Oncologic Drugs Advisory Committee; Notice of Meeting, 29721-29722 [2015-12403]
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Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices
29721
FDA has become aware that the drug
product listed in the table in this
document is no longer being marketed.
Application No.
Drug
Applicant
NDA 020908 .......
VAGIFEM (estradiol) Vaginal Tablets, 25 micrograms ...........
Novo Nordisk Inc., 800 Scudders Mill Rd., Plainsboro, NJ
08536.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug product listed in this document
was not withdrawn from sale for reasons
of safety or effectiveness. Accordingly,
the Agency will continue to list the drug
product listed in this document 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.
Approved ANDAs that refer to the
NDA listed in this document are
unaffected by the discontinued
marketing of the product subject to this
NDA. Additional ANDAs that refer to
this product may also be approved by
the Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for
estradiol vaginal tablets should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On March
17, 2015, the Agency submitted a
proposed collection of information
entitled, ‘‘Substances Prohibited From
Use in Animal Food or Feed’’ to OMB
for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0627. The
approval expires on April 30, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12404 Filed 5–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0510]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry: Notification of a
Health Claim or Nutrient Content Claim
Based on an Authoritative Statement
of a Scientific Body
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Substances Prohibited From Use in
Animal Food or Feed
Food and Drug Administration,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
HHS.
AGENCY:
Food and Drug Administration,
HHS.
Notice.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Substances Prohibited From Use in
Animal Food or Feed’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
VerDate Sep<11>2014
18:19 May 21, 2015
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BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0535]
ACTION:
[FR Doc. 2015–12400 Filed 5–21–15; 8:45 am]
Food and Drug Administration
Food and Drug Administration
AGENCY:
On March
13, 2015, the Agency submitted a
proposed collection of information
entitled, ‘‘Guidance for Industry:
Notification of a Health Claim or
Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body’’ to OMB for review and clearance
under 44 U.S.C. 3507. An Agency may
not conduct or sponsor, and a person is
not required to respond to, a collection
of information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0374. The
approval expires on April 30, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
[FR Doc. 2015–12396 Filed 5–21–15; 8:45 am]
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
[Docket No. FDA–2015–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Guidance for Industry: Notification of
a Health Claim or Nutrient Content
Claim Based on an Authoritative
Statement of a Scientific Body’’ has
been approved by the Office of
Frm 00120
Fmt 4703
Sfmt 4703
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
PO 00000
Food and Drug Administration
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
E:\FR\FM\22MYN1.SGM
22MYN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
29722
Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 9, 2015, from 8 a.m. to
12:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Lauren D. Tesh,
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, FAX:
301–847–8533, ODAC@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
biologics license application 125547,
necitumumab injection, application
submitted by Eli Lilly and Company.
The proposed indication (use) for this
product is in combination with
gemcitabine and cisplatin for first-line
treatment of patients with locally
advanced or metastatic squamous nonsmall cell lung cancer.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
VerDate Sep<11>2014
18:19 May 21, 2015
Jkt 235001
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 24, 2015. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. to 11:30 a.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before June 16,
2015. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 17, 2014.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Lauren D.
Tesh at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12403 Filed 5–21–15; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Advisory Committee; Medical Imaging
Drugs Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Renewal of Federal advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Medical Imaging 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 Medical Imaging
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the May 18, 2015,
expiration date.
DATES: Authority for the Medical
Imaging Drugs Advisory Committee will
expire on May 18, 2017, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Lauren D. Tesh, Division of Advisory
Committee and Consultant
Management, Office of Executive
Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002; 301–796–9001, email:
MIDAC@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
Medical Imaging Drugs Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The 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 diagnostic and therapeutic
procedures using radioactive
pharmaceuticals and contrast media
used in diagnostic radiology and makes
appropriate recommendations to the
Commissioner.
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29721-29722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12403]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Oncologic Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Oncologic Drugs Advisory Committee.
General Function of the Committee: To provide advice and
[[Page 29722]]
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on July 9, 2015, from 8
a.m. to 12:30 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Lauren D. Tesh, 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, FAX: 301-847-
8533, ODAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: The committee will discuss biologics license application
125547, necitumumab injection, application submitted by Eli Lilly and
Company. The proposed indication (use) for this product is in
combination with gemcitabine and cisplatin for first-line treatment of
patients with locally advanced or metastatic squamous non-small cell
lung cancer.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
24, 2015. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11:30 a.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before June 16, 2015. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by June 17, 2014.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Lauren D. Tesh at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12403 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P
