83 FR 63513 - Proposed Data Collection Submitted for Public Comment and Recommendations
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 | 63513-63515 | |
| FR Document | 2018-26637 |
[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)] [Notices] [Pages 63513-63515] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26637] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-19-0017; Docket No. CDC-2018-0109] 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 Application for Training (OMB Control No. 0920-0017). The Training and Continuing Education Online (TCEO) system is used in the management of the accreditation [[Page 63514]] process for non-federal educators who develop public health and healthcare educational activities and for non-federal health professionals who seek continuing education necessary to maintain professional licensures and certifications. This request for revision is to add new questions to the TCEO New Participant Registration, a new TCEO Post-Course Evaluation, and a new TCEO Follow-up Evaluation. Both new evaluation tools will improve the quality of educational activities. Each TCEO tool ensures compliance with accreditation requirements. DATES: CDC must receive written comments on or before February 8, 2019. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0109 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Jeffrey M. Zirger, Acting Lead, 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 Jeffery M. Zirger, 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 Application for Training (OMB Control No. 0920-0017, Exp 06/30/ 2019)--Revision--Division of Scientific Education and Professional Development (DSEPD), Center for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC). Background and Brief Description DSEPD requests a three-year Revision to the Training and Continuing Education Online (TCEO) system, which will comprise four data collection and management tools. Requested revisions are (1) to add questions to the existing TCEO New Participant Registration and (2) to introduce a Post-Course Evaluation and a Follow-Up Evaluation. No changes are requested for the existing TCEO Proposal Tool. TCEO provides access to CDC educational activities that offer continuing education to public health and healthcare professionals (learners) to maintain their professional licensures and certifications. Licensures and certifications are mandatory for certain health professionals to provide services that prevent and mitigate illness and save lives. Employees of hospitals, universities, medical centers, state and local health departments, and federal agencies participate in CDC's accredited educational activities to learn about current public health and healthcare practices. CDC is accredited by seven accreditation organizations to provide continuing education for public health and healthcare professionals. CDC and CDC-funded educational activities include classroom study, conferences, and electronic learning (e-learning). The TCEO Proposal expedites submission, review, and accreditation processes for these CDC and CDC-funded educational activities. The information collected from educational developers provides CDC with the information necessary to meet accreditation requirements. CDC reviews proposals to ensure compliance with requirements and awards continuing education when activities meet accreditation standards. The educational activities that can offer continuing education are then added to TCEO for learners to access. Accreditation organizations require a method of tracking learners who complete an educational activity and some require collection of profession-specific data, among other requirements. CDC requires health professionals who seek continuing education to establish an account by completing the TCEO New Participant Registration. CDC relies on this electronic form to collect information needed to coordinate learner registrations for educational activities. The proposed inclusion of two new evaluation tools is required by accreditation organizations to ensure compliance with accreditation standards. Public health professionals will be required to take the TCEO Post-course Evaluation after they have participated in an educational activity and before they can earn continuing education. Health professionals who have received continuing education for the activity will be encouraged to complete the TCEO Follow-up Evaluation when a link is sent to them from TCEO by email. Reports on responses to both tools will be submitted to accreditation organizations when they conduct audits or when CDC requests renewal of accreditation. Both new tools provide information to help CDC improve the quality of its educational activities. Proposed changes not only ensure that CDC is in compliance with accreditation requirements, changes will improve the quality of educational activities, while continuing to offer accredited educational activities at no cost to learners. Because of the increasing demand for accredited educational activities that offer free CE for licensures and certifications, TCEO experiences a continued increase in educational activities completed each year by registered learners. Every year, the number of times learners complete steps to earn continuing education increases by approximately 15%. The [[Page 63515]] two new evaluation tools will be shared with all learners who complete educational activities in TCEO, causing the annual burden estimate to increase significantly. The annual burden table has been updated to reflect the new TCEO Post-course Evaluation (66,667 burden hours) and the new TCEO Follow-up Evaluation (2,000 burden hours), for a total of 85,934 burden hours that include all four TCEO tools. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondents Form name respondents responses per response (in (in hours) respondent hours) ---------------------------------------------------------------------------------------------------------------- Educational Developers (Health TCEO Proposal... 120 1 5 600 Educators). Public Health and Health Care TCEO New 200,000 1 5/60 16,667 Professionals (Learners). Participant Registration. Public Health and Health Care TCEO Post-course 200,000 2 10/60 66,667 Professionals (Learners). Evaluation. Public Health and Health Care TCEO Follow-up 20,000 2 3/60 2,000 Professionals (Learners). Evaluation. --------------------------------------------------------------- Total..................... ................ 420,120 .............. .............. 85,934 ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention (CDC). [FR Doc. 2018-26637 Filed 12-7-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices 63513
because the majority of new HIV early infection) or concordant negative a research assistant and then
infections occur each year among this (indicating one or more false-positive electronically entered into the CASI
population. In each year of the study, an test results in Phase 1). system. Data to be collected via CASI
average of 1,667 participants will be The follow-up schedule will consist include questions on sociodemographic
recruited from the Public Health— of up to nine visits scheduled at regular characteristics, medical care, HIV
Seattle and King County (PHSKC) STD intervals over a 70-day period. At each testing, pre-exposure prophylaxis,
Clinic, which serves as the primary follow-up visit, participants will be antiretroviral treatment, sexually
study site, and an additional 200 tested with the new HIV tests and transmitted diseases (STD) history,
persons will be enrolled from other additional oral fluid and blood symptoms of early HIV infection,
clinics in the greater Seattle area. specimens will also be collected for substance use and sexual behavior. Data
Information collection will be storage and use in future HIV test
from the surveys will be merged with
conducted in two phases. evaluations at CDC. Participants will be
HIV test results and relevant clinical
Phase 1: After a clinic client consents followed up only to the point at which
to participate, he/she will be assigned a all their test results become concordant. data using the unique identification (ID)
unique participant ID and will then At each time point, participants will be number.
undergo testing with the seven new HIV asked to complete the Phase 2 HIV CDC will use findings to update
tests under study. While awaiting test Symptom and Care survey that collects guidelines for HIV testing and diagnosis
results, participants will undergo information on symptoms associated in the United States. The guidelines will
additional specimen collections and with early HIV infection, as well as help HIV test providers choose which
complete the Phase 1 Enrollment access to HIV care and treatment since HIV tests to use, and target tests
Survey. the last Phase 2 visit. When all tests appropriately to persons at different
Phase 2: All Phase 1 participants become concordant (i.e., at the last levels of risk. Findings will also be
whose results on the seven tests under Phase 2 visit) participants will complete disseminated through articles in peer-
investigation are not in agreement with the Phase 2 behavioral survey to reviewed journals and the technical
one another (‘‘discordant’’) will be identify any behavioral changes during assistance provided by CDC to grantees
considered to have a potential early HIV follow-up. Of the 50 Phase 2 that provide HIV testing and diagnostic
infection. Nucleic amplification testing participants, it is estimated that no more services.
that detects viral nucleic acids will be than 26, annually, will have early HIV
conducted to confirm an HIV diagnosis infection. There are no changes to the
and rule out false positives. Study All data for the proposed information previously approved information
investigators expect that each year, 50 collection will be collected via an collection instruments or burden
participants with discordant test results electronic Computer Assisted Self- estimates. The participation of
will be invited to participate in serial Interview (CASI) survey. Participants respondents is voluntary and there are
follow-up specimen collections to assess will complete the surveys on an no costs to respondents other than their
the time point at which all HIV test encrypted computer, with the exception time. The total estimated annualized
results resolve and become concordant of the Phase 2 Symptom and Care burden for the proposed project is 2,110
positive (indicating enrollment during survey, which will be administered by hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Persons eligible for study ............................... Phase 1 Consent ........................................... 2,334 1 15/60
Enrolled participants ....................................... Phase 1 Enrollment Survey A ........................ 1,667 1 45/60
Phase 1 Enrollment Survey B ........................ 200 1 60/60
Phase 2 Consent ........................................... 50 1 15/60
Phase 2 HIV Symptom and Care survey ...... 50 9 5/60
Phase 2 Behavioral Survey ........................... 50 1 30/60
Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND SUMMARY: The Centers for Disease
Acting Lead, Information Collection Review HUMAN SERVICES Control and Prevention (CDC), as part of
Office, Office of Scientific Integrity, Office its continuing effort to reduce public
of Science, Centers for Disease Control and Centers for Disease Control and burden and maximize the utility of
Prevention. Prevention government information, invites the
[FR Doc. 2018–26634 Filed 12–7–18; 8:45 am] general public and other Federal
BILLING CODE 4163–18–P [60Day–19–0017; Docket No. CDC–2018– agencies the opportunity to comment on
0109] a proposed and/or continuing
information collection, as required by
Proposed Data Collection Submitted the Paperwork Reduction Act of 1995.
for Public Comment and This notice invites comment on a
Recommendations proposed information collection project
AGENCY: Centers for Disease Control and titled Application for Training (OMB
Prevention (CDC), Department of Health Control No. 0920–0017). The Training
and Human Services (HHS). and Continuing Education Online
(TCEO) system is used in the
ACTION: Notice with comment period.
management of the accreditation
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![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
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Document Created: 2018-12-08 00:21:17
Document Modified: 2018-12-08 00:21:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before February 8, 2019. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger, 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] | |
| FR Citation | 83 FR 63513 |
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