# Proposed Data Collections Submitted for Public Comment and Recommendations

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2012-11082

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** May 8, 2012
- **Citation:** 77 FR 27067

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day 0920-12IW]
Proposed Data Collections Submitted for Public Comment and Recommendations

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
omb@cdc.gov.

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 respondents
Organization
Form name

Number of
respondents

Number of
responses per
respondent

Avg. burden/
rsponse

Total burden
(in hours)

Medical and allied health professionals and students
Artic RTC

Foundations Pre
Foundations Post

30
30

1
1

15/60
15/60

8
8

Foundations Follow-Up
18
1
10/60
3

FASD 201 Pre
30
1
10/60
5

FASD 201 Post
30
1
10/60
5

FASD 201 Follow-Up
18
1
10/60
3

Intro to FASDs Pre
80
1
15/60
20

Intro to FASDs Post
80
1
15/60
20

Intro to FASDs Follow-Up
48
1
10/60
8

Train-the-Trainer Pre
25
1
15/60
6

Train-the-Trainer Post
25
1
15/60
6

Train-the-Trainer Follow-Up
15
1
15/60
4

Online I Pre
100
1
10/60
17

Online I Post
100
1
10/60
17

Online II Pre
100
1
10/60
17

Online II Post
100
1
10/60
17

Online III Pre
100
1
10/60
17

Online III Post
100
1
10/60
17

Classroom Post
150
1
6/60
15

Special Event Post
150
1
6/60
15

Nursing Students
Frontier RTC

Pre-test
Post-test
Follow-up

410
410
410

1
1
1

15/60
15/60
15/60

103
103
103

Social Work Students

Pre-test
Post-test
Follow-up

410
410
410

1
1
1

15/60
15/60
15/60

103
103
103

Allied Health Practitioners

Pre-test
Post-test
Follow-up

200
200
200

1
1
1

15/60
15/60
15/60

50
50
50

Training of Trainers Participants

Pre-test
Post-test
Follow-up

100
100
100

1
1
1

15/60
15/60
15/60

25
25
25

Academic Faculty/Students Online

Pre-test
Post-test
Follow-up

150
150
150

1
1
1

15/60
15/60
15/60

38
38
38

Practitioner Online

Pre-test
Post-test
Follow-up

160
160
160

1
1
1

15/60
15/60
15/60

40
40
40

Medical and Allied Health Care Providers and Students
Great Lakes RTC

Foundations/QUALTRICS online Pre
Foundations/QUALTRICS online Post

450

450

1

1

5/60

10/60

38

75

Medical Students and Providers

Foundations/QUALTRICS online 6-Mo F/U
310
1
5/60
26

Medical and Allied Health Care Providers and Students

SBI/QUALTRICS online Pre
SBI/QUALTRICS online Post

120

120

1

1

8/60

13/60

16

26

SBI/QUALTRICS online 6-Mo Follow-up
108
1
8/60
14

ID and Treatment of FASD/QUALTRICS online Pre
270
1
8/60
36

ID and Treatment of FASD/QUALTRICS online Post
270
1
13/60
59

ID and Treatment of FASD/QUALTRICS online 6-Mo Follow-up
258
1
8/60
34

FASD/QUALTRICS online Comprehensive Pre
220
1
15/60
55

FASD/QUALTRICS online Comprehensive Post
220
1
20/60
73

FASD/QUALTRICS online Comprehensive 6-Mo Follow-up
204
1
15/60
51

Physicians and Medical Students

Clinical Experience A
Clinical Experience B

25
25

1
1

5/60
5/60

2
2

Training of Trainers Participants/Regional State Training Partners/Advisory Committee Members

Key Informant Interview
Key Informant Interview
Key Informant Interview

16
15
10

1
1
1

15/60
20/60
15/60

4
5
3

Training of Trainer Participants

Harvard Minute Feedback
100
1
1/60
2

Staff and Training of Trainer Graduates

Training Activity Reporting (TARF)
180
1
2/60
6

Academic Faculty/Health Professionals/Professionals/Health Profession Students
Midwest RTC

Knowledge Pre
Knowledge Post
Knowledge Assessment 3 mo Follow-up
Event Eval

1080
1080
1080

1110

1
1
1

1

7/60
7/60
7/60

5/60

126
126
126

93

Health Professionals

Continuing Education Event, Pre
250
1
5/60
21

Continuing Education Event, Post
250
1
5/60
21

Continuing Education Event, 3 mo Follow-up
250
1
5/60
21

Modified Index, Pre
75
1
10/60
13

Modified Index, 3 mo Follow-up
75
1
10/60
13

Academic Faculty

Utilization of FAS/FASD Curriculum, Pre
50
1
5/60
4

Utilization of FAS/FASD Curriculum 3 mo Follow-up
50
1
5/60
4

Medical and allied health students and residents
Southeast RTC

FASD Pre
FASD Post
FASD 3 Mo Follow-up

500
500
300

1
1
1

10/60
15/60
10/60

83
125
50

Total

15,640

2,658

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]
BILLING CODE 4163-18-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2012-11082. Public record. Not legal advice.
