4164-01-P
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 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 [INSERT DATE
OF PUBLICATION IN THE FEDERAL REGISTER]. This announcement is open to receive a
maximum of 75 applications. Applications will be accepted until 11:59 p.m. Eastern Time on
[INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]
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 https://duke.qualtrics.com/jfe/form/SV_3DllHjcaGryUIlg. For those applicants
unable to submit an application electronically, please call FDA’s Patient Affairs Staff at 301796-8460 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, 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 FDA
Staff discuss an array of topics related to 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. 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,
D.C. 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 https://ctticlinicaltrials.org/wp-content/uploads/2023/05/PEC-Framework_Revised-Apr-102023_FINAL.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_3DllHjcaGryUIlg. 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:
•

Please explain why and how you would be able to represent and express the patient voice
for the disease area(s) you selected above.

•

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).

•

Please provide a few examples of any experience you have with medical product
development or understanding regulatory processes.

•

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 résumé 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, résumé or bio, and letter of endorsement should
all be submitted at the same time.
The résumé 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 [INSERT DATE 30
DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER] 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 [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER].
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: 7/8/2024 8:45 am; Publication Date: 7/9/2024]