[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]
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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.
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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2016, to obtain input on four issued draft guidance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 [email protected] (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]
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