Part I Overview Information


Department of Health and Human Services

Participating Organizations
Food and Drug Administration (FDA), (http://www.fda.gov)

Components of Participating Organizations
N/A

Title:  Food Safety and Security Monitoring Project (U18), FERN Radiological Health Laboratories

Note:  Availability of Cooperative Agreements under a Limited Competition

Note:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-FD-10-004

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)
93.448

Key Dates
Release/Posted Date: April 16, 2010
Opening Date:  April 16, 1010 (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):  June 11, 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): N/A
Expiration Date: June 12, 2010

Due Dates for E.O. 12372

Single Point of Contact program under E.O. 12372 is applicable for FDA. http://www.whitehouse.gov/omb/grants/spoc.html

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 FDA
    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. Resource Sharing Plan
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. Arbitration 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), is announcing the availability of cooperative agreements for equipment, supplies, personnel, training, and facility upgrades to Food Emergency Response Laboratory Network (FERN) radiological laboratories of State, local, and tribal governments. The cooperative agreements are to enable the analyses of foods and food products in the event that redundancy and/or additional laboratory surge capacity is needed by FERN for analyses related to radiological terrorism or other emergency situations. These cooperative agreements are also intended to expand participation in networks to enhance Federal, State, local, and tribal governmental food safety and security efforts.

The goal of ORA's cooperative agreement program is to complement, develop, and improve State, local, and Indian tribal food safety and security testing programs. This will be accomplished through the provision of equipment, supplies, personnel, facility upgrades, training in current food testing methodologies, participation in proficiency testing to establish additional reliable laboratory sample analysis capacity, analysis of surveillance samples, and, in cooperation with FDA, participation in method enhancement activities designed to extend analytical capabilities. In the event of a large-scale radiological terrorism event affecting foods or food products, the recipient may be required to perform selected radiological analyses of domestic and imported food samples collected and supplied to the laboratory by FDA or other Federal agencies through FDA. These samples may consist of, but are not limited to, the following: Vegetables and fruits (fresh and packaged), juices (concentrate and diluted), grains and grain products, seafood and other fish products, milk and other dairy products, infant formula, baby foods, bottled water, condiments, and alcoholic products (beer, wine, scotch).

All grant application projects that are developed at State, local, and tribal levels must have national implications or application that can enhance Federal food safety and security programs.

There are two key project areas identified for this effort:

1. The use of gamma spectrometry analysis for the screening and identification of gamma-emitting radionuclides in foods, and

2. The use of beta spectrometry analysis for the screening and identification of beta-emitting radionuclides in foods.

It should be emphasized that in all of the projects, there is a particular desire to promote a continuing, reliable capability and capacity for laboratory sample analyses of foods and food products for the rapid detection and identification of radionuclides. With this in mind, it is desirable that sample analyses will be completed within 2 weeks of receipt, and the results will be reported to FERN. The format and reporting media will be established by FERN. Shorter timeframes may be sought for special testing such as proficiency tests or special assignments.

FDA will support the projects covered by this notice under the authority of section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188). This program is described in the Catalog of Federal Domestic Assistance under number 93.448.

ORA is the primary inspection and analysis component of FDA and has approximately 1,600 investigators, inspectors, and analysts who cover the country's approximately 95,000 FDA-regulated businesses. These investigators inspect more than 15,000 facilities per year and ORA laboratories analyze several thousand samples per year. ORA conducts special investigations, conducts food inspection recall audits, performs consumer complaint inspections, and collects samples of regulated products. Increasingly, ORA has been called upon to expand the testing program that addresses the increasing threat to food safety and security through intentional radiological terrorism events. Toward this end, ORA has developed radiological screening and analysis methodologies that are used to evaluate foods and food products in such situations. However, in the event of a large-scale emergent incident, analytical sample capacity in ORA field laboratories has a finite limit.  Information from ongoing relationships with State partners indicates limited redundancy in State food testing laboratories; both in terms of analytical capabilities and analytical sample capacity. Several State food testing laboratories lack the specialized equipment and/or the specific methodological expertise required to perform analyses for screening foods and food products involving radiological terrorism events.

The events of September 11, 2001, reinforced the need to enhance the security of the U.S. 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:

Subtitle A of the Bioterrorism Act, "Protection of Food Supply," section 312, "Surveillance and Information Grants and Authorities," amends part B of Title 111 of the Public Health Service Act to authorize the Secretary of Health and Human Services to award grants to States and Indian tribes to expand participation in networks to enhance Federal, State, and local food safety efforts. This may include meeting the costs of establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation.

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 Cooperative Agreement award mechanism to provide support to registered FERN Radiological Labs.  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) How often samples will be sent, (2) directions on how tests should be executed, (3) on-site monitoring, (4) supply of equipment used, (5) FDA training on processes, and (6) enhancement and extension of analytical methodology.

FDA will provide specific procedures and protocols for the two project areas (see section I of this document) to be used for the analysis of collected food samples. FDA will provide guidance on the specific foods to be collected and analyzed by the successful applicant.  State personnel will be responsible for the collection of surveillance samples.

Only proposed projects designed to address and fulfill the specific objectives of any one or more of the project areas will be considered for funding. Applicants may also apply for facility upgrades, personnel, training, and surveillance sample collection. These grants are not to fund or conduct food inspections for food safety regulatory agencies.

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 also uses the non-modular budget formats.  Applicants must complete and submit a detailed categorical budget using the Research & Related Budget Component.

2. Funds Available

The total amount of funding available in Fiscal Year (FY) 2010 is $1,250,000. 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 supplies, facility upgrades, surveillance sample collection, personnel, the provision of training in current analytical methodology (including travel to training sites), and for the analysis of foods and food products.

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 of 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 make up to 5 awards in FY 2010 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 in the budget to travel to FDA for meetings with program staff about the progress of the project and travel for training.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

FDA grants policies as described in the D

1. Eligible Applicants

1.A. Eligible Institutions

This cooperative agreement program is only available to State, Local, and Tribal government FERN laboratories with food regulatory authority to conduct onsite inspections and is authorized by section 312 of the Bioterrorism Act. All grant application projects that are developed at State, local, and tribal levels must have national implications or application that can enhance Federal food safety and security programs.  Only registered FERN Radiological laboratories that are currently receiving funding under this cooperative agreement program may apply for these competing continuation awards.

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 Policy Statement: http:www.hhs.gov/grantsnet/adminis/gpd/index.htm.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is programmatically distinct.

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 applicationSeveral 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 FDA. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by FDA (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 (See Section IV.6., “Special Instructions,” regarding appropriate required budget component.)  

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-Domestic [non-U.S.] Entities)

Not applicable.

SPECIAL INSTRUCTIONS   

Not applicable.

Applications Involving a Single Institution

Not applicable.

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: April 16, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): N/A
Application Due Date(s): June 11, 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 FDA

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 FDA in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

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 will not be 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, FDA 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 AOR/SO have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to FDA for further processing.

Upon receipt, applications will be evaluated for completeness by the FDA. 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 not 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 HHS Grants Policy Statement.

These grants are not to fund or conduct food inspections for food safety regulatory agencies. They may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 25 percent of the grant award amount.

6. Other Submission Requirements 

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

The rationale and design to meet the goals of the cooperative agreement.

A full description of the prospective project's intended goals and objectives and how each will guide a full project plan. This section should lay a foundation for the entire program.

Expertise in the use of gamma or beta spectroscopy in the analysis of foods or animal tissues. Specifically address and provide the qualifications of all personnel that will be assigned to the project. Curriculum vitae or resumes for key laboratory personnel, including information on personnel that have experience in gamma and beta spectroscopy, must be provided.

Sample Analysis Commitment. The variety and number of samples analyzed in the current food or animal tissue programs. The laboratory will be required to analyze surveillance and emergency response food samples. Therefore, an estimate of the number of food samples that can be analyzed for radionuclides by each project area (i.e., gamma spectroscopy, beta spectroscopy), must be submitted. This estimate should be for a 3-year period. The estimate should also address the number of samples that can be analyzed in a 2-week period. The procedures to be used will be supplied by FDA. This information will be provided after the award is given, so recipients will be aware of requirements/responsibilitiesIn addition, if a cooperative agreement

is awarded, awardees will be informed of any additional documentation that should be submitted to FERN.

The adequacy of facilities, support services, and quality control and quality assurance procedures and practices for food and animal tissue analysis.

This section should include:

(1) A summary description of procedures in place to monitor sample workflow, including the tracking and monitoring of sample analyses and a description of the current quality assurance program.

(2) A discussion of the laboratory's ability to complete and report on a given sample analysis within the required 2-week time frame.

(3) The name and address of the laboratory facility where the equipment will be installed and the name of the responsible individual at the facility.

Laboratory Facilities. A complete description of the name and address of the facility, and the name of the most responsible individual of the facility where the necessary equipment is installed and where the work will take place must be provided.

For the facility, the following information must be provided:

(1)   Floor diagrams of the current laboratory;

(2)   A description of the envisaged space, to include a floor-plan diagram;

(3)   Area where the equipment is to be installed. The installation of equipment in a laboratory will require adequate and appropriate space and physical plant supplies, such as power, water, etc.;

(4)   A detailed description of the proposed facilities upgrade including drawings and cost estimates;

(5)   Operational support areas to be used for the project, including details about the availability of ancillary laboratory safety and support equipment and facilities, such as the numbers and types of chemical fume hoods available;

(6)   Details describing the sample receiving and sample storage areas and a description of any existing chain-of-custody procedures.

(7)   A detailed description of laboratory access procedures, including a description of practices and systems which limit access to laboratory space by unauthorized personnel. Additional procedures for access to the space(s) dedicated to the equipment provided, if any, should also be included.

Laboratory Personnel Qualifications. Qualifications of all personnel that will be assigned to the project must be provided.

Laboratory Management Practices. Abilities and procedures in place to recall personnel and establish extended work weeks and commitment to analyze emergency response samples.

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 to include abilities and procedures in place to recall personnel, establish extended work weeks, etc.; and

(3) A summary description of any security procedures or processes to evaluate the background of laboratory personnel. This should include any procedures for evaluating subcontractors who have access to laboratory space, such as cleaning personnel, and for the safeguarding of sensitive information and materials.

Equipment.  Provide a detailed description and availability of all equipment that will be used to accomplish the project.

FDA will purchase and have all needed major equipment for the two project areas delivered to the awardee’s laboratory.  The equipment purchased by the FDA will remain the property of FDA under loan to the awardee’s laboratory for a minimum of 5 years at which point in time it may or may not be released as surplus property.  FDA may terminate the loan at any time.  The equipment may not be transferred by the awardee’s laboratory to a third party, and the awardee’s laboratory assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardee’s laboratory.

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

The Research Strategy section of the competing continuation application may not exceed 30 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits.

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:

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 

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

All grant application projects that are developed at State, local, and tribal levels must have national implications or application that can enhance Federal food safety and security programs.

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

2. Review and Selection Process

Review Process

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 institution's/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).

To be a FERN radiological laboratory, an applicant institution must have an approval letter from the FERN National Program Office approving the applicant institution as a FERN Radiological laboratory prior to the application receipt date.

As part of the ad hoc review, all applications will:

All grant application projects that are developed at State, local, and tribal levels must have national implications or application that can enhance Federal food safety and security programs.

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 with respect to existing and projected laboratory sample analysis and testing capacity and capability. Final funding decisions will be made by the Commissioner of Food and Drugs (the Commissioner) or his designee.

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. Funding decisions will be made by the Commissioner or his 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/ORO/DFSR cooperative agreement.

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.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects’ involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain, and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the American Veterinary Medical Association (AVMA) Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Resubmission Applications.   Resubmissions are not allowed for this FOA.

Renewal Applications.  Renewals are not allowed for this FOA.

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

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.

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

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession, use, and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s), as listed in [citation/link].

Applications from Foreign Organizations.  Foreign applications are not allowed for this FOA.

Resource Sharing Plans.  Not applicable.

Security Measures.  Reviewers will assess the security procedures, processes, and background checks in place to evaluate new and existing laboratory personnel and determine whether they are adequate to safeguard sensitive information and ensure security of the program/project.  This includes policies for hiring foreign nationals and students.

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:

See also Section IV.5. “Funding Restrictions.” And Section VI, 2A “Terms and Conditions”.

3. Anticipated Announcement and Award Dates

Notification regarding the results of the review in the form of a summary statement is anticipated by May, 2010. It is anticipated that all awards will be made by July 1, 2010.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the FDA's Grants Management Office will notify applicants who have been selected for an award.

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NGA 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 pre-costs incurred before receipt of the NGA are at the recipient's risk.

2. Administrative and National Policy Requirements

These agreements will be subject to all policies and requirements that govern the research grant programs of PHS, including provisions of 42 CFR part 52, 45 CFR parts 74 and 92, and the PHS Grants Policy Statement.

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 Project Director/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, local, and tribal Governments are eligible to apply), and other DHHS, PHS, and the FDA 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. Project Director/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 have 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.

Participation in the Food Emergency Response Network (FERN) program will include access to non-public information from the FDA.  Therefore, in order to participate, laboratory officials must sign a confidentiality agreement pursuant to 21 CFR 20.88. 

Laboratories that possess, use, or transfer select agents must comply with the relevant statutory and regulatory requirements, including 18 U.S.C. 175b and 42 CFR Part 73.  Among other things, such laboratories must obtain a certificate of registration from the Secretary of the Department of Health and Human Services (DHHS) and may not provide an individual with access to a select agent unless the individual has been approved by the Secretary of DHHS.

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 DHHS, PHS, and FDA policies.

2. A.2. FDA Responsibilities

An FDA Project Officer (PO) will have substantial programmatic involvement that is above and 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 and grants. The PO ’s responsibilities include, but are not limited to, post-award monitoring of project/program performance, including reviewing progress reports and making site visits; and other activities complementary to those of the GMO. The PO and the GMO work as a team in many of these activities.

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

3. Reporting

An annual Financial Status Report (FSR) (SF-269) must be sent to FDA's grants management officer within 90 days of the budget period end date of each 12-month grant. Failure to file the annual FSR in a timely fashion will be grounds for suspension or termination of the grant.

For continuing cooperative agreements, mid-year reports and an annual program progress report are also required. For such cooperative agreements, the Non-Competing Continuation 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. A status report on the training, availability and operational readiness of personnel and equipment that is used for the project;

2. A summary report on any proficiency testing performed;

3. A summary status of FDA samples analyzed and time to complete individual sample testing;

4. A summary description of any other relevant testing performed on the equipment;

5. Status and results of method extension and enhancement studies.

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

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

Awardees will be required to submit the PHS 2590 annually and financial statements as required in the DHHS Grants Policy Statement.  http://www.hhs.gov/asrt/og/grantinformation/hhsgps107.pdf

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 requirements as well as security background screening.

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):

Tim McGrath
FDA/ ORA
Division of Field Science
5600 Fishers Lane, Rm. 12-41
Rockville, MD  20857
Telephone: (301) 827-1028
Email: timothy.mcgrath@fda.hhs.gov

2. Peer Review Contact(s):

Jennifer Gabb
FDA/ ORA
Division of Federal Relations
5600 Fishers Lane, Rm. 12-07
Rockville, MD  20857
Telephone: (301) 827-2899
Email: Jennifer.gabb@fda.hhs.gov

3. Financial/Grants Management Contact(s):

Camille R. Peake
Division of Acquisition Support and Grants
5630 Fishers Lane, Rm. 2105
Rockville, MD 20857
Telephone: (301) 827-7175
Fax: 301-827-7101
Email: Camille.Peake@fda.hhs.gov

Section VIII. Other Information


Required Federal Citations (If applicable)

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

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan (NIH Policy Adopted by the FDA):
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness, and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Policy for Genome-Wide Association Studies (GWAS) (NIH Policy Adopted by the FDA):
NIH/DHHS is
interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository (if applicable). For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the Agency-designated GWAS data repository, or provide an appropriate explanation of why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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

Access to Research Data through the Freedom of Information Act (FOIA) (NIH Policy Adopted by the FDA):
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/DHHS 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.

Inclusion of Women And Minorities in Clinical Research (NIH Policy Adopted by the FDA):
It is the policy of the NIH/DHHS that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH/DHHS staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research (NIH Policy Adopted by the FDA):
The NIH/DHHS maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research conducted or supported by the NIH unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants (NIH Policy Adopted by the FDA):
NIH/DHHS policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Public Access Policy Requirement (NIH Policy Adopted by the FDA):
In accordance with the NIH/DHHS Public Access Policy, investigators funded by the FDA must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/) an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH/DHHS Public Access Policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

Sharing Research Data (NIH Policy Adopted by the FDA):
Investigators submitting an application to the FDA seeking $500,000 or more in direct costs in any single year (if applicable) are expected to include a plan for data sharing or state why this is not possible (see http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions on issues related to institutional policies and local institutional review board (IRB) rules as well as local, State and Federal laws and regulations, including the Privacy Rule.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241), Section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 USC 247b-20),  and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

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


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