60 day FRN

Attachment 23- 60day.pdf

National Coal Workers' Health Surveillance Program (CWHSP)

60 day FRN

OMB: 0920-0020

Document [pdf]
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74094

Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Notices

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ATSDR administrator must prepare
Toxicological Profiles for substances
enumerated on the priority list of
hazardous substances. This list
identifies 275 hazardous substances
which, according to ATSDR and U.S.
EPA, pose the most significant potential
threat to human health. The availability
of the revised priority list of 275
hazardous substances was announced in
the Federal Register on November 03,
2011 (76 FR 68193). In addition, ATSDR
has the authority to prepare
Toxicological Profiles for substances not
found at sites on the National Priorities
List, in an effort to ‘‘. . . establish and
maintain inventory of literature,
research, and studies on the health
effects of toxic substances’’ under
CERCLA Section 104(i)(1)(B). ATSDR
also prepares Toxicological Profiles in
response to requests for consultation
under section 104(i)(4), and as
otherwise necessary to support the sitespecific response actions conducted by
ATSDR.
Each profile will include an
examination, a summary, and an
interpretation of available toxicological
information and epidemiological
evaluations. This information and these
data identify the levels of significant
human exposure for the substance and
for the associated health effects. The
profiles must also include a
determination of whether adequate
information on the health effects of each
substance is available (or in the process
of development) in order to identify
levels of significant human exposure. If
adequate information is not available,
ATSDR, in cooperation with the
National Toxicology Program (NTP), is
required to ensure the initiation of a
program of research to provide such
information.
Set 26 Toxicological Profiles:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–0020]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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 to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. To request more
information on the below proposed
project or to obtain a copy of the
information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including the use of
automated collection techniques or
other forms of information technology;
and (e) estimates of capital or start-up
costs and costs of operation,
maintenance, and purchase of services
Name
CAS
to provide information. Burden means
1 Trichlorothe total time, effort, or financial
ethylene(UPDATE) ............
79–01–6 resources expended by persons to
2 Tetrachloroethylene (UPgenerate, maintain, retain, disclose or
DATE) ...............................
127–18–4 provide information to, or for, a Federal
3 Hydrogen Sulfide/Caragency. This includes the time needed
bonyl Sulfide (UPDATE) ...
7783–06–4
463–58–1 to review instructions; to develop,
4 Parathion (NEW) .............
56–38–2 acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
Sascha Chaney,
information, processing and
Acting Director, Office of Policy, Planning
maintaining information, and disclosing
and Evaluation, National Center for
and providing information; to train
Environmental Health/Agency for Toxic,
personnel and to be able to respond to
Substances and Disease Registry.
a collection of information, to search
[FR Doc. 2014–29258 Filed 12–12–14; 8:45 am]
data sources, to complete and review
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the collection of information; and to

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transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project—Coal Workers’
Health Surveillance Program
(CWHSP)(OMB Control No. 0920–0020,
Expiration Date 2/28/2015)—Revision—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
NIOSH would like to submit an
Information Collection Request (ICR) to
revise the data collection instruments
being utilized within the Coal Workers’
Health Surveillance Program (CWHSP).
On May 1, 2014, the Mine Safety and
Health Administration (MSHA)
published final rule 30 CFR parts 70, 71,
72, 75, and 90. The new MSHA rule
added surface coal miners, a respiratory
health assessment, and spirometry
testing for chronic obstructive
pulmonary disease (COPD) to the
previously mandated chest x-ray
examination program. These additions
are being referred to as the Expanded
CWHSP (an additional component
under the current CWHSP).
This request incorporates all
components that now fall under the
CWHSP. Those components include:
Coal Workers’ X-ray Surveillance
Program (CWXSP), B Reader Program,
Enhanced Coal Workers’ Health
Surveillance Program (ECWHSP),
Expanded Coal Workers’ Health
Surveillance Program, and National
Coal Workers’ Autopsy Study (NCWAS).
The CWHSP is a congressionallymandated medical examination program
for monitoring the health of coal miners
and was originally established under the
Federal Coal Mine Health and Safety
Act of 1969 with all subsequent
amendments (the Act). The Act provides
the regulatory authority for the
administration of the CWHSP. This
Program, which operates in accordance
with 42 CFR part 37, is useful in
providing information for protecting the
health of miners (whose participation is
entirely voluntary), and also in
documenting trends and patterns in the
prevalence of coal workers’
pneumoconiosis (‘black lung’ disease)
among miners employed in U.S. coal
mines. The total estimated annualized
burden hours of 13,471 is based on the
following collection instruments:
• Coal Mine Operator Plan (2.10) and
Coal Contractor Plan (2.18)—Under 42
CFR part 37, every coal operator and
coal contractor in the U.S. must submit
a plan approximately every 4 years,
providing information on how they plan
to notify their miners of the opportunity

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Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Notices
to obtain the medical examination.
Completion of this form with all
requested information (including a
roster of current employees) takes
approximately 30 minutes.
• Radiographic Facility Certification
Document (2.11)—X-ray facilities
seeking NIOSH approval to provide
miner radiographs under the CWHSP
must complete an approval packet
including this form which requires
approximately 30 minutes for
completion.
• Miner Identification Document
(2.9)—Miners who elect to participate in
the CWHSP must fill out this document
which requires approximately 20
minutes. This document records
demographic and occupational history,
as well as information required under
the regulations in relation to the
examinations.
• Chest Radiograph Classification
Form (2.8)—NIOSH utilizes a
radiographic classification system
developed by the International Labour
Office (ILO) in the determination of
pneumoconiosis among coal miners.
Physicians (B Readers) fill out this form
regarding their interpretations of the
radiographs (each image has two
separate interpretations, and
approximately 7% of the images require
additional interpretations). Based on
prior practice it takes the physician
approximately 3 minutes per form.
• Physician Application for
Certification (2.12)—Physicians taking
the B Reader examination are asked to
complete this registration form which
provides demographic information as
well as information regarding their
medical practices. It typically takes the
physician about 10 minutes to complete
this form.
• Guidelines for Spirometry in the
ECWHSP Mobile (Internal use, no form
number assigned)—Miners (both active

interpretation of results. It is estimated
that it will take the facility
approximately 20 minutes to complete
this form.
• Pathologist Invoice—Under the
NCWAS, the invoice submitted by the
pathologist must contain a statement
that the pathologist is not receiving any
other compensation for the autopsy.
Each participating pathologist may use
their individual invoice as long as this
statement is added. It is estimated that
only 5 minutes is required for the
pathologist to add this statement to the
standard invoice that they routinely use.
• Pathologist Report—Under the
NCWAS the pathologist must submit
information found at autopsy, slides,
blocks of tissue, and a final diagnosis
indicating presence or absence of
pneumoconiosis. The format of the
autopsy reports is variable depending
on the pathologist conducting the
autopsy. Since an autopsy report is
routinely completed by a pathologist,
the only additional burden is the
specific request for a clinical abstract of
terminal illness and final diagnosis
relating to pneumoconiosis. Therefore,
only 5 minutes of additional burden is
estimated for the pathologist’s report.
• Consent, Release and History Form
(2.6)—This form documents written
authorization from the next-of-kin to
perform an autopsy on the deceased
miner. A minimum of essential
information is collected regarding the
deceased miner including an
occupational history and a smoking
history. From past experience, it is
estimated that 15 minutes is required for
the next-of-kin to complete this form.
As indicated by the below burden
table, the total annualized burden hours
for this request are 13,471. There are no
costs to respondents other than their
time.

and former) participating in the
ECWHSP component of the Program are
offered a spirometry test. This form is
administered by a NIOSH employee (or
contractor) in the ECWHSP Mobile Unit
during the initial intake process and
takes approximately 5 minutes to
complete. This information is required
to make sure that the test can be done
safely and that the miner is physically
capable of performing the spirometry
maneuvers.
• Spirometry Facility Certification
Document (2.14)—This new form is
analogous to the Radiographic Facility
Certification Document (2.11) and
records the spirometry facility
equipment/staffing information.
Spirometry facilities seeking NIOSH
approval to provide miner spirometry
testing under the CWHSP must
complete an approval packet which
includes this form. It is estimated that
it will take approximately 30 minutes
for this form to be completed at the
facility.
• Respiratory Assessment Form
(2.13)—This new form is designed to
assess respiratory symptoms and certain
medical conditions and risk factors. It is
estimated that it will take approximately
5 minutes for this form to be
administered to the miner by an
employee at the facility.
• Spirometry Results Notification
Form (2.15)—This new form will
replace previous forms 2.15, 2.16 and
2.17. It is used to: Collect information
that will allow NIOSH to identify the
miner in order to provide notification of
the spirometry test results; assure that
the test can be done safely; record
certain factors that can affect test
results; provide documentation that the
required components of the spirometry
examination have been transmitted to
NIOSH for processing; and conduct
quality assurance audits and

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ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden/response
(in hrs)

Total
burden
(in hrs)

Form name

Coal Mine Operator ...........................
Coal Mine Contractor ........................
X-ray Facility Supervisor ...................
Coal Miner .........................................
B Reader Physician ...........................
Physicians taking the B Reader Examination.
NIOSH employee (or contractor) ......

2.10 ..................................................
2.18 ..................................................
2.11 ..................................................
2.9 ....................................................
2.8 ....................................................
2.12 ..................................................

388
575
40
14,560
31,000
100

1
1
1
1
1
1

30/60
30/60
30/60
20/60
3/60
10/60

194
288
20
4,853
1,550
17

Guidelines for Spirometry in the
ECWHSP Mobile Unit—No Form
# assigned (internal document).
2.14 ..................................................
2.13 ..................................................
2.15 ..................................................
Invoice —No standard form .............

4,560

1

5/60

380

200
14,560
14,560
5

1
1
1
1

30/60
5/60
20/60
5/60

100
1,213
4,853
1

Spirometry Facility Supervisor ..........
Spirometry Facility Employee ............
Spirometry Technician .......................
Pathologist .........................................

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Number of
respondents

Number of
responses
per respondent

Type of
respondents

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Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Total
burden
(in hrs)

Pathologist .........................................

5

l

5/60

1

Next-of-kin for deceased miner .........

Pathology Report—No standard
form.
2.6 ....................................................

5

1

15/60

1

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

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

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

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

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

13,471

[FR Doc. 2014–29219 Filed 12–12–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–0621]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (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

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Number of
respondents

Average
burden/response
(in hrs)

Form name

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.

emcdonald on DSK67QTVN1PROD with NOTICES

Number of
responses
per respondent

Type of
respondents

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]. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
National Youth Tobacco Surveys
(NYTS) 2015–2017—Revision—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) has periodically
collected information about tobacco use
among adolescents since 2004 (National
Youth Tobacco Survey (NYTS) 2004,
2006, 2009, 2011, 2012, 2013, and 2014;
OMB no. 0920–0621, exp. 1/31/2015).
At present, the NYTS is the most
comprehensive source of nationally
representative tobacco data among
students in grades 9–12, and the only
source of such data for students in
grades 6–8. The NYTS has provided
national estimates of tobacco use
behaviors, information about exposure
to pro- and anti-tobacco influences, and
information about racial and ethnic
disparities in tobacco-related topics.
Information collected through the NYTS

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is used to identify trends over time, to
inform the development of tobacco
cessation programs for youth, and to
evaluate the effectiveness of existing
interventions and programs.
CDC is requesting OMB approval to
conduct additional cycles of the NYTS
in the spring of 2015, 2016, and 2017.
The survey will be conducted among
nationally representative samples of
students attending public and private
schools in grades 6–12, and will be
administered to students as an optically
scannable booklet of multiple-choice
questions. Information supporting the
NYTS also will be collected from
state-, district-, and school-level
administrators and teachers. During the
2015–2017 timeframe, a number of
changes will be incorporated that reflect
CDC’s ongoing collaboration with FDA
and the need to measure progress
toward meeting strategic goals
established by the Family Smoking
Prevention and Tobacco Control Act.
The 2015 survey will examine the
following topics: Use of cigarettes,
smokeless tobacco, cigars, pipes, bidis,
snus, hookahs, electronic vapor
products, and dissolvable tobacco
products; knowledge and attitudes;
media and advertising; access to tobacco
products; secondhand smoke exposure;
and cessation. Information collection
will occur annually.
Results of the NYTS will continue to
be used for public health program
planning and evaluation. Information
collected through the NYTS is also
expected to provide multiple measures
and data for monitoring progress on
multiple tobacco-related objectives for
Healthy People 2020.
OMB approval is requested for three
years. Participation is voluntary and the
total estimated annualized burden hours
are 15,504. There are no costs to
respondents other than their time.

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