Council on Graduate Medical Education; Notice of Meeting, 34464 [2010-14562]
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34464
Federal Register / Vol. 75, No. 116 / Thursday, June 17, 2010 / Notices
easier for laboratories to develop and
offer tests on a rapid timeline, the
absence of a level playing field creates
a competitive disadvantage and
potential disincentive to innovation by
other manufacturers whose tests are
approved or cleared by the agency for
similar indications. In addition, as set
out above, it means that some
diagnostics critical for patient care may
not be developed in a manner that
provides a reasonable assurance of
safety and effectiveness.
In response to these public health
concerns, the agency believes it is time
to reconsider its policy of enforcement
discretion over LDTs. The public must
be assured that the tests used in the
provision of health care, whether
developed by a laboratory or other
manufacturer, are safe and effective.
However, The FDA recognizes that there
are issues unique to the laboratory
community that should be taken into
consideration so that patients will
receive the desired benefits of
innovative, yet safe and effective,
diagnostic tests. FDA recognizes the
importance of implementing an
oversight framework that fosters
innovation in this area while assuring
that such tests are safe and effective. For
example, the field of genomics and
genetic testing has the potential to
revolutionize patient care. As a second
example, fostering innovation in tests
for rare diseases and conditions is
another important public health
concern. In these and other categories,
it is important that FDA provide a
reasonable, predictable, and consistent
regulatory policy for ensuring the safety
and effectiveness of LDTs and provide
sufficient time for implementation.
Therefore, this policy should encourage
innovation, improve patient outcomes,
strengthen patient confidence in the
reliability of these products, and help
reduce health care costs.
At this time, FDA believes that a riskbased application of oversight to LDTs
is the appropriate approach to achieve
the desired public health goals and
would like to hear from stakeholders,
including laboratory professionals,
clinicians, patients, and industry, as we
develop our draft oversight framework,
to define the issues that pose the
greatest concern to the public health.
The public meeting announced in this
notice will serve as a forum to discuss
issues and stakeholder concerns
surrounding LDT oversight. Following
the public meeting and the close of the
public docket the FDA will move
forward expeditiously to develop a draft
oversight framework for public
comment to provide predictability as
quickly as possible. The FDA also
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intends to phase in such a framework
over time based on the level of risk of
the test.
II. Agenda
FDA will start the public meeting
with a series of presentations
introducing the history and current
regulatory status of LDTs. The
remainder of the meeting will be
divided into four sessions highlighting
areas in which FDA hopes to gain
public input from critical perspectives
in response to its proposal to develop an
oversight framework, as well as to hear
stakeholder opinions on which issues
around laboratory developed testing
present the greatest concern to the
public health. These sessions include
the following: (1) Patient
Considerations, (2) Challenges for
Laboratories, (3) Direct to Consumer
Marketing of Testing, and (4) Education
and Outreach. Each session will consist
of approximately 2 hours of public
presentations focused on the session
topic followed by an expert panel
discussion and a question-and-answer
period. This public meeting agenda will
be available on the Internet at https://
www.fda.gov/MedicalDevices/News
Events/WorkshopsConferences/
default.htm.
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. A link to the
transcripts will also be available on the
Internet at https://www.fda.gov/Medical
Devices/NewsEvents/Workshops
Conferences/default.htm approximately
45 days after the meeting. The transcript
may be viewed at the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either
hardcopy or on CD–ROM, after
submission of a Freedom of Information
request. Written requests are to be sent
to Division of Freedom of Information
(HFI–35), Office of Management
Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Council on Graduate Medical
Education; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Council on Graduate Medical
Education (COGME).
Dates and Times: July 13, 2010, 12 p.m.–
2 p.m. EST.
Place: This meeting will be held via
conference call. The access information for
the call is:
1–866–646–2286, and the Participant
Passcode is: 3379871.
Status: The meeting will be open to the
public.
Agenda: On July 13, the meeting will be
called to order with remarks from the
COGME Chair. The Council members will
review the draft version of the 20th COGME
report entitled, ‘‘Advancing Primary Care.’’
The draft report was sent to select
organizations for feedback. The purpose of
this call is to discuss the comments offered.
The Council members may vote to finalize
the report.
Agenda items are subject to change as
priorities dictate.
For Further Information Contact: Anyone
interested in obtaining a roster of members or
other relevant information should write or
contact Jerald M. Katzoff, Executive
Secretary, COGME, Division of Medicine and
Dentistry, Bureau of Health Professions,
Parklawn Building, Room 9A–27, 5600
Fishers Lane, Rockville, Maryland 20857,
Telephone (301) 443–4443. The Web address
for information on the Council is: https://
cogme.gov.
Dated: June 10, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0004]
FDA 225–09–0012
Memorandum of Understanding
Between the Food and Drug
Administration and Drugs.Com;
Correction of Effective Date
AGENCY:
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HHS.
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SUMMARY: The Food and Drug
Administration (FDA) is providing
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[Federal Register Volume 75, Number 116 (Thursday, June 17, 2010)]
[Notices]
[Page 34464]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14562]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Council on Graduate Medical Education; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: Council on Graduate Medical Education (COGME).
Dates and Times: July 13, 2010, 12 p.m.-2 p.m. EST.
Place: This meeting will be held via conference call. The access
information for the call is:
1-866-646-2286, and the Participant Passcode is: 3379871.
Status: The meeting will be open to the public.
Agenda: On July 13, the meeting will be called to order with
remarks from the COGME Chair. The Council members will review the
draft version of the 20th COGME report entitled, ``Advancing Primary
Care.'' The draft report was sent to select organizations for
feedback. The purpose of this call is to discuss the comments
offered. The Council members may vote to finalize the report.
Agenda items are subject to change as priorities dictate.
For Further Information Contact: Anyone interested in obtaining
a roster of members or other relevant information should write or
contact Jerald M. Katzoff, Executive Secretary, COGME, Division of
Medicine and Dentistry, Bureau of Health Professions, Parklawn
Building, Room 9A-27, 5600 Fishers Lane, Rockville, Maryland 20857,
Telephone (301) 443-4443. The Web address for information on the
Council is: https://cogme.gov.
Dated: June 10, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-14562 Filed 6-16-10; 8:45 am]
BILLING CODE 4165-15-P
