[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44774-44775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18057]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-14-0109]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: 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)--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.

[[Page 44775]]

    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 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 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 under 42 CFR 84.43. There is no fee or form 
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. The total request burden hours are 102,429.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Business or other for-profit..........  Standard Application for              63               7             229
                                         the Approval of
                                         Respirators Version 7
                                         and Version 8.
Business or other for-profit..........  Audit...................              60               1              24
                                        (42 CFR 84.43)..........
----------------------------------------------------------------------------------------------------------------


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. 2014-18057 Filed 7-31-14; 8:45 am]
BILLING CODE 4163-18-P