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  1. Developing Products for Rare Diseases & Conditions

Orphan Products Natural History Grants Program Application Instructions and Helpful Hints for 2016 Receipt Date

Orphan Products Natural History Grants Program Application Instructions and Helpful Hints for 2016 Receipt Date

Section I. General Information

 

Getting Started:

1. Applicants should first review the detailed RFA announcement.

 

2. Letter of Intent

Applicants are strongly encouraged to submit a Letter of Intent to the FDA via email. Although a Letter of Intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and plan the review. The Letter of Intent is due by August 31, 2016.  See RFA for more details.

 

3. All applications must be submitted electronically through Grants.gov. Applicants should review the Request for Application (RFA) that has been published in the Federal Register as well as the publication in the NIH Guide prior to getting started.

 

OPD Hint: Applicants are encouraged to begin the pre-application/registration process at least 4-6 weeks prior to the grant submission date.

 

4. Prior to electronically submitting a grant application, the following steps are required:

 

Step 1: Obtain a Data Universal Number System (DUNS) number

 

Step 2: Register with the System for Award Management (SAM) - A valid Taxpayer

Identification Number (TIN) or Employer Identification Number (EIN) is

necessary for SAM registration.

 

Step 3: Register with and obtain Username & Password on Grants.gov

 

Step 4: E-Business Point of Contact (EBiz POC) authorizes roles, which includes the

Authorized Organization Representative (AOR) role on Grants.gov

 

Step 5: Track Role Request Status

 

Steps 1 through 5, in detail, can be found at:

http://www.grants.gov/web/grants/applicants/organization-registration.html

 

Step 6: Register with eRA Commons

 

5. If the study intends to provide support for specific product development under an active IND or IDE, the corresponding IND or IDE must be referenced.  Any proposed changes to an IND or IDE should be submitted to the applicable FDA IND/IDE review division a minimum of 30 days before the grant application deadline.  An IND or IDE, however, is not required for an application to be eligible.

 

6. Application materials will open via Grants.gov approximately 60 days prior to the application receipt date. At this time (and after their pre-application process has been completed), applicants can download a copy of the application package on Grants.gov, complete it offline, and then upload and submit their application by following the instructions in the Apply for Grants link on the website.

 

Note: Not all of the information in the Application Guide will apply to the Orphan Products Natural History Grant application.

 

7. We strongly encourage using the ‘‘Tips’’ posted on Grants.gov under the announcement number when preparing your submission. We also strongly encourage using the information contained in this document when preparing your submission.

 

Application Due Date:

October 14, 2016, by 11:59 PM Eastern Time.

 

Applicants are encouraged to apply early in order to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

 

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date.

 

Late applications are generally not accepted for this FOA.

 

Award Amounts:

Application budgets should reflect the actual needs of the proposed project and should not exceed the following in maximum total costs (direct and indirect) and maximum years of support:

 

Prospective Natural History Studies:

YR 01: $400,000

YR 02: $400,000

YR 03: $400,000

YR 04: $400,000

YR 05: $400,000

 

Retrospective Natural History Studies or Survey Studies:

YR 01: $150,000

YR 02: $150,000

 

Please refer to the RFA for more detailed descriptions of the types of studies and the budget duration limitations.

 

Section II. Tips for Completing Form SF424 (R&R)

 

This is not a full instruction guide and does not cover all sections of the SF424 (R&R) forms. Please refer to the applicable SF424 (R&R) Application Guide posted by NIH for detailed instructions on completing the SF424 (R&R) forms. The following are FDA/OPD specific items that you may need to complete the application.

 

Please note that the following page limitations do differ from NIH page limits:

·       Research Plan - maximum 25 pages

 

Applications may not be accepted for review and may be returned for the following reasons:

·       The applicant organization is ineligible.

·       The application is received after the specified receipt date.

·       The application is incomplete.

·       The application is not responsive to the Request for Applications (RFA).

·       The material presented in the application is insufficient to permit an adequate review.

·       The dollar amount requested in the application exceeds the recommended threshold stated in the RFA.

 

A. SF424 (R&R) “APPLICATION FOR FEDERAL ASSISTANCE” (Page 1):

 

Type of Submission:

“Pre-application” is not used by this Agency.

 

OPD Hint: All applications submitted in response to the RFA in 2016 will be considered “Application” unless you are submitting a “Changed/Corrected Application” to make corrections to an already submitted application during this cycle.

 

Date Received by State/State Application Identifier:

Leave these fields blank.

 

Federal Identifier:

The “Type of Application” is “New” for 2016 submissions, thus leave the Federal Identifier field blank, unless you are submitting a “Changed/Corrected” application in which case you need to enter the grants.gov tracking number (########) previously assigned.  

 

Agency Routing Number:

Leave this section blank as it is not used by this Agency.

 

Type of Application:

All applications submitted in response to the 2016 RFA are “New” applications.

 

Name of Federal Agency:

Enter “Food and Drug Administration” in this block.

 

Descriptive Title of Applicant’s Project:

In the title block, be sure to include ALL of the following information in the order provided:  (1) Type of study (Retrospective, Prospective or Survey); (2) Name of the disease/condition to be studied; and (3) Brief summary/description of the study’s purpose. 

 

OPD Hint: Please note that the title field is limited to 200 characters, including the spaces between words and punctuation.  An appropriate descriptive title example is “Prospective/Retrospective/Survey Natural History Study in Disease to XXXX”.

 

OPD Hint: Use abbreviations as needed to ensure the descriptive title information is not truncated.

 

Proposed Project (Start and Ending Date):

Start Date: This should be the date that the study is proposed to begin, not necessarily the date funding is expected.

 

Ending Date: This should be the date that the study is proposed to end.

 

B. SF424 (R&R) “APPLICATION FOR FEDERAL ASSISTANCE” (Page 2):

 

Estimated Project Funding:

Total Federal Funds Requested:

Enter total (direct and indirect) Federal funds requested from OPD for the entire project period.   Please note that for Prospective Natural History Studies, the application budget should not exceed the maximum of $400,000 total costs (direct and indirect) per year for a maximum of 5 years of support. For Retrospective Natural History Studies or Survey Studies, the application budget should not exceed the maximum of $150,000 total costs (direct and indirect) per year for a maximum of 2 years of support.

 

Total Non-Federal Funds Requested:

Enter total amounts that will be used for this study that are not from federal sources. Please include sources and more detailed information on allocations in the budget justification sections.

 

C. SF424 “RESEARCH & RELATED Other Project Information”:

 

Human Subjects:

Most applications will involve human subject participation, and will not be exempt from Federal regulations regarding human subject protection. Check “no” to the question “is the project exempt from Federal regulations?”

 

Vertebrate Animals:

“No” should be checked to “are vertebrate animals used.”

 

Project Summary/Abstract (Project Description):

The Project Summary must contain a concise, self-contained summary of the proposed study suitable for dissemination to the public. It should be informative to other persons working in the same or related fields and, insofar as possible, understandable to a scientifically or technically literate lay reader. The Project Summary is meant to serve as a succinct and accurate description of the proposed work when separated from the application. State the application’s broad, long-term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the OPD Natural History Grants Program). The objectives of the project should be clearly stated by including such items as a brief background and rationale, hypotheses and expected results, specific aims, unique features, and study design and methods for achieving the stated goals. Avoid describing past accomplishments and use of first person. Do not include proprietary or confidential information or trade secrets, as this description may be used for purposes other than review.

 

OPD Hint: Be concise and succinct, but complete as there is a one page limit for this section (no longer than 30 lines of text). This page limit is based on a single-spaced page with 0.5 inch margins in 11 point font or larger. An abstract which exceeds this allowable length may be flagged as an error by the Agency upon submission. This would require a corrective action before the application can be accepted.

 

Project Narrative (Public Health Relevance Statement):

This section represents a second component of the Project Summary, which is Relevance. In two or three sentences, describe the relevance of the project to public health using succinct, plain language that can be understood by a general, lay audience. There is a one page limit for this section.

 

Facilities and Other Resources:

Describe the resources available at each performance site. Describe how the scientific environment and existing resources in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, intellectual rapport, and database platforms).  Describe any special facilities used for working with biohazards or other potentially dangerous substances. Information about select agents must be described in the Research Plan (Select Agent Research).

 

Note: Clinical Resources associated with the study performance site(s) need to be described in detail. For example, for a prospective study, a discussion of the resources available to the applicant to show that adequate enrollment can be achieved within the proposed timeframe of the study should be included, such as the number of patients presenting to the clinic yearly with the disease or condition that meet the proposed entry criteria of the study along with a discussion of any competing clinical trials or other potential barriers that may limit enrollment. For a retrospective study, agreements and/or consent to show that the applicant has access to existing medical records and registry data should be provided.

 

Other Attachments: Foreign component:

Please provide justification if the proposed study requires the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (US), or if the study requires the use of these to augment existing US resources. Indicate how the proposed project has specific relevance to the mission and objectives of FDA and has the potential for significantly advancing sciences in the United States.

  

“Senior/Key Person Profile (Expanded) Form”:

Provide a Biographical Sketch (biosketch) for each senior/key person involved with the study. Key personnel include all principal investigators, co-investigators, and performance site investigators responsible for the design and conduct of the study.

 

OPD Hint: A sample of a completed biosketch can be found at https://grants.nih.gov/node/826.

 

Budget:

The FDA OPD Grants Programs use the Research & Related (R&R) Budget Component.

 

The RFA specifies that for Prospective Natural History Studies, the application budget should not exceed the maximum of $400,000 total costs (direct and indirect) per year for a maximum of 5 years of support. For Retrospective Natural History Studies or Survey Studies, the application budget should not exceed the maximum of $150,000 total costs (direct and indirect) per year for a maximum of 2 years of support

 

Applicants must provide a detailed budget for each requested year and attach a budget justification.

 

The budget justification should:  

·       Clearly explain the rationale for all costs requested in the proposed project.

·       Include a rationale if the budget has more than a standard escalation from the initial to the future year(s) of support.

·       Explain any exclusions applied to the Facilities and Administrative (F&A) base calculation.

·       Provide a rationale if any of the requested costs are higher than usual and customary.

·       Be appropriate for the length of the study and not be padded to meet the maximal limitations of the RFA. 

·       Correlate with all costs specified in the detailed budget. 

·       State if the overall costs for the proposed study exceeds the limitations of this funding mechanism, and if so, explain how the additional costs to complete the proposed study will be covered (i.e., other grants, corporate funding, etc).

·       State if other grants have been or will be applied for, and describe contingency plans should those funds not be obtained.

 

Note: The PHS 398 Modular Budget program does not apply to the OPD Natural History grant program and should not be used.

 

Budgets for Multiple Institutions: “R&R Subaward Budget Attachment(s) Form”:

When multiple institutions are involved, one institution must be designated as the primary institution and funding for the other institution(s) must be requested via a subcontract to be administered by the primary institution. Individual budgets for all institutions that will be subcontracts should be attached separately to the Research & Related Subaward Budget Attachment(s) Form. A separate budget justification should also be submitted for each subaward.

  

D. SF424 “PHS 398 Research Plan”:

The goal of the Orphan Products Natural History Grants Program is to support studies that advance rare disease medical product development through characterization of the natural history of rare diseases/conditions, including identification of genotypic and phenotypic subpopulations, and development and/or validation of clinical outcome measures, biomarkers and/or companion diagnostics.  Each application should propose one discrete study designed to advance rare disease medical product development through characterization of the natural history of a rare disease/condition. Natural History studies can be retrospective, prospective or surveys.

 

Application Type:

All applications submitted in response to the 2016 RFA will be “New” applications as noted on SF424 (R&R) Page 1 item 8.

 

Research Plan Attachments:

The Research Plan should include sufficient information for evaluation of the project independent of other documents such as previous applications. Be specific and informative, and avoid redundancies.

 

Note: Each of the items below should be saved and attached as a single file. Begin each text section of the Research Plan with a section header: Introduction, Specific Aims, Research Strategy, etc.

 

OPD Hint: Please follow the page limitations for each section. Agency validations will include checks for page limits, which may result in errors. However, while these computer validations help minimize incomplete and/or noncompliant applications, they do not replace the validations conducted by FDA staff. Applications found not to comply with the requirements at any point may delay the review process.

 

Introduction to Application (Resubmitted or Revised Applications only):

Does not apply as all applications being submitted in response to the 2016 RFA are New Applications.

 

Specific Aims:

This section is limited to 1 page. Generally, this section begins with a brief narrative describing the overall goals and objectives of the project and the hypothesis to be tested followed by a list of the Specific Aims. State concisely the specific objectives of the proposed research and summarize the specific aims and expected outcomes, including the potential impact the results of the proposed research will exert on the research field(s) involved. This section should succinctly list the specific objectives of the research proposed, e.g., to characterize the natural history of a rare disease, delineate genotypic/phenotypic variations, describe emerging symptoms due to change in standard of care, identify and validate biomarkers, develop clinical outcome measures, and/or assist in the development of a new treatment(s).

 

Research Strategy:

The entirety of the Research Strategy Section is limited to 25 pages for the OPD Natural History Grants Program. Please note, FDA does not follow the order/headings that are included in the NIH’s 424 R&R Application Guide. The following are suggestions for the organization of this Section:

 

Background and Significance:

·       Applicants must include documentation, supplemented by authoritative references, to support that the estimated prevalence of the rare disease or condition in the US is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the US per year). If applicable, if you have received or applied for Orphan Drug designation, please include your designation number and date of submission in this section. Additional information regarding the population estimate and rationale may be required upon request.

·       Applicants must include the landscape of the disease including what the current treatment options and standard of care options are for this rare disease, what is being done in terms of assisting product development currently for this rare disease, what competing natural history studies are ongoing, and how this study will progress the existing knowledge.

·       Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. Describe the state of existing knowledge, including literature citations and highlights of relevant data and explain the gaps that the project is intended to fill. Show that the objectives are attainable within a stated time frame.

·       Include information on Preliminary Studies. Discuss the PD/PI’s preliminary studies, data, and/or experience pertinent to the application, or any other study results to support the proposed study. Provide full details including citations for any published studies used in support of this application.

·       If a retrospective chart review or survey is being proposed, provide justification of why a retrospective study is proposed versus a prospective study for the rare disease and what impact this data will make on the field.

·       Explain how the proposed study will either help support product approval or provide essential data needed for product development. If the study intends to provide support for the development of a specific product under an active IND or IDE, the corresponding IND or IDE must be referenced. An IND or IDE, however, is not required for an application to be eligible.

 

Study Plan:

·       Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the proposed study. Include a brief description of the study design, how data will be collected, analyzed, and interpreted, as well as any resource sharing plans as appropriate. Please provide the complete protocol in an appendix along with informed consent forms (see Appendix below).

·       Explain how patient/stakeholder input was included in study design and data elements of interest.

·       Discuss challenges, potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.

·       If applicable, the statistical analysis should be described in adequate detail to show that the power of the study is sufficient to detect a meaningful benefit.

·       If a prospective study is being proposed, the study plan section must include details of a proposed interim analysis to be conducted to report on findings, progress, and need for continuing the study.

·       Describe plans for data dissemination and future analyses.  Plans for sustainability should be described if a long-term prospective study is proposed. 

 

Note: If an applicant has multiple Specific Aims, the applicant may address Significance and Study Plan for each Specific Aim individually, or may address Significance and Study Plan for all of the Specific Aims collectively.

 

Protection of Human Subjects:

The purpose of this section is to describe the involvement of human subjects to ensure the protection of the rights and welfare of the participants in a research project:

·       Describe the proposed involvement of human subjects in the work outlined in the Research Strategy section. Describe and justify the characteristics of the subject population, including their anticipated number, age range, and health status if relevant. Describe and justify the sampling plan, as well as the recruitment and retention strategies and the criteria for inclusion or exclusion of any subpopulation.

·       Explain the rationale for the involvement of special vulnerable populations, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

·       If relevant to the proposed research, describe procedures for assignment to a study group.

·       List any collaborating sites where human subjects research will be performed, and describe the role of those sites and collaborating investigators in performing the proposed research. Explain how data from the site(s) will be obtained, managed, and protected.

·       Describe the research material obtained from living individuals in the form of specimens, records, or data. Indicate who will have access to individually identifiable private information about human subjects. Provide information about how the specimens, records, and/or data will be collected, managed, and protected as well as whether material or data that include individually identifiable private information will be collected specifically for the proposed research project.

·       Describe the potential risks to subjects (physical, psychological, financial, legal, or other), and assess their likelihood and seriousness to the human subjects. Where appropriate, describe alternative treatments and procedures, including the risks and potential benefits of the alternative treatments and procedures, to participants in the proposed research.

·       Describe plans for the recruitment of subjects (where appropriate) and the process for obtaining informed consent. If the proposed studies will include children, describe the process for meeting requirements for parental permission and child assent. Consent forms, assent forms, and any other information given to a subject, even if in draft form, are a requirement of the RFA and should be sent with the grant application and included in an Appendix.

·       If applicable, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. Studies that involve clinical procedures must include a general description of the plan for data and safety monitoring and adverse event reporting to the IRB, the FDA, and others, as appropriate, to ensure the safety of subjects.

 

It is an OPD policy that data and safety monitoring of a natural history study is to be commensurate with the risks posed to study participants and with the size and complexity of the study. Risks imposed by natural history studies include mainly privacy issues and adverse events associated with invasive clinical procedures. The OPD requires that a Grantee and any third party engaged in supporting the clinical research be responsible for oversight of data and safety monitoring, ensuring that monitoring systems are in place, that the quality of the monitoring activity is appropriate, and that the OPD Project Officer is informed of recommendations emanating from monitoring activities.

 

Preliminary monitoring details including protocol adherence and data integrity should be submitted as part of the Research Plan portion of the grant application. The plan will be examined as part of the peer review process, including evaluating the informed consent documents as well as the plan to monitor the integrity of the data collected and protocol compliance. Any comments and concerns will be included in an administrative note in the summary statement. OPD staff will ensure that all concerns are resolved before a grant award is made. While IRB approval is not needed at time of submission of a grant application, IRB approval from the IRB of record must be on file with the FDA grants management office before an award to fund the study will be made. If IRB approval has been attained, please specify such in this section and include a copy of the approval letter.

 

Inclusion of Women and Minorities:

This section is required for applicants answering “yes” to the question “Are human subjects involved?” on the R&R Other Project Information Cover Page and the research does not fall under Exemption 4.

 

Applicants for PHS clinical research grants are encouraged to include minorities and women in study populations so that research findings can be of benefit to all people at risk of the disease or condition under study. It is recommended that applicants place special emphasis on including minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy applies to research subjects of all ages. If women or minorities are excluded or poorly represented in clinical research, the applicant should provide a clear and compelling rationale that shows their inclusion is inappropriate.

 

Targeted/Planned Enrollment:

Provide a description of the planned enrollment of research subjects and their distribution by ethnicity/race and sex/gender by attaching the following form:  Enrollment

 

Inclusion of Children:

FDA regulations at 21 CFR parts 50, subpart D contain additional requirements that must be met by IRBs reviewing clinical investigations regulated by FDA and involving children as subjects. FDA is part of HHS; accordingly, the research project grants under this program are supported by HHS, and HHS regulations at 45 CFR parts 46, subpart D also apply to research involving children as subjects.

 

Vertebrate Animals:

Not applicable for OPD grants.

 

Select Agent Research:

Typically not applicable for OPD grants.

 

Multiple PD/PI Leadership Plan:

For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. For applications designating multiple PD/PIs, all such individuals must be assigned the PD/PI role on the Senior/Key Profile form, even those at organizations other than the applicant organization. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, the process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

 

Consortium/Contractual Arrangements:

Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee. The signature of the Authorized Organization Representative on the SF424 (R&R) cover form (Item 17) signifies that the applicant and all proposed consortium participants understand and agree to the following statement:

 

The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the agency’s consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy.

 

Describe any contractual arrangements briefly. This would include such things as collaborating clinical study sites or subcontracts to groups providing data access, data monitoring/auditing, laboratory, or statistical services. Include any letter of support in the “Letters of Support” Section.

 

Letters of Support (e.g., Consultants):

Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. Examples of letters that should be included in this section include:

 

        A letter of collaboration from each PD/PI at all clinical sites outside of the primary clinical site acknowledging their commitment to the study.

        Letters acknowledging a subcontracted service such as data management, statistical support, consulting services, or testing services.

        Letters of support from individuals serving on a steering committee or DSMB.

        Provision of a plan to include patient/stakeholder input in study design and data elements of interest.

 

Provide letters from each explaining how they will support the study. Letters should include what the rates/charges for services will be, if applicable. If letters note rates/charges, please make sure the costs corroborate with those specified in the budget section.

 

Resource Sharing Plan(s):

Not applicable for OPD grants.

 

Appendix:

The appendix should include the following items:

 

        Complete, detailed protocol.

        Informed consent/assent form(s) and other documents provided to patients.

        Investigator’s brochure (if applicable).

        Copies of publications supporting research strategy and prevalence estimates.

        IRB approval letter (if available).

        Correspondences between the applicant and the FDA Review Division regarding the clinical trial (if applicable)

        A copy of the applicant’s orphan drug designation letter (if applicable).

        Surveys, questionnaires, and other data collection instruments.

        Financial support records such as other grants obtained, private funding secured, etc. to complete the study.

        Letters of collaboration/support for the conduct of the study.

 

Items that should not be included in the appendix:

 

•   Photographs or color images of gels, micrographs, etc., are no longer accepted as Appendix material. These images must be included in the  Research Strategy PDF. However, images embedded in publications are allowed.

•   Publications that are publicly accessible. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References cited section, the Progress Report Publication List section, and/or the Biographical Sketch section.

 

Note: All attachments must in PDF format only and not be password protected. There is a limit of 10 appendices total. If the pages in any attachment are greater than 11 x 11 inches or less than 8.5 x 8.5 inches, please adjust with software that can change the page size from actual to an 8.5 x 11 inch size. See the applicable SF424 (R&R) Application Guide at http://grants.nih.gov/grants/how-to-apply-application-guide.htm for page limitations and appendix guidance in detail.

 

Applicants are encouraged to be as concise as possible while including the information needed for expert scientific review of their proposal; however, the appendices should not be used to circumvent page limitations, such as the specified page limit for the Research Strategy.

 

OPD Hint: It is recommended that all appendices be given a name that is meaningful to reviewers rather than relying on sequential order.  Appendix material may not appear in the assembled application in the order attached, so it is important to use filenames for attachments that are descriptive of the content.  A summary sheet listing all of the items included as appendices is also encouraged, but not required. When including a summary sheet, it should be included in the first appendix attachment. Applications that do not follow the appendix requirements may be delayed in the review process.

 

E. Other Information:

 

Please be aware that the following documentation must be received by the FDA before an award is made:

·       Federal Wide Assurance

Federal Wide Assurance (FWA or assurance) obtained from Office for Human Research Protections (OHRP) for the IRB of record for all performance sites must be on file with the FDA grants management office before an award to fund the study will be made. No awardee or performance site institution may spend funds on human subject research or enroll subjects without the approved and applicable assurance(s) on file with OHRP.

·       IRB of Record

Any institution receiving Federal funds must have an institutional review board (IRB) of record even if that institution is overseeing research conducted at other performance sites. An awardee institution must have its own IRB of record. The IRB of record may be an IRB already being used by one of the “performance sites,” but it must specifically be registered as the IRB of record with the OHRP.

·       IND/IDE

All new and continuing grants which have referenced INDs/IDEs must comply with all regulatory requirements necessary to keep the status of their IND/IDE active and in effect, that is, not on clinical hold. Only medical foods that do not need pre-market approval and devices that are classified as non-significant risk (NSR) are free from these IND/IDE requirements. Please note that IND/IDEs are not required to apply or be funded.

 

Useful links:

OOPD Web Page:

(http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/ucm2005525.htm)

 

RFA Link:

(http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-16-043.html)

Grants 101:  

http://www.grants.gov/web/grants/learn-grants/grants-101.html

 

eRA:

Creating User Accounts

(http://grants.nih.gov/grants/ElectronicReceipt/files/Grantee_Registration_Process_for_Commons.pdf)

(https://commons.era.nih.gov/commons-help/174.htm)   

 

Federal Wide Assurance:

Office for Human Resource Protections

(http://www.hhs.gov/ohrp/)

(http://ori.hhs.gov/reg-sub-part-a)

(http://ori.hhs.gov/phs-admin-action-bulletin-board)

 

Data Universal Number System (DUNS) number:

(http://fedgov.dnb.com/webform)

 

System for Award Management (SAM): Federal Contractor Registry disclaimer icon

 

Credential Provider registration:

(https://apply07.grants.gov/apply/OrcRegister)

 

HHS/Financial Management:

(https://rates.psc.gov/)

 

Orphan Research Grants Program Resource List:

Grants.Gov Submitting your Application (http://grants.nih.gov/grants/submitapplication.htm)

NIH Forms and Applications (http://grants.nih.gov/grants/forms.htm)

 

Salary Cap Summary (FY 1990 to Present)

(http://grants.nih.gov/grants/policy/salcap_summary.htm)

 

Grants.gov Registration Instructions for Domestic and Foreign Organizations:

Grantee Registration Process in NIH eRA Commons: Detailed Steps

(http://grants.nih.gov/grants/ElectronicReceipt/files/grantee_registration_process_for_commons.pdf)

 

Additional Grants.gov Electronic Submission Process Resources:

(http://www.grants.gov/web/grants/applicants/applicant-faqs.html)

(http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm)