Document ID: FDA-2015-D-3719-0001
Agency: fda
Document Type: Proposed Rule
Title: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments
Posted Date: 2015-10-30T04:00Z

[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66845-66847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27703]

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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a 1-day 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). These draft guidances were 
issued by FDA in response to stakeholders' requests for guidance on 
FDA's current views about how manufacturers, establishments, and 
distributors of HCT/Ps and health care professionals can meet the 
criteria under the Agency's regulations that apply to HCT/Ps. FDA will 
consider information it obtains from the public hearing in the 
finalization of these guidances.

DATES: The public hearing will be held on April 13, 2016, from 8 a.m. 
to 5 p.m. The meeting may be extended or end early depending on the 
level of public participation. Persons seeking to attend or to present 
at the public hearing must register by January 8, 2016. Section IV 
provides attendance and registration information. Electronic or written 
comments will be accepted after the public hearing until April 29, 
2016.

ADDRESSES: The public hearing will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public hearing 
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.
    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.

[[Page 66846]]

     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-2015-D-3719 for ``Draft Guidances Relating to the Regulation of 
Human Cells, Tissues, or Cellular or Tissue-Based Products; Public 
Hearing; Request for Comments.'' 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.
    A link to the live Webcast of this public hearing will be available 
at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on the day of the public 
hearing. A video record of the public hearing will be available at 
http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm. A video record of the 
public hearing will be available at the same Web site address for 1 
year.

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: 

I. Background

    HCT/Ps are defined in Sec.  1271.3(d) (21 CFR 1271.3(d)) as 
articles containing or consisting of human cells or tissues that are 
intended for implantation, transplantation, infusion, or transfer into 
a human recipient. FDA has implemented a risk-based approach to the 
regulation of HCT/Ps. Under the authority of section 361 of the Public 
Health Service (PHS) Act (42 U.S.C. 264), FDA established regulations 
for all HCT/Ps to prevent the introduction, transmission, and spread of 
communicable diseases. These regulations can be found in part 1271. An 
HCT/P is regulated solely under section 361 of the PHS Act and part 
1271, if it meets all of the following criteria (Sec.  1271.10(a)):
     The HCT/P is minimally manipulated;
     The HCT/P is intended for homologous use only, as 
reflected by the labeling, advertising, or other indications of the 
manufacturer's objective intent;
     The manufacture of the HCT/P does not involve the 
combination of the cells or tissues with another article, except for 
water, crystalloids, or a sterilizing, preserving, or storage agent, 
provided that the addition of water, crystalloids, or the sterilizing, 
preserving, or storage does not raise new clinical safety concerns with 
respect to the HCT/P; and
     Either
    [cir] The HCT/P does not have a systemic effect and is not 
dependent upon the metabolic activity of living cells for its primary 
function, or
    [cir] The HCT/P has a systemic effect or is dependent upon the 
metabolic activity of living cells for its primary function, and is for 
the following uses:
    [ssquf] Autologous,
    [ssquf] Allogeneic, in a first-degree or second-degree blood 
relative, or
    [ssquf] Reproductive.
    If an HCT/P does not meet all of the criteria set forth under Sec.  
1271.10(a), the HCT/P will be regulated as a drug, device, and/or 
biological product under the Federal Food, Drug, and Cosmetic Act, and/
or section 351 of the PHS Act (42 U.S.C. 262).
    In certain circumstances as provided in Sec.  1271.15, an 
establishment that manufactures HCT/Ps may be excepted from the 
requirements in part 1271. For example, an establishment is excepted 
from the requirements if it ``removes HCT/Ps from an individual and 
implants such HCT/Ps into the same individual during the same surgical 
procedure'' (Sec.  1271.15(b)).

II. Draft Guidances

    As part of its commitment to public outreach and to explain the 
Agency's current thinking on the regulatory framework for HCT/Ps, FDA 
has issued the following four draft guidances:
     Same Surgical Procedure Exception under Sec.  1271.15(b): 
Questions and Answers Regarding the Scope of the Exception; Draft 
Guidance for Industry (Same Surgical Procedure Exception Draft 
Guidance);
     Minimal Manipulation of Human Cells, Tissues, and Cellular 
and Tissue-Based Products; Draft Guidance for Industry and Food and 
Drug Administration Staff (Minimal Manipulation Draft Guidance);
     Human Cells, Tissues, and Cellular and Tissue-Based 
Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft 
Guidance for Industry (Adipose Tissue Draft Guidance); and
     Homologous Use of Human Cells, Tissues, and Cellular and 
Tissue-Based Products; Draft Guidance for Industry and Food and Drug 
Administration Staff (Homologous Use Draft Guidance).
    The Same Surgical Procedure Exception Draft Guidance was published 
in the Federal Register of October 23, 2014 (79 FR 63348), and provides 
answers to common questions regarding the scope of the exception.
    The Minimal Manipulation Draft Guidance was published in the 
03'Federal Register of December 23, 2014 (79 FR 77012), and provides 
recommendations for meeting the Sec.  1271.10(a)(1) criterion of 
minimal manipulation.
    The Adipose Tissue Draft Guidance was published in the Federal 
Register of December 24, 2014 (79 FR 77414), and

[[Page 66847]]

provides those who manufacture and use adipose tissue with 
recommendations for complying with the regulatory framework for HCT/Ps.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of the Homologous Use Draft Guidance which provides 
recommendations for applying the Sec.  1271.10(a)(2) homologous use 
criterion, and is also announcing the reopening of the comment periods 
on the Same Surgical Procedure Exception, Minimal Manipulation, and 
Adipose Tissue Draft Guidances.

III. Purpose and Scope of the Public Hearing

    The purpose of this public hearing is to obtain comments on these 
four draft guidances. FDA is seeking feedback, both general and 
specific, from a broad group of stakeholders, including HCT/P 
manufacturers, tissue establishments, biological and device product 
manufacturers, health care professionals, clinicians, biomedical 
researchers, and the public. For example, FDA would like comments on 
the scope of each guidance, including the particular topics covered, 
the particular questions posed, whether there are additional issues for 
which they seek guidance, and whether FDA's recommendations for each 
topic are sufficiently clear and consistent within and across documents 
to provide meaningful guidance to stakeholders. In addition, FDA 
welcomes any comments that will enhance the usefulness and clarity of 
these documents.
    FDA recommends that comments exclude discussion of products which 
do not meet the definition of an HCT/P, such as platelet rich plasma. 
FDA also recommends that stakeholders coordinate comments when possible 
in order to allow for presentation of a wide range of perspectives 
within the allotted time of the meeting.

IV. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal 
facility with security procedures and limited seating. Attendance is 
free and will be on a first-come, first-served basis. Individuals who 
wish to present at the public hearing must register by sending an email 
to CBERPublicEvents@fda.hhs.gov on or before January 8, 2016, and 
provide complete contact information, including name, title, 
affiliation, address, email, and phone number. Those without email 
access may register by contacting Sherri Revell or Loni Warren 
Henderson at 240-402-7800. You should identify each guidance you wish 
to comment on in your presentation so that FDA can consider that 
information in organizing the presentations. Individuals and 
organizations with common interests should consolidate or coordinate 
their presentations and request time for a joint presentation. FDA will 
do its best to accommodate requests to speak and will determine the 
amount of time allotted for each oral presentation, and the approximate 
time that each oral presentation is scheduled to begin. FDA will notify 
registered presenters of their scheduled times, and make available an 
agenda at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on or before February 5, 
2016. Once FDA notifies registered presenters of their scheduled times, 
presenters should submit an electronic copy of their presentation to 
CBERPublicEvents@fda.hhs.gov by March 11, 2016.
    If you need special accommodations because of a disability, please 
contact Sherri Revell or Loni Warren Henderson at 240-402-7800 at least 
7 days before the meeting.
    A link to the live Web cast of this public hearing will be 
available at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on the day of the public 
hearing. A video record of the public hearing will be available at 
http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm following the meeting. A 
video record of the public hearing will be available at the same Web 
site address for 1 year.

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with part 15 (21 CFR part 15). The 
hearing will be conducted by a presiding officer, accompanied by FDA 
senior management from the Office of the Commissioner and the Center 
for Biologics Evaluation and Research.
    Under Sec.  15.30(f), the hearing is informal and the rules of 
evidence do not apply. No participant may interrupt the presentation of 
another participant. Only the presiding officer and panel members may 
question any person during or at the conclusion of each presentation. 
Public hearings under part 15 are subject to FDA's policy and 
procedures for electronic media coverage of FDA's public administrative 
proceedings (21 CFR part 10, subpart C). Under 21 CFR 10.205, 
representatives of the electronic media may be permitted, subject to 
certain limitations, to videotape, film or otherwise record FDA's 
public administrative proceedings, including presentations by 
participants. The hearing will be transcribed as stipulated in Sec.  
15.30(b) (see section VI). To the extent that the conditions for the 
hearing, as described in this document, conflict with any provisions 
set out in part 15, this document acts as a waiver of those provisions 
as specified in Sec.  15.30(h).

VI. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at www.regulations.gov and http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm. It may be viewed at the Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852. A transcript will also be available in either hardcopy or on 
CD-ROM, after submission of a Freedom of Information request. The 
Freedom of Information office address is available on the Agency's Web 
site at http://www.fda.gov.

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27703 Filed 10-29-15; 8:45 am]
 BILLING CODE 4164-01-P