[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Pages 10632-10633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04372]


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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 
Clostridium difficile Infection Not Responsive to Standard Therapies; 
Draft Guidance for Industry; Availability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 or Agency) is announcing 
the availability of a draft document 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Not Responsive to Standard Therapies; Draft Guidance for Industry.'' 
The draft guidance document provides members of the medical and 
scientific community and other interested persons with notice that, 
when finalized, we intend to exercise enforcement discretion under 
limited conditions, regarding the investigational new drug (IND) 
requirements for the use of fecal microbiota for transplantation (FMT) 
to treat C. difficile infection not responding to standard therapies. 
The draft guidance replaces the draft guidance of the same title dated 
March 2014 and, when finalized, is intended to supersede the document 
of the same title, dated July 2013.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 31, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Since your comment will be made 
public, you are solely responsible for ensuring that your comment does 
not include any confidential information that you or a third party may 
not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-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.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies, total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments, and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments

[[Page 10633]]

received, go to http://www.regulations.gov and insert the docket 
number, found in brackets in the heading of this document, into the 
``Search'' box and follow the prompts, and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. 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: Gretchen Opper, 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 
``Enforcement Policy Regarding Investigational New Drug Requirements 
for Use of Fecal Microbiota for Transplantation to Treat Clostridium 
difficile Infection Not Responsive to Standard Therapies.'' The draft 
guidance document provides members of the medical and scientific 
community and other interested persons with notice that, when 
finalized, we intend to exercise enforcement discretion under limited 
conditions, regarding the IND requirements for the use of FMT to treat 
C. difficile infection not responding to standard therapies. FDA 
intends to exercise this discretion, provided that: (1) The licensed 
health care provider treating the patient obtains adequate consent from 
the patient or his or her legally authorized representative for the use 
of FMT products. 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 its reasonably foreseeable risks; (2) the FMT 
product is not obtained from a stool bank; and (3) 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.
    FDA has developed this policy to assure that patients with C. 
difficile infection not responding to standard therapies may have 
access to this treatment, while addressing and controlling the risks 
that centralized manufacturing in stool banks presents to subjects. FDA 
intends for this to be an interim policy, while the Agency develops a 
comprehensive approach for the study and use of FMT products under IND.
    A stool bank is defined, for the purpose of this guidance, as an 
establishment that collects, prepares, and stores FMT product for 
distribution to other establishments, health care providers, or other 
entities for use in patient therapy or clinical research. An 
establishment that collects or prepares FMT products solely under the 
direction of licensed health care providers for the purpose of treating 
their patients (e.g., a hospital laboratory) is not considered to be a 
stool bank under this guidance.
    In the draft guidance, FDA provides that the stool bank sponsor may 
request a waiver of certain IND regulations relating to the obligations 
of investigators and subinvestigators (e.g., certain sections of the 
Statement of Investigator Form FDA 1572 that may not be applicable to 
FMT provided to the health care provider to treat their patients) (21 
CFR 312.10). FDA is requesting comments on which IND regulations are 
appropriate to waive. In particular, FDA is requesting comments on the 
requirement for institutional review board review of the use of FMT to 
treat patients with C. difficile infection not responding to standard 
therapies when the FMT is provided by a stool bank (21 CFR 
312.23(a)(1)(iv) and 21 CFR 312.66).
    In the draft guidance, FDA proposes a revised policy with regard to 
patient access to FMT. The provision that the donor be known either to 
the patient or to the treating licensed health care provider, a concept 
that was used in the March 2014 draft guidance, was subject to 
difficulties in interpretation, and the revised approach more 
accurately reflects our intent to mitigate risk, based on the number of 
patients exposed to a particular donor or manufacturing practice rather 
than the risk inherent from any one donor. Although FDA acknowledges 
that directed donations present different risks than stool bank 
donations, the number of persons exposed through a directed donation 
will be limited. FDA also requests comments on this revised policy. The 
draft guidance replaces the draft guidance of the same title, dated 
March 2014 and, when finalized, is intended to supersede the document 
of the same title, dated July 2013.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Enforcement 
Policy Regarding Investigational New Drug Requirements for Use of Fecal 
Microbiota for Transplantation to Treat Clostridium 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

    The draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 312 have been approved under 
OMB control number 0910-0014. The collections of information in 21 CFR 
part 50 have been approved under OMB control number 0910-0755.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04372 Filed 2-29-16; 8:45 am]
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