Gastrointestinal Drugs Advisory Committee; Notice of Meeting, 7587-7588 [2012-3203]
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Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
study (an in vivo fasting study) to
demonstrate BE of generic nitroglycerin
metered spray/sublingual products and
generic nitroglycerin metered aerosol/
sublingual products. In both of the
revised draft guidances, FDA notes that
even though we have not requested
comparative in vitro studies, in vitro
studies outlined in the 2002 guidance
for industry, ‘‘Nasal Spray and
Inhalation Solution, Suspension, and
Spray Drug Products—Chemistry,
Manufacturing, and Controls
Documentation,’’ should still be
submitted for chemistry, manufacturing,
and controls evaluation.
In December 2010, G. Pohl-Boskamp
GmbH and Company KG (Pohl),
manufacturer of the RLD Nitrolingual
Pumpspray, filed a citizen petition
challenging FDA’s Draft Nitroglycerin
Spray BE Recommendations of February
2010 (Docket No. FDA–2010–P–0648).
FDA is reviewing the issues raised in
the petition and will consider any
comments on the Revised Draft
Nitroglycerin Spray BE
Recommendations before responding to
Pohl’s citizen petition and finalizing its
BE recommendation for nitroglycerin
metered spray/sublingual products.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidances, when
finalized, will represent the Agency’s
current thinking on the design of BE
studies to support ANDAs for
nitroglycerin metered spray/sublingual
products and nitroglycerin metered
aerosol/sublingual products. They do
not create or confer any rights for or on
any person and do not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
erowe on DSK2VPTVN1PROD with NOTICES
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the documents at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
VerDate Mar<15>2010
14:46 Feb 10, 2012
Jkt 226001
Dated: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3233 Filed 2–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Gastrointestinal 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). At least one portion of the
meeting will be closed to the public.
Name of Committee: Gastrointestinal
Drugs 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 13, 2012, from 8 a.m. to
5 p.m.
Location: Hilton Washington, DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel phone number is 301–589–5200.
Contact Person: Nicole Vesely, 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: GIDAC@fda.hhs.gov,
FAX: 301–847–8533, 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
and provide general advice on the
appropriate target populations,
objectives and designs of trials intended
to evaluate products for the control of
hyperbilirubinemia (increased levels of
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7587
bilirubin in the body) in newborn
infants.
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: On March 13, 2012, from
8 a.m. to 12:30 p.m., the meeting is open
to the public. 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 28, 2012.
Oral presentations from the public will
be scheduled between approximately 11
a.m. and 12 noon. 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
17, 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 21, 2012.
Closed Presentation of Data: On
March 13, 2012, from 1:15 p.m. to 5
p.m., the meeting will be closed to
permit discussion and review of trade
secret and/or confidential commercial
information (5 U.S.C. 552b(c)(4)).
During this session, the committee will
discuss the drug development program
of an investigational drug.
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 Nicole
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7588
Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
Vesely 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: February 7, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–3203 Filed 2–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0102]
Antiparasitic Drug Use and Resistance
in Ruminants and Equines; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public meeting
entitled ‘‘Antiparasitic Drug Use and
Resistance in Ruminants and Equines.’’
The purpose of the meeting is to discuss
the current state of anthelmintic
resistance in the United States and
worldwide, tools for the evaluation of
antiparasitic resistance, evaluation of
the effectiveness of drugs against
resistant parasites, and the scientific
rationale for the use of combinations of
antiparasitic drugs in ruminants and
equines.
Date and Time: The public
meeting will be held on March 5 and 6,
2012, from 8 a.m. to 5:30 p.m.
Location: The meeting will be held at
the Hilton Washington, DC/Rockville
Hotel & Executive Meeting Center, 1750
Rockville Pike, Rockville, MD 20852–
1699; 1–800–774–1500; FAX 301–468–
0163; https://rockvillehotel-px.rtrk.com/.
Contact Person: Aleta Sindelar, Center
for Veterinary Medicine (HFV–3), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–276–
9004, FAX: 240–276–9030, email:
Aleta.Sindelar@fda.hhs.gov.
Requests for Oral Presentations and
Registration: Interested persons may
present data, information, or views,
erowe on DSK2VPTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
14:46 Feb 10, 2012
Jkt 226001
orally or in writing, on the topic of the
discussion of the meeting. Written
submissions may be made to the contact
person on or before February 27, 2012.
Oral presentations from the public
during the open public comment period
will be scheduled between
approximately 2 p.m. and 3 p.m. on
March 5, 2012, and 10:30 a.m. and 12
noon on March 6, 2012. Those desiring
to make oral presentations should notify
the contact person by February 20, 2012,
and submit a brief statement of the
general nature of information they wish
to present and an indication of the
approximate time requested to make
their presentation. Time allotted for
each presentation may be limited. The
contact person will inform each speaker
of their schedule prior to the meeting.
Registration is not required for this
meeting; however, early arrival is
recommended because seating may be
limited. If you need special
accommodations due to a disability,
please contact Aleta Sindelar, (see
Contact Person) at least 7 days in
advance.
Comments: Regardless of attendance
at the public meeting, interested persons
may submit either electronic or written
comments regarding this document.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
The docket will remain open for written
or electronic comments for 60 days
following the meeting.
SUPPLEMENTARY INFORMATION: The main
purpose of the meeting is to explore and
discuss ways in which antiparasitic
drugs can be used, alone or in
combination, to maximize antiparasitic
drug efficacy and minimize parasitic
resistance in ruminant and equine
species. Other topics for discussion
include:
(1) The current state of anthelmintic
resistance in the United States and in
other parts of the world;
(2) The factors that have contributed
to the development of anthelmintic
resistance;
(3) The role of refugia in the
management of anthelmintic resistance;
(4) The use of mathematical modeling
as a tool for evaluating resistance;
(5) The use of the fecal egg count
reduction test in the detection and
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management of anthelmintic resistance;
and
(6) Ways to maximize the
effectiveness of anthelmintics for today
and the future.
Agenda: The meeting will allow for
public comment and discussion on
current challenges regarding the use of
antiparasitic drugs in ruminants and
equines. The agenda for the public
meeting will be made available on the
Agency’s Web site at https://
www.fda.gov/AnimalVeterinary/
NewsEvents/CVMUpdates/default.htm.
Transcripts: FDA will prepare a
meeting transcript and make it available
on the Agency’s Web site (see Agenda)
after the meeting. FDA anticipates that
transcripts will be available
approximately 30 business days after
the meeting. The transcript will be
available for public examination at the
Division of Dockets Management (see
Comments section of this document),
between 9 a.m. and 4 p.m., Monday
through Friday. A transcript will also be
available in either hardcopy or on CD–
ROM, after submission of a Freedom of
Information request. Written requests
are to be sent to Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857.
Dated: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3221 Filed 2–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Blood Products Advisory Committee;
Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The meeting of the Blood
Products Advisory Committee
scheduled for February 29, 2012 is
cancelled. This meeting was announced
in the Federal Register of January 30,
2012 (77 FR 4567). FDA intends to
convene at a future date a public
scientific workshop to discuss the
evaluation of possible new plasma
products manufactured following
storage at room temperature for up to 24
hours.
FOR FURTHER INFORMATION CONTACT:
Bryan Emery or Pearl Muckelvene,
SUMMARY:
E:\FR\FM\13FEN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7587-7588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3203]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Gastrointestinal 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Gastrointestinal Drugs 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 13, 2012, from 8
a.m. to 5 p.m.
Location: Hilton Washington, DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
Contact Person: Nicole Vesely, 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:
GIDAC@fda.hhs.gov, FAX: 301-847-8533, 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 and provide general advice on
the appropriate target populations, objectives and designs of trials
intended to evaluate products for the control of hyperbilirubinemia
(increased levels of bilirubin in the body) in newborn infants.
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: On March 13, 2012, from 8 a.m. to 12:30 p.m., the
meeting is open to the public. 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 28, 2012. Oral presentations from the public will be
scheduled between approximately 11 a.m. and 12 noon. 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 17, 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 21, 2012.
Closed Presentation of Data: On March 13, 2012, from 1:15 p.m. to 5
p.m., the meeting will be closed to permit discussion and review of
trade secret and/or confidential commercial information (5 U.S.C.
552b(c)(4)). During this session, the committee will discuss the drug
development program of an investigational drug.
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 Nicole
[[Page 7588]]
Vesely 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: February 7, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-3203 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P
