83 FR 27011 - Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 112 (June 11, 2018)

Page Range		27011-27012
FR Document		2018-12442

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.

Federal Register, Volume 83 Issue 112 (Monday, June 11, 2018)

[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27011-27012]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12442]


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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, [email protected].

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

[[Page 27012]]

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 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/DrugSafetyandRiskManagementAdvisoryCommittee/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

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

and Research, Food and Drug ‘‘Discontinued Drug Product List’’ DEPARTMENT OF HEALTH AND
Administration, 10903 New Hampshire section of the Orange Book. HUMAN SERVICES
Ave., Bldg. 51, Rm. 6236, Silver Spring, Fresenius Kabi USA, LLC submitted a
MD 20993–0002, 301–796–8363, Food and Drug Administration
citizen petition dated January 22, 2018
Stacy.Kane@fda.hhs.gov. (Docket No. FDA–2018–P–0327), under [Docket No. FDA–2018–N–1728]
SUPPLEMENTARY INFORMATION: In 1984, 21 CFR 10.30, requesting that the
Congress enacted the Drug Price Agency determine whether Advisory Committee; Drug Safety and
Competition and Patent Term MUTAMYCIN (mitomycin) injectable, 5 Risk Management Advisory
Restoration Act of 1984 (Pub. L. 98–417) Committee; Renewal
mg/vial and 20 mg/vial, was withdrawn
(the 1984 amendments), which from sale for reasons of safety or AGENCY: Food and Drug Administration,
authorized the approval of duplicate effectiveness. HHS.
versions of drug products under an
After considering the citizen petition ACTION:Notice; renewal of advisory
ANDA procedure. ANDA applicants
and reviewing Agency records and committee.
must, with certain exceptions, show that
the drug for which they are seeking based on the information we have at this
SUMMARY: The Food and Drug
approval contains the same active time, FDA has determined under
Administration (FDA) is announcing the
ingredient in the same strength and § 314.161 that MUTAMYCIN
renewal of the Drug Safety and Risk
dosage form as the ‘‘listed drug,’’ which (mitomycin) injectable, 5 mg/vial and 20 Management Advisory Committee by
is a version of the drug that was mg/vial, was not withdrawn for reasons the Commissioner of Food and Drugs
previously approved. ANDA applicants of safety or effectiveness. The petitioner (the Commissioner). The Commissioner
do not have to repeat the extensive has identified no data or other has determined that it is in the public
clinical testing otherwise necessary to information suggesting that this product interest to renew the Drug Safety and
gain approval of a new drug application was withdrawn for reasons of safety or Risk Management Advisory Committee
(NDA). effectiveness. We have carefully for an additional 2 years beyond the
The 1984 amendments include what reviewed our files for records charter expiration date. The new charter
is now section 505(j)(7) of the Federal concerning the withdrawal of will be in effect until May 31, 2020.
Food, Drug, and Cosmetic Act (21 U.S.C. MUTAMYCIN (mitomycin) injectable, 5 DATES: Authority for the Drug Safety
355(j)(7)), which requires FDA to mg/vial and 20 mg/vial, from sale. We and Risk Management Advisory
publish a list of all approved drugs. have also independently evaluated Committee will expire on May 31, 2018,
FDA publishes this list as part of the relevant literature and data for possible unless the Commissioner formally
‘‘Approved Drug Products With postmarketing adverse events. We have determines that renewal is in the public
Therapeutic Equivalence Evaluations,’’ found no information that would interest.
which is known generally as the indicate that this drug product was FOR FURTHER INFORMATION CONTACT:
‘‘Orange Book.’’ Under FDA regulations, withdrawn from sale for reasons of Philip Bautista, Center for Drug
drugs are removed from the list if the safety or effectiveness. Evaluation and Research, Food and
Agency withdraws or suspends Drug Administration, 10903 New
Accordingly, the Agency will
approval of the drug’s NDA or ANDA Hampshire Ave, Bldg. 31, Rm. 2417,
continue to list MUTAMYCIN
for reasons of safety or effectiveness or Silver Spring, MD 20993–0002, 301–
if FDA determines that the listed drug (mitomycin) injectable, 5 mg/vial and 20
mg/vial, in the ‘‘Discontinued Drug 796–9001, DSaRM@fda.hhs.gov.
was withdrawn from sale for reasons of
Product List’’ section of the Orange SUPPLEMENTARY INFORMATION: Pursuant
safety or effectiveness (21 CFR 314.162).
Book. The ‘‘Discontinued Drug Product to 41 CFR 102–3.65 and approval by the
A person may petition the Agency to Department of Health and Human
List’’ identifies among other items, drug
determine, or the Agency may Services pursuant to 45 CFR part 11 and
products that have been discontinued
determine on its own initiative, whether by the General Services Administration,
a listed drug was withdrawn from sale from marketing for reasons other than
safety or effectiveness. FDA will not FDA is announcing the renewal of the
for reasons of safety or effectiveness. Drug Safety and Risk Management
This determination may be made at any begin procedures to withdraw approval
of approved ANDAs that refer to this Advisory Committee. The committee is
time after the drug has been withdrawn a discretionary Federal advisory
from sale, but must be made prior to drug product. Additional ANDAs for
committee established to provide advice
approving an ANDA that refers to the this drug product may also be approved
to the Commissioner.
listed drug (§ 314.161 (21 CFR 314.161)). by the Agency as long as they meet all The Drug Safety and Risk
FDA may not approve an ANDA that other legal and regulatory requirements Management Advisory Committee
does not refer to a listed drug. for the approval of ANDAs. If FDA advises the Commissioner or designee
MUTAMYCIN (mitomycin) injectable, determines that labeling for this drug in discharging responsibilities as they
5 mg/vial and 20 mg/vial, is the subject product should be revised to meet relate to helping to ensure safe and
of NDA 050450, held by Bristol current standards, the Agency will effective drugs for human use and, as
Laboratories Inc., and initially approved advise ANDA applicants to submit such required, any other product for which
on May 28, 1974. MUTAMYCIN has labeling. FDA has regulatory responsibility.
been shown to be useful in the therapy Dated: June 5, 2018. The Committee reviews and evaluates
of disseminated adenocarcinoma of the information on risk management, risk
daltland on DSKBBV9HB2PROD with NOTICES

Leslie Kux,
stomach or pancreas in proven communication, and quantitative
Associate Commissioner for Policy.
combinations with other approved evaluation of spontaneous reports for
chemotherapeutic agents and as [FR Doc. 2018–12441 Filed 6–8–18; 8:45 am] drugs for human use and for any other
palliative treatment when other BILLING CODE 4164–01–P product for which FDA has regulatory
modalities have failed. MUTAMYCIN responsibility. The Committee also
(mitomycin) injectable, 5 mg/vial and 20 advises the Commissioner regarding the
mg/vial, is currently listed in the scientific and medical evaluation of all

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27012 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices

information gathered by the Department DEPARTMENT OF HEALTH AND issues related to physician workforce
of Health and Human Services and the HUMAN SERVICES development and graduate medical
Department of Justice with regard to education, leading to selection a topic
safety, efficacy, and abuse potential of Health Resources and Services for its 24th Report to Congress. An
drugs or other substances, and Administration agenda will be available on the COGME
recommends actions to be taken by the website https://www.hrsa.gov/
Council on Graduate Medical advisorycommittees/bhpradvisory/
Department of Health and Human
Education COGME/ prior to the meeting. Please
Services with regard to the marketing,
investigation, and control of such drugs AGENCY: Health Resources and Service note that agenda items are subject to
or other substances. Administration (HRSA), Department of change as priorities dictate.
Health and Human Services (HHS). Public Participation: Members of the
The Committee shall consist of a core public will have the opportunity to
of 11 voting members including the ACTION: Notice of Advisory Council
provide comments. Public participants
Chair. Members and the Chair are meeting. may submit written statements in
selected by the Commissioner or SUMMARY: In accordance with the advance of the scheduled meeting. Oral
designee from among authorities Federal Advisory Committee Act, this comments will be honored in the order
knowledgeable in the fields of risk notice announces a public meeting of they are requested and may be limited
communication, risk management, drug the Council on Graduate Medical as time allows. Requests to provide
safety, medical, behavioral, and Education (COGME). This notice is written statements or make oral
biological sciences as they apply to risk being published less than 15 days prior comments to the COGME should be sent
management, and drug abuse. Members to the meeting date due to unforeseen to Dr. Kennita R. Carter.
will be invited to serve for overlapping administrative delays. Since this meeting is held in a Federal
terms of up to 4 years. Almost all non- government building, attendees must go
DATES: Wednesday, June 20, 2018, from
Federal members of this committee through a security check to enter the
8:30 a.m. to 5:00 p.m. ET, and Thursday, building. Non-U.S. Citizen attendees
serve as Special Government June 21, 2018, from 8:30 a.m. to 2:00
Employees. The core of voting members must notify HRSA of their planned
p.m. ET. attendance at least 10 workdays prior to
may include one technically qualified ADDRESSES: This meeting is an in person the meeting in order to facilitate their
member, selected by the Commissioner meeting and will offer virtual access entry into the building. All attendees are
or designee, who is identified with through teleconference and webinar. required to present government-issued
consumer interests and is recommended The address for the meeting is 5600 identification prior to entry. Individuals
by either a consortium of consumer- Fishers Lane, Rockville, Maryland who plan to participate and require
oriented organizations or other 20857. special assistance, such as sign language
interested persons. In addition to the • The conference call-in number is 1– interpretation or other reasonable
voting members, the Committee may 800–619–2521; passcode: 9271697. accommodations, should notify Dr.
include one non-voting member who is • The webinar link is https:// Kennita Carter, using the address and
identified with industry interests. hrsa.connectsolutions.com/cogme. phone number above at least 10
Further information regarding the FOR FURTHER INFORMATION CONTACT: business days prior to the meeting.
most recent charter and other Kennita R. Carter, MD, Designated
Amy P. McNulty,
information can be found at https:// Federal Official, Division of Medicine
and Dentistry, Bureau of Health Acting Director, Division of the Executive
www.fda.gov/AdvisoryCommittees/ Secretariat.
CommitteesMeetingMaterials/Drugs/ Workforce, HRSA, Address: 5600
[FR Doc. 2018–12512 Filed 6–8–18; 8:45 am]
DrugSafetyandRiskManagement Fishers Lane, 15N–116, Rockville,
Maryland 20857; (2) call 301–945–3505; BILLING CODE 4165–15–P
AdvisoryCommittee/default.htm or by
or (3) send an email to KCarter@
contacting the Designated Federal
hrsa.gov.
Officer (see FOR FURTHER INFORMATION DEPARTMENT OF HEALTH AND
CONTACT). In light of the fact that no SUPPLEMENTARY INFORMATION: HUMAN SERVICES
change has been made to the committee Background: COGME provides advice
name or description of duties, no and recommendations to the Secretary National Institutes of Health
amendment will be made to 21 CFR of HHS and to Congress on a range of
issues, including: The nature and Request for Information (RFI): Input on
14.100. Report From Council of Councils on
financing of medical education training;
This document is issued under the the development of performance Assessing the Safety of Relocating At-
Federal Advisory Committee Act (5 measures and longitudinal evaluation Risk Chimpanzees
U.S.C. app.). For general information methods of medical education AGENCY: National Institutes of Health,
related to FDA advisory committees, programs; foreign medical school HHS.
please check https://www.fda.gov/ graduates; and the supply and ACTION: Notice.
AdvisoryCommittees/default.htm. distribution of the physician workforce
Dated: June 5, 2018. in the United States, including any SUMMARY: The National Institutes of
Leslie Kux, projected shortages or excesses. COGME Health (NIH) is informing the research
submits reports to the Secretary of HHS; community and other interested parties
daltland on DSKBBV9HB2PROD with NOTICES

Associate Commissioner for Policy.
the Senate Committee on Health, that it received from the NIH Council of
[FR Doc. 2018–12442 Filed 6–8–18; 8:45 am]
Education, Labor, and Pensions; and the Councils the report of its Working
BILLING CODE 4164–01–P House of Representatives Committee on Group on Assessing the Safety of
Energy and Commerce. Relocating At-Risk Chimpanzees, and
Agenda: During the meeting, the the agency will consider
COGME members will discuss the recommendations contained in the
strategic directions of the Council and report (see https://dpcpsi.nih.gov/sites/

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Document Created: 2018-11-02 11:58:31
Document Modified: 2018-11-02 11:58:31

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; renewal of advisory committee.
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.
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, [email protected]
FR Citation		83 FR 27011

83 FR 27011 - Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 112 (June 11, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration