Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal, 44887-44888 [2018-19067]
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Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
44887
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Activity/21 CFR section
Labeling of articles intended for lay use in the repairing
and/or
refitting
of
dentures—
801.405(b)(1).
Dentures; information regarding temporary and
emergency use—801.405(c).
Labeling requirements for hearing aids—
801.420(c)(1).
Technical data for hearing aids—801.420(c)(4) ....
Hearing aids, opportunity to review User Instructional Brochure—801.421(b).
Hearing aids, availability of User Instructional Brochure—801.421(c).
User labeling for menstrual tampons—801.430(d)
Menstrual tampons, ranges of absorbency—
801.430(e)(2).
User labeling for latex condoms—801.435(b), (c),
and (h).
Labeling for IVDs—809.10(a) and (b) ....................
Labeling for general purpose laboratory reagents—809.10(d)(1).
Labeling for ASRs—809.10(e) ...............................
Labeling for OTC test sample collection systems
for drugs of abuse testing—809.10(f).
Advertising and promotional materials for ASRs—
809.30(d).
Labeling of sunlamp products—1040.20(d) ...........
Total ................................................................
1 There
Dated: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19086 Filed 8–31–18; 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
Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
35
1
35
4 ..................................
140
35
1
35
4 ..................................
140
124
12
1,488
40 ................................
59,520
124
10,000
12
160
1,488
1,600,000
80 ................................
.30 (20 minutes) ..........
119,040
480,000
10,000
5
50,000
8,500
16
16
8
8
128
128
.17 ...............................
(10 minutes) ................
2 ..................................
2 ..................................
51
6
306
100 ..............................
30,600
1,700
300
6
2
10,200
600
80 ................................
40 ................................
816,000
24,000
300
20
25
1
7,500
20
1 ..................................
100 ..............................
7,500
2,000
300
25
7,500
1 ..................................
7,500
19
1
19
10 ................................
190
........................
........................
........................
.....................................
9,024,946
256
256
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of recordkeepers/
respondents and records/disclosures has
been adjusted to reflect updated Agency
data. These adjustments result in an
increase of 1,598,48 hours since the last
OMB approval.
AGENCY:
Number of
disclosures
per
respondent
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
SUMMARY:
VerDate Sep<11>2014
17:54 Aug 31, 2018
Jkt 244001
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
expiration date. The new charter will be
in effect until August 27, 2020.
DATES: Authority for the Cardiovascular
and Renal Drugs Advisory Committee
will expire on August 27, 2020, 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, email: CRDAC@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
Cardiovascular and Renal Drugs
Advisory Committee. The committee is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Cardiovascular and Renal Drugs
Advisory Committee advises the
Commissioner or designee in
discharging responsibilities as they
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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.
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. 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
E:\FR\FM\04SEN1.SGM
04SEN1
44888
Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
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/
CardiovascularandRenalDrugsAdvisory
Committee/ucm094743.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: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19067 Filed 8–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3123]
Advisory Committee; Endocrinologic
and Metabolic 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 Endocrinologic and
Metabolic 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 Endocrinologic
and Metabolic Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until
August 27, 2020.
DATES: Authority for the Endocrinologic
and Metabolic Drugs Advisory
Committee will expire on August 27,
2020, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
LaToya Bonner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:54 Aug 31, 2018
Jkt 244001
Silver Spring, MD 20993–0002, 301–
796–9001, email: EMDAC@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
Endocrinologic and Metabolic 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
the Food and Drug Administration has
regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of endocrine and
metabolic disorders, and makes
appropriate recommendations to the
Commissioner.
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
endocrinology, metabolism,
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 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/
EndocrinologicandMetabolicDrugs
AdvisoryCommittee/ucm100261.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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19066 Filed 8–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3037]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for Quantitative Testing for the
Development of FDA Communications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the creation of a
new collection of information entitled
‘‘Generic Clearance for Quantitative
Testing for the Development of FDA
Communications.’’
DATES: Submit either electronic or
written comments on the collection of
information by November 5, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 5,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 5, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
E:\FR\FM\04SEN1.SGM
04SEN1
]]>Agencies
[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44887-44888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19067]
-----------------------------------------------------------------------
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 expiration date. The new charter will be in
effect until August 27, 2020.
DATES: Authority for the Cardiovascular and Renal Drugs Advisory
Committee will expire on August 27, 2020, 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, 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 Cardiovascular and Renal Drugs Advisory Committee. The
committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner.
The Cardiovascular and Renal Drugs Advisory 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 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.
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. 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
[[Page 44888]]
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/
CardiovascularandRenalDrugsAdvisoryCommittee/ucm094743.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: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19067 Filed 8-31-18; 8:45 am]
BILLING CODE 4164-01-P
