Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-15BEZ; Docket No. CDC-2015-0081]

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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a newly proposed information collection request entitled

Improving Fetal Alcohol Spectrum Disorders Prevention Practice through Practice and Implementation Centers and National Partnerships.

DATES:

Written comments must be received on or before November 16, 2015.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2015-0081 by any of the following methods:

• Federal eRulemaking Portal:

Regulation.gov.

Follow the instructions for submitting comments.

• Mail: Leroy A. Richardson, 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. All relevant comments received will be posted without change to

Regulations.gov

, including any personal information provided. For access to the docket to read background documents or comments received, go to

Regulations.gov

.

Please note:

All public comment should be submitted 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 the 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 OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

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; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

Proposed Project

Improving Fetal Alcohol Spectrum Disorders Prevention and Practice through Practice and Implementation Centers and National Partnerships—New—National Center on Birth Defects and Developmental Disabilities

(NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The National Center on Birth Defects and Developmental Disabilities seeks to collect training evaluation data from healthcare practitioners and staff in health systems where FASD-related practice and systems changes are implemented, and grantees of Practice and Implementation Centers and national partner organizations related to prevention, identification, and treatment of fetal alcohol spectrum disorders (FASDs).

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.

The purpose of this program is to expand previous efforts from FASD training programs and shift the perspective from individual training for practicing health care professionals to one that capitalizes on prevention opportunities and the ability to impact health care practice at the systems level.

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 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 out” feasibility and acceptability of materials, especially among health care 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 as part of high impact evaluation studies. The high impact evaluation studies will be focused assessments of two to three specific grantee efforts that seem likely to result in achievement of program objectives.

• 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 20,554 respondents will participate in the evaluation each year, for a total estimated burden of 4528.0 hours annually. There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents

DSW/

Organization

Form name

Number of

respondents

Number of

responses per

respondent

Average

burden per

response

(in hours)

Total

burden

hours

FASD Core Training Participants

All

FASD Core Training Survey—Pre-Test

4,013

1

15/60

1,003

FASD Core Training Participants

All

FASD Core Training Survey—Post-Test

4,013

1

15/60

1,003

FASD Core Training Participants

All

FASD Core Training Survey—6 Month Follow-Up

4,013

1

20/60

1,338

Project Grantee Staff

Westat (Cross-Site Evaluator)

DSW Report

90

2

10/60

30

Project Grantee Staff

Westat (Cross-Site Evaluator)

Key Informant Interview—DSW Project Director

6

3

60/60

18

National Partner Staff

Westat (Cross-Site Evaluator)

Key Informant Interview—National Partner

6

3

60/60

18

Health System Staff

Westat (Cross-Site Evaluator)

Key Informant Interview—Health System Staff

60

3

30/60

90

Nurses

Nursing

Key Informant Interviews with Champions

14

1

45/60

10

Nurses

Nursing

Online Survey with “Friends”/Members of the Network

34

2

15/60

17

Healthcare Organization Representatives

Nursing

Online Survey with Healthcare Organization Representatives

67

1

30/60

33

Nurses and Nursing Students

Nursing

Brief Online Questionnaire for Nursing Organization Memberships

2,934

1

10/60

489

Physicians and students in allied health professions

Obstetrics & Gynecology

Avatar Training Satisfaction Survey

1,200

1

6/60

120

Students in allied health professions

Obstetrics & Gynecology

Proficiency Ratings Scale—Standardized Patient Version

600

1

6/60

60

Physicians

Obstetrics & Gynecology

Proficiency Ratings Scale—Provider—Baseline

600

1

6/60

60

Physicians

Obstetrics & Gynecology

Proficiency Rating Scale—Provider—1 Month Follow-Up

600

1

2/60

20

Physicians

Obstetrics & Gynecology

FASD Training Event Evaluation

124

1

2/60

4

Residency Directors, Training Coordinators, Clinic Directors

Obstetrics & Gynecology

Pre- Assessment of Training Implementation

14

1

30/60

7

Residency Directors, Training Coordinators, Clinical Directors, Physicians

Obstetrics & Gynecology

Post-Assessment of Training Implementation

14

1

30/60

7

Physicians

Pediatrics

FASD Core Training Survey—Pediatrics 3 Month Follow-Up

120

1

15/60

30

Physicians

Pediatrics

Pediatrics DSW Baseline Survey

535

1

4/60

36

Physicians

Pediatrics

Pediatrics DSW Year 4 Survey

535

1

4/60

36

Physicians

Pediatrics

FASD Toolkit User Survey

50

1

15/60

13

Physicians

Social Work & Family Physicians

Family Medicine Comprehensive Practice Evaluation

62

1

8/60

8

Medical and allied health professionals

National Organization on Fetal Alcohol Syndrome

NOFAS Webinar Survey—Post-Test

400

1

5/60

33

Medical and allied health professionals

National Organization on Fetal Alcohol Syndrome

NOFAS Webinar Survey—3 Month Follow-Up

400

1

5/60

33

General public

National Organization on Fetal Alcohol Syndrome

NOFAS Outcomes Vignette

50

1

10/60

8

TOTAL

4,524

Leroy A. Richardson,

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

[FR Doc. 2015-23088 Filed 9-14-15; 8:45 am]

BILLING CODE 4163-18-P