Memorandum of Understanding Between the Food and Drug Administration and the University of Pennsylvania, 52385-52392 [E8-20932]
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Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices
52385
TABLE 3.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition No.
10–57
Title of Standard
Reference No. and Date
Phakic Intraocular Lenses
ANSI Z80.13–2007
Safety Standard for Platform Lifts and Stairway Chairlifts
ASME A18.1–2005
Standard Terminology Relating to Flexible Barrier Packaging
ASTM F17–07a
I. Physical Medicine
16–161
J. Sterility
14–255
IV. List of Recognized Standards
FDA maintains the agency’s current
list of FDA recognized consensus
standards in a searchable database that
may be accessed directly at FDA’s
Internet site at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA
will incorporate the modifications and
minor revisions described in this notice
into the database and, upon publication
in the Federal Register, this recognition
of consensus standards will be effective.
FDA will announce additional
modifications and minor revisions to
the list of recognized consensus
standards, as needed, in the Federal
Register once a year, or more often, if
necessary.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under the new provision of
section 514 of the act by submitting
such recommendations, with reasons for
the recommendation, to the contact
person (see FOR FURTHER INFORMATION
CONTACT). To be properly considered
such recommendations should contain,
at a minimum, the following
information: (1) Title of the standard, (2)
any reference number and date, (3)
name and address of the national or
international standards development
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply, and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
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VI. Electronic Access
Persons interested in obtaining a copy
of ‘‘Guidance on the Recognition and
Use of Consensus Standards’’ by using
the Internet. CDRH maintains an entry
on the Internet for easy access to
information including text, graphics,
and files that may be downloaded to a
personal computer with Internet access.
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Updated on a regular basis, the CDRH
home page includes device safety alerts,
Federal Register reprints, information
on premarket submissions [including
lists of approved applications and
manufacturers’ addresses], small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
at https://www.regulations.gov.
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://www.fda.gov/cdrh/fedregin.html.
Dated: August 27, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E8–20939 Filed 9–8–08; 8:45 am]
VII. Submission of Comments and
Effective Date
ACTION:
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) written or
electronic comments regarding this
document. Two copies of any mailed
comments are to be submitted, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. FDA will consider any
comments received in determining
whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
020. These modifications to the list or
recognized standards are effective upon
publication of this notice in the Federal
Register.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
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BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0043]
[FDA No. 225–08–8001]
Memorandum of Understanding
Between the Food and Drug
Administration and the University of
Pennsylvania
AGENCY:
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA and
the University of Pennsylvania (Penn).
The purpose of this MOU is to establish
terms of collaboration between FDA and
Penn focused primarily but not
exclusively, in the areas of translational
therapeutics, diagnostics,
bioinformatics, new clinical trial
models, drug/device co-development,
and pharmacoepidemiology. Beyond the
collaborations in the traditional
academic programs for training,
research, and outreach, this MOU will
also include collaborations with Penn
extended partnerships such as the
Institute for Translational Medicine and
Therapeutics which includes the
Children’s Hospital of Philadelphia, the
Wistar Institute, and the University of
Sciences in Philadelphia.
DATES: The agreement became effective
on July 24, 2008.
FOR FURTHER INFORMATION CONTACT:
For FDA: Wendy R. Sanhai, Office of
the Commissioner, Office of
Scientific and Medical Programs
(HF–18), Food and Drug
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Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
7867.
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For Penn: Glenn N. Gaulton, PENN
Medicine, University of
Pennsylvania, 421 Curie Blvd.,
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Philadelphia, PA 19104–6160, 215–
898–2874.
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
SUPPLEMENTARY INFORMATION:
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Register, the agency is publishing notice
of this MOU.
Dated: September 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
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Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices
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Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices
[FR Doc. E8–20932 Filed 9–8–08; 8:45 am]
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]]>Agencies
[Federal Register Volume 73, Number 175 (Tuesday, September 9, 2008)]
[Notices]
[Pages 52385-52392]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20932]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0043]
[FDA No. 225-08-8001]
Memorandum of Understanding Between the Food and Drug
Administration and the University of Pennsylvania
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 FDA and the University of
Pennsylvania (Penn). The purpose of this MOU is to establish terms of
collaboration between FDA and Penn focused primarily but not
exclusively, in the areas of translational therapeutics, diagnostics,
bioinformatics, new clinical trial models, drug/device co-development,
and pharmacoepidemiology. Beyond the collaborations in the traditional
academic programs for training, research, and outreach, this MOU will
also include collaborations with Penn extended partnerships such as the
Institute for Translational Medicine and Therapeutics which includes
the Children's Hospital of Philadelphia, the Wistar Institute, and the
University of Sciences in Philadelphia.
DATES: The agreement became effective on July 24, 2008.
FOR FURTHER INFORMATION CONTACT:
For FDA: Wendy R. Sanhai, Office of the Commissioner, Office of
Scientific and Medical Programs (HF-18), Food and Drug
[[Page 52386]]
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7867.
For Penn: Glenn N. Gaulton, PENN Medicine, University of
Pennsylvania, 421 Curie Blvd., Philadelphia, PA 19104-6160, 215-898-
2874.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), 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: September 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
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