[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Notices]
[Pages 64472-64473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22487]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-21-0109]


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 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 July 20, 
2020 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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 No. 0920-0109, Exp. 10/31/2020) -- Revision -- National 
Institute for Occupational Safety and Health (NIOSH), Centers for 
Disease Control and Prevention (CDC).

[[Page 64473]]

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.
    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 Form for the Approval of 
Respirators (SAF) (currently Version 9). Respirator manufacturers are 
the respondents (estimated to average 140 each year over the years 
2020-2023) and upon completion of the SAF their requests for approval 
are evaluated. A total of 375 applications were submitted in CY2019. To 
date, 300 applications have been submitted in CY2020. The increased 
submission rate is due to the publication of a new respirator class, 
PAPR100, as well certification requests due to COVID 19. No survey was 
conducted to more thoroughly analyze the reasons for the change in 
number of respondents. The applications are submitted at will and 
taking into account both historical conditions and as well as the 
current situation, our prediction of the number of respondents each 
year between CY2020 and CY2022 is 140. 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.
    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. Audits may occur periodically, typically 
every second year, or as a result of a reported issue. Sixty-four site 
audits from 90 respirator approval holders were scheduled for the 2020 
fiscal year. There is an average fee of $12,656 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. It is estimated that the average over the next three years 
(FY21-FY23) will be seventy. The total estimated burden hours are 
129,920.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Business or other for-profit.......  Standard Application Form               140               4             229
                                      for the Approval of
                                      Respirators.
Business or other for-profit.......  Audit......................              70               1              24
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-22487 Filed 10-9-20; 8:45 am]
BILLING CODE 4163-18-P