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
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Center for Devices and Radiological Health (CDRH)
Center for Veterinary Medicine (CVM)
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Orphan Products Development (OPD)
Office of Regulatory Affairs

Title:  FDA Small Scientific Conference Program (R13/U13)
Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

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 (R&R) forms and 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 with Grants.gov and eRA Commons is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: RFA-FD-08-003

For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport .

Catalog of Federal Domestic Assistance Number(s)
93.103

Key Dates
Release/Posted Date: April 8, 2008
Opening Date:  May, 1, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s): October 15; January 15; April 15; July 15
Expiration Date: July 16, 2011
Note: For some conference grant applications, the time from submission to funding is shorter than the regular cycle. A second level of review by a Board/Council is not required for applications with budgets less than $50,000 total costs; therefore, funding selections may be made sooner than the cycle indicated above.

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This funding opportunity provides updated guidelines for the Food and Drug Administration support of conferences and scientific meetings.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support

Section III. Eligibility Information
1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Resource Sharing Plan(s)
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 Contact(s)
1. Scientific/Research Contact(s)
2. Program Contact(s)
3. Conference Grant Coordinator

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The FDA recognizes the value of supporting high quality conferences/scientific meetings that are relevant to its scientific mission and to the public health. A conference/scientific meeting is defined as a gathering, symposium, seminar, scientific meeting, workshop or any other organized, formal meeting where persons assemble to coordinate, exchange, and disseminate information or to explore or clarify a defined subject, problem, or area of knowledge. Support of such meetings is contingent on the fiscal and programmatic interests and priorities of the individual Centers, which are linked to the FDA  Grant Web site http://www.fda.gov/  Therefore, a conference grant application is required to contain a letter from the appropriate FDA staff (see Contacts List) documenting advance permission.  Investigators are urged to initiate contact well in advance of the application receipt date. Please note that agreement to accept an application does not guarantee funding.

FDA Conference Grant program information can be obtained from the Grants Management Team at 301 – 827-7168

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the Conference/Scientific Meeting (R13 /U13) grant award mechanisms. Under the R13 mechanism, the applicant will be solely responsible for planning, directing, and executing the proposed project. Multiple year awards may be made to a permanently sponsoring organization for conferences held annually or biennially on a recurring topic. The total project period for an application requesting support may not exceed five years.

The FDA U13 is a cooperative agreement award mechanism. Under the U13 mechanism, the Project Director/Principal Investigator (PD/PI) retains 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/PI, as described in Section VI.2.A.

This funding opportunity uses just-in-time budget concepts. It also uses the non-modular budget format. Applicants must complete and submit a detailed categorical budget as described in Section 4.7 of the SF424 (R&R) Application Guide.

2. Funds Available

Because the nature and scope of the proposed activities will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the number of applications, quality, duration, and costs of the applications received.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Application(s) may be submitted by an organization that has any of the following characteristics:

Foreign institutions are not eligible to apply for conference grant support. An international conference can be supported through the U.S. representative organization of an established international scientific or professional society.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to conduct the proposed conference is invited to work with that individual’s institution 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 programs.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Most Centers will accept applications for up to five years when a series of annual or biannual meetings is proposed by a permanently sponsoring organization. Support for meetings held on a less frequent schedule must be applied for individually.

Section IV. Application and Submission Information


Registration and Instructions for Submission via Grants.gov

FDA is accepting new applications for this program electronically via www.grants.gov.  To download the SF424 (R&R) Application forms and SF424 (R&R) Application Guide for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that site.

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

The Project Director/Principal Investigator (PD/PI) should work with their institutions/organizations to make sure they are registered in the eRA Commons.

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

Both the PD/PI(s) and AOR/SO need separate accounts in the eRA Commons since both are authorized to view the application image.  Note that if a PD/PI is already registered in the eRA Commons, another registration to apply for an FDA opportunity is not necessary.

Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

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

 Note: For some conference applications, the PD/PI identified is not an employee of the applicant organization. For other conferences, the PD/PI is an employee of the applicant organization. Therefore, for electronic receipt, applicants have the following two options:

a) Conference applicant organizations/institutions can name a scientific director who is an employee of the organization/institution and register that individual in the Commons. It is important to note that only the named scientific director at the institution will be able to access the Summary Statement, priority score, etc. If the applicant names someone else to be the scientific director for the conference, the applicant organization is responsible for sharing that information with the other individual (PD/PI).

b). Conference applicants/institutions may continue to use an "affiliated" individual as the PD/PI. In this case, the applicant organization will need to officially affiliate the PD/PI with the conference organization in the Commons.

Following are the steps to affiliate a PD/PI to an institution:

1) PD/PI gives Commons user ID and email address to the administrator of the new institution. (The email address must be the one that is contained in the Personal Profile for the PI.)

2) Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)

3) Administrator selects "Administration" tab and then "Accounts" tab.

4) Administrator selects "Create Affiliation" tab.

5) Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."

Note: The account cannot have any other roles attached to it other than the PD/PI.

1. Request Application Information

Applicants must download the SF424 (R &R) application forms and SF424 (R&R) Application Guide for this FOA through http://www.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 Gladys M. Bohler, 301-827-7168, gladys.melendez-bohler@fda.hhs.gov

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

2. Content and Form of Application Submission

Special instructions for applicants who are submitting a renewal or revision: Applicants submitting a renewal or resubmission are required to enter the previous grant number into the Federal Identifier field in the SF424 (R&R) Cover Component form (box #8).  Renewal and resubmission applications that do not include this number will receive an error.  Applicants should log on to the eRA Commons to obtain the previous grant number.  If the number is not available in Commons, contact Marc Pitts, 301- 827-7162 at FDA to get the previous grant number in order to submit the application. Visit http://era.nih.gov/ElectronicReceipt/resubmission_FAQ.htm for additional information.

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

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to FDA. There are fields within the SF424 (R&R) application components that, 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
PHS398 Research & Related Budget

Optional Components:
PHS398 Cover Letter

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Release/Posted Date: April 8, 2008
Opening Date:  May 1, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s): October 15; January 15; April 15; July, 15
Expiration Date: July 16, 2011

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/Apply and follow steps 1-4. Note: Applications in response to this FOA may only be submitted to Grants.gov through Grants.gov/Apply.

PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3. C. Application Processing

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

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

Upon receipt, applications will be evaluated for completeness.  Incomplete applications will not be reviewed.

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

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction (limited to one page) addressing the previous critique. Note, such an application is considered a "resubmission" for the SF424 (R&R).

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

Pre-Award Costs are allowable. A grantee may, at its own risk and without FDA prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal (formerly, “competing continuation”) award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without FDA prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain FDA approval before incurring the cost. FDA prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on FDA either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. FDA expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See DHHS Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

6. Other Submission Requirements and Information

Advance permission to submit an application is required for all FDA conference grant applications, including new, resubmission (formerly “revision/amended”), renewal (formerly “competing continuation”), and revision (formerly “supplemental”) applications. Advance permission to submit an application should be requested early in the process and no later than six weeks before the receipt date. The letter from an FDA Center documenting advance permission to submit an application must be submitted with the application. All applicants must include the advance permission letter from the FDA staff member who has agreed to accept assignment of the application. The FDA staff member granting advance permission must be one of the contacts designated at the Conference Grant Web site http://grants.nih.gov/grants/guide/contacts/parent_R13_U13.html)  Attach the letter as part of the PHS 398 Cover Letter component (PDF). If an application is received without a permission letter, it will not be accepted for review. Note that advance permission to submit an application does not guarantee funding.

The application will be assigned based on FDA Receipt and Referral Guidelines. This means that there may be FDA Center dual assignments and their may be the opportunity to co-fund the conference. Only one advance permission letter is required per application. Dual assignments do not require advance permission to submit an application.

The following instructions are to be used in conjunction with the SF424 (R&R) Application Guide accompanying the SF424 (R&R) application form:

SF424 (R&R) Cover Component. Enter the title of the conference or scientific meeting on line item 11.

Research and Related Project/Performance Site Locations. Enter the site of the conference or meeting as the Performance Site.

Research and Related Senior/Key Person: Personnel are defined as the PD/PI and those responsible for the scientific planning and organization of the meeting. Attach a biographical sketch for PD/PI, Co-Chair, key personnel, and confirmed key speakers.

Research and Related Budget: The appropriate Center/Program conference award contact should be consulted for guidance regarding any Center/Program specific budget requirements. Enter the direct costs requested. Provide a narrative justification for each proposed personnel position, including role and proposed level of effort. Include information regarding efforts to obtain funding for this conference/meeting from other sources.

Allowable Costs: Salary (in proportion to the time or effort spent directly on the conference/meeting); rental of necessary equipment; travel and per diem or subsistence allowances; supplies needed for conduct of the meeting (only if received for use during the budget period); conference services; publication costs; registration fees; speakers’ fees.

Non-allowable costs: Purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment; tips; bar charges; personal telephone calls; laundry charges; dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; facilities and administrative costs/indirect costs. Please also refer to the DHHS Grants Policy Statement for additional information regarding costs.

PHS 398 Research Plan Component: Submit one attachment, which may not exceed 10 pages, under the Research Design and Methods section (line item 5). Note that this section will be called “Conference Plan” in the system-generated Table of Contents. Letters of agreement from key speakers and participants should be attached at line item 13. Do not complete Sections 2 – 4 and the Human Subjects Sections (Items 6-10) of the PHS 398 Research Plan.

In the “Conference Plan” section of the application (uploaded as attachment #5), describe the objectives, specific program, and logistical arrangements for the meeting. Describe the format and agenda, including the principal topics to be covered, problems to be addressed, and developments or contributions the meeting might stimulate. Provide a detailed justification for the meeting, including the scientific need, timeliness, and usefulness of the meeting to the scientific community. Describe the composition and role of the organizing committee, and provide the names and credentials of key participants in the meeting, including the basis for their selection and documentation of their agreement to participate.

Describe plans for the appropriate involvement of women, minorities, and persons with disabilities in the planning and implementation of the proposed meeting. Estimate the expected size and composition of the audience, as well as the method of selection. Describe plans for publicizing the meeting and publication of the proceedings. Identify related meetings held on the subject during the past three years. If this is one of a series of periodic meetings held by a permanent sponsoring organization, briefly describe and evaluate the last meeting in the series.

Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible: meeting topic(s); tentative dates, locations, and participants; and contingency plans for future meetings dependent upon, for example, the outcome of the first year’s meeting or developments in the field.

A critical part of the application for FDA support of conferences is documentation of appropriate representation of women, racial/ethnic minorities, persons with disabilities, and other individuals who have been traditionally underrepresented in science. These individuals must be included in all aspects of planning, organization, and implementation of FDA sponsored and/or supported meetings. “Appropriate representation” means representation based on the availability of these scientists from these groups known to be working in a particular field of biomedical or behavioral research. If appropriate representation is not apparent, no award will be issued until program staff is assured of concerted recruitment efforts. Organizers of scientific meetings must document compliance with the Guidelines for Inclusion of Women, Minorities, and Persons with Disabilities in Scientific Meetings Supported by the NIH/FDA (http://grants.nih.gov/grants/funding/r13/index.htm). This Web site also includes addresses and information for offices at FDA that support conference activities.

Appendix: The appendix is limited to announcements and reports of previous meetings under the same sponsorship. No other information or material should be submitted as appendices.

PHS 398 Checklist Component: The checklist is required; however, no information regarding F&A should be included as this is not an allowable cost for this mechanism.

Resource Sharing Plan(s)

Not applicable.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the FDA Centers on the basis of an advance permission letter. Applications lacking such a letter will not be reviewed. Dual assignments will be made on the basis of established PHS referral guidelines. An appropriate evaluation group convened by the accepting Center/Program will evaluate the application for scientific and technical merit.

The following will be considered in making funding decisions:

In their critiques, reviewers will be asked to comment on each of the following criteria, which will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to deserve a high priority score.

Significance: Does this conference/scientific meeting address an important health problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these endeavors on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Is the purpose of the conference and its relevance to FDA clear?  Is the conference timely in terms of currency of issues to be addressed?

Approach: Is the format and agenda for the meeting appropriate for achieving the goals of the conference? Is the meeting timely for the subject matter? How well do the plans for inclusion of women, minorities, and persons with disabilities provide for their appropriate representation in the planning, organization, and implementation of the proposed meeting?

Innovation: Does the meeting employ novel approaches or methods to fulfill its purpose?

Investigators: Is the PD/PI well suited for organizing and fulfilling the goals of this conference? Are the qualifications of the PD/PI appropriate and past performance adequate? Are the key personnel and selected speakers appropriate and well suited for their described roles in the conference?

Environment: How appropriate is the meeting site? Does the applicant organization have the ability to contribute to the probability of success? Do the proposed meetings, exhibits, interactions, etc., take advantage of unique features of the environment or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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

Inclusion of Women, Minorities and Persons with Disabilities in NIH/FDA Supported Conference Grants: (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-066.html)

FDA affirms that the value of scientific meetings is enhanced by including participants from all segments of the scientific population and, when appropriate, members of the lay community, in both the planning and conduct of such meetings. The adequacy of plans to include women, minorities and persons with disabilities in the planning and execution of a scientific meeting or conference is important to its success and relevance and will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed plan. Does the amount requested from FDA appear reasonable as partial support of the total conference given the plan, facilities, travel, and speakers?  The priority score should not be affected by the evaluation of the budget.

Previous Experience:  Is there previous experience with the organization/or the principal investigator in similar undertakings?  If so, what?

2.C. Resource Sharing Plan(s)

Not Applicable.

3. Anticipated Announcement and Award Dates

Not Applicable.

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. For details, applicants may refer to the DHHS Grants Policy Statement Part II: Terms and Conditions of  FDA Grant Awards, http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

A formal email notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee authorized representative.

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

2. Administrative and National Policy Requirements

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

The following Terms and Conditions will be incorporated into the NoA and will be provided to the PD/PI 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 OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U13), 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 above.

2.A.1. Project Director/Principal Investigator (PD/PI) Rights and Responsibilities

Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the conference.

The PD/PI will retain custody of, and have primary rights to, information developed under the cooperative agreement, subject to government rights of access, consistent with the current DHHS, PHS, and FDA policies. Publication and copyright agreements and the requirements for financial status reports; retention of records; and terminal progress reports will be as stated in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

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

Awardees are responsible for identifying specific milestones for conferences that will be supported during the project period, when multi-year conferences are supported.

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.

An FDA Project Scientist will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond the normal program stewardship for grants. Substantial involvement as a partner would include, for example, assisting in planning the agenda, selecting speakers, organizing a symposium, determining the content of the meeting, or determining the acceptability of submitted papers. Substantial involvement would not include serving as an invited speaker or providing limited advice.

Additionally, an agency Program Official or Center Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA. The assigned Program Director will also serve as the Project Scientist.

2.A.3. Collaborative Responsibilities

Not Applicable.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: one chosen by the awardee, a second member selected by the CENTER, and the third member with expertise in the relevant area who is chosen by the other two. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the PHS Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the DHHS Grants Policy Statement. Reports must be submitted two months prior to the next budget period start date. The Progress Report should include a report of the previous meeting supported by the current grant, as well as a full description of the next planned meeting.

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 two areas: scientific/research, and financial or grants management issues.

1. Scientific/Research Contacts:

Consult the FDA Web site, http://www.fda.gov/ and direct your questions to the appropriate individual. Issues that remain after consultation with Center staff and that are not addressed in this FOA may be directed to:

Michelle Hawley
Acting Team Leader
Grants and Assistance Agreements Team
Division of Acquisition Support and Grants
Office of Acquisitions & Grants Services
phone - 301-827-1991
e-mail - Michelle.Hawley@fda.hhs.gov

Section VIII. Other Information


Required Federal Citations

URLs in FDA Grant Applications or Appendices:
All applications and proposals for FDA funding must be self-contained within specified page limitations. Unless otherwise specified in an FDA solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

FDA's authority to enter into grants and cooperative agreements is detailed under title XVII of the Public Health Service Act (42 U.S.C. 300u-1) and/or the Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602) (21 U.S.C. 360hh-ss, formerly 42 U.S.C. 263b-n).

All awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement.  The DHHS Grants Policy Statement can be found at 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.