What changed between these versions
A small clarification and a minor scope adjustment. v2 reorganizes and consolidates the instructions for the interim final rule in Section 2(a), making the requirements clearer. Additionally, v2 removes a provision that granted the Secretary of Health and Human Services discretion to make additional changes to the Code of Federal Regulations sections beyond the specified replacements.
Overview
A handful of changes primarily concentrated within Section 2. · v2 clarifies the instructions for the interim final rule and slightly narrows the Secretary's discretion regarding additional regulatory changes.
The primary change in v2 is the restructuring of Section 2(a), which consolidates and clarifies the directives for the Secretary of Health and Human Services regarding the publication of the interim final rule. This reorganization integrates the specific requirements for replacing "animal" references and adding the "nonclinical test" definition directly into the main instruction paragraph. A notable deletion is the removal of the Secretary's authority to make additional changes to the specified CFR sections beyond the explicit replacements, thereby tightening the scope of the rule-making power.
Deletions
This subsection stated, "The Secretary may make such additional changes to the sections of title 21, Code of Federal Regulations, described in subparagraphs (A) through (V) of paragraph (1) as the Secretary determines appropriate to fully implement the replacement required under such paragraph."
The removal of this provision eliminates the Secretary's explicit discretionary authority to make additional changes to the specified CFR sections beyond the direct replacement of "animal" references with "nonclinical" references. This narrows the scope of the Secretary's rule-making power under this Act.
Modifications
This change clarifies the direct requirements of the interim final rule by integrating them into a single, cohesive paragraph, making the Secretary's obligations more explicit and easier to follow without altering the substance of those obligations.
Before
The interim final rule was instructed to be published "pursuant to subsections (b) and (c)," where subsection (b) detailed replacing "animal" references in specific CFR sections and subsection (c) instructed adding the "nonclinical test" definition to other CFR sections.
After
The interim final rule's requirements are now directly enumerated within Section 2(a)(1) as subparagraphs (A) and (B), explicitly stating that the rule shall "amend the sections... to replace any references to 'animal' tests... with a reference to nonclinical tests" and "add the definition of 'nonclinical test' ... to sections 312.3, 314.3, 315.2, and 601.31 of title 21, Code of Federal Regulations."