sent to FDA by February 2, 2022.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nomination should be sent to Margaret Ames (see
FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives should be submitted electronically by
accessing the FDA Advisory Committee Membership Nomination Portal:
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member of an
FDA advisory committee can also be obtained by visiting FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993, 301-796-5960, email:
[email protected].
SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for
nonvoting industry representatives to the panels listed in the table in
this document.
I. Medical Devices Advisory Committee
The Committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions the Federal Food, Drug, and
Cosmetic Act (FD&C Act) envisions for device advisory panels. With the
exception of the Medical Devices Dispute Resolution Panel, each panel,
according to its specialty area, advises the Commissioner of Food and
Drugs (the Commissioner) regarding recommended classification or
reclassification of devices into one of three regulatory categories;
advises on any possible risks to health associated with the use of
devices; advises on formulation of product development protocols;
reviews premarket approval applications for medical devices; reviews
guidelines and guidance documents; recommends exemption of certain
devices from the application of portions of the FD&C Act; advises on
the necessity to ban a device; and 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 Committee also provides recommendations to the
Commissioner or designee on complexity categorization of in vitro
diagnostics under the Clinical Laboratory Improvement Amendments of
1988.
------------------------------------------------------------------------
Panels Function
------------------------------------------------------------------------
Circulatory System Devices Panel.. Reviews and evaluate data concerning
the safety and effectiveness of
marketed and investigational
devices for use in the circulatory
and vascular systems and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
Obstetrics and Gynecology Devices Reviews and evaluates data
Panel. concerning the safety and
effectiveness of marketed and
investigational devices for use in
obstetrics and gynecology and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
Radiological Devices Panel........ Reviews and evaluates data
concerning the safety and
effectiveness of marketed and
investigational diagnostic or
therapeutic radiological and
nuclear medicine devices and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
------------------------------------------------------------------------
II. Qualifications
Persons nominated for the device panels should be full-time
employees of firms that manufacture products that would come before the
panel, or consulting firms that represent manufacturers, or have
similar appropriate ties to industry.
III. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer
[[Page 94]]
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
r[eacute]sum[eacute] 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.
Dated: December 27, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28453 Filed 12-30-21; 8:45 am]
BILLING CODE 4164-01-P
