Notice2023-13330
Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal
Primary source
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Published
June 23, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 the May 18, 2025, expiration date.
Full Text
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<title>Federal Register, Volume 88 Issue 120 (Friday, June 23, 2023)</title>
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[Federal Register Volume 88, Number 120 (Friday, June 23, 2023)]
[Notices]
[Pages 41108-41109]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13330]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1727]
Advisory Committee; Medical Imaging Drugs 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
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 the
May 18, 2025, expiration date.
DATES: Authority for the Medical Imaging Drugs Advisory Committee will
expire on May 18, 2025, unless the Commissioner formally determines
that renewal is in the public interest.
[[Page 41109]]
FOR FURTHER INFORMATION CONTACT: Yvette Waples, 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, <a href="/cdn-cgi/l/email-protection#d09d9994919390b6b4b1feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="733e3a373230331517125d1b1b005d141c05">[email protected]</span></a>.
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 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 of Food and
Drugs.
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 4 years. Non-Federal members of this committee will
serve as Special Government Employees, representatives, 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. In addition to the voting members, the Committee may include
one non-voting representative member who is identified with industry
interests. There may also be an alternate industry representative.
Further information regarding the most recent charter and other
information can be found at <a href="https://www.fda.gov/advisory-committees/medical-imaging-drugs-advisory-committee/medical-imaging-drugs-advisory-committee-charter">https://www.fda.gov/advisory-committees/medical-imaging-drugs-advisory-committee/medical-imaging-drugs-advisory-committee-charter</a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: June 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13330 Filed 6-22-23; 8:45 am]
BILLING CODE 4164-01-P
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