80 FR 30686 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 103 (May 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 103 (May 29, 2015)
| Page Range | 30686-30686 | |
| FR Document | 2015-13004 |
[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)] [Notices] [Page 30686] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-13004] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces a forthcoming meeting of public advisory committees of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. General Function of the Committees: To provide advice and recommendations to the Agency on FDA's regulatory issues. DATES: Date and Time: The meeting will be held on July 7, 2015, from 8 a.m. to 5 p.m. and July 8, 2015, from 8 a.m. to 4:30 p.m. ADDRESSES: Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 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. FOR FURTHER INFORMATION CONTACT: 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, 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 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. SUPPLEMENTARY INFORMATION: Agenda: The committees will discuss the results of post-marketing studies evaluating the misuse and/or abuse of reformulated OXYCONTIN (oxycodone hydrochloride) extended-release tablets, supplemental new drug application (sNDA) 022272, manufactured by Purdue Pharma L.P. The committees will discuss whether these studies have demonstrated that the reformulated OXYCONTIN product has had a meaningful impact on abuse of OXYCONTIN. 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 http://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 June 22, 2015. Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 10:30 a.m. on July 8, 2015. 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 June 12, 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 June 15, 2015. 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: May 26, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-13004 Filed 5-28-15; 8:45 am] BILLING CODE 4164-01-P
![30686 Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices
publication of this document in the Center for Drug Evaluation and proposed participants, and an
Federal Register. Therefore, a comment Research, Food and Drug indication of the approximate time
is best assured of having its full effect Administration, 10903 New Hampshire requested to make their presentation on
if OMB receives it within 30 days of Ave. Bldg. 31, Rm. 2417, Silver Spring, or before June 12, 2015. Time allotted
publication. Written comments and MD 20993–0002, 301–796–9001, FAX: for each presentation may be limited. If
recommendations for the proposed 301–847–8533, AADPAC@fda.hhs.gov, the number of registrants requesting to
information collection should be sent or FDA Advisory Committee speak is greater than can be reasonably
directly to the following: Office of Information Line, 1–800–741–8138 accommodated during the scheduled
Management and Budget, Paperwork (301–443–0572 in the Washington, DC open public hearing session, FDA may
Reduction Project, Fax: 202–395–7285, area). A notice in the Federal Register conduct a lottery to determine the
Email: OIRA_SUBMISSION@ about last minute modifications that speakers for the scheduled open public
OMB.EOP.GOV, Attn: Desk Officer for impact a previously announced hearing session. The contact person will
the Administration for Children and advisory committee meeting cannot notify interested persons regarding their
Families. always be published quickly enough to request to speak by June 15, 2015.
provide timely notice. Therefore, you Persons attending FDA’s advisory
Robert Sargis, committee meetings are advised that the
should always check the Agency’s Web
Reports Clearance Officer. Agency is not responsible for providing
site at http://www.fda.gov/
[FR Doc. 2015–13009 Filed 5–28–15; 8:45 am] access to electrical outlets.
AdvisoryCommittees/default.htm and
BILLING CODE 4184–01–P scroll down to the appropriate advisory FDA welcomes the attendance of the
committee meeting link, or call the public at its advisory committee
advisory committee information line to meetings and will make every effort to
DEPARTMENT OF HEALTH AND accommodate persons with physical
learn about possible modifications
HUMAN SERVICES disabilities or special needs. If you
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
require special accommodations due to
Food and Drug Administration a disability, please contact Stephanie L.
Agenda: The committees will discuss
[Docket No. FDA–2015–N–0001]
the results of post-marketing studies Begansky at least 7 days in advance of
evaluating the misuse and/or abuse of the meeting.
Joint Meeting of the Drug Safety and FDA is committed to the orderly
Risk Management Advisory Committee reformulated OXYCONTIN (oxycodone
conduct of its advisory committee
and the Anesthetic and Analgesic Drug hydrochloride) extended-release tablets,
meetings. Please visit our Web site at
Products Advisory Committee; Notice supplemental new drug application
http://www.fda.gov/
of Meeting (sNDA) 022272, manufactured by
AdvisoryCommittees/
Purdue Pharma L.P. The committees
AGENCY: Food and Drug Administration, AboutAdvisoryCommittees/
will discuss whether these studies have
HHS. ucm111462.htm for procedures on
demonstrated that the reformulated
public conduct during advisory
ACTION: Notice. OXYCONTIN product has had a
committee meetings.
meaningful impact on abuse of Notice of this meeting is given under
SUMMARY: This notice announces a OXYCONTIN.
forthcoming meeting of public advisory the Federal Advisory Committee Act (5
FDA intends to make background U.S.C. app. 2).
committees of the Food and Drug material available to the public no later
Administration (FDA). The meeting will than 2 business days before the meeting. Dated: May 26, 2015.
be open to the public. If FDA is unable to post the background Jill Hartzler Warner,
Name of Committees: Drug Safety and Associate Commissioner for Special Medical
material on its Web site prior to the
Risk Management Advisory Committee Programs.
meeting, the background material will
and the Anesthetic and Analgesic Drug [FR Doc. 2015–13004 Filed 5–28–15; 8:45 am]
be made publicly available at the
Products Advisory Committee.
General Function of the Committees: location of the advisory committee BILLING CODE 4164–01–P
To provide advice and meeting, and the background material
recommendations to the Agency on will be posted on FDA’s Web site after
the meeting. Background material is DEPARTMENT OF HEALTH AND
FDA’s regulatory issues. HUMAN SERVICES
available at http://www.fda.gov/
DATES: Date and Time: The meeting will
AdvisoryCommittees/Calendar/
be held on July 7, 2015, from 8 a.m. to Food and Drug Administration
default.htm. Scroll down to the
5 p.m. and July 8, 2015, from 8 a.m. to appropriate advisory committee meeting [Docket No. FDA–2008–N–0500]
4:30 p.m. link.
ADDRESSES: Location: FDA White Oak Procedure: Interested persons may Agency Information Collection
Campus, 10903 New Hampshire Ave., present data, information, or views, Activities; Submission for Office of
Building 31 Conference Center, the orally or in writing, on issues pending Management and Budget Review;
Great Room (Rm. 1503), Silver Spring, before the committee. Written Comment Request; Requirements on
MD 20993–0002. Answers to commonly submissions may be made to the contact Content and Format of Labeling for
asked questions including information person on or before June 22, 2015. Oral Human Prescription Drug and
regarding special accommodations due presentations from the public will be Biological Products
to a disability, visitor parking, and scheduled between approximately 8:30
transportation may be accessed at AGENCY: Food and Drug Administration,
Lhorne on DSK2VPTVN1PROD with NOTICES
a.m. and 10:30 a.m. on July 8, 2015. HHS.
http://www.fda.gov/ Those individuals interested in making
AdvisoryCommittees/ ACTION: Notice.
formal oral presentations should notify
AboutAdvisoryCommittees/ the contact person and submit a brief SUMMARY: The Food and Drug
ucm408555.htm. statement of the general nature of the Administration (FDA) is announcing
FOR FURTHER INFORMATION CONTACT: evidence or arguments they wish to that a proposed collection of
Contact Person: Stephanie L. Begansky, present, the names and addresses of information has been submitted to the
VerDate Sep<11>2014 15:17 May 28, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\29MYN1.SGM 29MYN1](https://thefederalregister.org/doc/80_FR_30789/page/1.svg)
Document Created: 2015-12-15 15:31:11
Document Modified: 2015-12-15 15:31:11
| 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. | |
| Dates | Date and Time: The meeting will be held on July 7, 2015, from 8 a.m. to 5 p.m. and July 8, 2015, from 8 a.m. to 4:30 p.m. | |
| Contact | 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 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. | |
| FR Citation | 80 FR 30686 |
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