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HHSGrants Policy StatementU.S. Department of Health and Human ServicesOffice of the Assistant Secretary for Resources andTechnologyOffice of GrantsJanuary 1, 2007

IntroductionThe Department of Health and Human Services Grants Policy Statement (HHS GPS)is intended to make available in a single document the general terms and conditionsof HHS discretionary grant and cooperative agreement awards. These general termsand conditions are common across all HHS Operating Divisions (OPDIVs) 1 and applyas indicated in the HHS GPS unless there are statutory, regulatory, or award-specificrequirements to the contrary (as specified in individual Notices of Award). The HHSawarding offices are components of the OPDIVs and Staff Divisions (hereafter“OPDIVs”) that have grant-awarding authority.This document also is designed to be useful to those interested in the HHS grantsprocess by providing information about that process and its associated authoritiesand about responsibilities. The HHS GPS is available online from the HHS home pageat http://www.hhs.gov/grantsnet.HHS GPS OrganizationThe HHS GPS has four parts and an appendix, which allow general information,application information, and other types of reference material to be separated fromlegally binding terms and conditions: Part I: HHS Grants Process. Part I describes the OPDIVs, their role, and theroles of other HHS organizations in HHS grants; specifies recipient and HHSstaff responsibilities; outlines the grant application and review processes; andexplains the various resources available to those interested in the HHS grantsprocess. Part II: Terms and Conditions of HHS Grant Awards. Part II includes generallyapplicable terms and conditions. This part also specifies the terms andconditions that apply to particular types of grants, recipients, and activitiesthat differ from, supplement, or elaborate on the general terms andconditions. Part III: Points of Contact. Part III lists pertinent offices and officials withtheir addresses and telephone numbers. Part IV: OPDIV-Specific Information and Terms and Conditions. Part IV, whichsupplements Parts I, II, and III for a given OPDIV, contains any OPDIVsupplementary information and OPDIV-specific terms and conditions of award.This includes statutory, regulatory, or public policy requirements that applyonly to that OPDIV or its programs. OPDIV-specific terms and conditions inPart IV take precedence if they conflict with requirements in Part II of theHHS GPS.1As indicated under “Applicability,” the National Institutes of Health (NIH)maintains its own Grants Policy Statement. While the requirements of both policystatements are equivalent, the NIH GPS addresses only research and researchrelated matters as well as requirements that apply only to NIH.i

Appendices: The appendices include all abbreviations and a glossary of termsused throughout the HHS GPS for ease of reference.Supersession and ApplicabilitySupersessionApplicants for HHS grants and recipients have historically relied on a variety ofsources for information about the grants processes and requirements of HHS and itscomponent OPDIVs. For the recipients of grants from the OPDIVs constituting thePublic Health Service (PHS), the primary source of information for recipients was thePublic Health Service Grants Policy Statement. This HHS GPS supersedes in itsentirety the Public Health Service Grants Policy Statement, dated April 1, 1994, andaddendum, dated January 24, 1995.ApplicabilityThis policy statement applies only to HHS discretionary grant programs and only toawards to organizational entities made by OPDIVs other than the National Institutesof Health (NIH). It does not apply to awards under mandatory grant programs(e.g., entitlement programs) or to awards made directly to individuals (e.g.,scholarships). In 1998 (and with subsequent updates), NIH issued its own NIHGrants Policy Statement. Until further notice, NIH will continue to issue and maintainits own Grants Policy Statement in lieu of the HHS GPS. 2Recipients are not directly subject to the requirements of HHS Grants PolicyDirectives and implementing HHS Grants Administration Manuals (or any predecessorOPDIV manuals), which are internal documents guiding HHS operations. If an OPDIVimplements a requirement in an internal document that does affect recipients, it willnot do so by citing that document; rather, the requirement is placed on the recipientthrough explicit coverage in the NoA.Cooperative AgreementsThe Federal Grant and Cooperative Agreement Act of 1977, 31 U.S.C. 6301, definesthe cooperative agreement as an alternative assistance instrument to be used in lieuof a grant whenever substantial Federal involvement with the recipient duringperformance is anticipated. The difference between grants and cooperativeagreements is the degree of Federal programmatic involvement rather than the typeof administrative requirements imposed. Therefore, statutes, regulations, policies,and the information contained in this policy statement that are applicable to grantsalso apply to cooperative agreements, unless the award itself provides otherwise.2This HHS GPS is issued as a preliminary step by HHS to standardize andstreamline award terms and conditions. Once there are government-wide changesunder the Federal Financial Assistance Management Improvement Act of 1999, 31U.S.C. 6101 note, HHS will use this document to reflect those changes.ii

Subrecipients and Contractors under GrantsThe information contained in this policy statement applies directly to the primaryrecipients of HHS funds. The HHS GPS indicates in Part II whether requirementsmust be applied to or “flowed down” to subawards or contracts under grants.Recipients are responsible for specifying those requirements in subawards (whichincludes consortium agreements) or contracts, as applicable.Effective DateThis document is effective for all new, competing continuation, and non-competingcontinuation HHS grant and cooperative agreement awards with beginning dates onor after January 1, 2007. This document reflects current HHS requirements asspecified in 45 CFR parts 74 and 92.The information in this document is subject to change following its issuance due tochanges in statutes, regulations, or policies adopted subsequent to its effective date.To ensure that applicants and recipients are aware of changes, recipients shouldrefer to the Federal Register and Code of Federal Regulations (Titles 45 and 42).These documents are available online at http://www.gpoaccess.gov/.ConventionsCertain conventions are followed throughout this document. The term “grant” is usedto mean both grants and cooperative agreements; however, for clarity, certainsections mention both grants and cooperative agreements. The term “recipient”generally is used to refer to the organization to which an OPDIV makes a grant orcooperative agreement award. However, depending on the context, the terms“grantee” may be used rather than “recipient.” “HHS” may be used in this documentto refer to the entire organization or to its component organizations, or else tocontrast an action by an OPDIV with an action by a recipient or other organization. Areference to Part I, II, III, or IV without further elaboration means the correspondingpart of the HHS GPS. Although most of the requirements in the HHS GPS apply tothe covered activities of all OPDIVs, if a requirement applies more narrowly, theexception is explicitly noted.MaintenanceThe Office of Grants—part of the HHS Office of the Assistant Secretary for Resourcesand Technology—is responsible for developing and maintaining this document, whichwill be reissued periodically. Interim changes will be posted on the HHS and OPDIVWeb sites (see Part I). Each change, including its applicability and effective date andthe affected sections of the HHS GPS specified, will be described, and the necessarylanguage to implement it as a term or condition of award will be provided. The Officeof Grants welcomes comments and suggestions for future versions of the HHS GPS.iii

Table of ContentsPart I: HHS Grants Process. I-1General Information . I-1HHS Grant-Awarding Operating Divisions. I-1Types of HHS Financial Assistance Programs . I-3Sources of Requirements. I-4Roles and Responsibilities. I-4Roles and Responsibilities of OPDIV Staff Members and Other HHSOffices . I-5Roles and Responsibilities of Recipients and Their Principals . I-6Fraud, Waste, and Abuse. I-7Paperwork Reduction Act. I-8Sources of Information about HHS Grant Processes and Programs. I-9Application and Application Review Processes . I-9Grants.gov and Funding Opportunity Announcements. I-9Eligibility . I-11Suspension and Debarment. I-13Delinquency on Federal Debt . I-14Lobbying . I-15Application Process. I-15Types of Applications and Letters of Intent . I-15Application Forms . I-16Preparing an Application . I-17Public Policy Requirements . I-18Research-Related Requirements. I-18National Environmental Policy Act . I-19Preservation of Cultural and Historic Resources . I-20iv

Protection of Wetlands. I-21Uniform Relocation Act and Real Property Acquisition Policies Act. I-22The Application Budget . I-22Indirect Costs. I-23Matching or Cost Sharing . I-24Research Patient Care Costs . I-25Third-Party Reimbursement. I-25Submitting an Application. I-25Executive Order 12372 and Public Health System Reporting RequirementsI-26Use of Application Information . I-27Freedom of Information Act. I-28Privacy Act. I-29Objective Review of Applications . I-29Disposition of Applications . I-30Business Management Reviews and Other Pre-Award Activities . I-31Assurances of Compliance . I-31Cost Analysis . I-32Assessment of Financial and Other Management Systems. I-32The Notice of Award . I-33Project Period and Budget Period . I-34Other Terms and Conditions . I-35Payment. I-36SMARTLINK II/ACH. I-36CASHLINE/ACH . I-36Cash Request . I-37Post-Award Administration . I-37v

Part II: Terms and Conditions of Award .II-1Overview of Terms and Conditions of Award .II-1General, Program-Specific, and Award-Specific Terms and Conditions .II-1Effect and Order of Precedence .II-1Flow-Down of Requirements under Subawards and Contracts under GrantsII-2Public Policy Requirements .II-2Standards of Conduct for Recipient Employees .II-7Hatch Act .II-8Age Discrimination Act of 1975.II-8Civil Rights Act of 1964 .II-8Education Amendments of 1972 .II-8Rehabilitation Act of 1973 .II-8Biological Agents and Toxins .II-9USA PATRIOT Act.II-9Public Health Security and Bioterrorism Preparedness andResponse Act .II-9Human Subjects.II-9Office for Human Research Protections’ and Recipient Responsibilities II10Protection of Research Subjects’ Identities . II-12Animal Welfare . II-12Other Research-Related Requirements . II-13Research Misconduct . II-13Financial Conflict of Interest . II-14Recombinant DNA and Human Gene Transfer Research . II-15Human Embryonic Stem Cell Research and Cloning. II-16Research on Human Fetal Tissue . II-16Transplantation of Human Fetal Tissue. II-18vi