Dear Institutional Official:

As the recipient of a grant or cooperative agreement (hereinafter referred to as grant) from the National Institutes of Health (NIH), there is a great deal of information that your organization will need in order to be successful. This letter highlights key requirements, provides referrals to important sources of information, and identifies NIH and other Department of Health and Human Services (HHS) offices that have responsibility for certain administrative functions. Information available through these resources is critical to those with responsibility for the administrative and fiscal management of NIH grant awards. This letter can also be helpful to established grantee organizations because it updates previous issues and cites new and current provisions.

Requirements and Provisions

Terms of Award

Acceptance of a grant award from NIH carries with it the responsibility to be aware of and comply with the terms and conditions of award. Each Notice of Grant Award (NGA) states:

“…This award is based on the application submitted to, and as approved by, the NIH . . . and is subject to the terms and conditions incorporated either directly or by reference in the following:

• Grant program legislation and program regulation cited in this Notice of Grant Award.
• Restrictions on the expenditure of Federal funds in appropriation acts, to the extent those restrictions are pertinent to the award.
• Code of Federal Regulations/Regulatory Requirements - 45 CFR Part 74 or 45 CFR Part 92 as applicable.
• The National Institutes of Health Grants Policy Statement (NIHGPS) in effect at the beginning date of the budget period.
• The award notice including any special terms and conditions….”

The National Institutes of Health Grants Policy Statement

The NIHGPS (revised 12/03) is a term and condition for all NIH grant awards. NIHGPS, Part II, Terms of Award contains the legally binding requirements for all grant recipients. By drawing funds from the appropriate payment system, the grantee agrees to the terms and conditions of an award.

The NIHGPS covers policy topics such as expanded authorities, modular applications, SNAP (streamlined non-competing award process), prior approval requirements, and awards to foreign entities. A search mechanism is provided to facilitate easy access to the information that is contained within the NIHGPS.

PDF and HTML versions of the NIHGPS are at: http://grants.nih.gov/grants/policy/nihgps_2003/index.htm.

45 CFR Part 74 and 45 CFR Part 92

Administrative regulations found at Title 45, Code of Federal Regulations (CFR), Parts 74 and 92, are the HHS rules and requirements that govern the administration of grants. Part 74 is applicable to all recipients except those covered by Part 92, which governs awards to state and local governments. As is the case for the NIHGPS, these regulations are a term and condition of award. Grant recipients must be aware of and comply with the regulations.

The CFR volume that includes Parts 74 and 92 can be accessed from HHS GrantsNet (http://www.hhs.gov/grantsnet/). Hard copy can be ordered by calling 202-512-1800, emailing ContactCenter@gpo.gov, or by writing to:

U.S. Government Printing Office
Superintendent of Documents732 North Capitol St., NW
Mail Stop SSOP
Washington, D.C. 20401

Reporting Requirements

Financial Status Report (FSR) (SF 269 or 269A) - Reports of expenditures are required as documentation of the financial status of grants according to the official accounting records of the grantee organization. Financial or expenditure reporting is accomplished using the SF 269 (long form) or SF 269A (short form). The long form (SF 269) must be used when reporting program income (see NIHGPS for further explanation of grant-related program income).

For grants that are not awarded under the Streamlined Non-Competing Award Process (SNAP), an FSR for each budget period must be submitted within 90 days after the close of the budget period (see NIHGPS). FSRs for grants subject to SNAP are due 90 days after the close of the competitive segment.

Institutions are strongly encouraged to submit FSRs electronically through the eRA Commons (see Electronic Research Administration below). This system will also allow institutions to view currently due and late FSRs.

FSRs for NIH awards that are submitted in paper format should be addressed to:

National Institutes of Health
Office of Financial Management
Attn: Government Accounting Branch
2115 East Jefferson Street , MSC 8500
Suite 4B432
Bethesda , MD 20892-8500 (regular or US Postal Service Express mail)
Bethesda , MD 20852 (other commercial courier mail delivery only)

Visit the Government Accounting Branch, OFM, website for an FSR point of contact list and FAQs at http://ofm.od.nih.gov/gov_acc.asp. 

See Payment Management System for information about payments for NIH grant awards and related reporting requirements.

Progress Report - All NIH grant awards require, at a minimum, an annual progress report, which is submitted using the Non-Competing Grant Progress Report ( PHS Form 2590). If a PHS 2590 will not be submitted because continuation support is not desired, a final progress report must be submitted within 90 days after the expiration or termination of the project (see NIHGPS). For those awards under SNAP, grantees are required to follow the special SNAP instructions in the PHS 2590.

Institutions are strongly encouraged to submit SNAP Progress Reports electronically through the eRA Commons (see Electronic Research Administration below). For non-SNAP grants, paper progress reports (original and one copy) must be submitted to the following centralized mailing address:

Division of Extramural Activities Support
Office of Extramural Research, NIH
6705 Rockledge Drive , Room 2207, MSC 7987
Bethesda , MD 20892-7287 (regular or US Postal Service Express mail)
Bethesda , MD 20817 (other commercial courier mail delivery only)

Inventions Report - The Bayh-Dole Act (P.L. 96-517) affords grantees the right to elect title and retain ownership to inventions they develop with funding under an NIH grant award (“subject inventions”).  In accepting an award, the grantee agrees to comply with applicable NIH policies, the Bayh-Dole Act, and its Government-wide implementing regulations found at Title 37, Code of Federal Regulations (CFR) Part 401. A significant part of the regulations require that the grantee report all subject inventions to the awarding agency (see NIHGPS), as well as include an acknowledgement of federal support in any patents. NIH participates in the trans-government Interagency Edison system ( http://www.iedison.gov) and expects NIH funding recipients to use this system to comply with Bayh-Dole and related intellectual property reporting requirements. The system allows for grantees to submit reports electronically via the Internet. In addition, the invention must be reported in continuation applications (competing or non-competing). Invention reporting information and questions should be directed as follows:

Division of Extramural Inventions and Technology Resources (DEITR),
Office of Policy for Extramural Research Administration (OPERA), OER, NIH
6705 Rockledge Drive, MSC 7980
Bethesda, MD 20892-7980
tel: 301-435-1986
e-mail: Edison@od.nih.gov

Invention reporting documents or questions pertaining to continuation applications should be directed to the NIH awarding Institute or Center, as specified on the NGA.

The invention also must be included on the Final Invention Statement and Certification (HHS 568), which is required within 90 days following the expiration or termination of the project (see NIHGPS.) The Final Invention Statement and Certification should be directed to the NIH awarding Institute or Center, as specified on the Notice of Grant Award, unless it is submitted through the NIH Commons. A downloadable version of the HHS 568 is at: http://grants.nih.gov/grants/hhs568.pdf or: https://s-edison.info.nih.gov/iEdison/hhs568.pdf.

Grantees are reminded that the above-mentioned reports are due at certain specific times during the life cycle of a grant award. It is important that all reports are accurate, complete, and submitted on time.

Protection of Human Subjects in Research

Every institution proposing to "engage" in human subjects research is required to obtain from the HHS Office for Human Research Protections (OHRP) a Federal-wide Assurance (FWA) that indicates that it will comply with the regulations pertaining to the protection of human subjects in research ( 45 CFR Part 46), unless the research is exempt under 45 CFR 46.101(b).

An institution becomes engaged in human subjects research when its employees or agents plan to (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes (45 CFR 46.102(d)(f)). An institution is automatically considered to be engaged in human subjects research whenever it receives a direct HHS award to support such research.

NIH awards permitting research involving human subjects will be made only after OHRP has issued an FWA to the institution. In addition, the grantee must provide certification to the NIH that the research has been reviewed and approved by an Institutional Review Board (IRB) within 12 months of the budget period start date, and that the research will be subject to continuing review by the IRB.

Instructions for obtaining FWAs and registering IRBs are found on the OHRP website. Obtaining FWAs and providing certification of IRB review and approval are "just-in-time" procedures (i.e., may be provided to NIH after peer review but prior to funding) as specified in the NIHGPS.

The grantee institution bears ultimate responsibility for protecting human subjects under the award, including human subjects at all collaborating sites, and for ensuring that collaborating sites have FWAs and certification of IRB review and approval before human subjects research is conducted.

Additional information is available on NIH websites regarding Human Subjects Research, Data Safety and Monitoring for clinical trials, required education for the protection of human research participants, and inclusion of women, minorities & children. "Protecting Human Research Subjects: Institutional Review Board Guidebook" is available at: http://www.hhs.gov/ohrp/irb/irb_guidebook.htm.

Care and Use of Laboratory Animals in Research

The Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) governs the use of all live vertebrate animals in activities supported by the NIH. This policy provides for institutional oversight of the humane use of animal research subjects and requires that domestic institutions follow the Guide for the Care and Use of Laboratory Animals . Awards involving the use of animals will not be made unless the NIH Office of Laboratory Animal Welfare (OLAW) has approved an Animal Welfare Assurance and the Institutional Animal Care and Use Committee (IACUC) has approved those components of the application related to the care and use of animals. Collaborating institutions and performance sites where animal work will be conducted under the award must also obtain the necessary Assurances. Except in exceptional circumstances, awards are not made until the institution provides verification of IACUC review and approval in accord with the NIHGPS. Obtaining Assurances and providing verification of IACUC approval are just-in-time procedures (i.e., may be provided to NIH after peer review but prior to funding).

Additional resources are available on the OLAW website, including a sample Animal Welfare Assurance, PHS Policy Tutorial, IACUC Guidebook, Guide for the Care and Use of Laboratory Animals , and Frequently Asked Questions. To obtain information regarding animal welfare assurance requirements contact:

Office of Laboratory Animal Welfare
Rockledge 1, Suite 360 , MSC 7982
6705 Rockledge Drive
Bethesda, MD 20892-7982 (regular or US Postal Service Express mail)
Bethesda, MD 20817 (other commercial courier mail delivery only)
tel: 301-496-7163
fax: 301-402-2803
e-mail address: olawdoa@mail.nih.gov

Recombinant DNA

Organizations planning to conduct research involving recombinant DNA, including human gene transfer, are required to comply with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). The NIH Office of Biotechnology Activities oversees the implementation of the NIH Guidelines.

Institutions subject to the NIH Guidelines must establish a standing Institutional Biosafety Committee. The requirements for the composition of this committee can be found in Section IV-B-2-a of the NIH Guidelines and are summarized at:http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm

For additional information contact:

Office of Biotechnology Activities
National Institutes of Health
6705 Rockledge Drive, Suite 750, MSC 7985
Bethesda, MD 20892-7985 (regular or US Postal Service Express mail)
Bethesda, MD 20817 (other commercial courier mail delivery only)
tel: 301-496-9838
fax: 301-496-9839
e-mail address: oba@nih.gov

Research Integrity and Research Misconduct

The HHS Office of Research Integrity (ORI) is responsible for implementing the assurance system related to procedures on scientific misconduct. An organization receiving NIH grant support for research is required to certify compliance with 42 CFR Part 93, Subpart A “PHS Policies on Research Misconduct." By signing the application, the Authorized Organizational Representative certifies that the organization has established administrative policies as required by the regulation. ORI requires an annual report (PHS Form 6349) detailing aggregate information on allegations, inquiries and investigations that were handled by a grantee organization. The annual report confirms that the organization has established internal policies and procedures and will comply with PHS regulations for reviewing, investigating and reporting allegations of misconduct in science conducted at, or sponsored by, the organization.

To obtain the above referenced forms, or for additional information regarding scientific misconduct and research integrity, contact:

Office of Research Integrity
Assurance Program
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
tel: 240-453-8400
fax: 301- 443-5351

Financial Conflict of Interest

NIH requires grantees and investigators to comply with the requirements of 42 CFR Part 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought." This Subpart promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct or reporting of research funded under PHS grants will be biased by any conflicting financial interest of an investigator as defined in the regulation. Additional information is available on this conflict of interest website: http://grants2.nih.gov/grants/policy/coi/index.htm.

Select Agent Research

Grantees who conduct research involving Select Agents (HHS and USDA Select Agents and Toxins are listed at: http://www.cdc.gov/od/sap/docs/salist.pdf) must complete registration with CDC or USDA, depending on the agent, before using NIH funds. Regulatory requirements are at 42 CFR 73, 7 CFR 331 and 9 CFR 121, and can be accessed from: http://www.cdc.gov/od/sap/final_rule.htm. In addition, research involving both Select Agents and recombinant DNA is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules.

Public Policy Requirements

Applicants, upon signing an application requesting Federal assistance, certify compliance with a number of public policy requirements, some of which are established or originate in legislative or regulatory provisions. These policies govern such areas as objectivity in research, civil rights, environmental impact, biosafety, drug-free workplace, debarment and suspension, Federal debt, and lobbying with Federal funds, and are intended to ensure fairness and equity, as well as physical and other protections in activities which receive PHS financial assistance. The public policy requirements and objectives governing NIH awards are fully presented in the NIHGPS; it is important that grantees understand their compliance responsibilities with these public policy requirements.

Public policy requirements concerning civil rights, handicapped individuals, sex discrimination, and age discrimination require the one-time submission of Assurance Form HHS 690 prior to award. In all subsequent applications, the grantee certifies that the form (or the previous forms HHS 441, 641, 639-A, and 680) has been filed. To inquire as to whether your organization has previously filed the HHS 690 or the previous forms, contact the HHS Office for Civil Rights at (202) 619-0403.

Public Access Policy

NIH funded investigators are requested to submit to the NIH National Library of Medicine's (NLM) PubMed Central (PCM) an electronic version of a final manuscript upon acceptance for publication, resulting from research supported, in whole or in part, with direct costs from NIH. Information and resources about the policy are available at: http://publicaccess.nih.gov/

Cost Principles

The costs of a grant-supported activity are comprised of allowable direct costs, plus the allocable portion of the organization's associated facilities and administrative (F&A) costs. Direct costs are costs that can be specifically identified with a particular project or program, while F&A costs are incurred for common or joint objectives and which therefore cannot be identified specifically with a particular project or program. The allowability, reasonableness and necessity of direct and F&A costs that may be charged to NIH grants are outlined in the following five sets of cost principles:

These cost principles are a term of NIH grant awards implemented in applicable HHS regulations (45 CFR Part 74 and 45 CFR Part 92).

Facilities & Administrative Cost Rate Negotiations

The payment of facilities & administrative (F&A) costs is based upon rates established through a formal agreement between the grantee organization and the cognizant Federal agency. The negotiated rate is applied to the applicable direct cost base to determine the amount of F&A costs to be awarded. HHS Division of Cost Allocation Regional Offices (see list at end of letter) negotiate F&A rates for educational institutions, hospitals and non-profit organizations. The NIH Division of Financial Advisory Services will negotiate an F&A rate for commercial (for-profit) organizations. HHS/NIH recognizes F&A cost rates applicable to research activities negotiated by other Federal agencies adjusted for the HHS treatment of independent (self-sponsored) research and development (IR&D) costs.

Some exceptions to reimbursement of F&A costs are listed below. See the NIH GPS for additional information:

• NIH does not reimburse F&A costs on grants to individuals, grants to other agencies of the Federal Government, construction grants, conference grants, or NRSA individual fellowships.
• NIH reimburses limited F&A costs (8% of modified total direct costs less tuition and fees, equipment, and subawards in excess of $25,000) for institutional research training grants and career (K) awards.
• NIH reimburses limited F&A costs (8% of modified total direct costs less equipment) to foreign grantees to support the cost of compliance with public policy requirements.
• F&A rates are not negotiated for Phase I SBIR/STTR awards, but applicants may request up to 40% F&A for Phase I. If Phase II applicants request more than 25% F&A, NIH will negotiate a rate with the applicant.

Administrative Standards for Grants (see also Terms of Award)

The Office of Management and Budget (OMB) has established administrative standards for organizations receiving Federal assistance.

HHS has implemented these requirements in its grant regulations ( 45 CFR Part 74 and 45 CFR Part 92).

The OMB website is: http://www.whitehouse.gov/omb/; copies of the OMB Circulars are available from: http://www.whitehouse.gov/omb/circulars/ or by calling (202) 395-3080.

Audit Requirements

For fiscal years ending after 12/31/2003, NIH grantees or subrecipients that expend $500,000 or more in Federal awards during their fiscal year are subject to an audit requirement. Organizations expending less than $500,000 during their fiscal year are not required to have an annual audit for that year, but must make their grant related records available to NIH or other designated officials for review or audit.

Audit requirements for State and local governments, and non-profit organizations (including colleges, universities, hospitals, etc.) receiving Federal awards or subawards, are defined in OMB Circular A-133, Subpart B, Audits of States, Local Governments, and Non-Profit Organizations (revised 6/27/03). A completed data collection form (SF-SAC) and the audit reporting package must be submitted to:

Federal Audit Clearinghouse
Bureau of the Census
1201 E 10th Street
Jeffersonville, IN 47132
Tel: 888-222-9907
http://harvester.census.gov/sac/

Audit requirements for commercial/for-profit and foreign organizations are defined in 45 CFR Part 74.26(d) and the NIH GPS, respectively. Commercial/for-profit and foreign organizations are provided with two options to satisfy the audit requirements: either (1) a financial-related audit of all HHS awards as defined in, and in accordance with, the Government Auditing Standards (commonly known as the Yellow Book); or (2) an audit that meets the requirements of OMB Circular A-133. The data collection form ( SF-SAC) is not required to accompany the audit report. Audit reports of commercial/for-profit and foreign organizations should be submitted to:

National External Audit Review Center
HHS Office of Audit Services
1100 Walnut Street, Suite 1750
Kansas City , MO 64106-2197
tel: 800-732-0679 or 816-268-3610

Additional information relating to audit requirements for for-profit organizations is available at http://oamp.od.nih.gov/dfas/faqforprofitaudits.asp.

It is imperative that grantees submit required audit within the specified time limits.

Electronic Research Administration (eRA)

eRA Commons

The eRA Commons provides grantees with the ability to conduct extramural research business electronically with the NIH. However, all grantee institutions and Principal Investigators (PIs) must be registered in the eRA Commons. The Commons is the only place where PIs can review assignment information, peer review outcomes, Summary Statements, and other related grant documents such as submitted applications and Notices of Grant Awards. Institutional officials can check the status of grant applications, submit Just-In-Time information, submit SNAP Progress Reports, review applications and Notice of Grant Awards, access the face page of Progress Reports, and submit electronic FSRs, no-cost extension notifications, and closeout documents. For more information, go to: https://commons.era.nih.gov/commons/. Details on the Commons registration process can be found at: https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. For additional information or user support contact the NIH Commons User Support Branch at commons@od.nih.gov. The Help Desk can also be reached by telephone:

866-504-9552 (toll free)
301-402-7469 (voice)
301-451-5675 (fax)
301-451-5939 (TTY)

Electronic Submission of Applications

NIH is presently transitioning from paper to electronic submission of grant applications via the online portal of Grants.gov, using the government-wide electronic application form SF424 (R&R). In addition to new application forms and processes, electronic submission requires that two systems with separate registration and validation processes work together - Grants.gov, the federal government's single on-line portal to find and apply for federal funding, and eRA Commons, the system that allows applicants to interact electronically with NIH. 

A unique quality of electronic submission is that applications must be submitted in response to a specific Funding Opportunity Announcement. To accommodate investigator-initiated applications, NIH utilizes Parent Announcements which can be found at: http://grants.nih.gov/grants/guide/parent_announcements.htm. Additional information about the process of electronic submission, including a transition timeline, Frequently Asked Questions, training resources and other useful information can be found at: http://era.nih.gov/ElectronicReceipt/index.htm.

Electronic Access to Grant-Related Resources

NIH Guide for Grants and Contracts

The NIH Guide for Grants and Contracts (NIH Guide), published daily and indexed weekly, provides information to the research community regarding NIH Program Announcements (PAs), Requests for Applications (RFAs), Requests for (contract) Proposals (RFPs), Parent Announcements, Requests for Information (RFI), and Notices of new or changed NIH grants policy. PAs and RFAs are also known government-wide as Funding Opportunity Announcements (FOAs) and can also be found at www.grants.gov/.

The NIH Guide is available at http://grants.nih.gov/grants/guide/index.html. A listserv subscription to the weekly Table of Contents is highly recommended as the best means of keeping up-to-date with NIH announcements, policy changes and clarifications, and FOAs. To subscribe visit: http://grants.nih.gov/grants/guide/listserv.htm.  

NIH Extramural Research Training and Research Career Opportunities

A wealth of information about NIH supported research training and research career opportunities on the NIH Office of Extramural Research Web site can be found at: http://grants.nih.gov/training/index.htm.

NIH Award Data

Data about awards is available on NIH's Award Data page, which includes:

• CRISP (Computer Retrieval of Information on Scientific Projects) - A searchable biomedical database of federally-supported research conducted at universities, hospitals, and other research institutions. If you have questions about CRISP, contact the Division of Research Documentation on 301-435-0650.
• Extramural Data and Award Trends - NIH award data presented in many formats including: research grants, current and long-term (historical) trends, awards by State and foreign site, and success rates. For further information or guidance concerning Extramural Data and Award Trends contact: DSAmail@mail.nih.gov.

NIH Grant Application Instructions and Forms

Details concerning application procedures, application forms, and dates for submission of applications are available at: http://grants.nih.gov/grants/forms.htm. Activity (mechanism) codes, organization codes, and definitions used in extramural programs can be found at http://grants.nih.gov/grants/funding/ac.pdf (PDF - 668 KB). The address to send questions about applications and forms is: grantsinfo@nih.gov.

Application forms for the majority of the NIH grant programs are described below:

SF424 Research and Research Related (R&R): Federal wide common application form for use by Federal agencies involved in research and research-related grant funding. NIH mechanisms that have transitioned to electronic submission require prospective grantees to submit through Grants.gov using the SF424 (R&R). . In addition, NIH collects information that is unique to NIH's requirements in electronic form components known as PHS398, which are part of SF424 (R&R) grant packages. Each FOA has unique instructions and required form set that can be downloaded from Grants.gov.

PHS 398: The entire paper Public Health Service Grant Application is used for grant mechanisms that have not transitioned to electronic submission using the SF424 (R&R). See http://era.nih.gov/ElectronicReceipt/files/NIH_Transition_Plan.pdf for the latest information on transition of mechanisms to electronic submission.

PHS 2590: Progress Report for a Public Health Service Grant (including Research Career Development Awards and Institutional National Research Service Awards). This form is used for non-competing continuation applications and is submitted to a central mailing address at the NIH (see Progress Report). For SNAP awards, the progress report is submitted electronically through the eRA Commons.

PHS 416-1 Application for Public Health Service Individual National Research Service Award (Fellowship).

PHS 416-9 Application for Public Health Service Individual National Research Service Award (Fellowship) Continuation.

Other Important Offices at NIH AND HHS

Payment Management System

The Payment Management System is administered by the Program Support Center (PSC), DHHS, and payments for NIH grant awards are made through the Division of Payment Management, with the exception of awards to individuals, foreign organizations, and agencies of the Federal Government (see below). Applicant organizations are assigned a 12-digit Entity Identification Number for payment and accounting purposes. That number is an expansion of the 9-digit Employer Identification Number assigned to an organization by the Internal Revenue Service.

Requests for downloadable forms and inquiries regarding payments should be directed to:

Division of Payment Management
11400 Rockville Pike
Rockwall Bldg.
Rockville, MD 20852
tel: 301-443-1660

Most grantees are required to file the Federal Cash Transactions Report (FCTR) (PSC 272) of disbursements with PMS within 45 days after the end of each quarter. Although it may be submitted electronically through the Electronic PSC 272 website, you must also print, sign, and mail the PSC 272 certification page to:

Division of Payment Management
P.O. Box 6021
Rockville, MD 20852
tel: 301-443-1660

Questions regarding payments of grants to individuals, foreign organizations, and agencies of the Federal Government should be addressed to:

Government Accounting Branch
Office of Financial Management
National Institutes of Health
2115 East Jefferson Street
Room 4B432, MSC 8500
Bethesda, MD 20892-8500
tel: 301-402-9123

Please note that grantees must file all SF 269 and PSC 272 reports by September 30th of the 5th fiscal year after funds are awarded.  Failure to do so will result in an automatic cancellation of any remaining balance, pursuant to Public Law No. 101-510 amended 31 U.S.C. Sections 1551-1557.  This is called expired appropriations and means that all unexpended funds/unobligated balances falling under the Expired-Year (M Year) of an award are returned to the U.S. Treasury, and are no longer available for use either by NIH or the grantee. Institutions will receive a “Grants Expiring Letter” if an unexpended balance of funds are about to expire. The letter is generally sent out in March of each year as a one time reminder that unexpended funds must be reported by September 30th to avoid loss of those funds.

Patient Care Costs

In instances where the proposed project represents a clinical research study, funds may be requested in a grant application for Patient Care Costs. Due to the special nature of these costs, a detailed explanation is required in the application as to how the total amount requested was determined. In situations where the amount requested for patient care results in an award that exceeds $100,000 in that category for a single budget period, the grantee organization must either have in place or take steps to develop a negotiated patient care rate agreement with HHS.

Hospitals and nonprofit organizations with questions concerning the negotiation of F&A cost rate agreements or patient care rate agreements should contact the appropriate office listed below.

HHS Division of Cost Allocation Regional Offices

For-profit organizations should contact:

Office of Acquisition Management and Policy, NIH
Division of Financial Advisory Services
6100 Executive Boulevard, Room 6B05, MSC 7540
Bethesda, MD 20982-7540
tel: 301-496-4401

For links to contact information sources for questions relating to NIH grants administration, and IC contacts and funding opportunities, visit:http://grants.nih.gov/grants/staff_list_grants_admin.htm.
We wish you great success in our partnership to improve the health of the Nation.

Sincerely,

Office of Policy for Extramural Research Administration
Office of Extramural Research
Office of the Director
National Institutes of Health