[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]


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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.

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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announced in this notice finalizes the draft guidance entitled 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


