Notice2022-25850
Proposed Data Collection Submitted for Public Comment and Recommendations
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 28, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 227 (Monday, November 28, 2022)</title>
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[Federal Register Volume 87, Number 227 (Monday, November 28, 2022)]
[Notices]
[Pages 73000-73002]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please Note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#6b0406092b080f08450c041d"><span class="__cf_email__" data-cfemail="046b6966446760672a636b72">[email protected]</span></a>.
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)
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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........... 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.
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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
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