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NIH "WELCOME WAGON" LETTER
Information for New Grantee Organizations

Updated: October, 2008

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Table of Contents
Requirements and Provisions
 

Terms of Award
The NIH Grants Policy Statement
45 CFR Part 74 and 45 CFR Part 92
Reporting Requirements
     Financial Status Report (FSR)
     Progress Report
     Inventions Report
Protection of Human Subjects in Research
Reporting Clinical Trials
Care and Use of Animals in Research

Recombinant DNA
Research Integrity and Misconduct
Financial Conflict of Interest
Select Agent Research
Public Policy Requirements
Public Access Policy
Cost Principles
Facilities and Admin Cost Rate Negotiations

Requirements and Provisions (Continued)
  Administrative Standards for Grants
Audit Requirements
Electronic Research Administration
  eRA Commons
Electronic Submission of Applications
Electronic Access to Grant-Related Resources
NIH Guide for Grants and Contracts
NIH Extramural Research Training and Research Career Opportunities
NIH Award Data
NIH Grant Application Instructions and Forms
Other Important Offices at NIH and HHS
  Payment Management System
Patient Care Costs
HHS Division of Cost Allocation Regional Offices

Dear Institutional Official:

As the recipient of a grant or cooperative agreement (hereinafter referred to as a 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.

While this Welcome Wagon letter highlights or summarizes important issues, it does not serve as a substitute for the NIH Grants Policy Statement or any other federal requirements or 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 Award (NoA) 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 Award.
  • Conditions on activities and expenditure of funds in other statutory requirements, such as those included in appropriation acts.
  • 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 cited in the Notice of Award.”

(See NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm for certain references cited above)

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 2 CFR Part 215 (Codified by HHS in Title 45, Code of Federal Regulations (CFR), Parts 74) and 45 CFR Part 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. 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 (PDF - 131 KB) (long form) or SF 269A (PDF - 30 KB) (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 required 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. Visit the Government Accounting Branch, OFM, website for an FSR point of contact list and FAQs.

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 Continuation 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 Link to Non-U.S. Government Site - Click for Disclaimer system 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 renewal and non-competing continuation applications. 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 renewal and non-competing continuation applications should be directed to the NIH awarding Institute or Center, as specified on the NOA.

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 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 (PDF - 48 KB) or: https://s-edison.info.nih.gov/iEdison/hhs568.pdf (PDF - 168 KB).

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" (PDF - 138 KB) 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.

Reporting Clinical Trials

Public Law 110-85, which was enacted on September 27, 2007 amends the Public Health Service Act to expand the scope of clinical trials that must be registered in ClinicalTrials.gov.  It also increases the number of registration fields that must be submitted, requires certain results information to be included and sets penalties for noncompliance. NOT-OD-08-O14 and NOT-OD-08-023 provide information to NIH grantees on responsibilities related to registration of their “applicable clinical trials” in ClinicalTrials.gov. Additional information on the registration requirements is available on the PRS Web site.

When submitting a non-competing progress report for grants that include an applicable clinical trial/s, the NCT number/s, Brief Title/s (as defined by ClinicalTrials.gov) and the identity of the responsible party (or parties) are to be included in the Human Subjects section of the progress report.

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 Link to Non-U.S. Government Site - Click for Disclaimer . 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 (PDF - 138 KB) 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 (PDF - 3 MB), Guide for the Care and Use of Laboratory Animals Link to Non-U.S. Government Site - Click for Disclaimer , 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: olaw@od.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 (FCOI)

NIH requires grantees and investigators to comply with the requirements of 42 CFR Part 50, Subpart F (PDF - 50 KB),"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 NIH grants will be biased by any conflicting financial interest of an Investigator. The regulation defines "Investigator" as the principal investigator (PI) and any other person who is responsible for the design, conduct, or reporting of NIH-funded research, and includes the Investigator’s spouse and dependent children.  

Although grantee institutions must comply with all provisions of the regulation, the following are some of the key requirements:

  • The Institution must maintain an appropriate written, enforced policy on conflict of interest that complies with the regulation, and must inform each Investigator of the policy, the Investigator's reporting responsibilities, and of the regulation. 
  • If the Institution carries out the NIH-funded research through subrecipients (e.g., consortia, subgrantees, contractors, or collaborators), the Institution must take reasonable steps to ensure that Investigators working for subrecipients comply with the regulation, either by requiring those Investigators to comply with the Institution's policy, or by requiring the subrecipients to provide assurances to the Institution that will enable the Institution to comply with the regulation.  
  • Investigators must update all financial disclosures during the period of award, either on an annual basis or as new reportable significant financial interests are obtained. 
  • Grantee institutions are responsible for complying with all of the following reporting requirements: 
    • By the time an application is submitted to the NIH, each Investigator who is planning to participate in the research must have submitted to the Institutional designated official a  listing of her/her known Significant Financial Interests (and those of his/her spouse and dependent children)  (1) that would reasonably appear to be affected by the research for which funding is sought from the NIH; and (2) in entities whose financial interests would reasonably appear to be affected by the research.
    • Prior to spending any funds under an award, the Institution must report to the NIH the existence of any conflicting financial interests.
    • For any interest that the Institution identifies as conflicting subsequent to the initial report under the award, the institution must report the FCOI and manage, reduce or eliminate it, at least on an interim basis, within sixty days of that identification.
    • Institutions carrying out NIH-funded research through subrecipients (e.g., subgrantees, contractors, or collaborators)  are responsible for reporting to the NIH any conflicting interests identified by its subrecipients.
    • Conflict of interest reports should be sent to the appropriate NIH Chief Grants Management Officer and should include the following information:
      • Grant number;
      • Principal Investigator or contact PI if the grant is awarded under the multiple PI model;
      • Name of the Investigator (if different from the PI) with the conflicting interest; and
      • Whether the conflict of interest has been managed, reduced, or eliminated.

Additional information is available on the conflict of interest website which includes the NIH Web-based Tutorial (Adobe Flash Player Link to Non-U.S. Government Site - Click for Disclaimer is required) and Frequently Asked Questions on Financial Conflict of Interest (FCOI) Requirements for NIH-Supported Institutions.

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 (PDF - 56 KB)) 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. 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

The Public Access Policy applies to all peer-reviewed articles resulting from research supported in whole or in part with direct costs from NIH, including research grant and career development award mechanisms.  Under the Policy, NIH-funded investigators are required by Federal law to submit (or have submitted for them) to PubMed Central an electronic version of the final, peer-reviewed manuscript upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The author's final peer-reviewed manuscript is defined as the final version accepted for journal publication on or after 4/7/2008, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy. For additional information see the Public Access Policy website.

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:

OMB Circular A-21 (2 CFR Part 220) (PDF - 383 KB)

Institutions of Higher Education

OMB Circular A-87 (2 CFR Part 225) (PDF - 361 KB)

State and Local Governments

OMB Circular A-122 (2 CFR Part 230) (PDF - 234 KB)

Nonprofit Organizations

45 CFR Part 74, Appendix E

Hospitals

48 CFR Subpart 31.2 (Federal Acquisition Regulations, or FAR)

For-profit Organizations

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.

OMB Circular A-110

Higher Education, Hospitals, and Other Nonprofit Organizations

Note: HHS has codified these standards in 45 CFR Part 74

OMB Circular A-102

State and Local Governments and Indian Tribes

Note: HHS has codified these standards in 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. All grantee institutions and Program Directors/Principal Investigators (PD/PIs) must be registered in the eRA Commons. The Commons is the only place where PD/PIs can review assignment information, peer review outcomes, Summary Statements, and other related grant documents such as submitted applications and Notices of Awards. Institutional officials can check the status of grant applications, submit Just-In-Time information, submit SNAP Progress Reports, review applications and Notice of Awards, access the face page of Progress Reports, and submit electronic FSRs, no-cost extension notifications, closeout documents and documents associated with NIH institutional training grants (appointment forms and termination notices). 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

All grant-related resources such as the NIHGPS, NIH Guide for Grants and Contracts, and other resources can be accessed electronically, searched and downloaded.

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 is on the NIH Office of Extramural Research Web site.

NIH Award Data

Extramural award data is available from NIH's Research Portfolio Online Reporting Tool (RePORT).  RePORT includes the new Reports, Data and Analysis (RDA) Website, (formerly called the Award Information and Data page), and CRISP (Computer Retrieval of Information on Scientific Projects).  CRISP is a searchable biomedical database of federally-supported research conducted at universities, hospitals, and other research institutions. If you have questions about statistics and award data, contact  DISHelp@mail.nih.gov, for questions about CRISP contact CRISPmail@mail.nih.gov. For comments on RePORT, or suggestions for additional content, please use the Feedback button found at the bottom of each RePORT page.

NIH Grant Application Instructions and Forms

The Forms and Applications webpage includes details concerning application procedures, application forms, and dates for submission of applications. 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): The Federal wide common application form used 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). 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 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 (PDF - 44 KB) for the latest information on transition of mechanisms to electronic submission.

PHS 2590: The Non-Competing Continuation Progress Report is required to request continued support for a Public Health Service grant (including Research Career Development Awards and Institutional National Research Service Awards). This form 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 (PDF - 26 KB)) 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

Northeast
26 Federal Plaza
Room 41-118
New York, NY 10278
tel: 212-264-2069 fax: 212-264-5478

Connecticut, Maine,
Massachusetts, New
Hampshire, New Jersey,
New York, Rhode Island,
Vermont, Puerto Rico, Virgin Islands

Mid-Atlantic
HHS Building , Room 5130
330 Independence Ave., S.W.
Washington, DC 20201
tel: 202-401-2808 fax: 202-619-3379

Alabama, Delaware,
District of Columbia,
Florida, Georgia, Kentucky
Maryland, Mississippi, North Carolina, Pennsylvania,
South Carolina, Tennessee, Virginia, West Virginia

Central States
1200 Main Tower Building
Room 1135
Dallas, TX 75202
tel: 214-767-3261 fax: 214-767-3264

Arkansas, Illinois, Indiana,
Iowa, Kansas, Louisiana,
Michigan, Minnesota,
Missouri, Nebraska, New
Mexico, Ohio, Oklahoma, Texas, Wisconsin

Western
50 United Nations Plaza
Room 304
San Francisco, CA 94102
tel: 415-437-7820 fax: 415-437-7823

Alaska, Arizona, California
Colorado, Hawaii, Idaho,
Montana, Nevada, North Dakota,
Oregon, South Dakota, Utah,
Washington, Wyoming


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.

You can receive updates on NIH policies and activities, and gain a better understanding of the operation of NIH extramural programs, by reading the NIH Extramural Nexus, an electronic monthly update from the Office of Extramural Research (OER). OER is the hub for grants policy and operations, grants administration, and the coordination of NIH's extramural programs and activities.  Subscriptions are available from the Subscription Center

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