Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal, 27011-27012 [2018-12442]
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Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
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.
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was withdrawn from sale for reasons of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a listed drug was withdrawn from sale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time after the drug has been withdrawn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
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‘‘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]
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27011
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.
Notice; renewal of advisory
committee.
ACTION:
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
SUMMARY:
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Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
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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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Council on Graduate Medical
Education
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of Advisory Council
meeting.
AGENCY:
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.
SUMMARY:
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
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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]
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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.
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/
SUMMARY:
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[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27011-27012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12442]
-----------------------------------------------------------------------
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]
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