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

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

Labeling of articles intended for lay use in the repairing and/or refitting of dentures— 

801.405(b)(1).

35 1 35 4 .................................. 140 

Dentures; information regarding temporary and 

emergency use—801.405(c).

35 1 35 4 .................................. 140 

Labeling requirements for hearing aids— 

801.420(c)(1).

124 12 1,488 40 ................................ 59,520 

Technical data for hearing aids—801.420(c)(4) .... 124 12 1,488 80 ................................ 119,040 

Hearing aids, opportunity to review User Instructional Brochure—801.421(b).10,000 160 1,600,000 .30 (20 minutes) .......... 480,000 

Hearing aids, availability of User Instructional Brochure—801.421(c).10,000 5 50,000 .17 ...............................

(10 minutes) ................

8,500 

User labeling for menstrual tampons—801.430(d) 16 8 128 2 .................................. 256 

Menstrual tampons, ranges of absorbency— 

801.430(e)(2).

16 8 128 2 .................................. 256 

User labeling for latex condoms—801.435(b), (c), 

and (h).

51 6 306 100 .............................. 30,600 

Labeling for IVDs—809.10(a) and (b) .................... 1,700 6 10,200 80 ................................ 816,000 

Labeling for general purpose laboratory reagents—809.10(d)(1).300 2 600 40 ................................ 24,000 

Labeling for ASRs—809.10(e) ............................... 300 25 7,500 1 .................................. 7,500 

Labeling for OTC test sample collection systems 

for drugs of abuse testing—809.10(f).

20 1 20 100 .............................. 2,000 

Advertising and promotional materials for ASRs— 

809.30(d).

300 25 7,500 1 .................................. 7,500 

Labeling of sunlamp products—1040.20(d) ........... 19 1 19 10 ................................ 190 

Total ................................................................ ........................ ........................ ........................ ..................................... 9,024,946 

1There 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. 

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 

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: 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 

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 


sradovich on DSK3GMQ082PROD with NOTICES
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. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: 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, 

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 

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. 

SUMMARY: 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. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 


sradovich on DSK3GMQ082PROD with NOTICES