NIH "WELCOME WAGON" LETTER
Information for New Grantee Organizations
Updated: January 23, 2014
Dear Institutional Official:
I. Requirements and Provisions
Acceptance of an award from NIH obligates the recipient (grantee) to be aware of and comply with the terms and conditions of award. Each Notice of Award states:
(See the Award Conditions website for these and other award terms references.)
A.1. The National Institutes of Health Grants Policy Statement
A. 2. Administrative Regulations (including Cost Principles)
Note that OMB is consolidating these documents into new consolidated guidance on Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards found at 2 CFR Part 200.Â Agency implementation guidance will be provided to the community through the NIH Guide for Grants and Contracts.
There are reporting requirements associated with every NIH grant. This section includes information on reports required by the Transparency Act, financial reports, progress reports, invention reports, and audit reports. Grantees are reminded that these reports are due at specific times during the life cycle of a grant. It is important that all reports are accurate, complete, and submitted on time. See also the following section on Public Policy Requirements for highlighted requirements that include ongoing reporting.
The Federal Funding Accountability and Transparency Act of 2006, as amended ("Transparency Act"), requires the establishment of a single searchable database, accessible to the public, with information on financial assistance awards made by Federal agencies. The Transparency Act also includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards. To fully implement the subaward reporting and executive compensation requirements of the Transparency Act, recipients of applicable NIH grants and cooperative agreements are required to report on all subawards over $25,000 to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov. This must occur no later than the end of the month following the month in which the obligation was made.
Progress reports are required annually to document grantee accomplishments and compliance with terms of award. They describe scientific progress, identify significant changes, report on personnel, and describe plans for the subsequent budget period or year.Â NIH is in the process of transitioning progress reporting to the federal-wide Research Performance Progress Report (RPPR).
Progress reports for NIH Streamlined Noncompeting Award Process (SNAP), Fellowship, and Multi-Year Funded awards, must be submitted using the RPPR via the eRA Commons. Progress reports for these awards submitted in another format will not be processed by the NIH and will require resubmission in the RPPR format.Â Refer to the notices NOT-OD-13-035 and NOT-OD-14-026 for more information.
NIH is piloting submission of progress reports for non-SNAP awards using the RPPR. Non-SNAP progress reports, including multi-project and training, submitted by Federal Demonstration Partnership (FDP) institutions may be submitted either electronically using the RPPR or in paper using the PHS 2590, but not both.Â Refer to the notice NOT-OD-13-113.Â Non-SNAP progress reports submitted by non-FDP institutions will continue to be submitted using the PHS 2590 until NIH announces an expansion of the RPPR Phase II pilot.Â For additional information and updates regarding this phased implementation for non-SNAP awards, please see the NIH RPPR webpage at http://www.grants.nih.gov/grants/rppr.
For non-SNAP grants for which paper progress reports (signed original copy â€“ no additional copy is required) are required, those paper progress reports must be submitted to the following centralized mailing address:
NIH Centralized Processing Center
Do not bind or staple the original.
For multi-year funded awards (where the project period and budget period are the same and are longer than one year), a progress report must be prepared and uploaded through the eRA Commons Status screen following the instructions posted atÂ https://grants.nih.gov/grants/policy/myf.htm .
For Individual Fellowships, a paper annual progress report is submitted using the PHS 416-9.Â Submission is to the centralized address referenced above.
Cash Transaction Reporting: NIH domestic grantees are required to report cash transaction data via the Payment Management System (PMS) using the Federal Financial Report (FFR) or Standard Form 425 (SF425) cash transaction data elements. The FFR cash transaction data must be filed within 30 days of the end of the calendar quarter. Additional information and training are available on the Division of Payment Management website: http://www.dpm.psc.gov/. A Quick Reference Guide for completing the FFR in the PMS is at http://www.dpm.psc.gov/grant_recipient/guides_forms/ffr_quick_reference.aspx.
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 funding 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 section 22.214.171.124 Invention ReportingÂ in the NIHGPS), as well as include an acknowledgement of federal support in any U.S. patent applications and issued patents thereon (see 37 CFR 401.14(a)(f)(4) for specific language). NIH participates in the trans-government Interagency Edison system and expects grantees 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),
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.
All subject inventions 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 section 8.6.3. Final Invention Statement and Certification in the NIHGPS.) The Final Invention Statement and Certification should be submitted through the eRA Commons using the Closeout feature. Paper submissions of the HHS-568 may be directed to the NIH Centralized Processing Center (see address under Progress Report in the section B.2 above). A downloadable version of the HHS 568 is at: https://grants.nih.gov/grants/hhs568.pdf.
The Small Business Act requires agencies to collect meaningful information from Small Business Concerns (SBC) and ensure that reporting requirements are streamlined to minimize the burden on small businesses. For information regarding reporting requirements, see the SBIR Policy Directive (Section 10(g)(4-9)) at http://www.sbir.gov/about/sbir-policy-directive and the STTR Policy Directive (Section 10(g)(3-8)) at http://www.sbir.gov/about/sttr-policy-directive.
NIH grantees or subrecipients that expend $500,000 or more in Federal awards (grants, cooperative agreements, and/or procurement contracts) 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. A completed data collection form (SF-SAC) and the Single Audit reporting package must be submitted on line using the Federal Audit Clearinghouse's Internet Data Entry System (IDES) found at: http://harvester.census.gov/fac/collect/ddeindex.html
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:
Department of Health and Human Services
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.
Upon signing an application requesting Federal assistance, applicants certify compliance with 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; grantees must understand their compliance responsibilities with these public policy requirements.
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).
Public Law 110-85, also known as the Food and Drug Administration Amendments Act (FDAAA), 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.
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. Foreign grantees are required to follow the International Guiding Principles for Biomedical Research Involving 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 also just-in-time procedures as specified in Section 2.5.1. Just-in-Time Procedures, of NIHGPS.Additional resources are available on the OLAW website, including a sample Animal Welfare Assurance, sample Foreign 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
Organizations planning to conduct research involving recombinant DNA, including human gene transfer, are required to comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid 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.
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 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
NIH requires grantees and investigators (except Phase I SBIR/STTR applicants and grantees) 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." A revised Final Rule amending this Public Health Service (PHS) regulation (and the companion regulation at 45 CFR Part 94, "Responsible Prospective Contractors," imposing similar requirements for research contracts) was published on August 25, 2011 in the Federal Register (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf). The 2011 revised FCOI regulation is applicable to an institution applying for or receiving PHS funding from a grant or cooperative agreement.
The requirements under the FCOI regulation promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator FCOIs. An "Investigator" is defined by the regulation as the Project Director or Principal Investigator and any other person, regardless of title or position, Â who is responsible for the design, conduct, or reporting of research funded by NIH, or proposed for such funding, which may include, for example, collaborators or consultants.
Although grantee institutions must comply with all provisions of the FCOI regulation, the following are some of the key requirements:
Additional information is available on the Office of Extramural Research Financial Conflict of Interest website which includes an archived Webinar, a Tutorial on the requirements of the revised Final Rule, and Frequently Asked Questions. General inquires about the FCOI regulation for grants and cooperative agreements may be directed to: FCOICompliance@mail.nih.gov. General inquiries about the FCOI regulation for research contracts may be directed to: email@example.com.
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. Â In addition, research involving both Select Agents and recombinant DNA is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules.
Payments for NIH grantees are made through the Payment Management System (PMS). PMS is administered by the Program Support Center, within the Division of Payment Management, DHHS. Applicant organizations are assigned a 12-digit Entity Identification Number (EIN) for payment and accounting purposes; this number is provided on the NoA. The EIN number is an expansion of the 9-digit Employer or Tax Identification Number assigned to an organization by the Internal Revenue Service. Inquiries regarding payments and requests for downloadable forms should be directed to PMS.
Facilities and Administrative Rates: The payment of facilities & administrative (F&A) costs is generally 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 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.
Exceptions to reimbursement of F&A costs on certain NIH grants are described in section 7.4 of the NIH GPS.
Patient Care Costs Rates: 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 in Part III. Contacts of the NIH GPS.
The eRA Commons provides grantees with the ability to conduct extramural research business electronically with the NIH. All grantee institutions, Program Directors/Principal Investigators (PD/PIs), and individuals in a postdoctoral role who participate in a project for at least one person month or more, 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 NoAs. Institutional officials can: 1) check the status of grant applications; 2) submit Just-In-Time information; 3) submit Progress Reports using the RPPR format; 4) review applications and NoAs; 5) access the face page for paper Progress Reports; and, 6) submit electronic FFRs, no-cost extension notifications, closeout documents and appointment forms and termination notices associated with NIH institutional training grants, institutional career development awards, individual fellowships, and research education grants. For general information, go to: http://era.nih.gov/commons/. Log-in to the eRA Commons at: https://commons.era.nih.gov/commons/. For additional information or user support contact the eRA Service Desk at https://grants.nih.gov/support/index.html.
The Office of Extramural Research (OER) is the hub for grants policy and operations, grants administration, and the coordination of NIH's extramural programs and activities. The OER provides comprehensive information about NIH Grants at:Â https://grants.nih.gov/grants/index.htm. You can also 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. Subscriptions are available from the Subscription Center.
The NIH Guide for Grants and Contracts (NIH Guide), published daily and indexed weekly, provides information to the research community regarding new or changed NIH grants policy, NIH Funding Opportunity Announcements (FOAs), Requests for (contract) Proposals (RFPs), and Requests for Information (RFI). FOAs can also be found at Grants.gov.
A listserv subscription to the weekly Table of Contents of the NIH Guide is highly recommended as the best means of keeping up-to-date with NIH announcements, policy changes and clarifications, and FOAs.
Extramural award data is available from NIH's Research Portfolio Online Reporting Tool (RePORT). RePORT includes a variety of frequently requested reports including a link to the RePORT Expenditures and Results (RePORTER) site, http://projectreporter.nih.gov/reporter.cfm , where expanded information on funded scientific programs is available. If you have questions about statistics and award data, contact RePort. For comments on RePORT, or suggestions for additional content, please use the Contact Us button found at the bottom of each RePORT page.
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