Advisory Committee; Patient Engagement Advisory Committee; Renewal

CourtFood And Drug Administration
Citation86 FR 68261
Publication Date01 December 2021
Record Number2021-26118
Federal Register, Volume 86 Issue 228 (Wednesday, December 1, 2021)
[Federal Register Volume 86, Number 228 (Wednesday, December 1, 2021)]
                [Notices]
                [Pages 68261-68262]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-26118]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                [Docket No. FDA-2019-N-2809]
                Advisory Committee; Patient Engagement Advisory Committee;
                Renewal
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Notice; renewal of Federal advisory committee.
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                SUMMARY: The Food and Drug Administration (FDA) is announcing the
                [[Page 68262]]
                renewal of the Patient Engagement Advisory Committee by the
                Commissioner of Food and Drugs (the Commissioner). The Commissioner has
                determined that it is in the public interest to renew the Patient
                Engagement Advisory Committee for an additional 2 years beyond the
                charter expiration date. The new charter will be in effect until the
                October 6, 2023, expiration date.
                DATES: Authority for the Patient Engagement Advisory Committee would
                have expired on October 6, 2021, unless the Commissioner had formally
                determined that renewal is in the public interest.
                FOR FURTHER INFORMATION CONTACT: Letise Williams, Office of the Center
                Director, Center for Devices and Radiological Health, Food and Drug
                Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5407, Silver
                Spring, MD 20993-0002, 301-796-8398, [email protected].
                SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
                the Department of Health and Human Services and by the General Services
                Administration, FDA is announcing the renewal of the Patient Engagement
                Advisory Committee (the Committee). The Committee is a discretionary
                Federal advisory committee established to provide advice to the
                Commissioner. The Committee advises the Commissioner or designee in
                discharging responsibilities as they relate to helping to ensure safe
                and effective devices for human use and, as required, any other product
                for which the Food and Drug Administration has regulatory
                responsibility.
                 The Committee provides advice to the Commissioner on complex
                scientific issues relating to medical devices, the regulation of
                devices, and their use by patients. Agency guidance and policies,
                clinical trial or registry design, patient preference study design,
                benefit-risk determinations, device labeling, unmet clinical needs,
                available alternatives, patient reported outcomes, device-related
                quality of life measures, or health status issues are among the topics
                that may be considered by the Committee. The Committee provides
                relevant skills and perspectives to improve communication of benefits,
                risks, and clinical outcomes, and increase integration of patient
                perspectives into the regulatory process for medical devices. It
                performs its duties by identifying new approaches, promoting
                innovation, recognizing unforeseen risks or barriers, and identifying
                unintended consequences that could result from FDA policy.
                 Pursuant to its Charter the Committee shall consist of a core of
                nine voting members, including the Chair. Members and the Chair are
                selected by the Commissioner or designee from among authorities who are
                knowledgeable in areas such as clinical research, patient experience,
                healthcare needs of patient groups in the United States, or are
                experienced in the work of patient and health professional
                organizations, methodologies for patient-reported outcomes and
                eliciting patient preferences, and strategies for communicating
                benefits, risks and clinical outcomes to patients and research
                subjects, as well as other relevant areas. Members will be invited to
                serve for overlapping terms of up to 4 years. Non-Federal members of
                this committee will serve as Special Government Employees,
                representative or Ex-Officio members. Federal members will serve as
                Regular Government Employees or Ex-Officios. The core of voting members
                may include one technically qualified member, selected by the
                Commissioner or designee, who is identified with consumer interests and
                is recommended by either a consortium of consumer-oriented
                organizations or other interested persons. The Commissioner or designee
                shall also have the authority to select from a group of individuals
                nominated by industry to serve temporarily as non-voting members who
                are identified with industry interests. The number of temporary members
                selected for a particular meeting will depend on the meeting topic.
                 The Commissioner or designee shall also have the authority to
                select members of other scientific and technical FDA advisory
                committees (normally not to exceed 10 members) to serve temporarily as
                voting members and to designate consultants to serve temporarily as
                voting members when: (1) Expertise is required that is not available
                among current voting standing members of the Committee (when additional
                voting members are added to the Committee to provide needed expertise,
                a quorum will be based on the combined total of regular and added
                members), or (2) to comprise a quorum when, because of unforeseen
                circumstances, a quorum is or will be lacking. Because of the size of
                the Committee and the variety in the types of issues that it will
                consider, FDA may, in connection with a particular committee meeting,
                specify a quorum that is less than a majority of the current voting
                members. The Agency's regulations (21 CFR 14.22(d)) authorize a
                committee charter to specify quorum requirements.
                 Further information regarding the most recent charter and other
                information can be found at https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee
                or by contacting the Designated Federal Officer (see FOR FURTHER
                INFORMATION CONTACT). In light of the fact that no change has been made
                to the committee name or description of duties, no amendment will be
                made to 21 CFR 14.100.
                 This notice is issued under the Federal Advisory Committee Act (5
                U.S.C. app.). For general information related to FDA advisory
                committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
                 Dated: November 23, 2021.
                Lauren K. Roth,
                Associate Commissioner for Policy.
                [FR Doc. 2021-26118 Filed 11-30-21; 8:45 am]
                BILLING CODE 4164-01-P
                

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