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was withdrawn from sale for reasons of 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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 


daltland on DSKBBV9HB2PROD with NOTICES
27012 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices 

information gathered by the Department 

of Health and Human Services and the 

Department of Justice with regard to 

safety, efficacy, and abuse potential of 

drugs or other substances, and 

recommends actions to be taken by the 

Department of Health and Human 

Services with regard to the marketing, 

investigation, and control of such drugs 

or other substances. 

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 risk 

communication, risk management, drug 

safety, medical, behavioral, and 

biological sciences as they apply to risk 

management, and drug abuse. Members 

will be invited to serve for overlapping 

terms of up to 4 years. Almost all nonFederal 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 consumeroriented 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/ 

DrugSafetyandRiskManagement

AdvisoryCommittee/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. 2018–12442 Filed 6–8–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Council on Graduate Medical 

Education 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of Advisory Council 

meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces a public meeting of 

the Council on Graduate Medical 

Education (COGME). This notice is 

being published less than 15 days prior 

to the meeting date due to unforeseen 

administrative delays. 

DATES: Wednesday, June 20, 2018, from 

8:30 a.m. to 5:00 p.m. ET, and Thursday, 

June 21, 2018, from 8:30 a.m. to 2:00 

p.m. ET. 

ADDRESSES: This meeting is an in person 

meeting and will offer virtual access 

through teleconference and webinar. 

The address for the meeting is 5600 

Fishers Lane, Rockville, Maryland 

20857. 

• The conference call-in number is 1– 

800–619–2521; passcode: 9271697. 

• The webinar link is https://

hrsa.connectsolutions.com/cogme. 

FOR FURTHER INFORMATION CONTACT: 

Kennita R. Carter, MD, Designated 

Federal Official, Division of Medicine 

and Dentistry, Bureau of Health 

Workforce, HRSA, Address: 5600 

Fishers Lane, 15N–116, Rockville, 

Maryland 20857; (2) call 301–945–3505; 

or (3) send an email to KCarter@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

Background: COGME provides advice 

and recommendations to the Secretary 

of HHS and to Congress on a range of 

issues, including: The nature and 

financing of medical education training; 

the development of performance 

measures and longitudinal evaluation 

methods of medical education 

programs; foreign medical school 

graduates; and the supply and 

distribution of the physician workforce 

in the United States, including any 

projected shortages or excesses. COGME 

submits reports to the Secretary of HHS; 

the Senate Committee on Health, 

Education, Labor, and Pensions; and the 

House of Representatives Committee on 

Energy and Commerce. 

Agenda: During the meeting, the 

COGME members will discuss the 

strategic directions of the Council and 

issues related to physician workforce 

development and graduate medical 

education, leading to selection a topic 

for its 24th Report to Congress. An 

agenda will be available on the COGME 

website https://www.hrsa.gov/ 

advisorycommittees/bhpradvisory/ 

COGME/ prior to the meeting. Please 

note that agenda items are subject to 

change as priorities dictate. 

Public Participation: Members of the 

public will have the opportunity to 

provide comments. Public participants 

may submit written statements in 

advance of the scheduled meeting. Oral 

comments will be honored in the order 

they are requested and may be limited 

as time allows. Requests to provide 

written statements or make oral 

comments to the COGME should be sent 

to Dr. Kennita R. Carter. 

Since this meeting is held in a Federal 

government building, attendees must go 

through a security check to enter the 

building. Non-U.S. Citizen attendees 

must notify HRSA of their planned 

attendance at least 10 workdays prior to 

the meeting in order to facilitate their 

entry into the building. All attendees are 

required to present government-issued 

identification prior to entry. Individuals 

who plan to participate and require 

special assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify Dr. 

Kennita Carter, using the address and 

phone number above at least 10 

business days prior to the meeting. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–12512 Filed 6–8–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Request for Information (RFI): Input on 

Report From Council of Councils on 

Assessing the Safety of Relocating AtRisk Chimpanzees 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Institutes of 

Health (NIH) is informing the research 

community and other interested parties 

that it received from the NIH Council of 

Councils the report of its Working 

Group on Assessing the Safety of 

Relocating At-Risk Chimpanzees, and 

the agency will consider 

recommendations contained in the 

report (see https://dpcpsi.nih.gov/sites/ 


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