60-day Federal Register Notice

Attachment B 60-day FRN 2019_07_05.pdf

EEOICPA Special Exposure Cohort Petition Forms (42 CFR Part 8)

60-day Federal Register Notice

OMB: 0920-0639

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32180

Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices

395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Study on Disparities in Distress
Screening among Lung and Ovarian
Cancer—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP) Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Within the cancer treatment
community, interest in the psychosocial
impacts of cancer diagnosis and
treatment is increasing. These
psychosocial impacts are wide ranging
and include not only anxiety related to
the illness and treatment side effects
such as pain, fatigue and cognition, but
also stress related to nonmedical issues
such as family relationships, financial
hardship, social stressors (e.g.
transportation), and stigmatization.
There is growing evidence that
addressing the psychosocial stresses of
cancer survivors increases both their
longevity and quality of life.
The 2016 Institute of Medicine
(currently, National Academies of

Sciences, Engineering, and Medicine)
ovarian cancer report, funded by CDC,
calls for increased study of the
psychosocial needs of ovarian cancer
survivors, recognizing the high rates of
depression, anxiety, and distress. Up to
60% of lung cancer survivors also
experience high levels of distress. Both
ovarian and lung cancer patients have
relatively low five-year survival rates
(45% and 17%, respectively). Therefore,
CDC believes that it is imperative to
develop a greater understanding about
the types of psychosocial services they
receive during their course of treatment
and follow-up care.
CDC proposes a new information
collection to examine the extent to
which disparities exist in distress
screening and follow-up among cancer
treatment facilities and programs across
the country. The study will include 50
healthcare facilities. From these
facilities, we will request existing
electronic health records (EHR) of 2,000
lung and ovarian cancer survivors. Data
elements collected will include patient
demographic information, cancer
diagnosis and treatment, experience
with distress screening and follow-up

care, and medical service utilization.
Patient names, addresses, birth dates
and Social Security Numbers will not be
collected.
Staff from twelve of the 50
participating healthcare facilities will be
invited to participate in an interview
and focus group to provide contextual
understanding about facilitators and
barriers to distress screening and followup processes. This is a one-time data
collection.
Results of this study will provide
CDC’s National Comprehensive Cancer
Control Program (NCCCP) with
information to assist with the
development of information, resources,
technical assistance, and future
evidence-based interventions to
improve the quality of life of lung and
ovarian cancer survivors. Summative
findings will be used to evaluate the
need to help with policy, systems, or
environmental changes that may
enhance the landscape of quality of life
services for cancer survivors in
communities at large. OMB approval is
requested for one year. The total
estimated annualized burden hours are
512.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Quantitative:
Healthcare Professionals (POC) .............
IT Staff .....................................................
Qualitative:
Healthcare Professionals .........................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–14298 Filed 7–3–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

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[60Day–19–0639; Docket No. CDC–19–0052]

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:

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Number of
respondents

Instrument

Number of
responses per
respondent

Average
burden per
response
(in hours)

Survey ............................................................
EMR data .......................................................

50
50

1
1

20/60
7.5

Key Informant Interview .................................
Focus Groups .................................................

12
72

1
1

1
1.5

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 Energy Employees Occupational
Illness Compensation Program Act of
2000 (EEOICPA) Special Exposure
Cohort Petitions. This information
collection project permits respondents
to submit petitions to HHS requesting
the addition of classes of employees to
the Special Exposure Cohort under
EEOICPA.

SUMMARY:

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Fmt 4703

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CDC must receive written
comments on or before September 3,
2019.

DATES:

You may submit comments,
identified by Docket No. CDC–2019–
0052 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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Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / 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, of
the 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:

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Proposed Project
Energy Employees Occupational
Illness Compensation Program Act of
2000 (EEOICPA) Special Exposure
Cohort Petitions. (OMB No. 0920–0639
exp. 10/31/2019)—Extension—National
Institute for Occupational Safety and
Health (NIOSH), Centers for Disease
Control and Prevention (CDC).

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Background and Brief Description
On October 30, 2000, the Energy
Employees Occupational Illness
Compensation Program Act of 2000
(EEOICPA), 42 U.S.C. 7384–7385 [1994,
supp. 2001] was enacted. The Act
established a compensation program to
provide a lump sum payment of
$150,000 and medical benefits as
compensation to covered employees
suffering from designated illnesses
incurred as a result of their exposure to
radiation, beryllium, or silica while in
the performance of duty for the
Department of Energy and certain of its
vendors, contractors and subcontractors.
This legislation also provided for
payment of compensation for certain
survivors of these covered employees.
This program has been mandated to be
in effect until Congress ends the
funding.
Among other duties, the Department
of Health and Human Services (HHS)
was directed to establish and implement
procedures for considering petitions by
classes of nuclear weapons workers to
be added to the ‘‘Special Exposure
Cohort’’ (the ‘‘Cohort’’). In brief,
EEOICPA authorizes HHS to designate
such classes of employees for addition
to the Cohort when NIOSH lacks
sufficient information to estimate with
sufficient accuracy the radiation doses
of the employees, and if HHS also finds
that the health of members of the class
may have been endangered by the
radiation dose the class potentially
incurred. HHS must also obtain the
advice of the Advisory Board on
Radiation and Worker Health (the
‘‘Board’’) in establishing such findings.
On May 28, 2004, HHS issued a rule
that established procedures for adding
such classes to the Cohort (42 CFR part
83). The rule was amended on July 10,
2007.
The HHS rule authorizes a variety of
respondents to submit petitions.
Petitioners are required to provide the
information specified in the rule to
qualify their petitions for a complete
evaluation by HHS and the Board. HHS
has developed two forms to assist the
petitioners in providing this required
information efficiently and completely.
Form A is a one-page form to be used
by EEOICPA claimants for whom
NIOSH has attempted to conduct dose
reconstructions and has determined that
available information is not sufficient to
complete the dose reconstruction. Form
B, accompanied by separate
instructions, is intended for all other
petitioners. Forms A and B can be
submitted electronically as well as in

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hard copy. Respondent/petitioners
should be aware that HHS is not
requiring respondents to use the forms.
Respondents can choose to submit
petitions as letters or in other formats,
but petitions must meet the
informational requirements stated in the
rule. NIOSH expects, however, that all
petitioners for whom Form A would be
appropriate will actually use the form,
since NIOSH will provide it to them
upon determining that their dose
reconstruction cannot be completed and
encourage them to submit the petition.
NIOSH expects the large majority of
petitioners for whom Form B would be
appropriate will also use the form, since
it provides a simple, organized format
for addressing the informational
requirements of a petition.
NIOSH will use the information
obtained through the petition for the
following purposes: (a) Identify the
petitioner(s), obtain their contact
information, and establish that the
petitioner(s) is qualified and intends to
petition HHS; (b) establish an initial
definition of the class of employees
being proposed to be considered for
addition to the Cohort; (c) determine
whether there is justification to require
HHS to evaluate whether or not to
designate the proposed class as an
addition to the Cohort (such an
evaluation involves potentially
extensive data collection, analysis, and
related deliberations by NIOSH, the
Board, and HHS); and, (d) target an
evaluation by HHS to examine relevant
potential limitations of radiation
monitoring and/or dosimetry-relevant
records and to examine the potential for
related radiation exposures that might
have endangered the health of members
of the class.
Finally, under the rule, petitioners
may contest the proposed decision of
the Secretary to add or deny adding
classes of employees to the cohort by
submitting evidence that the proposed
decision relies on a record of either
factual or procedural errors in the
implementation of these procedures.
NIOSH estimates that the average time
to prepare and submit such a challenge
is five hours. Because of the uniqueness
of this submission, NIOSH is not
providing a form. The submission will
typically be in the form of a letter to the
Secretary.
There are no costs to respondents
unless a respondent/petitioner chooses
to purchase the services of an expert in
dose reconstruction, an option provided
for under the rule.

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32182

Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hours)

Total burden
(in hrs.)

Form name

Petitioners .........................................

Form A, 42 CFR 83.9 ......................
Form B, 42 CFR 83.9 ......................
42 CFR 83.9 .....................................

2
5
1

1
1
1

3/60
5
6

6/60
25
6

42 CFR 83.18 ...................................

2

1

5

10

Authorization Form, 42 CFR 83.7 ....

3

1

3/60

9/60

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

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

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

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

41

Petitioners using a submission format other than Form B (as permitted by rule).
Petitioners Appealing final HHS decision (no specific form is required).
Claimant authorizing a party to submit petition on his/her behalf.
Total ...........................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–14304 Filed 7–3–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–19–19AYV; Docket No. CDC–2019–
0048]

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 State and Local Public Health
Laboratory Antibiotic Resistance
Testing. This collection will assist
public health laboratories to improve
detection and characterization of two
urgent antibiotic resistant threats in
healthcare-associated infections,
carbapenem-resistant Enterobacteriaceae
(CRE) and carbapenem-resistant
Pseudomonas aeruginosa (CRPA).
DATES: CDC must receive written
comments on or before September 3,
2019.
SUMMARY:

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Number of
responses per
respondent

Number of
respondents

Type of respondents

VerDate Sep<11>2014

17:54 Jul 03, 2019

Jkt 247001

You may submit comments,
identified by Docket No. CDC–2019–
0048 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.
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, of
the 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.
ADDRESSES:

PO 00000

Frm 00064

Fmt 4703

Sfmt 4703

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.
Proposed Project
State and Local Public Health
Laboratory Antibiotic Resistance
Testing—Existing Collection in use
without an OMB Control Number—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
This state and local laboratory testing
capacity collection is being
implemented by the Department of
Health and Human Services (HHS),
Centers for Disease Control and
Prevention (CDC) in response to
Executive Order 13676, with the
National Strategy of September 2014,
and to implement sub-objective 2.1.1 of
the National Action Plan of March 2015
for Combating Antibiotic Resistant
Bacteria. Data collected throughout this
network is also authorized by Section

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