Project 2025 Tracker / What’s done, what’s next

14. Department of Health and Human Services · Minor

Limit the CDC to facilitating rather than developing diagnostic tests

Not started

Printed page 453 14. Department of Health and Human Services

“When it comes to testing, the CDC’s role should similarly be to facilitate rather than supplant the efforts of private test developers, academic laboratories, state public health laboratories, and clinical testing providers.”

What has happened

  1. Not started

    Nothing narrowed the CDC's role in diagnostic testing. The CDC published no rule and no proposed rule in the whole window — a Federal Register query for the agency restricted to types RULE and PRORULE since 2025-01-20 returns zero documents — and full-text searches of the agency's documents for "diagnostic test" and "test development" return zero; "private test developers" returns zero across every agency. The agency's twelve in-window documents mentioning public health laboratories are Paperwork Reduction Act clearances (including the Laboratory Response Network's), the Title 42 border orders, and one 2025-08-20 notice of a hepatitis C diagnostics convening hosted by the Association of Public Health Laboratories at which public health, laboratory, academic and industry participants were invited to give individual input — the CDC in exactly the facilitating posture the Quote wants, but a single meeting, not a limit on the agency's role. No reorganization moved the function either: a search for "Statement of Organization" restricted to the CDC returns zero documents in the window. In Congress the nearest measure is H.R. 1108, the Diagnostics Testing Preparedness Plan Act of 2025, which would rewrite §319B of the Public Health Service Act to make the Secretary publish a plan whose stated purposes are to "facilitate the development and utilization of diagnostic tests" and to "facilitate coordination and collaboration among public and private entities" — the Quote's own verb, though addressed to the Secretary rather than limiting the CDC. It was referred to Energy and Commerce on 2025-02-07 and has had no further action; under the four-rung ladder that is `not-started`. The VALID Act of 2025 (H.R. 3694 / S. 1932) and H.R. 1463 (defunding the FDA laboratory-developed test rule) are likewise in committee. CDC's own laboratory pages were read on 2026-09-03 and they move the other way: *Partners with Laboratories for Readiness and Response*, page-dated 2025-02-24, describes CDC as doing both limbs at once — it "engages with the laboratory and testing community, provides reliable and timely laboratory testing during infectious disease outbreaks and harmful exposures", listing the Laboratory Response Network, CLIA and an MOU for Diagnostic Surge Testing Capacity alongside "reliable laboratory diagnostics for outbreaks and harmful exposures through high-quality laboratory science at CDC". Nothing on any CDC laboratory page limits CDC's own test development, and CDC continues to describe in-house diagnostics as a core function. HHS's FY 2027 Agency Performance Plan and Report of April 2026 says the same from the department's side, planning to expand CDC's laboratory and informatics infrastructure rather than narrow it.

Research log

What was searched, and what didn’t count as evidence

Research notes

  • The one thing that did move on diagnostics in the window is on the FDA’s side of the line, not the CDC’s: the vacatur of the FDA’s 2024 laboratory-developed test rule and the reversion of 21 CFR 809.3(a) to its pre-2024 text (2025-09-19). That is the instrument behind #1226, #1227 and #1228 at pp. 456–457, all researched. It changes how FDA regulates tests made by laboratories; it says nothing about whether the CDC develops its own.
  • The Quote’s grievance is the 2020 CDC test failure, and the ask is about agency practice rather than about any published instrument — another of the less significant asks that cannot be verified by construction. Not started here means something stronger than “no public instrument limits the role”: CDC says on its own in-window pages that developing and running diagnostics is part of what it does.
  • cdc.gov was recorded as refusing to open for us through 2026-09-01. It does open, and CDC’s laboratory pages were read on 2026-09-03.
  • One search covered this ask together with the other asks on its pages.
Action
restrict
Object
CDC role in diagnostic test development
ID
1210