Part I Overview Information

 

United States Department of Health and Human Services (HHS)

 

Issuing Organization

 

Agency for Toxic Substances and Disease Registry at www.atsdr.cdc.gov

 

Participating Organizations

 

Agency for Toxic Substances and Disease Registry, at www.atsdr.cdc.gov

Components of Participating Organizations

 

Division of Toxicology and Environmental Medicine (DTEM/ATSDR), at www.atsdr.cdc.gov

 

Title:  Program for Computational Toxicology Methods to Assess Health Effects from Exposures to Hazardous Substances (U01)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may differ from those used by the HHS National Institutes of Health (NIH).  If a CDC policy does not exist to cover an applicable topic, or is in the process of being drafted, then for purposes of this announcement, the NIH policy is hereby adopted by CDC and will be applicable to that particular topic.  In addition, if written guidance for completing this application is not available on the CDC website, then applicants will be directed elsewhere for that information

 
Authority. This program is authorized under Sections 104(i)(5)(A) and (15) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) : 42 U.S.C. Sections 9604(i)(5)(A) and (15).

 

Announcement Type: This is a new cooperative agreement announcement.

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance may 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. 

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, 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.

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see “Key Dates” below.)

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number: RFA-TS-07-002

Catalog of Federal Domestic Assistance Number(s):  93.206
Human Health Studies - Applied Research and Development

 

Key Dates

 

Release/Posted Date:
Letter of Intent Receipt Date:  June 8, 2007
Application Submission Receipt Date:  June 25, 2007
Peer Review Date:  July 2007
Council Review Date(s): . August 2007

Earliest Anticipated Start Date(s):  September 1, 2007

Expiration Date: 61 days after publication

 

Due Date for E.O. 12372

 

Due no later than 60 days after the application receipt date.

 

Additional Overview Content

Executive Summary

• This FOA solicits investigator-initiated (U01 cooperative agreement) applications from applicant organizations that propose to develop expanded computational models and model parameters to assess the human health risks from exposures to toxic chemicals in the environment.
• The Agency for Toxic Substances and Disease Registry (ATSDR) intends to commit a total of $110,000 to this RFA/PAR for payment of applications responsive to this announcement statement regarding the total amount to be awarded.
• Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The anticipated number of awards to be issued under this FOA is 1.  Approximate Average Award: $ 110,000.
• Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the activity code, quality, duration, and costs of the applications received.
• The budget period will start in September 2007 and will last for 12 months and the project period will be for 5 years (FY 2007 – FY 2012).
• Eligible Organizations:  Eligible applicants are States or state organizations and political divisions thereof, or their bona fide agents, such as state universities, state colleges, and state research institutions.  A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state government, you must provide a letter from the state as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.
• Eligible Project Directors/Principal Investigators (PD/PIs): Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.
• See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites:  http://grants1.nih.gov/grants/funding/424/SF424 RR Guide General.doc (MS Word);  http://grants1.nih.gov/grants/funding/424/SF424 RR Guide General.pdf  (PDF)
• Grants.gov Application Guide SF424 (R&R) - MS Word ; or Grants.gov Application Guide SF424 (R&R) - PDF
• For general information on SF424 (R&R) Application and Electronic Submission, see the following Web sites: SF424 (R&R) Application and Electronic Submission Information; http:/grants.nih.gov/grants/funding/424/index.htm; General Information on Electronic Submission of Grant Applications: http://era.nih.gov/Electronic Receipt/
• HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783. 

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

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(s) 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. Receipt and Review and Anticipated Start Dates
            1. Letter of Intent
        B. Submitting an Application to CDC
        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

            1. Recipient Rights and Responsibilities
            2. HHS/CDC Responsibilities
            3. Collaborative Responsibilities

    3. Reporting

Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

 

Section I. Funding Opportunity Description

 

1. Research Objectives

 

The ATSDR within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority area(s) Goal 8 - Promote Health for all Through a Healthy Environment, Objective 8.12 Minimize the Risks to Human Health and the Environment posed by Hazardous Sites and is in alignment with ATSDR performance Goal 2 - Determine Human Health Effects Associated with Exposures to Superfund-Related Priority Hazardous Substances. For more information, see www.whitehouse.gov/omb/mgmt-gpra/ and www.health.gov/healthypeople and, http://www.atsdr.cdc.gov/

 

In addressing its public health mission under CERCLA, as amended, ATSDR has the responsibility to evaluate the relationship between exposures to hazardous substances and adverse human health effects.  However, this relationship between exposures to hazardous substances and adverse health effects is complicated and difficult to evaluate.

 

Humans are exposed daily to chemicals in their environment, mostly as mixtures.  Exposures to chemicals may occur through the use of consumer products or in processed foods that are considered to be at safe concentrations or without harm.  Exposures to chemicals in other scenarios, e.g., accidental spills of hazardous substances or hazardous substances found at waste sites, may occur at potentially harmful levels.  

 

Assessing the human health risk associated with exposure to chemicals in such instances may rely on a number of assumptions, estimates, and rationalizations.   It may be necessary to estimate health risk by extrapolating from conditions in the studies that provide evidence of toxicity to the conditions of exposure that can occur in the environment.  For risk assessments based on animal data, the most obvious extrapolation is estimating toxicity in humans from the tested animal species.  However, other extrapolations may also be required, e.g., estimating low dose effects from results with high doses, predicting effects from one exposure route to another, and from one duration of exposure to another. 

 

Computational modeling tools provide a powerful approach for increasing the reliability of these extrapolations.  Models enable the scientific community to address these gaps in knowledge without the expense of extensive experimental  animal studies.  Thus, the ATSDR Computational Toxicology Lab (CompTox Lab) uses tools such as Structure Activity Relationship/Physiologically-Based Pharmacokinetic (SAR/PBPK) models to examine the impact of exposure to hazardous substances and environmental chemicals on human health.  By integrating these approaches, the dose, route, and length of exposure associated with chemical exposure hazards can be evaluated. 

 

Additionally, innovative tandem application of these approaches can be used to assess differences in health outcome from exposure to hazardous substances and chemicals as a function of age/gender. These models can be used to fill a research need or data gap on effects from the dose or route, of toxic chemical exposure or the effects among differing species/age in the absence laboratory experimental data. To date, several priority data needs for the ATSDR Substance-Specific Applied Research program have been filled through the use of SAR/PBPK modeling.

 

The ultimate aim of using PBPK modeling in risk assessment is to provide a measure of dose that better represents the biologically effective dose, which is the dose that causally relates to the adverse health outcome.  The improved dose metric can then be used in place of traditional dose metrics (such as concentration or exposure dose) in an appropriate dose-response model to provide a more accurate estimation of the human exposure conditions of concern.  Implicit in any application of pharmacokinetics to risk assessment is the assumption that the toxic effects can be related to the concentration of an active form of the substance in the relevant target tissue.

 

In recent years, communities, particularly in populations living in the vicinity of hazardous waste, have voiced concern that the impact of exposure to toxic chemicals, most often mixtures, has not been addressed thoroughly.   CERCLA and SARA mandate ATSDR to conduct research and develop methods to establish significant exposure levels and derive criteria so as to protect human health.  Additionally, through these efforts the agency addresses real life health risks posed by toxic chemicals through multiple routes and for cumulative exposures.

 

Limited experimental toxicity studies that are based on credible science and integrate well established innovative techniques have been supported under CompTox Lab. The program fully utilizes and integrates: (1) computational toxicology; (2) state-of-the-art experimental methods such as environmental genomics; (3) mechanistically-based, short-term toxicology studies; and (4) cellular and molecular biological methodologies.  The program meets the following critical requirements: (1) uses relatively simple, short-term, and inexpensive assays; (2) is based on the best science; (3) advances the understanding of mode and mechanisms of toxicity and interactions of environmental agents; and (4) broadens applicability or predictive capability of known methods.

 

 

The purpose of this program is to support independent investigator initiated research to develop expanded computational models to assess the human health risks from exposures to Superfund-related priority hazardous substances or other toxic chemicals in the environment.  Hazardous substances, as applies to this announcement, are those as defined by CERCLA. The list of priority hazardous substances found at CERCLA sites can be found at http://www.atsdr.cdc.gov/clist.html

 

In conducting research in this program, applicants are expected to accomplish the following objectives and work collaboratively with agency scientists.

 

Objectives :

 

• Evaluate the toxicity of individual priority chemicals, for multiple endpoints, using SAR/Quantitative Structure Activity Relationship (QSAR) models to support agency needs for site-specific health assessments, emergency response, and other exposure scenarios.

 

• Employ modeling capabilities using approaches to supplement and increase the interpretability of SAR models currently used by the agency Computational Toxicology and Methods Development Laboratory.

 

• Develop   and modify PBPK models for determining target organ/tissue dose under various exposure conditions at sites. 

 

• Incorporate available genomics information into PBPK models for determining the consequence of exposure in subpopulations that are potentially more susceptible to risks.

 

• Employ and modify, as needed models to predict individual risks under varying health conditions, e.g., disease states, age, body mass index, body burden of chemicals such as that reported in the National Health and Nutrition Examination Survey (NHANES) http://www.cdc.gov/nchs/nhanes.htm and the National Report on Human Exposure to Environmental Chemicals  http://www.cdc.gov/exposurereport/default.htm

 

• Develop integrated models that incorporate information from QSAR and or other computational tools to evaluate potential health risks from combined chemical exposures that occur often, e.g. at hazardous waste sites.

 

 

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

Section II. Award Information

 

1. Mechanism(s) of Support

 

This funding opportunity is a cooperative agreement for research and will use the U01 activity code.

 

The HHS/ATSDR U01 is a cooperative agreement assistance instrument. Under the cooperative agreement assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and HHS/ATSDR staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

The ATSDR intends to commit approximately $110,000 for direct and indirect cost dollars in FY2007 to fund 1 application. It is expected that the average award amount will be $110,000 to include direct and indirect costs. The amount is for the first 12-month budget period.  An applicant may request a project period of up to 5 years or 60 months.  An applicant may request up to $110,000 for the first 12-month budget period. The approximate total project period funded amount is $550,000 over 5 years.  The anticipated start date for new awards is September 1, 2007.

All estimated funding amounts are subject to availability of funds.

 

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

 

Although the financial plans of the ATSDR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information

 

1. Eligible Applicants

1.A. Eligible Institutions

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

Eligible applicants are states or state organizations and political subdivisions thereof, or their bona fide agents  

 

• State Public nonprofit organizations
• State Universities
• State Colleges
• State Research institutions
• State Political subdivisions of States (in consultation with States)

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status.  Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.

Failure to meet the stated eligibility criteria by the time of the application deadline will result in the return of the application without review. 

1. B. Eligible Investigators

 

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support.

  
2. Cost Sharing or Matching

 

Cost sharing or matching funds are not required for this research program.

 

3. Other-Special Eligibility Criteria

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

 

 

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions 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 the following:

·         Grants.gov, http://www.grants.gov/GetStarted

·         eRA Commons, http://era.nih.gov/ElectronicReceipt/preparing.htm

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

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

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

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already eRA Commons-registered, see the "List of Grantee Organizations Registered in eRA Commons.”
• Direct questions regarding the eRA Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time
  Email commons@od.nih.gov

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

• The individual designated as the PD/PI on the application must also be registered in the eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
• The PD/PI must hold a PD/PI account in the eRA Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
• This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the eRA Commons.
• Both the PD/PI and AOR/SO need separate accounts in the eRA Commons since both hold different roles for authorization and to view the application process.

Note that if a PD/PI is also an HHS 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 eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete 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 PGO TIMS: Telephone 770-488-2700, Email:  PGOTIM@cdc.gov

HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

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 (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC.

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, mandatory 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
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:

PHS398 Cover Letter File
Research & Related Sub award Budget Attachment(s) Form

• Note: While both budget components are included in the SF424 (R&R) forms package, the CDC U01 (activity code) uses ONLY the detailed Research & Related Budget for this FOA. (Do not use the PHS 398 Modular Budget.)
  
  
   

 

3. Submission Dates and Times

 

See Section IV.3.A for details

3. A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date: June 8, 2007

Application Submission Receipt Date(s): June 25, 2007

Peer Review Date (s): July 2007

Council Review Date (s): August 2007

Earliest Anticipated Start Date: September 1, 2007

3.A.1. Letter of Intent

 

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

·         Descriptive title of proposed research.

·         Name, address, and telephone number of the Principal Investigator.

·         Names of other key personnel.

·         Participating institutions.

·         Number and title of this funding opportunity.

 

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 ATSDR Program 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:

 

Gwendolyn Cattledge, Ph.D.
Scientific Review Administrator
National Center for Injury Control and Prevention

Center for Disease Control and Prevention

U.S. Department of Health and Human Services
4770- Buford Hwy, NE, Mailstop K-02
Atlanta, GA 30341
Telephone: (770) 488-4655
FAX: (770-488-4422
Email: GCattledge@cdc.gov

 

 

3. B. Submitting an Application to CDC

 

If the instructions in this announcement differ in any way from the SF424 (R&R) instructions, follow the instructions in this announcement.

 

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov.  Applicants will receive an e-mail notice of receipt from Grants.gov when HHS/CDC receives the application. 

 

All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time.  If HHS/CDC receives your submission after closing because of : (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee.  If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline. 

 

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.

 

Otherwise, HHS/CDC will not notify you upon receipt of your paper submission.  If you have a question about the receipt of your application, first contact your courier.  If you still have a question, contact the PGO-TIMS staff at: 770-488-2700.  Before calling, please wait two to three days after the submission deadline.  This will allow time for HHS/CDC to process and log submissions.

 

If submitting a paper application, it must be prepared using the 424 R&R instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and three signed photocopy(s) to the following address:

 

Technical Information Management Section – TS-07-002

CDC, Procurements and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Phone:  770-488-2700 EST

3. C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time on the application submission date(s) described above (Section IV.3.A.).  If HHS/CDC receives an application after that submission date 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.

·         If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, PGO, Technical Information Management Section, after two business days.

·         Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken.  Please remember that some warnings may not be applicable or may need to be addressed after application submission.

·         If the two day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.

·         If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the CDC late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment and must refer only to Commons errors and/or technical errors.

·         Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated will be evaluated for completeness and responsiveness by ATSDR and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.

 

There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons. 

The HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.

 

5. Funding Restrictions

 

All HHS/ATSDR awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS/PHS Grants Policy Statement.

 

Restrictions, which applicants must take into account while writing their budgets, are as follows:

 

• Funds relating to the conduct of research will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.

 

• Reimbursement of pre-award costs is not allowed.

6. Other Submission Requirements

 

Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI

 

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement.  If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.  If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately. 

 

Applicants’ research plan(s) should address activities they will conduct over the entire project period.

 

The HHS/ATSDR requires the PD/PI to fill in his/her eRA 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.

 

Research Plan Component Sections

 

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a. PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments. Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.

 

The following materials may be included in the Appendix:

Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

 

• Publications in press:  Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.
• Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.
• Manuscripts published but a publicly available online journal link is not available:  The entire article may be submitted electronically as a PDF attachment.
• Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.
• Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.

Do not to 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 not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.

Applicants should include in the research plan information to adequately describe the computational models with which they have experience with and their ability to access necessary data to modify, improve, or otherwise apply the model parameters.

 

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, whether or not any analytic tools will be provided, whether or not a data-sharing agreement will be required, and if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website through a data archive or enclave.) References to data sharing may also be appropriate in other sections of the application.

 

Data developed in the modification or improvement of computational models in the conduct of the research must be shared with the ATSDR for application to the assessment of human health risks from exposures to toxic substances at sites and elsewhere in the environment

 

 

Sharing Research Resources HHS/PHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the HHS/PHS Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by the HHS/ATSDR Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm.)  See Section VI.3. Reporting.

 

Section V. Application Review Information

 

1. Criteria

 

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

Scientific merit of the proposed project as determined by peer review

·         Availability of funds

·         Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by ATSDR in accordance with the review criteria stated below.

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

 

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score
• Receive a written critique; and
• Receive a second level of review by HHS/ATSDR from an appropriate national advisory council or board or group of senior science advisors.

 

• Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed in Section V.1. will be considered in making funding decisions.

 

The goals of HHS/ATSDR-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness. In the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them as appropriate for each application. 

 

• Significance
• Approach
• Innovation
• Investigators
• Environment

 

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.

Significance: Does this study address an important problem? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical 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?

 

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 investigators 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 investigative team bring complementary and integrated expertise to the project (if applicable)?

 

Environment: Does the scientific environment in which the applicant will do the work 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?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

 

The extent to which applicants have access to and experience with computational models and the merit of the plan to modify, improve, or otherwise apply the model parameters to fill gaps in knowledge about the health effects of toxic substances at waste sites and elsewhere in the environment.

Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. [see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] located at, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available  on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

 

Inclusion of Women and Minorities in Research:

Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R). 

 

Care and Use of Vertebrate Animals in Research: If applicants plan to use vertebrate animals in the project, HHS/CDC will assess the five items described under Section 2, item 12 Vertebrate Animals of the Research Plan component of the SF424 (R&R).   Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements are available on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Biohazards: If applicants propose the applicant has proposed materials or procedures that are potentially hazardous to research personnel and/or the environment, HHS/CDC will determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed?  Is each budget category realistic and justified in terms of the aims and methods?  The evaluation of the budget should not affect the priority score.

2.C. Sharing Research Data

 

Data Sharing Plan: HHS/ATSDR will assess the reasonableness of the data sharing plan. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. ATSDR program staff will be responsible for the administrative review of the plan for sharing research data.

2.D. Sharing Research Resources

HHS/PHS policy requires that recipients of grant awards make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication.  Please see http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. Investigators responding to this funding opportunity should include a plan on sharing research resources.

 

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (HHS/PHS 2590 http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.


 

3. Anticipated Announcement and Award Dates

 

September 1, 2007

 

Section VI. Award Administration Information

 

1. Award Notices

After the peer review of the application is completed, the applicant organization will receive a written critique called a “Summary Statement.”  The applicant organization and the PD/PI will be able to access the Summary Statement via the eRA Commons.

HHS/ATSDR will contact those applicants under consideration for funding for additional information.

 

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.  The NoA signed by the Grants Management Officer (GMO) is the authorizing document.  HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application. 

 

Selection of the application for award is not an authorization to begin performance.  Any cost incurred before receipt of the NoA is at the recipient’s risk.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5. Funding Restrictions.

 

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about requirements.  For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements are available Section VIII. Other Information on this document or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.
 

The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courtesy copy to the PD/PI at the time of award.

2.A. Cooperative Agreement

 

The following terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines; HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply); and other HHS/PHS, and HHS/CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U01, an "assistance" instrument (rather than an "acquisition" instrument) in which substantial HHS/ATSDR programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/ATSDR purpose is to support and stimulate the recipients' activities by involvement in, and otherwise working jointly with, the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole; although specific tasks and activities may be shared among the awardees and the HHS/ATSDR may share specific tasks and activities, as defined above.

2.A.1. Recipient Rights and Responsibilities

The Recipient will have the primary responsibility for the following:

 

Use computational toxicology methods to investigate the health effects associated with exposures to toxic substances at waste sites and elsewhere in the environment through one or more of the following:

 

Develop and apply biologically-based models to estimate and predict the potential for health effects from exposures to toxic substances across varying durations and doses

 

Develop or modify model parameters to estimate potential health risks at differing developmental stages (i.e., fetus, infant, toddlers, adolescents, adults, and aged) and health conditions and disease states to determine susceptible subpopulations at sites

 

Explore the use and role of knowledge of toxicogenomics in determining the susceptible subpopulations at sites

 

Develop and/or modify model parameters to investigate the interaction of chemical mixtures and the potential for health effects from exposures

 

Establish and maintain a plan and system for sharing data for the developed models and the modified parameters 

           

Participate in planning workshops or symposia to present research findings and exchange information on the application and utility of the methods and approaches developed.

 

Recipient Organization will retain custody of and have primary rights to the information, data and software developed under this award, subject to U.S. Government rights of access consistent with current HHS, HHS/PHS, and applicable HHS/CDC policies.

2.A.2. HHS/ATSDR Responsibilities

An HHS/ATSDR Scientist Collaborator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Provide consultative, administrative and technical assistance, as needed, in the development of the program of research activities, e.g. assist in selecting priority substances and/or exposure scenarios for model development.  

 

Collaborate with the recipient in the establishing a plan and system for sharing data on the developed models and the modified parameters 

 

Collaborate in the development and/or modification of model parameters, analysis of data, assistance in the interpretation of results, and synthesis of conclusions so as to effectively communicate with NCEH/ATSDR,  partners, and other interested parties.

 

Assist in writing and presenting publications of research results, including abstracts and journal articles.