Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridioides difficile, 73313-73314 [2022-26000]
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Federal Register / Vol. 87, No. 228 / Tuesday, November 29, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Newborn Screening Programs ........................
Set-up of ED3N Data Elements .....................
Ongoing transfer of ED3N Data Elements ....
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
Food and Drug Administration
Microbiota for Transplantation to Treat
Clostridium difficile Infection Not
Responsive to Standard Therapies’’
dated July 2013.
DATES: The announcement of the
guidance is published in the Federal
Register on November 29, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
[Docket No. FDA–2013–D–0811]
Electronic Submissions
Enforcement Policy Regarding
Investigational New Drug
Requirements for Use of Fecal
Microbiota for Transplantation To Treat
Clostridioides difficile Infection Not
Responsive to Standard Therapies;
Guidance for Industry; Availability
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’’).
[FR Doc. 2022–25992 Filed 11–28–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance entitled ‘‘Enforcement Policy
Regarding Investigational New Drug
Requirements for Use of Fecal
Microbiota for Transplantation to Treat
Clostridioides difficile Infection Not
Responsive to Standard Therapies;
Guidance for Industry.’’ The guidance
document informs members of the
medical and scientific community and
other interested persons notice that, at
this time, we intend to exercise
enforcement discretion with respect to
the investigational new drug application
(IND) requirements for the use of fecal
microbiota for transplantation (FMT) to
treat Clostridioides difficile (C. difficile)
infection not responding to standard
therapies under limited circumstances
described in the guidance. The guidance
announced in this notice finalizes the
draft guidance entitled ‘‘Enforcement
Policy Regarding Investigational New
Drug Requirements for Use of Fecal
Microbiota for Transplantation to Treat
Clostridium difficile Infection Not
Responsive to Standard Therapies’’
dated March 2016, and supersedes the
guidance entitled ‘‘Enforcement Policy
Regarding Investigational New Drug
Requirements for Use of Fecal
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondent
VerDate Sep<11>2014
16:29 Nov 28, 2022
Jkt 259001
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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
18
53
1
365
Average
burden per
response
(in hr)
40
1/60
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–D–0811 for ‘‘Enforcement Policy
Regarding Investigational New Drug
Requirements for Use of Fecal
Microbiota for Transplantation to Treat
Clostridium difficile Infection Not
Responsive to Standard Therapies; Final
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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
E:\FR\FM\29NON1.SGM
29NON1
73314
Federal Register / Vol. 87, No. 228 / Tuesday, November 29, 2022 / Notices
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, 240–402–7500.
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. Send
one self-addressed adhesive label to
assist the office in processing your
requests. 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:
Phillip Kurs, 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:
khammond on DSKJM1Z7X2PROD with NOTICES
I. Background
FDA is announcing the availability of
a document entitled ‘‘Enforcement
Policy Regarding Investigational New
Drug Requirements for Use of Fecal
Microbiota for Transplantation to Treat
Clostridioides difficile Infection Not
Responsive to Standard Therapies;
Guidance for Industry.’’ The guidance
informs members of the medical and
scientific community and other
interested persons of our policy
regarding the IND requirements for the
use of FMT to treat C. difficile infection
not responding to standard therapies. In
light of the considerations described in
the guidance, at this time, FDA intends
to exercise enforcement discretion with
respect to the applicable IND
requirements when the FMT product is
not obtained from a stool bank and
where: (1) the licensed health care
provider treating the patient obtains
appropriate consent from the patient or
his or her legally authorized
representative for the use of FMT
product. The consent should include, at
a minimum, a statement that the use of
VerDate Sep<11>2014
16:29 Nov 28, 2022
Jkt 259001
FMT products to treat C. difficile is
investigational and a discussion of the
product’s reasonably foreseeable risks;
(2) the stool donor and stool are
qualified by screening and testing
performed under the direction of the
licensed health care provider for the
purpose of providing the FMT product
for treatment of the patient; and (3) the
use of the FMT product does not raise
reported safety concerns or potential
significant safety concerns (e.g.,
concerns regarding inappropriate
storage or handling or concerns
regarding administration of product
collected without appropriate screening
or testing).
FDA has developed this policy to help
facilitate access to FMT for patients
with C. difficile infection not
responding to standard therapies, while
addressing and controlling the risks that
centralized manufacturing in stool
banks presents to individuals receiving
such products. We have concluded this
policy appropriately balances
considerations regarding patient safety
and facilitating access to unapproved
FMT products for unmet medical needs.
FDA will continue to work with
sponsors who intend to submit INDs for
use of FMT to treat C. difficile infection
not responding to standard therapies.
In the Federal Register of March 1,
2016 (81 FR 10632), FDA announced the
availability of the draft guidance
entitled ‘‘Enforcement Policy Regarding
Investigational New Drug Requirements
for Use of Fecal Microbiota for
Transplantation to Treat Clostridium
difficile Infection Not Responsive to
Standard Therapies’’ dated March 2016.
FDA received several comments on the
draft guidance and those comments
were considered as the guidance was
finalized. In the Federal Register on
September 11, 2019 (84 FR 47911), FDA
announced a part 15 hearing on the Use
of Fecal Microbiota for Transplantation
to Treat Clostridium difficile Infection
Not Responsive to Standard Therapies.
The hearing was held on November 4,
2019. FDA considered input from
stakeholders received as part of the
hearing as the guidance was finalized. A
summary of changes includes changes
to make clear that situations where use
of an FMT product raises reported safety
concerns or potential significant safety
concerns are outside the scope of this
enforcement policy; clarification of the
products that are the subject of the
guidance; and other editorial changes to
improve clarity. The guidance
announced in this notice finalizes the
draft guidance entitled ‘‘Enforcement
Policy Regarding Investigational New
Drug Requirements for Use of Fecal
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Microbiota for Transplantation to Treat
Clostridium difficile Infection Not
Responsive to Standard Therapies’’
dated March 2016, and supersedes the
guidance entitled ‘‘Enforcement Policy
Regarding Investigational New Drug
Requirements for Use of Fecal
Microbiota for Transplantation to Treat
Clostridium difficile Infection Not
Responsive to Standard Therapies’’
dated July 2013.
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 ‘‘Enforcement
Policy Regarding Investigational New
Drug Requirements for Use of Fecal
Microbiota for Transplantation to Treat
Clostridioides difficile Infection Not
Responsive to Standard 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 have
been approved under control number
0910–0014. The collections of
information in 21 CFR part 50 have been
approved under OMB control number
0910–0130.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/
biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: November 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26000 Filed 11–28–22; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[Federal Register Volume 87, Number 228 (Tuesday, November 29, 2022)]
[Notices]
[Pages 73313-73314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26000]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0811]
Enforcement Policy Regarding Investigational New Drug
Requirements for Use of Fecal Microbiota for Transplantation To Treat
Clostridioides difficile Infection Not Responsive to Standard
Therapies; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance entitled ``Enforcement
Policy Regarding Investigational New Drug Requirements for Use of Fecal
Microbiota for Transplantation to Treat Clostridioides difficile
Infection Not Responsive to Standard Therapies; Guidance for
Industry.'' The guidance document informs members of the medical and
scientific community and other interested persons notice that, at this
time, we intend to exercise enforcement discretion with respect to the
investigational new drug application (IND) requirements for the use of
fecal microbiota for transplantation (FMT) to treat Clostridioides
difficile (C. difficile) infection not responding to standard therapies
under limited circumstances described in the guidance. The guidance
announced in this notice finalizes the draft guidance entitled
``Enforcement Policy Regarding Investigational New Drug Requirements
for Use of Fecal Microbiota for Transplantation to Treat Clostridium
difficile Infection Not Responsive to Standard Therapies'' dated March
2016, and supersedes the guidance entitled ``Enforcement Policy
Regarding Investigational New Drug Requirements for Use of Fecal
Microbiota for Transplantation to Treat Clostridium difficile Infection
Not Responsive to Standard Therapies'' dated July 2013.
DATES: The announcement of the guidance is published in the Federal
Register on November 29, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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-2013-D-0811 for ``Enforcement Policy Regarding Investigational New
Drug Requirements for Use of Fecal Microbiota for Transplantation to
Treat Clostridium difficile Infection Not Responsive to Standard
Therapies; Final 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, 240-402-7500.
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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
[[Page 73314]]
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, 240-402-7500.
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. Send
one self-addressed adhesive label to assist the office in processing
your requests. 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: Phillip Kurs, 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 document entitled
``Enforcement Policy Regarding Investigational New Drug Requirements
for Use of Fecal Microbiota for Transplantation to Treat Clostridioides
difficile Infection Not Responsive to Standard Therapies; Guidance for
Industry.'' The guidance informs members of the medical and scientific
community and other interested persons of our policy regarding the IND
requirements for the use of FMT to treat C. difficile infection not
responding to standard therapies. In light of the considerations
described in the guidance, at this time, FDA intends to exercise
enforcement discretion with respect to the applicable IND requirements
when the FMT product is not obtained from a stool bank and where: (1)
the licensed health care provider treating the patient obtains
appropriate consent from the patient or his or her legally authorized
representative for the use of FMT product. The consent should include,
at a minimum, a statement that the use of FMT products to treat C.
difficile is investigational and a discussion of the product's
reasonably foreseeable risks; (2) the stool donor and stool are
qualified by screening and testing performed under the direction of the
licensed health care provider for the purpose of providing the FMT
product for treatment of the patient; and (3) the use of the FMT
product does not raise reported safety concerns or potential
significant safety concerns (e.g., concerns regarding inappropriate
storage or handling or concerns regarding administration of product
collected without appropriate screening or testing).
FDA has developed this policy to help facilitate access to FMT for
patients with C. difficile infection not responding to standard
therapies, while addressing and controlling the risks that centralized
manufacturing in stool banks presents to individuals receiving such
products. We have concluded this policy appropriately balances
considerations regarding patient safety and facilitating access to
unapproved FMT products for unmet medical needs. FDA will continue to
work with sponsors who intend to submit INDs for use of FMT to treat C.
difficile infection not responding to standard therapies.
In the Federal Register of March 1, 2016 (81 FR 10632), FDA
announced the availability of the draft guidance entitled ``Enforcement
Policy Regarding Investigational New Drug Requirements for Use of Fecal
Microbiota for Transplantation to Treat Clostridium difficile Infection
Not Responsive to Standard Therapies'' dated March 2016. FDA received
several comments on the draft guidance and those comments were
considered as the guidance was finalized. In the Federal Register on
September 11, 2019 (84 FR 47911), FDA announced a part 15 hearing on
the Use of Fecal Microbiota for Transplantation to Treat Clostridium
difficile Infection Not Responsive to Standard Therapies. The hearing
was held on November 4, 2019. FDA considered input from stakeholders
received as part of the hearing as the guidance was finalized. A
summary of changes includes changes to make clear that situations where
use of an FMT product raises reported safety concerns or potential
significant safety concerns are outside the scope of this enforcement
policy; clarification of the products that are the subject of the
guidance; and other editorial changes to improve clarity. The guidance
announced in this notice finalizes the draft guidance entitled
``Enforcement Policy Regarding Investigational New Drug Requirements
for Use of Fecal Microbiota for Transplantation to Treat Clostridium
difficile Infection Not Responsive to Standard Therapies'' dated March
2016, and supersedes the guidance entitled ``Enforcement Policy
Regarding Investigational New Drug Requirements for Use of Fecal
Microbiota for Transplantation to Treat Clostridium difficile Infection
Not Responsive to Standard Therapies'' dated July 2013.
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 ``Enforcement Policy Regarding
Investigational New Drug Requirements for Use of Fecal Microbiota for
Transplantation to Treat Clostridioides difficile Infection Not
Responsive to Standard 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under control
number 0910-0014. The collections of information in 21 CFR part 50 have
been approved under OMB control number 0910-0130.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: November 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26000 Filed 11-28-22; 8:45 am]
BILLING CODE 4164-01-P
