[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Proposed Rules]
[Pages 23661-23664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09372]


=======================================================================
-----------------------------------------------------------------------

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, and Cellular and Tissue-Based Products; Rescheduling of Public 
Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

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

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a 2-day public hearing to obtain input on four draft guidance documents 
relating to the regulation of human cells, tissues, and cellular and 
tissue-based products (HCT/Ps). FDA had announced a 1-day public 
hearing for April 13, 2016, to obtain input on the guidances, but on 
February 29, 2016, announced that due to considerable interest in the 
public hearing and to give stakeholders additional time to provide 
comments to the Agency, the hearing was postponed. FDA also stated its 
intent to extend the comment period for the four draft guidance 
documents and to schedule a scientific workshop to identify and discuss 
the scientific considerations and challenges to help inform the 
development of HCT/Ps subject to premarket approval, including stem 
cell-based products. FDA will consider information it obtains from the 
public hearing in the finalization of the four draft guidance 
documents.

DATES: The public hearing will be held on September 12 and 13, 2016, 
from 9 a.m. to 5 p.m. The hearing on September 13 may be extended or 
end early depending on the number of speakers scheduled. Persons 
(including FDA employees) seeking to view the hearing via a live 
Webcast are not required to register. Persons (including FDA employees) 
seeking to attend in person or to attend and speak at the public 
hearing must register by June 1, 2016.

[[Page 23662]]

FDA will notify registered speakers of their scheduled times, and make 
available an agenda at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on or before July 
1, 2016. Once FDA notifies registered speakers of their scheduled 
times, speakers should submit an electronic copy of their presentation 
to hhs.gov">CBERPublicEvents@fda.hhs.gov by August 1, 2016. Section IV of this 
document provides attendance and registration information. Electronic 
or written comments will be accepted after the public hearing until 
September 27, 2016.

ADDRESSES: The public hearing will be held at the National Institutes 
of Health (NIH), 9000 Rockville Pike, Bldg. 10, Masur Auditorium, 
Bethesda, MD 20892. Entrance for the public hearing attendees and 
speakers (non-FDA employees) is through Bldg. 66 (Gateway Center), 
where routine security check procedures will be performed. For parking 
and security information, please refer to http://www.nih.gov/about-nih/visitor-information.
    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-2015-D-3719 for ``Draft Guidances Relating to the Regulation of 
Human Cells, Tissues, and Cellular and Tissue-Based Products; 
Rescheduling of 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. Persons seeking to view the hearing via the live Webcast are 
not required to register. 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 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. 
HCT/Ps are regulated solely under section 361 of the PHS Act and part 
1271, if they meet all of the following criteria (Sec.  1271.10(a)):
     The HCT/P is minimally manipulated;
     The HCT/P is intended for homologous use, 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

[[Page 23663]]

agent 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 criterial 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 may not be required to comply with some or all of the 
requirements in part 1271. For example, an establishment is excepted 
from the requirements in part 1271 if it ``removes HCT/P's from an 
individual and implants such HCT/P's 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: \1\
---------------------------------------------------------------------------

    \1\ http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/default.htm.
---------------------------------------------------------------------------

     Same Surgical Procedure Exception under 21 CFR 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 FDA Staff 
(Homologous Use Draft Guidance).
    The Same Surgical Procedure Exception Draft Guidance was announced 
in the Federal Register of October 23, 2014 (79 FR 63348), and provides 
answers to common questions regarding the scope of the exception. 
Comments were requested by December 22, 2014.
    The Minimal Manipulation Draft Guidance was announced in the 
Federal Register of December 23, 2014 (79 FR 77012), and provides 
recommendations for meeting the Sec.  1271.10(a)(1) criterion of 
minimal manipulation. Comments were requested by February 23, 2015.
    The Adipose Tissue Draft Guidance was announced in the Federal 
Register of December 24, 2014 (79 FR 77414), and provides those who 
manufacture and use adipose tissue with recommendations for complying 
with the regulatory framework for HCT/Ps. Comments were requested by 
February23, 2015.
    The Homologous Use Draft Guidance was announced in the Federal 
Register of October 30, 2015 (80 FR 66850), and provides 
recommendations for meeting the Sec.  1271.10(a)(2) homologous use 
criterion. Comments were requested by April 29, 2016. Also in the 
Federal Register of October 30, 2015, FDA reopened the comment periods 
to FDA's public dockets on the three draft guidance documents: Same 
Surgical Procedure Exception Draft Guidance (Docket No. FDA-2014-D-
1584; 80 FR 66847); Minimal Manipulation Draft Guidance (Docket No. 
FDA-2014-D-1696; 80 FR 66844), and the Adipose Tissue Draft Guidance 
(Docket No. FDA-2014-D-1856; 80 FR 66849). Comments were requested by 
April 29, 2016.
    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, and Cellular and 
Tissue-Based Products; Public Hearing; Request for Comments,'' which 
was to be held on April 13, 2016. Comments were requested by April 29, 
2016.
    On February 29, 2016, FDA postponed the public hearing to give 
stakeholders additional time to provide comments to the Agency. FDA 
also stated its intent to extend the comment period for the four draft 
guidance documents and to schedule a scientific workshop to identify 
and discuss the 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 extension of the comment period for the four 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 HCT/Ps subject to 
premarket approval, including stem cell-based products. FDA will 
provide a summary of the scientific workshop at the public hearing.

III. Purpose and Scope of the Public Hearing

    The purpose of this public hearing is to obtain comments on the 
four draft guidances. FDA is seeking feedback on the four draft 
guidances, both general and specific, from a broad group of 
stakeholders, including 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 the four draft guidances, including the 
particular topics covered, the particular questions posed, whether 
there are additional issues for which guidance would be helpful, 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 comments that will enhance 
the usefulness and clarity of these documents.
    FDA recommends that comments exclude discussion of products that do 
not meet the definition of an HCT/P, such as platelet-rich plasma and 
other blood products. 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 hearing.

IV. Attendance and Registration

    The NIH campus is a Federal facility with security procedures and 
limited seating. Attendance is free.
    Persons (including FDA employees) seeking to view the hearing via a 
live Webcast are not required to register.
    Persons (including FDA employees) who wish to attend in person, but 
not speak at the public hearing, must register at https://www.eventbrite.com/e/part-15-hearing-on-draft-guidances-relating-to-the-regulation-of-hctps-registration-22921962206 on or before June 1, 
2016, and provide complete contact information, including name, title, 
affiliation, email, and phone number. Those without email access may 
register by contacting Sherri Revell or Loni Warren Henderson at 240-
402-8010. There will be no onsite registration for this hearing.
    Persons (including FDA employees) who wish to attend and speak at 
the

[[Page 23664]]

public hearing must register at https://www.eventbrite.com/e/part-15-hearing-on-draft-guidances-relating-to-the-regulation-of-hctps-registration-22921962206 on or before June 1, 2016. Persons who wish to 
attend and speak at the public hearing will be required to provide 
complete contact information, including name, title, affiliation, 
email, and phone number. To help FDA organize the presentations, 
persons who wish to attend and speak must also indicate whether they 
are speaking on their own behalf or on behalf of an organization. If 
speaking on behalf of an organization, the name of the organization 
must be provided. Persons who wish to attend and speak must also 
indicate if they will be speaking on the draft guidance documents. 
Individuals and organizations with common interests should consolidate 
or coordinate their presentations and request time for a joint 
presentation. There will be no open public session at the public 
hearing.
    FDA will do its best to accommodate requests to speak at the public 
hearing and will determine the amount of time allotted for each oral 
presentation, and the approximate time that each oral presentation will 
be scheduled to begin. Multiple speakers from the same organization 
will be given one presentation slot for that organization. If the 
number of persons or organizations requesting to speak is greater than 
can be reasonably accommodated, FDA will close registration for 
speakers. FDA will notify registered speakers of their scheduled times, 
and make available an agenda at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on or before July 1, 2016. Once FDA notifies registered 
speakers of their scheduled times, presenters should submit an 
electronic copy of their presentation to hhs.gov">CBERPublicEvents@fda.hhs.gov 
by August 1, 2016.
    If you need special accommodations because of a disability, please 
contact Sherri Revell or Loni Warren Henderson at 240-402-8010 at least 
7 days before the hearing.
    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 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, who will be 
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 Sec.  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 of this document). To the extent that the 
conditions for the hearing, as described in this notice, conflict with 
any provisions set out in part 15, this notice 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 
(see ADDRESSES). 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: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09372 Filed 4-21-16; 8:45 am]
 BILLING CODE 4164-01-P