Document ID: FDA-2016-N-0001-0045
Agency: fda
Document Type: Notice
Title: Scientific Evidence in Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval; Public Workshop
Posted Date: 2016-04-22T04:00Z

[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23708-23709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09373]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Scientific Evidence in Development of Human Cells, Tissues, and 
Cellular and Tissue-Based Products Subject to Premarket Approval; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER) is announcing a public workshop entitled 
``Scientific Evidence in Development of Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps) Subject to Premarket 
Approval. The purpose of the public workshop is to identify and discuss 
scientific considerations and challenges to help inform the development 
of HCT/Ps subject to premarket approval, including stem cell-based 
products.

DATES: The public workshop will be held on September 8, 2016, from 8:30 
a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room, 
Silver Spring, MD 20993-0002. Entrance for the public 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: Lori Jo Churchyard, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911.

SUPPLEMENTARY INFORMATION: The purpose of the public workshop is to 
identify and discuss scientific considerations and challenges to help 
inform the development of HCT/Ps subject to premarket approval, 
including stem cell-based products.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the rescheduling of a part 15 public hearing to September 12 and 13, 
2016, to obtain input on four issued draft guidance

[[Page 23709]]

documents relating to the regulation of HCT/Ps. FDA will provide a 
summary of the workshop at the part 15 public hearing.
    Registration: Persons (including FDA employees) seeking to view the 
public workshop via Adobe Connect or who wish to attend in person must 
register at http://www.eventbrite.com/o/food-amp-drug-administration-fda-6730245227 on or before August 1, 2016, and provide complete 
contact information, including name, title, affiliation, email, and 
phone number. There is no registration fee for the public workshop. 
Early registration is recommended because seating is limited and is on 
a first-come, first-served basis. There will be no onsite registration.
    If you need special accommodations due to a disability and/or have 
registration questions, please contact Tasha Johnson or Pauline 
Cottrell at CBERPublicEvents@fda.hhs.gov (Subject line: FDA SEDHC 
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/ucm492499.htm.

    Dated: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09373 Filed 4-21-16; 8:45 am]
 BILLING CODE 4164-01-P