Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Availability, 10814-10815 [2014-04095]

Download as PDF 10814 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Notices Estimated Total Annual Burden Hours: 7,680. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. 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Annual reports are available for public inspections between 9 a.m. and 4 p.m., Monday through Friday at the following locations: (1) The Library of Congress, 101 Independence Ave. SE., James Madison Memorial Bldg., Newspaper and Current Periodical Reading Room, Rm. 133, Washington, DC 20540; and (2) The Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: February 21, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–04144 Filed 2–25–14; 8:45 am] BILLING CODE 4160–01–P Notice The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2013. ADDRESSES: Copies are available from the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301–827– 6860. FOR FURTHER INFORMATION CONTACT: Teresa L. Hays, Committee Management Officer, Advisory Committee and Oversight Management Staff, Food and Drug Administration, 10903 New SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8220. SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2012, through September 30, 2013: VerDate Mar<15>2010 17:24 Feb 25, 2014 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0811] Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is SUMMARY: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 announcing the availability of a draft guidance for industry 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 2014. This draft guidance informs members of the medical and scientific community and other interested persons that we intend to exercise enforcement discretion 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, provided the licensed health care provider treating the patient obtains adequate informed consent from the patient or his or her legally authorized representative for use of the FMT products, the stool is obtained from a donor known to either the patient or the licensed health care provider treating the patient, and the 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 to treat his or her patient. This draft guidance, when finalized, is intended to supersede the guidance 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,’’ dated July 2013 (July 2013 Guidance). 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 March 28, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. 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 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written E:\FR\FM\26FEN1.SGM 26FEN1 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Notices tkelley on DSK3SPTVN1PROD with NOTICES comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: 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 2014. Fecal microbiota collected from healthy individuals are being investigated for use in the treatment of C. difficile infection that is not responsive to standard therapies. Published data suggest that the use of fecal microbiota to restore intestinal flora may be an effective therapy in the management of refractory C. difficile infection. However, the efficacy and safety profile of this intervention has not yet been fully evaluated in controlled clinical trials. In the Federal Register of July 18, 2013 (78 FR 42965), FDA announced the availability of the July 2013 Guidance. At that time, FDA informed members of the medical and scientific community, and other interested persons that it intended to exercise enforcement discretion regarding these requirements provided that the physician treating the patient obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT products. FDA received several comments on the guidance, all of which supported enforcement discretion with regard to the continued use of FMT products to treat C. difficile infection not responsive to standard therapies. Since publishing the July 2013 Guidance, FDA has reviewed and intends to modify its enforcement discretion policy. In this draft guidance, FDA explains that it intends to exercise enforcement discretion regarding the IND requirements for the use of FMT to treat C. difficile infection not responding to standard therapies provided that: (1) The licensed health care provider treating the patient obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT products; (2) the FMT product is VerDate Mar<15>2010 17:24 Feb 25, 2014 Jkt 232001 obtained from a donor known to either the patient or the licensed health care provider treating the patient; 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 to treat his or her patient. This policy does not extend to the use of an FMT product when the FMT product is manufactured from the stool of a donor who is not known by the patient and/or the licensed health care provider treating the patient, or the donor and donor stool are not qualified under the direction of the licensed health care provider. Furthermore, this policy does not extend to other uses of FMT. Data related to the use and study of FMT to treat diseases or conditions other than C. difficile infection are limited, and study of FMT for these other uses is not included in this enforcement policy. FDA intends to exercise this discretion on an interim basis while the Agency further considers the matter, and continues to evaluate its enforcement policy. 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 FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations. II. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit either electronic comments regarding this document to https:// www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 10815 Dated: February 20, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–04095 Filed 2–25–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ‘‘FDA/Xavier University Global Medical Device Conference (MedCon).’’ This 3-day public conference includes presentations from key FDA officials and industry experts with small group breakout sessions. The conference is intended for companies of all sizes and employees at all levels. Dates and Times: The public conference will be held on May 7, 2014, from 8:30 a.m. to 5 p.m.; May 8, 2014, from 8:30 a.m. to 5 p.m.; and May 9, 2014, from 8:30 a.m. to 12:45 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073 or 513–745–3020. Contact Persons: For information regarding this notice: Gina Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513– 679–2700, FAX: 513–679–2771, email: gina.brackett@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073, email: phillipsm4@ xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, and lunches for the 3 days of the conference. Early registration ends March 11, 2014. Advanced registration rates begin March 12, 2014. Standard registration rates begin April 9, 2014. There will be onsite registration. The cost of registration is as follows: SUMMARY: E:\FR\FM\26FEN1.SGM 26FEN1

Agencies

[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Notices]
[Pages 10814-10815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04095]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0811]


Guidance for Industry: Enforcement Policy Regarding 
Investigational New Drug Requirements for Use of Fecal Microbiota for 
Transplantation To Treat Clostridium difficile Infection Not Responsive 
to Standard Therapies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry 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 
2014. This draft guidance informs members of the medical and scientific 
community and other interested persons that we intend to exercise 
enforcement discretion 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, 
provided the licensed health care provider treating the patient obtains 
adequate informed consent from the patient or his or her legally 
authorized representative for use of the FMT products, the stool is 
obtained from a donor known to either the patient or the licensed 
health care provider treating the patient, and the 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 to treat his or her patient. This draft guidance, when 
finalized, is intended to supersede the guidance 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,'' dated July 
2013 (July 2013 Guidance).

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 March 28, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. 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 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written

[[Page 10815]]

comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: 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 2014.
    Fecal microbiota collected from healthy individuals are being 
investigated for use in the treatment of C. difficile infection that is 
not responsive to standard therapies. Published data suggest that the 
use of fecal microbiota to restore intestinal flora may be an effective 
therapy in the management of refractory C. difficile infection. 
However, the efficacy and safety profile of this intervention has not 
yet been fully evaluated in controlled clinical trials.
    In the Federal Register of July 18, 2013 (78 FR 42965), FDA 
announced the availability of the July 2013 Guidance. At that time, FDA 
informed members of the medical and scientific community, and other 
interested persons that it intended to exercise enforcement discretion 
regarding these requirements provided that the physician treating the 
patient obtains adequate informed consent from the patient or his or 
her legally authorized representative for the use of FMT products. FDA 
received several comments on the guidance, all of which supported 
enforcement discretion with regard to the continued use of FMT products 
to treat C. difficile infection not responsive to standard therapies.
    Since publishing the July 2013 Guidance, FDA has reviewed and 
intends to modify its enforcement discretion policy. In this draft 
guidance, FDA explains that it intends to exercise enforcement 
discretion regarding the IND requirements for the use of FMT to treat 
C. difficile infection not responding to standard therapies provided 
that: (1) The licensed health care provider treating the patient 
obtains adequate informed consent from the patient or his or her 
legally authorized representative for the use of FMT products; (2) the 
FMT product is obtained from a donor known to either the patient or the 
licensed health care provider treating the patient; 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 to treat his or her patient. This policy does 
not extend to the use of an FMT product when the FMT product is 
manufactured from the stool of a donor who is not known by the patient 
and/or the licensed health care provider treating the patient, or the 
donor and donor stool are not qualified under the direction of the 
licensed health care provider. Furthermore, this policy does not extend 
to other uses of FMT. Data related to the use and study of FMT to treat 
diseases or conditions other than C. difficile infection are limited, 
and study of FMT for these other uses is not included in this 
enforcement policy.
    FDA intends to exercise this discretion on an interim basis while 
the Agency further considers the matter, and continues to evaluate its 
enforcement policy. 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 FDA's current thinking on this 
topic. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirement of the applicable 
statutes and regulations.

II. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at https://www.regulations.gov.

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: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04095 Filed 2-25-14; 8:45 am]
BILLING CODE 4160-01-P
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