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Updates may still be coming so please check back periodically and with the www.grants.gov page for more instructions.
ALL Applications must be submitted electronically using SF424
(Research and Related Portable Document Format at http://grants.nih.gov/grants/forms.htm).
All FY 2009 and FY 2010 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 $400,000 in
total (direct plus indirect) costs per year for up to 4 years. A fourth year
of funding is available only for phase 2 or 3 clinical studies. Please note
that the dollar limitation will be total costs, not direct costs as in previous
years.
For FY 2009, the application receipt date is February 6, 2008 and for FY 2010, the application receipt date is February 4, 2009. Please note that there is only ONE receipt date for FY 2009 and FY 2010.
Notification regarding the results of the review is anticipated by September 2008 for
FY 2009 and by September 2009 for FY 2010. The earliest expected start date
for the FY 2009 and FY 2010 awards will be November 1, 2008 and November
1, 2009, respectively.
Application Helpful Hints
1. Face Page
a. Title of Project
Action Items:
i. In the title, please be sure to include all the following information: 1) the Phase of the study, 2) the name of the drug/device, 3) the name of the disease/condition to be studied, 4) IND/IDE #, 5) Date the protocol was submitted to FDA review division.
Please limit your character length to 81 characters to avoid errors.
ii. If this application is a re-submission, please indicate the previously
assigned grant application number on the face page to avoid errors.
iii. Please include the IND/IDE number and date it was submitted to the
review division in the title block.
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 as specified in the announcement for this program posted in the Federal Register. 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.
ii. The date the subject protocol was submitted to FDA for the IND/IDE review should also be provided in the title of the project.
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.
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 in the Background section.
Action Item:
Please provide such evidence in the Background section of the application. A current letter from the supplier as an appendix (referenced in the Background Section) 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.
7. Page Limits
The following are the maximum page limits for the following sections:
Introduction - maximum 3 pages
Research Plan - maximum 25 pages
Biographical Sketch - maximum 4 pages
Project Summary/Abstract – maximum 1 page
Project Narrative – maximum 1 page
Page limits are based on single-spaced pages, 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.
8. Resubmission Details
If this is a resubmission, revision or renewal, the
prior grant number is mandatory.
i. Responses to prior critiques (for a "resubmission") should be in the PHS 398 Research Plan component, upload #1 ("Introduction to Application"). Section 2.7 "Resubmission" of the SF424 (R&R) Application Guide provides details for the applicants. See: http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc
ii. Please note that acceptance of a resubmission application automatically withdraws the prior version, since two versions of the same application cannot be pending simultaneously. Introduction to Resubmission Application: The resubmission must include a brief Introduction (1-3 pages depending on the mechanism) that summarizes the substantial additions, deletions, and changes. The Introduction must also include responses to the criticisms and issues raised in the Summary Statement. Use Item 2.1, Introduction to Application, of the PHS 398 Research Plan component to provide this information.
9. Character Restrictions
On the SF424 R&R form the following character restrictions apply:
i. Applicant information: Name and PI contact information, position, and titles – must be < 40 characters
ii. Applicant information: Street address – must be < 50 characters
iii. Descriptive Title – must be < 81 characters
iv. Person to be contacted and Authorized Representative name and position/title – must be < 30 characters each
10. Attachments
i. Attachments must be in PDF only
ii. All attachments must not be password protectediii. There is a limit of 10 attachments total
iv. If pages are greater than 11 x 11 inches or less than 8.5 x 8.5 inches software should change the page size from actual to 8.5 x 11 inches.
v. It is recommended to give the appendices a name that is meaningful and not rely on sequential order.
vi. See Section 5.5 of the Research Plan Component http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc (Item 18) in the Application Guide describes the page limitations and appendix guidance in detail.
11. Other Information:
Please be aware that before an award is made, documentation of Federal Wide Assurance with Office for Human Research Protections (OHRP) (http://www.hhs.gov/ohrp/) and of IRB approval must be received by FDA. Also, the IND/IDE must be active (not on hold) and in regulatory compliance.
After an award is made, you must register your trial with ClinicalTrials.gov. Details are in the RFA.
Helpful links:
OOPD Web Page Links:
http://www.fda.gov/orphan/grants/index.htm
OPD Request for Applications (RFA) FY2009
Federal Register Notice: July 2, 2007
Federal Register Vol. 72, No. 127; Tuesday, July 3, 2007
Grants.gov
http://grants.nih.gov/grants/submitapplication.htm
http://grants.nih.gov/grants/forms.htm
http://www.grants.gov/help/submit_application_faqs.jsp#25
http://grants.nih.gov/grants/policy/salcap_summary.htm
http://era.nih.gov/ElectronicReceipt/preparing_grantsgov_reg.htm
eRA
http://era.nih.gov/ElectronicReceipt/files/Grantee_Registration_Process_for_Commons.pdf
https://commons.era.nih.gov/commons-help/174.htm
Federal Wide Assurance
http://www.hhs.gov/ohrp/
http://ori.dhhs.gov/misconduct/reg_subpart_a.shtml
DUNS
http://www.ombwatch.org/article/articleview/1795/1/84
(OMB Watcher for
additional information on DUNS Number requirement)
Central Contractor Registration
http://www.ccr.gov
www.grants.gov/CCRRegister
Credential Provider registration
www.grants.gov/CredentialProvider
HHS/Financial Management
http://rates.psc.gov/
Revised 11/2007