82 FR 60749 - Request for Nominations of Members for the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 245 (December 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 245 (December 22, 2017)
| Page Range | 60749-60750 | |
| FR Document | 2017-27538 |
[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)] [Notices] [Pages 60749-60750] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27538] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices 60749
regulations. This guidance is not subject transparency, and communication; at FDA. The PEC will be a joint
to Executive Order 12866. providing considerations for endeavor between the CTTI and FDA.
implementing new strategies to enhance The activities of the PEC may inform
II. Paperwork Reduction Act of 1995
patient engagement at FDA; and relevant FDA and CTTI activities. The
This draft guidance refers to proposing new models of collaboration PEC is not intended to advise or
previously approved collections of in which patients and patient advocates otherwise direct the activities of either
information found in FDA regulations. are partners in certain aspects of the organization, and membership will not
These collections of information are medical product development and FDA constitute employment by either
subject to review by the Office of review process. organization.
Management and Budget (OMB) under DATES: Nominations received by 11:59 The Food and Drug Administration
the Paperwork Reduction Act of 1995 p.m. Eastern Time on or before January Safety and Innovation Act (Pub. L. 112–
(44 U.S.C. 3501–3520). The collections 29, 2018, will be given first 144), section 1137, entitled ‘‘Patient
of information in 21 CFR 601.12 and consideration for membership on the Participation in Medical Product
Form FDA 356h have been approved PEC. Nominations received after the Discussions,’’ added section 569C to the
under OMB control number 0910–0338. submission deadline will be retained for Federal Food, Drug, and Cosmetic Act
III. Electronic Access future consideration. (21 U.S.C. 360bbb–8c). This provision
ADDRESSES: All nominations should be directs the Secretary of Health and
Persons with access to the internet Human Services to develop and
may obtain the draft guidance at either submitted to the FDA’s Patient Affairs
Staff in the OMPT. Email nominations implement strategies to solicit the views
https://www.fda.gov/BiologicsBlood of patients during the medical product
Vaccines/GuidanceCompliance are preferred and should be submitted
to PatientEngagementCollaborative@ development process and consider the
RegulatoryInformation/Guidances/ perspectives of patients during
default.htm or https:// fda.hhs.gov. Though not required, it is
appreciated if all nomination materials regulatory discussions. On November 4,
www.regulations.gov. 2014, FDA issued a Federal Register
are compiled into a single PDF file and
Dated: December 18, 2017. attached to the submission email. notice establishing a docket (FDA–
Leslie Kux, Nominations may also be submitted by 2014–N–1698) for public commenters to
Associate Commissioner for Policy. mail or delivery service to Patient submit information related to FDA’s
[FR Doc. 2017–27569 Filed 12–21–17; 8:45 am] Affairs Staff, Office of Medical Products implementation of this provision (79 FR
and Tobacco, Office of the 65410). Upon review of the comments
BILLING CODE 4164–01–P
Commissioner, Food and Drug received, one common theme, among
Administration, 10903 New Hampshire others, included establishing an external
DEPARTMENT OF HEALTH AND Ave., Bldg. 1, Rm. 1316, Silver Spring, group to provide input on patient
HUMAN SERVICES MD 20993. Only complete applications, engagement strategies across FDA’s
as described in section ‘‘IV. Nomination Centers.
Food and Drug Administration Process’’ of this document, will be Recent legislation in both section
considered. 3001 of the 21st Century Cures Act and
[Docket No. FDA–2017–N–6395] section 605 of the Food and Drug
FOR FURTHER INFORMATION CONTACT: Administration Reauthorization Act of
Request for Nominations of Members Andrea Furia-Helms, Office of Medical 2017 supports tools for fostering patient
for the Clinical Trials Transformation Products and Tobacco, Office of the participation in the regulatory process.
Initiative/Food and Drug Commissioner, Food and Drug The purpose of this notice is to
Administration Patient Engagement Administration, 10903 New Hampshire announce that the nomination process
Collaborative Ave., Bldg. 1, Rm. 1316, Silver Spring, for the PEC is now open, and to invite
AGENCY: Food and Drug Administration, MD 20993, 301–796–8455, and encourage nominations by the
HHS. PatientEngagementCollaborative@ submission deadline for appropriately
ACTION: Notice. fda.hhs.gov. qualified individuals. Self-nominations
SUPPLEMENTARY INFORMATION: are accepted.
SUMMARY: The Food and Drug
Administration (FDA or Agency), in I. Background and Purpose II. Criteria for Membership
collaboration with the Clinical Trials The CTTI is a public-private The PEC will include up to 16 diverse
Transformation Initiative (CTTI), is partnership co-founded by FDA and representatives of the patient
requesting nominations of patient Duke University whose mission is to community. Selected members will
advocates interested in participating on develop and drive adoption of practices include the following: (1) Patients who
the Patient Engagement Collaborative that will increase the quality and have personal disease experience; (2)
(PEC). The PEC will be an ongoing, efficiency of clinical trials. FDA and caregivers who support patients, such as
collaborative forum coordinated through CTTI have long involved patients and a parent, child, partner, other family
the Patient Affairs Staff, Office of considered patient perspectives in their member, or friend, and who have
Medical Products and Tobacco (OMPT), work. Furthering the engagement of personal disease experience through
Office of the Commissioner, and will be patients as valued partners across the this caregiver role; and (3)
hosted by CTTI. Through the PEC, the medical product research and representatives from patient groups
patient community and regulators will development continuum requires an who, through their role in the patient
be able to discuss an array of topics group, have direct or indirect disease
sradovich on DSK3GMQ082PROD with NOTICES
open forum for patients and regulators
regarding increasing meaningful patient to discuss and exchange ideas. experience. Please note that for
engagement in medical product The PEC will be an ongoing, purposes of this activity, the term
development and regulatory discussions collaborative forum in which the patient ‘‘caregiver’’ is not intended to include
at FDA. The activities of the PEC may community and regulators will discuss individuals who are engaged in
include, but are not limited to, an array of topics regarding increasing caregiving as health care professionals;
providing diverse perspectives on topics patient engagement in medical product and the term ‘‘patient group’’ is used
such as systematic patient engagement, development and regulatory discussions herein to encompass patient advocacy
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![60750 Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices
organizations, disease advocacy of the Patient Engagement Collaborative DEPARTMENT OF HEALTH AND
organizations, voluntary health Framework is available at https:// HUMAN SERVICES
agencies, nonprofit research www.ctti-clinicaltrials.org/framework-
foundations, and public health cttifda-patient-engagement- Food and Drug Administration
organizations. The ultimate goal of the collaborative. [Docket No. FDA–1995–D–0288 (Formerly
nomination and selection process is to Docket No. 95D–0052)]
identify individuals who can represent IV. Nomination Process
a collective patient voice for their Chemistry, Manufacturing, and
Any interested person may nominate
patient community. Controls Changes to an Approved
Selection criteria include the one or more qualified individuals for
membership on the PEC. Self- Application: Certain Biological
nominee’s potential to meaningfully Products; Draft Guidance for Industry;
contribute to the activities of the PEC, nominations are also accepted.
Availability
ability to represent and express the Nominations should include the
patient voice for his or her constituency, following: (1) A personal statement AGENCY: Food and Drug Administration,
ability to work in a constructive manner (maximum 800 words) from the HHS.
with involved stakeholders, and nominee explaining his or her interest ACTION: Notice of availability.
understanding of the clinical research in becoming a member of the PEC; (2)
enterprise. Consideration will also be a current, complete curriculum vitae or SUMMARY: The Food and Drug
given to ensuring the PEC includes resume that shows relevant activities Administration (FDA or Agency) is
diverse perspectives and experiences, announcing the availability of a draft
and experience; and (3) an optional
including but not limited to, document entitled ‘‘Chemistry,
letter of endorsement (maximum 800
sociodemographic and disease Manufacturing, and Controls Changes to
words) from a patient group with which an Approved Application: Certain
experience diversity. It is anticipated
that approximately half of the PEC the nominee has worked closely on Biological Products; Draft Guidance for
membership will be selected from activities relevant to the PEC. Industry.’’ The draft guidance is
eligible CTTI member organizations and The personal statement and optional intended to assist applicants and
individuals, and half will be selected letter of endorsement (if provided) manufacturers of certain licensed
from other nominees. Members are should emphasize information relevant biological products in determining
required to be citizens and residents of to the criteria for membership described which reporting category is appropriate
the United States. above. The letter may address topics for a change in chemistry,
Financial and other conflicts of such as the nominee’s involvement in manufacturing, and controls (CMC)
interest will not necessarily make patient advocacy activities, experiences information to an approved biologics
nominees ineligible for membership in that stimulated an interest in license application (BLA). The draft
the PEC. However, nominees cannot be participating in discussions about guidance provides applicants and
direct employees of the medical product manufacturers general and
patient engagement in medical product
development industry. administrative information on reporting
development and regulatory decision-
III. Responsibilities and Expectations making, and other information that may and evaluating changes and
be helpful in evaluating the nominee’s recommendations for reporting
Meetings of the PEC will typically be categories based on a tiered-reporting
held four times per year, either in- qualifications as a potential member of
system for specific changes. The draft
person (in the Washington, DC area) or the PEC.
guidance, when finalized, is intended to
by webinar, and additional meetings Nominations must provide the supersede the document entitled
may be organized as needed. nominee’s contact information (phone ‘‘Guidance for Industry: Changes to an
Accommodations will be made for and email preferred), as well as state Approved Application: Biological
members with special needs for travel or that the nominee is aware of the Products’’ dated July 1997 (July 1997
for participation in a meeting (e.g., nomination (unless self-nominated) and guidance).
accommodations for physical mobility is willing to serve as a member of the
impairments, dietary restrictions, etc.). DATES: Submit either electronic or
PEC. written comments on the draft guidance
Nominations for PEC membership are
encouraged for individuals of all racial, Additional information may be by March 22, 2018 to ensure that the
ethnic, sexual orientation, and cultural needed from nominees, including Agency considers your comment on this
groups with and without disabilities. information relevant to understanding draft guidance before it begins work on
Travel support will be provided. potential sources of conflict of interest, the final version of the guidance.
To help ensure continuity in its in which case nominees will be ADDRESSES: You may submit comments
activities and organizational knowledge, contacted directly. on any guidance at any time as follows:
the PEC will maintain staggered Dated: December 15, 2017. Electronic Submissions
membership terms for patient
Leslie Kux, Submit electronic comments in the
community representatives.
Membership terms are anticipated as 1- Associate Commissioner for Policy. following way:
to 2-year appointments, and will be [FR Doc. 2017–27538 Filed 12–20–17; 8:45 am] • Federal eRulemaking Portal:
determined during the process of BILLING CODE 4164–01–P https://www.regulations.gov. Follow the
instructions for submitting comments.
sradovich on DSK3GMQ082PROD with NOTICES
selecting members. Members may serve
up to two terms, with the possibility of Comments submitted electronically,
extensions. including attachments, to https://
Additional responsibilities and www.regulations.gov will be posted to
expectations are set forth in the Patient the docket unchanged. Because your
Engagement Collaborative Framework, comment will be made public, you are
which should be reviewed prior to solely responsible for ensuring that your
submitting a nomination. The full text comment does not include any
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Document Created: 2017-12-22 00:33:59
Document Modified: 2017-12-22 00:33:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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] | |
| FR Citation | 82 FR 60749 |
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