Proposed Data Collection Submitted for Public Comment and Recommendations, 63513-63515 [2018-26637]

Download as PDF 63513 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices because the majority of new HIV infections occur each year among this population. In each year of the study, an average of 1,667 participants will be recruited from the Public Health— Seattle and King County (PHSKC) STD Clinic, which serves as the primary study site, and an additional 200 persons will be enrolled from other clinics in the greater Seattle area. Information collection will be conducted in two phases. Phase 1: After a clinic client consents to participate, he/she will be assigned a unique participant ID and will then undergo testing with the seven new HIV tests under study. While awaiting test results, participants will undergo additional specimen collections and complete the Phase 1 Enrollment Survey. Phase 2: All Phase 1 participants whose results on the seven tests under investigation are not in agreement with one another (‘‘discordant’’) will be considered to have a potential early HIV infection. Nucleic amplification testing that detects viral nucleic acids will be conducted to confirm an HIV diagnosis and rule out false positives. Study investigators expect that each year, 50 participants with discordant test results will be invited to participate in serial follow-up specimen collections to assess the time point at which all HIV test results resolve and become concordant positive (indicating enrollment during early infection) or concordant negative (indicating one or more false-positive test results in Phase 1). The follow-up schedule will consist of up to nine visits scheduled at regular intervals over a 70-day period. At each follow-up visit, participants will be tested with the new HIV tests and additional oral fluid and blood specimens will also be collected for storage and use in future HIV test evaluations at CDC. Participants will be followed up only to the point at which all their test results become concordant. At each time point, participants will be asked to complete the Phase 2 HIV Symptom and Care survey that collects information on symptoms associated with early HIV infection, as well as access to HIV care and treatment since the last Phase 2 visit. When all tests become concordant (i.e., at the last Phase 2 visit) participants will complete the Phase 2 behavioral survey to identify any behavioral changes during follow-up. Of the 50 Phase 2 participants, it is estimated that no more than 26, annually, will have early HIV infection. All data for the proposed information collection will be collected via an electronic Computer Assisted SelfInterview (CASI) survey. Participants will complete the surveys on an encrypted computer, with the exception of the Phase 2 Symptom and Care survey, which will be administered by a research assistant and then electronically entered into the CASI system. Data to be collected via CASI include questions on sociodemographic characteristics, medical care, HIV testing, pre-exposure prophylaxis, antiretroviral treatment, sexually transmitted diseases (STD) history, symptoms of early HIV infection, substance use and sexual behavior. Data from the surveys will be merged with HIV test results and relevant clinical data using the unique identification (ID) number. CDC will use findings to update guidelines for HIV testing and diagnosis in the United States. The guidelines will help HIV test providers choose which HIV tests to use, and target tests appropriately to persons at different levels of risk. Findings will also be disseminated through articles in peerreviewed journals and the technical assistance provided by CDC to grantees that provide HIV testing and diagnostic services. There are no changes to the previously approved information collection instruments or burden estimates. The participation of respondents is voluntary and there are no costs to respondents other than their time. The total estimated annualized burden for the proposed project is 2,110 hours. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Number of respondents Form name Persons eligible for study ............................... Enrolled participants ....................................... Jeffrey M. Zirger, Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. Phase Phase Phase Phase Phase Phase 1 1 1 2 2 2 Consent ........................................... Enrollment Survey A ........................ Enrollment Survey B ........................ Consent ........................................... HIV Symptom and Care survey ...... Behavioral Survey ........................... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [FR Doc. 2018–26634 Filed 12–7–18; 8:45 am] [60Day–19–0017; Docket No. CDC–2018– 0109] BILLING CODE 4163–18–P 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: VerDate Sep<11>2014 17:10 Dec 07, 2018 Jkt 247001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 2,334 1,667 200 50 50 50 Number of responses per respondent 1 1 1 1 9 1 Average burden per response (in hours) 15/60 45/60 60/60 15/60 5/60 30/60 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 SUMMARY: E:\FR\FM\10DEN1.SGM 10DEN1 63514 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices process for non-federal educators who develop public health and healthcare educational activities and for nonfederal 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: 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. VerDate Sep<11>2014 17:10 Dec 07, 2018 Jkt 247001 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. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 CDC and CDC-funded educational activities include classroom study, conferences, and electronic learning (elearning). The TCEO Proposal expedites submission, review, and accreditation processes for these CDC and CDCfunded 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 professionspecific 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 Postcourse 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 E:\FR\FM\10DEN1.SGM 10DEN1 63515 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices 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 Number of respondents Type of respondents Form name Educational Developers (Health Educators). Public Health and Health Care Professionals (Learners). Public Health and Health Care Professionals (Learners). Public Health and Health Care Professionals (Learners). TCEO Proposal ................................ Total ........................................... Total burden (in hours) 1 5 600 TCEO New Participant Registration 200,000 1 5/60 16,667 TCEO Post-course Evaluation ......... 200,000 2 10/60 66,667 TCEO Follow-up Evaluation ............. 20,000 2 3/60 2,000 ........................................................... 420,120 ........................ ........................ 85,934 [FR Doc. 2018–26637 Filed 12–7–18; 8:45 am] BILLING CODE 4163–18–P 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 17:10 Dec 07, 2018 Average burden per response (in hours) 120 Jeffrey M. Zirger, Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention (CDC). VerDate Sep<11>2014 Number of responses per respondent Jkt 247001 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 omb@cdc.gov. 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: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Notices]
[Pages 63513-63515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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


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