[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78045-78046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-24-0109]


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'' 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 November 
28, 2022 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 (OMB Control No. 
0920-0109, Exp. 03/31/2024)--Revision--National Institute for 
Occupational Safety and Health (NIOSH), 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.
    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 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

[[Page 78046]]

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) and upon 
completion of the SAF, their requests for approval are evaluated. A 
total of 375 applications were submitted in CY2019, which preceded the 
surge in application received in conjunction with the COVID-19 
pandemic. The applications are submitted, at will, and taking into 
account both historical conditions as well as the current situation, 
our prediction of the number of respondents each year for the next 
three years 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 able to ensure 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.
    The secondary instruments for data collection for respirator 
approval functions are instruments used to collect data from human 
participants who are serving as test fixture surrogates to perform 
tests while wearing the respirator being evaluated. Such instruments 
are completed by the human participant or test operator and are limited 
to specific information required for the test.
    Approvals under 42 CFR part 84 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 because 
of a reported issue. Approximately, 50% of the sites are audited each 
year, each having a primary point of contact. It is estimated that the 
average number of site audits over the next three years will be 85.
    CDC requests OMB approval for an additional three years of data 
collection. The estimated annual burden hours are 131,059.

                                        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                 140               4             229
                                         form.
                                        Request manufacturing                 10               1           30/60
                                         code.
                                        Site audits, Part 1.....              85               1           30/60
                                        Site audits, Part 2.....              85               1            9/60
                                        Site audits (completed                70               2              16
                                         for each corrective
                                         action).
Member of general public..............  Information sheet                     10               1            9/60
                                         (initial participant
                                         visit only--contact
                                         info).
                                        Informed consent                      40               1           15/60
                                         (annually, all test
                                         participants).
                                        Health and wellness                   40               1           15/60
                                         screening (annually,
                                         all test participants).
                                        Health and wellness                   40              20            6/60
                                         screening (each test,
                                         fit testing).
                                        Health and wellness                   10              10           15/60
                                         screening (each test,
                                         man testing).
                                        Data collection form                  10              10           45/60
                                         (man testing).
                                        Capacity test...........              10               1            6/60
                                        Communication Tests.....              10               1               2
                                        Donning test............              10               1               1
                                        Fit test STP 5_5.1_6....              14              20            9/60
                                        Fit tests STP-9 and 10..              14              20            9/60
                                        Fogging test............              10               1           30/60
                                        LRPL_Bitrex_Donning.....              38               1               1
                                        Performance Test........              10               1               1
                                        Sound level STP-30_STP-               25               2            6/60
                                         111.
                                        Stressors...............              10               1               1
                                        Test 118................              10              25           30/60
                                        Test 147................              10               4            9/60
                                        Wearability test........              10               1           18/60
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-25083 Filed 11-13-23; 8:45 am]
BILLING CODE 4163-18-P