60 Day FRN

Atch_3_60-day Federal Register Notice.pdf

[NIOSH] Information Collection Provisions in 42 CFR Part 84 - Tests and Requirements for Certification and Approval of Respiratory Protective Devices

60 Day FRN

OMB: 0920-0109

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73000

Federal Register / Vol. 87, No. 227 / Monday, November 28, 2022 / Notices

A. Purpose

C. Public Comments

The General Services Administration
Acquisition Regulation (GSAR)
552.236–79, Construction-Contractor-asConstructor, requires the contractor to
submit proposals to establish the final
estimated cost of the work, to convert
the contract to a firm-fixed-price, and to
determine the final settlement for
construction-manager-as-constructor
(CMc) projects.
The CMc refers to a project
management and contracting technique
that is one of three predominant
methods used for acquiring construction
services by GSA. The other two methods
are design-bid-build and design-build.
The information is used by
contracting officers to evaluate
proposals and negotiate contract
modifications during contract
administration. GSA would be unable to
assess readily and equitably offers fairly
and competitively if they were not
allowed to collect data required in the
information collection.

A 60-day notice published in the
Federal Register at 87 FR 55007 on
September 8, 2022. No comments were
received.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the GSA Regulatory Secretariat Division,
by calling 202–501–4755 or emailing
[email protected]. Please cite OMB
Control No. 3090–0320, Construction
Manager as Constructor, in all
correspondence.

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B. Annual Reporting Burden
Total public reporting burden for this
collection of information is estimated to
average 400 total hours ($33,004)
annually, including the time for
reviewing instructions, searching
existing data sources, gathering, and
maintaining the data needed, and
completing and reviewing the collection
of information. The estimated burden
hours to the public for the below clauses
are as follows:
GSAR 552.236–79, ConstructionContractor-as-Constructor, requires the
contractor to submit proposals to
establish the final estimated cost of the
work, to convert the contract to a firmfixed-price, and to determine the final
settlement.
Respondents: 5.
Responses per Respondent: 1.
Total Annual Responses: 10.
Hours per Response: 40.
Total Response Burden Hours: 400.
Cost per Hour: $82.51.
Estimated Cost Burden to the Public:
$33,004.
GSAR 552.236–80, Accounting
Records, contains a recordkeeping
requirement that is subject to the
Paperwork Reduction Act (44 U.S.C.
3501, et seq.). The clause requires the
contractor to keep all relevant
documents for a period of three years
after the final payment. However, the
clause does not add burden to what is
already estimated for the existing FAR
clause at 52.215–2, Audit and Records
by a previous information collection
(see OMB Control Number 9000–0034).

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Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
[FR Doc. 2022–25828 Filed 11–25–22; 8:45 am]

West Virginia 26506; Telephone: (304)
285–5951; Email: [email protected].
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2022–25779 Filed 11–25–22; 8:45 am]
BILLING CODE 4163–18–P

BILLING CODE 6820–61–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel:
(SEP)—PAR 18–812, NIOSH Member
Conflict Review.
Date: February 9, 2023.
Time: 1 p.m.–3 p.m., EST.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Michael Goldcamp, Ph.D., Scientific
Review Officer, Office of Extramural
Programs, National Institute for
Occupational Safety and Health, CDC,
1095 Willowdale Road, Morgantown,

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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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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.

SUMMARY:

CDC must receive written
comments on or before January 27,
2023.

DATES:

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

ADDRESSES:

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khammond on DSKJM1Z7X2PROD with NOTICES

Federal Register / Vol. 87, No. 227 / Monday, November 28, 2022 / Notices
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: omb@
cdc.gov.
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.

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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,

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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

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Federal Register / Vol. 87, No. 227 / Monday, November 28, 2022 / Notices

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

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

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.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Business or other for-profit ..............

Standard Application Form for the
Approval of Respirators.
Audit ................................................
Human Participant—Consent ..........
Human Participant—Subject payment information.
Human Participant—Questionnaire
Human
Participant—Information
Sheet.
Human Participant—Data Collection
Form.

140

4

229

128,240

89
425
425

1
1
1

16
12/60
24/60

1424
85
170

425
425

1
1

12/60
12/60

85
85

150

1

4

600

..........................................................

130,689

Business or other for-profit ..............
Member of general public ................

Total ..........................................

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–1243; Docket No. CDC–2022–
0134]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 Rapid Response
Suicide Investigation Data Collection.
This data collection is designed to
inform the implementation of
prevention strategies in a state, county,
community, or vulnerable population

SUMMARY:

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Number of
respondents

Type of respondents

VerDate Sep<11>2014

19:33 Nov 25, 2022

Jkt 259001

where a possible suicide cluster or
increasing trend has been observed.
DATES: CDC must receive written
comments on or before January 27,
2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0134 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
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: omb@
cdc.gov.
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

PO 00000

Frm 00043

Fmt 4703

Sfmt 4703

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.

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