Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal, 30953 [2021-12174]
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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0463]
Advisory Committee; Medical Imaging
Drugs Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
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, 2023,
expiration date.
DATES: Authority for the Medical
Imaging Drugs Advisory Committee will
expire on May 18, 2023, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Joyce Yu, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–837–7126,
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 of Food and Drugs.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:15 Jun 09, 2021
Jkt 253001
The Committee shall consist 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. 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 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 https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
medical-imaging-drugs-advisorycommittee 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: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12174 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2217]
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by July 12,
2021.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0117. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
New Animal Drugs for Investigational
Use—21 CFR Part 511
OMB Control Number 0910–0117—
Extension
FDA has the authority under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) to approve new animal
drugs. A new animal drug application
(NADA) cannot be approved until,
among other things, the new animal
drug has been demonstrated to be safe
and effective for its intended use(s). To
properly test a new animal drug for an
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Animal Drugs
for Investigational Use
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Page 30953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12174]
[[Page 30953]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0463]
Advisory Committee; Medical Imaging Drugs Advisory Committee;
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
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, 2023, expiration date.
DATES: Authority for the Medical Imaging Drugs Advisory Committee will
expire on May 18, 2023, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Joyce Yu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-837-7126,
[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 of Food and
Drugs.
The Committee shall consist 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. 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 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 https://www.fda.gov/advisory-committees/human-drug-advisory-committees/medical-imaging-drugs-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: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12174 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P
