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The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 639-7570 or send an email to Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 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 for two years. 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 of 31,280 participants during the two year approval period. The estimated annual burden is 2654 hours. 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/ response
Medical and allied health professionals and studentsArctic RTCFoundations Pre30115/60
Foundations Post30115/60
Foundations Follow-Up18110/60
FASD 201 Pre30110/60
FASD 201 Post30110/60
FASD 201 Follow-Up18110/60
Intro to FASDs Pre80115/60
Intro to FASDs Post80115/60
Intro to FASDs Follow-Up48110/60
Train-the-Trainer Pre25115/60
Train-the-Trainer Post25115/60
Train-the-Trainer Follow-Up15115/60
Online I Pre, Post100210/60
Online II Pre, Post100210/60
Online III Pre, Post100210/60
Classroom and Special Event Post15026/60
Nursing StudentsFrontier RTCPre-test410115/60
Social Work StudentsPre-test410115/60
Allied Health PractitionersPre-test200115/60
Training of Trainers ParticipantsPre-test100115/60
Academic Faculty/Students OnlinePre-test150115/60
Practitioner OnlinePre-test160115/60
Medical and Allied Health Care Providers and StudentsGreat Lakes RTCFoundations Pre-, QUALTRICS online Pre45015/60
Foundations Post, QUALTRICS online Post450110/60
Foundations 6-mo F/U, QUALTRICS online 6-Mo F/U31015/60
Medical and Allied Health Care Providers and StudentsSBI Pre, QUALTRICS online Pre12018/60
SBI Post, QUALTRICS online Post120113/60
SBI 6-mo F/U, QUALTRICS online 6-Mo Follow-up10818/60
ID and Treatment of FASD Pre, QUALTRICS online Pre27018/60
ID and Treatment of FASD Post, QUALTRICS online Post270113/60
ID and Treatment of FASD 6-mo F/U, QUALTRICS online 6-Mo Follow-up25818/60
FASD ComprehensivePre, QUALTRICS online Comprehensive Pre220115/60
FASD Comprehensive Post, QUALTRICS online Comprehensive Post220120/60
FASD Comprehensive 6-mo F/U, QUALTRICS online Comprehensive 6-Mo Follow-up204115/60
Physicians and Medical StudentsClinical Experience A2515/60
Clinical Experience B2515/60
Training of Trainers Participants/Regional State Training Partners/Advisory Committee MembersKey Informant Interview16115/60
Key Informant Interview15120/60
Key Informant Interview10115/60
Training of Trainer ParticipantsHarvard Minute Feedback10011/60
Staff and Training of Trainer GraduatesTraining Activity Reporting (TARF)18012/60
Academic Faculty/Health Professionals/Professionals/Health Profession StudentsMidwest RTCKnowledge Pre108017/60
Knowledge Post, 3 mo F/U108027/60
Event Eval111015/60
Health ProfessionalsContinuing Education Event, Pre25015/60
Continuing Education Event, Post25015/60
Continuing Education Event, 3 mo Follow-up25015/60
Modified Index Pre, 3 mo online F/U75210/60
Academic FacultyUtilization of FAS/FASD Curriculum Pre, 3 mo online F/U5025/60
Medical and allied health students and residentsSoutheast RTCFASD Pre500110/60
FASD Post500115/60
FASD 3 Mo Follow-up300110/60

Dated: September 13, 2012.

Ron A. Otten,

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

[FR Doc. 2012-23048 Filed 9-21-12; 8:45 am]