Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop, 45999 [2015-18957]
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Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
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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.
Dated: July 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18969 Filed 7–31–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2015–N–0001]
Surrogate Endpoints for Clinical Trials
in Kidney Transplantation; Public
Workshop
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Surrogate Endpoints for
Clinical Trials in Kidney
Transplantation.’’ The purpose of the
public workshop is to discuss potential
surrogate endpoints for clinical trials for
drugs and therapeutic biologics used in
kidney transplantation, with a focus on
endpoints in conditions that represent
unmet medical needs. This public
workshop is intended to provide
information and gain perspective from
health care providers, academia, and
industry on the role of various
laboratory, histologic, and other
endpoints used to evaluate patient and
allograft outcome in clinical trials for
kidney transplantation.
Date and Time: The public workshop
will be held on September 28, 2015,
from 8 a.m. to 6 p.m.
Location: The public workshop will
be held at the Residence Inn Marriott,
2850 South Potomac Ave., Arlington,
VA 22202. Web site: https://
www.marriott.com/hotels/travel/wasryresidence-inn-arlington-capital-view/.
(FDA has verified the Web site address,
but FDA is not responsible for any
subsequent changes to the Web site after
this document publishes in the Federal
Register.) Seating will be available on a
first-come, first-served basis.
Contact Person: Ramou Pratt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6193,
Silver Spring, MD 20993–0002, 301–
796–3928 or 301–796–1600.
VerDate Sep<11>2014
18:35 Jul 31, 2015
Jkt 235001
FDA is
announcing a public workshop entitled
‘‘Surrogate Endpoints for Clinical Trials
in Kidney Transplantation.’’ The
purpose of the workshop is to discuss
potential clinical or surrogate endpoints
and biomarkers for clinical trials for
drugs and therapeutic biologics in
kidney transplantation. The input from
this public workshop will help in
developing topics for further discussion
and may serve to inform
recommendations on potential surrogate
endpoints in clinical trials for kidney
transplantation. The Agency encourages
individuals, patient advocates, industry,
consumer groups, health care
professionals, researchers, and other
interested persons to attend this public
workshop.
This workshop is part of the Agency’s
program to facilitate the development of
surrogate endpoints, clinical endpoints,
and other scientific methods for
predicting clinical benefit, in
accordance with section 901 of the Food
and Drug Administration Safety and
Innovation Act, titled ‘‘Enhancement of
Accelerated Patient Access to New
Medical Treatments,’’ which was signed
into law on July 9, 2012. During the
workshop, there will be a discussion on
potential surrogate endpoints and their
ability to predict clinical benefit.
This public workshop will include
discussion of allograft histology and
biomarkers, laboratory measures of
outcome, and other endpoints that may
serve as surrogates for patient
morbidity, graft function, and patient
and graft survival. Related topics for
discussion will include clinically
relevant risk factors and prognostic
factors in the kidney transplant
population. Patient selection and
enrichment strategies (inclusion/
exclusion criteria) will be considered.
The public workshop will include
scientific discussion on the following
topics:
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
Registration: Mail or fax your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to Ramou
Pratt (see Contact Person) by September
25, 2015. Registration is free for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space-available basis beginning at 8 a.m.
If you need special accommodations
because of a disability, please contact
Ramou Pratt (see Contact Person) at
least 7 days in advance.
• Surrogate endpoints and accelerated
approval
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
45999
• Unmet medical need in kidney
transplant patients
• Histology: Findings on kidney biopsy
(including protocol biopsies)
• Laboratory measurements and
outcomes, surrogates and biomarkers
• Patient selection criteria and
enrichment strategies
• Risk factors and prognostic factors
• Medication adherence
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop 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 hard
copy or on CD–ROM, after submission
of a Freedom of Information request.
Send written requests to the Division of
Freedom of Information, U.S. Food &
Drug Administration, 5630 Fishers
Lane, Rm. 1033, Rockville, MD 20857.
Transcripts will also be available on the
Internet at https://wcms.fda.gov/FDAgov/
Drugs/NewsEvents/ucm449248.htm
approximately 45 days after the
workshop.
Dated: July 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18957 Filed 7–31–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2138]
Agency Information Collection
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Management and Budget Review;
Comment Request; Guidance for
Industry on Adverse Event Reporting
for Outsourcing Facilities Under
Section 503B of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
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SUMMARY:
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Page 45999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18957]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Surrogate 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 entitled ``Surrogate Endpoints for Clinical Trials in Kidney
Transplantation.'' The purpose of the public workshop is to discuss
potential surrogate endpoints for clinical trials for drugs and
therapeutic biologics used in kidney transplantation, with a focus on
endpoints in conditions that represent unmet medical needs. This public
workshop is intended to provide information and gain perspective from
health care providers, academia, and industry on the role of various
laboratory, histologic, and other endpoints used to evaluate patient
and allograft outcome in clinical trials for kidney transplantation.
Date and Time: The public workshop will be held on September 28,
2015, from 8 a.m. to 6 p.m.
Location: The public workshop will be held at the Residence Inn
Marriott, 2850 South Potomac Ave., Arlington, VA 22202. Web site:
https://www.marriott.com/hotels/travel/wasry-residence-inn-arlington-capital-view/. (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.) Seating will be available
on a first-come, first-served basis.
Contact Person: Ramou Pratt, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, Rm. 6193, Silver Spring, MD 20993-0002, 301-796-3928 or 301-796-
1600.
Registration: Mail or fax your registration information (including
name, title, firm name, address, telephone and fax numbers) to Ramou
Pratt (see Contact Person) by September 25, 2015. Registration is free
for the public workshop. Early registration is recommended because
seating is limited. Registration on the day of the public workshop will
be provided on a space-available basis beginning at 8 a.m.
If you need special accommodations because of a disability, please
contact Ramou Pratt (see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop entitled
``Surrogate Endpoints for Clinical Trials in Kidney Transplantation.''
The purpose of the workshop is to discuss potential clinical or
surrogate endpoints and biomarkers for clinical trials for drugs and
therapeutic biologics in kidney transplantation. The input from this
public workshop will help in developing topics for further discussion
and may serve to inform recommendations on potential surrogate
endpoints in clinical trials for kidney transplantation. The Agency
encourages individuals, patient advocates, industry, consumer groups,
health care professionals, researchers, and other interested persons to
attend this public workshop.
This workshop is part of the Agency's program to facilitate the
development of surrogate endpoints, clinical endpoints, and other
scientific methods for predicting clinical benefit, in accordance with
section 901 of the Food and Drug Administration Safety and Innovation
Act, titled ``Enhancement of Accelerated Patient Access to New Medical
Treatments,'' which was signed into law on July 9, 2012. During the
workshop, there will be a discussion on potential surrogate endpoints
and their ability to predict clinical benefit.
This public workshop will include discussion of allograft histology
and biomarkers, laboratory measures of outcome, and other endpoints
that may serve as surrogates for patient morbidity, graft function, and
patient and graft survival. Related topics for discussion will include
clinically relevant risk factors and prognostic factors in the kidney
transplant population. Patient selection and enrichment strategies
(inclusion/exclusion criteria) will be considered. The public workshop
will include scientific discussion on the following topics:
Surrogate endpoints and accelerated approval
Unmet medical need in kidney transplant patients
Histology: Findings on kidney biopsy (including protocol
biopsies)
Laboratory measurements and outcomes, surrogates and
biomarkers
Patient selection criteria and enrichment strategies
Risk factors and prognostic factors
Medication adherence
Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop 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 hard copy or on CD-ROM, after submission of a
Freedom of Information request. Send written requests to the Division
of Freedom of Information, U.S. Food & Drug Administration, 5630
Fishers Lane, Rm. 1033, Rockville, MD 20857. Transcripts will also be
available on the Internet at https://wcms.fda.gov/FDAgov/Drugs/NewsEvents/ucm449248.htm approximately 45 days after the workshop.
Dated: July 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18957 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P
