Notice2024-15008
Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative
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Published
July 9, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 FDA's Patient Affairs Staff, 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 FDA staff are able to discuss an array of topics related to 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, caregiver, and patient advocate perspectives can inform medical product development and regulatory discussions.
Full Text
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<title>Federal Register, Volume 89 Issue 131 (Tuesday, July 9, 2024)</title>
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[Federal Register Volume 89, Number 131 (Tuesday, July 9, 2024)]
[Notices]
[Pages 56393-56395]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15008]
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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.
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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 FDA's Patient
Affairs Staff, 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 FDA staff are able to discuss an array of topics
related to 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, caregiver,
and patient advocate perspectives can inform medical product
development and regulatory discussions.
DATES: Applications can be submitted starting at 11:59 p.m. Eastern
Time on July 9, 2024. This announcement is open to receive a maximum of
75 applications. Applications will be accepted until 11:59 p.m. Eastern
Time on August 8, 2024 or until 75 applications are received, whichever
happens first.
ADDRESSES: All applications should be submitted to FDA's Patient
Affairs Staff in OCPP. The preferred application method is via the
online submission system provided by CTTI, available at <a href="https://duke.qualtrics.com/jfe/form/SV_3DllHjcaGryUIlg">https://duke.qualtrics.com/jfe/form/SV_3DllHjcaGryUIlg</a>. For those applicants
unable to submit an application electronically, please call FDA's
Patient Affairs Staff at 301-796-8460 to arrange for mail or delivery
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, Patient Affairs
Staff, Food and Drug Administration, 301-796-8460,
<a href="/cdn-cgi/l/email-protection#c898a9bca1ada6bc8da6afa9afada5ada6bc8ba7a4a4a9aaa7baa9bca1bead88aeaca9e6a0a0bbe6afa7be"><span class="__cf_email__" data-cfemail="d080b1a4b9b5bea495beb7b1b7b5bdb5bea493bfbcbcb1b2bfa2b1a4b9a6b590b6b4b1feb8b8a3feb7bfa6">[email protected]</span></a>.
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 FDA Staff discuss an array of topics related to
increasing patient engagement
[[Page 56394]]
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. During the fall of 2024, 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 experience with a disease or medical
condition; (2) caregivers who help support a patient--parent, child,
partner, other family member, or friend--as they manage their disease
or medical condition; 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 patient voices 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 patient voices for their constituency, ability to
work in a constructive manner with interested parties/groups (such as
patients, caregivers, advocates, academic institutions, government
agencies, medical product development companies), 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, and education level) 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. Meetings will be held
up to four times per year and will be conducted virtually with the
potential for in-person events (in the Washington, DC area).
Reasonable accommodations will be made for members with special
needs for participation in a meeting or for any necessary travel.
Applications for PEC membership are encouraged from individuals of all
ages, sexes, genders, sexual orientations, racial and ethnic groups,
education levels, income levels, geographic locations, 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, beginning January 1, 2025.
Additional responsibilities and expectations are set forth in the
PEC Framework, which should be reviewed prior to submitting an
application, and is available at <a href="https://ctti-clinicaltrials.org/wp-content/uploads/2023/05/PEC-Framework_Revised-Apr-10-2023_FINAL.pdf">https://ctti-clinicaltrials.org/wp-content/uploads/2023/05/PEC-Framework_Revised-Apr-10-2023_FINAL.pdf</a>.
IV. Application Process
Any interested person may apply for membership on the PEC. To
apply, go to <a href="https://duke.qualtrics.com/jfe/form/SV_3DllHjcaGryUIlg">https://duke.qualtrics.com/jfe/form/SV_3DllHjcaGryUIlg</a>.
The application is completed online and includes questions to help
determine eligibility for the PEC, demographic and other background
questions, and four brief essay questions. The brief essay questions,
to be answered in 500 characters or fewer (including spaces), are as
follows:
<bullet> Please explain why and how you would be able to represent
and express the patient voice for the disease area(s) you selected
above.
<bullet> Please give a few examples of experiences that demonstrate
how you use active listening and two-way communication to work across
interested parties/groups (such as patients, caregivers, advocates,
academic institutions, government agencies, medical product development
companies).
<bullet> Please provide a few examples of any experience you have
with medical product development or understanding regulatory processes.
<bullet> Please tell us why you are interested in becoming a member
of the PEC and how you would enrich our group discussions.
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 (or other
similar 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
[[Page 56395]]
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
August 8, 2024 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 August 8, 2024.
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 by email of
the final application decision no later than December 31, 2024.
Dated: July 3, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15008 Filed 7-8-24; 8:45 am]
BILLING CODE 4164-01-P
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