[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: 42CFR84.43]

[Page 516-517]
 
                         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 E_Quality Control
 
Sec. 84.43  Quality control records; review by the Institute; revocation 
of approval.

    (a) The applicant shall keep quality control inspection records 
sufficient to carry out the procedures required in MIL-STD-414, 11 June 
1957, including Change Notice No. 1, ``Sampling Procedures and Tables 
for Inspection by Variables for Percent Defective,'' or an approved 
equivalent sampling procedure. MIL-STD-105D, 29 April 1963, ``Sampling 
Procedures and Tables for Inspection by Attributes,'' is an example of 
an approved equivalent sampling procedure. MIL-STD-414 is incorporated 
by reference and has been approved by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be obtained from DODSSP, Standardization Document Order Desk, 700 
Robbins Avenue, Bldg. 4D, Philadelphia, Pa. 19111-5094. Copies may be 
inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 
Willowdale Road, Morgantown, WV 26505-2888, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. Copies of MIL-STD-105D may be inspected or obtained from 
the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale 
Road, Morgantown, WV 26505-2888.
    (b) The Institute reserves the right to have its representatives 
inspect the applicant's quality control test methods, equipment, and 
records, and to interview any employee or agent of the applicant in 
regard to quality control test methods, equipment, and records.
    (c) The Institute reserves the right to revoke, for cause, any 
certificate of approval where it is found that the applicant's quality 
control test methods,

[[Page 517]]

equipment, or records do not ensure effective quality control over the 
respirator for which the approval was issued.

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