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Please read the following helpful hints before completing your grant application. For FY 2007, applicants may submit the application as a paper copy using Grant Application Form PHS 398 (rev. 05/01) or electronically using SF424 (Research and Related Portable Document Format at http://grants.nih.gov/grants/forms.htm). However, for FY 2008, all applications must be submitted electronically through grants.gov.
The following hints will facilitate the review of your application by the Office of Orphan Products Development (OOPD). In the past, the most frequent errors noted on applications by OOPD include omission of the IND or IDE number in grant title, submission date of the study protocol to the IND or IDE, and documentation of prevalence of the disease or condition.
Special Notes:
Grants will be awarded up to $200,000 or up to $350,000 in total (direct plus indirect) costs per year for up to 3 years. Please note that the dollar limitation will be total costs, not direct costs as in previous years.
For FY 2007, the application receipt date is March 14, 2006 and for FY 2008, the application receipt date is February 7, 2007. Please note that there is only ONE receipt date for FY 2007 and FY 2008.
Notification regarding the results of the review is anticipated by September 2006 for FY 2007 and by September 2007 for FY2008. The earliest expected start date for the FY 2007 and FY 2008 awards will be November 1, 2006 and November 1, 2007, respectively.
Application Helpful Hints
1. Face Page
a. Title of Project
Action Items:
i. In the title, please be sure to include the Phase of the study, the name of the drug/device and the name of the disease/condition to be studied for paper.and electronic submissions.
ii. If this application is a re-submission, please indicate the previously assigned grant application number on the face page.
iii. Please include the IND/IDE number and date it was submitted to the review division in the title block for paper and electronic submissions.
iv. Please note that FDA does not adhere to the 25 character limit for the title as does NIH. However, it is helpful if your title does not exceed 50-55 characters.
b. IND/IDE
The study protocol proposed in the grant application must be under an active IND or IDE (not on clinical hold) to qualify the application for scientific and technical review. INDs or IDEs should be submitted to the review division at least thirty days before the grant application receipt date. Studies of approved products to evaluate new orphan indications are acceptable; however, these must also be conducted under an IND or IDE to support a change in labeling. Protocols that would otherwise be eligible for an exemption from the IND/IDE regulations must be conducted under an active IND/IDE to be eligible for funding under this FDA grant program.
Action Items:
i. The number assigned to the IND/IDE that includes the proposed study should appear on the face page of the application with the title of the project for paper and electronic submissions.
ii. The date the subject protocol was submitted to FDA for the IND/IDE review should also be provided for paper and electronic submissions.
c. Dun and Bradstreet Number (DUNS)
Beginning October 1, 2003, you are required to have a DUNS number to apply for a Federal grant. This is a nine-digit identification number which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. In order to apply electronically, applicants must have a DUNS number and register in the Central Contractor Registration database at http://www.ccr.gov.
Action Items:
i. To obtain a DUNS number, call 1-866-705-5711.
ii. Be certain to identify yourself as a Federal grant applicant when you call.
iii. Please place this number on the face page of the application.
d. Block 4c. NIH-defined Phase III clinical trial
This does not apply to the OOPD grants program and does not need to be completed for paper submissions.
2. Research Plan - Background and Significance
OOPD provides grants for clinical studies that will either result in or substantially contribute to market approval of products used in the prevention, diagnosis and/or treatment of rare diseases.
Action Items:
i. Please include in the “Background and Significance” section an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development.
ii. The prevalence, not incidence, of the population to be served by the product must be fewer than 200,000 individuals in the United States. Please include, in the "Background and Significance" section, a detailed explanation supplemented by authoritative references in support of the prevalence figure.
3. Consent Forms
Action Item:
Consent forms, assent forms, and any other information given to a subject, should be sent with the grant application, even if such a form is in a draft version.
4. Product Availability
Evidence that the product to be studied is available to the applicant in the form and quantity needed for the clinical trial must be included in the application.
Action Item:
Please provide such evidence. A current letter from the supplier as an appendix is acceptable.
5. SBIR/STTR
This information applies to Small Business Innovation Research and Small Business Technology Transfer grants. These questions do not apply to your OPD grant application. Therefore, any reference or request for information pertaining to an SBIR/STTR grant can be deleted/omitted/marked “not applicable”.
6. Budget
The NIH Modular Budget program does not apply to the OPD grant program. Therefore, the Budget Justification Page - Modular Research Grant Application can be deleted.
Action Items:
i. Delete the Modular Budget Justification page
ii. Please note the Other Support Format Page must be submitted with the grant application.
7. Page Limits
The narrative portion of the application (excluding appendices) should be no more than 100 pages, single-spaced, printed on 1 side, with ½ inch margins, in unreduced 12 pt. font.
Applications may not be accepted for review and may be returned for the following reasons:
1) The applicant organization is ineligible.
2) The application is received after the specified receipt date.
3) The application is incomplete.
4) The application is illegible.
5) The application is not responsive to the Request for Applications (RFA).
6) The material presented in the application is insufficient to permit an adequate review.
7) The dollar amount requested in the application exceeds the recommended threshold stated in the RFA.
For paper submissions, an original hard copy and two single-sided hard copies of the application (including appendices) must be submitted to one of the following addresses depending on type of mail delivery used:
8. Addesses
FOR REGULAR MAIL DELIVERY USE:
Grants Management Specialist
Division of Contracts and Grants Management (HFA-500)
Food and Drug Administration
5600 Fishers Lane,
Rockville, MD 20857
FOR EXPRESS MAIL DELIVERY USE:
Grants Management Specialist
Food and Drug Administration
Mail Code HFA-500 5630 Fishers Lane, Room 2105
Rockville, MD 20857
DO NOT SEND APPLICATIONS TO THE CENTER FOR SCIENTIFIC RESEARCH (CSR), NATIONAL INSTITUTES OF HEALTH (NIH).
9. Other information:
Please be aware that before an award is made, documentation of Assurance with OHRP and of IRB approval must be received by FDA. Also, the IND/IDE must be active and in regulatory compliance.
After an award is made, you must register your trial with ClinicalTrials.gov. Details are in the RFA.
Click here for links to:
OPD Request for Applications (RFA) FY2007
Federal Register Notice:December 19, 2005 (PDF)
OMB Watcher for additional information on DUNS Number requirement:
PHS 398 Forms and PHS Instructions
Central Contractor Registration http://www.ccr.gov
Credential Provider registration http://www.grants.gov
Note:
The PHS 398 Form has been modified to enable the fields to be filled in directly using Adobe Acrobat Reader software. However, FDA is unable to receive applications electronically by the Internet.
Rev. 1/2007