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NIH "WELCOME WAGON" LETTER Information for New Recipient Organizations
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Dear Institutional Official:
This letter provides important information that is critical to the successful administration and fiscal management of your grant award or cooperative agreement (hereinafter referred to as a “grant” or “award”) from the National Institutes of Health (NIH). Key requirements, referrals to important sources of information, and identification of NIH and other Department of Health and Human Services (HHS) offices with responsibility for certain administrative functions are included.
While this letter highlights or summarizes important issues, it does not serve as a substitute for the NIH Grants Policy Statement (NIHGPS) or any other federal requirements, provisions or terms of award.
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:
"...This award is based on the application submitted to, and as approved by, NIH . . . and is subject to the terms and conditions incorporated either directly or by reference in the following:
- The 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.
- 45 CFR Part 75.
- The National Policy Requirements and all other requirements described in the National Institutes of Health Grants Policy Statement including addenda in effect at the beginning date of the budget period.
- Federal Award Performance Goals: As required by the periodic report in the Research Performance Progress Report (RPPR) or in the Final RPPR when applicable.
- This award notice, INCLUDING THE TERMS AND CONDITIONS CITED BELOW.
(See the NIH Office of Extramural Research (OER) Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm for references cited above.
The NIHGPS is a term and condition for all NIH awards; Part II, Terms and Conditions of NIH Grant Awards contains the legally binding requirements for all grant recipients. By drawing funds from the designated payment system, the recipient agrees to the terms and conditions of an award.
The NIHGPS covers policy topics including, but not limited to, 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/policy/nihgps/index.htm
The HHS rules and requirements that govern the administration of grants are found at Title 2 Code of Federal Regulations (CFR) Part 200 (codified by HHS at 45 CFR Part 75). Part 75 applies to all recipients of NIH awards. These regulations (in addition to the NIHGPS) are a term and condition of award. Grant recipients must be aware of and comply with these regulations.
The Uniform regulations include reference to the applicable 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 currently outlined in the following three areas where recipients can locate the applicable set of cost principles:
Institutions of Higher Education, , State and Local Governments and Indian Tribes and Nonprofit Organizations
45 CFR Part 75 , Appendix IX
48 CFR Subpart 31.2 (Federal Acquisition Regulations, or FAR)
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. Recipients 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"), required the establishment of a single searchable database, accessible to the public, with information on financial assistance awards made by Federal agencies. Recipients of Federal grants are also required to report subaward and executive compensation (e.g., names and total compensation of the five most highly compensated officers) information in regards to first-tier subawards greater than or equal to $25,000 into the Federal Subaward Reporting System (FSRS http://www.fsrs.gov/) no later than the end of the month following the month in which the obligation was made.
In addition to those requirements, once fully implemented The Digital Accountability and Transparency Act of 2014, (DATA Act) will amend the Transparency Act, to require full disclosure of all Federal agency expenditures. Full implementation of the DATA Act will require the development of Government-wide data standards which will simplify financial reporting, and improve the quality of spending data made available on USAspending.gov.
Additional information on these reporting requirements can be found on the NIH FFATA web site at: http://grants.nih.gov/grants/public_accountability/ffata.htm.
Progress reports are required annually to document NIH recipient accomplishments and compliance with the terms and conditions of award. They describe scientific progress, identify significant changes, report on personnel, and describe plans for the subsequent budget period or year. NIH requires all recipients of NIH awards to submit type 5 progress reports using the Research Performance Progress Report (RPPR) module within eRA Commons. Annual Progress reports submitted in any other format will not be processed and will require resubmission in the RPPR format. Refer to notice NOT-OD-15-014 for more information.
Effective for fiscal year 2017, the NIH has replaced the Final Progress Report (FPR) with the Final Research Performance Progress Report (Final-RPPR). However, if the recipient organization has submitted a renewal application on or before the date that the Final-RPPR would be required for the most recent competitive segment, then the recipient must submit an "Interim-RPPR" to document the progress of that competitive segment.
The Final and Interim-RPPR will follow the same general format as the current annual RPPR with one exception. In accordance with NIH's implementation, recipients are now required to report on Project Outcomes, which should be in plain language because they will be made publicly available. This new requirement has not changed the deadline for submitting the final report. The Final and/or Interim-RPPR must be submitted via eRA Commons no later than 120 calendar days from the period of performance end date.
Based on this requirement, the NIH will discontinue its longstanding policy for renewal applications whereby, “whether funded or not,” the progress report contained in the renewal application may serve in lieu of a separate final progress report.
However, as stated in NOT-OD-17-022 and NOT-OD-17-037 implementation of the Final-RPPR for Small Business Innovation and Research (SBIR) and Small Business Technology Transfer (STTR) grants will occur at a later date due to unique final reporting requirements under the Small Business Administration's SBIR/STTR Policy Directive.
Cash Transaction Reporting: NIH domestic recipients 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: https://pms.psc.gov/. A Quick Reference Guide for completing the FFR in the PMS is at https://pms.psc.gov/resources_and_training/fctroverview.html.
Please note that recipients must file all cash transaction and expenditure 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 recipient. NIH recipients will receive a “Grants Expiring Letter” from the NIH Office of Financial Management if an unexpended balance of funds are about to expire. The letter is generally sent out in March of each year as a onetime reminder that unexpended funds must be reported by September 30th to avoid loss of those funds.
Expenditure Reporting: Reports of expenditures are required as documentation of the financial status of grants according to the official accounting records of the recipient organization. Expenditure reporting is also accomplished using the SF425.
Except for awards under the Streamlined Non-Competing Award Process (SNAP) and awards that require more frequent reporting, the FFR expenditure data is required annually and must be submitted within 90 days following the calendar quarter in which the budget period ended. A final expenditure report for all grants, including those subject to SNAP, is due 120 days after the close of the competitive segment.
Institutions must submit expenditure reports electronically through the eRA Commons (see eRA Commons below). This system will allow institutions to view currently due and late reports. Visit the Government Accounting Branch, OFM, website for a point of contact list and FAQs on expenditure reporting.
The Bayh-Dole Act (P.L. 96-517) grants recipients 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 recipient 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 recipient report all subject inventions to the awarding agency (see section 22.214.171.124 Invention Reporting 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 electronic Interagency Edison system and requires recipients to use this system to comply with Bayh-Dole and related intellectual property reporting requirements. 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
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 120 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 recipients or subrecipients (other than Federal institutions) that expend $750,000 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 $750,000 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 institutions of higher education) receiving Federal awards or subawards, are defined in 45 CFR Part 75, Subpart F, Audit Requirements. 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: https://harvester.census.gov/facides/account/login.aspx.
Audit requirements for for-profit (commercial) organizations, including for-profit hospitals, are defined in 45 CFR Part 75.501 (h)-(k). A for-profit organization is required to have a non-Federal audit if, during its fiscal year, it expended a total of $750,000 or more under one or more HHS awards (as a direct recipient or consortium participant). Foreign organizations must follow the same requirements as for-profit organizations as stated in the NIH GPS. 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 45 CFR Part 75, Subpart F- Audit Requirements. The data collection form (SF-SAC) is not required to accompany the audit report. Audit reports of for-profit and foreign organizations should be submitted to:
Department of Health and Human Services
Office of the Inspector General
Office of Audit Services
National External Audit Review Center
1100 Walnut Street, Suite 850
Kansas City , MO 64106-2197
tel: 800-732-0679 or 816-426-7720
Additional information relating to audit requirements for for-profit organizations is available at https://oamp.od.nih.gov/dfas/faq/for-profit-audits. It is imperative that recipients submit required audit within the specified time limits.
NIH grants are subject to requirements intended to ensure that recipient organizations handle their Federal awards responsibly. The term "public policy" indicates that the requirement is based on social, economic, or other objectives or considerations that may be attached to the expenditure of Federal funds by recipients, consortium participants, and contractors, in general, or may relate to the expenditure of Federal funds for research or other specified activities. Refer to Exhibit 4 in section 4.1 in the NIH Grants Policy Statement (GPS) for a list of Public Policy Requirements and Objectives.
Upon signing an application requesting Federal financial 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; recipients must 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 recipient certifies that the form has been filed. To inquire as to whether your organization has previously filed the HHS 690, contact the HHS Office for Civil Rights at (202) 619-0403.
Selected Public Policy Requirements are described below; some of these requirements include ongoing reporting. For a full list of all Public Policy Requirements, Objectives and Other Appropriation Mandates applicable to NIH grants, see Chapter 4 of the NIHGPS.
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 the institution 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 subject’s 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 recipient must provide certification to the NIH that the research has been reviewed and approved by an Institutional Review Board (IRB) within 12 months of the budget period start date, and that the research will be subject to continuing review by the IRB.
Instructions for obtaining FWAs and registering IRBs are found on the OHRP website. Obtaining FWAs and providing certification of IRB review and approval are "just-in-time" procedures (i.e., may be provided to NIH after peer review but prior to funding) as specified in Section 2.5.1. Just-in-Time Procedures, of NIHGPS.
The recipient 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/education-and-outreach/archived-materials/
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.
FDAAA includes the requirement that if an “applicable clinical trial” is funded in whole or in part by a grant from any agency of the Department of Health and Human Services, any grant or progress report forms required under such grant shall include a certification that the “responsible party” has made all required submissions for the applicable clinical trial to ClinicalTrials.gov.
For those awards that support an applicable clinical trial, applicants and recipients are required to certify compliance with FDAAA. Information on FDAAA requirements is available on the OER Clinical Trials.gov and FDAAA Web site.
NIH issued a policy on the Dissemination of NIH-Funded Clinical Trial Information. The policy is complementary to the requirements of FDAAA and establishes the expectation that all investigators conducting clinical trials funded in whole or in part by the NIH will ensure that these trials are registered at and results information is reported into ClinicalTrials.gov. The policy applies to all NIH-funded clinical trials regardless of the study phase, type of intervention, or whether they are subject to FDAAA. However, the policy does not apply to a clinical trial that uses NIH-supported infrastructure but does not receive NIH funds to support its content.
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 recipients 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
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)
E-mail address: email@example.com
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
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)
E-mail address: SciencePolicy@od.nih.gov
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 recipient 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
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
Fax: 301- 443-5351
Email Address: AskORI@hhs.gov
NIH requires recipients and investigators (except Phase I SBIR/STTR applicants and recipients) 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, 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 recipient institutions must comply with all provisions of the FCOI regulation, the following are some of the key requirements:
- The Institution must maintain an up-to-date and enforced policy on conflict of interest that complies with the regulation and make such policy publicly accessible. See 42 CFR Part 50.604(a) for more information.
- The Institution must inform each Investigator of the regulations, the Institution's FCOI policy, and of the Investigator's disclosure responsibilities.
- The Institution must require each Investigator to complete training regarding the Institution's FCOI policy, Investigator's disclosure responsibilities, and of the regulations prior to engaging in research related to any NIH-funded grant or cooperative agreement at least every four years thereafter, and immediately under certain circumstances. See 42 CFR Part 50.604(b) for more information.
- If the Institution carries out the NIH-funded research through subrecipients (e.g., consortia, subrecipients, contractors, or collaborators), the awardee Institution must take reasonable steps to ensure that any subrecipient Investigator complies with the regulation. The Institution must incorporate as part of a written agreement with the subrecipient terms that establish whether the FCOI policy of the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and address applicable disclosure or reporting requirements as provided in 42 CFR Part 50.604(c)(1).
- Investigators must update all financial disclosures related to his/her institutional responsibilities during the period of award at least annually, in accordance with the specific time period prescribed by the Institution and within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest (SFI).
- Recipient institutions are responsible for determining if an Investigator's SFI is related to his/her PHS-funded research, and, if so, whether the Investigator's SFI is an FCOI.
- Recipient institutions must provide initial and annual (i.e., ongoing) FCOI reports to the NIH through the eRA Commons FCOI Module, and comply with all of the reporting requirements.
- FCOI reports must include the required information provided under 42 CFR Part 50.605(b)(3).
- Prior to the Institution's expenditure of funds under a PHS-funded research project, the Institution shall post on a publicly accessible web site, or provide by written response within five business days, certain information concerning SFIs disclosed to the Institution. See 42 CFR 50.605(a)(5)(i) for more information.
- Institutions must complete and document a retrospective review in situations of noncompliance. If bias is found in the design, conduct or reporting of the PHS-funded research, the Institution must complete and submit a mitigation report. See 42 CFR Part 50.605(a)(3) and 50.605(b)(2) for more information.
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 inquiries 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: firstname.lastname@example.org.
Payments for NIH recipients, except for grants or cooperative agreements to Federal Institutions (see NOT-OD-17-052 for additional information), 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. Inquiries regarding payments to Federal recipients should be sent to your Grants Management Specialist.
Facilities and Administrative Rates: The payment of facilities & administrative (F&A) costs is generally based upon rates established through a formal agreement between the recipient organization and the cognizant agency for indirect costs. The negotiated rate is applied to the applicable direct cost base to determine the amount of F&A costs to be awarded. HHS’s Cost Allocation Services 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 recipient 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 recipients with the ability to conduct extramural research business electronically with the NIH. All recipient 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, grants administration, and the coordination of NIH's extramural programs and activities. The OER provides comprehensive information about NIH Grants at: https://grants.nih.gov/grants/oer.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.
Office of Policy for Extramural Research Administration
Office of Extramural Research
Office of the Director
National Institutes of Health