60 Day FRN

Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Notices
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,
Mailstop H21–8, Atlanta, Georgia 30329;
phone: 404–639–7570; Email: omb@
cdc.gov.

FOR FURTHER INFORMATION CONTACT:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–0020; Docket No. CDC–2021–
0095]

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 Coal Workers’ Health Surveillance
Program (CWHSP). The CWHSP is a
Congressionally mandated 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). HHS
proposes to revise the National Institute
for Occupational Safety and Health
(NIOSH) CWHSP regulations by
amending existing regulatory text to
allow compensation for pathologists
who perform autopsies on coal miners
at a market rate, on a discretionary basis
as needed for public health purposes.
DATES: CDC must receive written
comments on or before November 15,
2021.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2021–
0095 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, Mailstop 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
Regulations.gov.
Please note: Submit all Federal
comments through the Federal
eRulemaking portal (regulations.gov) or
by U.S. mail to the address listed above.

tkelley on DSK125TN23PROD with NOTICES

ADDRESSES:

VerDate Sep<11>2014

21:55 Sep 13, 2021

Jkt 253001

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.

SUPPLEMENTARY INFORMATION:

Proposed Project
Coal Workers’ Health Surveillance
Program (CWHSP), (OMB Control No.
0920–0020, Exp. 09/30/2021)—
Revision—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).

PO 00000

Frm 00060

Fmt 4703

Sfmt 4703

51157

Background and Brief Description
NIOSH would like to submit a
Revision Information Collection Request
(ICR) to revise the data collection
instruments being utilized within the
Coal Workers’ Health Surveillance
Program (CWHSP). This request
incorporates all components of 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 Congressionally
mandated 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, and also in documenting trends
and patterns in the prevalence of coal
workers’ pneumoconiosis (‘black lung’
disease) among U.S. coal miners.
HHS proposes to revise the CWHSP
regulations (42 CFR part 37) by
amending existing regulatory text to
allow compensation for pathologists
who perform autopsies on coal miners
at a market rate, on a discretionary basis
as needed for public health purposes.
These changes to 42 CFR 37 have
necessitated this revision ICR.
The total estimated annualized
burden hours of 11,741 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 four years,
providing information on how they plan
to notify their miners of the opportunity
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

E:\FR\FM\14SEN1.SGM

14SEN1

51158

Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Notices

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 at least two
separate interpretations, and
approximately 7% of the images require
additional interpretations). Based on
prior practice it takes the physician
approximately three 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.
• Spirometry Facility Certification
Document (2.14)—This 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 form is designed to assess
respiratory symptoms and certain

terminal illness and final diagnosis
relating to pneumoconiosis. Therefore,
only five 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.
• Authorization for Payment of
Autopsy Form (2.19)—Revised 42 CFR
part 37.204 outlines a need for a
physician pathologist to obtain written
authorization from NIOSH and
agreement regarding payment amount
for services specified in § 37.202 (a) by
completing the Authorization for
Payment of Autopsy form and
submitting it to the CWHSP for
authorization prior to completing an
autopsy on a coal miner. This is a new
form. It will be completed by the
pathologist who intends on conducting
an autopsy and the form will collect:
Demographic information on the
deceased miner, characteristics of the
miner’s pneumoconiosis (if known by
the pathologist), demographic and
medical licensure information from the
requesting pathologist, and proposed
payment amount to complete the
autopsy in accordance with § 37.203. It
is estimated that 15 minutes is required
for the pathologist to complete this
form.
CDC requests OMB approval for an
estimated 11,741 annual burden hours.
There are no costs to respondents other
than their time.

medical conditions and risk factors. It is
estimated that it will take approximately
five minutes for this form to be
administered to the miner by an
employee at the facility.
• Spirometry Results Notification
Form (2.15)—This form 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
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 five 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

tkelley on DSK125TN23PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
Respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
hours

Type of respondent

Form name

Coal Mine Operator ..........................
Coal Mine Contractor ........................
Radiograph Facility Supervisor .........
Coal Miner .........................................
Coal Miner—Radiograph ..................
B Reader Physician ..........................
Physicians taking the B Reader Examination.
Spirometry Facility Supervisor ..........
Spirometry Facility Employee ...........
Spirometry Technician ......................
Coal Miner—Spirometry ....................
Pathologist ........................................
Pathologist ........................................
Pathologist ........................................

2.10 ..................................................
2.18 ..................................................
2.11 ..................................................
2.9 ....................................................
No form required ..............................
2.8 ....................................................
2.12 ..................................................

220
160
20
8,500
8,500
10
220

1
1
1
1
1
1,760
1

30/60
30/60
30/60
20/60
15/60
3/60
10/60

110
80
10
2833
2125
880
37

2.14 ..................................................
2.13 ..................................................
2.15 ..................................................
No form required ..............................
2.19 ..................................................
Invoice—No standard form ..............
Pathology Report—No standard
form.
2.6 ....................................................

15
8,500
8,500
8,500
4
4
4

1
1
1
1
1
1
l

30/60
5/60
20/60
15/60
15/60
5/60
5/60

8
708
2833
2125
1
1
1

4

1

15/60

1

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

VerDate Sep<11>2014

21:55 Sep 13, 2021

Jkt 253001

PO 00000

Frm 00061

Fmt 4703

Sfmt 4703

E:\FR\FM\14SEN1.SGM

14SEN1

Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Notices

51159

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name

Number of
Respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

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

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

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

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

Type of respondent

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–19753 Filed 9–13–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–1039]

tkelley on DSK125TN23PROD with NOTICES

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 Information
Collection on Cause-Specific
Absenteeism in Schools 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 March 1,
2021 to obtain comments from the
public and affected agencies. CDC
received and replied to two nonsubstantive 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
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,

VerDate Sep<11>2014

21:55 Sep 13, 2021

Jkt 253001

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.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. 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
Information Collection on CauseSpecific Absenteeism in Schools (OMB
Control No. 0920–1039)—Reinstatement
with Change—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Information Collection on CauseSpecific Absenteeism in Schools aims to
improve; (1) understanding of the role of
influenza-like illness (ILI)-specific
absenteeism in schools in predicting
community-wide influenza
transmission, and (2) to detect withinhousehold transmission of influenza in
households from which a student has
been absent from school due to ILI.
Due to children’s naı¨ve immunity,
their susceptibility to infectious
diseases, and congregation of children at
schools, schools serve as amplification
points for influenza transmission.
Therefore, the collection of ILI-specific
absenteeism could provide information
needed to detect influenza outbreaks
early, before infection spreads to a
wider community. Such early detection

PO 00000

Frm 00062

Fmt 4703

Sfmt 4703

Total
burden
hours
11,741

of outbreaks will enable public health
and school authorities to implement
appropriate infection control and
prevention measures.
School children are frequently the
main introducers of influenza to their
families. Evaluating influenza
transmission within households where
students are absent from school because
of ILI may serve as an additional layer
of influenza surveillance, and could
contribute to understanding of influenza
transmission dynamics within the
surrounding community. Insights
gained from this information collection
will be used to strengthen the evidencebase of CDC’s Pre-Pandemic Guidance
prior to the next pandemic.
Since obtaining OMB approval in
December 2014, 2,466 Oregon School
District students with ILI have been
enrolled in the study. Of them, 68%
were positive for at least one respiratory
pathogen included in the PCR panel that
tests for presence of 17 common
respiratory viruses, and 29% of students
were found to be positive for influenza.
It was demonstrated that absenteeism
due to ILI in school children was highly
correlated with PCR-confirmed
influenza in enrolled school children,
and medically-attended influenza in the
surrounding community, suggesting that
ILI-specific school absenteeism can be
considered a useful tool for predicting
influenza outbreaks in the surrounding
community. For all six seasons, (2015–
2021) significant, positive crosscorrelations were achieved for
absenteeism due to illness (a–I) and
absenteeism due to ILI (a–ILI) at least 14
days in advance of MAI. Further
observations during influenza seasons
caused by other influenza strains are
needed to make these findings more
robust.
In the currently approved information
collection, information and
biospecimens are collected only from
students who were absent from school
because of ILI. This reinstatement with
change to the currently approved
information collection adds a household
transmission component, in which
information and biospecimens will be
collected from household members of
students absent from school because of
ILI. This aims to enhance current
knowledge and understanding around

E:\FR\FM\14SEN1.SGM

14SEN1