[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45223-45225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14920]


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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 are incorporated into general medical 
product development and regulatory processes.

DATES: Applications can be submitted starting at 11:59 p.m. Eastern 
Time on July 14, 2023. This announcement is open to receive a maximum 
of 75 applications. Applications will be accepted until 11:59 p.m. 
Eastern Time on August 14, 2023 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_6L8l7z4YfyCHFVY. 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, 
[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 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. 
112-144), 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

[[Page 45224]]

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 2023, 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 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, 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 
two 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, 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, 2024.
    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/2023/05/PEC-Framework_Revised-Apr-10-2023_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_6L8l7z4YfyCHFVY. 
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 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 (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 
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 14, 2023 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 14, 2023.
    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 December 31, 2023.


[[Page 45225]]


    Dated: July 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14920 Filed 7-13-23; 8:45 am]
BILLING CODE 4164-01-P