[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR84.11]

[Page 511]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 84_APPROVAL OF RESPIRATORY PROTECTIVE DEVICES--Table of Contents
 
                   Subpart B_Application for Approval
 
Sec. 84.11  Contents of application.

    (a) Each application for approval shall contain a complete written 
description of the respirator for which approval is requested together 
with drawings and specifications (and lists thereof) showing full 
details of construction of the respirator and of the materials used.
    (b) Drawings shall be titled, numbered, and dated; any revision 
dates shall be shown on the drawings, and the purpose of each revision 
being sought shall be shown on the drawing or described on an attachment 
to the drawing to which it applies.
    (c) Each application for approval shall contain a proposed plan for 
quality control which meets the minimum requirements set forth in 
subpart E of this part.
    (d) Each application shall contain a statement that the respirator 
has been pretested by the applicant as prescribed in Sec. 84.64, and 
shall include the results of such tests.
    (e) Each application for approval shall contain a statement that the 
respirator and component parts submitted for approval are either 
prototypes, or made on regular production tooling, with no operation 
included which will not be incorporated in regular production 
processing.

(The information collections contained in this section are approved 
under OMB control number 0920-0109)