[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14019-14020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5921]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-11-0109]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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
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. Audits take an average of 23.5 burden hours from
the respondent.
There are no costs to respondents other than their time.
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No. 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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Total....................................... .............. .............. .............. 138,840
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Dated: March 9, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2011-5921 Filed 3-14-11; 8:45 am]
BILLING CODE 4163-18-P