Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.  

Components of Participating Organizations

Office of Research /Veterinary Laboratory Response Network  (Vet-LRN)

Funding Opportunity Title

Evaluation of Salmonella in Symptomatic and Asymptomatic Pets: Study for the Vet-LRN Program (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-11-010

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103

FOA Purpose

This Funding Opportunity Announcement (FOA) issued by the Food and Drug Administration (FDA), Veterinary Laboratory Response Network, Cooperative Agreement Program, Grant mechanism (U18) is to solicit applications from institutions/organizations for inclusion into its Evaluation of Salmonella in symptomatic and asymptomatic pets Cooperative Agreement Program. The cooperative agreements are intended to fund additional personnel, equipment, supplies, and training to support activities related to the FDA activities related to feed safety, in State, territory, and tribal governments.

Key Dates
Posted Date

July 8, 2011

Open Date (Earliest Submission Date)

July 15, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

August 15, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August, 2011

Advisory Council Review

September, 2011

Earliest Start Date(s)

September, 2011

Expiration Date

August 16, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the (HHS Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background:

The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is announcing the availability of a cooperative agreement program to further enhance the ability of the Center to evaluate potential risks of Salmonella-contaminated feeds on human and animal health. Salmonella, a Gram-negative rod-shaped bacterium, is a pathogen of both humans and animals, causing an infection, salmonellosis. 

Salmonella can be present in many different environments, including water, soil, insects, feces, wild and farm raised animals, raw foods, factory and kitchen surfaces. Salmonellosis causes gastrointestinal disease in humans and animals.  Symptoms in people include nausea, vomiting, abdominal cramps, diarrhea, fever and headache (1).  Animals may also show signs of gastrointestinal disease, although they may harbor Salmonella bacteria, without showing signs of clinical disease (2-5).

Since 1999, a number of human salmonellosis outbreaks have been correlated with exposure due to contact with Salmonella-contaminated animal feeds in both Canada and the United States (6-10).  In 2006-7, Center for Disease Control (CDC) reported seventy human cases of salmonellosis were associated with Salmonella Schwarzengrund and this serotype, based on the pulsed-field gel electrophoresis (PFGE) pattern, was indistinguishable from Salmonella Schwarzengrund isolated from dry dog foods manufactured by a company in the United States (10). 

What remains generally unknown is the effect that Salmonella contaminated feeds have on the health of pets.  How frequently do cases of salmonellosis occur in pets, and how frequently do they develop a carrier state, where they harbor the bacteria but do not show signs of disease?  Since only a subpopulation of infected animals may be taken to a veterinarian, and an even smaller population of animals has actual fecal cultures taken for confirmation, it is likely that the number of cases of salmonellosis in pets is under-reported.  In addition, the serotypes of Salmonella involved in pet disease have not been adequately characterized. 

Research Objective:

In order to gain further insight into the prevalence of Salmonella infected animals following feed contamination, CVM is seeking proposals that will provide information on the prevalence of Salmonella in fecal samples from both symptomatic and asymptomatic animals brought to veterinary clinics. 

Research Approach:

Laboratories will participate in a multi-center study and CVM will coordinate methods among the participants.  Sampling protocols and culture methods will be standardized throughout the participating laboratories.  Patient fecal samples will be cultured for Salmonella from using well established and validated methods.  Serotyping methods will also be standardized among the participants.   These isolates will be submitted to CVM upon completion of the study.  A minimum of 100 symptomatic and 100 asymptomatic cases should be examined.  Appropriate institutional requirements for obtaining patient samples must be provided.  Microbiologic investigations must be conducted in laboratories with AAVLD or equivalent accreditation (http://data.memberclicks.com/site/aavld/Requirements%20v5%200%2009-16-10.pdf). 

Applicants are requested to propose methods that can be used to culture, identify and further serotype the isolates.  Additionally the applicants should provide documentation of their past performance or capabilities with the proposed methods. 

Recipients of this funding will collaborate with other cooperative agreement laboratories to develop a final standardized protocol for their microbiologic isolations. They will also be required to participate in one round of proficiency testing per year.  Further they will be required to report findings quarterly in a standardized format agreed upon by the cooperative laboratories.

References:

1.  http://www.fda.gov/food/foodsafety/foodborneillness/foodborneillnessfoodbornepathogensnaturaltoxins/badbugbook/ucm069966.htm

2. McKenzie E, Riehl J, Banse H, Kass PH, Nelson S Jr, Marks SL. Prevalence of diarrhea and enteropathogens in racing sled dogs. J Vet Intern Med. 2010 Jan-Feb;24(1):97-103.

3.  Finley R, Ribble C, Aramini J, Vandermeer M, Popa M, Litman M, Reid-Smith R.  The risk of salmonellae shedding by dogs fed Salmonella-contaminated commercial raw food diets. Can Vet J. 2007 Jan;48(1):69-75.

4. Schotte U, Borchers D, Wulff C, Geue L. Salmonella Montevideo outbreak in military kennel dogs caused by contaminated commercial feed, which was only recognized through monitoring. Vet Microbiol. 2007 Jan 31;119(2-4):316-23.

5. Sokolow SH, Rand C, Marks SL, Drazenovich NL, Kather EJ, Foley JE. Epidemiologic evaluation of diarrhea in dogs in an animal shelter. Am J Vet Res. 2005 Jun;66(6):1018-24

6. Characterization of Salmonella Associated with Pig Ear Dog Treats in Canada.  J Clin Microbiol, November 2001, 39(11):3962–3968.

7. Association between Handling of Pet Treats and Infection with Salmonella enterica serotype Newport Expressing the AmpC ß-Lactamase, CMY-2. J Clin Microbiol October 2003, 41(10):4578–4582.

8. Human Salmonellosis Associated with Animal-Derived Pet Treats --- United States and Canada, 2005.  CDC MMWR June 30, 2006/55(25):702-705.

9. A Multi-State Salmonella Typhimurium Outbreak Associated with Frozen Vacuum-Packed Rodents Used to Feed Snakes.  Zoonoses Public Health. October 2008, 55:481-487.

10. Multistate Outbreak of Human Salmonella Infections Caused by Contaminated Dry Dog Food --- United States, 2006—2007.  CDC MMWR May 16, 2008 /57(19):521-524

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

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement.  

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

CVM intends to commit $660,000 in FY 2011.

CVM intends to fund no more than 11 awards in FY 2011. Each award will not exceed $60,000 total - which includes direct and indirect costs..

Award Budget

Cooperative agreements will be awarded in amounts up to $60,000 in total (direct plus indirect) costs for 1 year, with the possibility of a second year of funding.  After the initial year of funding, future funding opportunities are planned but will be dependent upon the availability of funds.

Award Project Period

Scope of proposed project should be accomplished within 12 months from the date of the award.  Project periods is 12 months.

FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.    

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

R&R or Modular Budget Component

The total budget for all years of the proposed project must be requested in Budget Period 1 Do not complete Budget Periods 2 or 3.  They are not required and will not be accepted with the application.

Complete only Budget Period 1 of either the PHS398 Modular Budget component or the R&R Budget component. 

PHS398 Modular Budget Component (direct costs of $250,000 or less):

Follow all instructions in the SF 424 (R&R) Application Guide, noting the following specifications for R15 applications.

Budget Period 1: Direct Costs

Budget Period 1: Indirect Costs:

Budget Justification: Please attach the Personnel Justification and Consortium Justification.  If the requested budget requires any additional justification, attach an Additional Narrative Justification. 

R&R Budget Component (direct costs of $250,001 to $300,000):

Follow all instructions in the SF 424 (R&R) Application Guide, noting the following specifications for R15 applications.

Budget Period 1: Direct Costs

Budget Period 1: Indirect Costs:

Budget Justification: Follow all instructions in the SF424 (R&R) Application Guide. Since a primary objective of the AREA program is to expose students to meritorious research, PD/PIs are encouraged to include undergraduate (preferably, if available) and graduate students in the proposed research to the extent practical. If students are available and will be involved in the research, indicate aspects of the proposed research in which they will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide, with:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the FDA Grants Office and responsiveness by components of participating organizations, FDA. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the CVM's Vet-LRN Program , all applications submitted to the FDA in support of the evaluation of salmonella in symptomatic and asymptomatic pets are evaluated for scientific and technical merit through the FDA review system.

For this particular announcement, note the following:

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 strongly encouraged to contact FDA to resolve any unanswered questions about criteria before submitting their application.  Please direct all questions of a technical or scientific nature to the  Vet-LRN program staff and all questions of an administrative or financial nature to the grants management staff (see Agency Contacts, Section VII of this document).

Applications will be reviewed for adequate case load at the institution, technical expertise and ability to conduct the appropriate volume of cultures.  Institutions will be evaluated as to their accreditation status and geographical location to provide program balance and a diverse patient population.

Requested budget must be within the dollar limits outlined, up to $60,000 in total costs per year for up to 2 years.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Is the laboratory accredited bv AAVLD or a comparable accrediting agency?

Collaboration

Is the laboratory willing and able to support a collaborative effort with other cooperative agreement laboratories as well as participate in proficiency tests?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable.  Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children 

Generally not applicable.  Reviewers should bring any concerns to the attention of the Scientific Review Officer.

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 AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider 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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent 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).

Resource Sharing Plans

Not Applicable..

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with HHS review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate FDA Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the review of the applications are completed, the PD/PI will receive his or her Summary Statement (written critique) from the FDA Program Office. 

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement.

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: (provide specific language)


1. The study will be a collaborative effort that will require frequent interactions of the awardees among themselves and with the FDA. Applicants should explicitly indicate their willingness to:

a.   Participate in regular telephone conference calls with Vet-LRN staff and other cooperative agreement laboratories.

b.  Cooperate with other awardees in the development and design of research protocols

c.   Abide by common definitions; common methods for patient selection and enrollment; and common protocols, procedures, tests, and reporting forms.

d.  Define common procedures for quality control, data analysis, and interpretation.

d.  Indicate a willingness to participate in the design and implementation of a study of Salmonella in symptomatic and asymptomatic pets

e. Participate in site visits as requested by the FDA

f.  Cooperate with other awardees and FDA in the publication of study results and the eventual release to the scientific community of study procedures and other resources

g.  Accept the Cooperative Agreement Terms and Conditions of Award given below and work in a collaborative and collegial manner to foster the goals of the study.

2. The awardees will provide FDA all Salmonella isolates obtained through the course of the study.  This transfer will take place using the Material Transfer Agreement ("MTA") (http://www.ott.nih.gov/policy/MTA.pdf) which has been adopted for use by the National Institutes of Health ("NIH"), the Food and Drug Administration ("FDA") and the Centers for Disease Control and Prevention ("CDC") collectively referred to herein as the United States Public Health Service ("PHS") within the Department of Health and Human Services ("DHHS"), in all transfers of research material ("Research Material") whether PHS is identified below as its Provider or Recipient.

3. Any publication or oral presentation of the results of this research project must undergo the usual FDA Office of Research and Center review and approval process.  This process can take 30-90 days.

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 NIH policies.

2. A.2.FDA Responsibilities

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

The FDA Project Scientist will participate in Investigator Meetings; he/she or another FDA scientist may serve on other study committees, when appropriate.  The FDA reserves the right to terminate or curtail the study (or an individual award) in the event of substantive changes in the agreed-upon work-scope or methods with which FDA cannot concur.

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

The assigned program director may also serve as an FDA Project Scientist.

2.A.3. Collaborative Responsibilities

In this section, the CVM program director or project scientist should describe any areas of joint responsibility, including membership, duties, voting, etc. For example: A steering committee will serve as the governing board for the award or group of awards. Membership will include: (define PI(s), etc.; FDA/CVM representation should be limited to FDA Project Scientist if possible, and should not be the Chair.)

Awardees will collaborate with other awardees in the development and design of research protocols, they will abide by common definitions; common methods for patient selection and enrollment; and common protocols, procedures, tests, and reporting forms.  They will develop and adhere to common procedures for quality control, data analysis, and interpretation.

3. Reporting

When multiple years are involved, 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.

Awardee will provide the FDA project scientist with quarterly progress reports, consistent with the format that will be developed during research protocol development between the collaborating laboratories.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the HHS Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding FDA grant resources)
Telephone 301-827-7177
TTY 301-827-7039
Email: Vieda.Hubbard@fda.hhs.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Renate Reimschuessel
Program Director – Vet-LRN 
Office of Research
Center for Veterinary Medicine
Food and Drug Administration
8401 Muirkirk Road
Laurel, Maryland 20708
Telephone: (301) 210-4024
Email: renate.reimschuessel@fda.hhs.gov

Review Contact(s)

Michelle Fuller
Office of Management, Financial Resources
Center for Veterinary Medicine
Food and Drug Administration
7529 Standish Place
Rockville, Maryland  20855
Telephone: (240) 276-9736
Email: Michelle.Fuller@fda.hhs.gov.

Financial/Grants Management Contact(s)

Vieda Hubbard
Division of Acquisition Support and Grants
Office of Acquisition and Grants Services (HFA-500)
Food and Drug Administration
5630 Fishers Lane, Room 1079
Rockville, Maryland 20857
Telephone: (301) 827-7177
Email: Vieda.Hubbard@fda.hhs.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

1. Required Federal Citations

1.A.  Access to Research Data through the Freedom of Information Act (FOIA)

The Freedom of Information Act (FOIA), 5 U.S.C. 552, provides individuals with a right to access certain records in the possession of the Federal government, subject to certain exemptions. The government may withhold information pursuant to the exemptions and exclusions contained in the FOIA. The exact language of the exemptions can be found in the FOIA. Additional guidance on the exemptions and how they apply to certain documents can be found in the HHS regulations implementing the FOIA (45 CFR part 5) and FDA regulations implementing the FOIA (21 CFR part 20). Also, see the HHS Web site http://www.hhs.gov/foia/ and FDA Web site at http://www.fda.gov/RegulatoryInformation/FOI/default.htm

Data included in the application may be considered trade secret or confidential commercial information within the meaning of relevant statutes and implementing regulations. FDA will protect trade secret or confidential commercial information to the extent allowed under applicable law.

1.B.  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 as applicable 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

1.C.  Smoke-Free Workplace

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.

1.D.  Authority and Regulation

This program is not subject to the intergovernmental review requirements of Executive Order 12372. FDA's research program is described in the Catalog of Federal Domestic Assistance (CFDA), No. 93.103 http://www.cfda.gov/

FDA will support the clinical studies covered by this notice under the authority of section 301 of the PHS Act as amended (42 U.S.C. 241) and under applicable regulations at 42 CFR Part 52 and 45 CFR Parts 74 and 92.

All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement, dated January 1, 2007 http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.