80 FR 79047 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 243 (December 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 243 (December 18, 2015)
| Page Range | 79047-79047 | |
| FR Document | 2015-31825 |
[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)] [Notices] [Page 79047] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31825] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 January 22, 2016, from 8 a.m. to 5:30 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: Moon Hee V. Choi, 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. Agenda: The committee will discuss new drug application 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. 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 January 7, 2016. Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 2:40 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 December 29, 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 December 30, 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 disabilities. If you require accommodations due to a disability, please contact Moon Hee V. Choi 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: December 11, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-31825 Filed 12-17-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices 79047
and 60 days after publication of this in the Washington, DC area). A notice in Persons attending FDA’s advisory
document in the Federal Register. the Federal Register about last minute committee meetings are advised that the
Therefore, a comment is best assured of modifications that impact a previously Agency is not responsible for providing
having its full effect if OMB receives it announced advisory committee meeting access to electrical outlets.
within 30 days of publication. Written cannot always be published quickly FDA welcomes the attendance of the
comments and recommendations for the enough to provide timely notice. public at its advisory committee
proposed information collection should Therefore, you should always check the meetings and will make every effort to
be sent directly to the following: Office Agency’s Web site at http://www.fda. accommodate persons with disabilities.
of Management and Budget, Paperwork gov/AdvisoryCommittees/default.htm If you require accommodations due to a
Reduction Project, Email: OIRA_ and scroll down to the appropriate disability, please contact Moon Hee V.
SUBMISSION@OMB.EOP.GOV, Attn: advisory committee meeting link, or call Choi at least 7 days in advance of the
Desk Officer for the Administration for the advisory committee information line meeting.
Children and Families. to learn about possible modifications FDA is committed to the orderly
before coming to the meeting. conduct of its advisory committee
Robert Sargis,
Agenda: The committee will discuss meetings. Please visit our Web site at
Reports Clearance Officer. http://www.fda.gov/Advisory
new drug application 206488, eteplirsen
[FR Doc. 2015–31774 Filed 12–17–15; 8:45 am] Committees/AboutAdvisoryCommittees/
injection for intravenous infusion,
BILLING CODE 4184–01–P sponsored by Sarepta Therapeutics, Inc., ucm111462.htm for procedures on
for the treatment of Duchenne muscular public conduct during advisory
dystrophy (DMD) in patients who have committee meetings.
DEPARTMENT OF HEALTH AND a confirmed mutation of the DMD gene Notice of this meeting is given under
HUMAN SERVICES that is amenable to exon 51 skipping. the Federal Advisory Committee Act (5
Food and Drug Administration FDA intends to make background U.S.C. app. 2).
material available to the public no later Dated: December 11, 2015.
[Docket No. FDA–2015–N–0001] than 2 business days before the meeting. Jill Hartzler Warner,
If FDA is unable to post the background Associate Commissioner for Special Medical
Peripheral and Central Nervous
material on its Web site prior to the Programs.
System Drugs Advisory Committee;
meeting, the background material will [FR Doc. 2015–31825 Filed 12–17–15; 8:45 am]
Notice of Meeting
be made publicly available at the
BILLING CODE 4164–01–P
AGENCY: Food and Drug Administration, location of the advisory committee
HHS. meeting, and the background material
ACTION: Notice. will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
the meeting. Background material is HUMAN SERVICES
This notice announces a forthcoming available at http://www.fda.gov/
meeting of a public advisory committee AdvisoryCommittees/Calendar/ Food and Drug Administration
of the Food and Drug Administration default.htm. Scroll down to the
[Docket No. FDA–2013–E–0474]
(FDA). The meeting will be open to the appropriate advisory committee meeting
public. link. Determination of Regulatory Review
Name of Committee: Peripheral and Procedure: Interested persons may Period for Purposes of Patent
Central Nervous System Drugs Advisory present data, information, or views, Extension; XTANDI
Committee. orally or in writing, on issues pending
General Function of the Committee: before the committee. Written AGENCY: Food and Drug Administration,
To provide advice and submissions may be made to the contact HHS.
recommendations to the Agency on person on or before January 7, 2016. ACTION: Notice.
FDA’s regulatory issues. Oral presentations from the public will
Date and Time: The meeting will be be scheduled between approximately SUMMARY: The Food and Drug
held on January 22, 2016, from 8 a.m. 12:40 p.m. and 2:40 p.m. Those Administration (FDA) has determined
to 5:30 p.m. individuals interested in making formal the regulatory review period for
Location: FDA White Oak Campus, oral presentations should notify the XTANDI and is publishing this notice of
10903 New Hampshire Ave., Bldg. 31 contact person and submit a brief that determination as required by law.
Conference Center, the Great Room (Rm. statement of the general nature of the FDA has made the determination
1503), Silver Spring, MD 20993–0002. evidence or arguments they wish to because of the submission of an
Answers to commonly asked questions present, the names and addresses of application to the Director of the U.S.
including information regarding special proposed participants, and an Patent and Trademark Office (USPTO),
accommodations due to a disability, indication of the approximate time Department of Commerce, for the
visitor parking, and transportation may requested to make their presentation on extension of a patent which claims that
be accessed at: http://www.fda.gov/ or before December 29, 2015. Time human drug product.
AdvisoryCommittees/AboutAdvisory allotted for each presentation may be DATES: Anyone with knowledge that any
Committees/ucm408555.htm. limited. If the number of registrants of the dates as published (in the
Contact Person: Moon Hee V. Choi, requesting to speak is greater than can SUPPLEMENTARY INFORMATION section) are
mstockstill on DSK4VPTVN1PROD with NOTICES
Center for Drug Evaluation and be reasonably accommodated during the incorrect may submit either electronic
Research, Food and Drug scheduled open public hearing session, or written comments and ask for a
Administration, 10903 New Hampshire FDA may conduct a lottery to determine redetermination by February 16, 2016.
Ave., Bldg. 31, rm. 2417, Silver Spring, the speakers for the scheduled open Furthermore, any interested person may
MD 20993–0002, 301–796–9001, FAX: public hearing session. The contact petition FDA for a determination
301–847–8533, PCNS@fda.hhs.gov, or person will notify interested persons regarding whether the applicant for
FDA Advisory Committee Information regarding their request to speak by extension acted with due diligence
Line, 1–800–741–8138 (301–443–0572 December 30, 2015. during the regulatory review period by
VerDate Sep<11>2014 19:20 Dec 17, 2015 Jkt 238001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1](https://thefederalregister.org/doc/80_FR_79290/page/1.svg)
Document Created: 2015-12-18 01:38:54
Document Modified: 2015-12-18 01:38:54
| 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 79047 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR