83 FR 63515 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 236 (December 10, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 236 (December 10, 2018)
| Page Range | 63515-63516 | |
| FR Document | 2018-26633 |
[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)] [Notices] [Pages 63515-63516] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26633] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-19-18PR] 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 The World Trade Center Health Program (WTCHP): Impact Assessment and Strategic Planning for Translational Research (Part 1, Formative Research: Focus Groups) 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 15, 2018 to obtain comments from the public and affected agencies. The WTCHP is administered by the CDC/ National Institute for Occupational Safety and Health (NIOSH). CDC did not receive 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, 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 The World Trade Center Health Program: Impact Assessment and Strategic Planning for Translational Research (Part 1, Formative Research: Focus Groups)--New--National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description The World Trade Center Health Program (WTCHP) was established by the James Zadroga 9/11 Health and Compensation Act of 2010, Public Law 111-347 (hereafter referred to as ``the Zadroga Act''). Under subtitle C, the Zadroga Act requires the establishment of a research program on health conditions resulting from the 9/11 terrorist attacks. The Research to Care (RTC) model is the strategic framework employed by the WTCHP to prioritize, conduct, and assess research that informs excellence in clinical care for the population of responders and survivors affected by the 9/11 attacks in New York City. It is the focus of this assessment. The RTC model assumes the collective involvement of different 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 [[Page 63516]] 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 RAND Corporation to conduct an independent evaluation of the WTCHP RTC model including the research investments to date and the effectiveness with which the Program translates its research to different stakeholder groups. RAND was selected given the project team's expertise with similar assessments and NIOSH's requirement for an objective analysis. This work will ultimately provide guidance for the WTCHP on strategic directions, as well as produce new knowledge about the translation of research into improved outcomes for individuals and populations exposed to disasters such as, but not limited to, 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. Focus group discussions will be held in-person or by telephone or webinar format. Depending on the timing of OMB approval, RAND anticipates conducting focus groups shortly after, most likely in the winter/early spring of 2019. If this occurs, results will be analyzed in the spring of 2019. If the timing of OMB approval coincides with one of the twice-yearly NIOSH-sponsored research meetings in NYC, RAND plans to hold in-person focus groups with the stakeholder groups in attendance (NIOSH and principal investigators, typically); the remainder of the focus groups will be held by webinar to minimize burden on the participants. These focus groups are necessary to gather background information on the relationship between different stakeholders and the WTCHP that will complement data gathered during more detailed interviews with stakeholders in the interviews that will take place 6-12 months later. 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, including responsiveness to regulatory issues; uses and usefulness of WTCHP research; barriers to conduct and use of WTCHP research; and understanding of and perspectives on the relevance and usefulness of the Research-to-Care model. OMB approval is requested for one year. The total estimated burden in hours is 220. Participation is voluntary and there are no costs to the respondent other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondents Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- Principal Investigators of WTCHP- Focus Group Discussion 30 1 2 Funded Research. Guide and Brief Demographic Survey. Leadership from WTC Clinical Centers Focus Group Discussion 20 1 2 of Excellence and Other Stakeholders. Guide and Brief Demographic Survey. WTC Health Registry staff............. Focus Group Discussion 10 1 2 Guide and Brief Demographic Survey. Clinicians Caring for WTCHP Members... Focus Group Discussion 20 1 2 Guide and Brief Demographic Survey. WTCHP Responders and Survivors (State/ Focus Group Discussion 15 1 2 local govt). Guide and Brief Demographic Survey. WTCHP Responders and Survivors Focus Group Discussion 15 1 2 (private citizens). Guide and Brief Demographic Survey. ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2018-26633 Filed 12-7-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices 63515
two new evaluation tools will be shared has been updated to reflect the new hours that include all four TCEO tools.
with all learners who complete TCEO Post-course Evaluation (66,667 There are no costs to respondents other
educational activities in TCEO, causing burden hours) and the new TCEO than their time.
the annual burden estimate to increase Follow-up Evaluation (2,000 burden
significantly. The annual burden table hours), for a total of 85,934 burden
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Educational Developers (Health Edu- TCEO Proposal ................................ 120 1 5 600
cators).
Public Health and Health Care Pro- TCEO New Participant Registration 200,000 1 5/60 16,667
fessionals (Learners).
Public Health and Health Care Pro- TCEO Post-course Evaluation ......... 200,000 2 10/60 66,667
fessionals (Learners).
Public Health and Health Care Pro- TCEO Follow-up Evaluation ............. 20,000 2 3/60 2,000
fessionals (Learners).
Total ........................................... ........................................................... 420,120 ........................ ........................ 85,934
Jeffrey M. Zirger, is particularly interested in comments Focus Groups)—New—National
Acting Lead, Information Collection Review that: Institute for Occupational Safety and
Office, Office of Scientific Integrity, Office (a) Evaluate whether the proposed Health (NIOSH), Centers for Disease
of Science, Centers for Disease Control and collection of information is necessary Control and Prevention (CDC).
Prevention (CDC). for the proper performance of the
[FR Doc. 2018–26637 Filed 12–7–18; 8:45 am] functions of the agency, including Background and Brief Description
BILLING CODE 4163–18–P whether the information will have The World Trade Center Health
practical utility; Program (WTCHP) was established by
(b) Evaluate the accuracy of the the James Zadroga 9/11 Health and
DEPARTMENT OF HEALTH AND agencies estimate of the burden of the Compensation Act of 2010, Public Law
HUMAN SERVICES proposed collection of information, 111–347 (hereafter referred to as ‘‘the
including the validity of the Zadroga Act’’). Under subtitle C, the
Centers for Disease Control and methodology and assumptions used;
Prevention Zadroga Act requires the establishment
(c) Enhance the quality, utility, and of a research program on health
[30Day–19–18PR] clarity of the information to be conditions resulting from the 9/11
collected; terrorist attacks. The Research to Care
Agency Forms Undergoing Paperwork (d) Minimize the burden of the (RTC) model is the strategic framework
Reduction Act Review collection of information on those who employed by the WTCHP to prioritize,
are to respond, including, through the conduct, and assess research that
In accordance with the Paperwork use of appropriate automated,
Reduction Act of 1995, the Centers for informs excellence in clinical care for
electronic, mechanical, or other the population of responders and
Disease Control and Prevention (CDC) technological collection techniques or
has submitted the information survivors affected by the 9/11 attacks in
other forms of information technology,
collection request titled The World New York City. It is the focus of this
e.g., permitting electronic submission of
Trade Center Health Program (WTCHP): assessment.
responses; and
Impact Assessment and Strategic (e) Assess information collection The RTC model assumes the
Planning for Translational Research costs. collective involvement of different
(Part 1, Formative Research: Focus To request additional information on WTCHP stakeholders, including
Groups) to the Office of Management the proposed project or to obtain a copy members, researchers, clinicians, and
and Budget (OMB) for review and of the information collection plan and program administrators. It accounts for
approval. CDC previously published a instruments, call (404) 639–7570 or a variety of inputs that can affect the
‘‘Proposed Data Collection Submitted send an email to omb@cdc.gov. Direct progress and impact of WTCHP
for Public Comment and written comments and/or suggestions research. These inputs include people
Recommendations’’ notice on March 15, regarding the items contained in this and organizations (e.g., program
2018 to obtain comments from the notice to the Attention: CDC Desk members, providers, clinical centers of
public and affected agencies. The Officer, Office of Management and excellence, extramural researchers, and
WTCHP is administered by the CDC/ Budget, 725 17th Street NW, program staff), resources (e.g.,
National Institute for Occupational Washington, DC 20503 or by fax to (202) technology, data centers, the NYC 9/11
Safety and Health (NIOSH). CDC did not 395–5806. Provide written comments Health Registry) and regulatory rules,
receive comments related to the within 30 days of notice publication. principally the Zadroga Act. The
previous notice. This notice serves to program supports activities such as
allow an additional 30 days for public Proposed Project research prioritization, conduct of
and affected agency comments. The World Trade Center Health research, delivery of medical care, and
CDC will accept all comments for this Program: Impact Assessment and iterative assessments of the translation
proposed information collection project. Strategic Planning for Translational of research to improvements in health
The Office of Management and Budget Research (Part 1, Formative Research: care services and chronic disease
VerDate Sep<11>2014 17:10 Dec 07, 2018 Jkt 247001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1](https://thefederalregister.org/doc/83_FR_63751/page/1.svg)
![63516 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices
management. These activities aim to research into improved outcomes for held by webinar to minimize burden on
produce tangible outputs such as individuals and populations exposed to the participants.
research findings on WTC-related disasters such as, but not limited to, the These focus groups are necessary to
conditions, healthcare protocols, peer- 9/11 attacks. In the formative stage of gather background information on the
reviewed publications, quality our assessment, we propose to hold a relationship between different
assessment reports, and member and series of focus groups with different stakeholders and the WTCHP that will
provider education products. Finally, stakeholder groups to explore their complement data gathered during more
the model anticipates short-, perspectives on translational research in detailed interviews with stakeholders in
intermediate-, and long-term the context of the WTCHP. The focus the interviews that will take place 6–12
measurement of outcomes and serves as groups will each consist of a well- months later. Specific topics to be
a communication tool for program defined stakeholder group, and will last addressed in the focus groups will
planning and evaluation. approximately two hours. Focus group include: Conceptualizations of research
In 2016, NIOSH contracted with the discussions will be held in-person or by and ‘‘translational research;’’ relevance
RAND Corporation to conduct an telephone or webinar format. Depending of WTCHP research topics, potential
independent evaluation of the WTCHP on the timing of OMB approval, RAND gaps, and stakeholder priorities,
RTC model including the research anticipates conducting focus groups including responsiveness to regulatory
investments to date and the shortly after, most likely in the winter/ issues; uses and usefulness of WTCHP
effectiveness with which the Program early spring of 2019. If this occurs, research; barriers to conduct and use of
translates its research to different results will be analyzed in the spring of WTCHP research; and understanding of
stakeholder groups. RAND was selected 2019. If the timing of OMB approval and perspectives on the relevance and
given the project team’s expertise with coincides with one of the twice-yearly usefulness of the Research-to-Care
similar assessments and NIOSH’s NIOSH-sponsored research meetings in model.
requirement for an objective analysis. NYC, RAND plans to hold in-person OMB approval is requested for one
This work will ultimately provide focus groups with the stakeholder year. The total estimated burden in
guidance for the WTCHP on strategic groups in attendance (NIOSH and hours is 220. Participation is voluntary
directions, as well as produce new principal investigators, typically); the and there are no costs to the respondent
knowledge about the translation of remainder of the focus groups will be other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Principal Investigators of WTCHP-Funded Focus Group Discussion Guide and Brief 30 1 2
Research. Demographic Survey.
Leadership from WTC Clinical Centers of Ex- Focus Group Discussion Guide and Brief 20 1 2
cellence and Other Stakeholders. Demographic Survey.
WTC Health Registry staff .............................. Focus Group Discussion Guide and Brief 10 1 2
Demographic Survey.
Clinicians Caring for WTCHP Members ......... Focus Group Discussion Guide and Brief 20 1 2
Demographic Survey.
WTCHP Responders and Survivors (State/ Focus Group Discussion Guide and Brief 15 1 2
local govt). Demographic Survey.
WTCHP Responders and Survivors (private Focus Group Discussion Guide and Brief 15 1 2
citizens). Demographic Survey.
Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND Gynecology Devices Panel of the
Acting Lead, Information Collection Review HUMAN SERVICES Medical Devices Advisory Committee
Office, Office of Scientific Integrity, Office (Committee). The general function of the
of Science, Centers for Disease Control and Food and Drug Administration Committee is to provide advice and
Prevention. recommendations to the Agency on
[FR Doc. 2018–26633 Filed 12–7–18; 8:45 am] [Docket No. FDA–2018–N–4395] FDA’s regulatory issues. The meeting
BILLING CODE 4163–18–P will be open to the public. FDA is
Obstetrics and Gynecology Devices establishing a docket for public
Panel of the Medical Devices Advisory comment on this document.
Committee; Notice of Meeting; DATES: The meeting will be held on
Establishment of a Public Docket; February 12, 2019, from 8 a.m. to 6:30
Request for Comments p.m.
AGENCY: Food and Drug Administration, ADDRESSES: Hilton Washington, DC
HHS. North/Gaithersburg; Salons A, B, C, and
ACTION: Notice; establishment of a D; 620 Perry Pkwy., Gaithersburg, MD
public docket; request for comments. 20877. The hotel’s telephone number is
301–977–8900; additional information
SUMMARY: The Food and Drug available online at: https://www3.hilton.
Administration (FDA) is announcing a com/en/hotels/maryland/hilton-
forthcoming public advisory committee washington-dc-north-gaithersburg-
meeting of the Obstetrics and GAIGHHF/index.html. Answers to
VerDate Sep<11>2014 17:10 Dec 07, 2018 Jkt 247001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1](https://thefederalregister.org/doc/83_FR_63751/page/2.svg)
Document Created: 2018-12-08 00:22:18
Document Modified: 2018-12-08 00:22:18
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| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| Section | Notices | |
| FR Citation | 83 FR 63515 |
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