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 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 [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 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 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, 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 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://ctticlinicaltrials.org/wp-content/uploads/2021/07/patient_engagement_collaborative_frameworkrevised_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 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:
ï‚·

Please explain why you would have an outstanding ability to represent and express the
patient voice for the disease area(s) you selected above.

ï‚·

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.

ï‚·

Please explain how you have established an understanding of the medical product
development and regulatory processes.

ï‚·

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 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 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 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: 9/16/2022 8:45 am; Publication Date: 9/19/2022]