G/TBT/N/USA/783  
 
7 February 2013  
(13-0644)  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) (802) 
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 :    
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 applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  New drug 
applications (ICS 11.120). 
5. Title, number of pages and langua ge(s) of the notified document:  Guidances for 
Industry and Investigators on Safety Reporting Requirements for Investigational New Drug 
Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide; Availability (2 pages, in English)     
6. Description of content:  The Food and Drug Administration (FDA) is announcing the 
availability of two guidances for industry and investigators entitled “Safety Reporting 
Requirements for INDs and BA/BE Studies" and "Safety Reporting Requirements for INDs 
and BA/BE Studies--Small Entity Compliance Guide". These guidances are intended to help sponsors and investigators comply with the requirements in the final rule entitled 
"Investigational New Drug Safety Reporting Requirements for Human Drug and Biological 
Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans", published in the Federal Register on 29 September 2010 (75 FR 59935). FDA has prepared the Small Entity Compliance Guide in accordance with the Small Business 
Regulatory Enforcement Fairness Act. It is intended to help small businesses understand 
and comply with the regulations issued by FDA concerning safety reporting requirements for investigational new drug applications (IND) and bioavailability (BA) and bioequivalence 
(BE) studies.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health  
8. Relevant documents:   77 Federal Register (FR) 75439, 20 December 2012. 
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological 
Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies 
in Humans - Final Rule 
http://www.gpo.gov/fdsys/pkg/FR -2010-09-29/html /2010-24296.htm  
http://www.gpo.gov/fdsys/pkg/FR -2010-09-29/pd f/2010-24296.pdf  G/TBT/N/USA/783 
 
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  9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined 
10. Final date for comments:  - 
11. Text available from:  National enquiry point [  ], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:    
URLs: http://www.gpo.gov/fdsys/pkg/FR -2012-12-20/html /2012-30651.htm  
http://www.gpo.gov/fdsys/pkg/FR -2012-12-20/pd f/2012-30651.pdf