[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, [email protected].
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 [email protected] 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
[email protected] 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