NATIONAL INSTITUTES OF HEALTH
Office of Extramural Research |
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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. 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:
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: U.S. Government Printing Office The 45 CFR Parts 74 and 92 may also be accessed from HHS GrantsNet at:
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: Government Accounting Branch 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
A more detailed discussion of reporting obligations can be found in the NIHGPS discussion on monitoring and reporting, located at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part8.htm#_Toc54600141 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. 10th 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 8th 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: Office for Human Research Protections 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:
To obtain a copy of the videotape, contact: Education Program Coordinator 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: Office of Laboratory Animal Welfare 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 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: Office of Research Integrity 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. 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-21 | Institutions of Higher Education |
OMB Circular A-87 | State and Local Governments |
Nonprofit Organizations |
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45 CFR Part 74, Appendix E |
Hospitals |
FAR 48 Subpart 31.2 |
For-profit Organizations |
OMB Circular A-102 | State and Local Governments and Indian Tribes |
Higher Education, Hospitals, and Other Nonprofit Organizations | |
OMB Circular A-133 |
Audits of States, Local Governments, and Non-Profit Organization |
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. 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:
NIH award data presented in many formats including: 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. PHS 398 Application for Public Health Service Grant (including Research Career Development Awards and Institutional National Research Service Awards): this form is used for new, competing continuation, and supplemental applications. 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. 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 SF 424 Application for Federal Assistance: used for construction programs only PHS 5161-1 Application for Federal Assistance Non-Construction Programs (State and Local Government applicants only) 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 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: Division of Payment Management Questions regarding payments of grants to individuals, foreign organizations, and agencies of the Federal Government should be addressed to: Government Accounting Branch 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: |
Northeast 26 Federal Plaza Room 41-118 New York, NY 10278 (212) 264-2069 |
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 (202) 401-2814 |
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 (214) 767-3261 |
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 (415) 437-7820 |
Alaska, Arizona, California |
For-profit organizations should contact: Office of Acquisition Management and Policy, NIH 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. |
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