Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting, 1696-1697 [2012-324]
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1696
Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Notices
determine whether AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg, were
withdrawn from sale for reasons of
safety or effectiveness. In addition,
Lupin Pharmaceuticals, Inc. submitted a
citizen petition dated November 10,
2011 (Docket No. FDA–2011–P–0822),
under § 10.30, also requesting that the
Agency determine whether AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg, were
withdrawn from sale for reasons of
safety or effectiveness. Although the
citizen petitions did not address the
12.5 mg/75 mg strength, that strength
has also been discontinued. On our own
initiative, we have also determined
whether that strength was withdrawn
for safety or effectiveness reasons.
After considering the citizen petitions
and reviewing Agency records, and
based on the information we have at this
time, FDA has determined under
§ 314.161 that AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg and 12.5 mg/
75 mg were not withdrawn for reasons
of safety or effectiveness. The
petitioners have identified no data or
other information suggesting that
AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 mg/300 mg
and 12.5 mg/75 mg were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
AVALIDE (hydrochlorothiazide and
irbesartan), oral tablets, 25 mg/300 mg
and 12.5 mg/75 mg from sale. We have
also independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg and 12.5 mg/
75 mg were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg and 12.5 mg/
75 mg, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to AVALIDE
(hydrochlorothiazide and irbesartan),
oral tablets, 25 mg/300 mg and 12.5 mg/
75 mg, may 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
VerDate Mar<15>2010
15:02 Jan 10, 2012
Jkt 226001
Agency will advise ANDA applicants to
submit such labeling.
Dated: January 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–312 Filed 1–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology; 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: Advisory
Committee for Pharmaceutical Science
and Clinical Pharmacology.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 14, 2012, from 7:30 a.m.
to 3 p.m.
Location: Gaylord National Hotel and
Convention Center, Maryland Ballroom
C, 201 Waterfront St., National Harbor,
MD 20745. The hotel’s phone number is
(301) 965–4000.
Contact Person: Yvette Waples, 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, email:
ACPS–CP@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–(800) 741–8138 ((301) 443–0572 in
the Washington, DC area), and follow
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
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 and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: The committee will discuss
the clinical pharmacology aspects of
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pediatric clinical trial design and dosing
to optimize pediatric drug development.
FDA will seek input on how to
strategically inform pediatric clinical
trial design and dosing by utilizing
existing knowledge, including available
adult and nonclinical data. The
discussion will include the role of
modeling and simulation including
physiologically-based pharmacokinetic
modeling in pediatric drug
development. Modeling and simulation
is the application of mathematical
approaches to predicting what will
happen in a clinical trial with pediatric
patients when a particular dose of a
drug is used.
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 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 February 29, 2012.
Oral presentations from the public will
be scheduled between approximately
10:45 a.m. and 11:45 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 February 21, 2012. 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
February 22, 2012.
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
E:\FR\FM\11JAN1.SGM
11JAN1
Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Notices
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Yvette
Waples 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/AboutAdvisory
Committees/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: January 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–324 Filed 1–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Arthritis Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
pmangrum on DSK3VPTVN1PROD with NOTICES
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: Arthritis
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 12, 2012, from 8 a.m. to
5:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room,
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Philip A. Bautista,
Center for Drug Evaluation and
Research, Food and Drug
VerDate Mar<15>2010
15:02 Jan 10, 2012
Jkt 226001
Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring,
MD 20993–0002, (301) 796–9001, FAX:
(301) 847–8533, email:
AAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–(800)
741–8138 ((301) 443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
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 and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: The committee will discuss
the anti-nerve growth factor (Anti-NGF)
drug class that is currently under
development and the safety issues
possibly related to these drugs. These
drugs are being developed for the
treatment of a variety of chronic painful
conditions including osteoarthritis,
chronic lower back pain, diabetic
peripheral neuropathy, post-herpetic
neuralgia, chronic pancreatitis,
endometriosis, interstitial cystitis,
vertebral fracture, thermal injury, and
cancer pain. The committee will be
asked to determine whether reports of
joint destruction represent a safety
signal related to the Anti-NGF class of
drugs, and whether the risk benefit
balance for these drugs favors continued
development of the drugs as analgesics.
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 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 February 27, 2012.
Oral presentations from the public will
be scheduled between approximately
1:30 p.m. and 2:30 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
PO 00000
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Fmt 4703
Sfmt 4703
1697
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 February 16, 2012. 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
February 17, 2012.
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 Philip A.
Bautista 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: January 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–326 Filed 1–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Agency Information Collection
Activities: Fast Track Generic
Clearance for the Collection of
Qualitative Feedback on Agency
Service Delivery: IHS Web Site
Customer Service Satisfaction Survey
Indian Health Service, HHS.
30-Day notice of submission of
information collection approval from
the Office of Management and Budget
(OMB) and request for comments.
AGENCY:
ACTION:
E:\FR\FM\11JAN1.SGM
11JAN1
]]>Agencies
[Federal Register Volume 77, Number 7 (Wednesday, January 11, 2012)]
[Notices]
[Pages 1696-1697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-324]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology; 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: Advisory Committee for Pharmaceutical Science
and Clinical Pharmacology.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on March 14, 2012, from
7:30 a.m. to 3 p.m.
Location: Gaylord National Hotel and Convention Center, Maryland
Ballroom C, 201 Waterfront St., National Harbor, MD 20745. The hotel's
phone number is (301) 965-4000.
Contact Person: Yvette Waples, 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, email: ACPS-CP@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-(800) 741-8138 ((301) 443-0572 in the Washington,
DC area), and follow prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this
meeting. 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 and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: The committee will discuss the clinical pharmacology
aspects of pediatric clinical trial design and dosing to optimize
pediatric drug development. FDA will seek input on how to strategically
inform pediatric clinical trial design and dosing by utilizing existing
knowledge, including available adult and nonclinical data. The
discussion will include the role of modeling and simulation including
physiologically-based pharmacokinetic modeling in pediatric drug
development. Modeling and simulation is the application of mathematical
approaches to predicting what will happen in a clinical trial with
pediatric patients when a particular dose of a drug is used.
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 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
February 29, 2012. Oral presentations from the public will be scheduled
between approximately 10:45 a.m. and 11:45 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 February 21, 2012.
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 February 22, 2012.
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
[[Page 1697]]
accommodate persons with physical disabilities or special needs. If you
require special accommodations due to a disability, please contact
Yvette Waples 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: January 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-324 Filed 1-10-12; 8:45 am]
BILLING CODE 4160-01-P
