Notice2021-15643
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 23, 2021
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 of 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, 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 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 patients and patient advocates are partners in non-product specific aspects of the medical product development and FDA review process.
Full Text
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<title>Federal Register, Volume 86 Issue 139 (Friday, July 23, 2021)</title>
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[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39044-39046]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15643]
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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, Health and Human Services (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 of 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, 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 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 patients and patient advocates are partners in
non-product specific
[[Page 39045]]
aspects of the medical product development and FDA review process.
DATES: Applications submitted by 11:59 p.m. Eastern time on August 23,
2021, will be considered for membership in the PEC. Incomplete
applications and applications completed after the above-specified
deadline will not be reviewed.
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 <a href="https://duke.qualtrics.com/jfe/form/SV_eLDSvmVIXdsAdVP">https://duke.qualtrics.com/jfe/form/SV_eLDSvmVIXdsAdVP</a>. 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 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,
<a href="/cdn-cgi/l/email-protection#0a5a6b7e636f647e4f646d6b6d6f676f647e496566666b6865786b7e637c6f4a6c6e6b24626279246d657c"><span class="__cf_email__" data-cfemail="d282b3a6bbb7bca697bcb5b3b5b7bfb7bca691bdbebeb3b0bda0b3a6bba4b792b4b6b3fcbabaa1fcb5bda4">[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 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 September 2021, 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, (3) representatives from 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 his or her 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 and
disease experience diversity. 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
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 racial, ethnic,
cultural groups, sexual orientations, gender identities, 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
[[Page 39046]]
prior to submitting an application, available at <a href="https://www.ctti-clinicaltrials.org/framework-cttifda-patient-engagement-collaborative">https://www.ctti-clinicaltrials.org/framework-cttifda-patient-engagement-collaborative</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_eLDSvmVIXdsAdVP">https://duke.qualtrics.com/jfe/form/SV_eLDSvmVIXdsAdVP</a>.
The application process is completed online and includes answering
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, which
must be answered in 500 characters or fewer (including spaces), are as
follows:
<bullet> Please explain why you would have an outstanding ability
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
your outstanding ability to work across stakeholders in the medical
product development process.
<bullet> Please explain how you have developed a strong
understanding of the medical product development process.
<bullet> 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 form also requires submitting: (1) A
current, complete curriculum vitae or r[eacute]sum[eacute] that shows
relevant activities and experience (PDF format preferred) and (2) a
letter of endorsement (maximum 800 words) from a patient group with
which the applicant has worked closely on activities that are relevant
to the PEC (PDF format preferred). The letter of endorsement should
emphasize information relevant to the criteria for membership described
above. 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 making, and other
information that may be helpful in evaluating the applicant's
qualifications as a potential member of the PEC. Only complete
applications submitted by the deadline (see DATES) will be reviewed.
Additional information may be needed from applicants, including
information relevant to understanding potential sources of conflict of
interest, in which case applicants will be contacted directly.
Dated: July 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15643 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P
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