[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: 16CFR1702.3]

[Page 751-752]
 
                     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.  1702.3  Substantive requirements.

    (a) A petition filed under this part shall include the information 
required

[[Page 752]]

by this part, or a satisfactory explanation for the absence of the 
information. As provided by Sec.  1702.4, a petition which is not 
complete may be closed. To be considered complete, a petition shall 
include the following:
    (1) A statement of the justification for the exemption in accordance 
with Sec.  1702.7,
    (2) All reasonably available human experience data, reasonably 
available relevant experimental data (both human and animal), product 
and packaging specifications, labeling, and marketing history, in 
accordance with Sec. Sec.  1702.8 through 1702.14,
    (b) As used in this regulation, ``reasonably available'' information 
is data in the petitioner's possession; data that has previously been 
generated by the petitioner, and data that is obtainable from such 
sources as: Reports from Poison Control Centers; reports of adverse 
reactions that have been submitted to the petitioner; the medical, 
pharmacological, and toxicological literature; and information required 
by the FDA for an Investigational Exemption for a New Drug (IND) or a 
New Drug Application (NDA).