81 FR 10632 - 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of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 40 (March 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 40 (March 1, 2016)
| Page Range | 10632-10633 | |
| FR Document | 2016-04372 |
[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)] [Notices] [Pages 10632-10633] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04372] ----------------------------------------------------------------------- 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of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- 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of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry.'' The draft guidance document provides members of the medical and scientific community and other interested persons with notice that, when finalized, we intend to exercise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 The draft guidance replaces the draft guidance of the same title dated March 2014 and, when finalized, is intended to supersede the document of the same title, dated July 2013.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 31, 2016.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] BILLING CODE 4164-01-P
![10632 Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices
This determination of the regulatory document entitled ‘‘Enforcement Policy • Mail/Hand delivery/Courier (for
review period establishes the maximum Regarding Investigational New Drug written/paper submissions): Division of
potential length of a patent extension. Requirements for Use of Fecal Dockets Management (HFA–305), Food
However, the USPTO applies several Microbiota for Transplantation to Treat and Drug Administration, 5630 Fishers
statutory limitations in its calculations Clostridium difficile Infection Not Lane, Rm. 1061, Rockville, MD 20852.
of the actual period for patent extension. Responsive to Standard Therapies; Draft • For written/paper comments
In its application for patent extension, Guidance for Industry.’’ The draft submitted to the Division of Dockets
this applicant seeks 966 days of patent guidance document provides members Management, FDA will post your
term extension. of the medical and scientific community comment, as well as any attachments,
and other interested persons with notice except for information submitted,
III. Petitions marked and identified, as confidential,
that, when finalized, we intend to
Anyone with knowledge that any of exercise enforcement discretion under if submitted as detailed in
the dates as published are incorrect may limited conditions, regarding the ‘‘Instructions.’’
submit either electronic or written investigational new drug (IND) Instructions: All submissions received
comments and ask for a redetermination requirements for the use of fecal must include the Docket No. FDA–
(see DATES). Furthermore, any interested microbiota for transplantation (FMT) to 2013–D–0811 for ‘‘Enforcement Policy
person may petition FDA for a treat C. difficile infection not Regarding Investigational New Drug
determination regarding whether the responding to standard therapies. The Requirements for Use of Fecal
applicant for extension acted with due draft guidance replaces the draft Microbiota for Transplantation to Treat
diligence during the regulatory review guidance of the same title dated March Clostridium difficile Infection Not
period. To meet its burden, the petition 2014 and, when finalized, is intended to Responsive to Standard Therapies.’’
must be timely (see DATES) and contain supersede the document of the same Received comments will be placed in
sufficient facts to merit an FDA title, dated July 2013. the docket and, except for those
investigation. (See H. Rept. 857, part 1, DATES: Although you can comment on submitted as ‘‘Confidential
98th Cong., 2d sess., pp. 41–42, 1984.) any guidance at any time (see 21 CFR Submissions,’’ publicly viewable at
Petitions should be in the format 10.115(g)(5)), to ensure that the Agency http://www.regulations.gov or at the
specified in 21 CFR 10.30. considers your comment on this draft Division of Dockets Management
Submit petitions electronically to guidance before it begins work on the between 9 a.m. and 4 p.m., Monday
http://www.regulations.gov at Docket final version of the guidance, submit through Friday.
No. FDA–2013–S–0610. Submit written either electronic or written comments • Confidential Submissions—To
petitions (two copies are required) to the on the draft guidance by May 31, 2016. submit a comment with confidential
Division of Dockets Management (HFA– information that you do not wish to be
ADDRESSES: You may submit comments
305), Food and Drug Administration, made publicly available, submit your
as follows:
5630 Fishers Lane, Rm. 1061, Rockville, comments only as a written/paper
MD 20852. Petitions that have not been Electronic Submissions submission. You should submit two
made publicly available on http:// Submit electronic comments in the copies, total. One copy will include the
www.regulations.gov may be viewed in following way: information you claim to be confidential
the Division of Dockets Management • Federal eRulemaking Portal: http:// with a heading or cover note that states
between 9 a.m. and 4 p.m., Monday www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
through Friday. instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Dated: February 24, 2016. Comments submitted electronically, Agency will review this copy, including
including attachments, to http:// the claimed confidential information, in
Leslie Kux,
www.regulations.gov will be posted to its consideration of comments. The
Associate Commissioner for Policy.
the docket unchanged. Since your second copy, which will have the
[FR Doc. 2016–04370 Filed 2–29–16; 8:45 am] claimed confidential information
comment will be made public, you are
BILLING CODE 4164–01–P
solely responsible for ensuring that your redacted/blacked out, will be available
comment does not include any for public viewing and posted on
confidential information that you or a http://www.regulations.gov. Submit
DEPARTMENT OF HEALTH AND both copies to the Division of Dockets
HUMAN SERVICES third party may not wish to be posted,
such as medical information, your or Management. If you do not wish your
Food and Drug Administration anyone else’s Social Security number, or name and contact information to be
confidential business information, such made publicly available, you can
[Docket No. FDA–2013–D–0811] as a manufacturing process. Please note provide this information on the cover
that if you include your name, contact sheet and not in the body of your
Enforcement Policy Regarding comments, and you must identify this
information, or other information that
Investigational New Drug information as ‘‘confidential.’’ Any
identifies you in the body of your
Requirements for Use of Fecal information marked as ‘‘confidential’’
comments, that information will be
Microbiota for Transplantation To Treat will not be disclosed except in
posted on http://www.regulations.gov.
Clostridium difficile Infection Not
• If you want to submit a comment accordance with 21 CFR 10.20 and other
Responsive to Standard Therapies; applicable disclosure law. For more
with confidential information that you
Draft Guidance for Industry; information about FDA’s posting of
asabaliauskas on DSK5VPTVN1PROD with NOTICES
do not wish to be made available to the
Availability comments to public dockets, see 80 FR
public, submit the comment as a
AGENCY: Food and Drug Administration, written/paper submission and in the 56469, September 18, 2015, or access
HHS. manner detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/
ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/
default.htm.
SUMMARY: The Food and Drug Written/Paper Submissions Docket: For access to the docket to
Administration (FDA or Agency) is Submit written/paper submissions as read background documents or the
announcing the availability of a draft follows: electronic and written/paper comments
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![Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices 10633
received, go to http:// FDA has developed this policy to supersede the document of the same
www.regulations.gov and insert the assure that patients with C. difficile title, dated July 2013.
docket number, found in brackets in the infection not responding to standard The draft guidance is being issued
heading of this document, into the therapies may have access to this consistent with FDA’s good guidance
‘‘Search’’ box and follow the prompts, treatment, while addressing and practices regulation (21 CFR 10.115).
and/or go to the Division of Dockets controlling the risks that centralized The draft guidance, when finalized, will
Management, 5630 Fishers Lane, Rm. manufacturing in stool banks presents to represent the current thinking of FDA
1061, Rockville, MD 20852. subjects. FDA intends for this to be an on ‘‘Enforcement Policy Regarding
Submit written requests for single interim policy, while the Agency Investigational New Drug Requirements
copies of the draft guidance to the Office develops a comprehensive approach for for Use of Fecal Microbiota for
of Communication, Outreach and the study and use of FMT products Transplantation to Treat Clostridium
Development, Center for Biologics under IND. difficile Infection Not Responsive to
Evaluation and Research (CBER), Food A stool bank is defined, for the Standard Therapies.’’ It does not
and Drug Administration, 10903 New purpose of this guidance, as an establish any rights for any person and
Hampshire Ave., Bldg. 71, Rm. 3128, establishment that collects, prepares, is not binding on FDA or the public.
Silver Spring, MD 20993–0002. Send and stores FMT product for distribution You can use an alternative approach if
one self-addressed adhesive label to to other establishments, health care it satisfies the requirements of the
assist the office in processing your providers, or other entities for use in applicable statutes and regulations.
requests. The draft guidance may also be patient therapy or clinical research. An
establishment that collects or prepares II. Paperwork Reduction Act of 1995
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See FMT products solely under the The draft guidance refers to
the SUPPLEMENTARY INFORMATION section direction of licensed health care previously approved collections of
for electronic access to the draft providers for the purpose of treating information found in FDA regulations.
guidance document. their patients (e.g., a hospital laboratory) These collections of information are
is not considered to be a stool bank subject to review by the Office of
FOR FURTHER INFORMATION CONTACT:
under this guidance. Management and Budget (OMB) under
Gretchen Opper, Center for Biologics
In the draft guidance, FDA provides the Paperwork Reduction Act of 1995
Evaluation and Research, Food and that the stool bank sponsor may request
Drug Administration, 10903 New (44 U.S.C. 3501–3520). The collections
a waiver of certain IND regulations of information in 21 CFR part 312 have
Hampshire Ave., Bldg. 71, Rm. 7301, relating to the obligations of
Silver Spring, MD 20993–0002, 240– been approved under OMB control
investigators and subinvestigators (e.g., number 0910–0014. The collections of
402–7911. certain sections of the Statement of information in 21 CFR part 50 have been
SUPPLEMENTARY INFORMATION: Investigator Form FDA 1572 that may approved under OMB control number
I. Background not be applicable to FMT provided to 0910–0755.
the health care provider to treat their
FDA is announcing the availability of patients) (21 CFR 312.10). FDA is III. Electronic Access
a draft document entitled ‘‘Enforcement requesting comments on which IND Persons with access to the Internet
Policy Regarding Investigational New regulations are appropriate to waive. In may obtain the draft guidance at either
Drug Requirements for Use of Fecal particular, FDA is requesting comments http://www.fda.gov/
Microbiota for Transplantation to Treat on the requirement for institutional BiologicsBloodVaccines/
Clostridium difficile Infection Not review board review of the use of FMT GuidanceCompliance
Responsive to Standard Therapies.’’ The to treat patients with C. difficile RegulatoryInformation/Guidances/
draft guidance document provides infection not responding to standard default.htm or http://
members of the medical and scientific therapies when the FMT is provided by www.regulations.gov.
community and other interested persons a stool bank (21 CFR 312.23(a)(1)(iv)
with notice that, when finalized, we Dated: February 23, 2016.
and 21 CFR 312.66).
intend to exercise enforcement In the draft guidance, FDA proposes Leslie Kux,
discretion under limited conditions, a revised policy with regard to patient Associate Commissioner for Policy.
regarding the IND requirements for the access to FMT. The provision that the [FR Doc. 2016–04372 Filed 2–29–16; 8:45 am]
use of FMT to treat C. difficile infection donor be known either to the patient or BILLING CODE 4164–01–P
not responding to standard therapies. to the treating licensed health care
FDA intends to exercise this discretion, provider, a concept that was used in the
provided that: (1) The licensed health March 2014 draft guidance, was subject DEPARTMENT OF HEALTH AND
care provider treating the patient to difficulties in interpretation, and the HUMAN SERVICES
obtains adequate consent from the revised approach more accurately
patient or his or her legally authorized reflects our intent to mitigate risk, based Designation of a Class of Employees
representative for the use of FMT on the number of patients exposed to a for Addition to the Special Exposure
products. The consent should include, particular donor or manufacturing Cohort
at a minimum, a statement that the use practice rather than the risk inherent AGENCY: National Institute for
of FMT products to treat C. difficile is from any one donor. Although FDA Occupational Safety and Health
investigational and a discussion of its acknowledges that directed donations
asabaliauskas on DSK5VPTVN1PROD with NOTICES
(NIOSH), Centers for Disease Control
reasonably foreseeable risks; (2) the present different risks than stool bank and Prevention, Department of Health
FMT product is not obtained from a donations, the number of persons and Human Services (HHS).
stool bank; and (3) the stool donor and exposed through a directed donation ACTION: Notice.
stool are qualified by screening and will be limited. FDA also requests
testing performed under the direction of comments on this revised policy. The SUMMARY: HHS gives notice of a
the licensed health care provider for the draft guidance replaces the draft decision to designate a class of
purpose of providing the FMT product guidance of the same title, dated March employees from the Battelle
for treatment of the patient. 2014 and, when finalized, is intended to Laboratories—King Avenue site in
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Document Created: 2018-02-02 15:00:08
Document Modified: 2018-02-02 15:00:08
| 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 | 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. | |
| 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. | |
| FR Citation | 81 FR 10632 |
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