Information provided here is primarily for officials of organizations planning to submit a grant or cooperative agreement (hereinafter referred to as grant) application or receiving a grant from the National Institutes of Health (NIH) for the first time. The intent is to highlight key requirements, provide referrals to important sources of information, and identify NIH, [Public Health Service (PHS)] and Department of Health and Human Services (HHS) offices that have responsibility for certain administrative functions. Information available through these resources is important to those having responsibility for the administrative and fiscal management of NIH grant awards.

This letter may also be helpful to established grantee organizations because it updates previous issues and cites new and current provisions.

While the "Welcome Wagon" letter (http://grants.nih.gov/grants/funding/welcomewagon.htm) highlights or summarizes important issues, it is neither intended to nor does it serve as a substitute for the NIHGPS.

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. The Notice of Grant Award (NGA) states:

This award is based on the application submitted to, and as approved by, the NIH on the above-titled project and is subject to the terms and conditions incorporated either directly or by reference in the following:

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

The National Institutes of Health Grants Policy Statement

The NIHGPS (rev. 12/03) is a term and condition for all NIH grant awards with budget periods beginning on or after 12/1/03. In the 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 the award. The previous edition (3/1/01) is in effect for budget periods that began on or after 3/1/01 through 12/01/03.

The NIHGPS covers policy topics such as expanded authorities, modular applications, SNAP (streamlined non-competing application 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.

If you do not have a copy of the NIHGPS, you may access either PDF or an HTML version at http://grants.nih.gov/grants/policy/policy.htm.

45 CFR Part 74 and 45 CFR Part 92

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 may be ordered from the following:

The 45 CFR Parts 74 and 92 may also be accessed from HHS GrantsNet at:

Reporting Requirements

• Financial Status Report (FSR): The FSR is submitted on Standard Form 269 (SF 269, long form) or Standard Form 269A (SF 269A, short form) as the report of expenditures documenting the financial status of the award, according to the official accounting records of the grantee organization.

For grants that are not awarded under the 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 (see NIHGPS). When reporting grant-related program income, the long-form FSR (SF 269) must be used. (See NIHGPS for a further explanation of grant-related program income).

FSRs submitted to the NIH are submitted to the NIH Office of Financial Management for review and acceptance. FSRs for other PHS components other than NIH should be submitted directly to the Grants Management Officer of the PHS component that made the award.

FSRs for NIH awards should be sent to:

NIH has a system for the electronic transmittal of FSRs that allows participants to list currently due, and late FSRs, as well as to submit FSRs electronically. To register to use this system, contact the eRA Commons Help Desk at:

NIH Commons User Support Branch
Help Desk (866)504-9552 (Toll Free)
(301)402-7469 (Voice)
(301)451-5675 (Fax)
(301)451-5939 (TTY)
commons@od.nih.gov

• Progress Report: All NIH grant awards require, at a minimum, an annual progress report, which is submitted with as a part of the Annual Non-Competing Progress Report (PHS Form 2590). Refer to the competing or non-competing PHS forms and instructions for the appropriate instructions. 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).
  
  
• Inventions Report: The Bayh-Dole Act (P.L. 96-517) affords Grantees the right to retain the rights to patentable inventions that were conceived or first actually reduced to practice during the course of an NIH grant award (so-called subject inventions). In accepting an award, the grantee agrees to comply with the Government-wide patent 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.). NIH participates in the trans-government Interagency Edison system (http://www.iedison.gov/) and strongly encourages use of this system to comply with Bayh-Dole reporting requirements. The system allows for grantees to submit reports electronically over the Internet. In addition, the invention must be reported in continuation applications (competing or non- competing). Also, the invention 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.) Invention reporting information should be directed as follows:
  
  
• Extramural Intellectual Policy questions and Bayh-Dole-related documents or questions:
  • Extramural Inventions and Technology Resources Branch
    Office of Policy for Extramural Research Administration, OER, NIH
    6705 Rockledge Drive, MSC 7980
    Bethesda, MD 20892-7980
    TEL: (301) 435-1986
    e-mail: Edison@od.nih.gov
    
    
  • Invention report documents or questions pertaining to continuation applications should be directed to the NIH awarding Institute or Center, as specified on the NGA.
    
    
  • The Final Invention Statement and Certification should be directed to the NIH awarding Institute or Center, as specified on the Notice of Grant Award. A downloadable version of the HHS 568 is available at: http://grants.nih.gov/grants/hhs568.pdf.

Audit Requirements

Audit requirements for Federal award recipients are defined in OMB Circular A-133, Audits of States, Local Governments, and Non-Profit Organizations (June 30, 1997 with revisions published June 27, 2003). A for-profit organization is required to have a non-Federal audit if, during its fiscal year, it expended a total of $300,000* or more under one or more HHS awards and at least one of those awards is an HHS grant (as a direct grantee and/or under a consortium agreement). 45CFR 74.26(d) provides for-profit organizations with two options regarding the type of audit that will satisfy the audit requirements. The grantee may either have (1) a financial-related audit (as defined in, and in accordance with, the Government Auditing Standards (commonly known as the Yellow Book), GPO stock # 020-000-00-265-4, of all the HHS awards; or (2) an audit that meets the requirements of OMB Circular A-133. For-profit organizations spending less than $300,000* a year (calculated as above) 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.

OMB Circular A-133 now requires auditees to submit a completed data collection form (SF-SAC) with the audit reporting package to the Federal clearinghouse designated by OMB - currently the Federal Audit Clearinghouse, Bureau of the Census, 1201 E. 10^th Street, Jeffersonville, IN 47132. For questions concerning the submission process or to obtain a copy of the form, you may call the Federal Audit Clearinghouse (888-222-9907). Information can also be found on the Internet at http://harvester.census.gov/sac/. The data collection form is not required for audits of for-profit organizations. Audit reports of for-profit organizations should be submitted to the National External Audit Review Center, HHS Office of Audit Services, Lucas Place Room 514, 323 West 8^th Street, Kansas City, MO 64105.

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

* This threshold increases to $500,000 for grantee fiscal years ending after 12/31/2003.

Protection of Human Subjects in Research

Every applicant proposing to "engage" in human subjects research is required to provide an assurance to comply with the regulations pertaining to the protection of human subjects in research (45 CFR Part 46) unless the research is exempt under 45CFR46.101(b).

An applicant will be "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)].

Awards involving human subjects will only be made after Office for Human Research Protections (OHRP), HHS, has approved an Assurance of Compliance for the grantee. In addition, the grantee must provide certification, to the NIH, that the research has been reviewed and approved by 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.

The grantee institution bears ultimate responsibility for protecting human subjects under the award, including human subjects at all collaborating sites, and for ensuring that an assurance approved by OHRP and certification of IRB review and approval have been obtained before human subjects research can be conducted at each collaborating site.

Instructions are provided for the Federal Wide Assurance on the OHRP website. Certification of IRB review is under "just-in-time" procedures.

Additional information is available regarding Financial Conflict of Interest, and Data Safety and Monitoring for clinical trials, Required Education for the protection of human research participants, and inclusion of Women, Minorities & Children. Also, the URL for "Protecting Human Research Subjects: Institutional Review Board Guidebook" is http://www.hhs.gov/ohrp/irb/irb_guidebook.htm. To obtain information concerning a human subject assurance, contact OHRP at:

To assist IRB members, researchers, and institutional administrators, OHRP produced a 1993 publication entitled "Protecting Human Research Subjects: Institutional Review Board Guidebook." It is available for $45 from the U.S. Government Printing Office at (202) 512-1800; stock no. 017-040-00525-3. Ordering details can be found at http://www.hhs.gov/ohrp/references/resource.htm

In addition, OHRP provides an instructional videotape on the Protection of Human Subjects. This videotape, available free of charge, contains three components:

• Evolving Concern, Protection for Human Subjects
  
• Balancing Society's Mandates, IRB Review Criteria
  
• The Belmont Report, Basic Ethical Principles and Their Application

To obtain a copy of the videotape, contact:

Education Program Coordinator
Division of Human Subjects Protection
Office for Human Research Protections
Department of Health and Human Services
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Tel. 301-496-7005

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 research 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. No award involving the use of animals will 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. If there are performance sites or animal work will be conducted at an institution other than the awardee, that institution must also obtain the necessary Assurances. Verification of IACUC approval is under 'just-in-time' procedures.

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

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 Guidelines can be obtained from the Web site of the NIH Office of Biotechnology Activities, which oversees their implementation, at http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html

Institutions subject to the NIH Guidelines must establish a standing Institutional Biosafety Committee. The requirements for the composition of this committee may be found in Section IV-B-2-a of the NIH Guidelines and are summarized on the Web site of the NIH Office of Biotechnology Activities:

http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm

Investigators needing additional information should contact:

Office of Biotechnology Activities
National Institutes of Health
6705 Rockledge Drive
Bethesda, MD 20892-7985
Tel: (301) 496-9838
Fax: (301) 496-9839
e-mail address: oba@nih.gov
http://www4.od.nih.gov/oba

Office of Research Integrity

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 CFR 42 Part 50, Subpart A, and "Responsibilities for PHS Awardee" and Applicant Institutions for Dealing with Possible Misconduct in Science, as part of the grant application. ORI also 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 constitutes the organizational official's assurance to ORI 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:

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 in or flow down from 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 presented in the NIHGPS.

Public policy requirements concerning civil rights, handicapped individuals, sex discrimination, and age discrimination require the one-time submission of Assurance Form HHS 690 http://www.hhs.gov/ocr/pregrant/ps690.pdf prior to award and certification in all subsequent applications that the form (or the previous forms HHS 441, 641, 639-A, and 680) has been filed.

To obtain the forms, send an email to grantsinfo@nih.gov or call GRANTSINFO at (301) 435-0714.

To inquire as to whether your organization has previously filed the HHS 690 or the previous forms, contact the DHHS Office for Civil Rights at (202) 619-0403.

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 five sets of cost principles.

OMB Circular A-122

Nonprofit Organizations

45 CFR Part 74, Appendix E

Hospitals

For-profit Organizations

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 direct cost base for individual grants to determine the amount of total costs to be awarded. 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. NIH does not reimburse F&A costs on grants to individuals, or agencies of the Federal Government, or on construction and conference grants. F&A is provided to foreign grantees beginning with FY 2002 based on a rate of 8%.

F&A rates are not negotiated for Phase I SBIR/STTR awards.

Administrative Standards for Grants

In addition to the cost principles, OMB has established administrative standards and audit requirements for organizations receiving Federal assistance.

OMB Circular A-110

Audits of States, Local Governments, and Non-Profit Organization

• The OMB website is: http://www.whitehouse.gov/omb/.
  
• Copies of the Office of Management and Budget (OMB) Circulars are available on the Internet at: http://www.whitehouse.gov/omb/circulars/ or by calling (202) 395-7332.

Electronic Research Administration

The NIH Commons is the means by which NIH PIs can review the current status of their grant applications and review detailed information associated with their grants; institutional officials can see a summary view of grant applications, review the Notice of Grant Award, access the Progress Report face page, and submit electronic FSRs. 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 help desk at commons@od.nih.gov.

Electronic Access to Grant-Related Resources over the Internet

Anyone with an Internet connection can electronically access numerous grant-related resources such as the NIHGPS, NIH Guide for Grants and Contracts, and other grant resources at the following Internet address: http://grants.nih.gov/grants/oer.htm

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), and Notices of changes to NIH grants policy. The NIH Guide is available at http://grants.nih.gov/grants/guide/index.html.

NIH Extramural Research and Research Training Programs

You will find a wealth of information about NIH research and research training programs and funding opportunities on the NIH Office of Extramural Research Web site, at: http://grants.nih.gov/training/index.htm.

NIH Award Data

Data about NIH awards is available on NIH's Award Data page, located at http://grants.nih.gov/grants/award/award.htm. This page also includes:

• CRISP (Computer Retrieval of Information on Scientific Projects)

  A searchable biomedical database of federally-supported proposed research conducted at universities, hospitals, and other research institutions. You may access the CRISP Database at: http://crisp.cit.nih.gov/. If you have questions about CRISP, you may 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
  Award Trends - current and long-term (historical)
  Awards by State and Foreign Site
  Ranking Information
  Success Rates

If you need information or guidance about Extramural Data and Award Trends, please send an e-mail to: DSAmail@mail.nih.gov.

NIH GRANT APPLICATION INSTRUCTIONS AND FORMS

Details concerning application procedures, application forms, and dates for submission of applications may be obtained electronically by e-mail from grantsinfo@nih.gov. Activity (mechanisms) codes, organization codes, and definitions used in extramural programs can be found at http://grants.nih.gov/grants/funding/ac.pdf.

Application forms used for the majority of the NIH grant programs are listed below.

The PHS 398 and PHS 2590 instructions (HTML) and forms in Adobe Acrobat are available on the NIH web site (http://www.nih.gov/), under "Grants and Funding Opportunities," "Grants page." If you do not have access to the Internet, you may order the forms by calling GRANTSINFO at (301) 435-0714 or sending an e-mail to grantsinfo@nih.gov.

The NIH will mail (fourth class) application materials to institutional offices of sponsored research (or equivalent) upon request. Requests should be for the anticipated number needed for six to twelve months. Requests should be made by sending e-mail to: grantsinfo@nih.gov or by calling GRANTSINFO at (301) 435-0714.

OTHER IMPORTANT OFFICES AT NIH AND HHS

Payment Procedures

Payments for grants awarded by NIH are made through the Division of Payment Management with the exception of awards to individuals, foreign organizations, and agencies of the Federal Government, which are paid by the NIH Office of Financial Management. 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.

The Payment Management System is administered by the Program Support Center (PSC), DHHS. Requests for downloadable forms and inquiries regarding payments should be directed to:

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

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

Region/Address for Grantees Located In:

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

For-profit organizations should contact:

Note: If you need help accessing any files above that are labeled as PDF, RTF, MS Word, Excel, PowerPoint or RealPlayer, see Instructions For Downloading Documents and Electronic Forms.