[Federal Register Volume 73, Number 132 (Wednesday, July 9, 2008)]
[Notices]
[Pages 39322-39323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15560]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP); Request for Information (RFI):
High Throughput Screening (HTS) Approaches for Toxicology
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Request for Information (RFI) and notice of public meeting.
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SUMMARY: This notice is for planning purposes only. It does not
constitute a solicitation or Request for Proposal (RFP), nor does it
restrict the Government as to the ultimate acquisition approach. The
Government does not intend to award a contract on the basis of this RFI
or to otherwise pay for the information solicited. Any contract that
might be awarded based on information received or derived from this RFI
will be the outcome of the competitive process. Any purchases that
might result from information received or derived from this RFI will be
at the discretion of the Government.
Purpose: To ensure development of a rigorous and comprehensive
battery of HTS assays, the NTP seeks information and comments on the
identification and selection of critical cellular toxicity pathways for
interrogation in cell-based high throughput screens. The NTP is also
interested in receiving recommendations on particular molecular targets
within these critical cellular toxicity pathways that are most
informative for profiling the pathways, both in cell-based and
biochemical assay formats. In addition to information on cellular
pathways and targets, the NTP seeks information on technologies and
assay systems that might be used in the development of a comprehensive
approach to high throughput toxicity screening.
Responses to RFI: The Government requests a brief (no more than 1
page) description of the proposed presentation addressing one or more
of the points listed below or other directly related topics. In
considering responses to this RFI, please keep in mind the assay
protocol requirements for assays run at the NIH Chemical Genomics
Center (NCGC) (http://www.ncgc.nih.gov/guidance/HTS_Assay_Guidance_Criteria.html ).
Recommendations on the identification and selection of
critical cellular pathways involved in toxicity and associated with a
phenotypic manifestation of toxicity in vivo (disease outcome).
Information on assays that can be used to measure the
activity of a compound on a target within a critical pathway.
Information on the selection of the best targets within
pathways and networks in order to accurately and fully characterize the
activity of a compound within a specific pathway or the ability of a
compound to trigger a stress-responsive pathway resulting in a defined
toxicity or disease.
Information on assays, technologies, or methods that will
aid in identifying compounds which are active only after metabolic
activation.
New technologies or technologies under development that
can be exploited in HTS programs, such as those underway at the NCGC or
as secondary, targeted, follow-up testing to expand and more carefully
characterize the findings from initial screens.
All responses should include the following information: Company
name, company address, name of presenter, telephone number, and e-mail
address. Responses should be submitted by August 11, 2008, either
electronically via the meeting Web site or by fax, e-mail, or mail to:
Jennifer Smith, Contract Specialist, NIEHS, P.O. Box 12874, Mail Drop
EC-02, 79 T.W. Alexander Drive, Building 4401, Room 134, Research
Triangle Park, NC 27709; fax: 919-541-2712; e-mail:
[email protected]. Responses will be reviewed to ensure that the
Government, by extending an invitation to a party to participate in the
RFI meeting, will receive information directly relevant to its HTS
program for toxicity assessment and that the party fully understands
the nature of the meeting and the type of information sought.
Acknowledgement of receipt of responses will not be made nor will
respondents be notified of the Government's assessment of the
information received. No basis for claims against the Government shall
arise as a result of a response to this request for information or in
the Government's use of such information as either part of its
evaluation process or to develop specifications for any subsequent
announcement. Responses will not be returned. The summarized responses
(without identifiers) may appear in internal reports or be made
[[Page 39323]]
public. Although the NIH will provide safeguards to prevent the release
of identifying information, there is no guarantee of confidentiality.
Attendance and Registration: An informational public meeting will
be held on September 11-12, 2008, at the National Institute of
Environmental Health Sciences, 111 T.W. Alexander Drive, Research
Triangle Park, NC 27709. Attendance at the meeting is limited only by
the available space. The purpose of this meeting is for interested
parties to provide the Government information about assays, molecular
targets, and cellular pathways through brief presentations and a
question and answer session.
Parties interested in making a presentation at the meeting must
register on the meeting Web site: (http://ntp.niehs.nih.gov/go/32908).
Attendees not making presentations are also encouraged to register at
the Web site for planning purposes. The Government anticipates that
registered presenters will be allotted 20 minutes each for
presentations (limit of one speaker per organization); however, the
Government retains the right to limit the number of presentations and/
or limit the allotted time for presentations based upon the number of
registered presenters. Presenters will be notified about the scheduled
order of presentations and the list of presenters will be posted on the
meeting Web site at least one week prior to the meeting. It is
anticipated that the meeting will include time for questions and
information exchange. The slides from the presentations may appear in
internal reports or be made public. Further information will be made
available on the meeting Web site. Persons needing interpreting
services in order to attend should contact 301-402-8180 (voice) or 301-
435-1908 (TTY). For other special accommodations while on NIEHS campus,
contact 919-541-2475 or e-mail [email protected].
DATES: The informational public meeting will be held on September 11-
12, 2008. Registration deadline for presenters is August 11, 2008. The
number of registered presenters will be limited to approximately 25.
The date for submission of the 1-page description of the presentation
is also August 11 (see ``Responses to RFI''). Non-presenters may
register online through September 9, 2008, or until capacity is
reached.
Contact Information: Questions regarding RFI submissions should be
directed to Jennifer Smith, Contract Specialist, at 919-541-0424 or e-
mail [email protected]. Questions and answers will be posted on the
NTP Web site http://ntp.niehs.nih.gov/go/32908 as a resource to all
prospective participants (any identifying information will be removed
before posting). Questions regarding meeting registration and agenda
should be directed to Kristine Witt, 919-541-2761 or e-mail
[email protected].
Background
The National Toxicology Program (NTP) in facilitating the ``Roadmap
for the 21st Century'' (available at http://ntp.niehs.nih.gov/go/vision) is interested in identifying or developing rapid, mechanism-
based predictive screening assays for use in toxicity determinations.
Through its High Throughput Screening (HTS) Initiative (http://ntp.niehs.nih.gov/go/hts), the NTP is collaborating with the U.S.
Environmental Protection Agency (EPA) ToxCast Program (http://epa.gov/ncct/toxcast/) and the National Human Genome Research Institute's NIH
Chemical Genomics Center (NCGC) (http://www.ncgc.nih.gov/index.html )
to investigate the application of HTS approaches for defining toxicity
profiles of environmental compounds to use in hazard identification and
risk assessment.
Dated: June 27, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E8-15560 Filed 7-8-08; 8:45 am]
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