80 FR 45998 - Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		45998-45999
FR Document		2015-18969

The Food and Drug Administration (FDA) is announcing the sixth annual scientific workshop co-sponsored by the Agency and the Coalition Against Major Diseases (CAMD) Consortium of the Critical Path Institute (C-Path). The purpose of this public workshop is to initiate constructive discussion among scientists from FDA, the CAMD Consortium, and other interested parties regarding ongoing efforts to develop tools and methods to facilitate drug development for Alzheimer's disease and Parkinson's disease.

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

[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 45998-45999]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Sixth Annual Coalition Against Major Diseases/Food and Drug 
Administration Scientific Workshop; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the sixth 
annual scientific workshop co-sponsored by the Agency and the Coalition 
Against Major Diseases (CAMD) Consortium of the Critical Path Institute 
(C-Path). The purpose of this public workshop is to initiate 
constructive discussion among scientists from FDA, the CAMD Consortium, 
and other interested parties regarding ongoing efforts to develop tools 
and methods to facilitate drug development for Alzheimer's disease and 
Parkinson's disease.

DATES: The public scientific workshop will be held on October 15, 2015, 
from 8 a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public 
scientific workshop participants (non-FDA employees) is through 
Building 1, where routine security check procedures will be performed. 
For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Jacqueline Brooks-Leighton, Food and 
Drug Administration, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 4521, Silver Spring, MD 20993, 240-402-
5292, FAX: 301-796-9907, jacqueline.brooks-leighton@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA and C-Path seek to leverage their combined strengths to create 
new tools and methods to increase the efficiency of the drug 
development process and bring new treatments for Alzheimer's disease 
and Parkinson's disease. This annual public workshop brings together 
representatives from the pharmaceutical industry, the academic research 
community, patient advocacy groups, and governmental institutions; 
including, the National Institute of Aging, the National Institute of 
Neurological Disorders and Stroke, and the European Medicines Agency.
    The objectives of the workshop include:

1. Understanding the accomplishments of CAMD scientific projects
2. Discussing how these tools are currently or will be applied in drug 
development
3. Obtaining commitment for sharing information/data to begin 
quantifying benefits of these tools
4. Facilitating robust and open discussion among all parties of drug 
development in Alzheimer's and Parkinson's diseases

II. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal 
facility with security procedures and limited seating. Individuals who 
wish to participate in the scientific workshop (in person or via the 
Internet) must register on or before October 1, 2015, by visiting 
https://www.SignUp4.net/public/ap.aspx?EID=SIXT10E.
    Early registration is recommended; registration is free and will be 
on a first-come, first-served basis. However, FDA may limit the number 
of participants from each organization based on space limitations. 
Onsite registration on the day of the scientific workshop will be based 
on space availability. The registration deadline is October 14, 2015. 
An agenda will be provided approximately 2 weeks before the scientific 
workshop at the FDA Meeting Information page, which is available online 
at: http://www.fda.gov/Drugs/NewsEvents/ucm410863.htm.
    If you need special accommodations because of a disability, please 
contact Jacqueline Brooks-Leighton (see FOR FURTHER INFORMATION 
CONTACT) at least 7 days before the scientific workshop.
    A live webcast of this scientific workshop will be viewable at 
Adobe Connect Link: https://collaboration.fda.gov/camd101515/ on the 
day of the scientific workshop. A video record of the scientific 
workshop will be available at the same Web address for 1 year.

III. Transcripts

    Please be advised that as soon as a transcript 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

[[Page 45999]]

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

45998 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices

within 1 working day, using the PIN DEPARTMENT OF HEALTH AND community, patient advocacy groups,
described previously. HUMAN SERVICES and governmental institutions;
including, the National Institute of
B. Application Cover Sheet Procedures Food and Drug Administration Aging, the National Institute of
Step One—Create a user account and [Docket No. FDA–2015–N–0001] Neurological Disorders and Stroke, and
password. Log on to the ADUFA Web the European Medicines Agency.
site at http://www.fda.gov/ForIndustry/ Sixth Annual Coalition Against Major The objectives of the workshop
Diseases/Food and Drug include:
UserFees/
AnimalDrugUserFeeActADUFA/ Administration Scientific Workshop; 1. Understanding the accomplishments
default.htm and, under Tools and Public Workshop of CAMD scientific projects
2. Discussing how these tools are
Resources, click ‘‘The Animal Drug User AGENCY: Food and Drug Administration, currently or will be applied in drug
Fee Cover Sheet’’ and then click ‘‘Create HHS. development
ADUFA User Fee Cover Sheet.’’ For ACTION: Notice of public workshop. 3. Obtaining commitment for sharing
security reasons, each firm submitting information/data to begin
an application will be assigned an SUMMARY: The Food and Drug quantifying benefits of these tools
organization identification number, and Administration (FDA) is announcing the 4. Facilitating robust and open
each user will also be required to set up sixth annual scientific workshop co- discussion among all parties of drug
a user account and password the first sponsored by the Agency and the development in Alzheimer’s and
time you use this site. Online Coalition Against Major Diseases Parkinson’s diseases
instructions will walk you through this (CAMD) Consortium of the Critical Path
process. Institute (C-Path). The purpose of this II. Attendance and Registration
Step Two—Create an Animal Drug public workshop is to initiate The FDA Conference Center at the
User Cover Sheet, transmit it to FDA, constructive discussion among White Oak location is a Federal facility
and print a copy. After logging into your scientists from FDA, the CAMD with security procedures and limited
account with your user name and Consortium, and other interested parties seating. Individuals who wish to
password, complete the steps required regarding ongoing efforts to develop participate in the scientific workshop
to create an Animal Drug User Fee tools and methods to facilitate drug (in person or via the Internet) must
Cover Sheet. One cover sheet is needed development for Alzheimer’s disease register on or before October 1, 2015, by
and Parkinson’s disease. visiting https://www.SignUp4.net/
for each animal drug application or
supplement. Once you are satisfied that DATES: The public scientific workshop public/ap.aspx?EID=SIXT10E.
will be held on October 15, 2015, from Early registration is recommended;
the data on the cover sheet is accurate
8 a.m. to 5 p.m. registration is free and will be on a first-
and you have finalized the cover sheet,
ADDRESSES: The public workshop will come, first-served basis. However, FDA
you will be able to transmit it
be held at the FDA White Oak Campus, may limit the number of participants
electronically to FDA and you will be
10903 New Hampshire Ave., Bldg. 31 from each organization based on space
able to print a copy of your cover sheet
Conference Center, the Great Room (Rm. limitations. Onsite registration on the
showing your unique PIN.
1503A), Silver Spring, MD 20993–0002. day of the scientific workshop will be
Step Three—Send the payment for based on space availability. The
Entrance for the public scientific
your application as described in section workshop participants (non-FDA registration deadline is October 14,
VIII.A. employees) is through Building 1, where 2015. An agenda will be provided
Step Four—Please submit your routine security check procedures will approximately 2 weeks before the
application and a copy of the completed be performed. For parking and security scientific workshop at the FDA Meeting
Animal Drug User Fee Cover Sheet to information, please refer to http:// Information page, which is available
the following address: Food and Drug www.fda.gov/AboutFDA/ online at: http://www.fda.gov/Drugs/
Administration, Center for Veterinary WorkingatFDA/BuildingsandFacilities/ NewsEvents/ucm410863.htm.
Medicine, Document Control Unit WhiteOakCampusInformation/ If you need special accommodations
(HFV–199), 7500 Standish Pl., ucm241740.htm. because of a disability, please contact
Rockville, MD 20855. Jacqueline Brooks-Leighton (see FOR
FOR FURTHER INFORMATION CONTACT: FURTHER INFORMATION CONTACT) at least 7
C. Product, Establishment, and Sponsor Jacqueline Brooks-Leighton, Food and days before the scientific workshop.
Fees Drug Administration, Center for Drug A live webcast of this scientific
Evaluation and Research, 10903 New workshop will be viewable at Adobe
By December 31, 2015, FDA will issue Hampshire Ave., Bldg. 21, Rm. 4521, Connect Link: https://
invoices and payment instructions for Silver Spring, MD 20993, 240–402– collaboration.fda.gov/camd101515/ on
product, establishment, and sponsor 5292, FAX: 301–796–9907, the day of the scientific workshop. A
fees for FY 2016 using this fee schedule. jacqueline.brooks-leighton@fda.hhs.gov. video record of the scientific workshop
Payment will be due by January 31, SUPPLEMENTARY INFORMATION: will be available at the same Web
2016. FDA will issue invoices in address for 1 year.
November 2016 for any products, I. Background
establishments, and sponsors subject to FDA and C-Path seek to leverage their III. Transcripts
mstockstill on DSK4VPTVN1PROD with NOTICES

fees for FY 2016 that qualify for fees combined strengths to create new tools Please be advised that as soon as a
after the December 2015 billing. and methods to increase the efficiency transcript is available, it will be
Dated: July 28, 2015. of the drug development process and accessible at http://
bring new treatments for Alzheimer’s www.regulations.gov. It may be viewed
Leslie Kux,
disease and Parkinson’s disease. This at the Division of Dockets Management
Associate Commissioner for Policy. annual public workshop brings together (HFA–305), Food and Drug
[FR Doc. 2015–18913 Filed 7–31–15; 8:45 am] representatives from the pharmaceutical Administration, 5630 Fishers Lane, Rm.
BILLING CODE 4164–01–P industry, the academic research 1061, Rockville, MD 20852. A transcript

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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 10:51:15
Document Modified: 2018-02-23 10:51:15

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.
Dates		The public scientific workshop will be held on October 15, 2015, from 8 a.m. to 5 p.m.
Contact		Jacqueline Brooks-Leighton, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 21, Rm. 4521, Silver Spring, MD 20993, 240-402- 5292, FAX: 301-796-9907, [email protected]
FR Citation		80 FR 45998

80 FR 45998 - Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; 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