Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 59782-59783 [2014-23548]
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59782
Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
FDA acknowledges that according to
the CLIA (Clinical Laboratory
Improvement Amendments) program at
CMS (August 2014), there are
approximately 11,000 CLIA-certified
high complexity labs that have the
appropriate certifications to
manufacture LDTs. However, FDA is not
aware of information describing the
exact number of certified high
complexity laboratories currently
offering LDTs. Therefore, FDA has
relied upon the information provided by
New York State when creating these
estimates. FDA acknowledges that,
without firm data on the number of labs
offering LDTs or the number of tests
offered per lab, the estimate of the
number of respondents is necessarily
uncertain.
After the initial notification,
respondents will only notify FDA of
new tests or modifications that affect
performance or intended use. We
estimate the number of tests in
subsequent years to be approximately 5
percent of the estimated number of
initial notifications.
FDA bases its estimate of the average
burden per response on Agency creation
of a mock notification. We would expect
labs to take up to an hour for their first
notification and only 30 minutes for
subsequent notifications, due to
familiarity with the system.
Therefore, we estimate the total
reporting burden to respondents to be
5,850 hours for the first year and 325
hours for subsequent years.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 803
(medical device reporting) have been
approved under OMB control numbers
0910–0291 and 0910–0437; the
collections of information in 21 CFR
part 806 (reports of corrections and
removals) have been approved under
OMB control number 0910–0359; and
the collections of information in 21 CFR
part 807, subparts B and C (registration
and listing) have been approved under
OMB control number 0910–0625.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
VerDate Sep<11>2014
18:08 Oct 02, 2014
Jkt 235001
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, and
will be posted to the docket at https://
www.regulations.gov.
Comments will also be accepted at a
public meeting, which will be held prior
to finalizing this draft guidance. A 2-day
meeting is tentatively scheduled for
early January 2015 and will be
announced separately in the Federal
Register.
Dated: September 29, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–23586 Filed 9–30–14; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–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: 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 October 21, 2014, from 8 a.m.
to 4 p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (Rm. 1503), 10903
New Hampshire Ave., 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/Advisory
Committees/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:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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
supplemental new drug application
(sNDA) 203188, ivacaftor oral tablets,
submitted by Vertex Pharmaceuticals
Inc., for the treatment of cystic fibrosis
in patients with an R117H mutation in
the cystic fibrosis transmembrane
conductance regulator gene.
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 October 14, 2014.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 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 October
6, 2014. 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
E:\FR\FM\03OCN1.SGM
03OCN1
Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices
notify interested persons regarding their
request to speak by October 7, 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 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/Advisory
Committees/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: September 26, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–23548 Filed 10–2–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2014–N–0001]
Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD 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: Anesthetic and
Analgesic Drug Products 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 November 24, 2014, from 8 a.m.
to 5 p.m. and November 25, 2014, from
8 a.m. to 12 noon.
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
VerDate Sep<11>2014
18:08 Oct 02, 2014
Jkt 235001
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: Stephanie L.
Begansky, 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: AADPAC@
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 risk of serious neurologic adverse
reactions associated with epidural
steroid injections (ESI) administered to
reduce inflammation for pain
management. The committee will also
consider the efficacy of ESI and the
overall risk benefit balance of injecting
steroids in the epidural space to treat
pain. These considerations will assist
the Agency in our discussions of
possible regulatory options, including
but not limited to changes to the
product labeling.
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 November 7, 2014.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
59783
Oral presentations from the public will
be scheduled between approximately 2
p.m. and 3:30 p.m. on November 24,
2014. 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 October 30, 2014. 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
October 31, 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 Stephanie L.
Begansky 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/Advisory
Committees/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: September 26, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–23549 Filed 10–2–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2014–0414]
Cook Inlet Regional Citizens’ Advisory
Council (CIRCAC) Charter Renewal
Coast Guard, DHS.
Notice of recertification.
AGENCY:
ACTION:
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 79, Number 192 (Friday, October 3, 2014)]
[Notices]
[Pages 59782-59783]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23548]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-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 October 21, 2014, from 8
a.m. to 4 p.m.
Location: FDA White Oak Campus, Building 31, the Great Room, White
Oak Conference Center (Rm. 1503), 10903 New Hampshire Ave., 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 supplemental new drug
application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex
Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients
with an R117H mutation in the cystic fibrosis transmembrane conductance
regulator gene.
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
October 14, 2014. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 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 October 6, 2014. 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
[[Page 59783]]
notify interested persons regarding their request to speak by October
7, 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 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: September 26, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-23548 Filed 10-2-14; 8:45 am]
BILLING CODE 4164-01-P
