Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop, 49447-49448 [2012-20105]
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Federal Register / Vol. 77, No. 159 / Thursday, August 16, 2012 / Notices
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 Cindy Hong
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/Advisory
Committees/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 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20103 Filed 8–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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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: Endocrinologic
and Metabolic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
DATES: Date and Time: The meeting will
be held on October 18, 2012, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (Rm. 1503), 10903
New Hampshire Ave., Silver Spring, MD
20993–0002. Information regarding
special accommodations due to a
disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/Advisory
Committees/default.htm; under the
heading ‘‘Resources for You,’’ click on
‘‘Public Meetings at the FDA White Oak
Campus.’’ Please note that visitors to the
White Oak Campus must enter through
Building 1.
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Contact Person: Paul Tran, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver
Spring, MD 20993–0002, (301) 796–
9001, Fax: (301) 847–8533, email:
EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), to find out
further information regarding FDA
advisory committee information. 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/Advisory
Committees/Calendar/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) 203568,
mipomersen injection, by Genzyme
Corporation. The proposed indication
(use) is as an adjunct to maximally
tolerated lipid-lowering medications
and diet to reduce low-density
lipoprotein (LDL) cholesterol,
apolipoprotein B, total cholesterol, nonhigh density lipoprotein-cholesterol and
lipoprotein (a) in patients with
homozygous familial
hypercholesterolemia.
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 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 October 2, 2012.
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
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49447
participants, and an indication of the
approximate time requested to make
their presentation on or before
September 24, 2012. 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 September 25, 2012.
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 Paul Tran 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/Advisory
Committees/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 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20104 Filed 8–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Endpoints for Clinical Trials in Kidney
Transplantation; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
to discuss the endpoints for clinical
trials of drugs and therapeutic biologics
in kidney transplantation. This public
workshop is intended to provide
information and gain perspective from
health care providers, academia, and
industry on the role of various clinical,
laboratory, histologic, genomic/
proteomic, safety, and other endpoints
E:\FR\FM\16AUN1.SGM
16AUN1
mstockstill on DSK4VPTVN1PROD with NOTICES
49448
Federal Register / Vol. 77, No. 159 / Thursday, August 16, 2012 / Notices
used to evaluate patient and allograft
outcome in clinical trials of kidney
transplantation. The meeting will
include a discussion of measure of
patient and graft survival, evaluation of
the allograft by histology and
biomarkers, glomerular filtration rate or
other measures of renal function,
evaluation of safety, and other topics.
The input from this public workshop
will help in developing topics for
further discussion and may serve to
inform recommendations on potential
endpoints in clinical trials of kidney
transplantation.
Date and Time: The public workshop
will be held on September 10, 2012,
from 9 a.m. to 6 p.m., and on September
11, 2012, from 8 a.m. to 3 p.m.
Location: The public workshop will
be held at the Sheraton Silver Spring
Hotel, 8777 Georgia Ave., Silver Spring,
MD 20910, 301–589–0800. Seating is
limited and available only on a firstcome, first-served basis.
CONTACT PERSON FOR MORE INFORMATION:
Christine Moser or Ramou Mauer,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6209, Silver Spring,
MD 20993–0002, 301–796–1300 or 301–
796–1600.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited. Seating will be
available on a first-come, first-served
basis. To register electronically, email
registration information (including
name, title, firm name, address,
telephone, and fax number) to
endpoints@fda.hhs.gov. Persons without
access to the Internet can call Christine
Moser, 301–796–1300, or Ramou Mauer,
301–796–1600, to register.
Persons needing a sign language
interpreter or other special
accommodations should notify
Christine Moser or Ramou Mauer (see
CONTACT PERSON FOR MORE INFORMATION)
at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop
regarding potential clinical or surrogate
endpoints and biomarkers for clinical
trials of drugs and therapeutic biologics
in kidney transplantation. This public
workshop will include scientific
discussion on the following topics:
• Patient and graft survival;
• Allograft rejection, both cellular
and antibody-mediated, injury, and
recurrent disease;
• Glomerular filtration rate,
proteinuria, and other measures of renal
function;
• Proteomic, genomic, and
immunologic biomarkers;
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16:38 Aug 15, 2012
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• Measures of safety, including
cardiovascular and metabolic outcomes;
• Medication adherence; and
• Consideration of composite
endpoints.
The Agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be
available on the Internet at https://
www.fda.gov/Drugs/NewsEvents/
ucm305308.htm approximately 45 days
after the workshop.
Dated: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20105 Filed 8–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
discuss the informed consent process
and informed consent documents;
regulation, relating to drugs, devices,
and biologics; as well as inspections of
clinical investigators, of IRB, and
research sponsors.
Date and Time: The public workshop
will be held on November 14 and 15,
2012, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Radisson Plaza Lord
Baltimore Hotel, 20 West Baltimore St.,
Baltimore, MD 21201, 410–539–8400.
Attendees are responsible for their own
accommodations. Please mention
SoCRA to receive the hotel room rate of
$129.00 plus applicable taxes (available
until October 13, 2012, or until the
SoCRA room block is filled).
Contact: Cynthia A. Harris, Food and
Drug Administration, 6000 Metro Dr.,
Suite 101, Baltimore, MD 21215, 410–
779–5133, FAX: 410–779–5705; or
Society of Clinical Research Associates
(SoCRA), 530 West Butler Ave., Suite
109, Chalfont, PA 18914, 800–762–7292
or 215–822–8644; Fax: 215–822–8633,
email: SoCRAmail@aol.com, Web site:
https://www.socra.org.
Registration: The registration fee will
cover actual expenses including
refreshments, lunch, materials, and
speaker expenses. Seats are limited;
please submit your registration as soon
as possible. Workshop space will be
filled in order of receipt of registration.
Those accepted into the public
workshop will receive confirmation.
The cost of the registration is as follows:
COST OF REGISTRATION
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Food and Drug Administration Clinical
Trial Requirements, Compliance, and
Good Clinical Practice; Public
Workshop
AGENCY:
Food and Drug Administration,
SoCRA member ...............
SoCRA nonmember (includes membership).
Federal Government
SoCRA member.
Federal Government
SoCRA nonmember.
FDA Employee .................
$575.00.
$650.00.
$525.00.
$450.00.
Fee Waived.
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Baltimore District Office, in
cosponsorship with the Society of
Clinical Research Associates (SoCRA), is
announcing a public workshop. The
public workshop on FDA’s clinical trial
requirements is designed to aid the
clinical research professional’s
understanding of the mission,
responsibilities, and authority of the
FDA and to facilitate interaction with
FDA representatives. The program will
focus on the relationships among FDA
and clinical trial staff, investigators, and
institutional review boards (IRB).
Individual FDA representatives will
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If you need special accommodations
due to a disability, please contact
SoCRA or Cynthia Harris (see Contact)
at least 21 days in advance.
Extended periods of question and
answer and discussion have been
included in the program schedule.
SoCRA designates this education
activity for a maximum of 13.3
Continuing Education (CE) Credits for
SoCRA CE and continuing nurse
education (CNE). SoCRA designates this
educational activity for a maximum of
13.3 American Medical Association
Physician’s Recognition Award Category
1 Credit(s)TM. Physicians should claim
only the credit commensurate with the
extent of their participation. SoCRA is
E:\FR\FM\16AUN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Pages 49447-49448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20105]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Endpoints for Clinical Trials in Kidney Transplantation; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop to discuss the endpoints for clinical trials of drugs and
therapeutic biologics in kidney transplantation. This public workshop
is intended to provide information and gain perspective from health
care providers, academia, and industry on the role of various clinical,
laboratory, histologic, genomic/proteomic, safety, and other endpoints
[[Page 49448]]
used to evaluate patient and allograft outcome in clinical trials of
kidney transplantation. The meeting will include a discussion of
measure of patient and graft survival, evaluation of the allograft by
histology and biomarkers, glomerular filtration rate or other measures
of renal function, evaluation of safety, and other topics. The input
from this public workshop will help in developing topics for further
discussion and may serve to inform recommendations on potential
endpoints in clinical trials of kidney transplantation.
Date and Time: The public workshop will be held on September 10,
2012, from 9 a.m. to 6 p.m., and on September 11, 2012, from 8 a.m. to
3 p.m.
Location: The public workshop will be held at the Sheraton Silver
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910, 301-589-0800.
Seating is limited and available only on a first-come, first-served
basis.
CONTACT PERSON FOR MORE INFORMATION: Christine Moser or Ramou Mauer,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 6209, Silver Spring, MD 20993-
0002, 301-796-1300 or 301-796-1600.
Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early because space is
limited. Seating will be available on a first-come, first-served basis.
To register electronically, email registration information (including
name, title, firm name, address, telephone, and fax number) to
endpoints@fda.hhs.gov. Persons without access to the Internet can call
Christine Moser, 301-796-1300, or Ramou Mauer, 301-796-1600, to
register.
Persons needing a sign language interpreter or other special
accommodations should notify Christine Moser or Ramou Mauer (see
CONTACT PERSON FOR MORE INFORMATION) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding potential clinical or surrogate endpoints and biomarkers for
clinical trials of drugs and therapeutic biologics in kidney
transplantation. This public workshop will include scientific
discussion on the following topics:
Patient and graft survival;
Allograft rejection, both cellular and antibody-mediated,
injury, and recurrent disease;
Glomerular filtration rate, proteinuria, and other
measures of renal function;
Proteomic, genomic, and immunologic biomarkers;
Measures of safety, including cardiovascular and metabolic
outcomes;
Medication adherence; and
Consideration of composite endpoints.
The Agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm305308.htm approximately 45 days after
the workshop.
Dated: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20105 Filed 8-15-12; 8:45 am]
BILLING CODE 4160-01-P
