Monitoring

Grantees are responsible for managing the day-to-day operations of grant-supported activities using their established controls and policies, as long as they are consistent with NIH requirements. However, in order to fulfill their role in regard to the stewardship of Federal funds, NIH awarding offices monitor their grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the grantee, audit reports, site visits, and other information available to NIH. The names and telephone numbers of the individuals responsible for monitoring the programmatic and business management aspects of a project or activity will be provided to the grantee at the time of award.

Monitoring of a project or activity will continue for as long as NIH retains a financial interest in the project or activity as a result of property accountability, audit, and other requirements that continue for a period of time after the grant is administratively closed out and NIH is no longer providing active grant support (see "Administrative Requirements—Closeout").

Reporting

NIH requires that grantees periodically submit financial and progress reports. Other required reports may include annual invention utilization reports, lobbying disclosures, audit reports, reporting to the appropriate payment points (in accordance with instructions received from the payment office), and specialized programmatic reports. Grantees also are expected to publish and provide information to the public on the objectives, methodology, and findings of their NIH-supported research activities as specified in "Administrative Requirements—Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources."

The GMO is the receipt point for most required reports, including noncompeting continuation requests, final progress reports, final invention statements and certifications, and lobbying disclosure statements. Reports must be submitted in an original and two copies unless the instructions for submission specify otherwise. Submission of these reports to individuals other than the GMO may result in delays in processing or the submission being considered delinquent.

Grantees are allowed a specified period of time in which to submit required financial and progress reports (see 45 CFR 74.51 and 74.52, 92.40 and 92.41, and the discussion in this subsection). Failure to submit complete, accurate, and timely reports may indicate the need for closer monitoring by NIH or may result in possible award delays or enforcement actions, including withholding, removal of expanded authorities, or conversion to a reimbursement payment method (also see "Administrative Requirements—Enforcement Actions").

Progress Reports as Part of Noncompeting Continuation Requests

Progress reports usually are required annually as part of the noncompeting continuation request or competing continuation application. However, NIH may require these reports more frequently. The information to be included in the progress report as part of a noncompeting continuation request is specified in the PHS-2590 application instructions, which also include the alternate instructions for awards under SNAP (see "Administrative Requirements—Noncompeting Continuation Awards"). The NIH awarding office will specify the requirements for progress reporting under construction grants or grants supporting both construction activities, including acquisition or modernization, and non-construction activities.

Financial Reports

Reports of expenditures are required as documentation of the financial status of grants according to the official accounting records of the grantee organization. Financial or expenditure reporting is accomplished using the FSR (SF 269 or SF-269 A; the SF-269 is the "long form" and is required when a grantee is accountable for the use of program income).

Except for those awards under SNAP and awards requiring more frequent reporting, the FSR is required on an annual basis. An annual FSR is required for awards to foreign organizations and Federal institutions, whether or not they under SNAP. When required on an annual basis, the report must be submitted for each budget period no later than 90 days after the close of the budget period. The report also must cover any authorized extension in time of the budget period. If more frequent reporting is required, the NGA will specify both the frequency and due date.

For domestic awards under SNAP, in lieu of the annual FSR, NIH will use the quarterly FCTR (SF 272), submitted to PMS, to monitor the financial aspects of grants. The GMO may review the report for patterns of cash expenditures, including accelerated or delayed drawdowns, and to assess whether there are possible performance or financial management problems. For these awards, an FSR is required only at the end of a competitive segment. It must be submitted within 90 days after the end of the competitive segment and must report on the cumulative support awarded for the entire segment. An FSR must be submitted at this time whether or not a competing continuation award is made. If no further award is made, this report will serve as the final FSR (see "Administrative Requirements—Closeout").

FSRs may be transmitted electronically^[20] to OFM, NIH, which, for this purpose, is equivalent to submission to the GMO. Prior to submitting FSRs to NIH, grantees must ensure that the information submitted is accurate, complete, and consistent with the grantee's accounting system. The signature of the authorized organizational official on the FSR certifies that the information in the FSR is correct and complete and that all outlays and obligations are for the purposes set forth in grant documents, and represents a claim to the Federal Government. Filing a false claim may result in the imposition of civil or criminal penalties.

Unobligated Balances and Actual Expenditures

Disposition of unobligated balances is determined in accordance with the terms and conditions of award. (See "Administrative Requirements—Changes in Project and Budget" for NIH approval authorities for unobligated balances.)

Upon receipt of the annual FSR for awards other than those under expanded authorities, the GMO will compare the total of any unobligated balance shown and the funds awarded for the current budget with the NIH share of the approved budget for the current budget period. If the funds available exceed the NIH share of the approved budget for the current budget period, the GMO may select one of the following options:

• In response to a written request from the grantee, revise the current NGA to authorize the grantee to spend the excess funds for additional approved purposes;
• Offset the current award or a subsequent award by an amount representing some or all of the excess; or
• Restrict from use some or all of the excess funds in the current budget period and take that amount into account when making a subsequent award.

There may be instances where the grantee is required to revise or amend a previously submitted FSR. When the revision results in a balance due to NIH, the grantee must submit a revised FSR whenever the overcharge is discovered, no matter how long the lapse of time since the original due date of the report. Revised expenditure reports representing additional expenditures by the grantee that were not reported to NIH within the 90-day time frame may be submitted to the GMO with an explanation. This should be done as promptly as possible but no later than 1 year from the due date of the original report, i.e., 15 months following the end of the budget period (or competitive segment for awards under SNAP). If an adjustment is to be made, the NIH awarding office will advise the grantee of actions it will take to reflect the adjustment. NIH will not accept any revised report received after that date and will return it to the grantee.

Invention Reporting

All inventions made in the course of, or under, any NIH research grant, including SBIR/STTR awards, must be promptly and fully disclosed to NIH within 2 months after the inventor provides written disclosure to the grantee's authorized organizational official. The disclosure must be in writing, identify the applicable grant and the name of the inventor(s), and provide a complete technical description and other information as required by 37 CFR 401.14(c)(1) (see "Administrative Requirements—Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources" for the full text of the clause).

In addition to immediate invention disclosure, each application for competing or noncompeting continuation support of an NIH grant-supported research project must include either a listing of all inventions conceived or reduced to practice during the preceding budget period or a certification that no inventions were made during the applicable period.

The grantee also must also submit an annual utilization report when the grantee has elected title to an invention or when royalties or licensing fees are generated for inventions that are not patented. NIH has developed an optional on-line Extramural Invention Information Management System, known as "Edison," to facilitate grantee compliance with the disclosure and reporting requirements of 37 CFR 401.14(h). The Internet address for this system is http://www.iedison.gov. Information from these reports is not made publicly available.

Report to the Office of Research Integrity

The regulations governing research misconduct require the grantee to submit an annual report (Form 6349) to the Office of Research Integrity (ORI) detailing aggregate information on allegations, inquiries, and investigations handled by the grantee in the previous year. ORI automatically sends this form to NIH grantees at the end of the calendar year (see "Public Policy Requirements and Objectives—Ethical and Safe Conduct in Science and Organizational Operations—Research Misconduct").

Lobbying Disclosure

For awards subject to the anti-lobbying requirements described in "Public Policy Requirements and Objectives—Ethical and Safe Conduct in Science and Organizational Operations—Lobbying," grantees must submit the "Disclosure of Lobbying Activities" (Standard Form-LLL) for each payment or agreement to make payment from nonappropriated funds to any lobbying entity for influencing or attempting to influence an officer or employee of any agency, a member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with a "covered" Federal action.

Record Retention and Access

Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted. For awards under SNAP (other than those to foreign organizations and Federal institutions), the 3-year retention period will be calculated from the date the FSR for the entire competitive segment is submitted. Those grantees must retain the records pertinent to the entire competitive segment for 3 years from the date the FSR is submitted to NIH. Foreign organizations and Federal institutions are required to submit annual FSRs for all awards, including those under SNAP, and must retain these records for a period of 3 years from the date of submission of the annual FSR to NIH. See 45 CFR 74.53 and 92.42 for exceptions and qualifications to the 3-year retention requirement. Those sections also specify the retention period for other types of grant-related records, including F&A cost proposals and property records. See 45 CFR 74.48 and 92.36 for record retention and access requirements for contracts under grants.

Audit

An audit is a systematic review or appraisal made to determine whether internal accounting and other control systems provide reasonable assurance that:

• Financial operations are properly conducted.
• Financial reports are presented in a timely manner, fairly and accurately.
• The entity has complied with applicable laws, regulations, and other grant terms.
• Resources are managed and used in an economical and efficient manner.
• Desired results and objectives are being achieved in an effective manner.

NIH grantees (other than Federal institutions) are subject to the audit requirements of OMB Circular A-133, as implemented by 45 CFR 74.26 and 92.26, or the audit requirements stated in 45 CFR 74.26(d) and in this policy statement (for types of organizations to which OMB Circular A-133 does not directly apply). In general, OMB Circular A-133 requires a State government, local government or non-profit organization (including institutions of higher education) that expends $300,000 or more per year in Federal grants, cooperative agreements, and/or procurement contracts to have an annual audit by a public accountant or a Federal, State, or local government audit organization that meets the standards specified in generally accepted government auditing standards (GAGAS). The audit requirements for foreign grantees and for-profit grantees are addressed in the sections of this policy statement that provide specific requirements for those types of grantees.

When a grantee procures audit services, the procurement must comply with the procurement standards of 45 CFR Part 74 or 92, as applicable, including obtaining competition and making positive efforts to use small businesses, minority-owned firms, and women's business enterprises. Grantees should ensure that comprehensive solicitations, made available to interested firms, include all audit requirements and specify the criteria to be used for selection of the firm, and that they enter into written agreements with auditors that specify the rights and responsibilities of each party.

The OMB Circular explains in detail the scope, frequency, and other aspects of the audit. Some highlights of the Circular are as follows:

• Covered organizations expending $300,000 or more per year in Federal awards are required to have an audit made in accordance with the Circular. However, if the awards are under one program, the organization can have either a single organization-wide audit or a program-specific audit of the single program subject to the provisions of section 235 of the Circular. NIH's research awards may not be considered a single program for this purpose. Covered organizations expending less than $300,000 in any year are exempt from these audit requirements in that year but must have their records available for review as required by "Administrative Requirements—Monitoring—Record Retention and Access."
• The reporting package is comprised of the following: financial statements and schedule of expenditures of Federal awards; independent auditor's report(s), including an opinion on the financial statements and the schedule of expenditures of Federal awards, a report on compliance and internal control over financial reporting, and a report on compliance with requirements applicable to each major program and on internal control over such compliance requirements; a schedule of findings and questioned costs; and, if applicable, a summary of prior audit findings and a corrective action plan.
• An audit made in accordance with OMB Circular A-133 is in lieu of a financial audit under individual Federal awards. However, Federal agencies may request additional audits necessary to carry out their responsibilities under Federal law or regulation. Any additional audits will build upon work performed by the independent auditor.
• The data collection form and copies of the reporting package must be submitted to the designated Federal clearinghouse at the following address:

Federal Audit Clearinghouse
Bureau of the Census
1201 E. 10th Street
Jeffersonville, IN 47132

If the schedule of findings and questioned costs discloses an audit finding related to an HHS/NIH award or the schedule of prior audit findings reports the status of any audit finding relating to an HHS/NIH award, the Federal audit clearinghouse will provide copies of the audit report to the National External Audit Review Center (NEARC), Office of the Inspector General, HHS. NEARC will, in turn, distribute them within HHS for further action, as necessary. Audit reports should not be sent directly to the GMO.

Recipients must follow a systematic method for ensuring timely and appropriate resolution of audit findings and recommendations, whether discovered as a result of Government-initiated or recipient-initiated audits. Grantees are usually allowed 30 days from the date of request to respond to the responsible audit resolution official (Action Official) concerning audit findings. Failure to submit timely responses may result in cost disallowance or other actions by NIH or HHS. At the completion of the audit resolution process, the grantee will be notified of the Action Official's final decision. The grantee may appeal this decision if the adverse determination is of a type covered by the NIH/HHS grant appeals procedures (see "Administrative Requirements—Grant Appeals Procedures"). Refunds owed to the Government as a result of audit disallowances must be made in accordance with instructions issued by the Action Official or OFM, NIH.

It is imperative that grantees submit required OMB Circular A-133 audits within the time limits specified in the Circular. If grantees are delinquent in complying with the provisions of A-133, HHS/NIH will impose sanctions that may result in the loss of Federal funds. No audit costs will be allowed either as F&A costs or direct costs to Federal awards if the required audits have not been completed or have not been conducted in accordance with the provisions of OMB Circular A-133.

See "Allowability of Costs/Activities—Selected Items of Cost" for the allowability of grantee audit costs.

Enforcement Actions

A grantee's failure to comply with the terms and conditions of award, including confirmed instances of research misconduct, may cause NIH to take one or more enforcement actions, depending on the severity and duration of the non-compliance. NIH will undertake any such action in accordance with applicable statutes, regulations, and policies, and generally will afford the grantee an opportunity to correct the deficiencies prior to taking enforcement action unless public health or welfare concerns require immediate action. However, even if a grantee is taking corrective action, NIH may, at the same time, take proactive actions to protect the Federal Government's interests, including placing special conditions on awards or precluding the grantee from obtaining future awards for a specified period, or may take actions designed to prevent future noncompliance, such as closer monitoring. If NIH imposes sanctions on a grantee as a result of research misconduct or will more closely monitor an award(s) through the use of special conditions, NIH will share this information with other HHS components.

Modification of the Terms of Award

During grant performance, the designated GMO may impose special conditions to require correction of identified financial or administrative deficiencies. At the time the special conditions are imposed, the GMO will notify the grantee of the nature of the conditions; the reason why they are being imposed; the nature of the corrective action needed; the time allowed for completing corrective actions; and the method for requesting reconsideration of the conditions. See 42 CFR 52.9 and 45 CFR 74.14 or 92.12.

The awarding office also may, for reasonable cause, withdraw approval of the PI or other key personnel for a project. The qualifications and competence of the PI and other key personnel were evaluated prior to award, and, if the awarding office has a reasonable basis to conclude that the PI or other key personnel are no longer qualified to perform in that capacity, it may withdraw its approval of those individuals and request that the grantee designate a new PI or other key personnel.

The decision to modify the terms of an award by imposing special conditions, by withdrawing approval of the PI or other key personnel, or otherwise, is discretionary on the part of the IC.

Suspension, Termination, and Withholding of Support

When a grantee has failed to materially comply with the terms and conditions of a grant, NIH may suspend the grant, pending corrective action, or may terminate the grant for cause. The regulatory procedures that pertain to suspension and termination are specified in 45 CFR 74.61 and 74.62 and 92.43.

NIH will generally suspend (rather than immediately terminate) a grant and allow the grantee an opportunity to take appropriate corrective action prior to NIH's making a termination decision. NIH may decide to terminate the grant if the grantee does not take appropriate corrective action during the period of suspension. However, NIH may terminate without first suspending the grant if the deficiency is so serious as to warrant immediate termination or public health or welfare concerns require immediate action. Termination for cause may be appealed under the NIH/HHS grant appeals procedures (see "Administrative Requirements—Grant Appeals Procedures"). NIH may award a replacement grant for a limited period of time (up to 18 months) without competition pending the outcome of an appeal or other action by the grantee.

A grant also may be terminated, partially or totally, by the grantee or by NIH with the consent of the grantee. If the grantee decides to terminate a portion of a grant, NIH may determine that the remaining portion of the grant will not accomplish the purposes for which the grant was originally awarded. In any such case, NIH will advise the grantee of the possibility of termination of the entire grant and allow the grantee to withdraw its termination request. If the grantee does not withdraw its request for partial termination, NIH may initiate procedures to terminate the entire grant for cause.

See "Allowability of Costs/Activities—Selected Items of Cost" for the allowability of termination costs. Allowability of these costs does not vary whether a grant is terminated for cause by NIH, terminated by the grantee, or terminated by mutual agreement.

Withholding of support is a decision not to make a noncompeting continuation award within the current competitive segment. Withholding may occur for one or more of the following reasons:

• A grantee is delinquent in submitting required reports.
• Adequate Federal funds are not available to support the project.
• A grantee fails to show satisfactory progress in achieving the objectives of the project.
• A grantee failed to meet the terms of a previous award.
• A grantee's management practices fail to provide adequate stewardship of Federal funds.
• Any reason that would indicate that continued funding would not be in the best interests of the Government.

If a noncompeting continuation award is denied (withheld) because the grantee failed to comply with the terms and conditions of award in a previous budget period, the grantee may appeal that determination.

Other Enforcement Actions

Depending on the nature of the deficiency, NIH may use other means of obtaining grantee compliance. Other options available to NIH include, but are not limited to, temporary withholding of payment or other actions specified at 45 CFR 74.62 or 92.43, conversion from an advance payment method to a reimbursement method, suspension or debarment under 45 CFR Part 76, and other available legal remedies, including civil action. Suspension under 45 CFR Part 76 is a distinct action from "suspension" as a postaward remedy described under "Suspension, Termination, and Withholding of Support" in this subsection. The subject of debarment and suspension as an eligibility criterion is addressed in "Completing the Preaward Process—Eligibility" and "Public Policy Requirements and Objectives—Ethical and Safe Conduct in Science and Organizational Operations—Debarment and Suspension."

Recovery of Funds

NIH may administratively recover funds paid to a grantee in excess of the amount to which the grantee is finally determined to be entitled under the terms and conditions of the award, including misspent funds or unallowable costs incurred. If the grantee does not pay back the funds in accordance with the demand by the IC, which specifies the period of time for repayment, the IC may collect the debt by:

• Making an administrative offset against payments that would be due under other grant awards,
• Withholding advance payments that would otherwise be due, or
• Taking any other action permitted by statute.

Debt Collection

The Federal Debt Collection Act (Act), 31 U.S.C. 3711, and the Federal Claims Collection Standards (4 CFR Parts 101-105) require NIH to collect debts due to the Government and, except where prohibited by law, to charge interest on all delinquent debts owed to NIH by grantees (also see HHS claims collection regulations at 45 CFR Part 30). Debts may result from disallowances, recovery of funds, unobligated balances, or other circumstances.

Unless otherwise specified in law, regulation, or the terms and conditions of the award, debts are considered delinquent 30 days after notification to the grantee of the indebtedness. The interest on delinquent debts will be computed from the original notification date to the grantee of the indebtedness. The interest rate applied will be at the higher of the Current Value of Funds Rate or the private consumer rate of interest fixed by the Department of the Treasury. A higher rate may be charged if necessary to protect the interests of the Government. Penalties and administrative collection costs also will be charged in accordance with the Act and the implementing HHS regulations, as follows:

• A penalty charge of six percent a year will be assessed on debts that are more than 90 days overdue. Penalty charges will accrue from the date the debt became overdue until the indebtedness is paid.
• Delinquent debtors will be assessed charges to cover the Government's administrative costs of collecting overdue debts. From time to time, HHS will publish a notice in the Federal Register setting forth the amounts to be assessed for administrative collection costs.

If a grantee appeals a monetary adverse determination under 42 CFR Part 50, Subpart D or 45 CFR Part 16, collection will be suspended pending a final decision on the appeal. If the determination is sustained (either fully or partially), interest will be charged beginning with the date of the original notification to the grantee of the indebtedness.

Closeout

NIH will close out grants as soon as possible after expiration of a grant that will not be extended or after termination of a grant as provided in 45 CFR 74.71 to 74.73 or 92.50. Closeout includes timely submission of all required reports and adjustments for amounts due the grantee or NIH. Closeout of a grant does not automatically cancel any requirements for property accountability, record retention, or financial accountability. Following closeout, the grantee remains obligated to return funds due as a result of later refunds, corrections, or other transactions, and the Federal Government may recover amounts based on the results of an audit covering any part of the period of grant support.

Final Reports

Grantees are required to submit a final Financial Status Report, Final Invention Statement and Certification, and final progress report within 90 days of the end of grant support unless an extension is granted by the GMO. Failure to submit timely and accurate final reports may affect future funding to the organization or awards with the same PI.

Final Financial Status Report

A final FSR is required for:

• Any grant that is terminated.
• Any grant that is transferred to a new grantee.
• Awards, including awards under SNAP, which will not be competitively extended through award of a new competitive segment.

The final FSR must cover the period of time since the previous FSR submission or, for awards under SNAP, the entire competitive segment or as much of the competitive segment as has been funded prior to termination. Final FSRs must have no unliquidated obligations, and must indicate the exact balance of unobligated funds. Unobligated funds must be returned to NIH or must be reflected by an appropriate accounting adjustment in accordance with instructions from the GMO or from the payment office. For those organizations receiving their funds through PMS, final reports, as specified by PMS, must be submitted to that office. It is the responsibility of the grantee to reconcile reports submitted to PMS and to the NIH awarding office. Withdrawal of the unobligated balance following expiration or termination of a grant is not considered an adverse action and may not be appealed (see "Administrative Requirements—Enforcement Actions—Recovery of Funds").

Where the submission of a revised final FSR results in additional claims by the grantee, NIH will consider the approval of such claims subject to the following minimum criteria:

• The charges must represent allowable costs under the provisions of the grant.
• There must have been an unobligated balance for the given budget period that is sufficient to cover the additional claim. Such a claim may be considered regardless of whether the unobligated balance was moved forward to offset the award for a subsequent budget period.
• Funds must be available from the applicable appropriation.
• NIH must receive the revised FSR within 15 months of its due date.

Final Progress Report

The final progress report should include a summary of progress toward the achievement of the originally stated aims, a list of the results (positive or negative) considered significant, and a list of publications. The final progress report also should:

• Report on the inclusion of gender and minority study subjects (using the gender and minority inclusion table as provided in the PHS-2590).
• Where appropriate, indicate whether children were involved in the study or how the study was relevant for conditions affecting children (see "Public Policy Requirements and Objectives—Requirements for Inclusiveness in Research Design—Inclusion of Children as Subjects in Clinical Research" and the PHS-398).
• Describe any data, research materials (such as cell lines, DNA probes, animal models), protocols, software, or other information resulting from the research that is available to be shared with other investigators and how it may be accessed.

An original and one copy of this report should be submitted to the GMO.

Final Invention Statement and Certification

The grantee must submit a Final Invention Statement and Certification (HHS-568), whether or not an invention(s) results from work under the grant. The final invention statement/certification must be signed by the PI and an authorized organizational official and must list all inventions that were conceived or first actually reduced to practice during the course of work under the project, from the original effective date of support through the date of expiration or termination, whether or not previously reported. If there were no inventions, the statement should indicate "None."

Grant Appeals Procedures

HHS permits grantees to appeal certain postaward adverse administrative decisions made by HHS officials to an HHS Grant Appeals Board (see 45 CFR Part 16). NIH has established a first-level grant appeal procedure for discretionary grants and cooperative agreements that must be exhausted before an appeal may be filed with the HHS Departmental Appeals Board (see 42 CFR Part 50, Subpart D). NIH will assume jurisdiction for the following adverse determinations:

• Termination, in whole or in part, of a grant for failure of the grantee to carry out its approved project in accordance with the applicable law and the terms and conditions of such assistance or for failure of the grantee otherwise to comply with any law, regulation, assurance, term, or condition applicable to the grant.
• Determination that an expenditure not allowable under the grant has been charged to the grant or that the grantee has otherwise failed to discharge its obligation to account for grant funds.
• Denial (withholding) of a noncompeting continuation award under the project period system of funding for failure to comply with the terms of a previous award.
• Determination that a grant is void (i.e., a decision that an award is invalid because it was not authorized by statute or regulation or because it was fraudulently obtained).

The formal notification of an adverse determination will contain a statement of the grantee's appeal rights. As the first level in appealing an adverse determination, the grantee must submit a request for review to the NIH official specified in the adverse determination letter, detailing the nature of the disagreement with the adverse determination and providing supporting documents in accordance with the procedures contained in the notification. The grantee's request to NIH for review must be postmarked no later than 30 days after receipt of the written notification of the adverse determination except that, if the grantee can show good cause why an extension is warranted, an extension may be granted (42 CFR 50.406).

If the NIH decision on the appeal is adverse to the grantee or if a grantee's request for review is rejected on jurisdictional grounds, the grantee then has the option of submitting a request to the Departmental Appeals Board (DAB) for a further review of the case in accordance with the provisions of 45 CFR Part 16.

A grantee may not submit an appeal directly to the DAB, as it will review only those appeals that have been reviewed and acted on by NIH.

In addition to the adverse determinations indicated, the DAB is the single level of appeal for disputes related to the establishment of F&A cost rates, research patient care rates, and certain other cost allocations used in determining amounts to be reimbursed under NIH grants (e.g., cost allocation plans negotiated with State or local governments and computer, fringe benefit, and other negotiated special rates).^[21]

⁷ The scope and timing of this and other safety reporting requirements is under review. The OBA Home Page (http://www4.od.nih.gov/oba/) should be consulted for developments that may affect the timing of submission of safety reports.

⁸ After February 28, 2001 OHRP will no longer routinely accept assurances that are limited to HHS-supported research, to special categories of research, or to individual research projects. Current MPAs will remain in effect until the designated expiration date or December 31, 2003, whichever comes first; however, MPA organizations may file a new FWA at any time prior to that date and they are encouraged to do so as soon as possible. MPAs that have been administratively extended by OHRP must be replaced with an FWA no later than March 1, 2001. OHRP will not accept changes to existing MPAs (except for IRB membership updates). If changes are necessary, the or-ganization should file an FWA.

⁹ Protecting Human Subjects: Institutional Review Board Guidebook, 1993, Stock No. 017-040-00525-3, may be ordered from the Superintendent of Documents, Telephone: (202) 512-1800. This Guidebook is also available from OHRP’s Web site (http://www.hhs.gov/ohrp/irb/irb_guidebook.htm).

¹⁰ This policy has been in effect since October 1, 1998 for new applications submitted for a receipt date after that date. It is not mandatory for applications submitted for receipt dates prior to that date, competing awards made prior to that date, or non-competing awards resulting from competing awards made prior to that date.

¹¹ These requirements apply to data first produced under a competing award (new, competing continuation, or competing supplement) made after April 17, 2000, and any subsequent non-competing award pursuant to those competing awards.

¹² A few of the larger non-profit organizations that are specifically listed in Attachment C to OMB Circular A-122 are subject to the Federal cost principles applicable to commercial organizations (48 CFR Subpart 31.2) rather than to the cost principles for non-profit organizations.

¹³ The term “facilities and administrative costs” is not yet used universally in the cost principles and other documents cited in this section. This term and the term “indirect costs” may be used interchangeably to determine applicable policies. For NIH purposes, these costs will be referred to as “facilities and administrative,” or “F&A,” costs; however, other documents or non-NIH functions may refer to them as “indirect costs.”

¹⁴ These brochures are in the process of being updated. The Guide for State, Local, and Indian Tribal Govern-ments was updated and reissued in April 1997, superseding A Guide for State and Local Government Agencies (OASC-10); the other guides, although dated and not entirely consistent with recent changes to the cost principles, still may be used as guidance.

¹⁵ These brochures use the term “indirect costs.”

¹⁶ The following mechanisms are routinely included in EA/FDP: P01s, Ks, and all Rs except R43 and R41.

¹⁷ The following mechanisms are routinely included in EA/FDP: P01s, Ks, and all Rs except R43 and R41.

¹⁸ For this purpose, “data” means recorded information, regardless of the form or media on which it may be recorded, and includes writings, films, sound recordings, pictorial reproductions, drawings, designs, or other graphic representations, procedural manuals, forms, diagrams, work flow charts, equipment descriptions, data files, data processing or computer programs (software), statistical records, and other research data.

¹⁹ State governments will use, manage, and dispose of equipment acquired under a grant in accordance with State laws and procedures as specified in 45 CFR 92.32.

²⁰ Information about the electronic transmittal of FSRs may be obtained from OFM, NIH, at (301) 402-9123.

²¹The determination leading to such disputes may be made by an HHS official other than the GMO and may affect NIH grants as well as other HHS grants.