80 FR 47926 - Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 153 (August 10, 2015)

Page Range		47926-47927
FR Document		2015-19547

Federal Register, Volume 80 Issue 153 (Monday, August 10, 2015)

[Federal Register Volume 80, Number 153 (Monday, August 10, 2015)]
[Notices]
[Pages 47926-47927]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19547]


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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.

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    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: http://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: [email protected], 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 http://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 http://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: http://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

47926 Federal Register / Vol. 80, No. 153 / Monday, August 10, 2015 / Notices

based Work Plan Tool. The estimated Tool is estimated to be four hours per annual basis to satisfy routine
burden per response is three hours for response. Initial population of the tools cooperative agreement reporting
each Annual Work Plan Progress report. is a one-time activity which is requirements. CDC will use the
In addition, each awardee will submit annualized over the three years of the information collected to monitor each
an Annual Budget Progress Report using information collection request. Due to awardee’s progress and to identify
an Excel-based Budget Tool. The annualization, the 53 awardees are facilitators and challenges to program
estimated burden per response is two represented as 18 awardees (53/3) in the implementation and achievement of
hours for each Annual Budget Progress burden table. After completing the outcomes.
Report. initial population of the tools, pertinent OMB approval is requested for three
In Year one, each awardee will have information only needs to be updated years. Participation in the information
additional burden related to initial for each annual report. The same collection is required as a condition of
population of the reporting tools. Initial instruments will be used for all funding. There are no costs to
population of the Work Plan Tool is information collection and reporting. respondents other than their time. The
estimated to be six hours per response, Awardees will upload their total estimated annualized burden hours
and initial population of the Budget information to www.grants.gov on an are 445.

ESTIMATED ANNUALIZED BURDEN HOURS
Number Number of Average burden
Type of respondent Form name of responses per per response
respondents respondent (in hours)

State Tobacco Control Managers .......... Initial Population of the Work Plan Tool 18 1 6
Annual Work Plan Progress Report ...... 53 1 3
Initial Population of the Budget Tool ..... 18 1 4
Annual Budget Progress Report ........... 53 1 2

Leroy A. Richardson, Date and Time: The meeting will be Agenda: The committees will be
Chief, Information Collection Review Office, held on September 10, 2015, from 8 a.m. asked to discuss new drug application
Office of Scientific Integrity, Office of the to 5 p.m. (NDA) 206830, oxycodone immediate-
Associate Director for Science, Office of the release tablets, submitted by Purdue
Director, Centers for Disease Control and Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Pharma, with the proposed indication of
Prevention. the management of moderate to severe
[FR Doc. 2015–19579 Filed 8–7–15; 8:45 am] Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002. pain where the use of an opioid
BILLING CODE 4163–18–P
Answers to commonly asked questions analgesic is appropriate. It has been
formulated with the intent to provide
including information regarding special
abuse-deterrent properties. The
DEPARTMENT OF HEALTH AND accommodations due to a disability,
pharmacokinetic data demonstrate that
HUMAN SERVICES visitor parking, and transportation may
there is a significant food effect
be accessed at: http://www.fda.gov/
Food and Drug Administration resulting in a significant delay in
AdvisoryCommittees/
absorption and peak plasma
AboutAdvisoryCommittees/ concentration of oxycodone when taken
[Docket No. FDA–2015–N–0001] ucm408555.htm. with food. The applicant proposes to
Contact Person: Stephanie L. address this finding by labeling the
Joint Meeting of the Anesthetic and Begansky, Center for Drug Evaluation product to be taken on an empty
Analgesic Drug Products Advisory
and Research, Food and Drug stomach, but patients may have
Committee and the Drug Safety and
Administration, 10903 New Hampshire difficulty complying with these
Risk Management Advisory
Ave., Bldg. 31, Rm. 2417, Silver Spring, instructions as the product is dosed
Committee; Notice of Meeting
MD 20993–0002, 301–796–9001, FAX: every 4 to 6 hours as needed. The
AGENCY: Food and Drug Administration, 301–847–8533, email: AADPAC@ committees will be asked to discuss the
HHS. fda.hhs.gov, or FDA Advisory potential safety risks and the potential
Committee Information Line, 1–800– effects on efficacy associated with the
ACTION: Notice. 741–8138 (301–443–0572 in the delayed peak concentration when taken
Washington, DC area). A notice in the with food, and the feasibility of labeling
This notice announces a forthcoming Federal Register about last minute to be taken an empty stomach as a
meeting of two public advisory modifications that impact a previously means to mitigate the potential risks.
committees of the Food and Drug announced advisory committee meeting The committees will also be asked to
Administration (FDA). At least one cannot always be published quickly consider whether the potential public
portion of the meeting will be closed to enough to provide timely notice. health benefit of the product’s abuse-
the public. Therefore, you should always check the deterrent properties are sufficient to
Names of Committees: Anesthetic and Agency’s Web site at http:// outweigh the risk to patients who are
Analgesic Drug Products Advisory prescribed the product for the
tkelley on DSK3SPTVN1PROD with NOTICES

www.fda.gov/AdvisoryCommittees/
Committee and the Drug Safety and Risk default.htm and scroll down to the management of pain.
Management Advisory Committee. appropriate advisory committee meeting FDA intends to make background
General Function of the Committees: link, or call the advisory committee material available to the public no later
To provide advice and information line to learn about possible than 2 business days before the meeting.
recommendations to the Agency on modifications before coming to the If FDA is unable to post the background
FDA’s regulatory issues. meeting. material on its Web site prior to the

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Document Created: 2015-12-15 12:12:49
Document Modified: 2015-12-15 12:12:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
FR Citation		80 FR 47926

80 FR 47926 - Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 153 (August 10, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration