Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com; Correction of Effective Date, 34464-34465 [2010-14599]
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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.
[FR Doc. 2010–14562 Filed 6–16–10; 8:45 am]
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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:
[FR Doc. 2010–14654 Filed 6–16–10; 8:45 am]
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ACTION:
Food and Drug Administration,
HHS.
PO 00000
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is providing
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Federal Register / Vol. 75, No. 116 / Thursday, June 17, 2010 / Notices
notice to correct the effective date of the
memorandum of understanding (MOU)
between FDA and Drugs.Com that
published in the Federal Register of
May 26, 2010 (75 FR 29561). The
purpose of the cooperative program is to
extend the reach of FDA Consumer
Health Information and to provide
consumers with better information and
timely content concerning public health
and safety topics, including alerts of
emerging safety issues and product
recalls.
DATES: The agreement became effective
October 13, 2009.
FOR FURTHER INFORMATION CONTACT:
Jason Brodsky, Consumer Health
Information Staff, Office of External
Relations, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5378, Silver Spring,
MD 20993–0002, 301–796–8234, e-mail:
Jason.Brodsky@fda.hhs.gov.
Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–14599 Filed 6–16–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
mstockstill on DSKH9S0YB1PROD with NOTICES
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 75 FR 28811–28813,
dated April 24, 2010) is amended to
reflect the establishment of the Office of
the Associate Director for Program,
Office of the Director, Centers for
Disease Control and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows:
Delete in their entirety the titles and
function statements for the Office of
Strategy and Innovation (CAM) and the
Office of Chief of Public Health Practice
(CAR) and insert the following:
Office of the Associate Director for
Program (CAF). The mission of the
Office of the Associate Director for
Program is to increase the impact and
effectiveness of public health programs
and eliminate health disparities through
the application of science to practice,
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the promotion of policy interventions,
and the use of performance and
evaluation data for continuous
improvement.
Office of the Director (CAF1). (1)
Provides agency-wide direction,
standards, and technical assistance for
program planning, performance and
accountability, and program evaluation
and effectiveness; (2) serves as advisor
to the CDC Director, HHS and the
Administration on key programmatic
activities; (3) provides intensive analytic
and advisory assistance to enable
effective redesign of select program
priorities; (4) represents CDC vision,
mission, and program strategy internally
and externally; (5) develops and
promotes new initiatives based on
emerging issues, science, and policy; (6)
supports the harmonization and
integration of performance
measurement, accountability, and
program evaluation; (7) provides
agency-wide direction, standards, and
technical assistance to support and
guide program evaluation, monitoring,
and performance measurement by
programs; (8) supports the
harmonization and integration of
performance measurement,
accountability, and program evaluation;
(9) guides the collection and analysis of
performance and accountability data,
including Healthy People 2020, the
Program Assessment Rating Tool, the
Government Performance and Results
Act, and the American Recovery and
Reinvestment Act; (10) conducts
quarterly program reviews; (11)
supports assessment of program
effectiveness to guide further science,
policy, and programmatic efforts; (12)
provides financial support to conduct
both innovative program evaluations
and innovative methods for evaluating
programs; (13) manages evaluation
contracts; (14) guides performancebased strategic planning; (15) drives
short-term and long-term program
planning; (16) establishes routine,
continuous improvement based on
effective program evaluation, and
performance measurement; (17)
supports implementation of policy as
intervention; (18) supports evidencedriven program redesign; (19)
coordinates action planning for high
impact initiatives; and (20) develops,
promotes and coordinates new
initiatives.
Office of Women’s Health (CAF13).
The mission of the Office of Women’s
Health (OWH) is to provide leadership,
advocacy, and support for the agency’s
research, policy, and prevention
initiatives to promote and improve the
health of women and girls. As the
agency’s leader for women’s health
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issues, OWH: (1) Advises the CDC
Director and leads the Women’s Health
Workgroup in the advancement of
research, policies, and programs related
to the health of women and girls; (2)
provides leadership, assistance, and
consultation to the agency’s centers,
offices, and programs to address
women’s health issues; (3) advances
sound scientific knowledge, promotes
the role of prevention, and works to
improve the communication and
understanding of women’s health
priorities for public health action by
CDC and a diverse group of state and
local programs, providers, consumers,
and organizations; (4) creates, publishes,
and disseminates communicative
products and materials that highlight
CDC priorities, opportunities, and
strategies to improve health; (5)
establishes and fosters relationships
with others (i.e., government agencies,
professional groups, academic
institutions, organizations and small
businesses) to increase awareness and
strengthen implementation of women’s
health programs and practices; (6)
represents the agency and serves as a
liaison on women’s health issues within
and outside HHS; and (7) coordinates
and manages efforts through dialogues,
meetings, and other activities to
increase awareness of public health and
women’s health issues.
Dated June 6, 2010.
William P. Nichols,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–14424 Filed 6–16–10; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
[DHS Docket No. DHS–2009–0032]
Office for Civil Rights and Civil
Liberties; Guidance to Federal
Financial Assistance Recipients
Regarding Title VI Prohibition Against
National Origin Discrimination
Affecting Limited English Proficient
Persons
AGENCY: Office for Civil Rights and Civil
Liberties, DHS.
ACTION: Notice; proposed policy
guidance.
SUMMARY: The Department of Homeland
Security is publishing for public
comment proposed guidance to
recipients of Federal financial assistance
regarding Title VI’s prohibition against
national origin discrimination affecting
persons with limited English proficient
persons. This proposed guidance is
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]]>Agencies
[Federal Register Volume 75, Number 116 (Thursday, June 17, 2010)]
[Notices]
[Pages 34464-34465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14599]
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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: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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SUMMARY: The Food and Drug Administration (FDA) is providing
[[Page 34465]]
notice to correct the effective date of the memorandum of understanding
(MOU) between FDA and Drugs.Com that published in the Federal Register
of May 26, 2010 (75 FR 29561). The purpose of the cooperative program
is to extend the reach of FDA Consumer Health Information and to
provide consumers with better information and timely content concerning
public health and safety topics, including alerts of emerging safety
issues and product recalls.
DATES: The agreement became effective October 13, 2009.
FOR FURTHER INFORMATION CONTACT: Jason Brodsky, Consumer Health
Information Staff, Office of External Relations, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5378, Silver
Spring, MD 20993-0002, 301-796-8234, e-mail: Jason.Brodsky@fda.hhs.gov.
Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14599 Filed 6-16-10; 8:45 am]
BILLING CODE 4160-01-S
