Department of Health and Human Services (HHS) – Food and Drug Administration (FDA) – Centers for Disease Control and Prevention (CDC)

21 CFR § 10.90 — Intercenter Consultative Activities 45 CFR Part 2, Subpart A — Delegations of Authority for Rulemaking Concurrence

—OPTIONAL--

Notice of Proposed Rulemaking

Interagency Concurrence Requirements for Rulemaking at FDA and CDC

This change clears out outdated internal red tape that slows down FDA and CDC from doing their jobs. Cutting the extra layers doesn’t mean cutting oversight—final authority still sits with the HHS Secretary, and their office is required to keep staff in place to review all rules for quality and legality. We’re not weakening standards—we’re just making sure urgent, science-backed public health rules don’t get held up by unnecessary internal ping-pong.

FDA Office of Policy 10903 New Hampshire Avenue Silver Spring, MD 20993

regulations@fda.gov

Current regulations at 21 CFR § 10.90 and 45 CFR Part 2 require multi-level internal sign-off and concurrence from multiple HHS components before FDA or CDC may issue or amend a regulation. These dual-approval steps—often involving cross-office clearance through General Counsel, Assistant Secretaries, or other internal bodies—introduce significant delays in regulatory response. While originally designed to ensure internal consistency, these structures have become obstacles to timely action on pressing public health and medical product issues.

• This isn’t about removing guardrails—it’s about removing gridlock. Right now, rules that protect people’s health can get stuck bouncing between offices that aren’t even directly responsible for the science or the risk. By streamlining approvals, we let the experts move faster while still keeping full accountability through the Secretary’s office and the APA. Public health agencies still follow all the same public comment, transparency, and legal review processes—this just takes out the middlemen. It’s a smarter, faster way to do what we’re already supposed to be doing: protecting people. • Removes outdated layers of internal bureaucracy that slow the rulemaking process • Consolidates final authority with the Secretary of HHS, as permitted under statute • Ensures subject-matter review remains intact by requiring the Secretary’s office to maintain a permanent analytical staff • Supports regulatory agility at FDA and CDC without compromising oversight or coordination • Aligns with modern best practices in evidence-based, time-sensitive rule development

In 21 CFR § 10.90, delete all language relating to intercenter consultative activities and internal rulemaking concurrence. In 45 CFR Part 2, remove Subpart A (§§ 2.1–2.3) and replace with: “All final regulatory actions issued by agencies under the Department of Health and Human Services shall be signed by the Secretary or a designated appointee. The Secretary’s office shall retain an internal regulatory policy staff for review and coordination in lieu of separate multi-component concurrence processes.”

Robert F Kennedy

Secretary, Department of Health and Human Services