Memorandum of Understanding With Duke University, 46998-47008 [E9-22001]
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46998
Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices
Matters to be Discussed: The meeting will
convene to address matters related to the
conduct of Study section business and for the
study section to consider safety and
occupational health-related grant
applications. Agenda items are subject to
change as priorities dictate.
Contact Person for More Information: Price
Connor, PhD, NIOSH Health Scientist, 1600
Clifton Road, NE., Mailstop E–20, Atlanta,
Georgia 30333, Telephone (404) 498–2511,
Fax (404) 498–2571.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: September 3, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–21991 Filed 9–11–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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Office of the Director, National
Institutes of Health; Notice of Public
Forums
Notice is hereby given of two forums
of the working groups of the NIH
Scientific Management Review Board:
Deliberating Organizational Changes
and Effectiveness Working Group and
Substance Use, Abuse and Addition
Working Group. The forums will serve
as the first among a series of sessions for
gathering information on the agency’s
organizational structure and
recommendations for enhancing the
NIH mission through greater agency
flexibility and responsiveness.
The forums will be open to the public,
with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The input from these meetings will be
summarized in a report that will be
presented to the Scientific Management
Review Board in open session at an
upcoming meeting.
Name of Committee: Substance Use,
Abuse, and Addiction Working Group of the
Scientific Management Review Board.
Date: September 23, 2009.
Open: 8 a.m. to 3 p.m.
Agenda: Presentation and discussion will
include an overview of the science of
substance use, abuse, and addiction and the
public health needs in this area of research.
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Place: National Institutes of Health,
Building 60, Chapel and Lecture Hall, 9000
Rockville Pike, Bethesda, MD 20892.
Name of Committee: Deliberating
Organizational Change and Effectiveness
Working Group of the Scientific Management
Review Board.
Date: September 24, 2009.
Open: 8 a.m. to 3 p.m.
Agenda: Presentations and discussion will
include an overview of NIH mission and
function from scientific and stakeholder
perspectives, including elaboration upon the
principles and attributes fundamental to its
success.
Place: National Institutes of Health,
Building 60, Chapel and Lecture Hall, 9000
Rockville Pike, Bethesda, MD 20892.
Contact Person: Dr. Lyric Jorgenson, PhD,
NIH–AAAS Science and Technology Policy
Fellow, Office of Science Policy, Office of the
Director, NIH, National Institutes of Health,
Building 1, Room 218, MSC 0166, 9000
Rockville Pike, Bethesda, MD 20892,
smrb@mail.nih.gov, (301) 496–6837.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person. The
meeting will also be webcast. The draft
meeting agenda and other information about
the SMRB, including information about
access to the webcast, will be available at
https://smrb.od.nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxis, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Dated: August 28, 2009.
Lynn Hudson,
Acting Director, Office of Biotechnology
Activities.
[FR Doc. E9–22000 Filed 9–11–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the National Advisory
Child Health and Human Development
Council, September 21, 2009, 8 a.m. to
September 21, 2009, 5 p.m., National
Institutes of Health, Building 31, 31
Center Drive, Bethesda, MD 20892
which was published in the Federal
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Register on September 1, 2009, 74 FR
54224.
This notice is being amended to
provide additional attendee viewing and
Videocast access instructions for open
session of Council. In order to facilitate
public attendance at the open session of
Council, reserve seating will be made
available to the first five individuals
reserving seats in the main meeting
room, Conference Room 6. Please
Contact Ms. Lisa Kaeser, Program and
Public Liaison Office, NICHD, at 301–
496–0536 to make your reservation.
Additional seating will be available in
the meeting overflow rooms, Conference
Rooms 7 and 8. Individuals will also be
able to view the meeting via NIH
Videocast. Please go to the following
link for Videocast access instructions at:
https://www.nichd.nih.gov/about/
overview/advisory/nachhd/virtualmeeting-200910.cfm. The meeting is
partially closed to the public.
Dated: September 3, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–21998 Filed 9–11–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0667]
[FDA 225–09–0010]
Memorandum of Understanding With
Duke University
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between the Food
and Drug Administration and Duke
University. The purpose of this MOU is
to establish a framework for
collaboration between the Parties and
for pursuing specific collaborative
projects. This collaboration between the
Parties shall be known as the Cardiac
Safety Research Consortium.
DATES: The agreement became effective
August 4, 2009.
FOR FURTHER INFORMATION CONTACT:
Wendy R. Sanhai, Office of the
Commissioner (HZ–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7867,
FAX: 301–827–5891.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
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Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
Dated: August 31, 2009.
David Horowitz,
Assitant Commissioner for Policy.
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Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices
47008
Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices
[FR Doc. E9–22001 Filed 9–11–09; 8:45 am]
BILLING CODE 4160–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0407]
Pediatric Clinical Trials Workshop:
Unmet Needs, Trial Designs and
Clinically Meaningful Safety and
Effectiveness Outcomes
AGENCY:
Food and Drug Administration,
HHS.
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ACTION: Notice of public workshop;
request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Pediatric
Clinical Trials Workshop: Unmet Needs,
Trial Designs and Clinically Meaningful
Safety and Effectiveness Outcomes.’’
The purpose of the public workshop is
to solicit information from primary and
secondary health care providers,
academia, industry, and professional
societies on various aspects of device
clinical trials involving pediatric
diseases and patients. Information from
this public workshop will help
stimulate interest in pediatric device
clinical trial research methods, and
develop topics for further discussion
regarding the safety of pediatric device
clinical trials. The information gathered
in this and future workshops will help
to develop future guidance for
developing safe clinical trials for
devices intended for pediatric patients.
We encourage participation and
comments from workshop attendees on
the topics and questions discussed.
Please see instructions for registration
and for providing comments in the
sections of this document entitled
‘‘Registration’’ and ‘‘Comments.’’
Dates and Times: The public
workshop will be held on October 29,
2009, from 8 a.m. to 5:30 p.m. and
October 30, 2009, from 8 a.m. to 12
noon.
Location: The public workshop will
be held at the Holiday Inn College Park
located off I–95 at 10000 Baltimore
Ave., College Park, MD 20740. The hotel
front desk number is 1–301–345–6700.
For directions, please refer to the
meeting Web page: https://www.fda.gov/
MedicalDevices/NewsEvents/Workshops
Conferences/ucm170938.htm
Contact Person: Barbara Buch, Center
For Devices and Radiological Health,
Food and Drug Administration, Bldg.
66, rm. 1406, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
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796–5650, FAX: 301–847–8117, e-mail:
barbara.buch@fda.hhs.gov. If you need
special accommodations due to a
disability, (such as wheelchair access or
a sign language interpreter), please
notify Barbara Buch by September 30,
2009.
Registration: Registration and seating
will be on a first-come, first-served basis
and discussion preference will be
afforded to clinical research
investigators involved in pediatric
clinical device trials, health care givers,
and patient advocates. Please provide
your name, title, organization affiliation,
address, and e-mail contact information.
There is no registration fee to attend the
workshop. There will be no onsite
registration. Please register
electronically at https://www.fda.gov/
MedicalDevices/NewsEvents/Workshops
Conferences/default.htm by September
30, 2009. Due to limited space, and to
maximize participation, attendees are
asked to delegate one or two
representatives from their organizations
to participate in the general sessions. A
report of The Workshop and The
Information presented will be available
following the meeting via a link on the
meeting Web page. If you wish to make
an oral comment during or to attend the
public workshop, please note this in
your registration information. The
online registration form will instruct
you as to the information you should
provide prior to the meeting. In general,
a summary of the presentation and an
electronic copy of the presentation
should be submitted by October 1, 2009.
We will try to accommodate all persons
who wish to make oral comments
during the general sessions. However,
we strongly recommend that you
provide written comments as instructed
in this document to ensure that your
opinion, comments, and suggestions are
captured. Please refer to the section,
‘‘Comments’’ for instructions on how to
submit written comments.
Comments: The deadline for
submitting comments regarding this
public workshop is November 30, 2009.
Regardless of attendance at the public
workshop, interested persons may
submit written or electronic comments.
Written comments should be submitted
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Electronic
comments should be submitted to
https://www.regulations.gov. Comments
should be identified 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.
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SUPPLEMENTARY INFORMATION:
I. Why Are We Holding This Public
Workshop?
The purpose of the public workshop
is to solicit expert input on topics
related to pediatric device clinical trials.
The agency seeks discussion between
FDA and other interested parties
regarding the conduct of clinical trials
to investigate device use in pediatric
populations. Other purposes of the
public workshop are, to identify any
gaps in such research, and to provide
information about evaluating the shortand long-term safety and effectiveness
of pediatric medical devices using valid
and sound scientific methods. Since the
2007 Food and Drug Administration
Amendments Act was signed into law,
there has been increased interest in
conducting scientifically sound clinical
research related to pediatric
populations. It is hoped that this
meeting will provide a forum for open
discussion and information exchange
among interested parties, FDA, and
other stakeholders to lay a framework
for further research into the use of
devices to treat disorders and diseases
that affect pediatric patients.
II. What Will Be the Format for the
Meeting?
The format for the meeting will
include a general session in the morning
on the first day. Invited expert speakers
will present information regarding
current needs and concerns about
clinical trials that involve pediatric
patients. These presentations will
provide the topics for the small breakout
groups, which will begin in the
afternoon session of day one and
continue through the morning of day
two of the public workshop. Each of the
smaller breakout group discussion
sessions will be led and moderated by
a panel of experts in each of the
specialty focus areas listed in section III
of this document. Each small group
session will begin with an invited
presentation to describe the issues of
concern in the specific specialty. This
will be followed by a moderated
question and comment session
including both prespecified questions
posed to the assembled group and any
that arise during the workshop’s
discussions. Those in attendance will
have the opportunity in these small
group discussions to participate in the
discussion, ask questions, and provide
comments for consideration. Small
group discussions will be concluded in
the morning of day two. Small group
participation will be limited by space
and will be available on a first-come,
first-served basis. When registering for
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]]>Agencies
[Federal Register Volume 74, Number 176 (Monday, September 14, 2009)]
[Notices]
[Pages 46998-47008]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22001]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0667]
[FDA 225-09-0010]
Memorandum of Understanding With Duke University
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between the Food and Drug
Administration and Duke University. The purpose of this MOU is to
establish a framework for collaboration between the Parties and for
pursuing specific collaborative projects. This collaboration between
the Parties shall be known as the Cardiac Safety Research Consortium.
DATES: The agreement became effective August 4, 2009.
FOR FURTHER INFORMATION CONTACT: Wendy R. Sanhai, Office of the
Commissioner (HZ-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7867, FAX: 301-827-5891.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c),
[[Page 46999]]
which states that all written agreements and MOUs between FDA and
others shall be published in the Federal Register, the agency is
publishing notice of this MOU.
Dated: August 31, 2009.
David Horowitz,
Assitant Commissioner for Policy.
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