28856 Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Compounding outsourcing facility Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Submission of adverse event reports including copy of labeling and other information as described in the guidance .................................................................................. 55 1 55 1.1 61 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of recordkeeping Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Records of adverse events, including records of efforts to 

obtain the data elements for each adverse event report 55 1 55 16 880 

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

This is the first extension of the 

information collection and we have 

retained the currently approved burden 

estimate. Based on our review of Agency 

data, we estimate that annually 55 

outsourcing facilities (‘‘Number of 

Respondents’’ and ‘‘Total Annual 

Responses’’ in table 1) will submit 

adverse event reports to FDA as 

specified in the guidance and that 

preparing and submitting this 

information will take approximately 1.1 

hours per registrant (‘‘Average Burden 

per Response’’ in table 1). Likewise, we 

estimate that annually 55 outsourcing 

facilities (‘‘Number of Recordkeepers’’ 

in table 2) will maintain records of 

adverse events as specified in the 

guidance and that preparing and 

maintaining the records will take 

approximately 16 hours per registrant 

(‘‘Average Burden per Recordkeeping’’ 

in table 2). 

Dated: June 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13294 Filed 6–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2194] 

Novartis Pharmaceuticals Corporation, 

et al.; Withdrawal of Approval of Five 

New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of five new drug 

applications (NDAs) from multiple 

applicants. The holders of the 

applications notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of July 

23, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6248, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in the 

table have informed FDA that these drug 

products are no longer marketed and 

have requested that FDA withdraw 

approval of the applications under the 

process in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

NDA 020831 ...... Foradil Aerolizer (formoterol fumarate) Powder, 0.012 milligram (mg)/inhalation.Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 07936. 

NDA 022504 ...... Axiron (testosterone) Transdermal Metered Solution, 30 mg/ 

1.5 milliliter (mL) actuation.

Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 

46285. 

NDA 050585 ...... Rocephin (ceftriaxone sodium) for Injection, equivalent to 

(EQ) 10 gram (g) base/vial, EQ 250 mg base/vial (IV/IM), 

EQ 500 mg base/vial (IV/IM), EQ 1 g base/vial (IV/IM), EQ 

2 g base/vial (IV/IM), EQ 500 mg base/vial, N/A; N/A, 1% 

(Rocephin kit), EQ 1 g base/vial, N/A; N/A, 1% (Rocephin 

kit).

Hoffmann-La Roche, Inc., c/o Genentech, Inc., 1 DNA Way, 

South San Francisco, CA 94080. 

NDA 050624 ...... Rocephin (ceftriaxone sodium) with Dextrose in Plastic Container Injection, EQ 10 mg base/mL, EQ 20 mg base/mL, 

and EQ 40 mg base/mL.

Do. 

NDA 202763 ...... Testosterone Gel, 25 mg/2.5 g packet, 50 mg/5 g packet ...... ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN 

56623. 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 28857 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of July 23, 2018. 

Introduction or delivery for introduction 

into interstate commerce of products 

without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in the table 

that are in inventory on July 23, 2018 

may continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: June 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13293 Filed 6–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID: FEMA–2018–0009; OMB No. 

1660—NEW] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request; Transcript 

Request Form 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice and request for 

comments. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) will 

submit the information collection 

abstracted below to the Office of 

Management and Budget for review and 

clearance in accordance with the 

requirements of the Paperwork 

Reduction Act of 1995. The submission 

will describe the nature of the 

information collection, the categories of 

respondents, the estimated burden (i.e., 

the time, effort and resources used by 

respondents to respond) and cost, and 

the actual data collection instruments 

FEMA will use. 

DATES: Comments must be submitted on 

or before July 23, 2018. 

ADDRESSES: Submit written comments 

on the proposed information collection 

to the Office of Information and 

Regulatory Affairs, Office of 

Management and Budget. Comments 

should be addressed to the Desk Officer 

for the Department of Homeland 

Security, Federal Emergency 

Management Agency, and sent via 

electronic mail to dhsdeskofficer@

omb.eop.gov. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information or 

copies of the information collection 

should be made to Director, Information 

Management Division, 500 C Street SW, 

Washington, DC 20472, email address 

FEMA-Information-CollectionsManagement@fema.dhs.gov or Clarence 

(Smiley) White, Chief, Operations and 

Support Branch, United States Fire 

Administration, 301–447–1055 or by 

email at Smiley.White@fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection 

previously published in the Federal 

Register on February 22, 2018 at 83 FR 

7752 with a 60 day public comment 

period. FEMA received two anonymous 

public comments that were not relevant 

to the information collection. The 

purpose of this notice is to notify the 

public that FEMA will submit the 

information collection abstracted below 

to the Office of Management and Budget 

for review and clearance. 

Collection of Information 

Title: Transcript Request Form. 

Type of Information Collection: New 

information collection. 

OMB Number: 1660—NEW. 

Form Titles and Numbers: FEMA 

Form 064–0–0–12, Transcript Request 

Form. 

Abstract: FEMA provides training to 

advance the professional development 

of personnel engaged in fire prevention 

and control and emergency management 

activities through its Center for 

Domestic Preparedness (CDP), 

Emergency Management Institute (EMI), 

National Fire Academy (NFA), National 

Training and Education Division, 

National Domestic Preparedness 

Consortium, and Rural Domestic 

Preparedness Consortium. FEMA 

collects information from students who 

have completed courses at the National 

Fire Academy (NFA) and the Emergency 

Management Institute (EMI) for the 

purpose of fulfilling the student’s 

request to provide a copy of their 

transcript for their personal records 

and/or for transmittal to an institution 

of higher education that delivers 

training and education also in support 

of the FEMA mission. 

Affected Public: Individuals or 

households; Business or other for-profit; 

Not-for-profit institutions; State, Local 

or Tribal Government. 

Estimated Number of Respondents: 

4,500. 

Estimated Number of Responses: 

4,500. 

Estimated Total Annual Burden 

Hours: 225 hours. 

Estimated Total Annual Respondent 

Cost: $7,978.50. 

Estimated Respondents’ Operation 

and Maintenance Costs: $0. 

Estimated Respondents’ Capital and 

Start-Up Costs: $0. 

Estimated Total Annual Cost to the 

Federal Government: $28,899.24. 

Comments 

Comments may be submitted as 

indicated in the ADDRESSES caption 

above. Comments are solicited to (a) 

evaluate whether the proposed data 

collection is necessary for the proper 

performance of the agency, including 

whether the information shall have 

practical utility; (b) evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) minimize the burden 

of the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Rachel Frier, 

Records Management Branch Chief, Office 

of the Chief Administrative Officer, Mission 

Support, Federal Emergency Management 

Agency, Department of Homeland Security. 

[FR Doc. 2018–13291 Filed 6–20–18; 8:45 am] 

BILLING CODE 9111–45–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID: FEMA–2018–0024; OMB No. 

1660–0140] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Integrated Public 

Alert and Warning Systems (IPAWS) 

Memorandum of Agreement 

Applications 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice and request for 

comments. 

SUMMARY: The Federal Emergency 

Management Agency, as part of its 

continuing effort to reduce paperwork 

and respondent burden, invites the 

general public to take this opportunity 

to comment on an extension, without 

change, of a currently approved 


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