81 FR 13376 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 49 (March 14, 2016)

Page Range		13376-13377
FR Document		2016-05683

Federal Register, Volume 81 Issue 49 (Monday, March 14, 2016)

[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13376-13377]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Peripheral and Central Nervous System Drugs Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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 April 25, 2016, from 8 
a.m. to 5:30 p.m. This meeting is a reschedule of a postponed meeting 
announced in the Federal Register of December 18, 2015 (80 FR 79047), 
originally scheduled for January 22, 2016.
    Location: College Park Marriott Hotel and Conference Center, 
Chesapeake Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783. 
The conference center's telephone number is 301-985-7300.
    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: [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 (NDA) 
206488,

[[Page 13377]]

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 
April 11, 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 April 1, 2016. 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 April 4, 2016.
    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: March 9, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05683 Filed 3-10-16; 8:45 am]
 BILLING CODE 4164-01-P

13376 Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices

http://www.fda.gov. Send faxed requests Evaluation and Research, in co- SUPPLEMENTARY INFORMATION: ISPE is an
to 301–827–9267. sponsorship with the International association of engineers, scientists,
Dated: March 8, 2016. Society for Pharmaceutical Engineering manufacturing, quality, and industrial
Leslie Kux,
(ISPE), is announcing a meeting entitled professionals involved in the
‘‘Fifth Annual FDA–ISPE Quality development, manufacture, quality
Associate Commissioner for Policy.
Conference.’’ The purpose of the control, and regulation of
[FR Doc. 2016–05621 Filed 3–11–16; 8:45 am]
meeting is to discuss manufacturing, pharmaceuticals and related products.
BILLING CODE 4164–01–P compliance, and management practices This co-sponsored meeting facilitates
that create, implement, and sustain a discussion and problem solving around
culture of high quality and result in technical, quality, compliance, and
DEPARTMENT OF HEALTH AND
reliable pharmaceutical and biologic other manufacturing issues.
HUMAN SERVICES
products that support patient health. Registration: There is a registration fee
Food and Drug Administration DATES: The meeting will be held on June to attend this meeting. The registration
6, 7, and 8, 2016, from 8:30 a.m. to 4 fee is charged to help defray the costs
[Docket No. FDA–2016–N–0001] of programming and facilities. Seats are
p.m.
limited, and registration will be on a
The Fifth Annual Food and Drug ADDRESSES: The meeting will be held at first-come, first-served basis.
Administration-International Society the Bethesda North Marriott Hotel & To register, please complete
for Pharmaceutical Engineering Conference Center, 5701 Marinelli Rd., registration online at http://
Quality Conference Bethesda, MD 20852. www.ispe.org/events. FDA has verified
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: the Web address, but FDA is not
HHS. Susan Krys, ISPE, 7200 Wisconsin Ave., responsible for subsequent changes to
ACTION: Notice of meeting. Suite 305, Bethesda, MD 20814, 301– the Web site after this document
364–9202, FAX: 240–204–6024, email: publishes in the Federal Register. The
SUMMARY: The Food and Drug skrys@ispe.org, or Sau (Larry) Lee, 301– costs of registration for the different
Administration’s (FDA) Center for Drug 796–2905, email: Sau.Lee@fda.hhs.gov. categories of attendees are as follows:

Category Cost

Industry Representatives:
ISPE Members ........................................................................................................................................ $1,895 (early-bird); $2,095 (onsite).
Non-members .......................................................................................................................................... $2,275 (early-bird); $2,475 (onsite).
Academic ........................................................................................................................................................ $1,425 (early-bird); $1,575 (onsite).
Government .................................................................................................................................................... $700 (early-bird); $700 (onsite).

Accommodations: Attendees are DEPARTMENT OF HEALTH AND Location: College Park Marriott Hotel
responsible for their own hotel HUMAN SERVICES and Conference Center, Chesapeake
accommodations. Attendees making Ballroom, 3501 University Blvd. East,
reservations at the Bethesda North Food and Drug Administration Hyattsville, MD 20783. The conference
Marriott Hotel & Conference Center in [Docket No. FDA–2016–N–0001] center’s telephone number is 301–985–
Bethesda, MD are eligible for a reduced 7300.
rate of $209 USD, not including Peripheral and Central Nervous Contact Person: Moon Hee V. Choi,
applicable taxes. To receive the reduced System Drugs Advisory Committee; Center for Drug Evaluation and
rate, contact the Bethesda North Notice of Meeting Research, Food and Drug
Marriott Hotel (1–301–822–9200 or 1– Administration, 10903 New Hampshire
800–859–8003) and identify yourself as AGENCY: Food and Drug Administration, Ave., Bldg. 31, Rm. 2417, Silver Spring,
an attendee of the meeting. If you need HHS. MD 20993–0002, 301–796–9001, FAX:
special accommodations due to a ACTION: Notice. 301–847–8533, email: PCNS@
disability, please contact Susan Krys at fda.hhs.gov, or FDA Advisory
This notice announces a forthcoming Committee Information Line, 1–800–
least 7 days in advance.
meeting of a public advisory committee 741–8138 (301–443–0572 in the
Transcripts: We expect that of the Food and Drug Administration Washington, DC area). A notice in the
transcripts will be available (FDA). The meeting will be open to the Federal Register about last minute
approximately 30 days after the public. modifications that impact a previously
meeting. A transcript will be available Name of Committee: Peripheral and announced advisory committee meeting
in either hard copy or on CD–ROM, after Central Nervous System Drugs Advisory cannot always be published quickly
submission of a Freedom of Information Committee. enough to provide timely notice.
request. The Freedom of Information General Function of the Committee: Therefore, you should always check the
office address is available on the To provide advice and Agency’s Web site at http://
Agency’s Web site at http:// recommendations to the Agency on www.fda.gov/AdvisoryCommittees/
www.fda.gov. Send faxed requests to FDA’s regulatory issues.
jstallworth on DSK7TPTVN1PROD with NOTICES

default.htm and scroll down to the
301–827–9267. Date and Time: The meeting will be appropriate advisory committee meeting
Dated: March 8, 2016. held on April 25, 2016, from 8 a.m. to link, or call the advisory committee
5:30 p.m. This meeting is a reschedule information line to learn about possible
Leslie Kux,
of a postponed meeting announced in modifications before coming to the
Associate Commissioner for Policy. the Federal Register of December 18, meeting.
[FR Doc. 2016–05627 Filed 3–11–16; 8:45 am] 2015 (80 FR 79047), originally Agenda: The committee will discuss
BILLING CODE 4164–01–P scheduled for January 22, 2016. new drug application (NDA) 206488,

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Document Created: 2016-03-12 01:00:12
Document Modified: 2016-03-12 01:00:12

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		81 FR 13376

81 FR 13376 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 49 (March 14, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration