G/TBT/N/USA/1167  
 
25 July 2016  
(16-3923)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: UNITED STATES OF AMERICA 
If applicable, name of local government involved (Article 3.2 and 7.2):  
2. Agency responsible: Food and Drug Administration (FDA), Health and Human Services 
(HHS) [1185] 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above : 
Please submit comments to: USA WTO TBT Enquiry Point 
Email: usatbtep@nist.gov   
3. Notified under Article 2.9.2 [X], 2.10 .1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: 
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Topical antimicrobial 
drug products. Sterilization and disinfection (ICS: 11.080) 
5. Title, number of pages and language(s) of the notified document: Safety and 
Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-
Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record (27 pages, in English) 
6. Description of content: The Food and Drug Administration (FDA or Agency) is issuing this 
proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 
TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are 
proposing to establish conditions under which OTC consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are generally recognized as safe and generally recognized as effective (GRAS/GRAE). 
In the 1994 TFM, certain antiseptic active ingredients were proposed as being GRAS for 
antiseptic rub use by consumers based on safe ty data evaluated by FDA as part of its 
ongoing review of OTC antiseptic drug products. However, in light of more recent scientific 
developments and changes in the use patterns of these products, we are now proposing 
that additional safety data are necessary to  support the safety of antiseptic active 
ingredients for this use. We also are proposing that all consumer antiseptic rub active 
ingredients have in vitro data characterizing the ingredient's antimicrobial properties and 
in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety  
8. Relevant documents: 81 Federal Register (FR) 42911, 30 June 2016; Title 21 Code of 
Federal Regulations (CFR) Part 310. Will appear in the Federal Register when adopted. G/TBT/N/USA/1167 
 
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  9. Proposed date of adoption: To be determined 
Proposed date of entry into force: To be determined   
10. Final date for comments: 27 December 2016 
11. Texts available from: National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
https://members.wto.org/crnattachm ents/2016/TBT/USA/16_2901_00_e.pdf