[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)]
[Notices]
[Pages 60749-60750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27538]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6395]


Request for Nominations of Members for the Clinical Trials 
Transformation Initiative/Food and Drug Administration Patient 
Engagement Collaborative

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency), in 
collaboration with the Clinical Trials Transformation Initiative 
(CTTI), is requesting nominations of patient advocates interested in 
participating on the Patient Engagement Collaborative (PEC). The PEC 
will be an ongoing, collaborative forum coordinated through the Patient 
Affairs Staff, Office of Medical Products and Tobacco (OMPT), Office of 
the Commissioner, and will be hosted by CTTI. Through the PEC, the 
patient community and regulators will be 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 certain aspects of the medical product 
development and FDA review process.

DATES: Nominations received by 11:59 p.m. Eastern Time on or before 
January 29, 2018, will be given first consideration for membership on 
the PEC. Nominations received after the submission deadline will be 
retained for future consideration.

ADDRESSES: All nominations should be submitted to the FDA's Patient 
Affairs Staff in the OMPT. Email nominations are preferred and should 
be submitted to [email protected]. Though not 
required, it is appreciated if all nomination materials are compiled 
into a single PDF file and attached to the submission email. 
Nominations may also be submitted by mail or delivery service to 
Patient Affairs Staff, Office of Medical Products and Tobacco, Office 
of the Commissioner, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 1316, Silver Spring, MD 20993. Only complete 
applications, as described in section ``IV. Nomination Process'' of 
this document, will be considered.

FOR FURTHER INFORMATION CONTACT: Andrea Furia-Helms, Office of Medical 
Products and Tobacco, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1316, Silver 
Spring, MD 20993, 301-796-8455, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background and Purpose

    The CTTI is a public-private partnership co-founded 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 will be an ongoing, collaborative forum in which the 
patient community and regulators will discuss an array of topics 
regarding increasing patient engagement in medical product development 
and regulatory discussions at FDA. The PEC will be a joint endeavor 
between the CTTI and FDA. 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 (79 FR 65410). 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.
    Recent legislation in both section 3001 of the 21st Century Cures 
Act and section 605 of the Food and Drug Administration Reauthorization 
Act of 2017 supports tools for fostering patient participation in the 
regulatory process.
    The purpose of this notice is to announce that the nomination 
process for the PEC is now open, and to invite and encourage 
nominations by the submission deadline for appropriately qualified 
individuals. Self-nominations are accepted.

II. Criteria for Membership

    The PEC will include up to 16 diverse representatives of the 
patient community. 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 health care professionals; and the term 
``patient group'' is used herein to encompass patient advocacy

[[Page 60750]]

organizations, disease advocacy organizations, voluntary health 
agencies, nonprofit research foundations, and public health 
organizations. The ultimate goal of the nomination and selection 
process is to identify individuals who can represent a collective 
patient voice for their patient community.
    Selection criteria include the nominee'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. It is anticipated that approximately half of the PEC 
membership will be selected from eligible CTTI member organizations and 
individuals, and half will be selected from other nominees. Members are 
required to be citizens and residents of the United States.
    Financial and other conflicts of interest will not necessarily make 
nominees ineligible for membership in the PEC. However, nominees cannot 
be direct employees of the medical product development industry.

III. Responsibilities and Expectations

    Meetings of the PEC will typically be held four times per year, 
either in-person (in the Washington, DC area) or by webinar, and 
additional meetings may be organized as needed. Accommodations will be 
made for members with special needs for travel or for participation in 
a meeting (e.g., accommodations for physical mobility impairments, 
dietary restrictions, etc.). Nominations for PEC membership are 
encouraged for individuals of all racial, ethnic, sexual orientation, 
and cultural groups with and without disabilities. Travel support will 
be provided.
    To help ensure continuity in its activities and organizational 
knowledge, the PEC will maintain staggered membership terms for patient 
community representatives. Membership terms are anticipated as 1- to 2-
year appointments, and will be determined during the process of 
selecting members. Members may serve up to two terms, with the 
possibility of extensions.
    Additional responsibilities and expectations are set forth in the 
Patient Engagement Collaborative Framework, which should be reviewed 
prior to submitting a nomination. The full text of the Patient 
Engagement Collaborative Framework is available at https://www.ctti-clinicaltrials.org/framework-cttifda-patient-engagement-collaborative.

IV. Nomination Process

    Any interested person may nominate one or more qualified 
individuals for membership on the PEC. Self-nominations are also 
accepted.
    Nominations should include the following: (1) A personal statement 
(maximum 800 words) from the nominee explaining his or her interest in 
becoming a member of the PEC; (2) a current, complete curriculum vitae 
or resume that shows relevant activities and experience; and (3) an 
optional letter of endorsement (maximum 800 words) from a patient group 
with which the nominee has worked closely on activities relevant to the 
PEC.
    The personal statement and optional letter of endorsement (if 
provided) should emphasize information relevant to the criteria for 
membership described above. The letter may address topics such as the 
nominee'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 
nominee's qualifications as a potential member of the PEC.
    Nominations must provide the nominee's contact information (phone 
and email preferred), as well as state that the nominee is aware of the 
nomination (unless self-nominated) and is willing to serve as a member 
of the PEC.
    Additional information may be needed from nominees, including 
information relevant to understanding potential sources of conflict of 
interest, in which case nominees will be contacted directly.

    Dated: December 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27538 Filed 12-20-17; 8:45 am]
 BILLING CODE 4164-01-P