[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4140-01-P