OIRA review adds a centralized check of a proposed rule before it is finalized. It can scrutinize the rule’s analysis and implications, giving the executive branch an opportunity to assess how the proposal fits with broader priorities and to seek changes.
That review can shape a rule without replacing the agency responsible for it. Understanding what OIRA review adds—and what it does not—helps clarify where policy choices are examined and how a proposal may change on the way to becoming a final rule.
| Rule | Review-stage detail | What the material says |
|---|---|---|
| FDA proposed GRAS rule | OIRA completed review July 31, 2026 | Cleared as “Consistent with Change” |
| CMMC final rule | 32 CFR; in OIRA review | Last phase before publication |
| DoD 48 CFR final rule | Reached OIRA review; July 22, 2025, noted as a major step | Cleared |
| FAA Part 108 final rule | Filed with OIRA July 10 | One of the final stages before publication |
- July 31, 2026 Date OIRA completed its review of the FDA proposed GRAS rule
- July 22, 2025 Date identified as a major step for DoD’s 48 CFR final rule
- July 10 Date the FAA filed its final Part 108 rule with OIRA
- 32 CFR Regulatory title cited for the CMMC final rule
- 48 CFR Regulatory title cited for DoD’s final rule
What does OIRA review add to a federal rule?
OIRA review adds a centralized check of a significant federal rule’s costs, benefits and consistency with the president’s priorities before publication. For the FDA’s proposed GRAS rule, OIRA’s “Consistent with Change” clearance indicated that revisions had been made or would be incorporated, showing that review can alter a proposal’s substance as well as affect its path to publication.
Substance as well as timing
The FDA example distinguishes OIRA review from a purely procedural pause: the clearance status points to changes in the proposed rule, not simply a later publication date. The review also considers the rule’s costs and benefits and its fit with presidential priorities.
Other rules illustrate the review’s place in the process, rather than its specific outcome: the CMMC final rule reached OIRA in its last phase before publication, while the FAA’s Part 108 rule entered review at one of its final stages. Stakeholders can also engage directly with OIRA during the review period about a rule’s impacts.
How can OIRA review change a rule?
OIRA review can change a rule’s provisions by prompting revisions before the rule is published. In the FDA’s proposed GRAS rule, the review status “Consistent with Change” indicates that changes were made or were expected to be incorporated.
The GRAS proposal as an example
The FDA GRAS proposal shows what that status can—and cannot—tell readers. It signals that OIRA’s review involved changes, but the available material does not identify which proposed provisions changed, what wording was revised, or whether specific requirements were altered.
OIRA’s attention to costs and benefits can also bring a rule’s expected effects into discussion before publication. For the FDA proposal, however, the status alone does not reveal how those considerations affected its text; it is evidence of a changed or change-bound review, not a record of the revisions.
When does OIRA review happen in the rulemaking process?
OIRA review happens late in the rulemaking process, often shortly before publication, for both proposed and final rules. The examples span a final rule under 32 CFR, the Department of Defense’s final rule under 48 CFR, the FAA’s final Part 108 rule and the FDA’s proposed GRAS rule.
- CMMC, 32 CFR: The CMMC final rule moved to OIRA review as its last phase before publication.
- Department of Defense, 48 CFR: Its final rule reached OIRA review and was cleared; July 22, 2025, was identified as a major step in the process.
- FAA, Part 108: The FAA filed its final rule with OIRA on July 10, with review described as one of the final stages before publication.
- FDA, proposed GRAS rule: OIRA review also applies before publication to a proposed rule, not only to final rules.
These cases place OIRA review near the end of the process, but at different rulemaking stages: the CMMC, DoD and FAA examples concern final rules, while FDA’s GRAS example concerns a proposal. Review can also affect a rule’s substance: the GRAS proposal was cleared as “Consistent with Change,” indicating revisions were made or would be incorporated.
How can stakeholders engage during OIRA review?
Stakeholders can engage directly with OIRA during a rule’s review to raise concerns about its impacts. The opportunity is tied to the specific rule being reviewed: examples in the supplied material include the FDA’s proposed GRAS rule, DoD’s CMMC rule, DoD’s 48 CFR rule and the FAA’s Part 108 rule.
For each of those rules, engagement concerns that rule’s potential effects; the material does not prescribe a format or deadline for stakeholder input. Nor does it guarantee that raising a concern will change the rule: OIRA review may involve revisions, but no particular stakeholder concern is assured a response or a specific outcome.
What does OIRA review not authorize it to do?
Do not mistake clearance for a published rule.
OIRA review does not establish that OIRA replaces the agency responsible for a rule, and a clearance does not by itself mean the rule has been published. The examples distinguish review from publication: OIRA review was described as the last phase before publication for the CMMC final rule and as one of the final stages for the FAA’s Part 108 rule.
- FDA’s proposed GRAS rule: OIRA cleared the proposal as “Consistent with Change,” indicating revisions were made or would be incorporated. That label does not identify the provisions changed or promise a particular final outcome.
- CMMC and FAA Part 108: Their movement through OIRA review is described as preceding publication, not as OIRA publishing either rule on the agency’s behalf.
OIRA’s assessment of costs and benefits and its consideration of presidential priorities describe aspects of review; the supplied material does not present them as authority to issue a rule for an agency. It also does not set out OIRA’s full legal powers or review procedures, so these examples cannot establish broader limits—or broader powers—beyond what they specifically describe.
How should readers interpret an OIRA review status?
Readers should treat an OIRA review status as a marker of a rule’s place in the process, not as the rule’s final text or a full account of its changes. For the FDA’s proposed GRAS rule, “Consistent with Change” indicates that revisions were made or are expected before the proposal moves forward; the status alone does not identify those revisions.
- FDA proposed GRAS rule: “Consistent with Change” signals changes, but does not specify their content.
- CMMC final rule: OIRA review was described as the last phase before publication, not publication itself.
- FAA Part 108 final rule: OIRA review was described as one of the final stages before publication.
These statuses distinguish a review milestone from publication: CMMC and FAA Part 108 were still in review, while the FDA proposal’s clearance status signaled revisions without spelling them out. A review-stage update can confirm where a rule stands, but readers need the published rule to assess its final wording and the details of any changes.
Frequently asked questions
What does OIRA review add to a federal rule?
Does OIRA review mean a rule has been published?
Can stakeholders contact OIRA during review?
What does “Consistent with Change” mean?
Key takeaways
- OIRA reviews significant federal rules, including proposals and rules nearing publication.
- The review weighs costs and benefits and considers alignment with presidential priorities.
- The FDA proposed GRAS rule’s “Consistent with Change” status is evidence that review can lead to revisions.
- OIRA review is a stage before publication, as illustrated by the CMMC and FAA Part 108 rules.
Sources
- Rolle IT Cybersecurity — “DoD’s 48 CFR Final Rule Reaches OIRA Review & is Cleared”
- natlawreview.com — “White House OIRA Completes Review of FDA Proposed GRAS Rule”
- verticalavi.org — “Part 108 final rule sent to OIRA for review – Vertical Aviation International”
- cmmcaudit.org — “CMMC Final Rule moves to OIRA review”
- ballotpedia.org — “Completed OIRA review of federal administrative agency rules – Ballotpedia”
