
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66844-66845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27705]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-D-1696]


Minimal Manipulation of Human Cells, Tissues, and Cellular and 
Tissue-Based Products; Draft Guidance for Industry and Food and Drug 
Administration Staff; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the 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of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft 
Guidance for Industry and Food and Drug Administration Staff,'' 
published in the Federal Register of December 23, 2014. FDA is 
reopening the comment period to allow interested persons additional 
time to submit comments and any new information.

DATES: Submit either electronic or written comments on the draft 
guidance by April 29, 2016.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 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-1696 for ``Minimal Manipulation of Human Cells, Tissues, and 
Cellular and Tissue-Based Products; Draft Guidance for Industry and 
Food and Drug Administration Staff; Reopening the Comment Period.'' 
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

[[Page 66845]]

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 J. Churchyard, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    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. The draft guidance document provides human 
cells, tissues, and cellular and tissue-based product (HCT/P) 
manufacturers, health care providers, and FDA staff with 
recommendations for meeting the 21 CFR 1271.10(a)(1) criterion of 
minimal manipulation. Interested persons were originally given until 
February 23, 2015, to comment on the draft guidance.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
four other related documents. In a separate document, FDA is announcing 
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'' (part 15 hearing) to be held on April 
13, 2016, to provide stakeholders with the opportunity to discuss FDA's 
policy on regulation of HCT/Ps related to the four draft guidances on 
the following topics: Homologous use, same surgical procedure 
exception, minimal manipulation, and adipose tissue.
    In a separate document, FDA is announcing 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.''
    In separate documents, FDA is also reopening the comment periods to 
FDA's public dockets on the previously issued draft guidance documents 
on the following topics related to HCT/Ps: Adipose tissue (Docket No. 
FDA-2014-D-1856) and same surgical procedure exception (Docket No. FDA-
2014-D-1584).

II. Reopening of Comment Period

    Following publication of December 23, 2014, notice of availability, 
FDA received a request to allow interested persons additional time to 
comment. In conjunction with the part 15 hearing and announcement of 
availability of the homologous use draft guidance, FDA is reopening the 
comment period to allow potential respondents to thoroughly evaluate 
and address pertinent issues. The minimal manipulation draft guidance 
and other related guidances (homologous use, same surgical procedure 
exception, adipose tissue) all deal with the interpretation of the 
regulations under 21 CFR part 1271 that will be addressed as part of 
the part 15 hearing.

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27705 Filed 10-29-15; 8:45 am]
BILLING CODE 4164-01-P


