60d FRN - published

Att 3 60-day FRN.pdf

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

60d FRN - published

OMB: 0920-0109

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Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices

are either U.S.-made or designated
country end products, except as listed
in paragraph (b) of the provision.
Offerors are not allowed to provide
other than a U.S.-made or designated
country end product, unless the
requirement is waived.
Respondents: 397.
Responses per Respondent: 2.
Total Responses: 794.
Hours per Response: .25.
Total Burden Hours: 199.
2. Buy American and Trade
Agreements—Construction provisions
and clauses provide that an offeror/
contractor requesting to use foreign
construction material due to
unreasonable cost of domestic
construction material shall provide
adequate information to permit
evaluation of the request.
—52.225–9, Buy American—
Construction Materials
—52.225–10, Notice of Buy American
Requirements—Construction
Materials
—52.225–11, Buy American—
Construction Materials under Trade
Agreements
—52.225–12, Notice of Buy American
Requirements—Construction
Materials under Trade Agreements
—52.225–21, Required Use of American
Iron, Steel and Manufactured Goods—
Buy American—Construction
Materials
—52.225–23, Required Use of American
Iron, Steel and Manufactured Goods—
Buy American—Construction
Materials under Trade Agreements
Respondents: 853.
Responses per Respondent: 2.3.
Total Responses: 1,990.
Hours per Response: 5.
Total Burden Hours: 10,045.
3. Duty-Free Entry. The clause at FAR
52.225–8, Duty-Free Entry (formerly
OMB clearance 9000–0022), is included
in solicitations and contracts for
supplies that may be imported into the
United States and for which duty-free
entry may be obtained in accordance
with FAR 25.903(a), if the value of the
acquisition (1) exceeds the simplified
acquisition threshold; or (2) does not
exceed the simplified acquisition
threshold, but the savings from waiving
the duty is anticipated to be more than
the administrative cost of waiving the
duty. The contracting officer analyzes
the information submitted by the
contractor to determine whether or not
supplies should enter the country dutyfree.
Respondents: 1,330.
Responses per Respondent: 10.
Total Responses: 13,300.
Hours per Response: 0.5.

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Total Burden Hours: 6,650.
4. Summary
Respondents: 7,863.
Responses per Respondent: 5.4.
Total Responses: 42,499.
Hours per Response: .5.
Total Burden Hours: 23,497.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755.
Please cite OMB Control No. 9000–
0024, Buy American, Trade Agreements,
and Duty-Free Entry in all
correspondence.
Dated: October 16, 2017.
Lorin S. Curit,
Director, Federal Acquisition Policy Division,
Office of Government-wide Acquisition
Policy, Office of Acquisition Policy, Office
of Government-wide Policy.
[FR Doc. 2017–22717 Filed 10–19–17; 8:45 am]
BILLING CODE 6820–EP–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–FY–0109; Docket No. CDC–2017–
0074]

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

SUMMARY:

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general public and other Federal
agencies the opportunity to provide
comment on a proposed and/or
continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the Respiratory Protective
Devices information collection project.
DATES: CDC must receive written
comments on or before December 19,
2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0074 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
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.
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 Leroy A.
Richardson, 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

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Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices
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.
Proposed Project
Respiratory Protective Devices—42
CFR part 84—Regulation—(0920–
0109)—Revision—National Institute for
Occupational Safety and Health
(NIOSH), of the 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

forecast. The best estimate for the
annual number of respondents is the
number from the most recent year for
which data exists, 73 in 2016, an
increase from 63 in 2014. Those 73
applicants submitted 542 applications
in 2016, providing the current best
estimate. 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. In
2016, $2,662,329.00 was accepted.
Applicants are required to provide
test data that shows that the
manufacturer is capable of ensuring 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.
Also, 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
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.
NIOSH scheduled Sixty-three site audits
from 92 respirator approval holders for
the 2016 fiscal year.
There is an average fee of $8,833 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.

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.
In accordance with 42 CFR part 84,
NIOSH performs the following
activities: (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. To
establish the scope and intent of
request, NIOSH collects information
from those who request services under
42 CFR part 84.
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
for the Approval of Respirators (SAF),
currently Version 9.
Respirator manufacturers are the
respondents (estimated to average 73
each year over the years 2017–2020).
Upon submission of the SAF, NIOSH
evaluates their applications for
approval. Respirator manufacturers
submit applications according to their
business needs, which depends upon
market conditions, technical advances,
and other factors that are not easy to

srobinson on DSKBC5CHB2PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden hours
per response
(in hours)

Total
burden
(in hours)

Type of respondents

Form name

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

73

7

229

117,019

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

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

63

1

24

1,512

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

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

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

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

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

118,531

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Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–22774 Filed 10–19–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–1049]

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 National
Notifiable Diseases Surveillance System
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 April 26, 2017 to obtain
comments from the public and affected
agencies. CDC received three 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

Health (DASH), Centers for Disease
Control and Prevention.
Currently, the questionnaires are the
only standardized reporting process for
HIV/STD prevention activities among
LEAs, SEAs, and NGOs funded by
DASH. The nine questionnaires will
seek data that: (1) Provides standardized
information about how HIV/STD
prevention funds are used by funded
agencies; (2) provides descriptive and
process information about program
activities; and (3) provides greater
accountability for use of public funds.
Funded agencies will complete the
questionnaires on a Web site managed
by DASH and its contractor, Karna.
Respondents will complete the
questionnaires on a semi-annual basis.
The questionnaires pertain to the
approaches that funded agencies are
using to meet their goals. Approaches
include helping districts and schools
deliver exemplary sexual health
education (ESHE) emphasizing HIV and
other STD prevention; increasing
adolescent access to key sexual health
services (SHS); and establishing safe
and supportive environments (SSE) for
students and staff.
Each SEA complete activities for all
approaches. Therefore, each SEA will
complete a questionnaire for each
approach (ESHE, SHS, and SSE).
Likewise, each LEA will be completing
activities for all approaches. Therefore,
each LEA will complete a questionnaire
for each approach (ESHE, SHS, and
SSE). Each NGO will respond to the
questionnaire for the approach they are
implementing in support of SEAs or
LEAs. Two NGOs will respond to the
ESHE questionnaire, two NGOs will
respond to the SHS questionnaire, and
two NGOs will respond to the SSE
questionnaire.
There are no costs to respondents
other than their time. The estimated
annualized time burden for all funded
agencies is 820 hours.

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 or
send an email to [email protected]. 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
Promoting Adolescent Health through
School-Based HIV/STD Prevention
(OMB Control Number 0920–1049,
Expiration Date 2/28/2018)—
Extension—National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention, Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The proposed project is a semi-annual
Web-based questionnaire to assess
programmatic activities among funded
agencies which include local education
agencies (LEA), state education agencies
(SEA), and non-governmental
organizations (NGO) funded by the
Division of Adolescent and School

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ESTIMATED ANNUALIZED BURDEN HOURS
Form name

State Education Agency ................................

Exemplary Sexual Health Education Measures.
Sexual Health Services Measures ................
Safe and Supportive Environments Measures.
Exemplary Sexual Health Education Measures.
Sexual Health Services Measures ................
Safe and Supportive Environments Measures.
Exemplary Sexual Health Education Measures.

Local Education Agency ................................

Non-governmental organization .....................

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Number of
responses per
respondent

Number of
respondents

Type of respondents

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Average
Burden per
response
(in hours)

19

2

4

19
19

2
2

3
1

17

2

6

17
17

2
2

3
6

2

2

30/60

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