Notices. Notice with comment period

1,881 words·~9 min read·/register/2019/07/10/2019-14684·

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BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-19-1129; Docket No. CDC-2019-0058] 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 titled, Improving Fetal Alcohol Spectrum Disorders

(FASD)Prevention and Practice through Practice and Implementation Centers and National Partnerships (PICs). The purpose of FASD PICs is to collect training evaluation data from healthcare practitioners and staff in health systems where FASD-related practice and systems changes are implemented, and from grantees of Practice and Implementation Centers and national partner organizations related to prevention, identification, and treatment of fetal alcohol spectrum disorders (FASDs). DATES: CDC must receive written comments on or before September 9, 2019. ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-0058 by any of the following methods: • *Federal eRulemaking Portal: Regulations.gov* . Follow the instructions for submitting comments. • *Mail:* Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to *Regulations.gov* . *Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.* FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, 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. 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 Improving Fetal Alcohol Spectrum Disorders

(FASD)Prevention and Practice through Practice and Implementation Centers and National Partnerships” project (OMB Control No. 0920-1129, Exp. 8/31/2019))—Revision — National Center for Birth Defects and Developmental Disability (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description Prenatal exposure to alcohol is a leading preventable cause of birth defects and developmental disabilities. The term `fetal alcohol spectrum disorders' describes the full continuum of effects that can occur in an individual exposed to alcohol in utero. These effects include physical, mental, behavioral, and learning disabilities. All of these have lifelong implications. Since 2002, CDC funded FASD Regional Training Centers

(RTCs)to provide education and training to healthcare professionals and students about FASD prevention, identification, and treatment. In July 2013, CDC convened an expert review panel to evaluate the effectiveness of the RTC program overall and to make recommendations about the program. The panel highlighted several accomplishments of the RTCs and proposed several changes for future programming:

(1)The panel identified a need for more comprehensive coverage nationally with discipline-specific trainings, increased use of technology, greater collaboration with medical societies, and stronger linkages with national partner organizations to increase the reach of training opportunities, and

(2)The panel suggested that the training centers focus on demonstrable practice change and sustainability and place a stronger emphasis on primary prevention of FASDs. In addition, it was recommended that future initiatives have stronger evaluation components. Based on the recommendations of the expert review panel, CDC is placing increased focus on prevention, demonstrating practice change, achieving national coverage, and strengthening partnerships between FASD Practice and Implementation Centers, or PICs (the newly redesigned RTCs), and medical societies and national partner organizations. The National Organization on Fetal Alcohol Syndrome (NOFAS) also participates in this project as a resource to the PICS and national partners. The PICs and national partners are asked to closely collaborate in discipline-specific workgroups

(DSWs)and identify strategies that will increase the reach of the program on a national level. While a major focus of the grantees' work will be national, regional approaches will be used to develop new content and test feasibility and acceptability of materials, especially among healthcare providers and medical societies. In addition, CDC is placing a stronger emphasis on evaluation, with both individual DSW/NOFAS evaluations and a cross-site evaluation. CDC requests OMB approval to collect program evaluation information from

(1)healthcare practitioners from disciplines targeted by each DSW, including training participants,

(2)health system staff, and

(3)cooperative agreement grantees over a three-year period. Healthcare practitioners will complete surveys to provide information on whether project trainings impacted their knowledge and practice behavior regarding FASD identification, prevention, and treatment. The information will be used to improve future trainings and assess whether knowledge and practice changes occurred. Some participants will also complete qualitative key informant interviews to gain additional information on practice change. Health system employees will be interviewed or complete surveys as part of projects to assess healthcare systems change, including high impact evaluation studies and DSW systems change projects. The high impact evaluation studies will be primarily qualitative assessments of two to three specific grantee efforts that seem likely to result in achievement of program objectives. The DSW systems change projects will employ online surveys to assess systems change in selected health systems across the U.S. Grantees will complete program evaluation forms to track perceptions of DSW collaboration and perceptions of key successes and challenges encountered by the DSW. It is estimated that 29,573 respondents will participate in the evaluation each year, for a total estimated burden of 3790 hours annually. There are no costs to respondents other than their time. Estimated Annualized Burden Hours Type of respondents Form name Number of respondents Number responses per respondent Average burden per response (in hours) Total burden hours Project Grantee Staff DSW Report 90 2 10/60 30 Project Grantee Staff High Impact Study: Discipline Specific Workgroup Discussion Guide for Project Staff 10 2 60/60 20 Health Care System Staff High Impact Study: Key Informant Interview—Health Care System Staff 10 2 60/60 20 FASD Core Training Participants FASD Core Training Survey—Pre-Test 4013 1 9/60 602 FASD Core Training Participants FASD Core Training Survey—Post-Test 4013 1 5/60 335 FASD Core Training Participants FASD Core Training Survey—6 Month Follow-Up 4013 1 6/60 402 Nurses Pre-Training Survey for Nursing 667 1 9/60 101 Nurses Post-Training Survey for Nursing 550 1 9/60 83 Nurses Six Month Follow-Up Training Survey for Nursing 440 1 9/60 66 Nurses Nursing DSW Polling Questions 417 1 5/60 35 Nurses Key Informant Interviews with Champions 14 2 45/60 21 Nurses Brief Questionnaire for Nursing Organization Memberships 2,934 1 10/60 489 Nurses Friends & Members of the Network Survey 34 2 10/60 12 Healthcare Organization Representatives Healthcare Organization Utilization Survey 234 1 30/60 117 Obstetrician-Gynecologists and students in allied health professions OBGYN SBI Knowledge & Agency 600 1 2/60 20 Obstetrician-Gynecologists OBGYN BI-MI Proficiency Rating Scale—Provider Skills Training Baseline 600 1 3/60 30 Students in allied health professions OBGYN BI-MI Proficiency Rating Scale—Standardized Patient Version 600 1 3/60 30 Obstetrician-Gynecologists OBGYN BI-MI Proficiency Rating Scale—Provider Follow Up (3m & 6m) 600 2 3/60 60 Obstetrician-Gynecologists and students in allied health professions OBGYN Telecom Training Satisfaction Survey 480 1 5/60 40 Obstetrician-Gynecologists and students in allied health professions OBGYN Avatar Training Satisfaction Survey 120 1 5/60 10 Obstetrician-Gynecologists OBGYN FASD-SBI Training Event Evaluation 124 1 2/60 5 Residency Directors, Training Coordinators, Clinical Directors, Obstetrician-Gynecologists OBGYN Qualitative Key Informant Interview—Pre-Training 34 1 25/60 15 Residency Directors, Training Coordinators, Clinical Directors, Obstetrician-Gynecologists OBGYN Qualitative Key Informant Interview—Post-Training 34 1 25/60 15 Certified Medical Assistants and students Medical Assistant—Pre-Test Survey 334 1 10/60 56 Students in allied health professions Medical Assistant—Pre-Test Survey (Academic) 67 1 10/60 12 Certified Medical Assistants and students Medical Assistant—Post-Test Survey 334 1 10/60 56 Students in allied health professions Medical Assistant—Post-Test Survey (Academic) 67 1 10/60 12 Certified Medical Assistants and students Medical Assistant Follow Up Survey 200 1 10/60 34 Students in allied health professions Medical Assistant Follow Up Survey (Academic) 17 1 10/60 3 Certified Medical Assistants and students Medical Assistants Change in Practice Survey 250 1 15/60 63 Pediatricians Survey of Pediatricians—Baseline and Follow Up 534 2 10/60 178 Pediatricians AAP Post-Training Evaluation Survey 120 1 7/60 14 Pediatricians AAP Pre-Training Evaluation Survey 120 1 7/60 14 Pediatricians AAP Three Month Follow Up Evaluation Survey 120 1 2/60 4 Pediatricians AAP Six Month Follow Up Evaluation Survey 120 1 5/60 10 Pediatricians FASD Toolkit User Survey 50 1 15/60 13 Pediatricians FASD Toolkit Evaluation Focus Group/Guided Interview 10 1 30/60 5 Pediatricians Pediatric FASD Regional Education and Awareness Liaisons Work Plan 10 1 20/60 4 Pediatricians Pediatric FASD Regional Liaison/Champion Training Session Evaluation 10 1 4/60 1 Family Medicine Physicians Family Medicine Evaluation Questions Addendum for Practice or Individual Provider 62 1 8/60 9 Family medicine physicians, social workers, social work students Social Work and Family Physicians Pre-training Survey 1167 1 8/60 156 Family medicine physicians, social workers, social work students Social Work and Family Physicians Post-training Survey 1167 1 5/60 98 Family medicine physicians, social workers, social work students Social Work and Family Physicians 6-Month Follow Up Survey 1167 1 8/60 156 NOFAS webinar attendees NOFAS Webinar Survey 601 1 2/60 20 NOFAS webinar attendees NOFAS Three Month Follow-Up Webinar Questionnaire 601 1 2/60 20 NOFAS training participants NOFAS Pre-Test Survey 551 1 3/60 28 NOFAS training participants NOFAS Post-Test Survey 551 1 3/60 28 Systems change project participants Clinical Process Improvement Survey 246 2 10/60 82 Systems change project participants TCU Organizational Readiness Survey 246 2 10/60 82 Systems change project participants Organizational Readiness to Change Assessment 220 2 10/60 74 TOTAL 29,573 3,790 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019-14684 Filed 7-9-19; 8:45 am]

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