
[Federal Register Volume 78, Number 140 (Monday, July 22, 2013)]
[Notices]
[Page 43889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17528]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Synergizing Efforts in Standards Development for Cellular 
Therapies and Regenerative Medicine Products; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

    The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER), is announcing a public workshop 
entitled ``Synergizing Efforts in Standards Development for Cellular 
Therapies and Regenerative Medicine Products.'' The purpose of the 
public workshop is to bring together a broad range of stakeholders to 
discuss current and future standards development activities involving 
cellular therapies and regenerative medicine products.
    Date and Time: The public workshop will be held on October 7, 2013, 
from 8:30 a.m. to 4:30 p.m.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. Please visit the 
following Web site for location, parking, security, and travel 
information: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Sherri Revell, Center for Biologics Evaluation and 
Research (HFM-49), Food and Drug Administration, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-3079, 
email: CBERPublicEvents@fda.hhs.gov (Subject line: SESDCTRMP Workshop).
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, telephone, and fax numbers) to Sherri 
Revell (see Contact Person) or email to CBERPublicEvents@fda.hhs.gov 
(Subject line: SESDCTRMP Workshop Registration) by September 23, 2013. 
There is no registration fee 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 7:30 a.m.
    Streaming Webcast of the Public Workshop: For those unable to 
attend in person, FDA will Webcast the public workshop. To join the 
Webcast of the public workshop, please go to: https://collaboration.fda.gov/sesdctrmpworkshop/. If you have never attended an 
Adobe Connect meeting before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. Get a 
quick overview: http://www.adobe.com/go/connectpro_overview. 
Registration is not required for those attending via Adobe Connect.
    If you need special accommodations due to a disability, please 
contact Sherri Revell (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: Standardization efforts concerning the 
clinical development of cellular therapies and regenerative medicine 
products have generated a great deal of interest. These efforts include 
standards development, expert opinion position papers, and professional 
practice guidelines. However, relatively little is done to coordinate 
the various existing efforts. In the public workshop, FDA hopes to 
bring together a broad range of stakeholders of cellular therapies and 
regenerative medicine products in order to:
     Inform stakeholders about the types of standards and 
standards organizations that are available currently, the role that the 
Federal Agencies play in standards development, and the potential role 
that stakeholders can play in standards development.
     Provide a high-level overview of current standards 
development activities in the fields of cellular therapy and 
regenerative medicine and the regulatory application of standards.
     Provide opportunity for discussion of areas of high 
interest for current or future standards development in the fields of 
cellular therapy and regenerative medicine and to explore ways to 
minimize redundancy and maximize collaboration.
    We encourage all who have an interest in the development of 
cellular therapies and regenerative medicine products to attend the 
public workshop.
    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.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm. 
Transcripts of the public workshop may also be requested in writing 
from the Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: July 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17528 Filed 7-19-13; 8:45 am]
BILLING CODE 4160-01-P


