Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting, 47926-47927 [2015-19547]
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47926
Federal Register / Vol. 80, No. 153 / Monday, August 10, 2015 / Notices
based Work Plan Tool. The estimated
burden per response is three hours for
each Annual Work Plan Progress report.
In addition, each awardee will submit
an Annual Budget Progress Report using
an Excel-based Budget Tool. The
estimated burden per response is two
hours for each Annual Budget Progress
Report.
In Year one, each awardee will have
additional burden related to initial
population of the reporting tools. Initial
population of the Work Plan Tool is
estimated to be six hours per response,
and initial population of the Budget
Tool is estimated to be four hours per
response. Initial population of the tools
is a one-time activity which is
annualized over the three years of the
information collection request. Due to
annualization, the 53 awardees are
represented as 18 awardees (53/3) in the
burden table. After completing the
initial population of the tools, pertinent
information only needs to be updated
for each annual report. The same
instruments will be used for all
information collection and reporting.
Awardees will upload their
information to www.grants.gov on an
annual basis to satisfy routine
cooperative agreement reporting
requirements. CDC will use the
information collected to monitor each
awardee’s progress and to identify
facilitators and challenges to program
implementation and achievement of
outcomes.
OMB approval is requested for three
years. Participation in the information
collection is required as a condition of
funding. There are no costs to
respondents other than their time. The
total estimated annualized burden hours
are 445.
ESTIMATED ANNUALIZED BURDEN HOURS
Number
of
respondents
Type of respondent
Form name
State Tobacco Control Managers ..........
Initial Population of the Work Plan Tool
Annual Work Plan Progress Report ......
Initial Population of the Budget Tool .....
Annual Budget Progress Report ...........
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–19579 Filed 8–7–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Joint Meeting of the Anesthetic and
Analgesic Drug Products Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of two public advisory
committees of the Food and Drug
Administration (FDA). At least one
portion of the meeting will be closed to
the public.
Names of Committees: Anesthetic and
Analgesic Drug Products Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
VerDate Sep<11>2014
18:16 Aug 07, 2015
Jkt 235001
18
53
18
53
Date and Time: The meeting will be
held on September 10, 2015, from 8 a.m.
to 5 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: 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.
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average burden
per response
(in hours)
1
1
1
1
6
3
4
2
Agenda: The committees will be
asked to discuss new drug application
(NDA) 206830, oxycodone immediaterelease tablets, submitted by Purdue
Pharma, with the proposed indication of
the management of moderate to severe
pain where the use of an opioid
analgesic is appropriate. It has been
formulated with the intent to provide
abuse-deterrent properties. The
pharmacokinetic data demonstrate that
there is a significant food effect
resulting in a significant delay in
absorption and peak plasma
concentration of oxycodone when taken
with food. The applicant proposes to
address this finding by labeling the
product to be taken on an empty
stomach, but patients may have
difficulty complying with these
instructions as the product is dosed
every 4 to 6 hours as needed. The
committees will be asked to discuss the
potential safety risks and the potential
effects on efficacy associated with the
delayed peak concentration when taken
with food, and the feasibility of labeling
to be taken an empty stomach as a
means to mitigate the potential risks.
The committees will also be asked to
consider whether the potential public
health benefit of the product’s abusedeterrent properties are sufficient to
outweigh the risk to patients who are
prescribed the product for the
management of pain.
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
E:\FR\FM\10AUN1.SGM
10AUN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 153 / Monday, August 10, 2015 / Notices
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: On September 10, 2015,
from 9:30 a.m. to 5 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 committees. Written
submissions may be made to the contact
person on or before August 26, 2015.
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 August
18, 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 August 19, 2015.
Closed Presentation of Data: On
September 10, 2015, from 8 a.m. to 9:30
a.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 committees will
discuss the drug development program
of an investigational product.
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/
AdvisoryCommittees/
VerDate Sep<11>2014
18:16 Aug 07, 2015
Jkt 235001
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: August 4, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–19547 Filed 8–7–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Joint Meeting of the Anesthetic and
Analgesic Drug Products Advisory
Committee and the Drug Safety and
Risk Management 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 Committees: Joint meeting of
the Anesthetic and Analgesic Drug
Products Advisory Committee and the
Drug Safety and Risk Management
Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 11, 2015, from 8 a.m.
to 5 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: 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–
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
47927
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 committees will discuss
new drug application (NDA) 208090,
oxycodone extended-release capsules
for oral use, submitted by Collegium
Pharmaceuticals, proposed for the
management of pain severe enough to
require daily, around-the-clock, longterm opioid treatment and for which
alternative options are inadequate. This
product has been formulated with the
intent to provide abuse-deterrent
properties. Pharmacokinetic data
demonstrate that, in order to deliver the
intended amount of oxycodone, the
drug product must be taken with food.
The committees will be asked to discuss
the potential safety risks and the
potential effects on efficacy associated
with the extent of the food effect, and
potential fluctuations in oxycodone
levels that may occur if the product is
not taken consistently with the same
amount of food. In addition, the
committees will be asked to review and
discuss whether the data characterizing
the abuse-deterrent properties support
the likelihood that this drug product
will have a meaningful effect on abuse
and whether potential benefits to the
public from abuse-deterrent properties
outweigh potential risks to patients from
the effect of food. The committees will
be asked to vote on whether this
product should be approved for
marketing in the United States.
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: On September 11, 2015,
from 9:30 a.m. to 5 p.m., the meeting is
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 80, Number 153 (Monday, August 10, 2015)]
[Notices]
[Pages 47926-47927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19547]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Joint Meeting of the Anesthetic and Analgesic Drug Products
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of two public advisory
committees of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
Names of Committees: Anesthetic and Analgesic Drug Products
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee.
General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 10, 2015, from
8 a.m. to 5 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: 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 committees will be asked to discuss new drug
application (NDA) 206830, oxycodone immediate-release tablets,
submitted by Purdue Pharma, with the proposed indication of the
management of moderate to severe pain where the use of an opioid
analgesic is appropriate. It has been formulated with the intent to
provide abuse-deterrent properties. The pharmacokinetic data
demonstrate that there is a significant food effect resulting in a
significant delay in absorption and peak plasma concentration of
oxycodone when taken with food. The applicant proposes to address this
finding by labeling the product to be taken on an empty stomach, but
patients may have difficulty complying with these instructions as the
product is dosed every 4 to 6 hours as needed. The committees will be
asked to discuss the potential safety risks and the potential effects
on efficacy associated with the delayed peak concentration when taken
with food, and the feasibility of labeling to be taken an empty stomach
as a means to mitigate the potential risks. The committees will also be
asked to consider whether the potential public health benefit of the
product's abuse-deterrent properties are sufficient to outweigh the
risk to patients who are prescribed the product for the management of
pain.
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
[[Page 47927]]
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: On September 10, 2015, from 9:30 a.m. to 5 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 committees. Written submissions may be made to the contact person
on or before August 26, 2015. 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 August 18, 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 August 19, 2015.
Closed Presentation of Data: On September 10, 2015, from 8 a.m. to
9:30 a.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 committees will discuss the drug
development program of an investigational product.
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/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: August 4, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-19547 Filed 8-7-15; 8:45 am]
BILLING CODE 4164-01-P
