Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record

Rule Summary: This proposed rule will amend the rules for over-the-counter antiseptic drug products, requiring additional data to support safety for these uses. This will include in vitro data characterizing the ingredient's antimicrobial properties and in vivo clinical simulation studies showing reductions in the amount of certain bacteria.

Restrictions: 53

 Word Count: 41638

Costs Monetized: Yes 

Benefits Monetized: Yes

TABLE DESCRIPTION FOR POTENTIAL MIDNIGHT REGULATIONS:

1. Regulation Title: The official title of the rulemaking used by the issuing agency.
    
2. RIN: Regulation Identifier Number—a unique tracking number assigned by the Regulatory Information Service Center to each regulation under development or review by an agency.
    
3. Stage: Shows where the rulemaking is in the regulatory process. Stages include:
    a. Open comment period: the proposed rule has been published in the Federal Register and the agency is taking public comments.
   b. Closed comment period: the public comment period for a rulemaking is closed.
   c. Pending final review: OIRA is reviewing what the agency intends to publish as the final regulation.
    
4. Restrictions: The number of binding constraints or “restrictions” in the proposed regulation’s text. These are words that indicate an obligation to comply such as “shall” or “must.” Given the difficulty of measuring regulations, counting restrictions is one of the best ways to measure the size and scope of regulations. These numbers are obtained from using RegData. 
    
5. Top Industry: The industry likely to be most affected by the regulation. Obtained using RegData.
    
6. Costs Monetized: Shows whether the agency provides a quantitative estimate of the costs associated with the rule.
    
7. Benefits Monetized: Shows whether the agency provides a quantitative estimate of the benefits associated with the rule.