Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 51283 

P–2044), under 21 CFR 10.30, 

requesting that the Agency determine 

whether REVEX (nalmefene 

hydrochloride injection), 0.1 mg base/ 

mL and 1.0 mg base/mL, was withdrawn 

from sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

(and comments submitted to the docket) 

and reviewing Agency records, and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that REVEX (nalmefene 

hydrochloride injection), 0.1 mg base/ 

mL and 1.0 mg base/mL, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that REVEX (nalmefene 

hydrochloride injection), 0.1 mg base/ 

mL and 1.0 mg base/mL, was withdrawn 

for reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

REVEX (nalmefene hydrochloride 

injection), 0.1 mg base/mL and 1.0 mg 

base/mL, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list REVEX (nalmefene 

hydrochloride injection), 0.1 mg base/ 

mL and 1.0 mg base/mL, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to this drug product may be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: October 19, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23952 Filed 11–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2017–0109; Control 

Number: 1625–0030] 

Collection of Information Under 

Review by Office of Management and 

Budget; OMB 

AGENCY: Coast Guard, DHS. 

ACTION: Thirty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995 the 

U.S. Coast Guard is forwarding an 

Information Collection Request (ICR), 

abstracted below, to the Office of 

Management and Budget (OMB), Office 

of Information and Regulatory Affairs 

(OIRA), requesting approval for 

reinstatement, without change, of the 

following collection of information: 

1625–0030, Oil and Hazardous 

Materials Transfer Procedures. Our ICR 

describes the information we seek to 

collect from the public. Review and 

comments by OIRA ensure we only 

impose paperwork burdens 

commensurate with our performance of 

duties. 

DATES: Comments must reach the Coast 

Guard and OIRA on or before December 

4, 2017. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number [USCG–2017–0109] to the Coast 

Guard using the Federal eRulemaking 

Portal at http://www.regulations.gov. 

Alternatively, you may submit 

comments to OIRA using one of the 

following means: 

(1) Email: dhsdeskofficer@

omb.eop.gov. 

(2) Mail: OIRA, 725 17th Street NW., 

Washington, DC 20503, attention Desk 

Officer for the Coast Guard. 

A copy of the ICR is available through 

the docket on the Internet at http://

www.regulations.gov. Additionally, 

copies are available from: Commandant 

(CG–612), Attn: Paperwork Reduction 

Act Manager, U.S. Coast Guard, 2703 

Martin Luther King Jr. Ave. SE., Stop 

7710, Washington, DC 20593–7710. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Anthony Smith, Office of Information 

Management, telephone 202–475–3532, 

or fax 202–372–8405, for questions on 

these documents. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

This Notice relies on the authority of 

the Paperwork Reduction Act of 1995; 

44 U.S.C. 35, as amended. An ICR is an 

application to OIRA seeking the 

approval, extension, or renewal of a 

Coast Guard collection of information 

(Collection). The ICR contains 

information describing the Collection’s 

purpose, the Collection’s likely burden 

on the affected public, an explanation of 

the necessity of the Collection, and 

other important information describing 

the Collection. There is one ICR for each 

Collection. The Coast Guard invites 

comments on whether this ICR should 

be granted based on the Collection being 

necessary for the proper performance of 

Departmental functions. In particular, 

the Coast Guard would appreciate 

comments addressing: (1) The practical 

utility of the Collection; (2) the accuracy 

of the estimated burden of the 

Collection; (3) ways to enhance the 

quality, utility, and clarity of 

information subject to the Collection; 

and (4) ways to minimize the burden of 

the Collection on respondents, 

including the use of automated 

collection techniques or other forms of 

information technology. These 

comments will help OIRA determine 

whether to approve the ICR referred to 

in this Notice. 

We encourage you to respond to this 

request by submitting comments and 

related materials. Comments to Coast 

Guard or OIRA must contain the OMB 

Control Number of the ICR. They must 

also contain the docket number of this 

request [USCG–2017–0109], and must 

be received by December 4, 2017. 

Submitting Comments 

We encourage you to submit 

comments through the Federal 

eRulemaking Portal at http://

www.regulations.gov. If your material 

cannot be submitted using http://

www.regulations.gov, contact the person 

in the FOR FURTHER INFORMATION

CONTACT section of this document for 

alternate instructions. Documents 

mentioned in this notice, and all public 

comments, are in our online docket at 

http://www.regulations.gov and can be 

viewed by following that Web site’s 

instructions. Additionally, if you go to 

the online docket and sign up for email 

alerts, you will be notified when 

comments are posted. 

We accept anonymous comments. All 

comments received will be posted 

without change to http://

www.regulations.gov and will include 

any personal information you have 

provided. For more about privacy and 

the docket, you may review a Privacy 

Act notice regarding the Federal Docket 

Management System in the March 24, 

2005, issue of the Federal Register (70 

FR 15086). 


ethrower on DSK3G9T082PROD with NOTICES
51284 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 

OIRA posts its decisions on ICRs 

online at http://www.reginfo.gov/public/ 

do/PRAMain after the comment period 

for each ICR. An OMB Notice of Action 

on each ICR will become available via 

a hyperlink in the OMB Control 

Number: 1625–0030. 

Previous Request for Comments 

This request provides a 30-day 

comment period required by OIRA. The 

Coast Guard published the 60-day 

Notice (82 FR 35980, August 2, 2017) 

required by 44 U.S.C. 3506(c)(2). 

We received three comments from 

two commenters to the 60-day Notice. 

The first comment was about the 

language used in our Notice. The 

commenter stated that the 33 CFR 

155.720 transfer procedure requirements 

apply to a vessel with a capacity of 250 

barrels or more of oil or hazardous 

materials, rather than our Notice 

language of a vessel with a cargo 

capacity of 250 barrels or more of oil or 

hazardous materials (emphasis added). 

We agree and have revised the language 

in our 30-day Notice to correct the error. 

While the language we used in the 60- 

day Notice was inaccurate, our burden 

calculation did include vessels with a 

capacity of 250 barrels or more of oil or 

hazardous materials. 

The second and third comments were 

about the lightering requirements in 33 

CFR 156.210(b). While these comments 

relate to ICR 1625–0042 ‘‘Requirements 

for Lightering of Oil and Hazardous 

Material Cargoes’’ and not the subject of 

this ICR Notice, we have responded to 

the comments below. The second 

comment stated that the Coast Guard 

should update the Headquarters point of 

contact (POC) in the regulations for 

submitting hazardous material 

lightering operation requests. We agree 

that the POC is unclear; submissions 

should be made to Commandant (CG– 

ENG) vice Commandant (CG–5). We will 

revise this item in an upcoming 

technical amendment rulemaking. The 

third comment requested that the Coast 

Guard update the regulation that they 

consider outdated. We will consider 

updating this requirement in a future 

rulemaking. The comments result in no 

changes to the Collection. 

Information Collection Request 

Title: Oil and Hazardous Materials 

Transfer Procedures. 

OMB Control Number: 1625–0030. 

Summary: Vessels with a capacity of 

250 barrels or more of oil or hazardous 

materials must develop and maintain 

transfer procedures. Transfer procedures 

provide basic safety information for 

operating transfer systems with the goal 

of pollution prevention. 

Need: Title 33 U.S.C. 1231 authorizes 

the Coast Guard to prescribe regulations 

related to the prevention of pollution. 

Title 33 CFR 155 prescribes pollution 

prevention regulations including those 

related to transfer procedures. 

Forms: None. 

Respondents: Operators of certain 

vessels. 

Frequency: On occasion. 

Hour Burden Estimate: The estimated 

burden has decreased from 160 hours to 

149 hours a year due to a decrease in the 

estimated annual number of responses. 

Authority: The Paperwork Reduction Act 

of 1995; 44 U.S.C. 35, as amended. 

Dated: October 31, 2017. 

James D. Roppel, 

U.S. Coast Guard, Acting Chief, Office of 

Information Management. 

[FR Doc. 2017–23971 Filed 11–2–17; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2017–0955] 

Information Collection Request to 

Office of Management and Budget; 

OMB Control Number: 1625–0031 

AGENCY: Coast Guard, DHS. 

ACTION: Sixty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

U.S. Coast Guard intends to submit an 

Information Collection Request (ICR) to 

the Office of Management and Budget 

(OMB), Office of Information and 

Regulatory Affairs (OIRA), requesting an 

extension of its approval for the 

following collection of information: 

1625–0031, Plan Approval and Records 

for Electrical Engineering Regulations— 

Title 46 CFR Subchapter J. Our ICR 

describes the information we seek to 

collect from the public. Before 

submitting this ICR to OIRA, the Coast 

Guard is inviting comments as 

described below. 

DATES: Comments must reach the Coast 

Guard on or before January 2, 2018. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number [USCG–2017–0955] to the Coast 

Guard using the Federal eRulemaking 

Portal at http://www.regulations.gov. 

See the ‘‘Public participation and 

request for comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

A copy of the ICR is available through 

the docket on the Internet at http://

www.regulations.gov. Additionally, 

copies are available from: Commandant 

(CG–612), ATTN: Paperwork Reduction 

Act Manager, U.S. Coast Guard, 2703 

Martin Luther King Jr. Ave. SE., Stop 

7710, Washington, DC 20593–7710. 

FOR FURTHER INFORMATION CONTACT: 

Contact Mr. Anthony Smith, Office of 

Information Management, telephone 

202–475–3532, or fax 202–372–8405, for 

questions on these documents. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

This Notice relies on the authority of 

the Paperwork Reduction Act of 1995; 

44 U.S.C. Chapter 35, as amended. An 

ICR is an application to OIRA seeking 

the approval, extension, or renewal of a 

Coast Guard collection of information 

(Collection). The ICR contains 

information describing the Collection’s 

purpose, the Collection’s likely burden 

on the affected public, an explanation of 

the necessity of the Collection, and 

other important information describing 

the Collection. There is one ICR for each 

Collection. 

The Coast Guard invites comments on 

whether this ICR should be granted 

based on the Collection being necessary 

for the proper performance of 

Departmental functions. In particular, 

the Coast Guard would appreciate 

comments addressing: (1) The practical 

utility of the Collection; (2) the accuracy 

of the estimated burden of the 

Collection; (3) ways to enhance the 

quality, utility, and clarity of 

information subject to the Collection; 

and (4) ways to minimize the burden of 

the Collection on respondents, 

including the use of automated 

collection techniques or other forms of 

information technology. In response to 

your comments, we may revise this ICR 

or decide not to seek an extension of 

approval for the Collection. We will 

consider all comments and material 

received during the comment period. 

We encourage you to respond to this 

request by submitting comments and 

related materials. Comments must 

contain the OMB Control Number of the 

ICR and the docket number of this 

request [USCG–2017–0955], and must 

be received by January 2, 2018. 

Submitting Comments 

We encourage you to submit 

comments through the Federal 

eRulemaking Portal at http://

www.regulations.gov. If your material 

cannot be submitted using http://

www.regulations.gov, contact the person 

in the FOR FURTHER INFORMATION

CONTACT section of this document for 


ethrower on DSK3G9T082PROD with NOTICES