80 FR 45999 - Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 148 (August 3, 2015)

Page Range		45999-45999
FR Document		2015-18957

Federal Register, Volume 80 Issue 148 (Monday, August 3, 2015)

[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Page 45999]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18957]


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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.

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    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: 
http://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 http://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 http://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

Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 45999

will also be available in either hard Registration: Mail or fax your • Unmet medical need in kidney
copy or on CD–ROM, after submission registration information (including transplant patients
of a Freedom of Information request. name, title, firm name, address, • Histology: Findings on kidney biopsy
Written requests are to be sent to telephone and fax numbers) to Ramou (including protocol biopsies)
Division of Freedom of Information Pratt (see Contact Person) by September • Laboratory measurements and
(ELEM–1029), Food and Drug 25, 2015. Registration is free for the outcomes, surrogates and biomarkers
Administration, 12420 Parklawn Dr., public workshop. Early registration is • Patient selection criteria and
Element Bldg., Rockville, MD 20857. recommended because seating is enrichment strategies
Dated: July 29, 2015. limited. Registration on the day of the • Risk factors and prognostic factors
Leslie Kux, public workshop will be provided on a • Medication adherence
Associate Commissioner for Policy. space-available basis beginning at 8 a.m. Transcripts: Please be advised that as
[FR Doc. 2015–18969 Filed 7–31–15; 8:45 am] If you need special accommodations soon as possible after a transcript of the
BILLING CODE 4164–01–P
because of a disability, please contact public workshop is available, it will be
Ramou Pratt (see Contact Person) at accessible at http://
least 7 days in advance. www.regulations.gov. It may be viewed
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: FDA is at the Division of Dockets Management
HUMAN SERVICES announcing a public workshop entitled (HFA–305), Food and Drug
‘‘Surrogate Endpoints for Clinical Trials Administration, 5630 Fishers Lane, Rm.
Food and Drug Administration in Kidney Transplantation.’’ The 1061, Rockville, MD 20852. A transcript
[Docket No. FDA–2015–N–0001] purpose of the workshop is to discuss will also be available in either hard
potential clinical or surrogate endpoints copy or on CD–ROM, after submission
Surrogate Endpoints for Clinical Trials and biomarkers for clinical trials for of a Freedom of Information request.
in Kidney Transplantation; Public drugs and therapeutic biologics in Send written requests to the Division of
Workshop kidney transplantation. The input from Freedom of Information, U.S. Food &
this public workshop will help in Drug Administration, 5630 Fishers
AGENCY: Food and Drug Administration, Lane, Rm. 1033, Rockville, MD 20857.
HHS. developing topics for further discussion
and may serve to inform Transcripts will also be available on the
ACTION: Notice of public workshop. Internet at http://wcms.fda.gov/FDAgov/
recommendations on potential surrogate
The Food and Drug Administration endpoints in clinical trials for kidney Drugs/NewsEvents/ucm449248.htm
(FDA) is announcing a public workshop transplantation. The Agency encourages approximately 45 days after the
entitled ‘‘Surrogate Endpoints for individuals, patient advocates, industry, workshop.
Clinical Trials in Kidney consumer groups, health care Dated: July 29, 2015.
Transplantation.’’ The purpose of the professionals, researchers, and other Leslie Kux,
public workshop is to discuss potential interested persons to attend this public Associate Commissioner for Policy.
surrogate endpoints for clinical trials for workshop. [FR Doc. 2015–18957 Filed 7–31–15; 8:45 am]
drugs and therapeutic biologics used in This workshop is part of the Agency’s BILLING CODE 4164–01–P
kidney transplantation, with a focus on program to facilitate the development of
endpoints in conditions that represent surrogate endpoints, clinical endpoints,
unmet medical needs. This public and other scientific methods for DEPARTMENT OF HEALTH AND
workshop is intended to provide predicting clinical benefit, in HUMAN SERVICES
information and gain perspective from accordance with section 901 of the Food
health care providers, academia, and and Drug Administration Safety and Food and Drug Administration
industry on the role of various Innovation Act, titled ‘‘Enhancement of
laboratory, histologic, and other Accelerated Patient Access to New [Docket No. FDA–2014–D–2138]
endpoints used to evaluate patient and Medical Treatments,’’ which was signed
allograft outcome in clinical trials for into law on July 9, 2012. During the Agency Information Collection
kidney transplantation. workshop, there will be a discussion on Activities; Submission for Office of
Date and Time: The public workshop potential surrogate endpoints and their Management and Budget Review;
will be held on September 28, 2015, ability to predict clinical benefit. Comment Request; Guidance for
from 8 a.m. to 6 p.m. Industry on Adverse Event Reporting
Location: The public workshop will This public workshop will include
discussion of allograft histology and for Outsourcing Facilities Under
be held at the Residence Inn Marriott, Section 503B of the Federal Food,
2850 South Potomac Ave., Arlington, biomarkers, laboratory measures of
outcome, and other endpoints that may Drug, and Cosmetic Act
VA 22202. Web site: http://
www.marriott.com/hotels/travel/wasry- serve as surrogates for patient AGENCY: Food and Drug Administration,
residence-inn-arlington-capital-view/. morbidity, graft function, and patient HHS.
(FDA has verified the Web site address, and graft survival. Related topics for ACTION: Notice.
but FDA is not responsible for any discussion will include clinically
subsequent changes to the Web site after relevant risk factors and prognostic SUMMARY: The Food and Drug
this document publishes in the Federal factors in the kidney transplant Administration (FDA) is announcing
population. Patient selection and that a proposed collection of
mstockstill on DSK4VPTVN1PROD with NOTICES

Register.) Seating will be available on a
first-come, first-served basis. enrichment strategies (inclusion/ information has been submitted to the
Contact Person: Ramou Pratt, Center exclusion criteria) will be considered. Office of Management and Budget
for Drug Evaluation and Research, Food The public workshop will include (OMB) for review and clearance under
and Drug Administration, 10903 New scientific discussion on the following the Paperwork Reduction Act of 1995.
Hampshire Ave., Bldg. 22, Rm. 6193, topics: DATES: Fax written comments on the
Silver Spring, MD 20993–0002, 301– • Surrogate endpoints and accelerated collection of information by September
796–3928 or 301–796–1600. approval 2, 2015.

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Document Created: 2018-02-23 10:51:51
Document Modified: 2018-02-23 10:51:51

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 of public workshop.
FR Citation		80 FR 45999

80 FR 45999 - Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 148 (August 3, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration