83 FR 44887 - Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 171 (September 4, 2018)

Page Range		44887-44888
FR Document		2018-19067

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.

Federal Register, Volume 83 Issue 171 (Tuesday, September 4, 2018)

[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44887-44888]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 44887

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Total Average
Number of disclosures Total
Activity/21 CFR section annual burden per
respondents per hours
disclosures disclosure
respondent

Labeling of articles intended for lay use in the re- 35 1 35 4 .................................. 140
pairing and/or refitting of dentures—
801.405(b)(1).
Dentures; information regarding temporary and 35 1 35 4 .................................. 140
emergency use—801.405(c).
Labeling requirements for hearing aids— 124 12 1,488 40 ................................ 59,520
801.420(c)(1).
Technical data for hearing aids—801.420(c)(4) .... 124 12 1,488 80 ................................ 119,040
Hearing aids, opportunity to review User Instruc- 10,000 160 1,600,000 .30 (20 minutes) .......... 480,000
tional Brochure—801.421(b).
Hearing aids, availability of User Instructional Bro- 10,000 5 50,000 .17 ............................... 8,500
chure—801.421(c). (10 minutes) ................
User labeling for menstrual tampons—801.430(d) 16 8 128 2 .................................. 256
Menstrual tampons, ranges of absorbency— 16 8 128 2 .................................. 256
801.430(e)(2).
User labeling for latex condoms—801.435(b), (c), 51 6 306 100 .............................. 30,600
and (h).
Labeling for IVDs—809.10(a) and (b) .................... 1,700 6 10,200 80 ................................ 816,000
Labeling for general purpose laboratory re- 300 2 600 40 ................................ 24,000
agents—809.10(d)(1).
Labeling for ASRs—809.10(e) ............................... 300 25 7,500 1 .................................. 7,500
Labeling for OTC test sample collection systems 20 1 20 100 .............................. 2,000
for drugs of abuse testing—809.10(f).
Advertising and promotional materials for ASRs— 300 25 7,500 1 .................................. 7,500
809.30(d).
Labeling of sunlamp products—1040.20(d) ........... 19 1 19 10 ................................ 190

Total ................................................................ ........................ ........................ ........................ ..................................... 9,024,946
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The number of recordkeepers/ determined that it is in the public relate to helping to ensure safe and
respondents and records/disclosures has interest to renew the Cardiovascular and effective drugs for human use and, as
been adjusted to reflect updated Agency Renal Drugs Advisory Committee for an required, any other product for which
data. These adjustments result in an additional 2 years beyond the charter FDA has regulatory responsibility.
increase of 1,598,48 hours since the last expiration date. The new charter will be The committee reviews and evaluates
OMB approval. in effect until August 27, 2020. available data concerning the safety and
Dated: August 28, 2018. DATES: Authority for the Cardiovascular effectiveness of marketed and
and Renal Drugs Advisory Committee investigational human drug products for
Leslie Kux,
will expire on August 27, 2020, unless use in the treatment of cardiovascular
Associate Commissioner for Policy.
the Commissioner formally determines and renal disorders and makes
[FR Doc. 2018–19086 Filed 8–31–18; 8:45 am] appropriate recommendations to the
BILLING CODE 4164–01–P
that renewal is in the public interest.
Commissioner.
FOR FURTHER INFORMATION CONTACT: The committee shall consist of a core
Jennifer Shepherd, Center for Drug of 11 voting members including the
DEPARTMENT OF HEALTH AND Evaluation and Research, Food and Chair. Members and the Chair are
HUMAN SERVICES Drug Administration, 10903 New selected by the Commissioner or
Hampshire Ave., Bldg. 31, Rm. 2417, designee from among authorities
Food and Drug Administration Silver Spring, MD 20993–0002, 301– knowledgeable in the fields of
[Docket No. FDA–2018–N–3091] 796–9001, email: CRDAC@fda.hhs.gov. cardiology, hypertension, arrhythmia,
SUPPLEMENTARY INFORMATION: Pursuant angina, congestive heart failure,
Advisory Committee; Cardiovascular to 41 CFR 102–3.65 and approval by the diuresis, and biostatistics. Members will
and Renal Drugs Advisory Committee; Department of Health and Human be invited to serve for overlapping terms
Renewal Services pursuant to 45 CFR part 11 and of up to 4 years. Almost all non-Federal
AGENCY: Food and Drug Administration, by the General Services Administration, members of this committee serve as
HHS. FDA is announcing the renewal of the Special Government Employees. The
ACTION:Notice; renewal of advisory Cardiovascular and Renal Drugs core of voting members may include one
Advisory Committee. The committee is technically qualified member, selected
sradovich on DSK3GMQ082PROD with NOTICES

committee.
a discretionary Federal advisory by the Commissioner or designee, who
SUMMARY: The Food and Drug committee established to provide advice is identified with consumer interests
Administration (FDA) is announcing the to the Commissioner. and is recommended by either a
renewal of the Cardiovascular and Renal The Cardiovascular and Renal Drugs consortium of consumer-oriented
Drugs Advisory Committee by the Advisory Committee advises the organizations or other interested
Commissioner of Food and Drugs (the Commissioner or designee in persons. In addition to the voting
Commissioner). The Commissioner has discharging responsibilities as they members, the committee may include

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44888 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices

one non-voting member who is Silver Spring, MD 20993–0002, 301– U.S.C. app.). For general information
identified with industry interests. 796–9001, email: EMDAC@fda.hhs.gov. related to FDA advisory committees,
Further information regarding the SUPPLEMENTARY INFORMATION: Pursuant please check https://www.fda.gov/
most recent charter and other to 41 CFR 102–3.65 and approval by the AdvisoryCommittees/default.htm.
information can be found at https:// Department of Health and Human Dated: August 28, 2018.
www.fda.gov/AdvisoryCommittees/ Services pursuant to 45 CFR part 11 and Leslie Kux,
CommitteesMeetingMaterials/;Drugs/ by the General Services Administration, Associate Commissioner for Policy.
CardiovascularandRenalDrugsAdvisory FDA is announcing the renewal of the
Committee/ucm094743.htm or by [FR Doc. 2018–19066 Filed 8–31–18; 8:45 am]
Endocrinologic and Metabolic Drugs
contacting the Designated Federal BILLING CODE 4164–01–P
Advisory Committee (the Committee).
Officer (see FOR FURTHER INFORMATION The Committee is a discretionary
CONTACT). In light of the fact that no Federal advisory committee established
change has been made to the committee DEPARTMENT OF HEALTH AND
to provide advice to the Commissioner.
name or description of duties, no The Committee advises the HUMAN SERVICES
amendment will be made to 21 CFR Commissioner or designee in Food and Drug Administration
14.100. discharging responsibilities as they
This document is issued under the relate to helping to ensure safe and [Docket No. FDA–2018–N–3037]
Federal Advisory Committee Act (5 effective drugs for human use and, as
U.S.C. app.). For general information required, any other product for which Agency Information Collection
related to FDA advisory committees, the Food and Drug Administration has Activities; Proposed Collection;
please check https://www.fda.gov/ regulatory responsibility. Comment Request; Generic Clearance
AdvisoryCommittees/default.htm. The Committee reviews and evaluates for Quantitative Testing for the
data concerning the safety and Development of FDA Communications
Dated: August 28, 2018.
effectiveness of marketed and AGENCY: Food and Drug Administration,
Leslie Kux,
investigational human drug products for HHS.
Associate Commissioner for Policy. use in the treatment of endocrine and
[FR Doc. 2018–19067 Filed 8–31–18; 8:45 am] ACTION: Notice.
metabolic disorders, and makes
BILLING CODE 4164–01–P appropriate recommendations to the SUMMARY: The Food and Drug
Commissioner. Administration (FDA or Agency) is
The Committee shall consist of a core announcing an opportunity for public
DEPARTMENT OF HEALTH AND of 11 voting members including the comment on the proposed collection of
HUMAN SERVICES Chair. Members and the Chair are certain information by the Agency.
selected by the Commissioner or Under the Paperwork Reduction Act of
Food and Drug Administration designee from among authorities 1995 (PRA), Federal Agencies are
[Docket No. FDA–2018–N–3123] knowledgeable in the fields of required to publish notice in the
endocrinology, metabolism, Federal Register concerning each
Advisory Committee; Endocrinologic epidemiology or statistics, and related proposed collection of information and
and Metabolic Drugs Advisory specialties. Members will be invited to to allow 60 days for public comment in
Committee, Renewal serve for overlapping terms of up to 4 response to the notice. This notice
years. Almost all non-Federal members solicits comments on the creation of a
AGENCY: Food and Drug Administration,
of this committee serve as Special new collection of information entitled
HHS.
Government Employees. The core of ‘‘Generic Clearance for Quantitative
ACTION:Notice; renewal of advisory voting members may include one
committee. Testing for the Development of FDA
technically qualified member, selected Communications.’’
SUMMARY: The Food and Drug by the Commissioner or designee, who
is identified with consumer interests DATES: Submit either electronic or
Administration (FDA) is announcing the written comments on the collection of
renewal of the Endocrinologic and and is recommended by either a
consortium of consumer-oriented information by November 5, 2018.
Metabolic Drugs Advisory Committee by
organizations or other interested ADDRESSES: You may submit comments
the Commissioner of Food and Drugs
persons. In addition to the voting as follows. Please note that late,
(the Commissioner). The Commissioner
members, the Committee may include untimely filed comments will not be
has determined that it is in the public
one non-voting member who is considered. Electronic comments must
interest to renew the Endocrinologic
identified with industry interests. be submitted on or before November 5,
and Metabolic Drugs Advisory Further information regarding the 2018. The https://www.regulations.gov
Committee for an additional 2 years most recent charter and other electronic filing system will accept
beyond the charter expiration date. The information can be found at https:// comments until midnight Eastern Time
new charter will be in effect until www.fda.gov/AdvisoryCommittees/ at the end of November 5, 2018.
August 27, 2020. CommitteesMeetingMaterials/Drugs/ Comments received by mail/hand
DATES: Authority for the Endocrinologic EndocrinologicandMetabolicDrugs delivery/courier (for written/paper
and Metabolic Drugs Advisory AdvisoryCommittee/ucm100261.htm or submissions) will be considered timely
Committee will expire on August 27, by contacting the Designated Federal if they are postmarked or the delivery
2020, unless the Commissioner formally
sradovich on DSK3GMQ082PROD with NOTICES

Officer (see FOR FURTHER INFORMATION service acceptance receipt is on or
determines that renewal is in the public CONTACT). In light of the fact that no before that date.
interest. change has been made to the committee
FOR FURTHER INFORMATION CONTACT: name or description of duties, no Electronic Submissions
LaToya Bonner, Center for Drug amendment will be made to 21 CFR Submit electronic comments in the
Evaluation and Research, Food and 14.100. following way:
Drug Administration, 10903 New This document is issued under the • Federal eRulemaking Portal:
Hampshire Ave., Bldg. 31, Rm. 2417, Federal Advisory Committee Act (5 https://www.regulations.gov. Follow the

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Document Created: 2018-09-01 02:59:55
Document Modified: 2018-09-01 02:59:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; renewal of advisory committee.
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.
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]
FR Citation		83 FR 44887

83 FR 44887 - Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 171 (September 4, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration