Part I Overview Information


Department of Health and Human Services

Participating Organizations
Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) in coordination with the Center for Veterinary Medicine (CVM) http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm

Components of Participating Organizations
N/A

Title:  Feed Safety and BSE/Ruminant Feed Ban Support Project (U18)

Note:  This is a Limited Competition solicitation.

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to use the Adobe Forms B and for this FOA submission please consult with your Program Official Caleb Michaud at 301-827-4389 or your Grant Specialist, Gladys M. Bohler at 301-827-7168 for additional information regarding page limits and the FDA Peer Review Process

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-FD-10-002

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 (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.449

Key Dates
Release/Posted Date:  May 6, 2010
Opening Date:  May 15, 2010 (Earliest date an application may be submitted to Grants.gov)  
Letters of Intent Receipt Date(s): N/A
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 Due Date(s): July 15, 2010   
AIDS Application Due Date(s): N/A
Peer Review Date(s): July, 2010 
Council Review Date(s):N/A
Earliest Anticipated Start Date(s): August, 2010  
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: July 16, 2010

Due Dates for E.O. 12372

Single Point of Contact program under E.O. 12372 is applicable for FDA . See http://www.whitehouse.gov/omb/grants_spoc/ for details

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. Receipt, 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
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
         1. Principal Investigator Rights and Responsibilities
         2. FDA Responsibilities
         3. Collaborative Responsibilities
         4. Dispute Resolution Process
3. Reporting

Section VII. Agency Contacts
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

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) in coordination with the Center for Veterinary Medicine (CVM), is announcing the availability of cooperative agreements to further enhance the infrastructure of State, territorial, and tribal animal feed safety and bovine spongiform encephalopathy (BSE) prevention programs.  These cooperative agreements are intended to fund additional personnel, equipment, supplies, and training to support activities related to the FDA ruminant feed ban (21 CFR parts 589.2000 - 2001, referred to as the BSE/ruminant feed ban) as well as other activities related to feed safety, in State, territory, and tribal governments.

The goal of FDA’s ORA Cooperative Agreement Program is to enhance, complement, develop and improve State/territory/tribal animal feed safety and surveillance programs. This will be accomplished through the provision of funding for additional equipment, supplies, funding for personnel, training in current feed testing methodologies recognized by FDA, participation in proficiency testing to establish additional reliable laboratory sample analysis capacity, and analysis of surveillance samples as well as State/territorial/tribal government compliance inspections. This will also require extensive cooperation and coordination with FDA District Offices to minimize duplication of inspections.

Under these cooperative agreements, the State, territory, and tribal governments would enhance their feed safety and/or BSE/ruminant feed ban programs to increase the ability to locate and visit firms involved in the manufacture, distribution, and transportation of animal feed and operations feeding livestock in their jurisdiction. Verification of compliance with the BSE/ruminant feed ban as well as other regulations related to feed safety will be conducted. In addition, funds could be used to increase State, territory, and tribal personnel dedicated to conducting these inspections. Funds could be used for supplies, training, and laboratory equipment for feed sample testing using analytical methods recognized by FDA.  Funds could also be used to conduct educational outreach activities and to develop materials needed to further and enhance the industries' knowledge of and compliance with feed safety regulations and the BSE/ruminant feed ban.

As a result of enhancing their feed safety and/or BSE/ruminant feed ban programs, an increase in State, territory, and tribal inspections under section 702 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 372) of renderers, protein blenders, feed mills that manufacture animal feeds, feed ingredient manufacturers, feed distributors an d transporters, salvagers of food and feed, and livestock feeders is expected.  Animal feed and feed ingredients utilizing materials prohibited under the BSE/ruminant feed ban are of significant interest, although other work related to feed safety may also be conducted. Finally, the Feed Safety and BSE/Ruminant Feed Ban Support Project funds are intended to supplement, not replace, State funding for program improvement.

All cooperative agreement projects that are developed at State, territorial, and tribal levels must have existing feed inspection and surveillance programs or propose in detail the development of a State/territory/tribal feed regulatory program.

There are eight key project areas identified for this effort that must be addressed:

(1) Hire and/or train State/territory/tribal personnel to conduct inspections. Training of State/territory/tribal personnel may be accomplished through the ORA University, training sponsored by the Association of American Feed Control Officials, or other training that meets State/territory/tribal and FDA requirements. New hires for this program must meet the State/territory/tribal agency’s qualifications for feed inspections and sampling techniques.

(2)  Hire and/or train laboratory personnel to conduct laboratory analyses of feed samples.  Laboratory analyses of samples collected under this program must utilize methodologies recognized by the FDA, or other professional groups, such as the Association of Official Analytical Chemists International (AOACI).

(3)  Identify animal feed and feed ingredient manufacturers, including renderers, protein blenders, feed mills, ingredient manufacturers, feed salvagers, distributors (including retailers), transporters of animal feed and feed ingredients, and on-farm animal feed mixers, as well as ruminant feeders within the State/territory/tribal jurisdiction where such firms have not already been identified and/or inspected for compliance with feed safety requirements, such as the BSE/ruminant feed ban.

(4)  Inspect animal feed and feed ingredient manufacturers, including renderers, protein blenders, feed mills, ingredient manufacturers, feed salvagers, distributors (including retailers), transporters of animal feed and feed ingredients, and on-farm animal feed mixers, as well as ruminant feeders within the State/territory/tribal jurisdiction where such firms have not already been identified and/or inspected for compliance with feed safety requirements, such as the BSE/ruminant feed ban. These inspections would be conducted under section 702 of the FD&C Act, using and completing the appropriate inspection forms and following the appropriate guidance to verify compliance.  For example, the FDA Ruminant Feed Ban Inspection Checklist and Ruminant Feed Ban Compliance Program would be used to verify compliance with the BSE/ruminant feed ban. These inspections would be conducted by officers and employees duly commissioned by FDA in accordance with section 702 of the FD&C Act.

(5)  Conduct surveillance sampling at establishments supplying ingredients or finished feed into the feed supply, including manufacturers, distributors, and livestock feeders.  Samples should be tested for the presence of materials prohibited under the BSE/ruminant feed ban or other contaminants, such as drug and pesticide residues, mycotoxins, heavy metals or the presence of pathogenic microorganisms.  This surveillance sampling would be conducted under section 702 of the FD&C Act and would be conducted by officers and employees duly commissioned by FDA in accor dance with section 702 of the FD&C Act.

(6)  Provide copies of all completed inspection reports, including any FDA Ruminant Feed Ban Inspection Checklists, analytical results for surveillance sampling, and reports of any other inspection work as a part of the mid-year program progress report to the FDA Project officer or designated office, as well as provide completed checklists and sample results in accordance with section 702 of the FD&C Act.

(7)  Be able to identify and quantify improvements to the existing State/territory/tribal feed safety and/or BSE/ruminant feed ban program or developing new programs (i.e., personnel hiring, personnel training, equipment upgrades, increase in inspections conducted) in the mi d-year report as a result of the cooperative agreement.

(8) Conduct educational outreach activities and develop materials needed to further and enhance the industries' knowledge of and compliance with feed safety requirements, such as but not limited to the BSE/ruminant feed ban and medicated feed good manufacturing practice regulations, for example.

FDA will support the projects covered by this notice under the authority of section 311 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188), which amends the FD&C Act by adding section 909 (21 U.S.C. 399). This program is described in the Catalog of Federal Domestic Assistance under number 93.449.

The events of September 11, 2001, reinforced the need to enhance the security and safety of the United States food supply. Congress responded by passing the Bioterrorism Act, which President George W. Bush signed into law on June 12, 2002. The Bioterrorism Act is divided into the following five titles:

Title I--National Preparedness for Bioterrorism and Other Public Health Emergencies,

Title II--Enhancing Controls on Dangerous Biological Agents and Toxins,

Title III--Protecting Safety and Security of Food and Drug Supply,

Title IV--Drinking Water Security and Safety, and

Title V--Additional Provisions.

Subtitle A of Title III—Protection of Food Supply, Section 311—Grants to States for Inspections, amends the FD&C Act by adding section 909 to authorize the Secretary of Health and Human Services to award grants to States, territories, and Indian tribes that undertake examinations, inspections, and investigations, and related activities under section 702 of the FD&C Act. The grant funds are only available for the costs of conducting these examinations, inspections, investigations, and related activities.

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

Section II. Award Information


1. Mechanism of Support

 This FOA will use the U18 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA provides support to State/territorial/tribal governments for them to develop new or enhance the capability of their existing feed safety and/or BSE/ruminant feed ban programs an d assist in an increased surveillance presence throughout the commercial feed channels.  These efforts will aid in preventing the introduction or amplification of BSE in the United States and help reduce the likelihood of public or animal health problems related to unsafe animal feed.

Substantive involvement by the awarding agency is inherent in the cooperative agreement award. Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement. Substantive involvement includes, but is not limited to, the following:

(1) FDA assistance and coordination in sharing information on the identification and location of all renderers, protein blenders, commercial animal feed manufacturers, distributors (including retailers), salvagers, transporters of animal feed and feed ingredients, on-farm animal feed mixers, and others involved in the manufacturing, distribution and use of livestock feed known to FDA an d the State/territorial/tribal agency,

(2) FDA assistance in training State/territorial/tribal feed safety and/or BSE/ruminant feed ban regulatory program personnel,

(3) FDA assistance in training State/territorial/tribal laboratory personnel to interpret analytical results from their feed testing efforts,

(4) FDA assistance in collecting feed surveillance samples at renderers, protein blenders, and feed mills that manufacture with materials prohibited under the BSE/ruminant feed ban,

(5) FDA assistance and cooperation in the location and inspection of firms for other feed safety hazards,

(6) FDA will assist in reviewing completed inspection reports and sample results provided as a part of the mid-year reports, and

(7) FDA will assist with joint inspections for training, compliance, auditing or other field activities as requested by the grantee.

State/territorial/tribal BSE/ruminant feed ban inspections are based on a determination of compliance of firms with the "Animal Proteins Prohibited In Ruminant Feeds" regulation, (21 CFR 589.2000), the “Cattle Materials Prohibited in Animal Food or Feed to Prevent the Transmission of Bovine Spongiform Encephalopathy” regulation (21 CFR 589.2001), as well as any subsequent regulations and guidance applicable to the BSE/ruminant feed ban. Other feed safety work performed under the cooperative agreement will be conducted under the applicable regulations and guidance relate d to feed safety.  Examples include the Good Manufacturing Practice regulations for medicated feed (21 CFR 225) and the regulations adopted under “New Animal Drugs for use in Animal Feeds” (21 CFR 558).

The BSE/ruminant feed ban regulations are designed to prevent the establishment and amplification of BSE through animal feed, by prohibiting the use of most mammalian proteins in ruminant feed, and the use of certain cattle tissues in all animal feed.  The regulations affect renderers, protein blenders, commercial animal feed manufacturers, distributors (including retailers), transporters of animal feed and feed ingredients, on-farm animal feed mixers, and ruminant feeders. Based on the need to control the entry and spread of this disease, the agency has set a goal to assist in the development of new or the enhancement of existing State/territory/tribal BSE/ruminant feed ban programs to help meet compliance with the regulation. 

Feed industry firms that are inspected under the BSE/ruminant feed ban regulations are also subject to feed safety regulations that address other hazards that might impact animal health or the safety of the meat, milk or eggs. Thus, when inspection visits are made to these facilities to determine their compliance with the BSE/ruminant feed ban regulations, it makes sense for the inspection visits to also address other areas involving feed safety at the same time.

In the Cooperative Agreement mechanism, the PD(s)/PI(s) retain(s) the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA staff being substantially involved as a partner with the PD(s)/PI(s), as described under the Section VI.2. Administrative Requirements, “Cooperative Agreement Terms, and Conditions of Award”.

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). It uses the Non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

U.S. applicants requesting $250,000 in annual direct costs must complete and submit budget requests using the Research & Related Budget component.

This funding opportunity will use an FDA cooperative agreement award mechanism. In the cooperative agreement mechanism, the PD(s)/PI(s) retain(s) the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA staff being substantially involved as a partner with the PD(s)/PI(s), as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The total amount of funding available in Fiscal Year (FY) 2010 is $3,000,000. Cooperative agreements will be awarded up to $250,000 in total (direct plus indirect) costs per year for up to 5 years. Support of these cooperative agreements will be for the funding of additional personnel, equipment, supplies, and training to support activities related to the FDA BSE/ruminant feed ban as well as other activities related to feed safety.

The length of support will depend on the nature of the project. For those projects with an expected duration of more than 1 year, 4 additional years of noncompetitive continuation support will depend on performance during the preceding year and availability of Federal funds. The total project period for an application requesting support may not exceed 5 years.

It is anticipated that FDA will issue 12 awards in FY2010 for this program. The number of projects funded will depend on the quality of the applications received and is subject to availability of Federal funds to support the projects.

Funds may be requested for travel to FDA for meetings with program staff about the progress of the project and for travel to attend training activities.

In addition, if a cooperative agreement is awarded, grantees will be informed if any additional documentation is needed to support their award. The project office will have continuous interaction with the grantee through inspection field audits, collection of mid-year and end of year progress reports, and provision of training, joint inspections, and compliance. There may be other regular meetings with the grantees to assist in fulfilling the requirements of the cooperative agreement.

These cooperative agreements will be made to either fund the development of new State/territory/tribal feed safety and/or BSE/ruminant feed ban programs or to enhance existing State/territory/tribal feed safety and/or BSE/ruminant feed ban programs for the funding of items such as: supplies, lab equipment, surveillance, sample collection, personnel, as well as for activities such as providing training in current inspectional and analytical methodology, developing educational materials for the regulated industry, analyzing feed and feed products, and conducting inspections. Successful applications will be selected for funding to ensure a broad geographic distribution of the program. Size of the existing or new State/territory/tribal program and number of facilities to be covered under the cooperative agreement will also be considered.

States/territories/tribes with current feed inspection contracts addressing the BSE/ruminant feed ban, medicated feed GMP’s and/or tissue residue investigation can maintain these contracts at the discretion of the State/territory/tribe and FDA. However, the facilities and work covered un der these contracts cannot be counted towards fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement.

These cooperative agreements are not to fund work that is covered by a contract, or that is unrelated to feed safety or the BSE/ruminant feed ban. 

Facilities and Administrative (F&A) costs requested by consortium participants are included in the total cost limitation.

Although the financial plans of the FDA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are included in the direct cost limitation..

FDA grants policies as described in the U.S. Department of health and Human Services (HHS) Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply*:  

*This cooperative agreement program is only available to State, Territory, and Tribal government agency feed safety and/or BSE/ruminant feed ban regulatory programs that undertake inspections and related activities under Section 702 of the FD&C Act and that are not currently funded under an existing cooperative agreement or contract.

1.B. Eligible Individuals

Any individual(s) 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 FDA support.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current DHHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may not submit more than one application

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

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, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

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 NIH eRA Commons.

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

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

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

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the 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 GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 480-0434

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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
PHS398 Checklist
PHS398 Research & Related Budget, as appropriate (See Section IV.6 regarding appropriate required budget component.)  
Research & Related Subaward Budget Attachment(s) Form

Optional Components:
PHS398 Cover Letter File

Foreign Organizations: N/A

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs: N/A

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: May 15, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application Due Date(s): July 15, 2010
Peer Review Date(s): July, 2010
Council Review Date(s): N/A.
Earliest Anticipated Start Date(s): August, 2010

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

In order to expedite the review, applicants are requested to notify the  Project Officer, Caleb Michaud by email caleb.michaud@fda.hhs.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

3.C.1 Submitting On-Time

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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified 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 weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the FDA Project Officer and Grants Management Specialist. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. 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 the application status in the Commons.

The FDA will not accept any application in response to this funding opportunity 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

This initiative is subject to intergovernmental review.

5. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

These cooperative agreements are not to fund inspections at licensed medicated feed mills or inspections that are related to the BSE/ruminant feed ban that are already addressed by a contract between FDA and the State/territory/tribe. These awards may be used only for the development of new State/territory/tribal feed safety and/or BSE/ruminant feed ban programs an d/or to enhance and supplement existing State/territory/tribal feed safety and/or BSE/ruminant feed ban program funding. States/territories/tribes with current medicated feed GMP, tissue residue investigation and/or BSE/ruminant feed ban contracts with FDA can maintain these contracts and continue to provide inspectional coverage at these types of firms at the discretion of the State/territory/tribe and FDA. However, the facilities and work covered under the contract cannot be counted towards fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement.

6. Other Submission Requirements 

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

The applicant must specifically address the following in the cooperative agreement application:

Laboratory Facilities. The applicant must provide a complete description of the facilities, including a complete description of the name and address of the facility conducting the feed sample testing, the name of the most responsible individual for the facility where the testing will be conducted, and the location and installation requirements of any equipment purchased with cooperative agreement funds.

For the facility, the following information must be provided:

(1)     Operational support areas to be used for the project, including details about the availability of ancillary laboratory safety and support equipment and facilities;

(2)     Details describing the sample receiving and sample storage areas, as well as a description of the chain-of-custody procedures;

(3)     A detailed description of the proposed upgrades to existing laboratory facilities to accommodate new equipment, including drawings and cost estimates. 

Laboratory Management Practices. For the laboratory, the following management information must be provided:

(1)     A summary description of any quality management system defined, in development, or in place as it relates to quality control and quality assurance procedures and practices;

(2)     A summary description of staffing management, specifically including feed sample testing abilities and procedures; and

(3)     A summary description of procedures in place to monitor feed sample workflow, including the tracking and monitoring of sample analyses in progress to include a description of the laboratory work product review process. Additionally, provide a description of the laboratory’s ability to perform and complete the feed sample analyses and provide a report of a sample analysis within a responsive and reasonable timeframe. The grantee shall utilize and follow laboratory testing procedures, methodologies, and protocols employed and accepted by FDA in the assessment of feed samples with respect to the analyte of interest, such as pesticide or drug residues, or prohibited animal protein.

In addition, if a cooperative agreement is awarded, grantees will be informed if any additional documentation should be needed to support their award.

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

The FDA requires the PD(s)/PI(s) 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.

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.”

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Budget Component

U.S. applicants requesting $250,000 in annual direct costs must complete and submit budget requests using the Research & Related Budget component.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Section V. Application Review Information


1. Criteria 

All grant application projects that are developed at State, Territory, and tribal levels must have national implication or application that can enhance Federal Feed safety and BSE/ruminant feed ban programs.

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

FDA grants management and program staff will review all applications submitted in response to this notice. To be responsive, an application must be submitted in accordance with the requirements of this notice. Applications found to be non-responsive will be returned to the applicant without further consideration. 

Applicants are encouraged to contact FDA to resolve any questions about criteria before submitting their application. Please see Agency Contacts, Section VII of this document, for further information.

The review criteria described below will be considered in the review process.  Overall technical merit and innovation are key criteria, although all factors will be considered as specified in the scoring below.  Further, program criteria will include availability of funds and overall program balance in terms of geography with respect to existing and projected awards.

2. Review and Selection Process

Review Process

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

As part of the scientific peer review, all applications will:

The mission of the FDA is to protect the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. As part of this mission, applications submitted to the FDA for grants or cooperative agreements to support public health safety are evaluated for scientific and technical merit through the FDA peer review system. 

FDA grants management and program staff will review applications sent in response to this notice. To be responsive, an application must be submitted in accordance with the requirements of this notice and must bear the original signature of the applicant institutions/organization's authorized official. If submitted electronically the original signature requirement does not apply.

If an application is found to be nonresponsive, it will not be considered for funding. Applicants are strongly encouraged to contact FDA to resolve any questions about criteria before submitting an application. Please direct all questions of a technical or scientific nature to ORA program staff and all questions of an administrative or financial nature to the grants management staff (see section VII of this document).

Applications will be considered for funding on the basis of their overall technical merit as determined through the review process. Program criteria will include availability of funds and overall program balance in terms of geography and with respect to existing inventory of feed firms within their State/Territory/Tribal geographic boundary.

A responsive application will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts in the subject field of the specific application. Final funding decisions will be made by the Commissioner of Food and Drugs or his/her designee.

A score will be assigned to each responsive application based on the scientific/technical review criteria. The review panel may advise the program staff about the appropriateness of the proposal to the goals of the ORA/Office of Regional Operations (ORO)/DFSR cooperative agreement.

Scored Review Criteria

The ad hoc expert panel will review the application based on the following scientific and technical merit criteria:

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications.  N/A

Renewal Applications.  N/A

Revision Applications. N/A

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations.  N/A

Select Agents Research. N/A

Resource Sharing Plans.  N/A.

Budget and Period of Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Security Measures. Security Measures. Reviewers will assess the security procedures, processes and background checks in place to evaluate new and existing laboratory personnel and will assess whether these measures are adequate to safeguard sensitive information and ensure security of the program/project. 

Selection Process

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

The recipient will be advised of award status within two weeks of application Review.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will receive his or her Summary Statement (written critique) electronically via email. 

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant. For details, applicants may refer to the DHHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

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 is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the DHHS Grants Policy Statement as part of the NoA. For these terms of award, see http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

Equipment purchased under this cooperative agreement is subject to the requirements of 45 CFR parts 92.31, “Real property.”

Applicants must adhere to the requirements of this notice. Special terms and conditions regarding FDA regulatory requirements and adequate progress of the study may be part of the awards notice.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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 NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA 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 FDA as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, or programmatic aspects of the grant and for day-to-day management of the project or program.  The PD/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff has sufficient clearance and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient organization to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.

2. A.2. FDA Responsibilities
 
An FDA Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

An FDA Project Officer (PO) will have substantial programmatic involvement that is beyond the normal stewardship role in awards as described below. The PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications an d grants. The PO’s responsibilities include, but are not limited to, post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the Grants Management Officer (GMO). The PO and the GMO work as a team in many of these activities.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Not Applicable.

2.A.4. Dispute Resolution Process

Awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

For continuing cooperative agreements, mid-year reports and an annual program progress report are also required. For such cooperative agreements, the Non-competing Continuation Grant Progress Report (PHS-2590) will be considered the program progress report for the fourth quarter of the budget period.

Mid-year progress reports must contain, but are not limited to the following:

1.     Progress report that covers accomplishments for each specific goal and objective outlined in grant application. Goals and objectives should be broken out and reported against. 

2.     Status report on the installation and operational readiness of any analytical equipment that is purchased.

3.     Status report on the hiring and training of State/territorial/tribal laboratory personnel.

4.     Copies of the inspection report on the firms for which Ruminant Feed Ban Inspection Checklists were completed including general assessment of compliance status.

5.     Summary report on the facility inventory that is maintained by the State/territory/tribal government.

6.     Status report on the hiring and training of personnel to conduct the inspections.

7.     Report on feed sample descriptions and subsequent analytical results.

8.     Where the examinations, inspections, or investigations and related activities undertaken under section 702 of the FD&C Act result in a State/territorial/tribal enforcement action, a summary report of the follow-up actions and final resolution of the findings.

9.     Summary of improvements (identify and quantify) in the overall State/territory/tribal BSE/ruminant feed ban program resulting from the cooperative agreement.

10.  Provide copies of all completed inspection reports, such as the BSE/ruminant feed ban checklist, as well as sample results, as a part of the mid-year program progress report to the FDA Project officer or designated office.

An annual Financial Status Report FSR (SF-269 or SF-269A as applicable) must be sent to FDA's grants management officer within 90 days of the budget period end date of the grant. Failure to file the FSR in a timely fashion will be grounds for suspension or termination of the grant.

A final program progress report, FSR, and invention statement must be submitted within 90 days after the expiration of the project period as noted on the Notice of Grant Award.

The final program progress report must provide full written documentation of the project, and summaries of findings, as described in the grant application. The documentation must be in a form and contain sufficient detail such that other State, local, and tribal governments could reproduce the final project.

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions or when an award is terminated.

Monitoring Activities

The program project officer will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project office/grants management office and the principal investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the study will depend on recommendations from the project officer.

The scope of the recommendation will confirm that:

(1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; (3) if necessary, there is an indication that corrective action has taken place; and (4) assurance that any replacement of personnel will meet the testing and inspection requirements.

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Shannon Jordre
FDA/ CVM
Division of Compliance
7519 Standish Place
Rockville, MD  20855
Telephone:  240-276-9229
E-mail:  shannon.jordre@fda.hhs.gov

2. Peer Review Contact(s):

Caleb Michaud
FDA/ ORA
Division of Federal Relations
5600 Fishers Lane, Rm. 12-07
Rockville, MD  20857
Telephone: (301) 827-4389
Email: Caleb.Michaud@fda.hhs.gov

3. Financial/Grants Management Contact(s):

Gladys M. Bohler
Division of Acquisition Support and Grants
5630 Fishers Lane, Rm. 2105
Rockville, MD 20857
Telephone: (301) 827-7168
Fax: 301-827-7101
Email: Gladys.Melendez-Bohler@fda.hhs.gov

Section VIII. Other Information


Required Federal Citations

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.

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

URLs in FDA Grant Applications or Appendices:
All applications and proposals for FDA 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 FDA 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. Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites.

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 subject to the intergovernmental review requirements of Executive Order 12372. FDA’s grant program is described in the Catalog of Federal Domestic Assistance (CFDA), No. 93.449 (http://www.cfda.gov/). FDA will support the awards covered by this notice under the authority of Sections 301 of the Public Health Service Act as amended (42 USC 241 and 284) and under applicable federal regulations at 42 CFR Part 52 and 45 CFR Parts 74 and 92. All grant awards will be subject to all policies and requirements that govern the grant programs of the PHS as incorporated in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

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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