Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting, 13376-13377 [2016-05683]
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Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
https://www.fda.gov. Send faxed requests
to 301–827–9267.
Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05621 Filed 3–11–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
The Fifth Annual Food and Drug
Administration-International Society
for Pharmaceutical Engineering
Quality Conference
AGENCY:
The meeting will be held at
the Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Rd.,
Bethesda, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Susan Krys, ISPE, 7200 Wisconsin Ave.,
Suite 305, Bethesda, MD 20814, 301–
364–9202, FAX: 240–204–6024, email:
skrys@ispe.org, or Sau (Larry) Lee, 301–
796–2905, email: Sau.Lee@fda.hhs.gov.
ADDRESSES:
Food and Drug Administration,
HHS.
ACTION:
Evaluation and Research, in cosponsorship with the International
Society for Pharmaceutical Engineering
(ISPE), is announcing a meeting entitled
‘‘Fifth Annual FDA–ISPE Quality
Conference.’’ The purpose of the
meeting is to discuss manufacturing,
compliance, and management practices
that create, implement, and sustain a
culture of high quality and result in
reliable pharmaceutical and biologic
products that support patient health.
DATES: The meeting will be held on June
6, 7, and 8, 2016, from 8:30 a.m. to 4
p.m.
Notice of meeting.
The Food and Drug
Administration’s (FDA) Center for Drug
SUMMARY:
ISPE is an
association of engineers, scientists,
manufacturing, quality, and industrial
professionals involved in the
development, manufacture, quality
control, and regulation of
pharmaceuticals and related products.
This co-sponsored meeting facilitates
discussion and problem solving around
technical, quality, compliance, and
other manufacturing issues.
Registration: There is a registration fee
to attend this meeting. The registration
fee is charged to help defray the costs
of programming and facilities. Seats are
limited, and registration will be on a
first-come, first-served basis.
To register, please complete
registration online at https://
www.ispe.org/events. FDA has verified
the Web address, but FDA is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register. The
costs of registration for the different
categories of attendees are as follows:
SUPPLEMENTARY INFORMATION:
Category
Cost
jstallworth on DSK7TPTVN1PROD with NOTICES
Industry Representatives:
ISPE Members ........................................................................................................................................
Non-members ..........................................................................................................................................
Academic ........................................................................................................................................................
Government ....................................................................................................................................................
Accommodations: Attendees are
responsible for their own hotel
accommodations. Attendees making
reservations at the Bethesda North
Marriott Hotel & Conference Center in
Bethesda, MD are eligible for a reduced
rate of $209 USD, not including
applicable taxes. To receive the reduced
rate, contact the Bethesda North
Marriott Hotel (1–301–822–9200 or 1–
800–859–8003) and identify yourself as
an attendee of the meeting. If you need
special accommodations due to a
disability, please contact Susan Krys at
least 7 days in advance.
Transcripts: We expect that
transcripts will be available
approximately 30 days after the
meeting. A transcript will be available
in either hard copy or on CD–ROM, after
submission of a Freedom of Information
request. The Freedom of Information
office address is available on the
Agency’s Web site at https://
www.fda.gov. Send faxed requests to
301–827–9267.
Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05627 Filed 3–11–16; 8:45 am]
BILLING CODE 4164–01–P
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18:20 Mar 11, 2016
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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.
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.
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$1,895 (early-bird); $2,095 (onsite).
$2,275 (early-bird); $2,475 (onsite).
$1,425 (early-bird); $1,575 (onsite).
$700 (early-bird); $700 (onsite).
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: PCNS@
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 https://
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,
E:\FR\FM\14MRN1.SGM
14MRN1
jstallworth on DSK7TPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
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 https://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
https://www.fda.gov/
AdvisoryCommittees/
VerDate Sep<11>2014
14:27 Mar 11, 2016
Jkt 238001
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than April 13, 2016.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Information Collection Request Title:
Bureau of Health Workforce
Performance Data Collection
OMB No. 0915–0061—Revision
Abstract: Over 40 Bureau of Health
Workforce (BHW) programs award
grants to health professions schools and
training programs across the United
States to develop, expand, and enhance
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13377
training, and to strengthen the
distribution of the health workforce.
These programs are authorized by the
Public Health Service Act (42 U.S.C. 201
et seq.), specifically Titles III, VII, and
VIII. Performance information regarding
these programs is collected in the HRSA
Performance Report for Grants and
Cooperative Agreements (PRGCA). Data
collection activities consisting of an
annual progress and annual
performance report satisfy statutory and
programmatic requirements for
performance measurement and
evaluation (including specific Title III,
VII and VIII requirements), as well as
Government Performance and Results
Act (GPRA) requirements. The
performance measures were last revised
in 2013 to ensure they addressed
programmatic changes, met evolving
program management needs, and
responded to emerging workforce
concerns—especially as a result of the
changes in the Affordable Care Act
(Pub. L. 111–148). As these revisions
were successful, BHW will continue to
use the same progress and performance
forms. BHW is reducing the reporting
burden by eliminating the semi-annual
performance report and moving to
annual progress and performance
reporting.
Need and Proposed Use of the
Information: The purpose of the data
collection is to analyze and report
grantee training activities and
education, identify intended practice
locations, and report outcomes of
funded initiatives. Data collected from
these grant programs also provide a
description of the program activities of
approximately 1,700 reporting grantees
to better inform policymakers on the
barriers, opportunities, and outcomes
involved in health care workforce
development. The measures focus on
five key outcomes: (1) Increasing the
workforce supply of diverse welleducated practitioners, (2) increasing
the number of practitioners that practice
in underserved and rural areas, (3)
enhancing the quality of education, (4)
increasing the recruitment, training, and
placement of under-represented groups
in the health workforce, and (5)
supporting educational infrastructure to
increase the capacity to train more
health professionals.
Likely Respondents: Respondents are
awardees of BHW health professions
grant programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
E:\FR\FM\14MRN1.SGM
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Agencies
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13376-13377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05683]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: PCNS@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 https://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 https://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 https://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