Proposed Data Collection Submitted for Public Comment and Recommendations, 11535-11536 [2018-05242]
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Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / 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. 2018–05243 Filed 3–14–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–18PR; Docket No. CDC–2018–
0021]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
Decision To Evaluate a Petition To
Designate a Class of Employees From
the De Soto Avenue Facility in Los
Angeles County, California, To Be
Included in the Special Exposure
Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services.
AGENCY:
ACTION:
Notice.
NIOSH gives notice of a
decision to evaluate a petition to
designate a class of employees from the
De Soto Avenue Facility in Los Angeles
County, California, to be included in the
Special Exposure Cohort under the
Energy Employees Occupational Illness
Compensation Program Act of 2000.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 1090 Tusculum
Avenue, MS C–46, Cincinnati, OH
45226–1938, Telephone 877–222–7570.
Information requests can also be
submitted by email to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
Authority: 42 CFR 83.9–83.12.
Pursuant to 42 CFR 83.12, the initial
proposed definition for the class being
evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: De Soto Avenue Facility.
Location: Los Angeles County,
California.
Job Titles and/or Job Duties: All
employees of the Department of Energy,
its predecessor agencies, and their
contractors and subcontractors who
worked at the De Soto Avenue Facility.
Period of Employment: January 1,
1965 through December 31, 1995.
Frank Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health.
[FR Doc. 2018–05277 Filed 3–14–18; 8:45 am]
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17:34 Mar 14, 2018
Jkt 244001
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 The World Trade Center Health
Program (WTCHP): Impact Assessment
and Strategic Planning for Translational
Research—Focus Group Protocol. This
project includes a series of focus groups
with different stakeholder groups to
explore their perspectives on the
decisions that each of them makes in the
context of the WTCHP.
DATES: CDC must receive written
comments on or before May 14, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0021 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.
SUMMARY:
Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
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
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
11535
Road, NE MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
omb@cdc.gov.
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.
Proposed Project
The World Trade Center Health
Program: Impact Assessment and
Strategic Planning for Translational
Research (Focus Group Protocol)—
New—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The James Zadroga 9/11 Health and
Compensation Act of 2010, Public Law
111–347 (hereafter referred to as ‘‘the
Zadroga Act’’), established the World
Trade Center Health Program (WTCHP).
Under subtitle C, the Zadroga Act
requires the establishment of a research
program on health conditions resulting
E:\FR\FM\15MRN1.SGM
15MRN1
11536
Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices
from the 9/11 terrorist attacks. Thus, the
CDC seeks a one-year OMB approval to
collect information using focus groups.
The WTCHP employs the Research-toCare (RTC) model strategic framework
employed to prioritize, conduct, and
assess research that informs excellence
in clinical care for the population of
responders and survivors affected by the
9/11 attack in New York City. The RTC
model assumes the collective
involvement of WTCHP stakeholders,
including members, researchers,
clinicians, and program administrators.
It accounts for a variety of inputs that
can affect the progress and impact of
WTCHP research. These inputs include
people and organizations (e.g., program
members, providers, clinical centers of
excellence, extramural researchers, and
program staff), resources (e.g.,
technology, data centers, the NYC 9/11
Health Registry) and regulatory rules,
principally the Zadroga Act.
The program supports activities such
as research prioritization, conduct of
research, delivery of medical care, and
iterative assessments of the translation
of research to improvements in health
care services and chronic disease
management. These activities aim to
produce tangible outputs such as
research findings on WTC-related
conditions, healthcare protocols, peerreviewed publications, quality
assessment reports, and member and
provider education products. Finally,
the model anticipates short-,
intermediate-, and long-term
measurement of outcomes and serves as
a communication tool for program
planning and evaluation.
In 2016, NIOSH contracted with the
Research and Development (RAND)
Corporation to evaluate the WTCHP
RTC model including the research
investments to date and the
effectiveness with which the Program
translates its research to different
stakeholder groups. This work will
ultimately provide guidance for the
WTCHP on strategic directions, as well
as produce generalizable knowledge
about the translation of research into
improved outcomes for individuals and
populations exposed to disasters such as
the 9/11 attacks. In the formative stage
of our assessment, we propose to hold
a series of focus groups with different
stakeholder groups to explore their
perspectives on translational research in
the context of the WTCHP. The focus
groups will each consist of a welldefined stakeholder group, and will last
approximately two hours.
These focus groups are necessary to
gather background information on the
relationship between different
stakeholders and the WTCHP that will
inform the development of more
detailed interview protocols to be used
with stakeholders in the next phase of
this evaluation. Specific topics to be
addressed in the focus groups will
include:
• Conceptualizations of research and
‘‘translational research.’’
• Relevance of WTCHP research
topics, potential gaps, and stakeholder
priorities.
• Uses and usefulness of WTCHP
research.
• Barriers to conduct and use of
WTCHP research.
• Understanding of and perspectives
on the relevance and usefulness of the
Research-to-Care model.
The total estimated burden hours is
360. There are no costs to the
respondent other than their time and
local travel to the location of the focus
group.
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
WTCH Researchers ............................
WTCH Research Users ......................
WTCH Funders (NIOSH) ....................
Focus Group Protocol ........................
Focus Group Protocol ........................
Focus Group Protocol ........................
40
70
10
1
1
1
3
3
3
120
210
30
Total .............................................
.............................................................
........................
........................
........................
360
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. 2018–05242 Filed 3–14–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. CDC–2016–0029]
Final Revised Vaccine Information
Materials for Varicella Vaccine
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
VerDate Sep<11>2014
17:34 Mar 14, 2018
Jkt 244001
Under the National
Childhood Vaccine Injury Act (NCVIA),
CDC must develop vaccine information
materials that all health care providers
are required to give to patients/parents
prior to administration of specific
vaccines. On March 15, 2016, CDC
published a notice in the Federal
Register (81 FR 13794) seeking public
comments on proposed updated vaccine
information materials for polio vaccine
and varicella vaccine. Following review
of comments submitted and
consultation as required under the law,
CDC has finalized the materials for
varicella vaccine. Copies of the final
vaccine information materials for
varicella vaccine are available to
download from https://www.cdc.gov/
vaccines/hcp/vis/ or https://
www.regulations.gov (see Docket
Number CDC–2016–0029).
SUMMARY:
PO 00000
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Beginning no later than June 1,
2018, each health care provider who
administers varicella vaccine to any
child or adult in the United States shall
provide copies of the relevant vaccine
information materials referenced in this
notice, dated February 12, 2018, in
conformance with the February 23, 2018
CDC Instructions for the Use of Vaccine
Information Statements prior to
providing such vaccinations.
DATES:
FOR FURTHER INFORMATION CONTACT:
Suzanne Johnson-DeLeon (msj1@
cdc.gov), National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, Mailstop A–19, 1600 Clifton
Road NE, Atlanta, Georgia 30329.
The
National Childhood Vaccine Injury Act
of 1986 (Pub. L. 99–660), as amended by
section 708 of Public Law 103–183,
added section 2126 to the Public Health
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Pages 11535-11536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05242]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-18-18PR; Docket No. CDC-2018-0021]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: 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 The World Trade Center Health
Program (WTCHP): Impact Assessment and Strategic Planning for
Translational Research--Focus Group Protocol. This project includes a
series of focus groups with different stakeholder groups to explore
their perspectives on the decisions that each of them makes in the
context of the WTCHP.
DATES: CDC must receive written comments on or before May 14, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0021 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 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
The World Trade Center Health Program: Impact Assessment and
Strategic Planning for Translational Research (Focus Group Protocol)--
New--National Institute for Occupational Safety and Health (NIOSH),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The James Zadroga 9/11 Health and Compensation Act of 2010, Public
Law 111-347 (hereafter referred to as ``the Zadroga Act''), established
the World Trade Center Health Program (WTCHP). Under subtitle C, the
Zadroga Act requires the establishment of a research program on health
conditions resulting
[[Page 11536]]
from the 9/11 terrorist attacks. Thus, the CDC seeks a one-year OMB
approval to collect information using focus groups.
The WTCHP employs the Research-to-Care (RTC) model strategic
framework employed to prioritize, conduct, and assess research that
informs excellence in clinical care for the population of responders
and survivors affected by the 9/11 attack in New York City. The RTC
model assumes the collective involvement of WTCHP stakeholders,
including members, researchers, clinicians, and program administrators.
It accounts for a variety of inputs that can affect the progress and
impact of WTCHP research. These inputs include people and organizations
(e.g., program members, providers, clinical centers of excellence,
extramural researchers, and program staff), resources (e.g.,
technology, data centers, the NYC 9/11 Health Registry) and regulatory
rules, principally the Zadroga Act.
The program supports activities such as research prioritization,
conduct of research, delivery of medical care, and iterative
assessments of the translation of research to improvements in health
care services and chronic disease management. These activities aim to
produce tangible outputs such as research findings on WTC-related
conditions, healthcare protocols, peer-reviewed publications, quality
assessment reports, and member and provider education products.
Finally, the model anticipates short-, intermediate-, and long-term
measurement of outcomes and serves as a communication tool for program
planning and evaluation.
In 2016, NIOSH contracted with the Research and Development (RAND)
Corporation to evaluate the WTCHP RTC model including the research
investments to date and the effectiveness with which the Program
translates its research to different stakeholder groups. This work will
ultimately provide guidance for the WTCHP on strategic directions, as
well as produce generalizable knowledge about the translation of
research into improved outcomes for individuals and populations exposed
to disasters such as the 9/11 attacks. In the formative stage of our
assessment, we propose to hold a series of focus groups with different
stakeholder groups to explore their perspectives on translational
research in the context of the WTCHP. The focus groups will each
consist of a well-defined stakeholder group, and will last
approximately two hours.
These focus groups are necessary to gather background information
on the relationship between different stakeholders and the WTCHP that
will inform the development of more detailed interview protocols to be
used with stakeholders in the next phase of this evaluation. Specific
topics to be addressed in the focus groups will include:
Conceptualizations of research and ``translational
research.''
Relevance of WTCHP research topics, potential gaps, and
stakeholder priorities.
Uses and usefulness of WTCHP research.
Barriers to conduct and use of WTCHP research.
Understanding of and perspectives on the relevance and
usefulness of the Research-to-Care model.
The total estimated burden hours is 360. There are no costs to the
respondent other than their time and local travel to the location of
the focus group.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total
Type of respondents Form name respondents responses per response (in burden (in
respondent hours) hours)
----------------------------------------------------------------------------------------------------------------
WTCH Researchers............... Focus Group 40 1 3 120
Protocol.
WTCH Research Users............ Focus Group 70 1 3 210
Protocol.
WTCH Funders (NIOSH)........... Focus Group 10 1 3 30
Protocol.
------------------------------------------------------------
Total...................... .................. .............. .............. .............. 360
----------------------------------------------------------------------------------------------------------------
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. 2018-05242 Filed 3-14-18; 8:45 am]
BILLING CODE 4163-18-P
