Incorporation of New Science Into Regulatory Decisionmaking Within the Center for Devices and Radiological Health; Public Meeting; Request for Comments, 67237-67238 [E9-30114]
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Federal Register / Vol. 74, No. 242 / Friday, December 18, 2009 / Notices
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program).
Dated: December 11, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E9–30123 Filed 12–17–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0575]
Incorporation of New Science Into
Regulatory Decisionmaking Within the
Center for Devices and Radiological
Health; Public Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD with NOTICES
ACTION: Notice of public meeting;
request for comments.
The Food and Drug Administration
(FDA) is announcing a public meeting
entitled: ‘‘Incorporation of New Science
Into Regulatory Decisionmaking Within
the Center for Devices and Radiological
Health.’’ The purpose of the public
meeting is to identify strategies and
means for incorporating new science
into the regulatory decisionmaking
process within the agency’s Center for
Devices and Radiological Health
(CDRH). New science may include novel
technologies or novel uses of existing
technologies, evolving information and
knowledge, or new methods to support
decisionmaking. FDA is seeking input
on a number of specific questions
regarding how CDRH should anticipate
and respond to new or evolving
scientific knowledge in a manner that is
consistent with our mission to protect
and promote the public health, and
requests comments on this topic.
Dates and Time: The public workshop
will be held on February 9, 2010, from
8 a.m. to 5 p.m. Persons interested in
attending the meeting must register by
5 p.m. on February 3, 2010.
Location: The public meeting will be
held at the Hilton Washington DC
North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877.
Contact Person: Maggie Dietrich, Food
and Drug Administration, Center for
Devices and Radiological Health, 10903
New Hampshire Ave., Bldg. 66, rm.
5449, Silver Spring, MD 20993–0002,
301–796–5094, FAX: 301–847–8510, email: maggie.dietrich@fda.hhs.gov.
Registration: Register online at https://
www.fda.gov/MedicalDevices/News
VerDate Nov<24>2008
17:33 Dec 17, 2009
Jkt 220001
Events/WorkshopsConferences/
default.htm (select the appropriate
meeting from the list). Provide complete
contact information for each attendee,
including name, title, affiliation,
address, e-mail, and telephone number.
Registration requests should be received
by February 3, 2010. Registration is free
and will be on a first-come, first-served
basis. Early registration is recommended
because seating is limited. FDA may
limit the number of participants from
each organization based on space
limitations. Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the public meeting will be provided
on a space-available basis beginning at
7 a.m.
If you need special accommodations
due to a disability, please contact
Maggie Dietrich (see Contact Person) at
least 7 days in advance.
Comments: FDA is holding this public
meeting to obtain information on a
number of specific questions regarding
how CDRH should anticipate and
respond to new or evolving scientific
knowledge in a manner that is
consistent with FDA’s mission to
protect and promote the public health.
The deadline for submitting comments
regarding this public meeting is
February 24, 2010.
Regardless of attendance at the public
meeting, interested persons may submit
written or electronic comments. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. Submit a single
copy of electronic comments or two
paper copies of any mailed comments,
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. Please also indicate the
specific question(s) addressed. (See
section II 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA’s CDRH uses science to guide
our regulatory decisions, including
those related to premarket approval or
clearance, postmarket oversight, and
compliance.
CDRH faces unique challenges in that
the products we regulate are constantly
changing, either through incremental or
disruptive advances. Simultaneously,
our understanding of the products we
oversee is subject to change as we obtain
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
67237
new scientific information or develop
new methods to assess existing data.
Given the ever-changing environment
in which we operate, CDRH’s regulatory
decisionmaking process must be able to
adapt as science evolves and as new
information emerges about the risks or
benefits of particular medical devices or
radiation-emitting electronic products.
For example, in some cases, new
information gathered about the riskbenefit profile of a device on the market
may justify requiring additional data on
similar types of devices during
premarket review, in order to provide
sufficient confidence in the product’s
safety and effectiveness. At the same
time, the center seeks to foster
innovation by providing industry with a
reasonable degree of predictability in
our regulatory pathways. Determining
the optimal way to anticipate and
respond to new science is an important
challenge, and the center seeks public
input on how to best address it.
CDRH has formed an internal Task
Force on Utilization of New Science in
Regulatory Decisionmaking to review
how the center uses science in our
regulatory decisionmaking process, and
to make recommendations for
enhancements. The principal goals of
the Task Force are: (1) To propose
systems that will allow CDRH to be
‘‘predictably adaptive’’ to new science;
and (2) to identify proactive steps that
CDRH can take to keep staff abreast of
new science and increase our technical
competence and analytic capability in
order to enhance our decisionmaking.
The notion of ‘‘predictable
adaptability’’ refers to having the
flexibility to appropriately respond to
changes in science, while doing so
through a reasonably consistent process.
Given that scientific knowledge is
continually changing, the model of
being ‘‘predictable’’ by always requiring
the same type and level of scientific
evidence to justify decisions will not
necessarily suffice. As the scientific
landscape changes, the kind of
information we need in order to make
well-supported decisions may change.
In the past, CDRH has sometimes
incorporated new science into our
regulatory decisionmaking on an ad hoc,
non-transparent basis. Such an
approach can result in inconsistent
regulatory expectations and less
predictable decisionmaking.
CDRH seeks to move toward a
different model of predictability:
Creating and adhering to clear
procedures for adapting to new science,
and applying a consistent rationale for
doing so in as timely and transparent a
manner as is appropriate and feasible. In
order to achieve this goal, the center
E:\FR\FM\18DEN1.SGM
18DEN1
67238
Federal Register / Vol. 74, No. 242 / Friday, December 18, 2009 / Notices
will need to identify how and when to
adapt to new science, with a full
consideration of the nature of the
science itself, public health
implications, and our statutory and
regulatory framework.
II. Public Meeting
As one step towards establishing the
center’s approach for incorporating new
science in regulatory decisionmaking,
CDRH will hold a public meeting to
discuss the issues the Task Force is
considering. The objective of the
meeting will be to hear input on these
issues from a broad range of external
constituencies, including industry
representatives, consumer and patient
advocates, academic experts, other
members of Government, and the
general public.
To focus the center’s strategies, CDRH
requests feedback related to the
following questions, which will serve as
the basis for discussion at the public
meeting:
sroberts on DSKD5P82C1PROD with NOTICES
A. Adapting to New Scientific
Information
(1) When CDRH gains new scientific
information about a particular product
or type of product, what should the
criteria be for changing CDRH’s
expectations of the evidence necessary
for pre- or postmarket regulatory
decisions, keeping in mind our mission
to protect and promote the public
health, as well as our statutory and
regulatory framework? What are
potential ‘‘triggers’’ for making such
changes?
(2) When such changes are warranted,
how should the center communicate
them to industry, consumers, and other
external constituencies? Should CDRH
have a new regulatory paradigm for
communicating with outside parties?
(3) When such changes are warranted,
how should CDRH apply them to
devices currently under review?
(4) When such changes are warranted,
how should CDRH apply them to
products currently on the market? For
example, how should CDRH treat ‘‘firstgeneration’’ products as new and
improved versions are developed?
B. Adapting to Novel Technologies or
Novel Uses of Existing Technologies
(1) Assessing the safety and
effectiveness of a novel technology can
be challenging because the extent of
information on and the level of
understanding of the technology’s riskbenefit profile or manufacturing process
is less mature than that of a technology
for which there is extensive ‘‘realworld’’ experience. What steps should
CDRH take to assure that novel
VerDate Nov<24>2008
17:33 Dec 17, 2009
Jkt 220001
technologies or novel uses of existing
technologies are safe and effective,
without creating barriers to innovation,
keeping in mind our statutory and
regulatory framework?
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
C. Enhancing CDRH’s Technical
Competence and Analytical Capability
[CMS–3221–N]
(1) With current resources, what
proactive steps should CDRH take to
address gaps in staff-members’
knowledge about new science and
reduce uncertainty in science-based
regulatory decisionmaking?
During the meeting, there will be a
moderated discussion between CDRH
staff and invited experts from the
private and public sectors about the
questions presented in this document.
The invited participants will not be
asked to develop consensus
recommendations, but rather to provide
their individual perspectives. The topics
for discussion will be presented in
conjunction with hypothetical case
studies for consideration. There will
also be an opportunity for general
attendees to provide feedback on the
discussion topics during periodic open
sessions.
In advance of the meeting, additional
information, including the case studies,
will be made available on the Internet.
This information will be placed on file
in the public docket (docket number
found in brackets in the heading of this
document), which is available at https://
www.regulations.gov. This information
will also be available on FDA’s Medical
Devices Web site at https://www.fda.gov/
MedicalDevices/NewsEvents/Workshops
Conferences/default.htm (select the
appropriate meeting from the list), along
with the agenda for the meeting.
Transcripts: Transcripts of the public
meeting may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public meeting at a cost of 10 cents per
page. A transcript of the public meeting
will be available on the Internet at
https://www.regulations.gov.
Dated: December 11, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and
Radiological Health.
[FR Doc. E9–30114 Filed 12–17–09; 8:45 am]
BILLING CODE 4160–01–S
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Centers for Medicare & Medicaid
Services
Medicare Program; Physician Quality
Reporting Initiative (PQRI): Listening
Session-February 2, 2010.
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
SUMMARY: This notice announces a
listening session to discuss the
Physician Quality Reporting Initiative
(PQRI). The purpose of the listening
session is to solicit input from
participating stakeholders on—
• The individual quality measures
and measures groups (for example,
suggestions for new measures groups or
suggestions for the composition of
existing measures group(s) being
considered for possible inclusion in the
proposed set of quality measures for use
in the 2011 PQRI program and;
• Key components of the design of
the PQRI program, such as possible
reporting mechanisms, reporting
periods, criteria for satisfactory
reporting, the group practice reporting
option, and public reporting of 2011
PQRI data.
Measure developers, eligible
professionals, professionals
associations, such as medical specialty
societies, and other interested
stakeholders are invited to participate,
in person or by teleconference.
The opinions and alternatives
provided during this meeting will assist
us as we evaluate the PQRI program for
2011. We anticipate posting a summary
of the individual quality measures and
measures groups for possible inclusion
in the proposed set of quality measures
as well as possible program design
options under consideration for use in
the 2011 PQRI program on the PQRI
section of the CMS Web site at https://
www.cms.hhs.gov/PQRI by January 18,
2010.
The meeting is open to the public, but
attendance is limited to space and
teleconference lines available.
DATES: Meeting Date: The listening
session will be held on Tuesday,
February 2, 2010 from 10 a.m. until 4:30
p.m. Eastern Standard Time (E.S.T).
Meeting Registration and Request for
Special Accommodations Deadline:
Registration opens on Monday,
December 21, 2009. For security
reasons, registration must be completed
no later than 5 p.m. E.S.T. on
Wednesday, January 27, 2010. Requests
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 74, Number 242 (Friday, December 18, 2009)]
[Notices]
[Pages 67237-67238]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30114]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0575]
Incorporation of New Science Into Regulatory Decisionmaking
Within the Center for Devices and Radiological Health; Public Meeting;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
meeting entitled: ``Incorporation of New Science Into Regulatory
Decisionmaking Within the Center for Devices and Radiological Health.''
The purpose of the public meeting is to identify strategies and means
for incorporating new science into the regulatory decisionmaking
process within the agency's Center for Devices and Radiological Health
(CDRH). New science may include novel technologies or novel uses of
existing technologies, evolving information and knowledge, or new
methods to support decisionmaking. FDA is seeking input on a number of
specific questions regarding how CDRH should anticipate and respond to
new or evolving scientific knowledge in a manner that is consistent
with our mission to protect and promote the public health, and requests
comments on this topic.
Dates and Time: The public workshop will be held on February 9,
2010, from 8 a.m. to 5 p.m. Persons interested in attending the meeting
must register by 5 p.m. on February 3, 2010.
Location: The public meeting will be held at the Hilton Washington
DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
Contact Person: Maggie Dietrich, Food and Drug Administration,
Center for Devices and Radiological Health, 10903 New Hampshire Ave.,
Bldg. 66, rm. 5449, Silver Spring, MD 20993-0002, 301-796-5094, FAX:
301-847-8510, e-mail: maggie.dietrich@fda.hhs.gov.
Registration: Register online at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate
meeting from the list). Provide complete contact information for each
attendee, including name, title, affiliation, address, e-mail, and
telephone number. Registration requests should be received by February
3, 2010. Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once they
have been accepted. Onsite registration on the day of the public
meeting will be provided on a space-available basis beginning at 7 a.m.
If you need special accommodations due to a disability, please
contact Maggie Dietrich (see Contact Person) at least 7 days in
advance.
Comments: FDA is holding this public meeting to obtain information
on a number of specific questions regarding how CDRH should anticipate
and respond to new or evolving scientific knowledge in a manner that is
consistent with FDA's mission to protect and promote the public health.
The deadline for submitting comments regarding this public meeting is
February 24, 2010.
Regardless of attendance at the public meeting, interested persons
may submit written or electronic comments. Submit written comments to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://www.regulations.gov. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, 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. Please also indicate the specific question(s)
addressed. (See section II 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's CDRH uses science to guide our regulatory decisions,
including those related to premarket approval or clearance, postmarket
oversight, and compliance.
CDRH faces unique challenges in that the products we regulate are
constantly changing, either through incremental or disruptive advances.
Simultaneously, our understanding of the products we oversee is subject
to change as we obtain new scientific information or develop new
methods to assess existing data.
Given the ever-changing environment in which we operate, CDRH's
regulatory decisionmaking process must be able to adapt as science
evolves and as new information emerges about the risks or benefits of
particular medical devices or radiation-emitting electronic products.
For example, in some cases, new information gathered about the risk-
benefit profile of a device on the market may justify requiring
additional data on similar types of devices during premarket review, in
order to provide sufficient confidence in the product's safety and
effectiveness. At the same time, the center seeks to foster innovation
by providing industry with a reasonable degree of predictability in our
regulatory pathways. Determining the optimal way to anticipate and
respond to new science is an important challenge, and the center seeks
public input on how to best address it.
CDRH has formed an internal Task Force on Utilization of New
Science in Regulatory Decisionmaking to review how the center uses
science in our regulatory decisionmaking process, and to make
recommendations for enhancements. The principal goals of the Task Force
are: (1) To propose systems that will allow CDRH to be ``predictably
adaptive'' to new science; and (2) to identify proactive steps that
CDRH can take to keep staff abreast of new science and increase our
technical competence and analytic capability in order to enhance our
decisionmaking.
The notion of ``predictable adaptability'' refers to having the
flexibility to appropriately respond to changes in science, while doing
so through a reasonably consistent process. Given that scientific
knowledge is continually changing, the model of being ``predictable''
by always requiring the same type and level of scientific evidence to
justify decisions will not necessarily suffice. As the scientific
landscape changes, the kind of information we need in order to make
well-supported decisions may change. In the past, CDRH has sometimes
incorporated new science into our regulatory decisionmaking on an ad
hoc, non-transparent basis. Such an approach can result in inconsistent
regulatory expectations and less predictable decisionmaking.
CDRH seeks to move toward a different model of predictability:
Creating and adhering to clear procedures for adapting to new science,
and applying a consistent rationale for doing so in as timely and
transparent a manner as is appropriate and feasible. In order to
achieve this goal, the center
[[Page 67238]]
will need to identify how and when to adapt to new science, with a full
consideration of the nature of the science itself, public health
implications, and our statutory and regulatory framework.
II. Public Meeting
As one step towards establishing the center's approach for
incorporating new science in regulatory decisionmaking, CDRH will hold
a public meeting to discuss the issues the Task Force is considering.
The objective of the meeting will be to hear input on these issues from
a broad range of external constituencies, including industry
representatives, consumer and patient advocates, academic experts,
other members of Government, and the general public.
To focus the center's strategies, CDRH requests feedback related to
the following questions, which will serve as the basis for discussion
at the public meeting:
A. Adapting to New Scientific Information
(1) When CDRH gains new scientific information about a particular
product or type of product, what should the criteria be for changing
CDRH's expectations of the evidence necessary for pre- or postmarket
regulatory decisions, keeping in mind our mission to protect and
promote the public health, as well as our statutory and regulatory
framework? What are potential ``triggers'' for making such changes?
(2) When such changes are warranted, how should the center
communicate them to industry, consumers, and other external
constituencies? Should CDRH have a new regulatory paradigm for
communicating with outside parties?
(3) When such changes are warranted, how should CDRH apply them to
devices currently under review?
(4) When such changes are warranted, how should CDRH apply them to
products currently on the market? For example, how should CDRH treat
``first-generation'' products as new and improved versions are
developed?
B. Adapting to Novel Technologies or Novel Uses of Existing
Technologies
(1) Assessing the safety and effectiveness of a novel technology
can be challenging because the extent of information on and the level
of understanding of the technology's risk-benefit profile or
manufacturing process is less mature than that of a technology for
which there is extensive ``real-world'' experience. What steps should
CDRH take to assure that novel technologies or novel uses of existing
technologies are safe and effective, without creating barriers to
innovation, keeping in mind our statutory and regulatory framework?
C. Enhancing CDRH's Technical Competence and Analytical Capability
(1) With current resources, what proactive steps should CDRH take
to address gaps in staff-members' knowledge about new science and
reduce uncertainty in science-based regulatory decisionmaking?
During the meeting, there will be a moderated discussion between
CDRH staff and invited experts from the private and public sectors
about the questions presented in this document. The invited
participants will not be asked to develop consensus recommendations,
but rather to provide their individual perspectives. The topics for
discussion will be presented in conjunction with hypothetical case
studies for consideration. There will also be an opportunity for
general attendees to provide feedback on the discussion topics during
periodic open sessions.
In advance of the meeting, additional information, including the
case studies, will be made available on the Internet. This information
will be placed on file in the public docket (docket number found in
brackets in the heading of this document), which is available at https://www.regulations.gov. This information will also be available on FDA's
Medical Devices Web site at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate
meeting from the list), along with the agenda for the meeting.
Transcripts: Transcripts of the public meeting may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public meeting at a cost of 10
cents per page. A transcript of the public meeting will be available on
the Internet at https://www.regulations.gov.
Dated: December 11, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-30114 Filed 12-17-09; 8:45 am]
BILLING CODE 4160-01-S
