60 Day FRN

43840

Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices

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. 2020–15617 Filed 7–17–20; 8:45 am]
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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
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 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.
SUMMARY:

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.

ADDRESSES:

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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.
FOR FURTHER INFORMATION CONTACT:

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

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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

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43841

Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices
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

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.

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

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Type of respondents

Form name

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

140

4

229

128,240

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

Standard Application Form for the
Approval of Respirators.
Audit .................................................

70

1

24

1,680

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

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

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

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

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

129,920

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee on Breast Cancer
in Young Women (ACBCYW); Notice of
Charter Renewal
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of charter renewal.
AGENCY:

This gives notice under the
Federal Advisory Committee Act of
October 6, 1972, that the Advisory
Committee on Breast Cancer in Young
Women (ACBCYW), Centers for Disease
Control and Prevention, Department of
Health and Human Services, has been
renewed for a 2-year period through
June 17, 2022.
FOR FURTHER INFORMATION CONTACT:
Jeremy McCallister, Designated Federal
SUMMARY:

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Officer, National Center for Chronic
Disease Prevention and Health
Promotion, CDC, 4770 Buford Highway
NE, Mailstop S107–4, Atlanta, Georgia
30341, Telephone (404) 639–7989, Fax
(770) 488–4760; Email: acbcyw@
cdc.gov.
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. 2020–15616 Filed 7–17–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2020–0083]

Advisory Committee on Immunization
Practices (ACIP)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting and request
for comment.
AGENCY:

In accordance with the
Federal Advisory Committee Act, the
CDC, announces the following meeting
of the Advisory Committee on
Immunization Practices (ACIP). This
meeting is open to the public. Time will
be available for public comment. The
meeting will be webcast live via the
World Wide Web.
DATES: The meeting will be held on
August 26, 2020 from 10:00 a.m. to 4:00
p.m., EDT (times subject to change).
Written comments must be received
on or before August 27, 2020.
ADDRESSES: For more information on
ACIP please visit the ACIP website:
SUMMARY:

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