27010 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices 

pharmaceutical compounding, 

pharmaceutical manufacturing, 

pharmacy, medicine, and related 

specialties. These members will include 

representatives from the National 

Association of Boards of Pharmacy, the 

United States Pharmacopeia, 

pharmacists with current experience 

and expertise in compounding, 

physicians with background and 

knowledge in compounding, and patient 

and public health advocacy 

organizations. 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 

or more technically qualified members, 

selected by the Commissioner or 

designee, who are identified with 

consumer interests and are 

recommended by either a consortium of 

consumer-oriented organizations or 

other interested persons. In addition to 

the voting members, the Committee may 

include one or more non-voting 

members who are 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/ 

PharmacyCompounding

AdvisoryCommittee/ucm381305.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 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12440 Filed 6–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1725] 

Advisory Committee; Peripheral and 

Central Nervous System 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 Peripheral and Central 

Nervous System 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 

Peripheral and Central Nervous System 

Drugs Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until June 4, 2020. 

DATES: Authority for the Peripheral and 

Central Nervous System Drugs Advisory 

Committee will expire on June 4, 2020, 

unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Yinghua Wang, 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: PCNS@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 

Peripheral and Central Nervous System 

Drugs Advisory Committee. The 

committee is a discretionary Federal 

advisory committee established to 

provide advice to the Commissioner. 

The Peripheral and Central Nervous 

System 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 

data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of neurologic 

diseases. 

The Committee shall consist of a core 

of nine voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

neurology, neuropharmacology, 

neuropathology, otolaryngology, 

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/ 

PeripheralandCentralNervousSystem

DrugsAdvisoryCommittee/default.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 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12443 Filed 6–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–P–0327] 

Determination That MUTAMYCIN 

(Mitomycin) Injectable, 5 Milligrams/ 

Vial and 20 Milligrams/Vial, 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 MUTAMYCIN 

(mitomycin) injectable, 5 milligrams 

(mg)/vial and 20 mg/vial, was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for MUTAMYCIN 

(mitomycin) injectable, 5 mg/vial and 20 

mg/vial, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 


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Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices 27011 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 

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, 

drugs are 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. 

MUTAMYCIN (mitomycin) injectable, 

5 mg/vial and 20 mg/vial, is the subject 

of NDA 050450, held by Bristol 

Laboratories Inc., and initially approved 

on May 28, 1974. MUTAMYCIN has 

been shown to be useful in the therapy 

of disseminated adenocarcinoma of the 

stomach or pancreas in proven 

combinations with other approved 

chemotherapeutic agents and as 

palliative treatment when other 

modalities have failed. MUTAMYCIN 

(mitomycin) injectable, 5 mg/vial and 20 

mg/vial, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Fresenius Kabi USA, LLC submitted a 

citizen petition dated January 22, 2018 

(Docket No. FDA–2018–P–0327), under 

21 CFR 10.30, requesting that the 

Agency determine whether 

MUTAMYCIN (mitomycin) injectable, 5 

mg/vial and 20 mg/vial, was withdrawn 

from sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that MUTAMYCIN 

(mitomycin) injectable, 5 mg/vial and 20 

mg/vial, was not withdrawn for reasons 

of safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that this product 

was withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

MUTAMYCIN (mitomycin) injectable, 5 

mg/vial and 20 mg/vial, 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 MUTAMYCIN 

(mitomycin) injectable, 5 mg/vial and 20 

mg/vial, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ identifies among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also 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: June 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12441 Filed 6–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1728] 

Advisory Committee; Drug Safety and 

Risk Management 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 Drug Safety and Risk 

Management 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 Drug Safety and 

Risk Management Advisory Committee 

for an additional 2 years beyond the 

charter expiration date. The new charter 

will be in effect until May 31, 2020. 

DATES: Authority for the Drug Safety 

and Risk Management Advisory 

Committee will expire on May 31, 2018, 

unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Philip Bautista, 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, DSaRM@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 

Drug Safety and Risk Management 

Advisory Committee. The committee is 

a discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. 

The Drug Safety and Risk 

Management 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 

information on risk management, risk 

communication, and quantitative 

evaluation of spontaneous reports for 

drugs for human use and for any other 

product for which FDA has regulatory 

responsibility. The Committee also 

advises the Commissioner regarding the 

scientific and medical evaluation of all 


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