82 FR 54349 - Evaluation of Devices Used With Regenerative Medicine Advanced Therapies; Draft Guidance for Industry; Availability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 | 54349-54351 | |
| FR Document | 2017-24836 |
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)] [Notices] [Pages 54349-54351] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24836] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6154] Evaluation of Devices Used With Regenerative Medicine Advanced Therapies; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.'' The draft guidance document, when finalized, will provide device manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as ``regenerative medicine advanced therapies'' or ``RMATs.'' Specifically, as required by the 21st Century Cures Act (Cures Act), [[Page 54350]] the draft guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type. DATES: Submit either electronic or written comments on the draft guidance by February 15, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. 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): 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-6154 for ``Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.'' 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 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. 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: Tami Belouin, 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 FDA is announcing the availability of a draft document entitled ``Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.'' The draft guidance, when finalized, will provide device manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as ``regenerative medicine advanced therapies'' or ``RMATs''. Specifically, as required by section 3034 of the 21st Century Cures Act (Pub. L. 114-255) (Cures Act), the draft guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type. The issuance of this draft guidance fulfills the statutory requirement set forth in section 3034(a) of the Cures Act. Furthermore, the Agency intends for this document, when finalized, to serve as a source of information about the Agency's current thinking about a wide range of concepts related to the regulation of devices, as they apply to devices used in the recovery, isolation, and delivery of RMATs. FDA has provided general information in the [[Page 54351]] draft guidance in lieu of specific examples because the Agency does not yet possess a wide body of experience regarding the evaluation of devices used with RMATs, given the recent establishment of the RMAT designation program in the Cures Act. As we gain more experience with such devices, we intend to incorporate such information into the final guidance. To that end, although you are welcome to comment on any aspect of the guidance, we encourage commenters to support their comments with information related to specific marketed devices or types of devices that are used in the recovery, isolation, and delivery of RMATs. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a document entitled ``Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.'' Among other things, that document provides information about the RMAT designation program. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on Evaluation of Devices Used with Regenerative Medicine Advanced Therapies. 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 This 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 21 CFR part 807 have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR 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.regulations.gov. Dated: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24836 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54349
workshop’s comment period by 30 days Staff, FDA will post your comment, as Radiological Health, 10903 New
to December 28, 2017, in response to well as any attachments, except for Hampshire Ave., Bldg. 66, Rm. 4644,
requests for an extension to allow information submitted, marked and Silver Spring, MD 20993, 301–796–
interested persons additional time to identified, as confidential, if submitted 6160, Paula.Caposino@fda.hhs.gov.
submit comments. as detailed in ‘‘Instructions’’ SUPPLEMENTARY INFORMATION: In the
DATES: FDA is extending the comment Instructions: All submissions received Federal Register of July 31, 2017 (82 FR
period for the public workshop ‘‘Cardiac must include the Docket No. FDA– 35532), FDA published a notice
Troponin Assays’’ published on July 31, 2017–N–4179 for ‘‘Cardiac Troponin announcing the public workshop
2017 (82 FR 35532). Submit either Assays; Public Workshop; Request for entitled ‘‘Cardiac Troponin Assays;
electronic or written comments by Comments.’’ Received comments, those Public Workshop; Request for
December 28, 2017. filed in a timely manner (see Comments’’ with a 120-day comment
ADDRESSES: You may submit comments ADDRESSES), will be placed in the docket period to request comments.
as follows. Please note that late, and, except for those submitted as The Agency has received requests for
untimely filed comments will not be ‘‘Confidential Submissions,’’ publicly a 30-day extension of the comment
considered. Electronic comments must viewable at https://www.regulations.gov period for the public workshop. The
be submitted on or before December 28, or at the Dockets Management Staff request conveyed concern that the
2017. The https://www.regulations.gov between 9 a.m. and 4 p.m., Monday current 120-day comment period does
electronic filing system will accept through Friday. not allow sufficient time to develop a
comments until midnight Eastern Time • Confidential Submissions—To meaningful or thoughtful response to
at the end of December 28, 2017. submit a comment with confidential the public workshop.
Comments received by mail/hand information that you do not wish to be FDA has considered the request and
delivery/courier (for written/paper made publicly available, submit your is extending the comment period for the
submissions) will be considered timely comments only as a written/paper public workshop for 30 days, until
if they are postmarked or the delivery submission. You should submit two December 28, 2017. The Agency
service acceptance receipt is on or copies total. One copy will include the believes that a 30-day extension allows
before that date. information you claim to be confidential adequate time for interested persons to
with a heading or cover note that states submit comments.
Electronic Submissions
‘‘THIS DOCUMENT CONTAINS Dated: November 13, 2017.
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Leslie Kux,
Agency will review this copy, including
• Federal eRulemaking Portal: the claimed confidential information, in Associate Commissioner for Policy.
https://www.regulations.gov. Follow the its consideration of comments. The [FR Doc. 2017–24922 Filed 11–16–17; 8:45 am]
instructions for submitting comments. second copy, which will have the BILLING CODE 4164–01–P
Comments submitted electronically, claimed confidential information
including attachments, to https:// redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on DEPARTMENT OF HEALTH AND
the docket unchanged. Because your https://www.regulations.gov. Submit HUMAN SERVICES
comment will be made public, you are both copies to the Dockets Management
solely responsible for ensuring that your Food and Drug Administration
Staff. If you do not wish your name and
comment does not include any contact information to be made publicly [Docket No. FDA–2017–D–6154]
confidential information that you or a available, you can provide this
third party may not wish to be posted, information on the cover sheet and not Evaluation of Devices Used With
such as medical information, your or in the body of your comments and you Regenerative Medicine Advanced
anyone else’s Social Security number, or must identify this information as Therapies; Draft Guidance for Industry;
confidential business information, such ‘‘confidential.’’ Any information marked Availability
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
that if you include your name, contact AGENCY: Food and Drug Administration,
except in accordance with 21 CFR 10.20 HHS.
information, or other information that and other applicable disclosure law. For
identifies you in the body of your ACTION: Notice of availability.
more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. SUMMARY: The Food and Drug
FR 56469, September 18, 2015, or access Administration (FDA or Agency) is
• If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you announcing the availability of a draft
fdsys/pkg/FR-2015-09-18/pdf/2015- document entitled ‘‘Evaluation of
do not wish to be made available to the 23389.pdf.
public, submit the comment as a Devices Used with Regenerative
Docket: For access to the docket to Medicine Advanced Therapies; Draft
written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper Guidance for Industry.’’ The draft
electronic and written/paper comments guidance document, when finalized,
Submissions’’ and ‘‘Instructions’’). received, go to https:// will provide device manufacturers,
Written/Paper Submissions www.regulations.gov and insert the applicants, and sponsors engaged in the
Submit written/paper submissions as docket number, found in brackets in the development of regenerative medicine
heading of this document, into the therapies, with our current thinking
sradovich on DSK3GMQ082PROD with NOTICES
follows:
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts regarding evaluation of devices used in
written/paper submissions): Dockets and/or go to the Dockets Management the recovery, isolation or delivery of
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, regenerative advanced therapies, which
Drug Administration, 5630 Fishers Rockville, MD 20852. FDA generally refers to as ‘‘regenerative
Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: medicine advanced therapies’’ or
• For written/paper comments Paula Caposino, Food and Drug ‘‘RMATs.’’ Specifically, as required by
submitted to the Dockets Management Administration, Center for Devices and the 21st Century Cures Act (Cures Act),
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![Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54351
draft guidance in lieu of specific RegulatoryInformation/Guidances/ • Federal eRulemaking Portal:
examples because the Agency does not default.htm or https:// https://www.regulations.gov. Follow the
yet possess a wide body of experience www.regulations.gov. instructions for submitting comments.
regarding the evaluation of devices used Dated: November 13, 2017. Comments submitted electronically,
with RMATs, given the recent Anna K. Abram,
including attachments, to https://
establishment of the RMAT designation www.regulations.gov will be posted to
Deputy Commissioner for Policy, Planning,
program in the Cures Act. the docket unchanged. Because your
Legislation, and Analysis.
As we gain more experience with comment will be made public, you are
such devices, we intend to incorporate [FR Doc. 2017–24836 Filed 11–16–17; 8:45 am]
solely responsible for ensuring that your
such information into the final BILLING CODE 4164–01–P
comment does not include any
guidance. To that end, although you are confidential information that you or a
welcome to comment on any aspect of third party may not wish to be posted,
the guidance, we encourage commenters DEPARTMENT OF HEALTH AND such as medical information, your or
to support their comments with HUMAN SERVICES anyone else’s Social Security number, or
information related to specific marketed Food and Drug Administration confidential business information, such
devices or types of devices that are used as a manufacturing process. Please note
in the recovery, isolation, and delivery [Docket No. FDA–2014–N–0987] that if you include your name, contact
of RMATs. information, or other information that
Elsewhere in this issue of the Federal Agency Information Collection identifies you in the body of your
Register, FDA is announcing the Activities; Proposed Collection; comments, that information will be
availability of a document entitled Comment Request; Generic Clearance posted on https://www.regulations.gov.
‘‘Expedited Programs for Regenerative for the Collection of Qualitative Data • If you want to submit a comment
Medicine Therapies for Serious on Tobacco Products and with confidential information that you
Conditions; Draft Guidance for Communications do not wish to be made available to the
Industry.’’ Among other things, that AGENCY: Food and Drug Administration, public, submit the comment as a
document provides information about HHS. written/paper submission and in the
the RMAT designation program. manner detailed (see ‘‘Written/Paper
This draft guidance is being issued ACTION: Notice.
Submissions’’ and ‘‘Instructions’’).
consistent with FDA’s good guidance SUMMARY: The Food and Drug
practices regulation (21 CFR 10.115). Written/Paper Submissions
Administration (FDA or Agency) is
The draft guidance, when finalized, will announcing an opportunity for public Submit written/paper submissions as
represent the current thinking of FDA comment on the proposed collection of follows:
on Evaluation of Devices Used with • Mail/Hand delivery/Courier (for
certain information by the Agency.
Regenerative Medicine Advanced written/paper submissions): Dockets
Under the Paperwork Reduction Act of
Therapies. It does not establish any Management Staff (HFA–305), Food and
1995 (PRA), Federal Agencies are
rights for any person and is not binding Drug Administration, 5630 Fishers
required to publish notice in the
on FDA or the public. You can use an Lane, Rm. 1061, Rockville, MD 20852.
Federal Register concerning each • For written/paper comments
alternative approach if it satisfies the proposed collection of information,
requirements of the applicable statutes submitted to the Dockets Management
including each proposed extension of an Staff, FDA will post your comment, as
and regulations. This guidance is not existing collection of information, and
subject to Executive Order 12866. well as any attachments, except for
to allow 60 days for public comment in information submitted, marked and
II. Paperwork Reduction Act of 1995 response to the notice. This notice identified, as confidential, if submitted
solicits comments on the Generic as detailed in ‘‘Instructions.’’
This draft guidance refers to
Clearance for the Collection of Instructions: All submissions received
previously approved collections of
Qualitative Data on Tobacco Products must include the Docket No. FDA–
information found in FDA regulations.
and Communications. 2014–N–0987 for ‘‘Generic Clearance for
These collections of information are
subject to review by the Office of DATES: Submit either electronic or the Collection of Qualitative Data on
Management and Budget (OMB) under written comments on the collection of Tobacco Products and
the Paperwork Reduction Act of 1995 information by January 16, 2018. Communications.’’ Received comments,
(44 U.S.C. 3501–3520). The collections ADDRESSES: You may submit comments those filed in a timely manner (see
of information in 21 CFR part 807 have as follows. Please note that late, ADDRESSES), will be placed in the docket
been approved under OMB control untimely filed comments will not be and, except for those submitted as
number 0910–0120; the collections of considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly
information in 21 CFR part 812 have be submitted on or before January 16, viewable at https://www.regulations.gov
been approved under OMB control 2018. The https://www.regulations.gov or at the Dockets Management Staff
number 0910–0078; the collections of electronic filing system will accept between 9 a.m. and 4 p.m., Monday
information in 21 CFR part 814 have comments until midnight Eastern Time through Friday.
been approved under OMB control at the end of January 16, 2018. • Confidential Submissions—To
number 0910–0231; and the collections Comments received by mail/hand submit a comment with confidential
of information in 21 CFR part 1271 have delivery/courier (for written/paper information that you do not wish to be
made publicly available, submit your
sradovich on DSK3GMQ082PROD with NOTICES
been approved under OMB control submissions) will be considered timely
number 0910–0543. if they are postmarked or the delivery comments only as a written/paper
service acceptance receipt is on or submission. You should submit two
III. Electronic Access before that date. copies total. One copy will include the
Persons with access to the internet information you claim to be confidential
may obtain the draft guidance at either Electronic Submissions with a heading or cover note that states
https://www.fda.gov/BiologicsBlood Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Vaccines/GuidanceCompliance following way: CONFIDENTIAL INFORMATION.’’ The
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Document Created: 2017-11-17 05:14:34
Document Modified: 2017-11-17 05:14:34
| 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 | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by February 15, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Tami Belouin, 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 | 82 FR 54349 |
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