[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19086-19087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-0109]


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 404-639-7570 or 
send comments to LeRoy Richardson, 1600 Clifton Road, MS-D74, Atlanta, 
GA 30333 or send an email 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)--Revision--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 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 Standard Application for the Approval of Respirators 
(SAF), currently Version 7. A replacement instrument which will collect 
the same information is in development.
    Respirator manufacturers are the respondents (estimated to average 
63 each year over the years 2014-2016) and upon completion of the SAF 
their

[[Page 19087]]

requests for approval are evaluated. The applications are submitted at 
will and the most reasonable prediction of respondents is the number 
from the most recent year, 63 in 2013. The decrease is likely due to 
random fluctuations and changes in business conditions. No survey was 
conducted to more thoroughly analyze the reasons for the change in 
number of respondents. Although there is no cost to respondents to 
submit other than their time to participate, respondents requesting 
respirator approval are required to submit fees for necessary testing 
as specified in 42 CFR Parts 84.20-22, 84.66, 84.258 and 84.1102. In 
calendar year 2013 $449,610.135 was accepted.
    Applicants are required to provide test data that shows that the 
manufacturer is capable of ensuring 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 is not required to follow the 
relevant NIOSH Standard Test Procedures. As additional testing is not 
required, providing proof that an adequate test has been performed is 
limited to providing existing paperwork.
    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. Sixty 
site audits were scheduled for the 2013 calendar year.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                     Expected     Average annual  Average burden
      Type of respondent         Response type     annual number   responses per     hours per     Total burden
                                                  of respondents    respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Business or other for-profit.  Standard                       63               7             229         100,989
                                Application for
                                the Approval of
                                Respirators
                                Version 7 and
                                Version 8.
Business or other for-profit.  Audit............              60               1              24           1,440
                                                 ---------------------------------------------------------------
    Total....................  .................  ..............  ..............  ..............         102,429
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Leroy Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-07650 Filed 4-4-14; 8:45 am]
BILLING CODE 4163-18-P