Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee, 106513-106514 [2024-31272]
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Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
106513
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued
21 CFR part 860, subpart D;
information collection activity
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden per response
Total hours
§ 860.250; withdrawal of request ......
5
1
5
0.17 (10 mins.) .................................
1
Total ...........................................
........................
........................
........................
...........................................................
14,379
1 FDA
assumes activities associated with review of the Acceptance Checklist are included in burden for submission of requests captured in row
1.
Our estimated burden for the
information collection reflects an
overall increase of 2,002 hours and a
corresponding increase of 11 responses.
We attribute this adjustment to an
increase in the number of submissions
we received over the last few years.
Since the publication of the 60-day
notice, we issued the guidance
document entitled ‘‘Electronic
Submission Template for Medical
Device De Novo Requests’’ (August 23,
2024, 89 FR 68166; https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
electronic-submission-templatemedical-device-de-novo-requests) and
are including it in this information
collection. Given that all submissions
were previously received electronically
and the ability to voluntarily submit De
Novo requests using eSTAR was
included in the previous information
collection request (ICR), inclusion of the
guidance in this ICR is not expected to
impact the estimated burden.
Dated: December 13, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31014 Filed 12–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0008]
Request for Nominations of Individuals
and Industry Organizations for the
Patient Engagement Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ddrumheller on DSK120RN23PROD with NOTICES1
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
requesting that any industry
organizations interested in participating
in the selection of a pool of nonvoting
industry representatives to serve as
temporary nonvoting members on the
Patient Engagement Advisory
SUMMARY:
VerDate Sep<11>2014
23:58 Dec 27, 2024
Jkt 265001
Committee (the Committee) in the
Center for Devices and Radiological
Health notify FDA in writing. FDA is
also requesting nominations for
temporary nonvoting industry
representatives to be included in a pool
of individuals to serve on the
Committee. Nominees recommended to
serve as a temporary nonvoting industry
representative may either be selfnominated or nominated by an industry
organization. This position may be filled
by representatives from different
medical device areas based on expertise
relevant to the topics being considered
by the Committee. Nominations will be
accepted for upcoming vacancies
effective with this notice. 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.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interest
must send a letter stating that interest to
the FDA by January 29, 2025, (see
sections I and II of this document for
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by January 29,
2025.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of a pool of nonvoting industry
representatives should be sent
electronically 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 on an FDA advisory
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
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 20993–0002, 301–796–5960, email:
margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for a pool of
nonvoting industry representatives for
the Committee. The list of needed
expertise on May 1, 2025, is identified
below:
• Cybersecurity
• Communication of Benefit & Risk
Information to Patients; Medical
Device Labeling
• Digital Health Technology/Artificial
Intelligence
• Health Equity
• Patient Engagement
• Patient Preference Elicitation
• Patient-Reported Outcomes
Development, Validation, and Use in
Regulatory Studies or Clinical
Practice
• Postmarket Studies, Including
Observational and Registry-Based
Studies
• Human Factors
FDA is publishing separate
documents regarding:
1. Request for Nominations for Voting
Members for the Patient Engagement
Advisory Committee
2. Request for Nominations for
Consumer Representative for the
Patient Engagement Advisory
Committee
I. General Description of the
Committee’s Duties
The Committee provides advice on
complex issues relating to medical
devices, the regulation of devices, and
their use by patients. Agency guidance
and policies, clinical trial or registry
design, patient preference study design,
benefit-risk determinations, device
labeling, unmet clinical needs, available
alternatives, patient reported outcomes
and device-related quality of life or
E:\FR\FM\30DEN1.SGM
30DEN1
106514
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
health status issues are among the topics
that may be considered by the
Committee. Members are knowledgeable
in areas such as clinical research,
primary care patient experience,
healthcare needs of patient groups in
the United States or are experienced in
the work of patient and health
professional organizations,
methodologies for eliciting patient
preferences, and strategies for
communicating benefits, risks and
clinical outcomes to patients and
research subjects. The Commissioner of
Food and Drugs (the Commissioner), or
designee, shall have the authority to
select from a group of individuals
nominated by industry to serve
temporarily as nonvoting members who
are identified with industry interests.
The number of temporary members
selected for a particular meeting will
depend on the meeting topic(s).
ddrumheller on DSK120RN23PROD with NOTICES1
II. Qualifications
Persons nominated for the Patient
Engagement Advisory Committee
should be full-time employees of firms
that manufacture medical device
products, 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 interest must 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 résumés or curriculum
vitae. The letter will also state that it is
the responsibility of the interested
organizations to confer with one another
and to select a candidate or candidates
(to serve in a pool of individuals with
varying areas of expertise) to represent
industry interest for the Committee,
within 60 days after the receipt of the
FDA letter. The interested organizations
are not bound by the list of nominees in
selecting a candidate or candidates.
However, if no individual is selected
within 60 days, the Commissioner will
select temporary nonvoting members (or
pool of individuals) to represent
industry interests.
IV. Nomination Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a
VerDate Sep<11>2014
23:58 Dec 27, 2024
Jkt 265001
temporary nonvoting industry
representative. Nominations must
include a cover letter and a current,
complete résumé or curriculum vitae for
each nominee, including current
business and/or home address,
telephone number, and 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). Nominations
should specify the advisory committee
for which the nominee is recommended
within 30 days of publication of this
document (see DATES). In addition,
nominations should 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 Committee. Only interested industry
organizations participate in the
selection process. Persons who
nominate themselves as nonvoting
industry representatives will not
participate in the selection process.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14,
relating to advisory committees.
Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31272 Filed 12–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
On August
15, 2024, the Agency submitted a
proposed collection of information
entitled ‘‘National Agriculture and Food
Defense Strategy Survey’’ to OMB for
review and clearance under 44 U.S.C.
3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
0910–0855. The approval expires on
November 30, 2027. A copy of the
supporting statement for this
information collection is available on
the internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: December 16, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31298 Filed 12–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4597]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Shortages Data Collection
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
[Docket No. FDA–2024–N–0846]
The Food and Drug
Administration (FDA or Agency) is
announcing that a collection of
information entitled ‘‘Shortages Data
Collection’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA).
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10 a.m.–12 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUMMARY:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
National Agriculture and Food Defense
Strategy Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that a collection of
information entitled ‘‘National
Agriculture and Food Defense Strategy
Survey’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA).
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
SUMMARY:
PO 00000
Frm 00109
Fmt 4703
Sfmt 4703
On May
20, 2024, the Agency submitted a
proposed collection of information
entitled ‘‘Shortages Data Collection’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
SUPPLEMENTARY INFORMATION:
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106513-106514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31272]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
Request for Nominations of Individuals and Industry Organizations
for the Patient Engagement Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
requesting that any industry organizations interested in participating
in the selection of a pool of nonvoting industry representatives to
serve as temporary nonvoting members on the Patient Engagement Advisory
Committee (the Committee) in the Center for Devices and Radiological
Health notify FDA in writing. FDA is also requesting nominations for
temporary nonvoting industry representatives to be included in a pool
of individuals to serve on the Committee. Nominees recommended to serve
as a temporary nonvoting industry representative may either be self-
nominated or nominated by an industry organization. This position may
be filled by representatives from different medical device areas based
on expertise relevant to the topics being considered by the Committee.
Nominations will be accepted for upcoming vacancies effective with this
notice. 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.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interest must send a letter stating that interest to the FDA by January
29, 2025, (see sections I and II of this document for details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by January 29, 2025.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of a pool of
nonvoting industry representatives should be sent electronically 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 on 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 20993-0002, 301-796-5960,
email: [email protected].
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a pool of
nonvoting industry representatives for the Committee. The list of
needed expertise on May 1, 2025, is identified below:
Cybersecurity
Communication of Benefit & Risk Information to Patients;
Medical Device Labeling
Digital Health Technology/Artificial Intelligence
Health Equity
Patient Engagement
Patient Preference Elicitation
Patient-Reported Outcomes Development, Validation, and Use in
Regulatory Studies or Clinical Practice
Postmarket Studies, Including Observational and Registry-Based
Studies
Human Factors
FDA is publishing separate documents regarding:
1. Request for Nominations for Voting Members for the Patient
Engagement Advisory Committee
2. Request for Nominations for Consumer Representative for the Patient
Engagement Advisory Committee
I. General Description of the Committee's Duties
The Committee provides advice on complex issues relating to medical
devices, the regulation of devices, and their use by patients. Agency
guidance and policies, clinical trial or registry design, patient
preference study design, benefit-risk determinations, device labeling,
unmet clinical needs, available alternatives, patient reported outcomes
and device-related quality of life or
[[Page 106514]]
health status issues are among the topics that may be considered by the
Committee. Members are knowledgeable in areas such as clinical
research, primary care patient experience, healthcare needs of patient
groups in the United States or are experienced in the work of patient
and health professional organizations, methodologies for eliciting
patient preferences, and strategies for communicating benefits, risks
and clinical outcomes to patients and research subjects. The
Commissioner of Food and Drugs (the Commissioner), or designee, shall
have the authority to select from a group of individuals nominated by
industry to serve temporarily as nonvoting members who are identified
with industry interests. The number of temporary members selected for a
particular meeting will depend on the meeting topic(s).
II. Qualifications
Persons nominated for the Patient Engagement Advisory Committee
should be full-time employees of firms that manufacture medical device
products, 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
interest must 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 r[eacute]sum[eacute]s or curriculum vitae. The
letter will also state that it is the responsibility of the interested
organizations to confer with one another and to select a candidate or
candidates (to serve in a pool of individuals with varying areas of
expertise) to represent industry interest for the Committee, within 60
days after the receipt of the FDA letter. The interested organizations
are not bound by the list of nominees in selecting a candidate or
candidates. However, if no individual is selected within 60 days, the
Commissioner will select temporary nonvoting members (or pool of
individuals) to represent industry interests.
IV. Nomination Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a temporary nonvoting industry
representative. Nominations must include a cover letter and a current,
complete r[eacute]sum[eacute] or curriculum vitae for each nominee,
including current business and/or home address, telephone number, and
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). Nominations should specify the
advisory committee for which the nominee is recommended within 30 days
of publication of this document (see DATES). In addition, nominations
should 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
Committee. Only interested industry organizations participate in the
selection process. Persons who nominate themselves as nonvoting
industry representatives will not participate in the selection process.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14, relating to advisory
committees.
Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31272 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P
