Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 69636-69637 [2012-28201]
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69636
Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices
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: Cindy Hong, 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:
PADAC@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
new drug application (NDA) 203108, for
olodaterol (proposed trade name
Striverdi Respimat) metered dose
inhaler, sponsored by Boehringer
Ingelheim, for the proposed indication
of long-term, once-daily maintenance
bronchodilator treatment of airflow
obstruction in patients with chronic
obstructive pulmonary disease (COPD),
including chronic bronchitis and/or
emphysema.
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 January 14, 2013.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
VerDate Mar<15>2010
15:12 Nov 19, 2012
Jkt 229001
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 January
4, 2013. 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 January 7, 2013.
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 Cindy Hong
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: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28205 Filed 11–19–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Pulmonary-Allergy 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
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
(FDA). The meeting will be open to the
public.
Name of Committee: PulmonaryAllergy 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 January 30, 2013, from 8 a.m.
to 4 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.
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: Cindy Hong, 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:
PADAC@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
the new drug application (NDA) 202049,
for mannitol inhalation powder
(proposed trade name BRONCHITOL),
for oral inhalation sponsored by
Pharmaxis, for the proposed indication
of management of cystic fibrosis in
patients aged 6 years and older to
improve pulmonary function.
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
E:\FR\FM\20NON1.SGM
20NON1
Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices
wreier-aviles on DSK5TPTVN1PROD with
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 January 14, 2013.
Oral presentations from the public will
be scheduled between approximately
12:30 p.m. to 1:30 p.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 January 4, 2013. 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 January 7, 2013.
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 Cindy Hong
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: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28201 Filed 11–19–12; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
15:12 Nov 19, 2012
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0974]
Development of Prioritized Therapeutic
Area Data Standards; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing the
intent to prioritize and develop
therapeutic area data standards to
facilitate the conduct of clinical
research and the regulatory review of
medical products. Therapeutic area
disease and domain specific data
standards should enable and enhance
the ability to integrate, analyze, report,
and share regulatory information. FDA
has developed a roadmap that provides
its current thinking on therapeutic area
priorities and has posted it on the FDA
Web site. FDA is actively participating
with regulated industry, the Clinical
Data Interchange Standards Consortium
(CDISC), the Critical Path Institute,
Health Level 7’s (HL7) Clinical
Interoperability Council, and other
stakeholders to support the
development of these therapeutic area
standards. The therapeutic area
standards will be developed
collaboratively based on open,
consensus-based data standards
development methodology.
DATES: To ensure that the Agency
considers your comments, submit either
electronic or written comments by
January 22, 2013.
ADDRESSES: Submit written requests for
a copy of the roadmap to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852–
1448. Send one self-addressed adhesive
label to assist that office in processing
your requests.
Submit electronic comments on
FDA’s objective to develop prioritized
therapeutic area data standards or on
the roadmap to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
69637
1061, Rockville, MD 20852. See the
section for
electronic access to the roadmap.
FOR FURTHER INFORMATION CONTACT:
Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1160,
Silver Spring, MD 20993–0002,
CDERDataStandards@fda.hhs.gov; or
Amy Malla, Center for Biologics
Evaluation and Research (HFM–25),
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852–1448, 301–827–
6085.
SUPPLEMENTARY INFORMATION:
SUPPLEMENTARY INFORMATION
I. Background
Traditionally, clinical study data
submitted to FDA is in a format that is
unique to each individual sponsor;
furthermore the data quality varies. This
has created inefficiencies in the review
process and impeded efforts to analyze
the data across applications when such
analyses could be beneficial to detect
trends in safety or efficacy or for other
reasons. Sponsor adoption of available
clinical trial data standards (CDISC/
SDTM) for the submission of product
applications have helped to improve the
quality and standardization of
submitted data. However, such a
voluntary approach has proved
insufficient to support both the current
business requirements as well as efforts
to modernize the review environment.
In 2011, the Center for Drug
Evaluation and Research (CDER)
identified a set of disease and
therapeutic areas that could benefit from
further standardization. These content
area standards are primarily intended to
support the efficient evaluation of
medical products as noted previously in
this document. Several factors were
considered in the identification of these
areas: (1) Areas of particular need, (2)
areas with existing data standardization
projects underway, and (3) areas with
greater drug development pipeline
activity. The initial prioritization was
based on the number of active
investigational new drug applications
(or INDs) and input from review
divisions, as well as from industry. The
three tiers of priority were assembled
into a roadmap and posted on the FDA
Web site at https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/
FormsSubmissionRequirements/
ElectronicSubmissions/ucm287408.htm.
The roadmap sets out a sequence of
standardization efforts to achieve
significant results by December 2017.
CDER established a small grants
program to fund projects that develop
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69636-69637]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28201]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Pulmonary-Allergy 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: Pulmonary-Allergy 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 January 30, 2013, from 8
a.m. to 4 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. 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: Cindy Hong, 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: PADAC@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 the new drug application (NDA)
202049, for mannitol inhalation powder (proposed trade name
BRONCHITOL), for oral inhalation sponsored by Pharmaxis, for the
proposed indication of management of cystic fibrosis in patients aged 6
years and older to improve pulmonary function.
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
[[Page 69637]]
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
January 14, 2013. Oral presentations from the public will be scheduled
between approximately 12:30 p.m. to 1:30 p.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 January 4, 2013. 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 January 7, 2013.
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 Cindy Hong 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: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28201 Filed 11-19-12; 8:45 am]
BILLING CODE 4160-01-P
