[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7188-7189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03385]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-0109]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Respiratory Protective Devices--42 CFR part 
84--Regulation to the Office of Management and Budget (OMB) for review 
and approval. CDC previously published a ``Proposed Data Collection 
Submitted for Public Comment and Recommendations'' notice on October 
20, 2017 to obtain comments from the public and affected agencies. CDC 
did not receive comments related to the previous notice. This notice 
serves to allow an additional 30 days for public and affected agency 
comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Respiratory Protective Devices--42 CFR part 84--Regulation (OMB 
Control Number 0920-0109, expiration November 30, 2017)--Reinstatement 
with Change--National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    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. 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.
    In accordance with 42 CFR part 84, NIOSH performs the following 
activities: (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 to 
applicants for testing and certification, and (5) establishes approval 
labeling requirements. To establish the scope and intent of request, 
NIOSH collects information from those who request services under 42 CFR 
part 84.
    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

[[Page 7189]]

for the Approval of Respirators (SAF), currently Version 9.
    Respirator manufacturers are the respondents (estimated to average 
73 each year over the years 2017-2020). Upon submission of the SAF, 
NIOSH evaluates their applications for approval. Respirator 
manufacturers submit applications according to their business needs, 
which depends upon market conditions, technical advances, and other 
factors that are not easy to forecast. The best estimate for the annual 
number of respondents is the number from the most recent year for which 
data exists, 73 in 2016, an increase from 63 in 2014. Those 73 
applicants submitted 542 applications in 2016, providing the current 
best estimate. A $200 fee is required for each application. Respondents 
requesting respirator approval or certain extensions of approval are 
required to submit additional fees for necessary testing and evaluation 
as specified in 42 CFR parts 84.20-22, 84.66, 84.258 and 84.1102. In 
2016, $2,662,329.00 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.
    Manufacturers with current approvals are subject to site audits by 
the Institute or its agents. Audits may occur periodically, typically 
every second year, or because of a reported issue. NIOSH completed 59 
site audits from 92 respirator approval holders for the 2016 fiscal 
year. There is an average fee of $8,833 for each audit to align with 
fee collection provisions of the Independent Offices Appropriations Act 
of 1952 (31 U.S.C. 9701), and OMB Circular A-25 Revised. There is no 
cost to respondents other than the time to participate. The total 
estimated burden hours are 118,435. Burden hours have increased due to 
a moderate increase in the estimated number of annual responses per 
respondent.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden  per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Business or other for-profit..........  Standard Application for              73               7             229
                                         the Approval of
                                         Respirators.
Business or other for-profit..........  Audit...................              59               1              24
----------------------------------------------------------------------------------------------------------------


Leroy A. 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. 2018-03385 Filed 2-16-18; 8:45 am]
 BILLING CODE 4163-18-P