2020-22492. 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 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 project titled Improving Fetal Alcohol Spectrum Disorders Prevention and Practice through National Partnerships. The purpose of this information collection is to assess and address the knowledge, attitude, skills and practice behaviors of healthcare professionals to prevent, identify, and treat fetal alcohol spectrum disorders (FASDs).

DATES:

CDC must receive written comments on or before December 14, 2020.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2020-0103 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.

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: [phone]; Email: [e-mail].

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 Prevention and Practice through National Partnerships (OMB Control No. 0920-1129, Exp. 8/31/2019)—Reinstatement with Change—National Center for 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 (NCBDDD) seeks to collect training and evaluation data from healthcare practitioners and staff in health systems where FASD-related practice and systems changes are implemented, and from grantees of 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 (FASD) 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 build upon previous efforts from FASD training programs and shift the perspective from individual training for practicing healthcare 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 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 medical societies and national partner organizations. While a major focus of the grantees' work will be national, regional approaches will be used to develop new content and to test out feasibility and acceptability of materials, especially among healthcare providers and medical societies.

CDC requests OMB approval to collect program evaluation information from; (1) healthcare practitioners from disciplines targeted by each grantee, including training participants, and (2) health system staff.

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 activities to assess readiness of healthcare systems to implement recommended practice changes.

It is estimated that 16,938 respondents will participate in the evaluation each year, for a total estimated burden of 2,338 hours annually. There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number responses per respondent	Average burden per response (in hours)	Total burden hours
Health Professionals	Health Professionals Survey	4013	1	9/60	602
FASD Core Training Participants	FASD Core Training Survey—Pre-Test	4013	1	9/60	602
FASD Core Training Participants	FASD Core Training Survey—Post-Test	4013	1	5/60	335
Nurses	Health Professionals Survey (Nursing)	667	1	9/60	101
Nurses	Key Informant Interviews with Champions	14	2	45/60	21
Certified Medical Assistants and students	Medical Assistant—Pre-Test Survey	334	1	10/60	56
Certified Medical Assistants and students	Medical Assistant—Post-Test Survey	334	1	10/60	56
Certified Medical Assistants and students	Medical Assistants Change in Practice Survey	250	1	15/60	63
Pediatricians	Pre-Test Screening, Assessment, and Diagnosis	120	1	10/60	20
Pediatricians	Post-Test Screening, Assessment, and Diagnosis	120	1	10/60	20
Pediatricians	Pre-Test ND-PAE	120	1	10/60	20
Pediatricians	Post-Test ND-PAE	120	1	10/60	20
Pediatricians	Pre-Test Treatment Across the Lifespan	120	1	7/60	14
Pediatricians	Post-Test Treatment Across the Lifespan	120	1	7/60	14
Family medicine physicians, social workers, social work students	Social Work and Family Physicians Pre-training Survey	1167	1	8/60	156
Family medicine physicians, social workers, social work students	Social Work and Family Physicians 6-Month Follow Up Survey	1167	1	8/60	156
Health Systems Professionals	TCU Organizational Readiness Survey	246	2	10/60	82
Total					2,338

Jeffrey M. Zirger,

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