Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting, 73324-73325 [2014-28881]
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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices
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Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH Steering
Committee meetings.
II. Guidance on Electronic Standards
for Transfer of Data
In the Federal Register of September
15, 2011 (76 FR 57060), FDA published
a notice of availability for a draft
guidance document entitled
‘‘Pharmacovigilance of Veterinary
Medicinal Products: Electronic
Standards for Transfer of Data’’ (VICH
GL35). Interested persons were given
until November 14, 2011, to comment
on the draft guidance. FDA received a
few comments on the draft guidance,
and those comments, as well as those
received by other VICH member
regulatory agencies, were considered as
the guidance was finalized. The
guidance announced in this document
finalizes the draft guidance dated
September 15, 2011. The final guidance
is a product of the Pharmacovigilance
Expert Working Group of the VICH.
In order to allow for electronic
exchange of this information between
stakeholders, further specification of the
field descriptors and their relationships,
including agreement on format of the
electronic message is essential. This
VICH guidance document is intended to
provide recommended standards to
construct a single electronic message to
transmit data elements for submission of
AERs to all member regions. The need
to transfer and disseminate information
quickly, accurately and easily between
Regulatory Authorities and Marketing
Authorization Holders on a worldwide
scope is especially pertinent to the
notification and assimilation of
information for pharmacovigilance.
Whereas the recommended definition of
the pharmacovigilance information has
been set forth within the draft guidance
entitled, ‘‘Pharmacovigilance of
Veterinary Medicinal Products:
Management of Adverse Event Reports
(AER’s)’’ (VICH GL24), and the final
guidances entitled ‘‘Pharmacovigilance
of Veterinary Medicinal Products:
Controlled Lists of Terms’’ (VICH GL30)
and ‘‘Pharmacovigilance of Veterinary
Medicinal Products: Data Elements for
Submission of Adverse Event Reports’’
(VICH GL42), this guidance defines
recommended electronic standards for
transfer of data. Please note that VICH
GL42 has been harmonized in GFI #188,
‘‘Data Elements for Submission of
Veterinary Adverse Event Reports to the
Center for Veterinary Medicine.’’
conform to FDA’s good guidance
practices regulation (21 CFR 10.115).
For example, the document has been
designated ‘‘guidance’’ rather than
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‘‘require,’’ or ‘‘requirement,’’ unless
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The guidance represents the Agency’s
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not create or confer any rights for or on
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FDA or the public. An alternative
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This guidance refers to previously
approved collections of information
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collections of information are subject to
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Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this guidance have been approved under
OMB control number 0910–0645.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to www.regulations.gov or
written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
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and 4 p.m., Monday through Friday.
VI. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–28830 Filed 12–9–14; 8:45 am]
BILLING CODE 4164–01–P
III. Significance of Guidance
This guidance, developed under the
VICH process, has been revised to
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee; Notice of
Postponement of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is postponing the
meeting of the Orthopaedic and
Rehabilitation Devices Panel of the
Medical Devices Advisory scheduled for
December 12, 2014. The meeting was
announced in the Federal Register of
September 22, 2014 (79 FR 56589). The
meeting is postponed from December
12, 2014, until February 20, 2015. The
location of the meeting has also
changed.
Date and Time: The meeting will be
held February 20, 2015, from 8 a.m. to
6 p.m.
Location: Hilton/Washington DC
North, 620 Perry Pkwy., Gaithersburg,
MD 20877. The hotel’s telephone
number is 301–977–8900.
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 February 13, 2015.
Oral presentations from the public will
be scheduled between approximately 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 February
4, 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 February 6, 2015.
Contact Person: Sara Anderson,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 1611, Silver Spring, MD 20993–
0002, or FDA Advisory Committee
SUMMARY:
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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices
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.
Dated: December 4, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–28881 Filed 12–9–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1998]
Patient-Focused Drug Development
Public Meeting on Chagas Disease
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting and an opportunity for
public comment on Patient-Focused
Drug Development for Chagas disease.
Patient-Focused Drug Development is
part of FDA’s performance
commitments in the fifth authorization
of the Prescription Drug User Fee Act
(PDUFA V). The meeting is intended to
allow FDA to obtain patients’
perspectives on the impact that Chagas
disease has on their daily lives, as well
as their perspectives on the available
therapies for Chagas disease. FDA is
also interested in discussing issues
related to scientific challenges in
developing drugs to treat Chagas
disease. In the afternoon, FDA will
provide information for and gain
perspective from patients and patient
advocacy organizations, health care
providers, academic experts, and
industry on various aspects of clinical
development of drug products intended
to treat Chagas disease. The input from
this public meeting will help in
developing topics for further discussion.
DATES: The meeting will be held on
April 28, 2015, from 9 a.m. to 5 p.m.
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SUMMARY:
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Registration to attend the meeting must
be received by April 20, 2015. See the
SUPPLEMENTARY INFORMATION section for
information on how to register for the
meeting. Submit electronic or written
comments by June 29, 2015.
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, Sections B and C of
the Great Room (Rm. 1503), Silver
Spring, MD 20993. Participants must
enter through Building 1 and undergo
security screening. For more
information on parking and security
procedures, please visit https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Room 1061, Rockville, MD 20852.
All comments should be identified with
the docket number found in brackets in
the heading of this document.
FDA will post the agenda
approximately 5 days before the meeting
at https://www.fda.gov/Drugs/
NewsEvents/ucm420130.htm.
FOR FURTHER INFORMATION CONTACT:
Pujita Vaidya, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1144,
Silver Spring, MD 20993, 301–796–
0684, FAX: 301–847–8443,
Pujita.Vaidya@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug
Development
FDA has selected Chagas disease as
the focus of a meeting under PatientFocused Drug Development, an
initiative that involves obtaining a better
understanding of patients’ perspectives
on the severity of the disease and the
available therapies for the condition.
Patient-Focused Drug Development is
being conducted to fulfill FDA’s
performance commitments made as part
of the authorization of PDUFA V under
Title I of the Food and Drug Safety and
Innovation Act (Public Law 112–144).
The full set of performance
commitments is available on the FDA
Web site at https://www.fda.gov/
downloads/forindustry/userfees/
prescriptiondruguserfee/
ucm270412.pdf.
FDA has committed to obtain the
patient perspective in 20 disease areas
during the course of PDUFA V. For each
disease area, the Agency will conduct a
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73325
public meeting to discuss the disease
and its impact on patients’ daily lives,
the types of treatment benefit that
matter most to patients, and patients’
perspectives on the adequacy of the
available therapies. These meetings will
include participation of FDA review
divisions, the relevant patient
community, and other interested
stakeholders.
On April 11, 2013, FDA published a
notice (78 FR 21613) in the Federal
Register announcing the disease areas
for meetings in fiscal years (FYs) 2013
through 2015, the first 3 years of the 5year PDUFA V time frame. To develop
the list of disease areas, the Agency
used several criteria that were outlined
in the April 11 notice. The Agency
obtained public comment on these
criteria and potential disease areas
through a notice for public comment
published in the Federal Register on
September 24, 2012 (77 FR 58849), and
through a public meeting held on
October 25, 2012. In selecting the
disease areas, FDA carefully considered
the public comments received and the
perspectives of its review divisions. On
October 8, 2014, FDA published a notice
in the Federal Register to initiate
another public process to determine the
disease areas for FYs 2016 through 2017
(79 FR 60857). More information,
including the list of disease areas and a
general schedule of meetings, is posted
at https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm326192.htm.
II. Public Meeting Information
A. Purpose and Scope of the Meeting
As part of Patient-Focused Drug
Development, FDA will obtain patient
and patient stakeholder input on
symptoms of Chagas disease (American
trypanosomiasis) that matter most to
patients and on current approaches to
treating Chagas disease. When left
untreated, acute Chagas disease may
progress to chronic Chagas disease.
There are currently no FDA-approved
drug therapies to treat acute or chronic
Chagas disease. FDA is committed to
working with all stakeholders to
develop safe and effective therapies for
affected individuals.
The questions that will be asked of
patients and patient stakeholders at the
meeting are listed in this section and
organized by topic. For each topic, a
brief patient panel discussion will begin
the dialogue, followed by a facilitated
discussion inviting comments from
other patients and patient stakeholders.
In addition to input received through
this public meeting, FDA is interested in
receiving patient input addressing these
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]]>Agencies
[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73324-73325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28881]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Notice of Postponement of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is postponing the
meeting of the Orthopaedic and Rehabilitation Devices Panel of the
Medical Devices Advisory scheduled for December 12, 2014. The meeting
was announced in the Federal Register of September 22, 2014 (79 FR
56589). The meeting is postponed from December 12, 2014, until February
20, 2015. The location of the meeting has also changed.
Date and Time: The meeting will be held February 20, 2015, from 8
a.m. to 6 p.m.
Location: Hilton/Washington DC North, 620 Perry Pkwy.,
Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900.
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
February 13, 2015. Oral presentations from the public will be scheduled
between approximately 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 February 4, 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 February 6, 2015.
Contact Person: Sara Anderson, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1611, Silver Spring, MD 20993-0002, or FDA Advisory Committee
[[Page 73325]]
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.
Dated: December 4, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-28881 Filed 12-9-14; 8:45 am]
BILLING CODE 4164-01-P
