Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 66850-66851 [2015-27704]
Download as PDF
66850
Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Proposed Rules
FDA’s public dockets on the previously
issued draft guidance documents on the
following topics related to HCT/Ps:
Minimal manipulation (Docket No.
FDA–2014–D–1696) and same surgical
procedure exception (Docket No. FDA–
2014–D–1584).
II. Reopening of Comment Period
Following publication of December
24, 2014, notice of availability, FDA
received several requests 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availability of the homologous use draft
guidance, FDA is reopening the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 adipose
tissue draft guidance and other related
guidances (homologous use, minimal
manipulation, same surgical procedure
exception) 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. 2015–27706 Filed 10–29–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1271
[Docket No. FDA–2015–D–3581]
Homologous Use of Human Cells,
Tissues, and Cellular and TissueBased Products; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
Notification of availability.
The Food and Drug
Administration (FDA or Agency) 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Tissue-Based Products; Draft Guidance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.’’ The draft
guidance document provides human
cells, tissues, and cellular and tissuebased product (HCT/P) manufacturers,
health care providers, and FDA staff,
with recommendations for applying the
criterion of ‘‘homologous use’’ as it
applies to HCT/Ps. The interpretation
and application of the homologous use
criterion and related definitions have
been of considerable interest to industry
tkelley on DSK3SPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
16:29 Oct 29, 2015
Jkt 238001
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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
HHS.
ACTION:
stakeholders since they were first
proposed during the Agency’s
rulemaking on HCT/Ps.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 29, 2016.
ADDRESSES: You may submit comments
as follows:
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–3581 for ‘‘Homologous Use of
Human Cells, Tissues, and Cellular and
Tissue-Based Products; Draft Guidance
for Industry and FDA Staff;
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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 https://
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: https://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 https://
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.
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002, or to the
Office of the Center Director, Guidance
and Policy Development, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
E:\FR\FM\30OCP1.SGM
30OCP1
Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS
Rm. 5431, Silver Spring MD 20993–
0002, or you may send an email request
to the Office of Combination Products at
combination@fda.gov. If you are
submitting a written request, send one
self-addressed adhesive label to assist
the office in processing your requests.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 240–402–8010. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Lori
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; or Angela Krueger, Office of
Device Evaluation, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring,
MD 20993–0002, 301–796–6380; or
Leigh Hayes, Office of Combination
Products, Office of the Commissioner,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
5125, Silver Spring, MD 20993–0002,
301–796–8938.
SUPPLEMENTARY INFORMATION:
I. Background
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.’’ The draft guidance document
provides HCT/P manufacturers, health
care providers, and FDA staff, with
recommendations for applying the
§ 1271.10(a)(2) (21 CFR 1271.10(a)(2))
criterion of homologous use. This
guidance will improve stakeholders’
understanding of the definition of
homologous use in § 1271.3(c), and how
to apply the regulatory criterion in
§ 1271.10(a)(2) to their HCT/P.
HCT/Ps are defined in § 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 riskbased 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 under part 1271 for all HCT/
Ps to prevent the introduction,
transmission, and spread of
communicable diseases. HCT/Ps are
regulated solely under section 361 of the
PHS Act and 21 CFR part 1271, if they
meet the criteria provided under
§ 1271.10(a).
VerDate Sep<11>2014
16:29 Oct 29, 2015
Jkt 238001
If an HCT/P does not meet all of the
criteria set out under § 1271.10(a), and
does not meet one of the exceptions in
§ 1271.15, 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).
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on
‘‘Homologous Use of Human Cells,
Tissues, and Cellular and Tissue-Based
Products.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirement of the applicable statutes
and regulations.
In a separate document published
elsewhere in this issue of the Federal
Register, FDA is announcing a public
hearing entitled ‘‘Draft Guidances
Relating to the Regulation of Human
Cells, Tissues or Cellular or TissueBased Products; Public Hearing; Request
for Comments’’ 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 separate documents published
elsewhere in this issue of the Federal
Register, 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: Minimal
manipulation (Docket No. FDA–2014–
D–1696), adipose tissue (Docket No.
FDA–2014–D–1856), and same surgical
procedure exception (Docket No. FDA–
2014–D–1584).
II. Paperwork Reduction Act of 1995
The draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in part 1271 have been
approved under OMB control number
0910–0543.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
66851
www.fda.gov/MedicalDevices/Device
RegulationandGuidance/Guidance
Documents/default.htm or https://
www.fda.gov/CombinationProducts/
GuidanceRegulatoryInformation/
default.htm or https://
www.regulations.gov. Persons unable to
download an electronic copy of the draft
guidance entitled ‘‘Homologous Use of
Human Cells, Tissues, and Cellular and
Tissue-Based Products; Draft Guidance
for Industry and FDA Staff’’ may send
an email request to CDRH-guidance@
fda.hhs.gov to receive an electronic
copy of the document.
Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27704 Filed 10–29–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 300
[REG–121496–15]
RIN 1545–BN02
Preparer Tax Identification Number
(PTIN) User Fee Update
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
by cross-reference to temporary
regulations.
AGENCY:
In the Rules and Regulations
section of this issue of the Federal
Register, the IRS is issuing temporary
regulations that will amend regulations
(TD 9503) relating to the imposition of
certain user fees on tax return preparers.
The temporary regulations reduce the
amount of the user fee to apply for or
renew a preparer tax identification
number (PTIN). The text of the
temporary regulations also serves as the
text of these proposed regulations.
DATES: Written or electronic comments
and requests for a public hearing must
be received by January 28, 2016.
ADDRESSES: Send submissions to:
CC:PA:LPD:PR (REG–121496–15), Room
5203, Internal Revenue Service, P.O.
Box 7604, Ben Franklin Station,
Washington, DC 20044. Submissions
may be hand-delivered Monday through
Friday between the hours of 8 a.m. and
4 p.m. to CC:PA:LPD:PR (REG–121496–
15), Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue NW.,
Washington, DC 20224 or sent
electronically via the Federal
eRulemaking Portal at https://
SUMMARY:
E:\FR\FM\30OCP1.SGM
30OCP1
Agencies
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66850-66851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27704]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1271
[Docket No. FDA-2015-D-3581]
Homologous Use of Human Cells, Tissues, and Cellular and Tissue-
Based Products; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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.'' 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 applying the criterion of ``homologous use'' as it
applies to HCT/Ps. The interpretation and application of the homologous
use criterion and related definitions have been of considerable
interest to industry stakeholders since they were first proposed during
the Agency's rulemaking on HCT/Ps.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, 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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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-3581 for ``Homologous Use of Human Cells, Tissues, and
Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA
Staff; Availability.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://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 https://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: https://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 https://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.
Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002, or to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health (CDRH), Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66,
[[Page 66851]]
Rm. 5431, Silver Spring MD 20993-0002, or you may send an email request
to the Office of Combination Products at combination@fda.gov. If you
are submitting a written request, send one self-addressed adhesive
label to assist the office in processing your requests. The draft
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Lori 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; or Angela Krueger, Office of Device Evaluation, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002,
301-796-6380; or Leigh Hayes, Office of Combination Products, Office of
the Commissioner, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5125, Silver Spring, MD 20993-0002, 301-796-8938.
SUPPLEMENTARY INFORMATION:
I. Background
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.'' The draft
guidance document provides HCT/P manufacturers, health care providers,
and FDA staff, with recommendations for applying the Sec.
1271.10(a)(2) (21 CFR 1271.10(a)(2)) criterion of homologous use. This
guidance will improve stakeholders' understanding of the definition of
homologous use in Sec. 1271.3(c), and how to apply the regulatory
criterion in Sec. 1271.10(a)(2) to their HCT/P.
HCT/Ps are defined in Sec. 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 under
part 1271 for all HCT/Ps to prevent the introduction, transmission, and
spread of communicable diseases. HCT/Ps are regulated solely under
section 361 of the PHS Act and 21 CFR part 1271, if they meet the
criteria provided under Sec. 1271.10(a).
If an HCT/P does not meet all of the criteria set out under Sec.
1271.10(a), and does not meet one of the exceptions in Sec. 1271.15,
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).
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on ``Homologous Use of
Human Cells, Tissues, and Cellular and Tissue-Based Products.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirement of the applicable statutes and regulations.
In a separate document published elsewhere in this issue of the
Federal Register, 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'' 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 separate documents published elsewhere in this issue of the
Federal Register, 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: Minimal manipulation (Docket No.
FDA-2014-D-1696), adipose tissue (Docket No. FDA-2014-D-1856), and same
surgical procedure exception (Docket No. FDA-2014-D-1584).
II. Paperwork Reduction Act of 1995
The draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 1271 have been approved under OMB
control number 0910-0543.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of
the draft guidance entitled ``Homologous Use of Human Cells, Tissues,
and Cellular and Tissue-Based Products; Draft Guidance for Industry and
FDA Staff'' may send an email request to CDRH-guidance@fda.hhs.gov to
receive an electronic copy of the document.
Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27704 Filed 10-29-15; 8:45 am]
BILLING CODE 4164-01-P