The Health Resources and Services Administration (HRSA) is the operating division of the U.S. Department of Health and Human Services (HHS) charged with improving access to health care for people who are geographically isolated or economically or medically vulnerable. HRSA does not fund investigator-initiated biomedical research the way the National Institutes of Health (NIH) does. Instead, it funds health-care service delivery, health workforce training, and program infrastructure through more than 90 programs and thousands of grantees, including community health centers, academic health workforce programs, state maternal and child health agencies, and HIV care providers. For a sponsored-programs office, that difference in mission changes almost everything downstream: how the award is structured, what “performance” means to the program officer, and which compliance framework governs the money.
This guide covers what a research administrator or grants office needs to know to manage an HRSA award competently: its bureau structure, how HRSA funding differs from NIH funding, the award lifecycle and mechanisms, the compliance framework (45 CFR Part 75 rather than 2 CFR 200 directly), and the point at which HRSA-funded program work can cross into human subjects research requiring IRB oversight.
HRSA’s Bureaus and Major Program Areas
HRSA organizes its programs by population and mission rather than by disease or discipline. The major bureaus and offices a grants office is likely to encounter are:
- Bureau of Primary Health Care — funds Federally Qualified Health Centers (FQHCs) and other Health Center Program grantees delivering comprehensive primary and preventive care in medically underserved areas.
- Bureau of Health Workforce — funds training and education programs across the health professions, along with scholarship and loan-repayment programs (including the National Health Service Corps) that place clinicians in shortage areas.
- Maternal and Child Health Bureau (MCHB) — administers the Title V Maternal and Child Health Services Block Grant along with discretionary programs supporting maternal, infant, child, and adolescent health; MCHB also funds a meaningful amount of applied research and evaluation in support of that mission, distinguishing it somewhat from HRSA’s more purely service-delivery bureaus.
- HIV/AIDS Bureau — administers the Ryan White HIV/AIDS Program, the primary federal program funding care and treatment services for people with HIV who are uninsured or underinsured.
- Health Systems Bureau — oversees a mix of programs including the national organ transplantation system (via its contract with the Organ Procurement and Transplantation Network) and other health-systems infrastructure programs.
- Federal Office of Rural Health Policy — funds programs specifically targeted at rural health-care access, workforce, and hospital sustainability.
Bureau and office names occasionally get restructured, so a grants office managing an active award should confirm current bureau assignment directly against the Notice of Award or the HRSA organization page rather than assuming continuity from a prior award cycle.
How HRSA Funding Differs From NIH Funding
This is the distinction that most affects how an office should staff and administer an HRSA award, and it is easy to get wrong by applying NIH-shaped assumptions to it.
- Purpose. NIH funds investigator-initiated or agency-solicited biomedical and behavioral research, reviewed for scientific merit through peer-review study sections. HRSA predominantly funds service delivery and workforce training — keeping a clinic open, training more clinicians, sustaining a state’s maternal health infrastructure — reviewed against programmatic criteria (need, capacity, service plan, sustainability) rather than scientific innovation. Some HRSA bureaus, notably MCHB, do fund applied research and evaluation, but this is the exception within HRSA’s portfolio, not the norm.
- Instrument. A substantial share of HRSA awards are structured as cooperative agreements rather than grants, meaning HRSA retains “substantial involvement” in project direction — approving work plans, participating in key decisions, sometimes co-authoring deliverables — rather than the largely hands-off relationship typical of an NIH R01.
- Reporting. Performance reporting is programmatic: number of patients served, workforce placements achieved, service capacity maintained, measured against the objectives in the approved work plan, rather than the progress-toward-hypotheses narrative expected in an NIH Research Performance Progress Report.
- Review and funding logic. Many HRSA programs use formula funding or a mix of formula and competitive discretionary funding (Title V is the clearest formula example), which has no real NIH analog outside a few training and center mechanisms.
The practical implication for a research office: don’t route an HRSA cooperative agreement through the same review and negotiation playbook built for NIH R-series awards. Scope of work, budget justification, and the deliverables a program officer will actually hold the grantee to are different in kind, not just in dollar amount.
HRSA Award Mechanisms and the Grant Lifecycle
The lifecycle shape is recognizably federal, but several steps are HRSA-specific:
- Notice of Funding Opportunity (NOFO). HRSA publishes funding opportunities as NOFOs — functionally the same instrument as what other agencies call a funding opportunity announcement (FOA), defining eligibility, required forms, review criteria, and the application deadline.
- Application via Grants.gov and HRSA EHB. The initial application package is typically submitted through Grants.gov. Post-award administration — progress reports, budget revisions, prior-approval requests, and non-competing continuation applications — then moves into HRSA’s Electronic Handbooks (EHB) system, HRSA’s own award-management portal. An office that only tracks Grants.gov and never sets up EHB access will miss post-award obligations.
- Notice of Award (NoA). As with other federal agencies, the NoA is the legally binding document establishing the award terms, budget period, and any special conditions — the document to check before assuming the terms match what was proposed.
- Non-competing continuations and progress reporting. Multi-year HRSA awards are typically funded in annual budget periods contingent on an approved non-competing continuation (NCC) application and satisfactory progress reporting, submitted through EHB.
- Carryover and prior approval. Carrying forward unobligated balances, rebudgeting above the threshold in the award terms, or changing scope generally requires prior approval — consistent with the prior approval requirements that apply across federal grant-making generally, but routed through EHB for HRSA specifically rather than through an agency-specific portal like NIH eRA Commons.
Compliance Requirements: 45 CFR Part 75, Not 2 CFR 200 Directly
The single most common mistake a research office makes on an HRSA award is citing 2 CFR Part 200 as the governing regulation. HHS — and therefore HRSA — has its own codification of the federal Uniform Guidance: 45 CFR Part 75, “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards.” Part 75 largely mirrors 2 CFR 200’s structure and substance (allowability, allocability, and reasonableness of costs; administrative requirements; audit requirements), but it is the HHS-specific regulatory text that actually governs an HRSA award, and it is what should be cited in policies, subaward agreements, and audit workpapers for HRSA funds rather than 2 CFR 200 itself.
Within that framework, an office administering HRSA funds should have processes covering:
- Cost allowability. The same allowable/allocable/reasonable cost principles that govern any Uniform Guidance-based federal award, applied under the Part 75 codification for HRSA and other HHS funds.
- Matching and cost sharing. Some HRSA programs carry statutory or NOFO-specified matching requirements (the specific percentage and basis vary by program and should be confirmed against the NOFO and Notice of Award for each award, never assumed from a prior cycle) — the general mandatory-versus-voluntary distinction works the same way it does under cost sharing requirements elsewhere in federal grants management.
- Subrecipient monitoring. HRSA awards that pass funds to subrecipients — common in multi-site health workforce and Ryan White awards — carry the same subrecipient monitoring obligations that apply under the Uniform Guidance generally: risk assessment before subaward, monitoring during the period of performance, and resolution of any audit findings.
- Audit. HRSA grantees spending federal awards above the Single Audit Act threshold (currently $1,000,000 in a fiscal year, following the 2024 revision to the Uniform Guidance) are subject to the same Single Audit requirement as any other recipient of federal funds, with findings reported through the Federal Audit Clearinghouse.
- HHS Grants Policy Statement. HRSA awards are also subject to the general terms in the HHS Grants Policy Statement, which supplements Part 75 with HHS-wide policy on topics like prior-approval thresholds and post-award requirements; program-specific NOFOs and the Notice of Award can layer additional, more restrictive terms on top of it.
When Does HRSA-Funded Work Become Human Subjects Research?
Most HRSA-funded activity — running a clinic, training clinicians, administering a block grant — is program operation, not research, and does not require IRB review on that basis alone. The line gets crossed when a grantee moves from delivering or monitoring a service to conducting a systematic investigation designed to contribute to generalizable knowledge: for example, when a required program evaluation is redesigned to test a generalizable hypothesis, involves a comparison or control condition, or is intended for publication as a contribution to the field rather than solely to report back to HRSA on program performance. That shift is what triggers a human subjects research determination under the Common Rule (45 CFR Part 46) and potential IRB review, independent of whether the underlying activity is HRSA-funded.
Because MCHB and some other HRSA bureaus explicitly fund applied research and evaluation rather than pure service delivery, a grants office working with those programs should build in a human-subjects screening step at proposal development, not wait until data collection has already started to ask the question.
Frequently Asked Questions
Is HRSA part of NIH?
No. HRSA and NIH are both operating divisions of HHS, but they are organizationally separate agencies with different missions — NIH funds biomedical and behavioral research; HRSA funds health-care access, service delivery, and workforce training. A single institution can hold awards from both simultaneously, administered under different rules.
Does HRSA fund research at all?
Some. Most HRSA funding is program and service-delivery focused, but bureaus such as the Maternal and Child Health Bureau fund applied research and evaluation activities in support of their mission, and any HRSA-funded activity can cross into human subjects research if it is designed to produce generalizable knowledge. Check each NOFO’s stated purpose rather than assuming based on the bureau alone.
What’s the difference between an HRSA grant and an HRSA cooperative agreement?
Both are financial assistance instruments, but a cooperative agreement gives HRSA “substantial involvement” in carrying out the project — approving work plans, participating in key decisions — while a standard grant is largely hands-off after award. Many HRSA programs, particularly multi-site or national programs, use cooperative agreements specifically so HRSA can coordinate activity across grantees.
What regulation governs HRSA grant compliance?
45 CFR Part 75, HHS’s own codification of the federal Uniform Guidance, governs cost principles, administrative requirements, and audit requirements for HRSA and other HHS awards — not 2 CFR Part 200 directly, though the two are substantively similar.
How does a grantee apply for HRSA funding?
Applications are typically submitted through Grants.gov in response to a published Notice of Funding Opportunity (NOFO). Once an award is made, post-award administration — progress reports, budget actions, non-competing continuations — moves to HRSA’s Electronic Handbooks (EHB) system.
When does an HRSA-funded program evaluation need IRB review?
When it stops being solely an internal report of program performance to HRSA and becomes a systematic investigation designed to produce generalizable knowledge — for example, a planned comparison, a publication intent, or a hypothesis-testing design. That determination should be made and documented before data collection begins, not after.
