80 FR 47927 - 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)
Food and Drug Administration
Federal Register Volume 80, Issue 153 (August 10, 2015)
| Page Range | 47927-47928 | |
| FR Document | 2015-19548 |
[Federal Register Volume 80, Number 153 (Monday, August 10, 2015)] [Notices] [Pages 47927-47928] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19548] ----------------------------------------------------------------------- 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 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 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, long-term 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 http://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 [[Page 47928]] 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 27, 2015. Oral presentations from the public will be scheduled approximately between 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 19, 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 20, 2015. Closed Presentation of Data: On September 11, 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. 2015-19548 Filed 8-7-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 153 / Monday, August 10, 2015 / Notices 47927
meeting, the background material will AboutAdvisoryCommittees/ 741–8138 (301–443–0572 in the
be made publicly available at the ucm111462.htm for procedures on Washington, DC area). A notice in the
location of the advisory committee public conduct during advisory Federal Register about last minute
meeting, and the background material committee meetings. modifications that impact a previously
will be posted on FDA’s Web site after Notice of this meeting is given under announced advisory committee meeting
the meeting. Background material is the Federal Advisory Committee Act (5 cannot always be published quickly
available at http://www.fda.gov/ U.S.C. app. 2). enough to provide timely notice.
AdvisoryCommittees/Calendar/ Dated: August 4, 2015. Therefore, you should always check the
default.htm. Scroll down to the Jill Hartzler Warner, Agency’s Web site at http://
appropriate advisory committee meeting www.fda.gov/AdvisoryCommittees/
Associate Commissioner for Special Medical
link. Programs. default.htm and scroll down to the
Procedure: On September 10, 2015, appropriate advisory committee meeting
[FR Doc. 2015–19547 Filed 8–7–15; 8:45 am]
from 9:30 a.m. to 5 p.m., the meeting is link, or call the advisory committee
BILLING CODE 4164–01–P
open to the public. Interested persons information line to learn about possible
may present data, information, or views, modifications before coming to the
orally or in writing, on issues pending meeting.
DEPARTMENT OF HEALTH AND
before the committees. Written Agenda: The committees will discuss
HUMAN SERVICES
submissions may be made to the contact new drug application (NDA) 208090,
person on or before August 26, 2015. Food and Drug Administration oxycodone extended-release capsules
Oral presentations from the public will for oral use, submitted by Collegium
be scheduled between approximately 1 [Docket No. FDA–2015–N–0001] Pharmaceuticals, proposed for the
p.m. and 2 p.m. Those individuals management of pain severe enough to
interested in making formal oral Joint Meeting of the Anesthetic and require daily, around-the-clock, long-
presentations should notify the contact Analgesic Drug Products Advisory term opioid treatment and for which
person and submit a brief statement of Committee and the Drug Safety and alternative options are inadequate. This
the general nature of the evidence or Risk Management Advisory product has been formulated with the
arguments they wish to present, the Committee; Notice of Meeting intent to provide abuse-deterrent
names and addresses of proposed AGENCY: Food and Drug Administration, properties. Pharmacokinetic data
participants, and an indication of the HHS. demonstrate that, in order to deliver the
approximate time requested to make ACTION: Notice. intended amount of oxycodone, the
their presentation on or before August drug product must be taken with food.
18, 2015. Time allotted for each This notice announces a forthcoming The committees will be asked to discuss
presentation may be limited. If the meeting of a public advisory committee the potential safety risks and the
number of registrants requesting to of the Food and Drug Administration potential effects on efficacy associated
speak is greater than can be reasonably (FDA). At least one portion of the with the extent of the food effect, and
accommodated during the scheduled meeting will be closed to the public. potential fluctuations in oxycodone
open public hearing session, FDA may Name of Committees: Joint meeting of levels that may occur if the product is
conduct a lottery to determine the the Anesthetic and Analgesic Drug not taken consistently with the same
speakers for the scheduled open public Products Advisory Committee and the amount of food. In addition, the
hearing session. The contact person will Drug Safety and Risk Management committees will be asked to review and
notify interested persons regarding their Advisory Committee. discuss whether the data characterizing
request to speak by August 19, 2015. General Function of the Committees: the abuse-deterrent properties support
Closed Presentation of Data: On To provide advice and the likelihood that this drug product
September 10, 2015, from 8 a.m. to 9:30 recommendations to the Agency on will have a meaningful effect on abuse
a.m., the meeting will be closed to FDA’s regulatory issues. and whether potential benefits to the
permit discussion and review of trade Date and Time: The meeting will be public from abuse-deterrent properties
secret and/or confidential commercial held on September 11, 2015, from 8 a.m. outweigh potential risks to patients from
information (5 U.S.C. 552b(c)(4)). to 5 p.m. the effect of food. The committees will
During this session, the committees will Location: FDA White Oak Campus, be asked to vote on whether this
discuss the drug development program 10903 New Hampshire Ave., Bldg. 31 product should be approved for
of an investigational product. Conference Center, the Great Room (Rm. marketing in the United States.
Persons attending FDA’s advisory 1503), Silver Spring, MD 20993–0002. FDA intends to make background
committee meetings are advised that the Answers to commonly asked questions material available to the public no later
Agency is not responsible for providing including information regarding special than 2 business days before the meeting.
access to electrical outlets. accommodations due to a disability, If FDA is unable to post the background
FDA welcomes the attendance of the visitor parking, and transportation may material on its Web site prior to the
public at its advisory committee be accessed at http://www.fda.gov/ meeting, the background material will
meetings and will make every effort to AdvisoryCommittees/ be made publicly available at the
accommodate persons with physical AboutAdvisoryCommittees/ location of the advisory committee
disabilities or special needs. If you ucm408555.htm. meeting, and the background material
require special accommodations due to Contact Person: Stephanie L. will be posted on FDA’s Web site after
a disability, please contact Stephanie L. Begansky, Center for Drug Evaluation the meeting. Background material is
tkelley on DSK3SPTVN1PROD with NOTICES
Begansky at least 7 days in advance of and Research, Food and Drug available at http://www.fda.gov/
the meeting. Administration, 10903 New Hampshire AdvisoryCommittees/Calendar/
FDA is committed to the orderly Ave., Bldg. 31, Rm. 2417, Silver Spring, default.htm. Scroll down to the
conduct of its advisory committee MD 20993–0002, 301–796–9001, Fax: appropriate advisory committee meeting
meetings. Please visit our Web site at: 301–847–8533, email: AADPAC@ link.
http://www.fda.gov/ fda.hhs.gov, or FDA Advisory Procedure: On September 11, 2015,
AdvisoryCommittees/ Committee Information Line, 1–800– from 9:30 a.m. to 5 p.m., the meeting is
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![47928 Federal Register / Vol. 80, No. 153 / Monday, August 10, 2015 / Notices
open to the public. Interested persons AboutAdvisoryCommittees/ Amount of Non-Competitive Awards:
may present data, information, or views, ucm111462.htm for procedures on $85,451,535.
orally or in writing, on issues pending public conduct during advisory Period of Supplemental Funding:
before the committees. Written committee meetings. December 1, 2015, to maximum April
submissions may be made to the contact Notice of this meeting is given under 30, 2016.
person on or before August 27, 2015. the Federal Advisory Committee Act (5
Oral presentations from the public will U.S.C. app. 2). CFDA Number: 93.224.
be scheduled approximately between 1 Dated: August 4, 2015. Authority: Section 330 of the Public
p.m. and 2 p.m. Those individuals Jill Hartzler Warner, Health Service Act, as amended (42 U.S.C.
interested in making formal oral 254b, as amended).
Associate Commissioner for Special Medical
presentations should notify the contact Programs.
person and submit a brief statement of Justification: Targeting the nation’s
[FR Doc. 2015–19548 Filed 8–7–15; 8:45 am] neediest populations and geographic
the general nature of the evidence or
BILLING CODE 4164–01–P areas, the Health Center Program
arguments they wish to present, the
names and addresses of proposed currently funds nearly 1,300 health
participants, and an indication of the centers that operate approximately
DEPARTMENT OF HEALTH AND
approximate time requested to make 9,000 service delivery sites in every
HUMAN SERVICES
their presentation on or before August state, the District of Columbia, Puerto
19, 2015. Time allotted for each Health Resources and Services Rico, the Virgin Islands, and the Pacific
presentation may be limited. If the Administration Basin. In 2013, more than 21 million
number of registrants requesting to patients, including medically
speak is greater than can be reasonably Health Center Program underserved and uninsured patients,
accommodated during the scheduled received comprehensive, culturally
open public hearing session, FDA may AGENCY: Health Resources and Services competent, quality primary health care
conduct a lottery to determine the Administration, HHS. services through the Health Center
speakers for the scheduled open public ACTION: Notice of Class Deviation from Program award recipients. Due to the
hearing session. The contact person will Competition Requirements for the vast size of the Health Center Program,
notify interested persons regarding their Health Center Program. the active grants are distributed across
request to speak by August 20, 2015. seven budget periods that begin on the
Closed Presentation of Data: On SUMMARY: In accordance with the
Awarding Agency Grants first of the month, December through
September 11, 2015, from 8 a.m. to 9:30 June.
a.m., the meeting will be closed to Administration Manual (AAGAM)
permit discussion and review of trade Chapter 2.04.103, the Bureau of Primary BPHC uses the information award
secret and/or confidential commercial Health Care (BPHC) has been granted a recipients report annually via the
information (5 U.S.C. 552b(c)(4)). class deviation from the exceptions to Uniform Data System (UDS) to
During this session, the committees will maximum competition requirements objectively determine the patient and
discuss the drug development program contained in the AAGAM Chapter service area requirements that new and
of an investigational product. 2.04.104A–5 to provide additional continuing applications must address.
Persons attending FDA’s advisory funding without competition to the 144 The requirements are available for
committee meetings are advised that the Health Center Program award recipients applicant use in June. The deviation
Agency is not responsible for providing whose budget period ends November allows BPHC to redistribute the award
access to electrical outlets. 30, 2015, for up to 5 months. The recipients with December 1 starting
FDA welcomes the attendance of the extension allows BPHC to eliminate the dates to budget period start dates later
public at its advisory committee December 1 budget period start date by in the fiscal year, thus allowing these
meetings and will make every effort to redistributing these grants to established award recipients comparable
accommodate persons with physical start dates later in the fiscal year, opportunity to prepare and submit
disabilities or special needs. If you thereby allowing award recipients applications while allowing BPHC to
require special accommodations due to comparable opportunity to prepare and remain compliant with internal process
a disability, please contact Stephanie L. submit applications while allowing timelines. By September 15, 2015,
Begansky at least 7 days in advance of BPHC to remain compliant with internal $85,451,535 will be awarded to these
the meeting. process timelines. 144 award recipients to continue
FDA is committed to the orderly SUPPLEMENTARY INFORMATION: approved activities for up to 5 months.
conduct of its advisory committee Intended Recipient of the Award: Award recipients will report progress
meetings. Please visit our Web site at Health Center Program award recipients and financial obligations made during
http://www.fda.gov/ with a project period end date of their budget period extension through
AdvisoryCommittees/ November 30, 2015. routine reports.
TABLE 1—AWARD RECIPIENTS
Prorated
New budget
Grant No. Award recipient name State award amount
period start ($)
tkelley on DSK3SPTVN1PROD with NOTICES
H80CS00057 ............. The Providence Community Health Centers, Inc ....................................... RI January ............... 460,800
H80CS00058 ............. East Boston Neighborhood Health Center Corporation ............................. MA February .............. 561,147
H80CS00059 ............. Wood River Health Services, Inc ................................................................ RI May ..................... 425,646
H80CS00060 ............. East Harlem Council for Human Services, Inc ........................................... NY April ..................... 652,402
H80CS00061 ............. William F. Ryan Community Health Center, Inc ......................................... NY January ............... 691,645
H80CS00062 ............. Newark Community Health Centers, Inc .................................................... NJ February .............. 633,059
H80CS00063 ............. Consejo De Salud De Puerto Rico, Inc ...................................................... PR January ............... 733,064
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Document Created: 2015-12-15 12:12:46
Document Modified: 2015-12-15 12:12:46
| 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 47927 |
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