and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Eye Institute (NEI) |
|
Funding Opportunity Title |
NEI Administrative Supplements to Small Business Innovative Research (SBIR) Grants for the Procurement of Expertise in the Federal Regulatory Approval Process for New Drugs and/or Devices (Admin Supp) |
Activity Code |
Administrative Supplement Additional funds may be awarded as supplements to parent awards using the following Activity Code(s): Administrative supplement requests may be submitted electronically for the following activity codes: |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PA-14-205 |
Companion Funding Opportunity |
None |
Only one application per parent award is allowed, as define in Section III. 3. Additional Information on Eligibility. |
|
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.867 |
Funding Opportunity Purpose |
NEI announces an Administrative Supplement opportunity available to eligible NEI awardees with active SBIR Phase I/II grants (see details below). These administrative supplements provide funds so that grantees can procure the services of consultants who are knowledgeable in the Federal regulatory process for approval of new drugs and/or devices. The purpose of these administrative supplements is to allow Small Business grantees to bring innovative vision and eye care products to the marketplace more efficiently. |
Posted Date |
May 2, 2014 |
Open Date (Earliest Submission Date) |
June 11, 2014 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
July 11, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
Not Applicable |
Advisory Council Review |
Not Applicable |
Earliest Start Date |
August 2014 |
Expiration Date |
July 12, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The Food and Drug Administration (FDA) is the primary regulatory agency ensuring the safety and high quality of medical products in the USA. As part of its mission, the FDA sets regulations and standards for the introduction of new medical products. Also, FDA approval is a requirement before a business may sell medical products in the USA. In recent times, therapeutics and medical devices have become increasingly complex, varied and rapidly changing. These characteristics are driven by the need for new and better treatments, and the emergence of new and innovative technologies. Consequently, the regulatory process of the FDA has become complex, varied, and more detailed. This complicated Federal regulatory environment poses daunting challenges to small businesses, since they may lack access to appropriate expertise in this arena.
These administrative supplements will allow NEI SBIR grantees to procure the much needed expertise to navigate the Federal regulatory process. NEI expects that each selected company will choose a consultant with ophthalmologic knowledge and expertise appropriate to the company s technology/product. The consultant should assist in developing a comprehensive regulatory plan aimed at optimizing the company's passage through the FDA approval process. This plan should identify the company's goals for its product, the appropriate regulatory path, and a likely regulatory strategy.
Funding Instrument |
The funding instrument will be the same as the parent award. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
Non-competing Administrative Supplements |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NEI expects to award ten supplements. |
Award Budget |
Application budgets are limited to no more than $25,000 and must reflect the actual needs of the proposed project. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes. |
Award Project Period |
The project and budget periods must be within the currently approved project period for the existing parent award. A minimum of three months must be remaining on the existing parent award. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
All organizations administering an eligible parent award may apply for a supplement under this announcement.
For-Profit Organizations
Only NEI-funded R43/R44 SBIR grantees are eligible to apply.
This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.
IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Only NEI-funded R43/R44 SBIR grantees are eligible to apply.
Individual(s) must hold an active grant or cooperative agreement, and the
research proposed in the supplement must be accomplished within the competitive
segment of the active award. Individuals are encouraged to work with their
organizations to develop applications for support.
For supplements to parent awards that include multiple PDs/PIs, the supplement
may be requested by any or all of the PDs/PIs (in accordance with the existing
leadership plan) and submitted by the awardee institution of the parent award. Do
not use this administrative supplement application to add, delete, or change
the PDs/PIs listed on the parent award. Visit the Multiple Program
Director/Principal Investigator Policy in the SF424 (R&R) Application Guide
for more information.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one supplement application per parent award is allowed.
Applicants must prepare applications using current forms in accordance with the Application Guide.
For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this announcement, or use the eRA Commons streamlined submission process.
All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent
award.
It is critical that applicants follow the instructions in the Application Guide
(SF424
(R&R) Application Guide or PHS 398
Application Guide, as appropriate) except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
All page limitations described in the Application Guide and the Table of Page Limits must be followed.
Electronic submission of request for administrative supplements is only available for single-project activity codes for which competing applications are submitted electronically. Visit the list of single-project Activity Codes Processed Electronically by eRA to determine if the single-project activity code of the parent award has transitioned to electronic submission. Submission of requests for administrative supplements for all other activity codes must use paper.
If the administrative supplement may be submitted electronically, then you may either (A) submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, (B) submit using the streamlined submission process of eRA Commons, or (C) submit using the paper-based PHS 398 Application forms and the PHS 398 Application Guide.
Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.
Instructions for Submissions using Grants.gov/Apply for electronic-based submissions
For single project grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Form. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms.
Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions
NIH now offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available.
Include the Research Strategy and any other required documentation (described below) as a PDF file using the Add Other Attachments function. Budget information should be entered for the grantee institution in the fields provided. There is no template or form available for subaward information; instead, all subaward information should be included as a separate attachment showing the funds requested (by budget period) using the same categories provided for the grantee institution. Also include a budget justification for the subawardee institution in the same file.
Instructions for Submissions using the PHS 398 Application Forms (for paper-based submissions)
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:
Jerome R. Wujek, Ph.D.,
Group Leader, Small Business Innovative Research Program
National Eye Institute (NEI)
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-9300
Telephone: 301-451-2020
Fax: 301-402-0528
Email: [email protected]
On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.
All instructions in the Application Guide must be followed for all Research Plan sections applicable to the proposed supplement activities. At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
All instructions in the Application Guide must be followed, with the following additional instructions:
All instructions in the Application Guide must be followed, with the following additional instructions:
All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, and should only include funds requested for the additional supplement activities.
A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, and should only include funds requested for the additional supplement activities.
All instructions in the Application Guide must be followed, with the following additional instructions:
IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions)
If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.
The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.
When conducting clinical research, follow all instructions for completing the Planned Enrollment Report as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing the Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications as described above. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
For electronic application submission, information on the
submission process and a definition of on-time submission are provided in the SF424(R&R)
Application Guide.
For paper-based application submission, information
on the process of receipt and determining if your application is considered
on-time is described in detail in the PHS 398 Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted using the instructions specified above.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
For applications submitted electronically on the SF424
(R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID
in the Credential field of the Senior/Key Person Profile form of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the (SAM). Additional information may be found in the Application
Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and/or responsiveness by the awarding Institute or Center. Applications that are incomplete and/or nonresponsive will not be reviewed.
Not Applicable
Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.
The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:
Budget and Period of Support
NIH Staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Overall Impact
Applications will be judged on the basis of company need, underlying technology, and commercial potential. Start-up and/or inexperienced companies will be given preference.
NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:
Will the administrative supplement increase or preserve the likelihood for the small business to advance the therapeutic/device through the FDA regulatory process?
In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.
Protections for Human Subjects:
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, NIH staff will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, NIH
staff will evaluate: 1) the justification for the exemption, 2) human subjects
involvement and characteristics, and 3) sources of materials. For additional
information on review of the Human Subjects section, please refer to the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
NIH Staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
NIH Staff will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.
Not Applicable
A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications.
This may be as an NoA for the supplemental activities only; alternatively, it
may be as either a revision to the current year NoA or included as part of a
future year NoA. The NoA signed by the grants management officer is the
authorizing document and will be sent via email to the grantee’s business
official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.
Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Non-Competing Grant Progress Report, PHS 2590 or RPPR, and financial statements as required in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA
Commons Help Desk (Questions regarding eRA Commons registration, submitting
and tracking an application, documenting system problems that threaten
submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
Jerome Wujek, Ph.D
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
Not Applicable
William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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