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Phase II Grants. If the applicant small business concern has currently effective negotiated indirect costs rates with a federal agency, such rates should be used when calculating proposed indirect costs. (However, these rates must be adjusted for independent [self-sponsored] research and development expenses, which are not allowable by the Department of Health and Human Services. A full discussion of "Indirect Costs" is contained in the SBIR and the STTR solicitations.) If the applicant small business concern does not have currently effective negotiated indirect costs rates with a federal agency, the applicant organization should propose estimated actual indirect costs. If being considered for an award, the applicant small business concern would be asked to submit detailed documentation justifying the proposed rate if it exceeded 25 percent of the total direct costs. However, applicant organizations are reminded that only actual indirect costs are to be charged to projects.
The Department of Health and Human Services (HHS) has specified requirements for non-Federal audits of for-profit (commercial) organizations in HHS' Title 45, Code of Federal Regulations (CFR), Part 74.26 , "Non-Federal Audits." Per the regulations, a for-profit (commercial) organization is subject to audit requirements for a non-Federal audit if, during its fiscal year, it expended $500,000* or more under HHS awards and at least one award is a HHS grant or subgrant. Title 45 CFR Part 74.26 essentially incorporates the thresholds and deadlines of Office of Management and Budget (OMB) Circular No. A-133, "Audits of States, Local Governments and Non-Profit Organizations," but provides for-profit organizations with two options regarding the type of audit that will satisfy the audit requirements either:
[* Note: The threshold was $300,000 for audits of fiscal years ending before January 1, 2004.]
Audits shall be completed and submitted to the following office within a period of time that is either (1) the earlier of 30 days after receipt of the auditor's report(s), or (2) nine months after the end of the audit period (that is, the organization's fiscal year):
Department of Health and Human Services
Office of Inspector General
Office of Audit Services
National External Audit Review Center
1100 Walnut Street, Suite 850
Kansas City, MO 64106-2197
Phone: 800-732-0679 or 816-426-7725
The HHS will be identifying organizations not meeting audit requirements. Failure to comply may jeopardize eligibility for receiving future HHS awards.
For more information about audit requirements, see the information posted at the NIH Division of Financial Advisory Services website, Non-Federal Audit Requirements for Commercial (For-Profit) Organizations http://oamp.od.nih.gov/dfas/dfas_faq.asp.
The NIH will consider no more than two amendments to an application for extramural support. As of May 7, 2003, there is no longer a time limit for the submission of the first and second revisions. This policy applies to all NIH extramural funding mechanisms. (See Revised NIH Policy on Submission of a Revised [Amended] Application, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-041.html.)
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