Fecal Microbiota for Transplantation; Public Workshop, 12763-12764 [2013-04232]

Download as PDF Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices learn about possible modifications before coming to the meeting. Agenda: On Thursday, March 14, 2013, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Public Law 107–109) and the for Dated: February 19, 2013. Pediatric Research Equity Act (Public Jill Hartzler Warner, Law 108–155) for: ACTEMRA Acting Associate Commissioner for Special (tocilizumab), ALIMTA (Pemetrexed Medical Programs. disodium), CREON (pancrelipase), [FR Doc. 2013–04141 Filed 2–22–13; 8:45 am] GADAVIST (gadobutrol), HIZENTRA BILLING CODE 4160–01–P [Immune Globulin Subcutaneous (Human), 20% Liquid], INOMAX (nitric oxide), INVEGA (paliperidone), DEPARTMENT OF HEALTH AND KEDBUMIN (albumin human), KYTRIL HUMAN SERVICES Injection (granisetron hydrochloride), LAMICTAL XR (lamotrigine), Food and Drug Administration MENACTRA [Meningococcal (Groups A, C, Y and W–135) Polysaccharide [Docket No. FDA–2013–N–0001] Diphtheria Toxoid Conjugate Vaccine], Pediatric Advisory Committee; Notice MOXEZA (moxifloxacin ophthalmic of Meeting solution 0.5%), NATROBA (spinosad), NEXIUM (esomeprazole magnesium), AGENCY: Food and Drug Administration, NEXIUM IV (esomeprazole sodium), HHS. UROXATRAL (alfuzosin ACTION: Notice. hydrochloride), and ZENPEP (pancrelipase). Also, there will be an This notice announces a forthcoming Informational Update on Codeine. meeting of a public advisory committee FDA intends to make background of the Food and Drug Administration material available to the public no later (FDA). The meeting will be open to the than 2 business days before the meeting. public. If FDA is unable to post the background Name of Committee: Pediatric material on its Web site prior to the Advisory Committee. meeting, the background material will General Function of the Committee: be made publicly available at the To provide advice and location of the advisory committee recommendations to the Agency on meeting, and the background material FDA’s regulatory issues. will be posted on FDA’s Web site after Date and Time: The meeting will be the meeting. Background material is held on Thursday, March 14, 2013 from available at http://www.fda.gov/ 8 a.m. to 5:30 p.m. AdvisoryCommittees/Calendar/ Location: Sheraton Silver Spring default.htm. Scroll down to the Hotel, 8777 Georgia Ave., Silver Spring, appropriate advisory committee meeting MD 20910, 301–589–0800 or visit the link. hotel’s Web site at http:// Procedure: Interested persons may www.sheratonsilverspring.com/. present data, information, or views, Contact Person: Walter Ellenberg, orally or in writing, on issues pending Office of the Commissioner, Food and before the committee. Written Drug Administration, 10903 New submissions may be made to the contact Hampshire Ave., Bldg. 32, rm. 5154, person on or before March 7, 2013. Oral Silver Spring, MD 20993, 301–796– presentations from the public will be 0885, email walter.ellenberg@ scheduled between approximately 11:30 fda.hhs.gov or FDA Advisory Committee a.m. and 12:30 p.m. Those individuals Information Line, 1–800–741–8138 interested in making formal oral (301–443–0572 in the Washington, DC presentations should notify the contact area). A notice in the Federal Register person and submit a brief statement of about last minute modifications that the general nature of the evidence or arguments they wish to present, the impact a previously announced names and addresses of proposed advisory committee meeting cannot participants, and an indication of the always be published quickly enough to approximate time requested to make provide timely notice. Therefore, you their presentation on or before February should always check the Agency’s Web 27, 2013. Time allotted for each site at http://www.fda.gov/ presentation may be limited. If the AdvisoryCommittees/default.htm and number of registrants requesting to scroll down to the appropriate advisory speak is greater than can be reasonably committee meeting link, or call the accommodated during the scheduled advisory committee information line to mstockstill on DSK4VPTVN1PROD with NOTICES Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). VerDate Mar<15>2010 17:22 Feb 22, 2013 Jkt 229001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 12763 open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 28, 2013. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Walter Ellenberg at 301–796–0885, email walter.ellenberg@fda.hhs.gov, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 19, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–04256 Filed 2–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Fecal Microbiota for Transplantation; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), are announcing a public workshop entitled ‘‘Fecal Microbiota for Transplantation.’’ The purpose of the public workshop is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with fecal microbiota for transplantation (FMT). E:\FR\FM\25FEN1.SGM 25FEN1 mstockstill on DSK4VPTVN1PROD with NOTICES 12764 Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices Date and Time: The public workshop will be held on May 2 and 3, 2013, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at Lister Hill Center Auditorium, National Institutes of Health, Bldg. 38A, 8600 Rockville Pike, Bethesda, MD 20894. Preregistered participants will receive additional information on security procedures, parking, and public transportation with their email registration confirmation. Contact Person: Chris Nguyen, Center for Biologics Evaluation and Research (HFM–49), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–2000, FAX: 301–827–3079, email: CBERPublicEvents@fda.hhs.gov (subject line: FMT Workshop). Registration: Mail or fax your registration information (including name, title, firm name, address, telephone, and fax numbers) to Chris Nguyen (see Contact Person) or email to CBERPublicEvents@fda.hhs.gov (subject line: FMT Workshop Registration) by April 18, 2013. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8 a.m. If you need special accommodations due to a disability, please contact Chris Nguyen (see Contact Person) at least 7 days in advance. SUPPLEMENTARY INFORMATION: Fecal microbiota samples that have been isolated from healthy individuals are being investigated for use in the treatment of Clostridium difficile colitis. Published data from case studies and metaanalyses suggest that the use of fecal microbiota to restore gut flora may be an effective therapy in the management of refractory C. difficile infection. However, the efficacy of this intervention has not yet been demonstrated in controlled clinical trials. Such controlled trials are needed to demonstrate the safety and effectiveness of FMT products for C. difficile infection refractory to conventional therapy. FMT is also being considered as a treatment for inflammatory bowel disease, obesity, and other disorders, and controlled trials are needed in these settings as well. Clinical studies to evaluate the safety and efficacy of FMT are regulated by FDA. FDA’s primary objectives in reviewing an investigational new drug application are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phases 2 and VerDate Mar<15>2010 17:22 Feb 22, 2013 Jkt 229001 3, to help insure that the quality of the scientific evaluation of the product is adequate to permit an evaluation of safety and effectiveness. In addition, the complex nature of FMT products presents specific scientific and regulatory challenges. To facilitate clinical development of FMT, CBER and NIAID are holding this workshop to provide a forum for the exchange of information, knowledge, and experience between CBER, NIAID, and the scientific-medical community. Transcripts: Please be advised that as soon as possible after a transcript of the public workshop is available, it will be accessible at: http://www.fda.gov/ BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/ TranscriptsMinutes/default.htm. Transcripts of the public workshop may also be requested in writing from the Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857. Dated: February 15, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–04232 Filed 2–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Draft Office of Health Assessment and Translation Approach for Systematic Review and Evidence Integration for Literature-Based Health Assessments—February 2013; Request for Comments; Notice of a Meeting The National Toxicology Program (NTP) requests public comments on the Draft Office of Health Assessment and Translation (OHAT) Approach for Systematic Review and Evidence Integration for LiteratureBased Health Assessments—February 2013 (available at http://ntp.niehs.nih .gov/go/38138). The NTP also plans to release two protocols to illustrate the application of this framework. These documents were prepared by the OHAT, Division of NTP, National Institute of Environmental Health Sciences (NIEHS). The NTP will hold a public web-based, informational meeting during the public-comment period to provide an overview of the framework, describe the contents in the case-study protocols, and respond to questions from the public on any of the documents. SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Public Comment Submissions: Deadline is June 11, 2013. Document Availability: Draft OHAT Approach—February 2013 will be available by February 26, 2013, and case-study protocols should be available on April 2, 2013, at http:// ntp.niehs.nih.gov/go/38673. Registration for public, web-based, informational meeting: Deadline is April 16, 2013. Meeting: April 23, 2013, 12:00–4:00 p.m. Eastern Daylight Time (EDT). The meeting may end earlier depending on the number of registered participants and will be cancelled if there are no registered participants by close of business on April 16, 2013. Registrants will receive information by email to access the web-based meeting on or before April 19, 2013. ADDRESSES: Agency Web site: The Draft OHAT Approach—February 2013, protocols, registration for web-based meeting, and public comments are at http://ntp.niehs.nih.gov/go/38673. Public Comment Submissions: Email: andrew.rooney@nih.gov or submit online at http://ntp.niehs.nih.gov/go/ 38673. TTY users should contact the Federal TTY Relay Service at (800) 877–8330. Requests must be made at least 5 business days in advance of the webbased meeting. FOR FURTHER INFORMATION CONTACT: Dr. Andrew Rooney, Deputy Director, OHAT, Division of NTP, NIEHS, P.O. Box 12233, K2–04, Research Triangle Park, NC 27709. Phone: 919–541–2999, Fax: 301–480–3299, Email: Andrew.Rooney@nih.gov. Hand Deliver/ Courier address: 530 Davis Drive, Room K2154, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: DATES: Background The OHAT, Division of NTP, NIEHS, has led an effort for the NTP to develop an approach for carrying out literaturebased health assessments that incorporates systematic review methodology. Systematic review and plans for developing the approach were introduced at the NTP Board of Scientific Counselors (BSC) meeting on June 21—22, 2012. A BSC working group reviewed an earlier draft of the approach (then called the draft NTP Approach) at a meeting on August 28— 29, 2012, and provided a draft report with recommendations to the BSC at its meeting on December 11, 2012; the report was unanimously accepted by the BSC. Information, presentations, and minutes (when available) from the June and December meetings are available at http://ntp.niehs.nih.gov/go/9741. E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12763-12764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04232]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Fecal Microbiota for Transplantation; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER), and the National Institutes of Health, 
National Institute of Allergy and Infectious Diseases (NIAID), are 
announcing a public workshop entitled ``Fecal Microbiota for 
Transplantation.'' The purpose of the public workshop is to exchange 
information with the medical and scientific community about the 
regulatory and scientific issues associated with fecal microbiota for 
transplantation (FMT).

[[Page 12764]]

    Date and Time: The public workshop will be held on May 2 and 3, 
2013, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at Lister Hill Center 
Auditorium, National Institutes of Health, Bldg. 38A, 8600 Rockville 
Pike, Bethesda, MD 20894. Preregistered participants will receive 
additional information on security procedures, parking, and public 
transportation with their email registration confirmation.
    Contact Person: Chris Nguyen, Center for Biologics Evaluation and 
Research (HFM-49), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-3079, 
email: CBERPublicEvents@fda.hhs.gov (subject line: FMT Workshop).
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, telephone, and fax numbers) to Chris 
Nguyen (see Contact Person) or email to CBERPublicEvents@fda.hhs.gov 
(subject line: FMT Workshop Registration) by April 18, 2013. There is 
no registration fee for the public workshop. Early registration is 
recommended because seating is limited. Registration on the day of the 
public workshop will be provided on a space available basis beginning 
at 8 a.m.
    If you need special accommodations due to a disability, please 
contact Chris Nguyen (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: Fecal microbiota samples that have been 
isolated from healthy individuals are being investigated for use in the 
treatment of Clostridium difficile colitis. Published data from case 
studies and metaanalyses suggest that the use of fecal microbiota to 
restore gut flora may be an effective therapy in the management of 
refractory C. difficile infection. However, the efficacy of this 
intervention has not yet been demonstrated in controlled clinical 
trials. Such controlled trials are needed to demonstrate the safety and 
effectiveness of FMT products for C. difficile infection refractory to 
conventional therapy. FMT is also being considered as a treatment for 
inflammatory bowel disease, obesity, and other disorders, and 
controlled trials are needed in these settings as well.
    Clinical studies to evaluate the safety and efficacy of FMT are 
regulated by FDA. FDA's primary objectives in reviewing an 
investigational new drug application are, in all phases of the 
investigation, to assure the safety and rights of subjects, and, in 
Phases 2 and 3, to help insure that the quality of the scientific 
evaluation of the product is adequate to permit an evaluation of safety 
and effectiveness. In addition, the complex nature of FMT products 
presents specific scientific and regulatory challenges.
    To facilitate clinical development of FMT, CBER and NIAID are 
holding this workshop to provide a forum for the exchange of 
information, knowledge, and experience between CBER, NIAID, and the 
scientific-medical community.
    Transcripts: Please be advised that as soon as possible after a 
transcript of the public workshop is available, it will be accessible 
at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm. 
Transcripts of the public workshop may also be requested in writing 
from the Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Rockville, MD 20857.

    Dated: February 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04232 Filed 2-22-13; 8:45 am]
BILLING CODE 4160-01-P