Food and Drug Administration/Xavier University Global Medical Device Conference, 10815-10816 [2014-04134]
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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 In this draft guidance,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
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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.
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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:
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10816
Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Notices
TABLE 1—REGISTRATION FEES 1
Early rate
(through 3/11/14)
Attendee Type
Industry ........................................................................................
Small Business (<100 employees) ..............................................
Startup Manufacturer ...................................................................
Academic .....................................................................................
FDA/Government Employee ........................................................
tkelley on DSK3SPTVN1PROD with NOTICES
1 The
Advanced rate
(3/12/14 to 4/8/14)
$1,195
$900
$200
$200
Fee Waived
$1,495
$1,000
$250
$250
Fee Waived
Standard rate
(4/9/14 to 5/9/14)
$1,695
$1,200
$300
$300
Fee Waived.
following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks.
To register online for the public
conference, please visit the
‘‘Registration’’ link on the conference
Web site at https://
www.XavierMedCon.com. FDA has
verified the Web site address, but is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register.
To register by mail, please send your
name, title, firm name, address,
telephone and fax numbers, email, and
payment information for the fee to
Xavier University, Attention: Mason
Rick, 3800 Victory Parkway, Cincinnati,
OH 45207. An email will be sent
confirming your registration.
Attendees are responsible for their
own accommodations. The conference
headquarters hotel is the Cincinnati
Hilton Netherlands Plaza, 35 West 5th
Street, Cincinnati, OH, 45202, 513–421–
9100. Special conference block rates are
available through April 16, 2014. To
make reservations online, please visit
the ‘‘Venue/Logistics’’ link at https://
www.XavierMedCon.com.
If you need special accommodations
due to a disability, please contact Marla
Phillips (see Contact Persons) at least 7
days in advance of the conference.
SUPPLEMENTARY INFORMATION: The
public conference helps fulfill the
Department of Health and Human
Services and FDA’s important mission
to protect the public health. The
conference will provide those engaged
in FDA-regulated medical devices (for
humans) with information on the
following topics:
• Center for Devices and Radiological
Health Future Vision and Strategy
Keynote Address;
• European Union Regulations: New
Regulations, Company Strategy, and
Open Discussion Forum;
• How to Implement the Unique
Device Identification Requirements;
• Update from the Office of Device
Evaluation;
• FDA Regulation of Health
Information Technology: Medical Apps,
Cybersecurity, and ‘‘the Cloud’’;
• Managing Scientific and Regulatory
Disagreement;
• Combination Products;
VerDate Mar<15>2010
17:24 Feb 25, 2014
Jkt 232001
• FDA Inspectional Approach—Panel
with current FDA investigators;
• Operationalizing Post-Market
Surveillance;
• 510(k) Process;
• Risk Management;
• Purchasing Controls;
• Office of Compliance Update; and
• Strategic Thinking on Access in
China.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The conference helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (21 U.S.C.
393), which includes working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. The
conference also is consistent with the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121)
by providing outreach activities by
Government Agencies to small
businesses.
Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–04134 Filed 2–25–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; National Institute
of Mental Health Recruitment and
Milestone Reporting System
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on August 2, 2013,
page 46994 and allowed 60-days for
public comment. One public comment
SUMMARY:
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was received regarding human subjects
research recruitment and retention and
the perception of coercion. The
recruitment and enrollment procedures
proposed by a NIMH-funded clinical
trial are reviewed and approved by an
IRB of record, which has agreed to
review human subject research projects
in accordance with 45 CFR Part 46 and
its Federal-wide Assurance. The IRB of
record ensures that the possibility of
coercion or undue influence is
minimized, that an investigator seeks
consent only under circumstances that
provide the prospective subject/
representative sufficient opportunity to
consider whether or not to participate.
To address these concerns, we plan to
add a statement about human subject
protections to the policy and add a link
to the human subjects training on the
policy Web page. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institute of Mental Health (NIMH),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Keisha Shropshire, NIMH
Project Clearance Liaison, Science
Policy and Evaluation Branch, OSPPC,
NIMH, NIH, Neuroscience Center, 6001
Executive Boulevard, MSC 9667,
E:\FR\FM\26FEN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Notices]
[Pages 10815-10816]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04134]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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:
[[Page 10816]]
Table 1--Registration Fees \1\
----------------------------------------------------------------------------------------------------------------
Early rate (through 3/ Advanced rate (3/12/14 Standard rate (4/9/14
Attendee Type 11/14) to 4/8/14) to 5/9/14)
----------------------------------------------------------------------------------------------------------------
Industry............................. $1,195 $1,495 $1,695
Small Business (<100 employees)...... $900 $1,000 $1,200
Startup Manufacturer................. $200 $250 $300
Academic............................. $200 $250 $300
FDA/Government Employee.............. Fee Waived Fee Waived Fee Waived.
----------------------------------------------------------------------------------------------------------------
\1\ The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks.
To register online for the public conference, please visit the
``Registration'' link on the conference Web site at https://www.XavierMedCon.com. FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.
To register by mail, please send your name, title, firm name,
address, telephone and fax numbers, email, and payment information for
the fee to Xavier University, Attention: Mason Rick, 3800 Victory
Parkway, Cincinnati, OH 45207. An email will be sent confirming your
registration.
Attendees are responsible for their own accommodations. The
conference headquarters hotel is the Cincinnati Hilton Netherlands
Plaza, 35 West 5th Street, Cincinnati, OH, 45202, 513-421-9100. Special
conference block rates are available through April 16, 2014. To make
reservations online, please visit the ``Venue/Logistics'' link at
https://www.XavierMedCon.com.
If you need special accommodations due to a disability, please
contact Marla Phillips (see Contact Persons) at least 7 days in advance
of the conference.
SUPPLEMENTARY INFORMATION: The public conference helps fulfill the
Department of Health and Human Services and FDA's important mission to
protect the public health. The conference will provide those engaged in
FDA-regulated medical devices (for humans) with information on the
following topics:
Center for Devices and Radiological Health Future Vision
and Strategy Keynote Address;
European Union Regulations: New Regulations, Company
Strategy, and Open Discussion Forum;
How to Implement the Unique Device Identification
Requirements;
Update from the Office of Device Evaluation;
FDA Regulation of Health Information Technology: Medical
Apps, Cybersecurity, and ``the Cloud'';
Managing Scientific and Regulatory Disagreement;
Combination Products;
FDA Inspectional Approach--Panel with current FDA
investigators;
Operationalizing Post-Market Surveillance;
510(k) Process;
Risk Management;
Purchasing Controls;
Office of Compliance Update; and
Strategic Thinking on Access in China.
FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The conference helps to achieve objectives set forth
in section 406 of the Food and Drug Administration Modernization Act of
1997 (21 U.S.C. 393), which includes working closely with stakeholders
and maximizing the availability and clarity of information to
stakeholders and the public. The conference also is consistent with the
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.
104-121) by providing outreach activities by Government Agencies to
small businesses.
Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04134 Filed 2-25-14; 8:45 am]
BILLING CODE 4160-01-P
