Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov )

Components of Participating Organizations
This announcement is developed as an NIH Roadmap Initiative (http://nihroadmap.nih.gov). All NIH Institutes and Centers participate in roadmap initiatives. The announcement will be administered by the National Institute of Mental Health (NIMH) and the National Human Genome Research Institute (NHGRI) on behalf of the NIH.

Title:  Preapplication for the Molecular Libraries Probe Production Centers Network (MLPCN) [X02] 

Announcement Type
New

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-07-368

Catalog of Federal Domestic Assistance Number(s)
93.242, 93.310

Key Dates
Release/Posted Date: April 30, 2007
Opening Date:  May, 28, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: May 29, 2007
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date: June 28, 2007
Peer Review Date: August-September 2007
Council Review Date: Not Applicable
Earliest Anticipated Start Date: Not Applicable
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: June 29, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
         1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background: The NIH Roadmap, now administered by the NIH Office of Portfolio Analysis and Strategic Initiatives (OPASI), is a series of initiatives designed to pursue major new opportunities in biomedical research that cannot be addressed by any single NIH Institute or Center on its own, but that must be addressed by the agency as a whole.  The goal is to enable the rapid transformation of new scientific knowledge into tangible benefits for public health (http://nihroadmap.nih.gov/).  The Molecular Libraries and Imaging Initiative (MLI) is one of the components comprising the Roadmap theme of ‘New Pathways to Discovery,’ the goal of which is to build better tools to use in studying the many interconnected networks of molecules that comprise cells and tissues, their interactions, regulation, and the combination of molecular events that lead to disease.  The MLI will become the Molecular Libraries Program (MLP) in the production phase with the emphasis on probe discovery and development.

The Molecular Libraries Initiative was begun in FY 2004 to pilot a set of components aimed at developing selective and potent chemical probes for use in basic research.  The three main components were data production, data dissemination, and technology development.  Data production in the pilot phase involves  (a) the Molecular Libraries Small Molecule Repository (MLSMR) to establish and provide access to a unique and diverse library of compounds; (b) support of assay development under the Program Announcement "Solicitation of Assays for High Throughput Screening (HTS) in the Molecular Libraries Screening Centers Network, PAR-06-545 (R03) and PAR-06-259 (X01)”; and (c) the Molecular Libraries Screening Center Network (MLSCN) to implement assays provided  by the wider research community and generate chemical probes for the scientific community.  Data dissemination is supported by PubChem, the primary portal through which the screening and chemistry results of the MLSCN are made public.  Technology development supports advances in a number of aspects of the probe generation process, including: (a) “Assay Development for High Throughput Screening RFA-RM-07-008 (R21)” a program to support the development of bioassays in targeted areas of importance to scientific discovery and to rare and orphan diseases; (b) “Molecular Libraries Screening Instrumentation (RFA-RM-04-020)” to support the development of breakthrough instrumentation technologies and (c) the Cheminformatics Research Centers (CRCs) with multiple roles including high-level data analysis and dissemination with a focus on developing new understanding of cellular processes (genes and pathways). The FOAs (past and current) for these components can be found at http://nihroadmap.nih.gov/molecularlibraries.

In the pilot phase, the MLSCN comprises a collaborative network of nine extramural centers and one NIH intramural screening center.  Each screening center has implemented innovative HTS approaches to identify compounds that are active in target-based and phenotypic assays.  The MLSMR has acquired, at the time of this writing, and maintains a unique and diverse collection of 150,000 compounds obtained from both commercial and academic sources.  Active compounds identified through initial screening of the library are further developed within the MLSCN through a combination of structure-activity analysis and synthetic chemistry to obtain useful bioactive probes.  The centers have adopted an eleven-step process to provide consistent, high quality data on compound structures, screening data, and assay protocols publicly through the PubChem database (see chemical probe development path, https://mli.nih.gov/resources/MLPCN_X02_FAQ.htm). Information in PubChem is available to all researchers for use in biological and biomedical research studies (http://pubchem.ncbi.nlm.nih.gov/).

The MLSCN will undergo several strategic changes in the program for the production phase. In contrast to the ten centers of the pilot phase, that was organized around common principles, the Molecular Libraries Probe Production Centers Network (MLPCN), in the production phase, will be composed of different types of centers in order to provide improved handling of assays and enhanced chemistry support for the large number of active compounds identified by the screening centers.  Three types of centers have been identified to meet these challengesComprehensive Centers with the capability to screen 300-500K compounds against at least 25 assays per year and provide structure-activity relationship (SAR) analysis and support chemistry to identify potent and selective chemical probes; Specialized Screening Centers with the capability to provide expertise and experience in specific technologies needed to successfully implement complex and technically difficult assays that may not be amenable to HTS (e.g., high content screening, phenotypic assays, ion channel screening, whole organism screening); and Specialized Chemistry Centers with outstanding capabilities in applying medicinal and synthetic chemistry in order to advance early hits to chemical probe status.  As an integral part of the network, the Specialized Chemistry Centers will actively interact with both types of screening centers to generate probes. The integration of the probe pipeline, center cores and the overlapping roles of the comprehensive and specialized screening centers can be seen under “Center Infrastructure” at https://mli.nih.gov/resources/MLPCN_X02_FAQ.htm).

Objective of the program: The long-term goal of the MLP is to develop new small molecule tools that will contribute to the identification of molecular entities important to the maintenance of human health, and to accelerate the development of therapeutics.  The major programmatic goal is to establish a valuable community resource/repository for furthering research to benefit the public health. As a central component of the MLP, the MLPCN program will continue to offer HTS resources to the scientific community under its data sharing and Intellectual Property (IP) policies (see NIH Policy on Data Sharing and IP in the MLP, http://www.nimh.nih.gov/dnbbs/datasharing-ip.pdf).  These policies are designed to speed the dissemination of screening results and discovery of molecular research tools (e.g., ligands, imaging probes, and new activities of existing drugs) to the public sector for their immediate use. The MLP also intends to stimulate research in the following areas: 1) discovery of novel biological targets that can inform studies of cell function and disease mechanisms; 2) development, validation, and application of screening assays and disease models to evaluate the activities of novel small molecules; and 3) use of chemical genomic approaches to characterize the biology of genes of interest, cellular processes, and proteins associated with disease processes. (A complete set of defined terms used in this FOA can be found at “DEFINITIONS”, http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-017.html)

The NIH anticipates that the production phase of the MLPCN network will have sufficient capability to screen each year a minimum of 300-500K compounds in 100 assays that have been adapted for automated screening.  Thus, the specific goal of this announcement is to solicit pre-applications to participate in the network of the production phase MLPCN that, overall, will have the capabilities to:  1) implement a diverse array of both target-based and cell- phenotypic assays obtained from investigators in the public or private sector; 2) screen a large number of compounds in the MLSMR collection for biological activity in these assays; 3) provide synthetic chemistry to optimize screening hits into useful in vitro and/or in vivo biological probes; and 4) provide informatics support to track compounds, assays, and screening data, so that the MLPCN will be able to make all biological screening data, assay and reaction protocols freely available to the public through the PubChem database.

Scope and project period: The NIH expects to commit approximately $70 million to support 6-10 centers for a period of six years, (i.e. 2-4 comprehensive, high throughput centers, 2-3 high value targets, lower throughput specialized screening centers, and 2-3 specialized chemistry centers).  Continuation of the program beyond the initial 3-year project period will be determined by the outcome of an external scientific review of the overall MLP program, program priorities, and availability of funds.  Near the end of the six-year period, the MLPCN will implement a charge-back policy to recover some costs and to provide a gradual transition of the centers off of Roadmap funds. This aspect of the program does not have to be addressed in the X02 pre-application.

The application process has two steps:  Investigators interested in participating in the MLPCN must first submit a pre-application (X02), as described in this announcement.  This pre-application is not limited to the current MLSCN centers. The X02 pre-application will be subjected to peer review by a Special Emphasis Panel convened by NIMH and NHGRI.  No awards will be made under this announcement.  Successful applicants will then be invited to submit a full application for the anticipated January 4, 2008 submission date for a U54 cooperative agreement with an anticipated start date for funding of July 1, 2008.  It is expected that the PD/PI for the pre-application also will be the PD/PI of the U54 application.  The pre-application can be submitted by a single institution or by a consortium of institutions. Following that review, the NIH Roadmap Molecular Libraries Implementation Group (MLIIG, http://nihroadmap.nih.gov/molecularlibraries/members.asp) will invite successful applicants to submit a full U54 application.  Only applicants who have submitted a pre-application will be eligible to compete for the MLPCN.

The timeline for the program is given below.

June 28, 2007

Submission date for X02 pre-application

October 2007 

Invitations are made for full application

August-September, 2007 

Scientific merit review for pre-application

January 4, 2008

Submission date for U54 full application

March, 2008 

Scientific merit review for full application

May, 2008

National Advisory Council review of application

June 2008 

Awards announcement

July 1, 2008 

Starting date for the Production Phase of the MLPCN

Features of the MLPCN and Guidance for X02 Pre-applications

The planned capacity of the MLPCN is based on the number of screens anticipated to be performed in the last year of the MLSCN pilot program (~100).  As the upward trend in assay demand is expected to continue, it is anticipated that this level of capacity will be fully filled in the first year of the production phase.  It is important for applicants to note, however, that the MLSMR plans to increase the size of the screening library up to 500K compounds during the production phase.  Therefore, while the number of assays screened per year is anticipated to be constant, the scale of the work will increase substantially as the number of compounds to be screened per assay continues to grow. 

I. Comprehensive Screening Centers:  The Comprehensive Centers will provide rapid screening on a broad diversity of assays and detection platforms (e.g., enzymes/proteases, G-protein coupled receptors, kinases, cytotoxicity, protein-protein interactions, protein misfolding/degradation, high-content screening, transcription/expression, etc.).  These large, ultrahigh-throughput screening centers will contain all the necessary functions to take a project through the complete chemical probe development process from assay development to chemical synthesis of potent and selective probe compounds.  The key functionalities or cores required by these centers are: assay development, assay adaptation/implementation, HTS, informatics and chemistry.  A Comprehensive Center will be run under process management where production rate, program efficiency and costs will be carefully monitored by NIH program staff.  Each center is expected to screen a library of 300K-500K compounds per assay and to process 25 or more assays per year. A Comprehensive Center will be responsible for all three operational stages in the probe generation pipeline:

II. Specialized Screening Centers: Certain types of assays requiring multiple steps or specialized instrumentation (e.g., phenotypic imaging assays, multiplexing flow cytometry, ion channel assays) may not fit well in the comprehensive center format due to their special requirements and slower screening rates.  These assays are critically important in the identification of protein function in cells and signaling pathways, yet pharmaceutical companies will not run these assays because of their low throughput and questionable disease relevance. However, assays of this type are windows to important biological phenomena and are an important objective of the MLP. Therefore, the MLP has introduced the concept of Specialized Screening Centers in the production phase. These centers will be smaller in scope, intended to focus on a specific type of assay or platform, and expected to complete a limited number of assays per year (about 5).  These centers will have assay development, assay adaptation/implementation, screening and informatic functional cores.  They will accept assays from the scientific community, as well as generate their own assays.

III. Specialized Chemistry Centers: The “hit-to-probe” optimization stage in the probe development process may require special tools and expertise, resources that are frequently in short supply in a screening center.  Specialized Chemistry Centers will perform cheminformatics, synthetic medicinal chemistry and limited pharmacology to advance active compounds identified by the Specialized Screening Centers or, in some instances, in the Comprehensive Centers. It is essential that compounds identified as research tools for the investigation of particular targets and biological processes by the MLPCN are reliable and capable of providing valid information on the activity of their intended targets.  The probe compounds produced by the centers will need to be usable by the research community for in vitro and/or in vivo studies.  In most cases, compounds identified by initial screening (“hits”) will not be ideal as research tools.  It is likely that properties such as affinity, specificity, and solubility will need to be improved using the chemistry resources of the Specialized Chemistry Center.

The primary goal of the MLPCN is the production of chemical probes. The minimum characteristics that a probe compound will need to have to be a useful research tool will be determined by the MLPCN Steering Group and the NIH Project Team; it is anticipated that such characteristics will include <100 nM affinity, >10-fold selectivity against related targets, and solubility in aqueous solutions or in a low concentration of DMSO. Most importantly, a chemical probe must represent an improvement over existing probes for the designated target. NIH recognizes that whatever the characteristics of the probes, further modification may be necessary to produce compounds that are useful for in vivo studies.  For this reason, all probes, as well as the data and hits from which they are derived, will be made available to all researchers. 

Technical Assistance for the Application Process

A teleconference or video web cast will be held to provide technical assistance and will occur in May 2007 with further information posted in the NIH Guide and available at http://www.mli.nih.gov/.  Potential applicants will be able to participate in the technical assistance teleconference calls and to ask questions of program staff involved in managing this program. Applicants are encouraged to submit their questions or comments to MLPCN@mail.nih.gov in advance of the meeting. 

This announcement uses electronic submission via Grants.gov (http://www.grants.gov/) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT. The application process is substantially different than using the PHS 398 form. Applicants are strongly encouraged to learn about electronic submission at http://era.nih.gov/ElectronicReceipt/index.htm.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

The pre-application submitted in response to this announcement will not result in an award using any of the traditional NIH mechanisms. A highly meritorious pre-application will result in an invitation to submit a U54 application. For tracking purposes, each pre-application will be assigned a number that will use the X02 mechanism.

2. Funds Available

No grant monies are awarded for the X02 pre-application mechanism.  

For Future Related RFA:  Number of Centers and Funding Available to Each Center

2-4 Comprehensive Centers with a budget of up to $13 million total cost per year per center will collectively meet the anticipated aggregate demand of 75-100 assays per year.

4-6 Specialized Centers (Screening and Chemistry), with a budget of up to $3.5 million total cost per center per year, will specialize in either the first (screening/informatics) or second (chemistry/pharmacology) half of the probe development process. Examples of the types of lower-throughput, high-value screens a Specialized Screening Center could perform include those for complex cellular phenotypes that require high-resolution imaging techniques.  The Specialized Screening Centers are expected to meet the projected need of 10-20 such assays in aggregate per year. In an analogous way, Specialized Chemistry Centers will be funded to perform the cheminformatics, SAR and synthetic chemistry required to optimize the hits obtained from the screens run in either the Specialized Screening or, in some cases, Comprehensive Centers.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions


You may submit an application(s) if your institution/organization has any of the following characteristics:

Foreign institutions are not eligible to apply for a MLPCN center.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Foreign investigators can serve as a PD/PI on a core, a member, or consultant for a center.

2. Cost Sharing or Matching

Not applicable.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

An individual can participate as the PD/PI of the center in only one pre-application. There are no limits on the number of pre-applications that can be submitted by one organization.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact Grants Info: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan

Optional Components:
PHS398 Cover Letter File

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: May, 28, 2007 (Earliest date an application may be submitted to Grants.gov)
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Letters of Intent Receipt Date: May 29, 2007
Application Submission Date: June 28, 2007
Peer Review Date: September, 2007
Council Review Date: Not Applicable
Earliest Anticipated Start Date: Not Applicable

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Ingrid Y. Li, Ph.D.
NIH Molecular Libraries & Imaging Roadmap
National Institute of Mental Health, NIH
6001 Executive Boulevard, Room 7185, MSC 9641
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
FAX: (301) 402-4740:
Email: ili1@mail.nih.gov

Applicants are strongly encouraged to send the letter of intent by Email. Please do not submit the same letter by multiple routes (e-mail, FAX, or hard copy)

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this announcement, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

In order to expedite the review, applicants are requested to notify the NIMH Referral Office by email NIMHReferral@mail.nih.gov when the application has been submitted.  Please include the announcement number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions


Not applicable.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

Additional Instructions

General instructions for completing the SF424 components can be found in the Application Guide (http://grants2.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc ). Modifications to those instructions for this announcement are found below.

SF424 (R&R) Cover Component

1. Type of Submission. Check the pre-application box. If this submission is to change or correct a previously submitted application, click the Changed/Corrected Application box and enter the Grants.gov tracking number in the Federal Identification field.

16. Estimated Project Funding. Enter 0 in boxes a, b, and c.

20. Pre-Application. Do NOT attach the summary description at this line.

SF424 Research & Related Other Project Information

1. Are Human Subjects Involved? Check no even if human subjects will be used in some of the applications that will be part of the consortium.

2. Are Vertebrate Animals Used? Check no even if vertebrate animals will be used in some of the applications that will be part of the consortium.

9. Facilities and Other Resources.  Specify the resources for each of the functional cores. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed MLPCN program. As appropriate, briefly describe available resources, such as equipment, cell culture facilities, laboratory facilities, participating and affiliated units, geographical distribution of space and personnel, and consultative resources.

SF424 Senior/Key Person Profiles

Provide a profile for the PD/PI of the full U54 cooperative agreement application, the PD/PI of each core, the Program Manager, and for any other key personnel proposed. Profiles should also be presented for other senior/key persons who are part of the center but who are not PIs. If there are more than 8 profiles, appropriate templates can be found at http://grants.nih.gov/grants/funding/424/index.htm in the Addition Format Pages section. For the PI of the X02, the Project Role should be assigned as “PD/PI”. For all other personnel, please select “Other” under Project Role, and complete the Other Project Role Category to indicate that person’s role on the center project. For these individuals, “PI of linked application” would be an appropriate designation under Other Project Role Category.

It is expected that the proposed center will have a PD/PI for each of the functional cores and a Program Manager. The purpose of center management is to provide coordination and project management to the center.

PHS398 Cover Page Supplement

2. Human Subjects. Check no to both the Clinical Trial and Agency-Defined Phase III Clinical Trial questions.

4. Human Embryonic Stem Cells. Check no even if human embryonic stem cells will be used in some of the applications that will be part of the center.

PHS398 Research Plan Component for the X02 Preapplication

In order to ensure an effective review, the application should be clearly laid out and well organized. In particular, the main functions/center cores identified earlier in the announcement (Assay Development, Assay Adaptation/Implementation, HTS, Informatics and Chemistry) must be clearly addressed. The number of functional cores is determined by the type of center specified in the pre-application (see MLPCN Centers; http://mli.nih.gov/resources/MLPCN_X02_FAQ.htm).

Specific Instructions:

Applicants must construct the Research Plan component as a single document (a total of 15 pages for Specialized Centers and a total of 25 pages for Comprehensive Centers (both, including the Overview), with a maximum of 5 pages for each core).  Attach the single PDF document under 2. Research Plan Attachments, Number 5. Research Design and Methods. It is recommended that the Research Plan be divided into sections corresponding to the center cores. One of the cores should address Administration and Management, Cost Sharing, and Data Sharing.

OVERVIEW/SPECIFIC AIMS/BACKGROUND AND SIGNIFICANCE (2-5 pages). Clearly identify the type of center the applicant will be requesting funding for (Comprehensive Center, Specialized Screening Center, or Specialized Chemistry Center).  Provide an overview of the proposed center and describe how the overall center can contribute to the MLPCN Research Network to achieve the overall goals of the MLP, and list milestones for the first year of the program.  In subsequent years, milestones will be defined each year in negotiation with NIH program staff. (This section should address the data sharing, governance, willingness to collaborate with the MLSMR, assay provider, other centers, etc.). Specific Aims of Overall Center:  Describe the center type and goals.  Describe how the overall center can contribute to the MLPCN Research Network to achieve the overall goals of the Molecular Libraries Initiative.  Explain the proposed contribution of each of the functional units in achieving the objectives of the center. The Overview must contain a Summary Table with all of the functional cores that are expected to be in the future Center application.

OVERVIEW Progress Report:  Describe experience that the center has had in meeting milestones.  For centers that were funded as part of the MLSCN, describe milestones met and compliance with the MLP data sharing and IP policy. 

Each Center Core should contain the following.

Specific Aims.

The Comprehensive Screening Center should focus on a broad diversity of assays and detection platforms (e.g., enzymes/proteases, G-protein coupled receptors, kinases, cytotoxicity, protein-protein interactions, protein misfolding/degradation, high-content screening, transcription/expression, etc.), and be expected to complete a large number of assays per year (25 or more). In addition, a Comprehensive Center could focus on one or more major biological or disease areas, such as cancer, infectious diseases, or neurological disorders.  The major cores of these centers are assay development, assay adaptation/implementation, HTS, informatics and chemistry. Comprehensive Screening Centers are run under process management where production rate and costs are carefully monitored. 

The Specialized Screening Center should focus on assays and detection platforms that have special requirements and slower screening rates (e.g., phenotypic imaging assays, multiplexing flow cytometry, ion channels/transporters, yeast-based assays, and assays requiring a Biosafety Level 3 screening facility).  These assays are critically important in the identification of protein function in cells and signaling pathways.  Assays of this type are a principal objective of the Molecular Libraries Initiative and meeting this objective is the primary responsibility of the Specialized Screening Centers.  Smaller, and funded with smaller budgets, the specialized center would focus on a specific type of assay or platform and be expected to complete a limited number of assays per year (about 5).  They would contain assay development, assay adaptation/implementation, screening and informatics cores and accept assays from the scientific community as well as generate their own assays.

Specialized Chemistry Centers will perform the cheminformatics, medicinal and synthetic chemistry optimization required on the screens run in the Specialized Screening Centers and, in some cases, the Comprehensive Screening Centers.  In most cases, compounds identified by initial screening (“hits”) will not be ideal as research tools.  It is likely that properties such as affinity, specificity, and solubility will need to be improved before a useful compound is obtained.  Therefore, applicants should describe a plan for the provision of sufficient synthetic chemistry capability to generate a library of structurally related compounds (~100-300) around a confirmed hit and to test those compounds in the primary assay to identify derivatives with improved affinity, specificity and solubility.

Detailed descriptions of the three types of MLPCN centers can be found at https://mli.nih.gov/resources/MLPCN_X02_FAQ.htm.

Preliminary Studies.  The Preliminary Studies/Progress Report section of the Research Plan must contain data and information on a fully operational screening or probe development center. Applicants should describe the capabilities that they currently have to import a variety of assays from the scientific community and adapt them to a high throughput format. 

Research Designs and Methods.  Identify each proposed functional core by title and provide detailed information on each core, including results demonstrating existing production rates and established QC, QA standards. Describe the core’s activities, and how the key personnel will interact and coordinate with the other functional cores. Explain the proposed contribution of each of the functional cores in achieving the objectives of the center.

Human Subjects Sections. Do not include any attachments in sections 6-10 that deal with human subjects.

Vertebrate Animals. Do not use this attachment.

Consortium/Contractual Arrangements. Do not use this attachment.

Letters of Support. Include a letter documenting institutional commitment to the MLPCN program, including provision of funding, space, faculty positions, and/or commitments for construction or renovation.  A letter from an appropriate institutional official, generally a dean or provost, should follow the Research Plan. If multiple institutions are involved in the center application, a letter should come from each institution.

Appendix:  Do not include manuscripts submitted for publication. See NOT-OD-06-053

Publications:

For materials that cannot be submitted electronically or materials that cannot be converted to PDF format; (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Administrator for instructions following notification of assignment of the application to a study section. If the SRA is listed in the FOA, they should be contacted in advance to address acceptability of materials.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may be delayed in the review process.

Foreign Applications (Non-domestic (non-U.S.) Entity)

Not Applicable.

Plan for Sharing Research Data

During the pilot phase, the MLSCN developed a policy in consultation with the research community on data sharing and IP applicable to achieving the goals of the MLI (i.e., the NIH Policy on Data Sharing and IP in the MLP, http://www.nimh.nih.gov/dnbbs/datasharing-ip.pdf).  During the production phase, the NIH Project Team expects that the existing policies will be followed.  Consistent with such policy, all data generated by the MLPCN will be deposited into PubChem upon data verification. For this, the term “data” will include, but will not be limited to, assay descriptions, protocols and/or links to published assays implemented in the MLPCN; performance data for assays and compounds; primary data from HTS and data generated in the secondary screen (e.g., EC50s, IC50s, AC50s, counter screens); chemical structures, synthesis protocols, and/or links to published synthesis protocols for chemical analogs of hits, for probes, and the biological activity of analogs and chemical probes. PubChem is a public database through which the MLPCN data will be available to all researchers, in both the public and private sectors, for further use in studying biology and disease.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this pre-application announcement should include a sharing research resources plan addressing how unique research resources other than those addressed in the NIH Policy on Data Sharing and IP in the MLP (http://www.nimh.nih.gov/dnbbs/datasharing-ip.pdf) will be shared or explain why sharing is not possible.

During the production phase of the MLP, the NIH Project Team expects that the existing policies on data sharing and IP will be followed (see the NIH Policy on Data Sharing and IP in the MLP, http://www.nimh.nih.gov/dnbbs/datasharing-ip.pdf). Consistent with this policy, all data generated by the MLPCN will be deposited into PubChem upon data verification. For this, the term “data” will include, but will not be limited to, assay descriptions, protocols and/or links to published assays implemented in the MLPCN; performance data for assays and compounds; primary data from HTS and data generated in the secondary screens; chemical structures, synthesis protocols, and/or links to published synthesis protocols for chemical analogs of hits, for probes, and the biological activity of analogs and chemical probes.

All applicants must include a statement of willingness to abide by the NIH Data Sharing and IP in the MLP and include a plan for sharing any other types of research data in their application.  The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

The adequacy of the resources sharing plan and any related data sharing plans in meeting the programmatic goals will be considered by the NIH Project Team and MLIIG when making decisions about which X02 applicants will be invited to submit U54 applications.

Section V. Application Review Information


1. Criteria 

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Pre-applications that are complete and responsive to the announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened jointly by the National Institute of Mental Health and the National Human Genome Research Institute in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Because of the trans-NIH nature of the MLP and the NIH’s interest in providing probe development capability that can address a wide range of biomedical research interests, when making decisions about which centers will be invited to submit U54 applications, the NIH Roadmap Team will consider:

The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of the following criteria will be addressed and considered in assessing the pre-application, weighting them as appropriate.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Each Core will be assessed for the following:

Approach: Are the conceptual or framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? How effective is the overall organization of the cores in relation to the center's goals?  Will each core enhance collaborative and/or interdisciplinary research within the center and the wider research community?  Are procedures in place for quality control and quality assessment for assay and screening procedures? Are data management and support procedures developed sufficiently to allow tracking of compounds, assays, and screening data? 

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? What are the qualifications, experience, and commitment of the personnel involved in the cores? Does the PI have the scientific and organizational vision and experience to serve effectively as the center Director? Is there evidence of sufficient management capabilities for the center that include fiscal administration, procurement, property and personnel management, planning, and budgeting?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
What are the quality of the facilities or services provided by this functional unit (including procedures, techniques, and quality control)? Are facilities adequate for the overall functions of the center and to implement the goals of the MLP? Is there evidence for institutional commitment to the program, including provision of funding, space, faculty positions, and/or commitments for construction or renovation? Are the research environment and resources, including equipment and facilities, adequate?  Is there potential for interaction with scientists from other departments and components?

The overall application is assessed on the evaluation of the individual cores and the following criterion:

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the center have the potential for impact in automated screening and probe development? What is the effectiveness of the proposed center in meeting the goals of the Molecular Libraries Program?

2.A. Additional Review Criteria:

Not Applicable

2.B. Additional Review Considerations

Not Applicable

2.C. Sharing Research Data

The willingness of applicants to abide by the NIH Data Sharing and IP in the MLP ( http://www.nimh.nih.gov/dnbbs/datasharing-ip.pdf) and the reasonableness of the plan for sharing any other types of research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

The willingness of applicants to abide by the MLP guidance for data sharing will be considered by NIH staff in inviting X02 applicants to submit full U54 applications.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131).

Investigators responding to this pre-application announcement should include a sharing research resources plan addressing how unique research resources other than those addressed in the NIH Policy on Data Sharing and IP in the MLP (http://www.nimh.nih.gov/dnbbs/datasharing-ip.pdf) will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans in meeting the programmatic goals will be considered by NIH staff in inviting X02 applicants to submit full U54 applications.

3. Anticipated Announcement and Award Dates

After the peer review of the pre-application is completed, a written critique called a summary statement will be available on the NIH Commons, https://commons.era.nih.gov/commons/. Those applicants who will be invited to submit a full U54 MLPCN application will be notified by phone or e-mail no later than October, 2007.  Applicants who are not going to be invited to submit a full U54 application will be notified by e-mail.

Applicants who have concerns about the critique of their application must send their concerns to a program official no later than two weeks after the release of the summary statement. Since time will be short, e-mail is strongly preferred as the way to send your concerns to NIH. The two-week time period will allow the concerns to be considered by the Implementation Group when determining which teams will be invited to submit a full application. Summary statements will not be mailed to applicants, so applicants should make sure that they are monitoring the NIH Commons for the release of the summary statements. The contact information for concerns is:

Ingrid Li, Ph.D.
NIH Molecular Libraries & Imaging Roadmap
National Institute of Mental Health
6001 Executive Blvd, Room 7185, MSC 9641 
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
Fax: (301) 402-4740
Email: ili1@mail.nih.gov

Carson Loomis, Ph.D.
NIH Molecular Libraries & Imaging Roadmap
National Human Genome Research Institute, NIH
Division of Extramural Research
5635 Fishers Lane, Ste. 4076, MSC 9305
Bethesda, MD  20892-9306
Tel: 301-594-5936
Fax: 301-480-2770
Email:  LoomisC@mail.nih.gov

Section VI. Award Administration Information


1. Award Notices
Not Applicable

2. Administrative and National Policy Requirements

Not Applicable

3. Reporting

Not Applicable

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Ingrid Li, Ph.D.
NIH Molecular Libraries & Imaging Roadmap
National Institute of Mental Health
6001 Executive Blvd, Room 7185, MSC 9641 
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
Fax: (301) 402-4740
Email: ili1@mail.nih.gov

Carson Loomis, Ph.D.
NIH Molecular Libraries & Imaging Roadmap
National Human Genome Research Institute, NIH
Division of Extramural Research
5635 Fishers Lane, Ste. 4076, MSC 9305
Bethesda, MD  20892-9306
Tel: 301-594-5936
Fax: 301-480-2770
Email:  LoomisC@mail.nih.gov

2. Peer Review Contacts:

Yong Yao, Ph.D.
Scientific Review Branch
National Institute of Mental Health
6001 Executive Blvd, Room 6149, MSC 9608
Bethesda, MD 20892-9608
Rockville, MD 20852 (for overnight couriers)
Telephone: (301) 443-6102
Fax:(301) 402-0182
Email: yyao@mail.nih.gov

Rudy Pozzatti, Ph.D.
Office of Scientific Review
National Human Genome Research Institute
Building 31, Room B2B37, MSC 2032
Bethesda, MD 20982-2032
Telephone: (301) 402-0838
Fax: (301) 435-1580
Email: Rudy_Pozzatti@nih.gov

3. Financial or Grants Management Contacts:

Not Applicable

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles.  Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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