[Code of Federal Regulations]
[Title 16, Volume 2]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 16CFR1702.8]

[Page 752-753]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
             CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION
 
PART 1702--PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING 
ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS--Table of Contents
 
Sec.  1702.8  Human experience data.

    Human experience data constitutes the primary criterion used by the 
Commission in evaluating petitions for exemptions. Petitions shall 
therefore include a compilation of all reasonably available reports 
pertaining to human use of the particular substance, including the 
product brand as well as generic equivalents and involving adverse 
reports of personal injury, illness, and significant allergenicity. Such 
information in children is of particular importance in evaluating 
exemption requests. However, similar data in adults shall also be 
submitted if available. Human experience data may be obtained from such 
sources as:

[[Page 753]]

    (a) Reports from Poison Control Centers,
    (b) Reports of adverse reactions relative to the product that have 
been submitted to the company by physicians, hospitals, consumers, and 
other sources,
    (c) Extensive searches of the medical, pharmacological, and 
toxicological literature, and
    (d) For drugs, where the human experience data submitted is based on 
data required by FDA to be compiled for an Investigational Exemption for 
a New Drug (IND), 21 CFR part 312, or a New Drug Application (NDA), 21 
CFR part 314, a summary of the relevant data should be provided. The 
entire NDA and IND material need not be submitted.