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Proposed Data Collections Submitted for Public Comment and Recommendations

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Information about this document as published in the Federal Register.

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In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-7570 and send comments to Ron Otten, at CDC, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

Fetal Alcohol Spectrum Disorders Regional Training Centers—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

This program will collect program evaluation data from participants of trainings for medical and allied health students and practitioners regarding fetal alcohol spectrum disorders (FASDs) conducted by the FASD Regional Training Centers (RTCs) through a cooperative agreement with the CDC.

Prenatal exposure to alcohol is a leading preventable cause of birth defects and developmental disabilities. The term fetal alcohol spectrum disorders (FASDs) 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 effects have lifelong implications.

Health care professionals play a crucial role in identifying women at risk for an alcohol-exposed pregnancy and in identifying effects of prenatal alcohol exposure in individuals. However, despite the data regarding alcohol consumption among women of childbearing age and the estimated prevalence of FASDs, screening for alcohol use among female patients of childbearing age and screening for FASDs are not yet common standards of care. In addition, it is known from surveys of multiple provider types that although they might be familiar with the teratology and clinical presentation of FASDs, they report feeling less prepared to identify for referral or to diagnose a child and even less prepared to manage and coordinate the treatment of children with FASDs. Similarly, among obstetrician-gynecologists, although almost all report asking their patients about alcohol use during pregnancy, few use a proper screening tool for alcohol assessment.

There is a need for the training of medical and allied health students and practitioners in the prevention, management, and identification of FASDs, hence the recommendations that have been put forward in this area. As part of the fiscal year 2002 appropriations funding legislation, the U.S. Congress mandated that the CDC, acting through the NCBDDD Fetal Alcohol Syndrome (FAS) Prevention Team and in coordination with the National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol Effect (NTFFAS/FAE), other federally funded FAS programs, and appropriate nongovernmental organizations (NGOs), would (1) develop guidelines for the diagnosis of FAS and other negative birth outcomes resulting from prenatal exposure to alcohol; (2) incorporate these guidelines into curricula for medical and allied health students and practitioners, and seek to have them fully recognized by professional organizations and accrediting boards; and (3) disseminate curricula to and provide training for medical and allied health students and practitioners regarding these guidelines. As part of CDC's response to this mandate, a total of seven FASD RTCs have been established since 2002 to train medical and allied health students and professionals regarding the prevention, identification, and treatment of FAS and related disorders, now known collectively as FASDs. The FASD RTCs have developed and implemented ongoing FASD training programs and courses throughout their regions reaching medical and allied health professionals and students. Trainings are delivered in academic settings (medical and allied health schools) and via continuing education events for practicing medical and allied health professionals. Training delivery varies by RTC depending on the target audience and setting. Examples include grand round presentations, a five-week online course for practicing social work, nursing, and substance abuse professionals, a two-hour face-to-face training for nursing and social work students, and a train-the-trainer model with 1- to 5-day trainings for trainers who then deliver at least two trainings per year to students and professionals.

CDC requests OMB approval to collect program evaluation information from training participants over a three-year period. Training participants will be completing program evaluation forms to provide information on whether the training met the educational goals. The information will be used to improve future trainings.

It is estimated that 15,640 participants will be trained each year, for a total estimated burden of 5,316 hours (2,658 hours annually). There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondentsOrganizationForm nameNumber of respondentsNumber of responses per respondentAvg. burden/ rsponseTotal burden (in hours)
Medical and allied health professionals and studentsArtic RTCFoundations Pre Foundations Post30 301 115/60 15/608 8
Foundations Follow-Up18110/603
FASD 201 Pre30110/605
FASD 201 Post30110/605
FASD 201 Follow-Up18110/603
Intro to FASDs Pre80115/6020
Intro to FASDs Post80115/6020
Intro to FASDs Follow-Up48110/608
Train-the-Trainer Pre25115/606
Train-the-Trainer Post25115/606
Train-the-Trainer Follow-Up15115/604
Online I Pre100110/6017
Online I Post100110/6017
Online II Pre100110/6017
Online II Post100110/6017
Online III Pre100110/6017
Online III Post100110/6017
Classroom Post15016/6015
Special Event Post15016/6015
Nursing StudentsFrontier RTCPre-test Post-test Follow-up410 410 4101 1 115/60 15/60 15/60103 103 103
Social Work StudentsPre-test Post-test Follow-up410 410 4101 1 115/60 15/60 15/60103 103 103
Allied Health PractitionersPre-test Post-test Follow-up200 200 2001 1 115/60 15/60 15/6050 50 50
Training of Trainers ParticipantsPre-test Post-test Follow-up100 100 1001 1 115/60 15/60 15/6025 25 25
Academic Faculty/Students OnlinePre-test Post-test Follow-up150 150 1501 1 115/60 15/60 15/6038 38 38
Practitioner OnlinePre-test Post-test Follow-up160 160 1601 1 115/60 15/60 15/6040 40 40
Medical and Allied Health Care Providers and StudentsGreat Lakes RTCFoundations/QUALTRICS online Pre Foundations/QUALTRICS online Post450 4501 15/60 10/6038 75
Medical Students and ProvidersFoundations/QUALTRICS online 6-Mo F/U31015/6026
Medical and Allied Health Care Providers and StudentsSBI/QUALTRICS online Pre SBI/QUALTRICS online Post120 1201 18/60 13/6016 26
SBI/QUALTRICS online 6-Mo Follow-up10818/6014
ID and Treatment of FASD/QUALTRICS online Pre27018/6036
ID and Treatment of FASD/QUALTRICS online Post270113/6059
ID and Treatment of FASD/QUALTRICS online 6-Mo Follow-up25818/6034
FASD/QUALTRICS online Comprehensive Pre220115/6055
FASD/QUALTRICS online Comprehensive Post220120/6073
FASD/QUALTRICS online Comprehensive 6-Mo Follow-up204115/6051
Physicians and Medical StudentsClinical Experience A Clinical Experience B25 251 15/60 5/602 2
Training of Trainers Participants/Regional State Training Partners/Advisory Committee MembersKey Informant Interview Key Informant Interview Key Informant Interview16 15 101 1 115/60 20/60 15/604 5 3
Training of Trainer ParticipantsHarvard Minute Feedback10011/602
Staff and Training of Trainer GraduatesTraining Activity Reporting (TARF)18012/606
Academic Faculty/Health Professionals/Professionals/Health Profession StudentsMidwest RTCKnowledge Pre Knowledge Post Knowledge Assessment 3 mo Follow-up Event Eval1080 1080 1080 11101 1 1 17/60 7/60 7/60 5/60126 126 126 93
Health ProfessionalsContinuing Education Event, Pre25015/6021
Continuing Education Event, Post25015/6021
Continuing Education Event, 3 mo Follow-up25015/6021
Modified Index, Pre75110/6013
Modified Index, 3 mo Follow-up75110/6013
Academic FacultyUtilization of FAS/FASD Curriculum, Pre5015/604
Utilization of FAS/FASD Curriculum 3 mo Follow-up5015/604
Medical and allied health students and residentsSoutheast RTCFASD Pre FASD Post FASD 3 Mo Follow-up500 500 3001 1 110/60 15/60 10/6083 125 50

Dated: April 30, 2012.

Ron A. Otten,

Director, Office of Scientific Integrity, Office of the Associate Director for Science (OADS), Office of the Director, Centers for Disease Control and Prevention.

[FR Doc. 2012-11082 Filed 5-7-12; 8:45 am]