82 FR 54290 - Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 221 (November 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 221 (November 17, 2017)
| Page Range | 54290-54292 | |
| FR Document | 2017-24838 |
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)] [Rules and Regulations] [Pages 54290-54292] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24838] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2017-D-6146] Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; 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 document entitled ``Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.'' The guidance provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff, with FDA's current thinking on the regulatory criteria of minimal manipulation and homologous use. The guidance is intended to improve stakeholders' understanding of the definitions of minimal manipulation and homologous use and how the regulatory criteria apply to their HCT/Ps. It also informs manufacturers, healthcare providers, and other interested persons that the Agency generally intends to exercise enforcement discretion over the next 36 months under limited conditions, with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/Ps. DATES: The announcement of the guidance is published in the Federal Register on November 17, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: [[Page 54291]] 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-6146 for ``Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the 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, Rm. 5431, Silver Spring, MD 20993-0002; or you may send an email request to the Office of Combination Products (OCP) at [email protected]. If you are submitting a written request, send one self-addressed adhesive label to assist that office in processing your request. The 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 guidance document. 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; or Angela Krueger, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1676, 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. 5129, Silver Spring, MD 20993-0002, 301- 796-8938. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ``Regulatory Considerations for Human Cells, Tissues, Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.'' The guidance provides HCT/P manufacturers, healthcare providers, and FDA staff, with our current thinking on the criteria under part 1271 (21 CFR part 1271), specifically the Sec. 1271.10(a)(1) (21 CFR 1271.10(a)(1)) criterion of minimal manipulation and the Sec. 1271.10(a)(2) criterion of homologous use. The interpretation of the minimal manipulation and homologous use criteria and definitions of related key terms have been of considerable interest to industry stakeholders since the criteria and definitions were first proposed.\1\ The guidance document is intended to improve stakeholders' understanding of the definitions of minimal manipulation in Sec. 1271.3(f) and homologous use in Sec. 1271.3(c). It will also facilitate stakeholders' understanding of how the regulatory criteria in Sec. 1271.10(a)(1) and (2) apply to their HCT/Ps. The guidance document explains the regulatory scope of the regulations, as well as the Agency's compliance policy regarding certain regulatory requirements relating to HCT/Ps. In addition, the guidance document informs manufacturers, health care providers, and other interested persons that over the next 36 months, we intend to exercise enforcement discretion under limited [[Page 54292]] conditions with respect to the IND application or premarket approval (BLA) requirements, for certain HCT/Ps. --------------------------------------------------------------------------- \1\ ``Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products'' 63 FR 26744 at 26748- 49 (May 14, 1998) https://www.thefederalregister.org/fdsys/pkg/FR-1998-05-14/pdf/98-12751.pdf. --------------------------------------------------------------------------- In the Federal Register of December 23, 2014 (79 FR 77012), FDA announced the availability of the draft guidance entitled ``Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff'' dated December 2014 (Minimal Manipulation Draft Guidance), and in the Federal Register of December 24, 2014 (79 FR 77414), FDA announced the availability of draft guidance entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry'' dated December 2014 (Adipose Draft Guidance). Additionally, in the Federal Register of October 30, 2015 (80 FR 66850), FDA announced the availability of the draft guidance entitled ``Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff'' dated October 2015 (Homologous Use Draft Guidance). Also in the Federal Register of October 30, 2015, FDA reopened the comment period on the Minimal Manipulation Draft Guidance (80 FR 66844), Adipose Draft Guidance (80 FR 66849), and a third HCT/P-related guidance addressing the same surgical procedure exception in Sec. 1271.15(b) (80 FR 66847) (Same Surgical Procedure Exception Draft Guidance). Comments on these three HCT/P-related guidances, as well as the Homologous Use Draft Guidance, were requested by April 29, 2016. Lastly, the Federal Register of October 30, 2015 (80 FR 66845), FDA announced a 1-day part 15 (21 CFR part 15) public hearing to obtain input on the four HCT/P-related guidances to be held on April 13, 2016. Due to considerable interest in the public hearing and to give stakeholders additional time to provide comments to the Agency, on February 29, 2016, FDA announced that the hearing was postponed. In the Federal Register of April 22, 2016 (81 FR 23661 and 81 FR 23664, respectively), FDA announced the rescheduled part 15 hearing date of September 12 and 13, 2016, and an extension of the comment period from April 29, 2016, until September 27, 2016, on the four HCT/P-related guidances. Also in the Federal Register of April 22, 2016 (81 FR 23708), FDA announced a public workshop on the ``Scientific Evidence in Development of HCT/Ps Subject to Premarket Approval.'' FDA received numerous comments on the Minimal Manipulation Draft Guidance, Homologous Use Draft Guidance, and the Adipose Draft Guidance in response to the request for comments, and those comments were considered in developing the final guidance in this notification. The guidance document announced in this notification finalizes the Minimal Manipulation Draft Guidance and the Homologous Use Draft Guidance. The guidance document also finalizes certain material related to adipose tissue that was included in the Adipose Draft Guidance. The material in this guidance document related to adipose tissue, together with the material related to adipose tissue included in the guidance finalizing the Same Surgical Procedure Exception Draft Guidance, the availability of which is announced elsewhere in this issue of the Federal Register, supersedes the Adipose Draft Guidance. Accordingly, FDA does not intend to finalize the Adipose Tissue Guidance, which is now withdrawn. Finally, this guidance supersedes the guidance entitled ``Minimal Manipulation of Structural Tissue (Jurisdictional Update) Guidance for Industry and FDA Staff'' dated September 2006. FDA is also announcing via this Federal Register notification that, with the publication of this guidance document, it will cease posting the Tissue Reference Group (TRG) annual reports on FDA's Web site. The TRG was created as specified in the ``Proposed Approach to the Regulation of Cellular and Tissue-Based Products'' dated February 28, 1997 (March 4, 1997; 62 FR 9721). The purpose of the TRG is to provide a single reference point for product specific questions received by FDA (either through the Centers, or from the Office of Combination Products) concerning jurisdiction and applicable regulation of HCT/Ps. In 1998, the TRG began publishing its recommendations in an annual report that was posted on FDA's Web site. Originally intended to assist industry in understanding the scientific rationale for the TRG recommendations, the recommendations are stated in general terms in order to protect proprietary information. As a result, FDA has received feedback from stakeholders that the annual reports do not provide helpful information. Therefore, we are announcing that although the TRG will continue to provide recommendations, the TRG annual reports will no longer be posted on FDA's Web site. We note that this final guidance is intended to help clarify the minimal manipulation and homologous use criteria in Sec. 1271.10(a)(1) and (2), and thus addresses many of the questions that had been posed to the TRG. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.'' 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 requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 The 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 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. Dated: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24838 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
![54290 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Rules and Regulations
Procedure Exception under 21 CFR HCT/Ps Subject to Premarket default.htm or https://
1271.15(b): Questions and Answers Approval.’’ www.regulations.gov.
Regarding the Scope of the Exception.’’ FDA received numerous comments on Dated: November 13, 2017.
The guidance provides tissue the draft guidance and the Adipose
Anna K. Abram,
establishments and health care Draft Guidance in response to the
request for comments, and those Deputy Commissioner for Policy, Planning,
professionals with FDA’s current Legislation, and Analysis.
thinking on the scope of the exception comments were considered in
[FR Doc. 2017–24839 Filed 11–16–17; 8:45 am]
set forth in part 1271 (21 CFR part developing the final guidance. The
guidance announced in this notification BILLING CODE 4164–01–P
1271), specifically the exception set
forth in § 1271.15(b) (21 CFR finalizes the draft guidance of the same
1271.15(b)). This guidance does not title dated October 2014. This guidance
also finalizes certain material related to DEPARTMENT OF HEALTH AND
address the other exceptions in HUMAN SERVICES
§ 1271.15. The guidance, presented in adipose tissue that was included in the
question and answer format, provides Adipose Draft Guidance. Food and Drug Administration
FDA’s current interpretation of this The material in this guidance related
regulation and includes examples based to adipose tissue, together with the
21 CFR Part 1271
on inquiries received by the Agency material in the final guidance entitled
since the final rule entitled ‘‘Human ‘‘Regulatory Considerations for Human [Docket No. FDA–2017–D–6146]
Cells, Tissues, and Cellular and Tissue- Cell, Tissues, and Cellular and Tissue-
Based Products: Minimal Manipulation Regulatory Considerations for Human
Based Products; Establishment
and Homologous Use; Guidance for Cells, Tissues, and Cellular and
Registration and Listing’’ published in
Industry and Food and Drug Tissue-Based Products: Minimal
the Federal Register of January 19, 2001
Administration Staff’’ dated November Manipulation and Homologous Use;
(66 FR 5447).
2017 (Minimal Manipulation and Guidance for Industry and Food and
In the Federal Register of October 23, Drug Administration Staff; Availability
2014 (79 FR 63348), FDA announced the Homologous Use Guidance) related to
availability of the draft guidance of the adipose tissue, supersedes the Adipose AGENCY: Food and Drug Administration,
same title. Additionally, in the Federal Draft Guidance. Accordingly, FDA does HHS.
Register of December 24, 2014 (79 FR not intend to finalize the Adipose Draft ACTION: Notification of availability.
77414), FDA announced the availability Guidance, which is now withdrawn.
of the draft guidance entitled ‘‘Human Elsewhere in this issue of the Federal SUMMARY: The Food and Drug
Cells, Tissues, and Cellular and Tissue- Register, FDA is announcing the Administration (FDA or Agency) is
Based Products (HCT/Ps) from Adipose availability of the Minimal announcing the availability of a
Tissue: Regulatory Considerations; Draft Manipulation and Homologous Use document entitled ‘‘Regulatory
Guidance for Industry’’ dated December Guidance. Considerations for Human Cells,
This guidance is being issued Tissues, and Cellular and Tissue-Based
2014 (Adipose Draft Guidance).
consistent with FDA’s good guidance Products: Minimal Manipulation and
In the Federal Register of October 30,
practices regulation (21 CFR 10.115). Homologous Use; Guidance for Industry
2015, FDA reopened the comment
The guidance represents the current and Food and Drug Administration
period for three HCT/P-related draft
thinking of FDA on ‘‘Same Surgical Staff.’’ The guidance provides human
guidances (80 FR 66847, 66849, and
Procedure Exception under 21 CFR cells, tissues, and cellular and tissue-
66844, respectively) and announced the
1271.15(b): Questions and Answers based product (HCT/P) manufacturers,
availability of another HCT/P-related
Regarding the Scope of the Exception.’’ healthcare providers, and FDA staff,
draft guidance (80 FR 66850).
It does not establish any rights for any with FDA’s current thinking on the
Comments on the four HCT/P-related
person and is not binding on FDA or the regulatory criteria of minimal
guidances were requested by April 29,
public. You can use an alternative manipulation and homologous use. The
2016. Lastly, in the Federal Register of
approach if it satisfies the requirements guidance is intended to improve
October 30, 2015 (80 FR 66845), FDA
of the applicable statutes and stakeholders’ understanding of the
announced a 1-day part 15 (21 CFR part
regulations. This guidance is not subject definitions of minimal manipulation
15) public hearing to obtain input on the
to Executive Order 12866. and homologous use and how the
four HCT/P-related guidances to be held
on April 13, 2016. II. Paperwork Reduction Act of 1995 regulatory criteria apply to their HCT/
Due to considerable interest in the Ps. It also informs manufacturers,
The guidance refers to previously healthcare providers, and other
public hearing and to give stakeholders approved collections of information
additional time to provide comments to interested persons that the Agency
found in FDA regulations. These generally intends to exercise
the Agency, on February 29, 2016, FDA collections of information are subject to
announced that the hearing was enforcement discretion over the next 36
review by the Office of Management and months under limited conditions, with
postponed. In the Federal Register of Budget (OMB) under the Paperwork
April 22, 2016 (81 FR 23661 and 81 FR respect to the investigational new drug
Reduction Act of 1995 (44 U.S.C. 3501– (IND) application and premarket
23664, respectively), FDA announced 3520). The collections of information in
the rescheduled part 15 hearing date of approval (biologics license application
part 1271 have been approved under (BLA)) requirements, for certain HCT/
September 12 and 13, 2016, and an OMB control number 0910–0543.
extension of the comment period from Ps.
III. Electronic Access
rmajette on DSKBCKNHB2PROD with RULES
April 29, 2016, until September 27, DATES: The announcement of the
2016, on the four HCT/P-related Persons with access to the internet guidance is published in the Federal
guidances. Also in the Federal Register may obtain the guidance at either Register on November 17, 2017.
of April 22, 2016 (81 FR 23708), FDA https://www.fda.gov/ ADDRESSES: You may submit either
announced a public workshop to be BiologicsBloodVaccines/ electronic or written comments on
held on September 8, 2016, on the GuidanceCompliance Agency guidances at any time as
‘‘Scientific Evidence in Development of RegulatoryInformation/Guidances/ follows:
VerDate Sep<11>2014 13:56 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 E:\FR\FM\17NOR1.SGM 17NOR1](https://thefederalregister.org/doc/82_FR_54511/page/1.svg)
![54292 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Rules and Regulations
conditions with respect to the IND FDA received numerous comments on § 1271.10(a)(1) and (2), and thus
application or premarket approval the Minimal Manipulation Draft addresses many of the questions that
(BLA) requirements, for certain HCT/Ps. Guidance, Homologous Use Draft had been posed to the TRG.
In the Federal Register of December Guidance, and the Adipose Draft This guidance is being issued
23, 2014 (79 FR 77012), FDA announced Guidance in response to the request for consistent with FDA’s good guidance
the availability of the draft guidance comments, and those comments were practices regulation (21 CFR 10.115).
entitled ‘‘Minimal Manipulation of considered in developing the final The guidance represents the current
Human Cells, Tissues, and Cellular and guidance in this notification. thinking of FDA on ‘‘Regulatory
Tissue-Based Products; Draft Guidance The guidance document announced Considerations for Human Cells,
for Industry and Food and Drug in this notification finalizes the Minimal Tissues, and Cellular and Tissue-Based
Administration Staff’’ dated December Manipulation Draft Guidance and the Products: Minimal Manipulation and
2014 (Minimal Manipulation Draft Homologous Use Draft Guidance. The Homologous Use.’’ It does not establish
Guidance), and in the Federal Register guidance document also finalizes any rights for any person and is not
of December 24, 2014 (79 FR 77414), certain material related to adipose tissue binding on FDA or the public. You can
FDA announced the availability of draft that was included in the Adipose Draft use an alternative approach if it satisfies
guidance entitled ‘‘Human Cells, Guidance. The material in this guidance the requirements of the applicable
Tissues, and Cellular and Tissue-Based document related to adipose tissue, statutes and regulations. This guidance
Products (HCT/Ps) from Adipose Tissue: together with the material related to is not subject to Executive Order 12866.
Regulatory Considerations; Draft adipose tissue included in the guidance
finalizing the Same Surgical Procedure II. Paperwork Reduction Act of 1995
Guidance for Industry’’ dated December
2014 (Adipose Draft Guidance). Exception Draft Guidance, the The guidance refers to previously
Additionally, in the Federal Register of availability of which is announced approved collections of information
October 30, 2015 (80 FR 66850), FDA elsewhere in this issue of the Federal found in FDA regulations. These
announced the availability of the draft Register, supersedes the Adipose Draft collections of information are subject to
guidance entitled ‘‘Homologous Use of Guidance. Accordingly, FDA does not review by the Office of Management and
Human Cells, Tissues, and Cellular and intend to finalize the Adipose Tissue Budget (OMB) under the Paperwork
Tissue-Based Products; Draft Guidance Guidance, which is now withdrawn. Reduction Act of 1995 (44 U.S.C. 3501–
for Industry and FDA Staff’’ dated Finally, this guidance supersedes the 3520). The collections of information in
October 2015 (Homologous Use Draft guidance entitled ‘‘Minimal part 1271 have been approved under
Guidance). Manipulation of Structural Tissue OMB control number 0910–0543.
(Jurisdictional Update) Guidance for
Also in the Federal Register of III. Electronic Access
Industry and FDA Staff’’ dated
October 30, 2015, FDA reopened the
September 2006. Persons with access to the internet
comment period on the Minimal FDA is also announcing via this
Manipulation Draft Guidance (80 FR may obtain the guidance at either
Federal Register notification that, with https://www.fda.gov/BiologicsBlood
66844), Adipose Draft Guidance (80 FR the publication of this guidance
66849), and a third HCT/P-related Vaccines/GuidanceCompliance
document, it will cease posting the RegulatoryInformation/Guidances/
guidance addressing the same surgical Tissue Reference Group (TRG) annual
procedure exception in § 1271.15(b) (80 default.htm; or https://www.fda.gov/
reports on FDA’s Web site. The TRG MedicalDevices/DeviceRegulation
FR 66847) (Same Surgical Procedure was created as specified in the
Exception Draft Guidance). Comments andGuidance/GuidanceDocuments/
‘‘Proposed Approach to the Regulation default.htm; or https://www.fda.gov/
on these three HCT/P-related guidances, of Cellular and Tissue-Based Products’’
as well as the Homologous Use Draft CombinationProducts/
dated February 28, 1997 (March 4, 1997; GuidanceRegulatoryInformation/
Guidance, were requested by April 29, 62 FR 9721). The purpose of the TRG is
2016. Lastly, the Federal Register of default.htm; or https://
to provide a single reference point for www.regulations.gov.
October 30, 2015 (80 FR 66845), FDA product specific questions received by
announced a 1-day part 15 (21 CFR part FDA (either through the Centers, or from Dated: November 13, 2017.
15) public hearing to obtain input on the the Office of Combination Products) Anna K. Abram,
four HCT/P-related guidances to be held concerning jurisdiction and applicable Deputy Commissioner for Policy, Planning,
on April 13, 2016. regulation of HCT/Ps. Legislation, and Analysis.
Due to considerable interest in the In 1998, the TRG began publishing its [FR Doc. 2017–24838 Filed 11–16–17; 8:45 am]
public hearing and to give stakeholders recommendations in an annual report BILLING CODE 4164–01–P
additional time to provide comments to that was posted on FDA’s Web site.
the Agency, on February 29, 2016, FDA Originally intended to assist industry in
announced that the hearing was understanding the scientific rationale DEPARTMENT OF THE INTERIOR
postponed. In the Federal Register of for the TRG recommendations, the
April 22, 2016 (81 FR 23661 and 81 FR recommendations are stated in general Office of Surface Mining Reclamation
23664, respectively), FDA announced terms in order to protect proprietary and Enforcement
the rescheduled part 15 hearing date of information. As a result, FDA has
September 12 and 13, 2016, and an received feedback from stakeholders 30 CFR Part 943
extension of the comment period from that the annual reports do not provide
April 29, 2016, until September 27, helpful information. Therefore, we are [SATS No. TX–067–FOR; Docket ID: OSM–
rmajette on DSKBCKNHB2PROD with RULES
2016, on the four HCT/P-related announcing that although the TRG will 2016–0001; S1D1S SS08011000 SX064A000
guidances. Also in the Federal Register continue to provide recommendations, 189S180110; S2D2S SS08011000
of April 22, 2016 (81 FR 23708), FDA the TRG annual reports will no longer SX064A000 18XS501520]
announced a public workshop on the be posted on FDA’s Web site. We note Texas Regulatory Program
‘‘Scientific Evidence in Development of that this final guidance is intended to
HCT/Ps Subject to Premarket help clarify the minimal manipulation AGENCY:Office of Surface Mining
Approval.’’ and homologous use criteria in Reclamation and Enforcement, Interior.
VerDate Sep<11>2014 13:56 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\17NOR1.SGM 17NOR1](https://thefederalregister.org/doc/82_FR_54511/page/3.svg)
Document Created: 2017-11-17 05:15:00
Document Modified: 2017-11-17 05:15:00
| 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 | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on November 17, 2017. | |
| 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; or Angela Krueger, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1676, 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. 5129, Silver Spring, MD 20993-0002, 301- 796-8938. | |
| FR Citation | 82 FR 54290 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR