[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Notices]
[Pages 43840-43841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-0109; Docket No. CDC-2020-0080]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Respiratory Protective Devices--
42 CFR part 84--Regulation. The purpose of the data collection is to 
enable 42 CFR part 84 respirator approval certification activities.

DATES: CDC must receive written comments on or before September 18, 
2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0080 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Respiratory Protective Devices--42 CFR part 84--Regulation (OMB 
Control No. 0920-0109, Exp. 10/31/20)-- 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 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

[[Page 43841]]

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, 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 the 
manufacturer is capable of ensuring 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 70.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
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Business or other for-profit..  Standard                     140               4             229         128,240
                                 Application
                                 Form for the
                                 Approval of
                                 Respirators.
Business or other for-profit..  Audit...........              70               1              24           1,680
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............         129,920
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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. 2020-15658 Filed 7-17-20; 8:45 am]
BILLING CODE 4163-18-P