Defense Advanced Research Projects Agency and Food and Drug Administration Expanding In Vivo Biomarker Detection Devices Workshop, 79379-79381 [2010-31811]
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Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices
completely. Second, as initial testing, it
will allow FDA to assess the potential
effectiveness of messages and materials
in reaching and successfully
communicating with their intended
audiences. Testing messages with a
sample of the target audience will allow
FDA to refine messages while still in the
developmental stage. Respondents will
be asked to give their reaction to the
messages in either individual or group
settings. Third, as evaluative research, it
will allow FDA to ascertain the
effectiveness of the messages and the
distribution method of these messages
in achieving the objectives of the
message campaign. Evaluation of
campaigns is a vital link in continuous
improvement of communications at
FDA.
In the Federal Register of August 19,
2010 (75 FR 51271), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received comments
from two individuals and one trade
association. FDA acknowledges one
request for additional details on the
necessity and purpose of the
information to be collected, but notes
that comments were invited on FDA’s
request for a generic clearance related to
the formative testing of communications
about veterinary products and products
for animals. Under this generic
clearance, details of individual studies
(research questions, target audiences,
methodologies, and consultants) will be
tailored to specific communicationsrelated questions. For each study FDA
requests under this clearance, FDA will
provide OMB with these details on the
information collection. The
communication development process
will inform the purpose of the data
collection and the means by which the
data will be collected. For very early
message development, qualitative
research such as in-depth interviews or
focus groups will be appropriate. At
later communication development
stages, more quantitative data collection
would be more useful. FDA plans to use
the data collected under this generic
clearance to inform its communications
campaigns. The data will not be used for
the purposes of making policy or
regulatory decisions.
Audience targets are also informed by
the specific research question.
Nonetheless, FDA provided more
information by specifying some of the
groups more likely to be targeted in
tasks under this generic clearance,
including: Consumers, pet owners, large
animal producers, veterinarians, animal
distributors, pet shop owners,
stockyards staff and owners, abattoir
owners or staff, grocery meat
purchasers, agricultural extension
agents, and professors of food science
and related fields.
Furthermore, comments related to
ways to enhance the data collection and
to assess FDA’s estimate of burden
indicated that FDA should not limit
itself to in-house expertise. FDA
acknowledges that assistance may be
requested from experts in other
Government agencies. Depending on the
specific research question to be
addressed, FDA may consult experts in
the United States Department of
Agriculture and the United States
Environmental Protection Agency.
FDA received a comment relating to
the cruelty and sadism of animal testing.
In response to this comment, FDA notes
that its notice was for public comment
on data collection related to
communication studies. No animal
testing is involved.
FDA received a comment that made a
series of complaints against the Agency
unrelated to its notice for public
comment. Accordingly, those comments
are not addressed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 U.S.C. 393(d)(2)(D)
No. of
respondents
Annual frequency
per response
Total annual
responses
Hours per
response
Total
hours
Individual in-depth interviews ............................................
General public focus group interviews .............................
Intercept interviews: Central location ................................
Intercept interviews: Telephone 2 ......................................
Self-administered surveys .................................................
Gatekeeper reviews ..........................................................
Omnibus surveys ..............................................................
Total (general public) ........................................................
Veterinarian/scientific expert focus group interviews .......
360
288
200
2,000
2,400
300
1,200
............................
288
1
1
1
1
1
1
1
............................
1
360
288
200
2,000
2,400
300
1,200
..............................
288
.75
1.50
.25
.08
.25
.50
.17
............................
1.50
270
432
50
160
600
150
204
1,866
432
Total (overall) .............................................................
............................
............................
..............................
............................
2,298
1 There
2 These
are no capital costs or operating and maintenance costs associated with this collection of information.
are brief interviews with callers to test message concepts and strategies following their call-in request to an FDA Center 1–800
number.
Dated: December 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–31891 Filed 12–17–10; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
BILLING CODE 4160–01–P
jlentini on DSKJ8SOYB1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Defense Advanced Research Projects
Agency and Food and Drug
Administration Expanding In Vivo
Biomarker Detection Devices
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Mar<15>2010
17:18 Dec 17, 2010
Jkt 223001
PO 00000
Notice of public workshop.
Frm 00046
Fmt 4703
Sfmt 4703
The Food and Drug Administration
(FDA) is announcing the following
public workshop cosponsored with the
Defense Advanced Research Projects
Agency (DARPA): Expanding In Vivo
Biomarker Detection Devices Workshop.
The DARPA Defense Sciences Office
and the FDA Center for Devices and
Radiological Health (CDRH) are hosting
a workshop to discuss current state-ofthe-art and innovative research
opportunities in the area of in vivo
analytical devices capable of measuring
biomarkers that characterize normal
biological processes, pathologic
E:\FR\FM\20DEN1.SGM
20DEN1
jlentini on DSKJ8SOYB1PROD with NOTICES
79380
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices
processes, and pharmacologic
responses. In particular, this workshop
will focus on the technical challenges
for developing implanted or
continuously applied devices capable of
measuring and monitoring clinically
relevant molecular biomarkers (small
molecules, proteins, peptides, and
nucleic acids) to alert the user of the
need for clinical attention and/or to
inform the clinician with regard to
appropriate action.
Date and Time: The workshop will be
held on February 9, 2011, from 7:30 a.m.
to 5 p.m.
Location: The workshop will be held
at the Executive Conference Center at
Liberty Center, 4075 Wilson Blvd., suite
350, Arlington, VA 22203.
Contact: Jonathan Sackner-Bernstein,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
5410, Silver Spring, MD 20903, 301–
796–5420, e-mail: jonathan.sacknerbernstein@fda.hhs.gov; or Daniel
Wattendorf, Defense Advanced Research
Projects Agency, 3701 North Fairfax Dr.,
Arlington, VA 22203, 703–526–6630.
Administrative questions about the
workshop should be directed to the
attention of Ms. Jenifer Schimmenti
(jschimmenti@sainc.com).
Registration and Requests for
Presentations: Registration logistics will
be managed by DARPA according to
instructions posted on their Web site at
https://www.sa-meetings.com/
DARPA_FDA_Workshop (login:
DARPAFDA, password: arlington),
including instructions for registration
and presentation of previous or
potential research and development
capabilities consistent with the
workshop goals in order to facilitate
discussions. The deadline to submit
abstracts and requests for poster
presentations is listed on the DARPA
Web site. After the deadline posted, no
submissions will be considered.
If you need special accommodations
due to a disability, please contact Jenifer
Schimmenti (see Contact) at least 7 days
in advance.
Transcripts: There will not be a
transcription of this workshop.
SUPPLEMENTARY INFORMATION:
Currently available glucose
monitoring systems provide the most
developed approach to continuous
monitoring of a biomarker in real-time.
Despite FDA approval for human use
and extensive research and
development, these monitoring systems
exhibit several important limitations
including accuracy/precision,
durability, adaptability, and reliability.
For example, many of these
technologies are limited to detecting one
VerDate Mar<15>2010
17:18 Dec 17, 2010
Jkt 223001
biomarker (glucose) in real-time and the
approach cannot be used for the
detection of other classes of biomarkers
(e.g., nucleic acids), nor do they have
the capabilities for being multiplexed.
Additionally, these technologies also
require frequent secondary testing of
blood glucose levels to assure the
performance and accuracy of the device.
Such technical challenges limit the
ability to conveniently monitor health
status in real-time settings outside of the
patient-physician encounter. These
challenges are not isolated to
implantable/applied technologies.
Available in vitro tools are primarily
developed for intermittent
measurements, typically within a
clinical environment, and do not
account for biologic dynamics or
responses to environmental stimuli.
With accelerating advances in
genomics, epigenomics, transcriptomics,
proteomics, and microbiomics,
innumerable biomarkers could be
informative for the health/disease of
individuals and/or populations,
particularly when considering potential
exposure to allergens, infections, and
toxins. Owing to the typical paradigm
for development of diagnostic devices,
these next generation class of
biomarkers that function either as a
surrogate endpoint for efficacy or an
adverse response do not have their
clinical utility qualified in the realworld setting. Without a device to
accurately measure predictive
biomarkers either continuously or at an
acceptable interval, clinical utility may
be difficult to establish and translation
to accepted screening or diagnostic
testing may be impaired. Qualification
of biomarkers that inform an individual
to seek medical attention or guide a
medical provider toward an
intervention or clinical decision, within
the context of an implanted/applied
technology, is a priority.
DARPA and CDRH are seeking to
understand challenges and develop
technological advancements necessary
to enable in vivo medical devices for
biomarker detection. While glucose is a
critical biomarker, workshop interest
will focus broadly on technologies for
detection of next-generation biomarkers
including chemical biomarkers,
proteins, peptides, and nucleic acids.
The workshop will address the
challenges for developing in vivo
devices to clinically validate biomarkers
for disease screening, surveillance,
prediction of therapeutic response, or
prognosis, as well as the potential for
using an in vivo approach to measure
biomarkers for safety and effectiveness
of a therapy (metabolites, toxicity, or
surrogate endpoints) as part of a real-
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
time Phase 4 postmarketing
surveillance.
The workshop will not focus on the
discovery or identification of relevant
biomarkers or potential surrogates.
Instead, the workshop will focus on
critical topic areas and specific
technical challenges related to the
development of in vivo technologies
capable of biomarker detection.
We encourage you to address the
following specific technical challenges
related to development of in vivo
devices:
• Novel materials: Materials and
chemistries that can be safely applied
for continuous in vivo detection of
biomarkers, and do not induce/
stimulate a biological response (e.g.,
inflammation).
• Device design for analytical
validation: Methods for maximizing and
verifying accuracy, sensitivity,
specificity, reproducibility, and
reliability of in vivo biomarker detection
methods.
• Minimal invasiveness: Device
delivery methods and device size
reduction, to include issues related to
on-board versus external power,
communication, and processing.
• Maximum duration: Operational
lifetime of the implanted device to
include overcoming bio-fouling,
enhanced biocompatibility, and
continuous versus periodic
measurements.
• Capacity to measure multiple
biomarkers simultaneously.
• Capacity to be rapidly adapted to
measure an emerging biomarker of
concern.
• Potential for using an in vivo
approach to clinically validate
biomarkers for disease screening,
surveillance, prediction of therapeutic
response, or prognosis.
Ideally, these challenges are within
the context of the following, as
summarized in the Institute of Medicine
(IOM) Evaluation of Biomarker and
Surrogate Endpoints in Chronic Disease
2010 Consensus Report (https://
books.nap.edu/
openbook.php?record_id=12869):
1. Analytical validation to assure
biomarker tests are reliable,
reproducible, and adequately sensitive
and specific.
2. Qualification to assure the
measurement methods can be correlated
to a clinical outcome of concern.
3. Utilization analysis to determine
that the biomarker used to develop the
technology is appropriate.
The goals of this workshop are to
define the current state-of-the-art and
innovative research opportunities and
challenges in developing such devices.
E:\FR\FM\20DEN1.SGM
20DEN1
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices
Participants are asked to submit an
abstract of no more than 250 words to
explain their research efforts and how
they specifically pertain to the
objectives of the Expanding In Vivo
Biomarker Detection Devices Workshop.
A workshop representative will contact
participants after abstract submission.
Dated: December 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–31811 Filed 12–17–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0030]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; FOLOTYN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
FOLOTYN and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:18 Dec 17, 2010
Jkt 223001
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product FOLOTYN
(pralatrexate). FOLOTYN is indicated
for the treatment of patients with
relapsed or refractory peripheral T-cell
lymphoma. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for FOLOTYN (U.S. Patent
No. 6,028,071) from Southern Research
Institute, Sloan-Kettering Institute for
Cancer Research, and SRI International,
and the Patent and Trademark Office
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
March 3, 2010, FDA advised the Patent
and Trademark Office that this human
drug product had undergone a
regulatory review period and that the
approval of FOLOTYN represented the
first permitted commercial marketing or
use of the product. Thereafter, the
Patent and Trademark Office requested
that FDA determine the product’s
regulatory review period.
FDA has determined that the
applicable regulatory review period for
FOLOTYN is 4,591 days. Of this time,
4,406 days occurred during the testing
phase of the regulatory review period,
while 185 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: March 2,
1997. The applicant claims January 31,
1997, as the date the investigational new
drug application (IND) became effective.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
79381
However, FDA records indicate that the
IND effective date was March 2, 1997,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: March 24, 2009.
The applicant claims March 23, 2009, as
the date the new drug application
(NDA) for Folotyn (NDA 22–468) was
initially submitted. However, FDA
records indicate that NDA 22–468 was
submitted on March 24, 2009.
3. The date the application was
approved: September 24, 2009. FDA has
verified the applicant’s claim that NDA
22–468 was approved on September 24,
2009.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,826 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by February 18,
2011. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by June 20, 2011. To meet its
burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
E:\FR\FM\20DEN1.SGM
20DEN1
]]>Agencies
[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79379-79381]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31811]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Defense Advanced Research Projects Agency and Food and Drug
Administration Expanding In Vivo Biomarker Detection Devices Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing the following
public workshop cosponsored with the Defense Advanced Research Projects
Agency (DARPA): Expanding In Vivo Biomarker Detection Devices Workshop.
The DARPA Defense Sciences Office and the FDA Center for Devices
and Radiological Health (CDRH) are hosting a workshop to discuss
current state-of-the-art and innovative research opportunities in the
area of in vivo analytical devices capable of measuring biomarkers that
characterize normal biological processes, pathologic
[[Page 79380]]
processes, and pharmacologic responses. In particular, this workshop
will focus on the technical challenges for developing implanted or
continuously applied devices capable of measuring and monitoring
clinically relevant molecular biomarkers (small molecules, proteins,
peptides, and nucleic acids) to alert the user of the need for clinical
attention and/or to inform the clinician with regard to appropriate
action.
Date and Time: The workshop will be held on February 9, 2011, from
7:30 a.m. to 5 p.m.
Location: The workshop will be held at the Executive Conference
Center at Liberty Center, 4075 Wilson Blvd., suite 350, Arlington, VA
22203.
Contact: Jonathan Sackner-Bernstein, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, rm. 5410, Silver Spring, MD 20903,
301-796-5420, e-mail: jonathan.sackner-bernstein@fda.hhs.gov; or Daniel
Wattendorf, Defense Advanced Research Projects Agency, 3701 North
Fairfax Dr., Arlington, VA 22203, 703-526-6630. Administrative
questions about the workshop should be directed to the attention of Ms.
Jenifer Schimmenti (jschimmenti@sainc.com).
Registration and Requests for Presentations: Registration logistics
will be managed by DARPA according to instructions posted on their Web
site at https://www.sa-meetings.com/DARPA_FDA_Workshop (login:
DARPAFDA, password: arlington), including instructions for registration
and presentation of previous or potential research and development
capabilities consistent with the workshop goals in order to facilitate
discussions. The deadline to submit abstracts and requests for poster
presentations is listed on the DARPA Web site. After the deadline
posted, no submissions will be considered.
If you need special accommodations due to a disability, please
contact Jenifer Schimmenti (see Contact) at least 7 days in advance.
Transcripts: There will not be a transcription of this workshop.
SUPPLEMENTARY INFORMATION:
Currently available glucose monitoring systems provide the most
developed approach to continuous monitoring of a biomarker in real-
time. Despite FDA approval for human use and extensive research and
development, these monitoring systems exhibit several important
limitations including accuracy/precision, durability, adaptability, and
reliability. For example, many of these technologies are limited to
detecting one biomarker (glucose) in real-time and the approach cannot
be used for the detection of other classes of biomarkers (e.g., nucleic
acids), nor do they have the capabilities for being multiplexed.
Additionally, these technologies also require frequent secondary
testing of blood glucose levels to assure the performance and accuracy
of the device. Such technical challenges limit the ability to
conveniently monitor health status in real-time settings outside of the
patient-physician encounter. These challenges are not isolated to
implantable/applied technologies. Available in vitro tools are
primarily developed for intermittent measurements, typically within a
clinical environment, and do not account for biologic dynamics or
responses to environmental stimuli.
With accelerating advances in genomics, epigenomics,
transcriptomics, proteomics, and microbiomics, innumerable biomarkers
could be informative for the health/disease of individuals and/or
populations, particularly when considering potential exposure to
allergens, infections, and toxins. Owing to the typical paradigm for
development of diagnostic devices, these next generation class of
biomarkers that function either as a surrogate endpoint for efficacy or
an adverse response do not have their clinical utility qualified in the
real-world setting. Without a device to accurately measure predictive
biomarkers either continuously or at an acceptable interval, clinical
utility may be difficult to establish and translation to accepted
screening or diagnostic testing may be impaired. Qualification of
biomarkers that inform an individual to seek medical attention or guide
a medical provider toward an intervention or clinical decision, within
the context of an implanted/applied technology, is a priority.
DARPA and CDRH are seeking to understand challenges and develop
technological advancements necessary to enable in vivo medical devices
for biomarker detection. While glucose is a critical biomarker,
workshop interest will focus broadly on technologies for detection of
next-generation biomarkers including chemical biomarkers, proteins,
peptides, and nucleic acids. The workshop will address the challenges
for developing in vivo devices to clinically validate biomarkers for
disease screening, surveillance, prediction of therapeutic response, or
prognosis, as well as the potential for using an in vivo approach to
measure biomarkers for safety and effectiveness of a therapy
(metabolites, toxicity, or surrogate endpoints) as part of a real-time
Phase 4 postmarketing surveillance.
The workshop will not focus on the discovery or identification of
relevant biomarkers or potential surrogates. Instead, the workshop will
focus on critical topic areas and specific technical challenges related
to the development of in vivo technologies capable of biomarker
detection.
We encourage you to address the following specific technical
challenges related to development of in vivo devices:
Novel materials: Materials and chemistries that can be
safely applied for continuous in vivo detection of biomarkers, and do
not induce/stimulate a biological response (e.g., inflammation).
Device design for analytical validation: Methods for
maximizing and verifying accuracy, sensitivity, specificity,
reproducibility, and reliability of in vivo biomarker detection
methods.
Minimal invasiveness: Device delivery methods and device
size reduction, to include issues related to on-board versus external
power, communication, and processing.
Maximum duration: Operational lifetime of the implanted
device to include overcoming bio-fouling, enhanced biocompatibility,
and continuous versus periodic measurements.
Capacity to measure multiple biomarkers simultaneously.
Capacity to be rapidly adapted to measure an emerging
biomarker of concern.
Potential for using an in vivo approach to clinically
validate biomarkers for disease screening, surveillance, prediction of
therapeutic response, or prognosis.
Ideally, these challenges are within the context of the following,
as summarized in the Institute of Medicine (IOM) Evaluation of
Biomarker and Surrogate Endpoints in Chronic Disease 2010 Consensus
Report (https://books.nap.edu/openbook.php?record_id=12869):
1. Analytical validation to assure biomarker tests are reliable,
reproducible, and adequately sensitive and specific.
2. Qualification to assure the measurement methods can be
correlated to a clinical outcome of concern.
3. Utilization analysis to determine that the biomarker used to
develop the technology is appropriate.
The goals of this workshop are to define the current state-of-the-
art and innovative research opportunities and challenges in developing
such devices.
[[Page 79381]]
Participants are asked to submit an abstract of no more than 250 words
to explain their research efforts and how they specifically pertain to
the objectives of the Expanding In Vivo Biomarker Detection Devices
Workshop. A workshop representative will contact participants after
abstract submission.
Dated: December 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-31811 Filed 12-17-10; 8:45 am]
BILLING CODE 4160-01-P
