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45 CFR part 75 is no longer the rule for HHS grants. HHS repealed its own regulations on administering financial assistance awards and adopted the government-wide Uniform Guidance (2 CFR part 200) through a new HHS part, 2 CFR part 300. The change was made by an interim final rule published in the Federal Register on 2 October 2024 (89 FR 80055). This guide explains what changed, which sections of 2 CFR part 300 carry the HHS-specific material, and how to cite correctly in new work.
What it was and who ran it
Part 75 was the HHS-specific set of regulations for administering HHS financial assistance awards. It was the HHS counterpart to the OMB Uniform Guidance, so the topics were the same ones research administrators work with under 2 CFR part 200: cost principles, procurement, subawards, equipment and supplies, closeout and audit. That is why searches for “45 CFR 75” and “2 CFR 200” often land on the same questions.
Is 45 CFR part 75 still in effect?
No, 45 CFR part 75 is not in effect once the repeal takes effect. The HHS interim final rule states: “This rule also repeals HHS’ existing regulations governing the administration of HHS financial assistance awards.” The rule is effective October 1, 2025, except for amendatory instruction 2, which revises 2 CFR 300.1 and was effective October 1, 2024. HHS-specific content was either dropped, moved into 2 CFR part 300, or moved into the HHS Grants Policy Statement. If a document, subaward template or internal policy cites “45 CFR 75” (or “45 CFR part 75”), the citation points at regulations HHS has repealed.
Who it applied to and who it applies to now
45 CFR part 75 applied to recipients of HHS financial assistance awards. Those recipients now follow 2 CFR part 200 as adopted by HHS, plus the HHS-specific items in 2 CFR part 300. Some 2 CFR part 300 sections are aimed at particular recipient types: 300.218 covers for-profit recipients and 300.219 covers Federal agency recipients.
What it required and what replaced it
Section 300.106 of 2 CFR part 300 says: “The Department of Health and Human Services adopts the Office of Management and Budget (OMB) guidance in 2 CFR part 200, with the additions included in this part and part 376 of this chapter. Thus, this part gives regulatory effect to the OMB guidance and supplements the guidance as needed for the Department.”
In practice there are now two layers: the Uniform Guidance itself in 2 CFR part 200, and the HHS additions in 2 CFR part 300. The structure of part 300 is small: Subpart A is reserved; Subpart B holds 300.106 and 300.112; Subpart C holds 300.218 and 300.219; Subpart D holds 300.300, 300.305, 300.308 and 300.315; Subpart E holds 300.414, 300.477 and 300.478; and Appendix IX covers hospital research and development cost principles.
The Federal Register notice lists twelve HHS-specific items that remain in part 300. Everything else follows 2 CFR part 200 or the HHS Grants Policy Statement.
| 2 CFR 300 section | Subject |
|---|---|
| 300.106 | Adoption of 2 CFR part 200 |
| 300.112 | Conflict of interest (aligned with 42 CFR part 50, subpart F) |
| 300.218 | For-profit recipients |
| 300.219 | Federal agency recipients |
| 300.300 | Statutory and national policy requirements, including nondiscrimination |
| 300.305 | Federal payments to States |
| 300.308 | Prior approval for research patient care costs |
| 300.315 | Intangible property for primarily educational awards |
| 300.414 | Indirect cost limits (training awards and certain foreign or international awards) |
| 300.477 | Independent research and development |
| 300.478 | Shared responsibility payments |
| Appendix IX | Hospital research and development cost principles |
Compliance steps now
- Find every document, subaward template and internal policy that cites “45 CFR 75” or “45 CFR part 75”.
- Replace the citation with 2 CFR part 200 as adopted by 2 CFR 300.106.
- Where HHS has its own rule, cite the specific 2 CFR part 300 section from the table above, for example 2 CFR 300.112 for conflict of interest.
- Check the current text of 2 CFR part 200 for the dollar value of each threshold instead of relying on older summaries.
Typical timeline phases
The rule was staged. Phase 1 took effect on October 1, 2024, and changed eight Uniform Guidance flexibilities for HHS recipients. Phase 2, the repeal of the HHS regulations and the adoption of 2 CFR part 300 as the HHS layer, is effective October 1, 2025. The eight phase 1 items and where each lives in 2 CFR part 200 are:
| Phase 1 flexibility | 2 CFR 200 location |
|---|---|
| Micro-purchase and simplified acquisition thresholds | 200.320 |
| Closeout | 200.344 |
| Subaward threshold in modified total direct costs (MTDC) | 200.1 |
| Equipment threshold | 200.1, 200.313(e) |
| Supplies threshold | 200.1, 200.314(a) |
| Fixed amount subaward threshold | 200.333 |
| De minimis indirect cost rate | 200.414(f) |
| Audit threshold | 200.501 |
Read the dollar values for each threshold in the current text of 2 CFR part 200 rather than from older summaries, since this page lists the sections, not the figures.
Common mistakes
- Citing 45 CFR 75 in new subaward agreements or policies. Cite 2 CFR part 200 as adopted by 2 CFR 300.106, plus the specific 2 CFR part 300 section where HHS has its own rule.
- Looking for a 45 CFR 75 section number to find an HHS rule. The twelve items above are the ones HHS kept; check that list first, then 2 CFR part 200.
- Treating conflict of interest as a Uniform Guidance topic only. The HHS provision is in 2 CFR 300.112.
- Assuming indirect cost rules are identical for every HHS award. 2 CFR 300.414 holds HHS-specific limits for training awards and certain foreign or international awards.
- Mixing up the two dates. October 1, 2024 is phase 1 (the eight flexibilities); October 1, 2025 is when the repeal takes effect.
Related programs and rules
| Rule or policy | Relationship to 45 CFR part 75 |
|---|---|
| 2 CFR part 200 (Uniform Guidance) | Government-wide OMB guidance that HHS now adopts directly under 2 CFR 300.106. See budget justification and allowability review under 2 CFR 200. |
| 2 CFR part 300 (HHS) | Holds the twelve HHS-specific items that remain, listed in the table above. |
| HHS Grants Policy Statement | Receives some HHS policy provisions moved out of the repealed regulations, such as forms for HHS financial assistance (previously 45 CFR 75.206). |
| NIH Grants Policy Statement | See NIH Grants Policy Statement subaward requirements. |
More related reading:
- HRSA guide for research administrators
- How to calculate indirect (facilities and administrative) costs
- Federal grant closeout process and checklist
FAQ
Is 45 CFR part 75 still in effect?
No. HHS repealed it in the interim final rule (89 FR 80055), effective October 1, 2025, and adopted 2 CFR part 200 through 2 CFR part 300.
What is 45 CFR part 75?
It was the set of HHS regulations governing the administration of HHS financial assistance awards. HHS repealed those regulations in its interim final rule (89 FR 80055), effective October 1, 2025.
What is the difference between 45 CFR 75 and 2 CFR 200?
2 CFR part 200 is the government-wide OMB Uniform Guidance. 45 CFR part 75 was the HHS-specific set of regulations. HHS now adopts part 200 directly under 2 CFR 300.106, and keeps a small set of HHS additions in 2 CFR part 300.
Where did the HHS-specific rules go?
The rule keeps twelve HHS-specific items in 2 CFR part 300 (listed in the table above). Other HHS-specific content was dropped or moved to the HHS Grants Policy Statement.
When did the change take effect?
The rule is effective October 1, 2025, except for the instruction revising 2 CFR 300.1, which was effective October 1, 2024, when the eight phase 1 flexibilities began.
Sources
- HHS interim final rule, 89 FR 80055 (2 October 2024), Federal Register: govinfo.gov, FR-2024-10-02, 2024-21984. Date checked: 2026-10-29.
- 2 CFR part 300, Department of Health and Human Services: eCFR, title 2, part 300. Date checked: 2026-10-29.
