Notice2023-25083
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 14, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 218 (Tuesday, November 14, 2023)</title>
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[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78045-78046]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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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
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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
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