Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative, 57203-57205 [2022-20221]
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Federal Register / Vol. 87, No. 180 / Monday, September 19, 2022 / Notices
Silver Spring, MD 20993–0002, 301–
796–1546, Kaetochi.Okemgbo@
fda.hhs.gov.
Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ENDEP (amitriptyline hydrochloride)
oral concentrate, 40 mg/mL, is the
subject of ANDA 085749, held by
Hoffman-La Roche Inc., and initially
approved on December 23, 1977. ENDEP
(amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, is indicated for
relief of symptoms of depression.
Hoffman-La Roche Inc. has never
marketed ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/
mL. ANDA 085749 is listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated
January 11, 2022 (Docket No. FDA–
2022–P–0068), under 21 CFR 10.30,
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SUPPLEMENTARY INFORMATION:
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requesting that the Agency determine
whether ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/
mL, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/
mL, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that ENDEP
(amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, was withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
ENDEP (amitriptyline hydrochloride)
oral concentrate, 40 mg/mL, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/
mL, in the ‘‘Discontinued Drug Product
List’’ section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to ENDEP (amitriptyline hydrochloride)
oral concentrate, 40 mg/mL, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: September 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20195 Filed 9–16–22; 8:45 am]
BILLING CODE 4164–01–P
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57203
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6395]
Request for Applications for New
Members of the Clinical Trials
Transformation Initiative/Food and
Drug Administration Patient
Engagement Collaborative
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for applications.
The Food and Drug
Administration (FDA or Agency), in
collaboration with the Clinical Trials
Transformation Initiative (CTTI), is
requesting applications from patient
advocates interested in participating on
the Patient Engagement Collaborative
(PEC). The PEC is an ongoing,
collaborative forum coordinated through
the Office of Patient Affairs, Office of
Clinical Policy and Programs (OCPP),
Office of the Commissioner at FDA, and
is hosted by CTTI. Through the PEC, the
patient community and regulators are
able to discuss an array of topics
regarding increasing meaningful patient
engagement with diverse populations in
medical product development and
regulatory discussions at FDA. The
activities of the PEC may include, but
are not limited to, providing diverse
perspectives on topics such as
systematic patient engagement,
transparency, and communication;
providing considerations for
implementing new strategies to enhance
patient engagement at FDA; and
proposing new models of collaboration
in which patient and patient advocate
perspectives are incorporated into
general medical product development
and regulatory processes.
DATES: Applications can be submitted
starting at 11:59 p.m. eastern time on
September 19, 2022. This
announcement is open to receive a
maximum of 75 applications.
Applications will be accepted until
11:59 p.m. eastern time on October 19,
2022 or until 75 applications are
received, whichever happens first.
ADDRESSES: All applications should be
submitted to FDA’s Office of Patient
Affairs in OCPP. The preferred
application method is via the online
submission system provided by CTTI,
available at https://duke.qualtrics.com/
jfe/form/SV_5nI1VVWVOaD59ky. For
those applicants unable to submit an
application electronically, please call
FDA’s Office of Patient Affairs at 301–
796–8460 to arrange for mail or delivery
SUMMARY:
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Federal Register / Vol. 87, No. 180 / Monday, September 19, 2022 / Notices
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service submission. Only complete
applications, as described under section
IV of this document, will be considered.
FOR FURTHER INFORMATION CONTACT:
Wendy Slavit, Office of the
Commissioner, Office of Clinical Policy
and Programs, Office of Patient Affairs,
Food and Drug Administration, 301–
796–8460,
PatientEngagementCollaborative@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Purpose
The CTTI is a public-private
partnership cofounded by FDA and
Duke University whose mission is to
develop and drive adoption of practices
that will increase the quality and
efficiency of clinical trials. FDA and
CTTI have long involved patients and
considered patient perspectives in their
work. Furthering the engagement of
diverse patients as valued partners
across the medical product research and
development continuum requires an
open forum for patients and regulators
to discuss and exchange ideas.
The PEC is an ongoing, collaborative
forum in which the patient community
and regulators discuss an array of topics
regarding increasing patient engagement
in medical product development and
regulatory discussions at FDA. The PEC
is a joint endeavor between FDA and
CTTI. The activities of the PEC may
inform relevant FDA and CTTI
activities. The PEC is not intended to
advise or otherwise direct the activities
of either organization, and membership
will not constitute employment by
either organization.
The Food and Drug Administration
Safety and Innovation Act (Pub. L. 112–
14), section 1137, entitled ‘‘Patient
Participation in Medical Product
Discussions,’’ added section 569C to the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb–8c). This provision
directs the Secretary of Health and
Human Services to ‘‘develop and
implement strategies to solicit the views
of patients during the medical product
development process and consider the
perspectives of patients during
regulatory discussions.’’ On November
4, 2014, FDA issued a Federal Register
notice establishing a docket (FDA–
2014–N–1698) for public commenters to
submit information related to FDA’s
implementation of this provision. Upon
review of the comments received, one
common theme, among others, included
establishing an external group to
provide input on patient engagement
strategies across FDA’s Centers. After
considering the comments, FDA formed
the PEC in 2018 to discuss a variety of
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17:37 Sep 16, 2022
Jkt 256001
patient engagement topics. This group is
consistent with additional legislation
subsequently enacted in section 3001 of
the 21st Century Cures Act (Pub. L. 114–
255) and section 605 of the FDA
Reauthorization Act of 2017 (Pub. L.
115–52), further supporting tools for
fostering patient participation in the
regulatory process.
The PEC currently has 16 members.
To help ensure continuity in its
activities and organizational knowledge,
the PEC maintains staggered
membership terms. As of fall 2022, eight
members will complete a term and up
to eight new members will be selected.
The purpose of this notice is to
announce that the application process
for up to eight new members of the PEC
is now open, and to invite and
encourage applications by the
submission deadline for appropriately
qualified individuals.
II. Criteria for Membership
The PEC includes up to 16 diverse
representatives of the patient
community. Eight members from the
previous application process will
remain on the PEC. The current
application process is to select up to
eight new PEC members. Selected
members will include the following: (1)
patients who have personal disease
experience; (2) caregivers who support
patients, such as a parent, child,
partner, other family member, or friend,
and who have personal disease
experience through this caregiver role;
and/or (3) representatives of patient
groups who, through their role in the
patient group, have direct or indirect
disease experience. Please note that for
purposes of this activity, the term
‘‘caregiver’’ is not intended to include
individuals who are engaged in
caregiving as healthcare professionals;
and the term ‘‘patient group’’ is used
herein to encompass patient advocacy
organizations, disease advocacy
organizations, voluntary health
agencies, nonprofit research
foundations, and public health
organizations. The ultimate goal of the
application and selection process is to
identify individuals who can represent
a collective patient voice for their
patient community.
Selection criteria include the
applicant’s potential to meaningfully
contribute to the activities of the PEC,
ability to represent and express the
patient voice for their constituency,
ability to work in a constructive manner
with involved stakeholders, and
understanding of the clinical research
enterprise. Consideration will also be
given to ensuring the PEC includes
diverse perspectives and experiences,
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including but not limited to
sociodemographic factors (such as age,
gender, ethnicity, education level,
income) and disease experience. PEC
members are required to be residents of
the United States and must be 18 years
of age or older.
Financial and other conflicts of
interest will not necessarily make
applicants ineligible for membership in
the PEC. However, applicants cannot be
direct employees of the medical product
development industry or a currently
registered lobbyist for an FDA-regulated
industry.
III. Responsibilities and Expectations
Participation as a PEC member is
voluntary. Working meetings of the PEC
will typically be held two to four times
per year, either in person (in the
Washington, DC area) or virtually
(teleconference or webinar). Given the
ongoing COVID–19 pandemic, meetings
will be conducted virtually and may
resume in-person when it is safe to do
so. Additional meetings may be
organized as needed, and currently
include monthly, 1-hour
teleconferences.
Reasonable accommodations will be
made for members with special needs
for travel or for participation in a
meeting. Applications for PEC
membership are encouraged from
individuals of all ages, sexes, genders,
sexual orientations, racial and ethnic
groups, education levels, income levels,
and those with and without disabilities.
Travel support will be provided as
applicable.
To help ensure continuity in its
activities and organizational knowledge,
the PEC will maintain staggered
membership terms for patient
community representatives.
Membership terms for new members
will be 2-year appointments. Members
may serve up to two terms, with the
possibility of extensions.
Additional responsibilities and
expectations are set forth in the PEC
Framework, which should be reviewed
prior to submitting an application, and
is available at https://ctticlinicaltrials.org/wp-content/uploads/
2021/07/patient_engagement_
collaborative_framework_-_revised_
25jan2021.pdf.
IV. Application Process
Any interested person may apply for
membership on the PEC. To apply, go to
https://duke.qualtrics.com/jfe/form/SV_
5nI1VVWVOaD59ky. The application is
completed online and includes
questions to help determine eligibility
for the PEC, demographic and other
background questions, and four brief
E:\FR\FM\19SEN1.SGM
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Federal Register / Vol. 87, No. 180 / Monday, September 19, 2022 / Notices
essay questions. Many of the
demographic questions are optional.
The brief essay questions, to be
answered in 500 characters or fewer
(including spaces), are as follows:
• Please explain why you would have
an outstanding ability to represent and
express the patient voice for the disease
area(s) you selected above.
• Please give a few examples of
experiences that demonstrate your
outstanding ability to work across or
interact with stakeholders in the
medical product development and
regulatory processes.
• Please explain how you have
established an understanding of the
medical product development and
regulatory processes.
• Please tell us why you are
interested in becoming a member of the
PEC and how you would be able to
contribute.
Completing the application also
involves submitting: (1) A current onepage re´sume´ or bio that summarizes
your patient advocacy experience and
related activities (PDF format required)
and (2) A one-page letter of
endorsement from a patient group with
which the applicant has worked closely
on activities that are relevant to the PEC
(PDF format required). Please note, only
the application and the two documents
specified above will be reviewed. Your
completed application form, re´sume´ or
bio, and letter of endorsement should all
be submitted at the same time.
The re´sume´ or bio must provide
examples and descriptions of relevant
activities and experiences related to the
applicant’s qualifications for PEC
membership. The letter of endorsement
should emphasize information relevant
to the criteria for membership described
above. This letter must be from and
written by someone other than yourself.
The letter may address topics such as
the applicant’s involvement in patient
advocacy activities, experiences that
stimulated an interest in participating in
discussions about patient engagement in
medical product development and
regulatory decision processes, and other
information that may be helpful in
evaluating the applicant’s qualifications
as a potential member of the PEC.
Applications will be accepted until
11:59 p.m. eastern time on October 19,
2022 or until 75 applications are
received, whichever happens first. Only
complete applications will be
considered.
The application review period will
take a minimum of 2 months after 11:59
p.m. eastern time on October 19, 2022.
Additional information may be
needed from some applicants during the
review period, including information
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17:37 Sep 16, 2022
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relevant to understanding potential
sources of conflict of interest, in which
case applicants will be contacted
directly. All applicants (both those
selected for PEC membership and those
who are not selected) will be notified of
the final application decision no later
than the end of the 2022 calendar year.
Dated: September 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20221 Filed 9–16–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2109]
Cardiovascular and Renal Drugs
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Cardiovascular and Renal
Drugs Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
DATES: The meeting will be held
virtually on November 16, 2022, from
9:30 a.m. to 5 p.m. eastern time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/ucm408555.
htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2022–N–2109.
The docket will close on November 15,
2022. Either electronic or written
comments on this public meeting must
be submitted by November 15, 2022.
Please note that late, untimely filed
comments will not be considered. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. eastern time at the end
SUMMARY:
PO 00000
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57205
of November 15, 2022. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are received
on or before that date.
Comments received on or before
November 1, 2022, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is canceled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–N–2109 for ‘‘Cardiovascular and
Renal Drugs Advisory Committee;
E:\FR\FM\19SEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 180 (Monday, September 19, 2022)]
[Notices]
[Pages 57203-57205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20221]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6395]
Request for Applications for New Members of the Clinical Trials
Transformation Initiative/Food and Drug Administration Patient
Engagement Collaborative
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for applications.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency), in
collaboration with the Clinical Trials Transformation Initiative
(CTTI), is requesting applications from patient advocates interested in
participating on the Patient Engagement Collaborative (PEC). The PEC is
an ongoing, collaborative forum coordinated through the Office of
Patient Affairs, Office of Clinical Policy and Programs (OCPP), Office
of the Commissioner at FDA, and is hosted by CTTI. Through the PEC, the
patient community and regulators are able to discuss an array of topics
regarding increasing meaningful patient engagement with diverse
populations in medical product development and regulatory discussions
at FDA. The activities of the PEC may include, but are not limited to,
providing diverse perspectives on topics such as systematic patient
engagement, transparency, and communication; providing considerations
for implementing new strategies to enhance patient engagement at FDA;
and proposing new models of collaboration in which patient and patient
advocate perspectives are incorporated into general medical product
development and regulatory processes.
DATES: Applications can be submitted starting at 11:59 p.m. eastern
time on September 19, 2022. This announcement is open to receive a
maximum of 75 applications. Applications will be accepted until 11:59
p.m. eastern time on October 19, 2022 or until 75 applications are
received, whichever happens first.
ADDRESSES: All applications should be submitted to FDA's Office of
Patient Affairs in OCPP. The preferred application method is via the
online submission system provided by CTTI, available at https://duke.qualtrics.com/jfe/form/SV_5nI1VVWVOaD59ky. For those applicants
unable to submit an application electronically, please call FDA's
Office of Patient Affairs at 301-796-8460 to arrange for mail or
delivery
[[Page 57204]]
service submission. Only complete applications, as described under
section IV of this document, will be considered.
FOR FURTHER INFORMATION CONTACT: Wendy Slavit, Office of the
Commissioner, Office of Clinical Policy and Programs, Office of Patient
Affairs, Food and Drug Administration, 301-796-8460,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background and Purpose
The CTTI is a public-private partnership cofounded by FDA and Duke
University whose mission is to develop and drive adoption of practices
that will increase the quality and efficiency of clinical trials. FDA
and CTTI have long involved patients and considered patient
perspectives in their work. Furthering the engagement of diverse
patients as valued partners across the medical product research and
development continuum requires an open forum for patients and
regulators to discuss and exchange ideas.
The PEC is an ongoing, collaborative forum in which the patient
community and regulators discuss an array of topics regarding
increasing patient engagement in medical product development and
regulatory discussions at FDA. The PEC is a joint endeavor between FDA
and CTTI. The activities of the PEC may inform relevant FDA and CTTI
activities. The PEC is not intended to advise or otherwise direct the
activities of either organization, and membership will not constitute
employment by either organization.
The Food and Drug Administration Safety and Innovation Act (Pub. L.
112-14), section 1137, entitled ``Patient Participation in Medical
Product Discussions,'' added section 569C to the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-8c). This provision directs the
Secretary of Health and Human Services to ``develop and implement
strategies to solicit the views of patients during the medical product
development process and consider the perspectives of patients during
regulatory discussions.'' On November 4, 2014, FDA issued a Federal
Register notice establishing a docket (FDA-2014-N-1698) for public
commenters to submit information related to FDA's implementation of
this provision. Upon review of the comments received, one common theme,
among others, included establishing an external group to provide input
on patient engagement strategies across FDA's Centers. After
considering the comments, FDA formed the PEC in 2018 to discuss a
variety of patient engagement topics. This group is consistent with
additional legislation subsequently enacted in section 3001 of the 21st
Century Cures Act (Pub. L. 114-255) and section 605 of the FDA
Reauthorization Act of 2017 (Pub. L. 115-52), further supporting tools
for fostering patient participation in the regulatory process.
The PEC currently has 16 members. To help ensure continuity in its
activities and organizational knowledge, the PEC maintains staggered
membership terms. As of fall 2022, eight members will complete a term
and up to eight new members will be selected. The purpose of this
notice is to announce that the application process for up to eight new
members of the PEC is now open, and to invite and encourage
applications by the submission deadline for appropriately qualified
individuals.
II. Criteria for Membership
The PEC includes up to 16 diverse representatives of the patient
community. Eight members from the previous application process will
remain on the PEC. The current application process is to select up to
eight new PEC members. Selected members will include the following: (1)
patients who have personal disease experience; (2) caregivers who
support patients, such as a parent, child, partner, other family
member, or friend, and who have personal disease experience through
this caregiver role; and/or (3) representatives of patient groups who,
through their role in the patient group, have direct or indirect
disease experience. Please note that for purposes of this activity, the
term ``caregiver'' is not intended to include individuals who are
engaged in caregiving as healthcare professionals; and the term
``patient group'' is used herein to encompass patient advocacy
organizations, disease advocacy organizations, voluntary health
agencies, nonprofit research foundations, and public health
organizations. The ultimate goal of the application and selection
process is to identify individuals who can represent a collective
patient voice for their patient community.
Selection criteria include the applicant's potential to
meaningfully contribute to the activities of the PEC, ability to
represent and express the patient voice for their constituency, ability
to work in a constructive manner with involved stakeholders, and
understanding of the clinical research enterprise. Consideration will
also be given to ensuring the PEC includes diverse perspectives and
experiences, including but not limited to sociodemographic factors
(such as age, gender, ethnicity, education level, income) and disease
experience. PEC members are required to be residents of the United
States and must be 18 years of age or older.
Financial and other conflicts of interest will not necessarily make
applicants ineligible for membership in the PEC. However, applicants
cannot be direct employees of the medical product development industry
or a currently registered lobbyist for an FDA-regulated industry.
III. Responsibilities and Expectations
Participation as a PEC member is voluntary. Working meetings of the
PEC will typically be held two to four times per year, either in person
(in the Washington, DC area) or virtually (teleconference or webinar).
Given the ongoing COVID-19 pandemic, meetings will be conducted
virtually and may resume in-person when it is safe to do so. Additional
meetings may be organized as needed, and currently include monthly, 1-
hour teleconferences.
Reasonable accommodations will be made for members with special
needs for travel or for participation in a meeting. Applications for
PEC membership are encouraged from individuals of all ages, sexes,
genders, sexual orientations, racial and ethnic groups, education
levels, income levels, and those with and without disabilities. Travel
support will be provided as applicable.
To help ensure continuity in its activities and organizational
knowledge, the PEC will maintain staggered membership terms for patient
community representatives. Membership terms for new members will be 2-
year appointments. Members may serve up to two terms, with the
possibility of extensions.
Additional responsibilities and expectations are set forth in the
PEC Framework, which should be reviewed prior to submitting an
application, and is available at https://ctti-clinicaltrials.org/wp-content/uploads/2021/07/patient_engagement_collaborative_framework_-_revised_25jan2021.pdf.
IV. Application Process
Any interested person may apply for membership on the PEC. To
apply, go to https://duke.qualtrics.com/jfe/form/SV_5nI1VVWVOaD59ky.
The application is completed online and includes questions to help
determine eligibility for the PEC, demographic and other background
questions, and four brief
[[Page 57205]]
essay questions. Many of the demographic questions are optional. The
brief essay questions, to be answered in 500 characters or fewer
(including spaces), are as follows:
Please explain why you would have an outstanding ability
to represent and express the patient voice for the disease area(s) you
selected above.
Please give a few examples of experiences that demonstrate
your outstanding ability to work across or interact with stakeholders
in the medical product development and regulatory processes.
Please explain how you have established an understanding
of the medical product development and regulatory processes.
Please tell us why you are interested in becoming a member
of the PEC and how you would be able to contribute.
Completing the application also involves submitting: (1) A current
one-page r[eacute]sum[eacute] or bio that summarizes your patient
advocacy experience and related activities (PDF format required) and
(2) A one-page letter of endorsement from a patient group with which
the applicant has worked closely on activities that are relevant to the
PEC (PDF format required). Please note, only the application and the
two documents specified above will be reviewed. Your completed
application form, r[eacute]sum[eacute] or bio, and letter of
endorsement should all be submitted at the same time.
The r[eacute]sum[eacute] or bio must provide examples and
descriptions of relevant activities and experiences related to the
applicant's qualifications for PEC membership. The letter of
endorsement should emphasize information relevant to the criteria for
membership described above. This letter must be from and written by
someone other than yourself. The letter may address topics such as the
applicant's involvement in patient advocacy activities, experiences
that stimulated an interest in participating in discussions about
patient engagement in medical product development and regulatory
decision processes, and other information that may be helpful in
evaluating the applicant's qualifications as a potential member of the
PEC.
Applications will be accepted until 11:59 p.m. eastern time on
October 19, 2022 or until 75 applications are received, whichever
happens first. Only complete applications will be considered.
The application review period will take a minimum of 2 months after
11:59 p.m. eastern time on October 19, 2022.
Additional information may be needed from some applicants during
the review period, including information relevant to understanding
potential sources of conflict of interest, in which case applicants
will be contacted directly. All applicants (both those selected for PEC
membership and those who are not selected) will be notified of the
final application decision no later than the end of the 2022 calendar
year.
Dated: September 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20221 Filed 9-16-22; 8:45 am]
BILLING CODE 4164-01-P
