80 FR 66850 - Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 210 (October 30, 2015)

Page Range		66850-66851
FR Document		2015-27704

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of a draft document entitled ``Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.'' The draft guidance document provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, health care providers, and FDA staff, with recommendations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.

Federal Register, Volume 80 Issue 210 (Friday, October 30, 2015)

[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66850-66851]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-27704]

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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Based Products; Draft Guidance for Industry and Food and Drug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Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance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 The draft guidance document provides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: 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-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 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.
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 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or http://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/default.htm or http://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

Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Proposed Rules 66851

Rm. 5431, Silver Spring MD 20993– If an HCT/P does not meet all of the www.fda.gov/MedicalDevices/Device
0002, or you may send an email request criteria set out under § 1271.10(a), and RegulationandGuidance/Guidance
to the Office of Combination Products at does not meet one of the exceptions in Documents/default.htm or http://
combination@fda.gov. If you are § 1271.15, the HCT/P will be regulated www.fda.gov/CombinationProducts/
submitting a written request, send one as a drug, device, and/or biological GuidanceRegulatoryInformation/
self-addressed adhesive label to assist product under the Federal Food, Drug, default.htm or http://
the office in processing your requests. and Cosmetic Act, and/or section 351 of www.regulations.gov. Persons unable to
The draft guidance may also be obtained the PHS Act (42 U.S.C. 262). download an electronic copy of the draft
by mail by calling CBER at 1–800–835– The draft guidance is being issued guidance entitled ‘‘Homologous Use of
4709 or 240–402–8010. See the consistent with FDA’s good guidance Human Cells, Tissues, and Cellular and
SUPPLEMENTARY INFORMATION section for practices regulation (21 CFR 10.115). Tissue-Based Products; Draft Guidance
electronic access to the draft guidance The draft guidance, when finalized, will for Industry and FDA Staff’’ may send
document. represent FDA’s current thinking on an email request to CDRH-guidance@
‘‘Homologous Use of Human Cells, fda.hhs.gov to receive an electronic
FOR FURTHER INFORMATION CONTACT: Lori
Tissues, and Cellular and Tissue-Based copy of the document.
Churchyard, Center for Biologics
Products.’’ It does not establish any
Evaluation and Research, Food and rights for any person and is not binding
Dated: October 27, 2015.
Drug Administration, 10903 New on FDA or the public. You can use an Leslie Kux,
Hampshire Ave., Bldg. 71, Rm. 7301, alternative approach if it satisfies the Associate Commissioner for Policy.
Silver Spring, MD 20993–0002, 240– requirement of the applicable statutes [FR Doc. 2015–27704 Filed 10–29–15; 8:45 am]
402–7911; or Angela Krueger, Office of and regulations. BILLING CODE 4164–01–P
Device Evaluation, Center for Devices In a separate document published
and Radiological Health, Food and Drug elsewhere in this issue of the Federal
Administration, 10903 New Hampshire Register, FDA is announcing a public DEPARTMENT OF THE TREASURY
Ave., Bldg. 66, Rm. 1666, Silver Spring, hearing entitled ‘‘Draft Guidances
MD 20993–0002, 301–796–6380; or Relating to the Regulation of Human Internal Revenue Service
Leigh Hayes, Office of Combination Cells, Tissues or Cellular or Tissue-
Products, Office of the Commissioner, Based Products; Public Hearing; Request 26 CFR Part 300
Food and Drug Administration, 10903 for Comments’’ to be held on April 13,
New Hampshire Ave., Bldg. 32, Rm. [REG–121496–15]
2016, to provide stakeholders with the
5125, Silver Spring, MD 20993–0002, opportunity to discuss FDA’s policy on RIN 1545–BN02
301–796–8938. regulation of HCT/Ps related to the four
SUPPLEMENTARY INFORMATION: draft guidances on the following topics: Preparer Tax Identification Number
Homologous use, same surgical (PTIN) User Fee Update
I. Background
procedure exception, minimal AGENCY: Internal Revenue Service (IRS),
FDA is announcing the availability of manipulation, and adipose tissue.
a draft document entitled ‘‘Homologous Treasury.
In separate documents published
Use of Human Cells, Tissues, and ACTION: Notice of proposed rulemaking
elsewhere in this issue of the Federal
Cellular and Tissue-Based Products; by cross-reference to temporary
Register, FDA is also reopening the
Draft Guidance for Industry and FDA regulations.
comment periods to FDA’s public
Staff.’’ The draft guidance document dockets on the previously issued draft SUMMARY: In the Rules and Regulations
provides HCT/P manufacturers, health guidance documents on the following section of this issue of the Federal
care providers, and FDA staff, with topics related to HCT/Ps: Minimal Register, the IRS is issuing temporary
recommendations for applying the manipulation (Docket No. FDA–2014– regulations that will amend regulations
§ 1271.10(a)(2) (21 CFR 1271.10(a)(2)) D–1696), adipose tissue (Docket No. (TD 9503) relating to the imposition of
criterion of homologous use. This FDA–2014–D–1856), and same surgical certain user fees on tax return preparers.
guidance will improve stakeholders’ procedure exception (Docket No. FDA– The temporary regulations reduce the
understanding of the definition of 2014–D–1584). amount of the user fee to apply for or
homologous use in § 1271.3(c), and how
II. Paperwork Reduction Act of 1995 renew a preparer tax identification
to apply the regulatory criterion in
number (PTIN). The text of the
§ 1271.10(a)(2) to their HCT/P. The draft guidance refers to
HCT/Ps are defined in § 1271.3(d) as temporary regulations also serves as the
previously approved collections of text of these proposed regulations.
articles containing or consisting of information found in FDA regulations.
human cells or tissues that are intended DATES: Written or electronic comments
These collections of information are
for implantation, transplantation, subject to review by the Office of and requests for a public hearing must
infusion, or transfer into a human Management and Budget (OMB) under be received by January 28, 2016.
recipient. FDA has implemented a risk- the Paperwork Reduction Act of 1995 ADDRESSES: Send submissions to:
based approach to the regulation of (44 U.S.C. 3501–3520). The collections CC:PA:LPD:PR (REG–121496–15), Room
HCT/Ps. Under the authority of section of information in part 1271 have been 5203, Internal Revenue Service, P.O.
361 of the Public Health Service (PHS) approved under OMB control number Box 7604, Ben Franklin Station,
Act (42 U.S.C. 264), FDA established 0910–0543. Washington, DC 20044. Submissions
tkelley on DSK3SPTVN1PROD with PROPOSALS

regulations under part 1271 for all HCT/ may be hand-delivered Monday through
Ps to prevent the introduction, III. Electronic Access Friday between the hours of 8 a.m. and
transmission, and spread of Persons with access to the Internet 4 p.m. to CC:PA:LPD:PR (REG–121496–
communicable diseases. HCT/Ps are may obtain the draft guidance at either 15), Courier’s Desk, Internal Revenue
regulated solely under section 361 of the http://www.fda.gov/ Service, 1111 Constitution Avenue NW.,
PHS Act and 21 CFR part 1271, if they BiologicsBloodVaccines/Guidance Washington, DC 20224 or sent
meet the criteria provided under ComplianceRegulatoryInformation/ electronically via the Federal
§ 1271.10(a). Guidances/default.htm or http:// eRulemaking Portal at http://

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Document Created: 2015-12-14 15:29:20
Document Modified: 2015-12-14 15:29:20

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 of availability.
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.
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.
FR Citation		80 FR 66850

80 FR 66850 - Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 210 (October 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration