[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