Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal, 61003-61004 [2020-21465]
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61003
Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices
Topic
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Protection of Human Subjects: Informed Consent; Institutional Review Boards ........
Unique Device Identification System ...........................................................................
Quality System Regulation ...........................................................................................
Dated: September 24, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–21453 Filed 9–28–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1787]
Advisory Committee; Blood Products
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 Blood Products 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
Blood Products Advisory Committee for
an additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the May 13, 2022,
expiration date.
DATES: Authority for the Blood Products
Advisory Committee will expire on May
13, 2022, unless the Commissioner
formally determines that renewal is in
the public interest.
FOR FURTHER INFORMATION CONTACT:
Christina Vert, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10993
New Hampshire Ave., Bldg. 71, Rm.
6268, Silver Spring, MD 20993–0002,
240–402–8054 Christina.Vert@
fda.hhs.gov.
SUMMARY:
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
Blood Products Advisory Committee
(the Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Blood
Products Advisory Committee advises
the Commissioner or designee in
SUPPLEMENTARY INFORMATION:
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No.
21 CFR part; guidance; or FDA form
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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 shall consist of a core
of 17 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of clinical
and administrative medicine,
hematology, immunology, blood
banking, surgery, internal medicine,
biochemistry, engineering, biological
and physical sciences, biotechnology,
computer technology, statistics,
epidemiology, sociology/ethics, and
other related professions. 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 member who is
identified with industry interests.
The Commissioner or designee shall
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
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a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, a non-voting representative of
consumer interests and a non-voting
representative of industry interests will
be included in addition to the voting
members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/
BloodProductsAdvisoryCommittee/
ucm121602.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 visit us at https://www.fda.gov/
advisory-committees.
Dated: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–21454 Filed 9–28–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3091]
Advisory Committee; Cardiovascular
and Renal Drugs Advisory Committee;
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Cardiovascular and Renal
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 Cardiovascular and
Renal Drugs Advisory Committee for an
additional 2 years beyond the charter
SUMMARY:
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61004
Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices
expiration date. The new charter will be
in effect until August 27, 2022.
DATES: Authority for the Cardiovascular
and Renal Drugs Advisory Committee
will expire on August 27, 2022, unless
the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Joyce Yu, Division of Advisory
Committee and Consultant
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2438,
Silver Spring, MD 20993–0002, 301–
796–9001, email: CRDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 41
CFR 102–3, FDA is announcing the
renewal of the Cardiovascular and Renal
Drugs Advisory Committee (Committee).
The Committee is a discretionary
Federal advisory committee established
to provide advice to 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
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of cardiovascular
and renal disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
Under its Charter, the Committee
shall consist of a core of 11 voting
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of cardiology, hypertension, arrhythmia,
angina, congestive heart failure,
diuresis, and biostatistics. 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. 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 consumeroriented 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. There
may also be alternate industry
representative.
Further information regarding the
most recent charter and other
information can be found at https://
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www.fda.gov/advisory-committees/
cardiovascular-and-renal-drugsadvisory-committee/cardiovascularand-renal-drugs-advisory-committeecharter 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: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of Tuesday,
July 21, 2020 (85 FR 44096), appearing
on page 44096 in FR Doc. 2020–15727,
the following correction is made:
On page 44096, in the table, the
entries for ANDAs 076203 and 077456
are removed.
Dated: September 21, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–21456 Filed 9–28–20; 8:45 am]
BILLING CODE 4164–01–P
[FR Doc. 2020–21465 Filed 9–28–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1227]
Roerig Division of Pfizer Inc., et al.;
Withdrawal of Approval of 10
Abbreviated New Drug Applications;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
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[Docket No. FDA–2013–D–1445]
Blood Glucose Monitoring Test
Systems for Prescription Point-of-Care
Use; Guidance for Industry and Food
and Drug Administration Staff;
Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Blood Glucose
Monitoring Test Systems for
Prescription Point-of-Care Use.’’ This
guidance describes studies and
information that FDA recommends be
used when submitting premarket
notifications (510(k)s) for blood glucose
monitoring systems (BGMSs) that are for
prescription point-of-care use.
DATES: The announcement of the
guidance is published in the Federal
Register on September 29, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on July 21, 2020. The
document announced the withdrawal of
approval of 10 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of August 20,
2020. The document indicated that FDA
was withdrawing approval of the
following two ANDAs after receiving a
withdrawal request from Kadmon
Pharmaceuticals, LLC., 119
Commonwealth Dr., Warrendale, PA
15086: ANDA 076203, Ribavirin
Capsules, 200 milligrams (mg) and
ANDA 077456, Ribavirin Tablets, 200
mg, 400 mg, and 600 mg. Before FDA
withdrew the approval of these ANDAs,
Kadmon Pharmaceuticals, LLC.
informed FDA that it did not want the
approval of the ANDAs withdrawn.
Because Kadmon Pharmaceuticals,
LLC., timely requested that approval of
these ANDAs not be withdrawn, the
approval of ANDAs 076203 and 077456
are still in effect.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
SUMMARY:
Food and Drug Administration
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
E:\FR\FM\29SEN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61003-61004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21465]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3091]
Advisory Committee; Cardiovascular and Renal Drugs Advisory
Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Cardiovascular and Renal 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
Cardiovascular and Renal Drugs Advisory Committee for an additional 2
years beyond the charter
[[Page 61004]]
expiration date. The new charter will be in effect until August 27,
2022.
DATES: Authority for the Cardiovascular and Renal Drugs Advisory
Committee will expire on August 27, 2022, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Joyce Yu, Division of Advisory
Committee and Consultant Management, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2438, Silver Spring, MD 20993-0002, 301-796-9001, email:
[email protected].
SUPPLEMENTARY INFORMATION: Under 41 CFR 102-3, FDA is announcing the
renewal of the Cardiovascular and Renal Drugs Advisory Committee
(Committee). The Committee is a discretionary Federal advisory
committee established to provide advice to 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 available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of cardiovascular and renal disorders
and makes appropriate recommendations to the Commissioner of Food and
Drugs.
Under its Charter, the Committee shall consist of a core of 11
voting members including the Chair. Members and the Chair are selected
by the Commissioner or designee from among authorities knowledgeable in
the fields of cardiology, hypertension, arrhythmia, angina, congestive
heart failure, diuresis, and biostatistics. 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.
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 member who is identified with industry interests. There
may also be alternate industry representative.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/cardiovascular-and-renal-drugs-advisory-committee/cardiovascular-and-renal-drugs-advisory-committee-charter 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: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21465 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P
