80 FR 81233 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 249 (December 29, 2015)

The Food and Drug Administration (FDA or Agency) is correcting a notification of a public hearing entitled ``Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments'' that appeared in the Federal Register of October 30, 2015 (80 FR 66845). The document announced a public hearing to obtain input on four recently issued draft guidances relating to the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). The document published with conflicting information about who must register for the public hearing. This document corrects that error.

[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Proposed Rules]
[Pages 81233-81234]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32686]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2015-D-3719]


Draft Guidances Relating to the Regulation of Human Cells, 
Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request 
for Comments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments; 
correction.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is correcting 
a notification of a public hearing entitled ``Draft Guidances Relating 
to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based 
Products; Public Hearing; Request for Comments'' that appeared in the 
Federal Register of October 30, 2015 (80 FR 66845). The document 
announced a public hearing to obtain input on four recently issued 
draft guidances relating to the regulation of human cells, tissues, or 
cellular or tissue-based products (HCT/Ps). The document published with 
conflicting information about who must register for the public hearing. 
This document corrects that error.

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: In FR Doc. 2015-27703, appearing on pages 
66845 and 66847 in the Federal Register of Friday, October 30, 2015, 
the following corrections are made:
    1. On page 66845, in the third column under DATES, the third 
sentence is revised to read: ``Persons seeking to attend (including FDA 
employees) or to present at the public hearing must register by January 
8, 2016.''
    2. On page 66847, in the first column under section IV. Attendance 
and Registration, the third sentence is revised to read: ``Individuals 
who wish to attend (including FDA employees) or present at the public 
hearing must

[[Page 81234]]

register by sending an email to [email protected] on or 
before January 8, 2016, and provide complete contact information, 
including name, title, affiliation, address, email, and phone number.''

    Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32686 Filed 12-28-15; 8:45 am]
 BILLING CODE 4164-01-P