Fecal Microbiota for Transplantation; Public Workshop, 12763-12764 [2013-04232]
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Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices
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Agenda: On Thursday, March 14,
2013, the Pediatric Advisory Committee
will meet to discuss pediatric-focused
safety reviews, as mandated by the Best
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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.
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[FR Doc. 2013–04141 Filed 2–22–13; 8:45 am]
GADAVIST (gadobutrol), HIZENTRA
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mstockstill on DSK4VPTVN1PROD with NOTICES
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Notice of this meeting is given under
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17:22 Feb 22, 2013
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12763
open public hearing session, FDA may
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Notice of this meeting is given under
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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
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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: https://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 https://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:
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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 https://
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
https://ntp.niehs.nih.gov/go/38673.
Public Comment Submissions: Email:
andrew.rooney@nih.gov or submit online at https://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
https://ntp.niehs.nih.gov/go/9741.
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]]>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]
-----------------------------------------------------------------------
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).
[[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: https://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
