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, 42965-42966 [2013-17223]

Download as PDF Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices TKELLEY on DSK3SPTVN1PROD with NOTICES the farm-to-fork continuum and the impact of these conditions on Salmonella concentrations on tree nuts, including: • Typical storage conditions (e.g., time, temperature, relative humidity) for different tree nuts, from the time of harvest until the application of treatments designed to reduce bacterial contamination, and whether those storage conditions change Salmonella contamination levels; • The types of treatments designed to reduce bacterial contamination that are typically applied to different tree nuts before retail, the frequency with which these treatments are applied to different types of tree nuts, the exact processing conditions (e.g., time, temperature, relative humidity), and the efficacy of these treatments in reducing Salmonella contamination on different tree nuts; • Typical storage conditions (e.g., time, temperature, relative humidity) for different tree nuts, from the time treatments designed to reduce bacterial contamination are applied to the time the tree nuts are consumed, including typical storage conditions at retail and in the consumer home. • The types of handling practices that are typically applied to different tree nuts by the consumer before consumption that may change Salmonella contamination levels, and the typical conditions (e.g., time, temperature) that are applied during these practices. 5. Other comments, including the types of tree nuts that should be evaluated in this risk assessment and information about which types of tree nuts may enter the U.S. market without the application of treatments designed to reduce bacterial contamination. III. Comments Interested persons may submit either electronic comments and scientific data and information to https:// www.regulations.gov or written comments and scientific data and information 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. IV. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons VerDate Mar<15>2010 17:20 Jul 17, 2013 Jkt 229001 between 9 a.m. and 4 p.m., Monday through Friday. We have verified the Web site addresses in the References section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register. 1. Isaacs, S., J. Aramini, B. Ciebin, J.A. Farrar, R. Ahmed, D. Middleton, A.U. Chandran, L.J. Harris, M. Whoes, E. Chan, A.S. Pichette, K. Campbell, A. Gupta, L.Y. Lior, M. Pearce, C. Clark, F. Rodgers, F. Jamieson, I. Brophy, A. Ellis, ‘‘Salmonella Enteritidis PT30 Outbreak Investigation Working Group. An international outbreak of salmonellosis associated with raw almonds contaminated with a rare phage type of Salmonella enteritidis.’’ Journal of Food Protection, 68(1): pp. 191–198, 2005. 2. Outbreak of Salmonella serotype Enteritidis infections associated with raw almonds—United States and Canada, 2003– 2004. Morbidity and Mortality Weekly Report, 53(22): pp. 484–487, 2004. 3. Ward, L., G. Duckworth, S. O’Brien, ‘‘Salmonella java phage type Dundee—rise in cases in England: update.’’ Eurosurveillance, 3(12): p. 1435, 1999. 4. CDC (Centers for Disease Control and Prevention). Multistate Outbreak of Human Salmonella Enteritidis Infections Linked to Turkish Pine Nuts. Available at: https://www. cdc.gov/salmonella/pinenuts-enteriditis/ 111711/. Last updated: 11/2011 [accessed 08/2012]. 5. Danyluk, M.D., T.M. Jones, S.J. Abd, F. Schlitt-Dittrich, M. Jacobs, L.J. Harris. ‘‘Prevalence and amounts of Salmonella found on raw California almonds.’’ Journal of Food Protection, 70(4): pp. 820–827, 2007. 6. Freire, F.D.O., L. Offord. ‘‘Bacterial and yeast counts in Brazilian commodities and spices.’’ Brazilian Journal of Microbiology, 33(2): pp. 145–148, 2002. 7. StClair, V.J., M.M. Klenk. ‘‘Performance of 3 Methods for the Rapid Identification of Salmonella in Naturally Contaminated Foods and Feeds.’’ Journal of Food Protection, 53(11): pp. 961–964, 1990. 8. Riyaz-Ul-Hassan, S., V. Verma, A. Malik, G.N. Qazi. ‘‘Microbiological quality of walnut kernels and apple juice concentrate.’’ World Journal of Microbiology and Biotechnology, 19(8): pp. 845–850, 2003. 9. CDC (Centers for Disease Control and Prevention). Salmonella in Pistachio Nuts, 2009. Available at https://www.cdc.gov/ salmonella/pistachios/update.html. Last updated: 2009 (Accessed 08/2012). 10. FDA (Food and Drug Administration). Recalls, Market Withdrawals, & Safety Alerts. Available at https://www.fda.gov/Safety/ Recalls/default.htm. (Accessed 04/2013). 11. FDA (Food and Drug Administration). Enforcement Reports. Available at https:// www.fda.gov/Safety/Recalls/Enforcement Reports/default.htm. 12. National Research Council. Committee on Food Protection. 1975. Nuts, macaroni, and noodle products and dry blended foods in prevention of microbial and parasitic hazards associated with processed foods. A guide for the food processor, pp. 68–76. In: National Academies of Sciences (ed.). Prevention of Microbial and Parasitic PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 42965 Hazards associated with Processed Foods—A Guide for the Food Processor. National Academy of Science Publishing Office, Washington, DC. 13. Uesugi, A.R., M.D. Danyluk, R.E. Mandrell, L.J. Harris. ‘‘Isolation of Salmonella Enteritidis phage type 30 from a single almond orchard over a 5-year period.’’ Journal of Food Protection, 70(8): pp. 1784– 1789, 2007. Dated: July 9, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–17211 Filed 7–17–13; 8:45 am] BILLING CODE 4160–01–P 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 announcing the availability of a guidance for industry entitled ‘‘Enforcement Policy Regarding IND Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,’’ dated July 2013. This 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. FDA intends to exercise this discretion provided that the treating physician obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT products. Informed 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 potential risks. This policy does not extend to other uses of FMT. FDA intends to exercise this discretion on an interim basis while we further consider the matter. This guidance has an immediate implementation date because FDA has SUMMARY: E:\FR\FM\18JYN1.SGM 18JYN1 42966 Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices TKELLEY on DSK3SPTVN1PROD with NOTICES determined that prior public participation is not feasible or appropriate. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the 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 that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written 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 guidance for industry entitled ‘‘Enforcement Policy Regarding IND 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 (GGP) regulation § 10.115 (21 CFR 10.115). This guidance is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2)). The Agency made this determination because the guidance requires immediate implementation for public health reasons. This guidance deals with an urgent issue affecting patients with lifethreatening infections with C. difficile. Although this guidance document is immediately in effect, it remains subject to comment in accordance with the Agency’s GGPs regulation. Fecal microbiota collected from healthy individuals are being investigated for use in the treatment of C. difficile infection. Published data suggest that the use of fecal microbiota to restore intestinal flora may be an effective therapy in the management of VerDate Mar<15>2010 17:20 Jul 17, 2013 Jkt 229001 refractory C. difficile infection. However, the efficacy and safety profile of this intervention have not yet been fully evaluated in controlled clinical trials. In the Federal Register of February 25, 2013 (78 FR 12763), FDA announced a public workshop, entitled ‘‘Fecal Microbiota for Transplantation,’’ which was held on May 2 and 3, 2013. The purpose of the workshop was to provide a forum for the exchange of information, knowledge, and experience among the medical and scientific community about the regulatory and scientific issues associated with FMT. During that workshop, and in subsequent communications, physicians and scientists expressed concern to FDA that FMT is not appropriate for study under the Agency’s IND regulations (21 CFR part 312). Some health care providers stated that applying IND requirements will make FMT unavailable and suggested that an alternative regulatory approach is needed to ensure the widespread availability of FMT for individuals with C. difficile infection unresponsive to standard therapies. FDA acknowledges these concerns. The Agency 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 the treating physician obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT products. Informed 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 potential risks. FDA intends to exercise this discretion on an interim basis while the Agency further considers the matter. 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. This guidance represents the Agency’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 requirements of the applicable statutes and regulations. II. Comments 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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 guidance at either https:// www.fda.gov/RegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: July 12, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–17223 Filed 7–17–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on September 25, 2013, from 8 a.m. to 5 p.m. Location: Bethesda North Marriott Hotel and Conference Center, White Oak Room, 5701 Marinelli Rd., Bethesda, MD. The hotel phone number is 301– 822–9200. Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, email: ACPS-CP@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 78, Number 138 (Thursday, July 18, 2013)]
[Notices]
[Pages 42965-42966]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17223]


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

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 guidance for industry entitled ``Enforcement 
Policy Regarding IND Requirements for Use of Fecal Microbiota for 
Transplantation to Treat Clostridium difficile Infection Not Responsive 
to Standard Therapies,'' dated July 2013. This 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. FDA intends to exercise this 
discretion provided that the treating physician obtains adequate 
informed consent from the patient or his or her legally authorized 
representative for the use of FMT products. Informed 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 potential 
risks. This policy does not extend to other uses of FMT. FDA intends to 
exercise this discretion on an interim basis while we further consider 
the matter. This guidance has an immediate implementation date because 
FDA has

[[Page 42966]]

determined that prior public participation is not feasible or 
appropriate.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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 that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit electronic comments on the guidance to https://www.regulations.gov. Submit written 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 guidance for industry 
entitled ``Enforcement Policy Regarding IND 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 
(GGP) regulation Sec.  10.115 (21 CFR 10.115). This guidance is being 
implemented without prior public comment because the Agency has 
determined that prior public participation is not feasible or 
appropriate (Sec.  10.115(g)(2)). The Agency made this determination 
because the guidance requires immediate implementation for public 
health reasons. This guidance deals with an urgent issue affecting 
patients with life-threatening infections with C. difficile. Although 
this guidance document is immediately in effect, it remains subject to 
comment in accordance with the Agency's GGPs regulation.
    Fecal microbiota collected from healthy individuals are being 
investigated for use in the treatment of C. difficile infection. 
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 have not yet been fully evaluated in 
controlled clinical trials.
    In the Federal Register of February 25, 2013 (78 FR 12763), FDA 
announced a public workshop, entitled ``Fecal Microbiota for 
Transplantation,'' which was held on May 2 and 3, 2013. The purpose of 
the workshop was to provide a forum for the exchange of information, 
knowledge, and experience among the medical and scientific community 
about the regulatory and scientific issues associated with FMT. During 
that workshop, and in subsequent communications, physicians and 
scientists expressed concern to FDA that FMT is not appropriate for 
study under the Agency's IND regulations (21 CFR part 312). Some health 
care providers stated that applying IND requirements will make FMT 
unavailable and suggested that an alternative regulatory approach is 
needed to ensure the widespread availability of FMT for individuals 
with C. difficile infection unresponsive to standard therapies.
    FDA acknowledges these concerns. The Agency 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 the treating physician obtains adequate 
informed consent from the patient or his or her legally authorized 
representative for the use of FMT products. Informed 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 potential 
risks. FDA intends to exercise this discretion on an interim basis 
while the Agency further considers the matter.
    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.
    This guidance represents the Agency'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 requirements of the applicable 
statutes and regulations.

II. Comments

    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 guidance at 
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or https://www.regulations.gov.

    Dated: July 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17223 Filed 7-17-13; 8:45 am]
BILLING CODE 4160-01-P
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