Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26481 

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.40(a) and (c) ................................................................... 5,832 1 5,832 80 466,560 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The Estimated Annual Reporting 

Burden for Human Foods is no longer a 

part of this information collection. The 

burden has now been incorporated into 

OMB control number 0910–0541. 

Our estimated burden for the 

information collection reflects an 

overall increase of 453,834 hours 

(currently approved 231,224) and a 

corresponding increase of 7,108 annual 

responses (currently approved 15,527). 

The new estimated totals are 685,058 

hours and 22,635 annual responses. We 

attribute this adjustment to an increase 

in the number of EA submissions we 

received since the last extension. 

Dated: June 1, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12221 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1860] 

Advisory Committee; PulmonaryAllergy 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 Pulmonary-Allergy 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 Pulmonary-Allergy 

Drugs Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until May 30, 2020. 

DATES: Authority for the PulmonaryAllergy Drugs Advisory Committee will 

expire on May 30, 2020, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Chee, 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: 

PADAC@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 

Pulmonary-Allergy 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 

available data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of pulmonary 

disease and diseases with allergic and/ 

or immunologic mechanisms and makes 

appropriate recommendations to the 

Commissioner of Food and Drugs. 

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 

pulmonary medicine, allergy, clinical 

immunology, and epidemiology or 

statistics. 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/ 

Pulmonary-AllergyDrugsAdvisory

Committee/ucm107567.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: June 1, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12219 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0478] 

Sebela Ireland, Ltd. et al.; Withdrawal 

of Approval of 24 Abbreviated New 

Drug Applications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on February 23, 2018. The 

notice announced the voluntary 

withdrawal of approval of 24 

abbreviated new drug applications 

(ANDAs) from multiple applicants, 

effective March 26, 2018. The notice 

indicated that FDA was withdrawing 

approval of the following ANDA after 

receiving a withdrawal request from 

Sun Pharmaceutical Industries, Ltd., c/ 

o Sun Pharmaceutical Industries, Inc. 

(Sun Pharmaceutical), 2 Independence 

Way, Princeton, NJ 08540: ANDA 

077483, Benazepril Hydrochloride and 

Hydrochlorothiazide Tablets, 5 

milligrams (mg)/6.25 mg, 10 mg/12.5 

mg, 20 mg/12.5 mg, and 20 mg/25 mg. 

Before withdrawal of this ANDA 

became effective, however, Sun 


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