[Federal Register Volume 87, Number 227 (Monday, November 28, 2022)]
[Notices]
[Pages 73000-73002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25850]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-0109; Docket No. CDC-2022-0135]


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 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 January 27, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0135 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600

[[Page 73001]]

Clifton Road NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please Note: Submit all comments through the Federal eRulemaking 
portal (www.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 H21-8, Atlanta, Georgia 30329; Telephone: 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;
    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; and
    5. Assess information collection costs.

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 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 as increased certification requests due to COVID-19. 
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 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 
subjects who are serving as test fixture surrogates to perform tests 
while wearing the respirator being evaluated. Such instruments are 
completed by the human subject 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

[[Page 73002]]

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 89.
    CDC requests OMB approval for an additional three years of data 
collection. The estimated annual burden hours are 130,689.

                                        Estimated Annualized Burden Hours
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                                                                    Number of     Average burden
     Type of respondents           Form name        Number of     responses per    per response    Total burden
                                                   respondents      respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Business or other for-profit.  Standard                     140                4             229         128,240
                                Application
                                Form for the
                                Approval of
                                Respirators.
Business or other for-profit.  Audit...........              89                1              16            1424
Member of general public.....  Human                        425                1           12/60              85
                                Participant--Co
                                nsent.
                               Human                        425                1           24/60             170
                                Participant--Su
                                bject payment
                                information.
                               Human                        425                1           12/60              85
                                Participant--Qu
                                estionnaire.
                               Human                        425                1           12/60              85
                                Participant--In
                                formation Sheet.
                               Human                        150                1               4             600
                                Participant--Da
                                ta Collection
                                Form.
                              ----------------------------------------------------------------------------------
    Total....................  ................         130,689
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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. 2022-25850 Filed 11-25-22; 8:45 am]
BILLING CODE 4163-18-P