Document ID: FDA-2019-N-1422-0001
Agency: fda
Document Type: Notice
Title: Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal
Posted Date: 2019-05-06T04:00Z

[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: MIDAC@fda.hhs.gov.

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]
 BILLING CODE 4164-01-P