Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal

• Published date: 06 May 2019
• Citation: 84 FR 19791
• Record Number: 2019-09217
• Section: Notices
• Court: Food And Drug Administration

Federal Register, Volume 84 Issue 87 (Monday, May 6, 2019)

[Federal Register Volume 84, Number 87 (Monday, May 6, 2019)]
                [Notices]
                [Page 19791]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-09217]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                [Docket No. FDA-2019-N-1422]
                Advisory Committee; Medical Imaging Drugs Advisory Committee;
                Renewal
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Notice; renewal of advisory committee.
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                SUMMARY: The Food and Drug Administration (FDA) is announcing the
                renewal of the Medical Imaging Drugs 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 Medical
                Imaging Drugs Advisory Committee for an additional 2 years beyond the
                charter expiration date. The new charter will be in effect until May
                18, 2021.
                DATES: Authority for the Medical Imaging Drugs Advisory Committee will
                expire on May 18, 2019, unless the Commissioner formally determines
                that renewal is in the public interest.
                FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug
                Evaluation and Research, Food and Drug Administration, 10903 New
                Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
                796-9001, and email: [email protected].
                SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
                the Department of Health and Human Services pursuant to 45 CFR part 11
                and by the General Services Administration, FDA is announcing the
                renewal of the Medical Imaging Drugs 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
                drugs for human use and, as required, any other product for which FDA
                has regulatory responsibility.
                 The Committee reviews and evaluates data concerning the safety and
                effectiveness of marketed and investigational human drug products for
                use in diagnostic and therapeutic procedures using radioactive
                pharmaceuticals and contrast media used in diagnostic radiology and
                makes appropriate recommendations to the Commissioner.
                 The Committee shall consist of a core of 12 voting members
                including the Chair. Members and the Chair are selected by the
                Commissioner or designee from among authorities knowledgeable in the
                fields of nuclear medicine, radiology, epidemiology or statistics, and
                related specialties. Members will be invited to serve for overlapping
                terms of up to four years. Almost all non-Federal members of this
                committee serve as Special Government Employees. 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. In addition to the voting
                members, the Committee may include one non-voting member who is
                identified with industry interests.
                 Further information regarding the most recent charter and other
                information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/MedicalImagingDrugsAdvisoryCommittee/ucm273284.htm 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 document is issued under the Federal Advisory Committee Act (5
                U.S.C. app.). For general information related to FDA advisory
                committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.
                 Dated: May 1, 2019.
                Lowell J. Schiller,
                Principal Associate Commissioner for Policy.
                [FR Doc. 2019-09217 Filed 5-3-19; 8:45 am]
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