51282 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

589.2001(f); request for designation .................................... 1 1 1 80 80 

589.2001(f); response to request for review by FDA .......... 1 1 1 26 26 

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

Our estimate of the reporting burden 

for designation under § 589.2001(f) is 

based on estimates in the final rule 

entitled, ‘‘Substances Prohibited From 

Use in Animal Food or Feed,’’ 

published in the Federal Register of 

April 25, 2008, our experience, and the 

average number of requests for 

designation received in the past 3 years. 

The reporting burden for § 589.2001(f) is 

minimal because requests for 

designation are seldom submitted. Since 

2009, we have received two requests for 

designation. In the last 3 years, we have 

not received any new requests for 

designation; therefore, we estimate that 

one or fewer requests for designation 

will be submitted annually. Although 

we have not received any new requests 

for designation in the last 3 years, we 

believe these information collection 

provisions should be extended to 

provide for the potential future need of 

a foreign government to request 

designation under § 589.2001(f). Table 

2, row 1 presents the expected burden 

of requests for designation. Countries 

designated under § 589.2001(f) are 

subject to review by FDA to ensure that 

their designation remains appropriate. 

We assume a country’s response to a 

request for review will take about one 

third the time and effort of a request for 

designation. Table 2, row 2 presents the 

expected burden of a request for review. 

The burden for this information 

collection has not changed since the last 

OMB approval. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23948 Filed 11–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–2044] 

Determination That REVEX (Nalmefene 

Hydrochloride Injection), 0.1 Milligram 

Base/Milliliter and 1.0 Milligram Base/ 

Milliliter, Was Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that REVEX (nalmefene 

hydrochloride injection), 0.1 milligram 

(mg) base/milliliter (mL) and 1.0 mg 

base/mL, was not withdrawn from sale 

for reasons of safety or effectiveness. 

This determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for REVEX 

(nalmefene hydrochloride injection), 0.1 

mg base/mL and 1.0 mg base/mL, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Kelley Nduom, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6221, 

Silver Spring, MD 20993–0002, 301– 

796–8597. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

REVEX (nalmefene hydrochloride 

injection), 0.1 mg base/mL and 1.0 mg 

base/mL, is the subject of NDA 20–459, 

currently held by West-Ward 

Pharmaceuticals International Limited, 

and initially approved on April 17, 

1995. REVEX is indicated for the 

complete or partial reversal of opioid 

drug effects, including respiratory 

depression, induced by either natural or 

synthetic opioids. REVEX is also 

indicated in the management of known 

or suspected opioid overdose. 

In a letter dated June 5, 2009, Baxter 

Healthcare Corporation, the NDA holder 

at the time, notified FDA that the 

manufacturing and distribution of 

REVEX (nalmefene hydrochloride 

injection), 0.1 mg base/mL and 1.0 mg 

base/mL, had been discontinued on May 

21, 2008, for business reasons. REVEX 

(nalmefene hydrochloride injection), 0.1 

mg base/mL and 1.0 mg base/mL, is 

currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. 

Nirsum Pharmaceuticals, LLC, 

submitted a citizen petition dated 

March 31, 2017 (Docket No. FDA–2017– 


ethrower on DSK3G9T082PROD with NOTICES
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