80 FR 66849 - Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Reopening of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 210 (October 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 210 (October 30, 2015)
| Page Range | 66849-66850 | |
| FR Document | 2015-27706 |
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)] [Proposed Rules] [Pages 66849-66850] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27706] [[Page 66849]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2014-D-1856] Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notification; reopening of the comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry'' published in the Federal Register of December 24, 2014.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 DATES: Submit either electronic or written comments on the draft guidance by April 29, 2016.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-1856 for ``Human Cells, Tissues, and Cellular and Tissue- Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry.'' 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. 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 24, 2014 (79 FR 77414), FDA announced the availability of a draft document entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry'' dated December 2014. The draft guidance document provides sponsors, clinicians, and other establishments that manufacture and use adipose tissue, with recommendations for complying with the regulatory framework for human cells, tissues, and cellular and tissue-based products (HCT/Ps). For purposes of applying the HCT/P regulatory framework, FDA considers connective tissue, including adipose tissue, to be a structural tissue. 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 [[Page 66850]] 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
![Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Proposed Rules 66849
DEPARTMENT OF HEALTH AND Written/Paper Submissions Docket: For access to the docket to
HUMAN SERVICES read background documents or the
Submit written/paper submissions as electronic and written/paper comments
Food and Drug Administration follows: received, go to http://
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the
21 CFR Part 1271 written/paper submissions): Division of docket number, found in brackets in the
Dockets Management (HFA–305), Food heading of this document, into the
[Docket No. FDA–2014–D–1856]
and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Human Cells, Tissues, and Cellular and Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
Tissue-Based Products From Adipose • For written/paper comments Management, 5630 Fishers Lane, Rm.
Tissue: Regulatory Considerations; submitted to the Division of Dockets 1061, Rockville, MD 20852.
Draft Guidance for Industry; Management, FDA will post your FOR FURTHER INFORMATION CONTACT: Lori
Reopening of the Comment Period comment, as well as any attachments, J. Churchyard, Center for Biologics
except for information submitted, Evaluation and Research, Food and
AGENCY: Food and Drug Administration, marked and identified, as confidential,
HHS. Drug Administration, 10903 New
if submitted as detailed in Hampshire Ave., Bldg. 71, Rm. 7301,
Notification; reopening of the
ACTION: ‘‘Instructions.’’ Silver Spring, MD 20993–0002, 240–
comment period. Instructions: All submissions received 402–7911.
SUMMARY: The Food and Drug must include the Docket No. FDA– SUPPLEMENTARY INFORMATION:
Administration (FDA) is reopening the 2014–D–1856 for ‘‘Human Cells,
comment period for the draft document Tissues, and Cellular and Tissue-Based I. Background
entitled ‘‘Human Cells, Tissues, and Products from Adipose Tissue: In the Federal Register of December
Cellular and Tissue-Based Products Regulatory Considerations; Draft 24, 2014 (79 FR 77414), FDA announced
from Adipose Tissue: Regulatory Guidance for Industry.’’ Received the availability of a draft document
Considerations; Draft Guidance for comments will be placed in the docket entitled ‘‘Human Cells, Tissues, and
Industry’’ published in the Federal and, except for those submitted as Cellular and Tissue-Based Products
Register of December 24, 2014. FDA is ‘‘Confidential Submissions,’’ publicly from Adipose Tissue: Regulatory
reopening the comment period to allow viewable at http://www.regulations.gov Considerations; Draft Guidance for
interested persons additional time to or at the Division of Dockets Industry’’ dated December 2014. The
submit comments and any new Management between 9 a.m. and 4 p.m., draft guidance document provides
information. Monday through Friday. sponsors, clinicians, and other
DATES: Submit either electronic or • Confidential Submissions—To establishments that manufacture and
written comments on the draft guidance submit a comment with confidential use adipose tissue, with
by April 29, 2016. information that you do not wish to be recommendations for complying with
ADDRESSES: You may submit comments
made publicly available, submit your the regulatory framework for human
as follows: comments only as a written/paper cells, tissues, and cellular and tissue-
submission. You should submit two based products (HCT/Ps). For purposes
Electronic Submissions copies total. One copy will include the of applying the HCT/P regulatory
Submit electronic comments in the information you claim to be confidential framework, FDA considers connective
following way: with a heading or cover note that states tissue, including adipose tissue, to be a
• Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS structural tissue. Interested persons
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The were originally given until February 23,
instructions for submitting comments. Agency will review this copy, including 2015, to comment on the draft guidance.
Comments submitted electronically, the claimed confidential information, in Elsewhere in this issue of the Federal
including attachments, to http:// its consideration of comments. The Register, FDA is announcing four other
www.regulations.gov will be posted to second copy, which will have the related documents. In a separate
the docket unchanged. Because your claimed confidential information document, FDA is announcing a public
comment will be made public, you are redacted/blacked out, will be available hearing entitled ‘‘Draft Guidances
solely responsible for ensuring that your for public viewing and posted on http:// Relating to the Regulation of Human
comment does not include any www.regulations.gov. Submit both Cells, Tissues, or Cellular or Tissue-
confidential information that you or a copies to the Division of Dockets Based Products; Public Hearing; Request
third party may not wish to be posted, Management. If you do not wish your for Comments’’ (part 15 hearing) to be
such as medical information, your or name and contact information to be held on April 13, 2016, to provide
anyone else’s Social Security number, or made publicly available, you can stakeholders with the opportunity to
confidential business information, such provide this information on the cover discuss FDA’s policy on regulation of
as a manufacturing process. Please note sheet and not in the body of your HCT/Ps related to the four draft
that if you include your name, contact comments and you must identify this guidances on the following topics:
information, or other information that information as ‘‘confidential’’. Any Homologous use, same surgical
identifies you in the body of your information marked as ‘‘confidential’’ procedure exception, minimal
comments, that information will be will not be disclosed except in manipulation, and adipose tissue.
tkelley on DSK3SPTVN1PROD with PROPOSALS
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other In a separate document, FDA is
• If you want to submit a comment applicable disclosure law. For more announcing the availability of a draft
with confidential information that you information about FDA’s posting of document entitled ‘‘Homologous Use of
do not wish to be made available to the comments to public dockets, see 80 FR Human Cells, Tissues, and Cellular and
public, submit the comment as a 56469, September 18, 2015, or access Tissue-Based Products; Draft Guidance
written/paper submission and in the the information at: http://www.fda.gov/ for Industry and FDA Staff.’’
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ In separate documents, FDA is also
Submissions’’ and ‘‘Instructions’’). default.htm. reopening the comment periods to
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![66850 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Proposed Rules
FDA’s public dockets on the previously stakeholders since they were first Availability.’’ Received comments will
issued draft guidance documents on the proposed during the Agency’s be placed in the docket and, except for
following topics related to HCT/Ps: rulemaking on HCT/Ps. those submitted as ‘‘Confidential
Minimal manipulation (Docket No. DATES: Although you can comment on Submissions,’’ publicly viewable at
FDA–2014–D–1696) and same surgical any guidance at any time (see 21 CFR http://www.regulations.gov or at the
procedure exception (Docket No. FDA– 10.115(g)(5)), to ensure that the Agency Division of Dockets Management
2014–D–1584). considers your comment on this draft between 9 a.m. and 4 p.m., Monday
guidance before it begins work on the through Friday.
II. Reopening of Comment Period • Confidential Submissions—To
final version of the guidance, submit
Following publication of December submit a comment with confidential
either electronic or written comments
24, 2014, notice of availability, FDA information that you do not wish to be
on the draft guidance by April 29, 2016.
received several requests to allow made publicly available, submit your
interested persons additional time to ADDRESSES: You may submit comments
comments only as a written/paper
comment. In conjunction with the part as follows: submission. You should submit two
15 hearing and announcement of Electronic Submissions copies total. One copy will include the
availability of the homologous use draft information you claim to be confidential
guidance, FDA is reopening the Submit electronic comments in the
with a heading or cover note that states
comment period to allow potential following way:
‘‘THIS DOCUMENT CONTAINS
respondents to thoroughly evaluate and • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION’’. The
address pertinent issues. The adipose www.regulations.gov. Follow the Agency will review this copy, including
tissue draft guidance and other related instructions for submitting comments. the claimed confidential information, in
guidances (homologous use, minimal Comments submitted electronically, its consideration of comments. The
manipulation, same surgical procedure including attachments, to http:// second copy, which will have the
exception) all deal with the www.regulations.gov will be posted to claimed confidential information
interpretation of the regulations under the docket unchanged. Because your redacted/blacked out, will be available
21 CFR part 1271 that will be addressed comment will be made public, you are for public viewing and posted on http://
as part of the part 15 hearing. solely responsible for ensuring that your www.regulations.gov. Submit both
comment does not include any copies to the Division of Dockets
Dated: October 27, 2015.
confidential information that you or a Management. If you do not wish your
Leslie Kux, third party may not wish to be posted,
Associate Commissioner for Policy. name and contact information to be
such as medical information, your or made publicly available, you can
[FR Doc. 2015–27706 Filed 10–29–15; 8:45 am] anyone else’s Social Security number, or provide this information on the cover
BILLING CODE 4164–01–P confidential business information, such sheet and not in the body of your
as a manufacturing process. Please note comments and you must identify this
that if you include your name, contact information as ‘‘confidential.’’ Any
DEPARTMENT OF HEALTH AND information, or other information that
HUMAN SERVICES information marked as ‘‘confidential’’
identifies you in the body of your will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
Food and Drug Administration
posted on http://www.regulations.gov. applicable disclosure law. For more
• If you want to submit a comment information about FDA’s posting of
21 CFR Part 1271
with confidential information that you comments to public dockets, see 80 FR
[Docket No. FDA–2015–D–3581] do not wish to be made available to the 56469, September 18, 2015, or access
public, submit the comment as a the information at: http://www.fda.gov/
Homologous Use of Human Cells, written/paper submission and in the regulatoryinformation/dockets/
Tissues, and Cellular and Tissue- manner detailed (see ‘‘Written/Paper default.htm.
Based Products; Draft Guidance for Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Industry and Food and Drug
Written/Paper Submissions read background documents or the
Administration Staff; Availability
electronic and written/paper comments
AGENCY: Food and Drug Administration, Submit written/paper submissions as received, go to http://
HHS. follows: www.regulations.gov and insert the
ACTION: Notification of availability. • Mail/Hand delivery/Courier (for docket number, found in brackets in the
written/paper submissions): Division of heading of this document, into the
SUMMARY: The Food and Drug Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
Administration (FDA or Agency) is and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
announcing the availability of a draft Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
document entitled ‘‘Homologous Use of • For written/paper comments 1061, Rockville, MD 20852.
Human Cells, Tissues, and Cellular and submitted to the Division of Dockets Submit written requests for single
Tissue-Based Products; Draft Guidance Management, FDA will post your copies of the draft guidance to the Office
for Industry and FDA Staff.’’ The draft comment, as well as any attachments, of Communication, Outreach and
guidance document provides human except for information submitted, Development, Center for Biologics
cells, tissues, and cellular and tissue- marked and identified, as confidential, Evaluation and Research (CBER), Food
tkelley on DSK3SPTVN1PROD with PROPOSALS
based product (HCT/P) manufacturers, if submitted as detailed in and Drug Administration, 10903 New
health care providers, and FDA staff, ‘‘Instructions.’’ Hampshire Ave., Bldg. 71, Rm. 3128,
with recommendations for applying the Instructions: All submissions received Silver Spring, MD 20993–0002, or to the
criterion of ‘‘homologous use’’ as it must include the Docket No. FDA– Office of the Center Director, Guidance
applies to HCT/Ps. The interpretation 2015–D–3581 for ‘‘Homologous Use of and Policy Development, Center for
and application of the homologous use Human Cells, Tissues, and Cellular and Devices and Radiological Health
criterion and related definitions have Tissue-Based Products; Draft Guidance (CDRH), Food and Drug Administration,
been of considerable interest to industry for Industry and FDA Staff; 10903 New Hampshire Ave., Bldg. 66,
VerDate Sep<11>2014 16:29 Oct 29, 2015 Jkt 238001 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\30OCP1.SGM 30OCP1](https://thefederalregister.org/doc/80_FR_67059/page/2.svg)
Document Created: 2015-12-14 15:29:12
Document Modified: 2015-12-14 15:29:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification; reopening of the comment period. | |
| Dates | Submit either electronic or written comments on the draft guidance by April 29, 2016. | |
| 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. | |
| FR Citation | 80 FR 66849 |
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