Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop, 45999 [2015-18957]

Download as PDF Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices will also be available in either hard copy 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. 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: http:// 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 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–2138] Agency Information Collection Activities; Submission for Office of 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 Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by September 2, 2015. 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]


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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