Instructions for phs 398 and sf 424(R&R) Form Approved Through 08/31/2015




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5.9 Research on Transplantation of Human Fetal Tissue


In signing the application Face Page, the Authorized Organization Representative of the applicant organization certifies that if research on the transplantation of human fetal tissue is conducted, the applicant organization will make available, for audit by the Secretary, DHHS, the physician statements and informed consents required by section 498A (b)(2) and (c) of the Public Health Service Act, 42 U.S.C. 289g (b)(2) and (c), or ensure DHHS access to those records, if maintained by an entity other than the applicant organization.

5.10 Research Using Human Embryonic Stem Cells


In signing the application Face Page, the Authorized Organization Representative of the applicant organization certifies that if research using human embryonic stem cells is proposed, the applicant organization will identify hESCs to be used from the NIH Registry (http://stemcells.nih.gov/research/registry/), or, if a specific cell line cannot be referenced at the time of application, certify that one from the NIH Registry will be used, in accord with the NIH Guidelines on Human Stem Cell Research (http://stemcells.nih.gov/policy/2009guidelines.htm). See http://stemcells.nih.gov/index.asp for additional information on stem cells, and http://stemcells.nih.gov/policy/guidelines.asp for Federal policy statements and guidelines on federally funded stem cell research.

5.11 ClinicalTrials.gov Requirements


In signing the application Face Page (or for electronic applications, in checking the “I agree” box on line 17 of the SF424 (R&R) Cover component), the Authorized Organization Representative of the applicant organization certifies that if the research is an applicable clinical trial under Public Law 110-85, the applicant organization will be in compliance with the registration and reporting requirements of Public Law 110-85 (see Part III, Section 2.1.6).

PART III

Policies, Assurances, Definitions,


and Other Information


1. Policy

1.1 Applications That Include Consortium/Contractual Facilities and Administrative Costs


See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

NIH policy provides for exclusion of consortium/contractual F&A when determining if an applicant is in compliance with a direct cost limitation. This policy extends to all applications involving consortium/contractual facilities and administrative (F&A) costs, regardless of budget amount or budget format (e.g., modular and non-modular). (See also Notice OD-04-040.)

This policy applies to all solicited and investigator-initiated applications and to all active announcements (Request for Applications and Program Announcements), regardless of the announcement issue date.

This policy is particularly relevant to all applications that include a limitation on direct costs. While consortium F&A costs will continue to be requested and awarded, applicants should separate these costs when determining if a budget exceeds a direct cost limit.

This policy impacts eligibility to submit a modular budget. The modular budget format is used for applications requesting $250,000 or less in direct costs per year. Consortium/contractual F&A costs are not factored into this direct cost limit and may be requested in addition to the $250,000.

The policy also impacts applications requesting a budget of $500,000 direct costs or more for any year. These applications require prior approval from Institute/Center staff; however, the limit is exclusive of any consortium F&A costs.

The implications of this policy do not affect the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs since the statutory budget guidelines are based on total costs, not direct costs.

1.2 Resubmission of Unpaid RFA Applications and Resubmission of Applications with a Changed Grant Activity Code


See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html.

The majority of grant applications submitted to NIH each year are investigator-initiated. However, the Institutes and Centers of NIH also solicit grant applications on specific topics through the use of Requests for Applications (RFAs). Resubmissions of grant applications fall into the following categories:

1. Applications that were originally submitted in response to an RFA and then resubmitted as an investigator-initiated application.

2. Applications that were originally submitted as investigator-initiated applications and subsequently resubmitted in response to an RFA.

3. Applications that were originally submitted using one activity code and subsequently resubmitted using a different activity code (for example, an application that was originally an R01 and is resubmitted as an R21).

Since an RFA often has special considerations of eligibility, scientific scope, and review criteria, unfunded RFA applications must be resubmitted as new applications to another FOA. Similarly, a change of activity code (e.g., from an R01 to an R21, or from an R03 to an R01) usually involves a change of eligibility criteria, application characteristics, dollar limits, or time limits. This also suggests that consideration as a new application is the most appropriate course. Because the application will be new it will be easier to conform to the new application requirements, which should be an advantage to the applicant in the review process. Additionally, submission of a new application will allow the applicant to benefit fully from the NIH policy that allows an applicant one resubmission (see http://grants.nih.gov/grants/policy/amendedapps.htm).

NEW APPLICATIONS: The new application must be submitted on the scheduled due dates for new applications (see http://grants.nih.gov/grants/funding/submissionschedule.htm). Do not include an Introduction describing the changes and improvements made and do not mark text to indicate the changes. Although the investigator may still benefit from the previous review, the applicant should not explicitly address reviewers’ comments. The reviewers will not be provided with the previous Summary Statement. The investigator will be allowed to submit the new application and one resubmission of the application, should that be necessary.

POLICY: This general policy on application resubmission, stated below, applies to all grant applications that might be solicited via an RFA and to instances where there is a change in activity code. There may, however, be exceptions to this policy, which will be clearly identified in the original RFA or in a follow-up RFA.

1. When an application that was submitted in response to an RFA is not funded and the investigator wishes to resubmit an application on this topic as an investigator-initiated application, it is to be submitted as a new application, unless provision for a resubmission application is clearly delineated in the RFA. In addition, if a subsequent RFA specifically solicits resubmissions of unfunded applications from a previous RFA, the instructions in the second RFA should be followed. In all other cases, an application submitted in response to an RFA and then resubmitted as an investigator-initiated application must be prepared as a new application.

2. When a previously unfunded application that was originally submitted as an investigator-initiated application is to be submitted in response to an RFA, it is to be prepared as a new application.

3. When an unfunded application that was reviewed for a particular research grant activity code (for example, R01) is to be submitted for a different activity code (for example, R03), it is to be prepared as a new application.

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