[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Pages 14019-14020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5921]



Centers for Disease Control and Prevention


Proposed Data Collections Submitted for Public Comment and 

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-5960 
and send comments to Carol E. Walker, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Respiratory Protective Devices--42 CFR part 84--Regulation--(0920- 
0109)--Extension--National Institute for Occupational Safety and Health 
(NIOSH), of the Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    This data collection was formerly named Respiratory Protective 
Devices 30 CFR part 11 but in 1995, the respirator standard was moved 
to 42 CFR part 84. The regulatory authority for the National Institute 
for Occupational Safety and Health (NIOSH) certification program for 
respiratory protective devices is found in the Mine Safety and Health 
Amendments Act of 1977 (30 U.S.C. 577a, 651 et seq., and 657(g)) and 
the Occupational Safety and Health Act of 1970 (30 U.S.C. 3, 5, 7, 811, 
842(h), 844). These regulations have as their basis the performance 
tests and criteria for approval of respirators used by millions of 
American construction workers, miners, painters, asbestos

[[Page 14020]]

removal workers, fabric mill workers, and fire fighters. Regulations of 
the Environmental Protection Agency (EPA) and the Nuclear Regulatory 
Commission (NRC) also require the use of NIOSH-approved respirators. 
These regulations also establish methods for respirator manufacturers 
to submit respirators for testing under the regulation and have them 
certified as NIOSH-approved if they meet the criteria given in the 
above regulation. NIOSH, in accordance with 42 CFR Part 84: (1) Issues 
certificates of approval for respirators which have met specified 
construction, performance, and protection requirements; (2) establishes 
procedures and requirements to be met in filing applications for 
approval; (3) specifies minimum requirements and methods to be employed 
by NIOSH and by applicants in conducting inspections, examinations, and 
tests to determine effectiveness of respirators; (4) establishes a 
schedule of fees to be charged applicants for testing and 
certification; and (5) establishes approval labeling requirements. 
Information is collected from those who request services under 42 CFR 
part 84 in order to properly establish the scope and intent of request. 
Information collected from requests for respirator approval functions 
includes contact information and information about factors likely to 
affect respirator performance and use. Such information includes, but 
is not necessarily limited to, respirator design, manufacturing methods 
and materials, quality assurance plans and procedures, and user 
instruction and draft labels, as specified in the regulation.
    The main instrument for data collection for respirator approval 
functions is the SAF, Standard Application for the Approval of 
Respirators, currently Version 7. A replacement instrument, SAF V.8, 
which collects the same information is available for applicants without 
the requisite software environment for V.7. Respirator manufacturers 
are the respondents (estimated to average 75 each year over the years 
2011-2013) and upon completion of the SAF their requests for approval 
are evaluated. Although there is no cost to respondents to submit an 
application other than their time to participate, respondents 
requesting respirator approval are required to submit fees for 
necessary testing as specified in 42 CFR 84.20-22, 84.66, 84.258 and 
84.1102. In calendar year 2010 $395,564.00 was accepted. Applicants are 
required to provide test data that shows that the respirator is capable 
of meeting the specified requirements in 42 CFR part 84. The 
requirement for submitted test data is likely to be satisfied by 
standard testing performed by the manufacturer, and no extra burden is 
    42 CFR part 84 approvals offer corroboration that approved 
respirators are produced to certain quality standards. Although 42 CFR 
part 84, subpart E prescribes certain quality standards, it is not 
expected that requiring approved quality standards will impose an 
additional cost burden over similarly effective quality standards that 
are not approved under 42 CFR part 84. Manufacturers with current 
approvals are subject to site audits by the Institute or its agents. 
There is no fee associated with audits. Audits may occur periodically 
or as a result of a reported issue. An average of 61 site audits were 
conducted annually over the calendar years 2008-2010, and this rate is 
expected to continue. Audits take an average of 23.5 burden hours from 
the respondent.
    There are no costs to respondents other than their time.

                                                                      No. of        Avg. burden
                      Form                           Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs)        (in hrs)
Standard Application for the Approval of                      75               8             229         137,400
Audit...........................................              60               1              24           1,440
    Total.......................................  ..............  ..............  ..............         138,840

    Dated: March 9, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and 
[FR Doc. 2011-5921 Filed 3-14-11; 8:45 am]