Document ID: FDA-2014-D-1856-0086
Agency: fda
Document Type: Proposed Rule
Title: Draft Guidances Relating to the Regulation of Human Cells, Tissues,
and Cellular and Tissue-Based Products; Extension of Comment Periods
Posted Date: 2016-04-22T04:00Z

[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Proposed Rules]
[Pages 23664-23666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09366]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket Nos. FDA-2014-D-1584, FDA-2014-D-1696, FDA-2014-D-1856, and 
FDA-2015-D-3581]

Draft Guidances Relating to the Regulation of Human Cells, 
Tissues, and Cellular and Tissue-Based Products; Extension of Comment 
Periods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment periods.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the draft guidance documents entitled 
``Same Surgical Procedure Exception: Questions and Answers Regarding 
the Scope of the Exception; Draft Guidance for Industry''; ``Minimal 
Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based 
Products; Draft Guidance for Industry and Food and Drug Administration 
Staff''; ``Human Cells, Tissues, and Cellular and Tissue-Based Products 
from Adipose Tissue: Regulatory Considerations; Draft Guidance for 
Industry''; and ''Homologous Use of Human Cells, Tissues, and Cellular 
and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.'' 
The Agency is taking this action to allow interested persons additional 
time to submit comments and any new information.

DATES: FDA is extending the comment period on the four draft guidances 
announced in the Federal Register (see SUPPLEMENTARY INFORMATION). 
Submit either electronic or written comments by September 27, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or

[[Page 23665]]

anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-1584 for ``Same Surgical Procedure Exception under 21 CFR 
1271.15(b): Questions and Answers Regarding the Scope of the Exception; 
Draft Guidance for Industry''; Docket No. FDA-2014-D-1696 for ``Minimal 
Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based 
Products; Draft Guidance for Industry and Food and Drug Administration 
Staff''; Docket No. FDA-2014-D-1856 for ``Human Cells, Tissues, and 
Cellular and Tissue-Based Products from Adipose Tissue: Regulatory 
Considerations; Draft Guidance for Industry''; or Docket No. FDA-2015-
D-3581 for ``Homologous Use of Human Cells, Tissues, and Cellular and 
Tissue-Based Products; Draft Guidance for Industry and FDA Staff.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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, lori.olsenchurchyard@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 23, 2014 
(79 FR 63348), FDA announced the availability of a draft document 
entitled ``Same Surgical Procedure Exception under 21 CFR 1271.15(b): 
Questions and Answers Regarding the Scope of the Exception; Draft 
Guidance for Industry'' dated October 2014.
    In the Federal Register of December 23, 2014 (79 FR 77012), FDA 
announced the availability of a draft document entitled ``Minimal 
Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based 
Products; Draft Guidance for Industry and Food and Drug Administration 
Staff'' dated December 2014.
    In the Federal Register of December 24, 2014 (79 FR 77414), FDA 
announced the availability of a draft document entitled ``Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose 
Tissue: Regulatory Considerations; Draft Guidance for Industry'' dated 
December 2014.
    Following publication of these three notices of availability, FDA 
received requests to allow interested persons additional time to 
comment.
    In the Federal Register of October 30, 2015 (80 FR 66850), FDA 
announced the availability of a draft document entitled ``Homologous 
Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; 
Draft Guidance for Industry and FDA Staff'' dated October 2015.
    In the Federal Register of October 30, 2015 (80 FR 66845), FDA 
announced a public hearing in a notice entitled ``Draft Guidances 
Relating to the Regulation of Human Cells, Tissues, or Cellular or 
Tissue-Based Products; Public Hearing; Request for Comments''.
    The draft guidances on same surgical procedure, minimal 
manipulation, adipose tissue, and homologous use provide 
recommendations for complying with the regulatory framework for human 
cells, tissues, and cellular and tissue based products under 21 CFR 
part 1271 that were to be discussed during the part 15 (21 CFR part 15) 
hearing. In conjunction with the part 15 hearing and announcement of 
availability of the homologous use draft guidance, in the Federal 
Register of October 30, 2015 (80 FR 66847; 80 FR 66844; 80 FR 66849), 
FDA reopened the comment periods on the same surgical procedure, 
minimal manipulation, and adipose tissue draft guidances, respectively, 
to allow potential respondents time to thoroughly evaluate and address 
pertinent issues. Comments were requested by April 29, 2016. In this 
notice FDA is extending the comment period to September 27, 2016.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the rescheduling of a 2-day part 15 public hearing to September 12 and 
13, 2016, to obtain input from stakeholders on the four issued draft 
guidance documents. In a separate document, FDA is also announcing a 
public scientific workshop to identify and discuss scientific 
considerations and challenges to help inform the development of human 
cells, tissues, and cellular and tissue-based products subject to 
premarket approval, including stem cell-based products.

[[Page 23666]]

    Dated: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09366 Filed 4-21-16; 8:45 am]
 BILLING CODE 4164-01-P