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Notice

Proposed Data Collection Submitted for Public Comment and Recommendations

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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.

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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.

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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 Start Printed Page 32920disorders' 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 respondentsForm nameNumber of respondentsNumber responses per respondentAverage burden per response (in hours)Total burden hours
Project Grantee StaffDSW Report90210/6030
Project Grantee StaffHigh Impact Study: Discipline Specific Workgroup Discussion Guide for Project Staff10260/6020
Health Care System StaffHigh Impact Study: Key Informant Interview—Health Care System Staff10260/6020
FASD Core Training ParticipantsFASD Core Training Survey—Pre-Test401319/60602
FASD Core Training ParticipantsFASD Core Training Survey—Post-Test401315/60335
FASD Core Training ParticipantsFASD Core Training Survey—6 Month Follow-Up401316/60402
NursesPre-Training Survey for Nursing66719/60101
NursesPost-Training Survey for Nursing55019/6083
NursesSix Month Follow-Up Training Survey for Nursing44019/6066
NursesNursing DSW Polling Questions41715/6035
NursesKey Informant Interviews with Champions14245/6021
NursesBrief Questionnaire for Nursing Organization Memberships2,934110/60489
NursesFriends & Members of the Network Survey34210/6012
Healthcare Organization RepresentativesHealthcare Organization Utilization Survey234130/60117
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Obstetrician-Gynecologists and students in allied health professionsOBGYN SBI Knowledge & Agency60012/6020
Obstetrician-GynecologistsOBGYN BI-MI Proficiency Rating Scale—Provider Skills Training Baseline60013/6030
Students in allied health professionsOBGYN BI-MI Proficiency Rating Scale—Standardized Patient Version60013/6030
Obstetrician-GynecologistsOBGYN BI-MI Proficiency Rating Scale—Provider Follow Up (3m & 6m)60023/6060
Obstetrician-Gynecologists and students in allied health professionsOBGYN Telecom Training Satisfaction Survey48015/6040
Obstetrician-Gynecologists and students in allied health professionsOBGYN Avatar Training Satisfaction Survey12015/6010
Obstetrician-GynecologistsOBGYN FASD-SBI Training Event Evaluation12412/605
Residency Directors, Training Coordinators, Clinical Directors, Obstetrician-GynecologistsOBGYN Qualitative Key Informant Interview—Pre-Training34125/6015
Residency Directors, Training Coordinators, Clinical Directors, Obstetrician-GynecologistsOBGYN Qualitative Key Informant Interview—Post-Training34125/6015
Certified Medical Assistants and studentsMedical Assistant—Pre-Test Survey334110/6056
Students in allied health professionsMedical Assistant—Pre-Test Survey (Academic)67110/6012
Certified Medical Assistants and studentsMedical Assistant—Post-Test Survey334110/6056
Students in allied health professionsMedical Assistant—Post-Test Survey (Academic)67110/6012
Certified Medical Assistants and studentsMedical Assistant Follow Up Survey200110/6034
Students in allied health professionsMedical Assistant Follow Up Survey (Academic)17110/603
Certified Medical Assistants and studentsMedical Assistants Change in Practice Survey250115/6063
PediatriciansSurvey of Pediatricians—Baseline and Follow Up534210/60178
PediatriciansAAP Post-Training Evaluation Survey12017/6014
PediatriciansAAP Pre-Training Evaluation Survey12017/6014
PediatriciansAAP Three Month Follow Up Evaluation Survey12012/604
PediatriciansAAP Six Month Follow Up Evaluation Survey12015/6010
PediatriciansFASD Toolkit User Survey50115/6013
PediatriciansFASD Toolkit Evaluation Focus Group/Guided Interview10130/605
PediatriciansPediatric FASD Regional Education and Awareness Liaisons Work Plan10120/604
PediatriciansPediatric FASD Regional Liaison/Champion Training Session Evaluation1014/601
Family Medicine PhysiciansFamily Medicine Evaluation Questions Addendum for Practice or Individual Provider6218/609
Family medicine physicians, social workers, social work studentsSocial Work and Family Physicians Pre-training Survey116718/60156
Family medicine physicians, social workers, social work studentsSocial Work and Family Physicians Post-training Survey116715/6098
Family medicine physicians, social workers, social work studentsSocial Work and Family Physicians 6-Month Follow Up Survey116718/60156
NOFAS webinar attendeesNOFAS Webinar Survey60112/6020
NOFAS webinar attendeesNOFAS Three Month Follow-Up Webinar Questionnaire60112/6020
NOFAS training participantsNOFAS Pre-Test Survey55113/6028
NOFAS training participantsNOFAS Post-Test Survey55113/6028
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Systems change project participantsClinical Process Improvement Survey246210/6082
Systems change project participantsTCU Organizational Readiness Survey246210/6082
Systems change project participantsOrganizational Readiness to Change Assessment220210/6074
TOTAL29,5733,790
Start Signature

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.

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[FR Doc. 2019-14684 Filed 7-9-19; 8:45 am]

BILLING CODE 4163-18-P