[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Notices]
[Pages 28787-28788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12170]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-11-0109]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 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), 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 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 
expected.
    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.
    There are no costs to the respondents other than their time. The 
total estimated annual burden hours are 138,840.

[[Page 28788]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of      Avg. burden
                      Form                           Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs)        (in hrs)
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Standard Application for the Approval of                      75               8             229         137,400
 Respirators....................................
Audit...........................................              60               1              24           1,440
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    Dated: May 11, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 2011-12170 Filed 5-17-11; 8:45 am]
BILLING CODE 4163-18-P