[Federal Register Volume 84, Number 132 (Wednesday, July 10, 2019)]
[Notices]
[Pages 32919-32922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14684]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-19-1129; Docket No. CDC-2019-0058]
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.
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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 titled, Improving Fetal Alcohol Spectrum
Disorders (FASD) Prevention and Practice through Practice and
Implementation Centers and National Partnerships (PICs). The purpose of
FASD PICs is to collect training evaluation data from healthcare
practitioners and staff in health systems where FASD-related practice
and systems changes are implemented, and from grantees of Practice and
Implementation Centers and national partner organizations related to
prevention, identification, and treatment of fetal alcohol spectrum
disorders (FASDs).
DATES: CDC must receive written comments on or before September 9,
2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0058 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: 404-639-7570; Email:
[email protected].
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 (FASD) Prevention and
Practice through Practice and Implementation Centers and National
Partnerships'' project (OMB Control No. 0920-1129, Exp. 8/31/2019))--
Revision -- National Center for Birth Defects and Developmental
Disability (NCBDDD), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Prenatal exposure to alcohol is a leading preventable cause of
birth defects and developmental disabilities. The term `fetal alcohol
spectrum
[[Page 32920]]
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.
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
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
feasibility and acceptability of materials, especially among healthcare
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 or complete surveys as part of projects to assess
healthcare systems change, including high impact evaluation studies and
DSW systems change projects. The high impact evaluation studies will be
primarily qualitative assessments of two to three specific grantee
efforts that seem likely to result in achievement of program
objectives. The DSW systems change projects will employ online surveys
to assess systems change in selected health systems across the U.S.
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 29,573
respondents will participate in the evaluation each year, for a total
estimated burden of 3790 hours annually. There are no costs to
respondents other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number burden per Total burden
Type of respondents Form name respondents responses per response (in hours
respondent hours)
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Project Grantee Staff......... DSW Report...... 90 2 10/60 30
Project Grantee Staff......... High Impact 10 2 60/60 20
Study:
Discipline
Specific
Workgroup
Discussion
Guide for
Project Staff.
Health Care System Staff...... High Impact 10 2 60/60 20
Study: Key
Informant
Interview--Heal
th Care System
Staff.
FASD Core Training FASD Core 4013 1 9/60 602
Participants. Training
Survey--Pre-
Test.
FASD Core Training FASD Core 4013 1 5/60 335
Participants. Training
Survey--Post-
Test.
FASD Core Training FASD Core 4013 1 6/60 402
Participants. Training
Survey--6 Month
Follow-Up.
Nurses........................ Pre-Training 667 1 9/60 101
Survey for
Nursing.
Nurses........................ Post-Training 550 1 9/60 83
Survey for
Nursing.
Nurses........................ Six Month Follow- 440 1 9/60 66
Up Training
Survey for
Nursing.
Nurses........................ Nursing DSW 417 1 5/60 35
Polling
Questions.
Nurses........................ Key Informant 14 2 45/60 21
Interviews with
Champions.
Nurses........................ Brief 2,934 1 10/60 489
Questionnaire
for Nursing
Organization
Memberships.
Nurses........................ Friends & 34 2 10/60 12
Members of the
Network Survey.
Healthcare Organization Healthcare 234 1 30/60 117
Representatives. Organization
Utilization
Survey.
[[Page 32921]]
Obstetrician-Gynecologists and OBGYN SBI 600 1 2/60 20
students in allied health Knowledge &
professions. Agency.
Obstetrician-Gynecologists.... OBGYN BI-MI 600 1 3/60 30
Proficiency
Rating Scale--
Provider Skills
Training
Baseline.
Students in allied health OBGYN BI-MI 600 1 3/60 30
professions. Proficiency
Rating Scale--
Standardized
Patient Version.
Obstetrician-Gynecologists.... OBGYN BI-MI 600 2 3/60 60
Proficiency
Rating Scale--
Provider Follow
Up (3m & 6m).
Obstetrician-Gynecologists and OBGYN Telecom 480 1 5/60 40
students in allied health Training
professions. Satisfaction
Survey.
Obstetrician-Gynecologists and OBGYN Avatar 120 1 5/60 10
students in allied health Training
professions. Satisfaction
Survey.
Obstetrician-Gynecologists.... OBGYN FASD-SBI 124 1 2/60 5
Training Event
Evaluation.
Residency Directors, Training OBGYN 34 1 25/60 15
Coordinators, Clinical Qualitative Key
Directors, Obstetrician- Informant
Gynecologists. Interview--Pre-
Training.
Residency Directors, Training OBGYN 34 1 25/60 15
Coordinators, Clinical Qualitative Key
Directors, Obstetrician- Informant
Gynecologists. Interview--Post-
Training.
Certified Medical Assistants Medical 334 1 10/60 56
and students. Assistant--Pre-
Test Survey.
Students in allied health Medical 67 1 10/60 12
professions. Assistant--Pre-
Test Survey
(Academic).
Certified Medical Assistants Medical 334 1 10/60 56
and students. Assistant--Post-
Test Survey.
Students in allied health Medical 67 1 10/60 12
professions. Assistant--Post-
Test Survey
(Academic).
Certified Medical Assistants Medical 200 1 10/60 34
and students. Assistant
Follow Up
Survey.
Students in allied health Medical 17 1 10/60 3
professions. Assistant
Follow Up
Survey
(Academic).
Certified Medical Assistants Medical 250 1 15/60 63
and students. Assistants
Change in
Practice Survey.
Pediatricians................. Survey of 534 2 10/60 178
Pediatricians--
Baseline and
Follow Up.
Pediatricians................. AAP Post- 120 1 7/60 14
Training
Evaluation
Survey.
Pediatricians................. AAP Pre-Training 120 1 7/60 14
Evaluation
Survey.
Pediatricians................. AAP Three Month 120 1 2/60 4
Follow Up
Evaluation
Survey.
Pediatricians................. AAP Six Month 120 1 5/60 10
Follow Up
Evaluation
Survey.
Pediatricians................. FASD Toolkit 50 1 15/60 13
User Survey.
Pediatricians................. FASD Toolkit 10 1 30/60 5
Evaluation
Focus Group/
Guided
Interview.
Pediatricians................. Pediatric FASD 10 1 20/60 4
Regional
Education and
Awareness
Liaisons Work
Plan.
Pediatricians................. Pediatric FASD 10 1 4/60 1
Regional
Liaison/
Champion
Training
Session
Evaluation.
Family Medicine Physicians.... Family Medicine 62 1 8/60 9
Evaluation
Questions
Addendum for
Practice or
Individual
Provider.
Family medicine physicians, Social Work and 1167 1 8/60 156
social workers, social work Family
students. Physicians Pre-
training Survey.
Family medicine physicians, Social Work and 1167 1 5/60 98
social workers, social work Family
students. Physicians Post-
training Survey.
Family medicine physicians, Social Work and 1167 1 8/60 156
social workers, social work Family
students. Physicians 6-
Month Follow Up
Survey.
NOFAS webinar attendees....... NOFAS Webinar 601 1 2/60 20
Survey.
NOFAS webinar attendees....... NOFAS Three 601 1 2/60 20
Month Follow-Up
Webinar
Questionnaire.
NOFAS training participants... NOFAS Pre-Test 551 1 3/60 28
Survey.
NOFAS training participants... NOFAS Post-Test 551 1 3/60 28
Survey.
[[Page 32922]]
Systems change project Clinical Process 246 2 10/60 82
participants. Improvement
Survey.
Systems change project TCU 246 2 10/60 82
participants. Organizational
Readiness
Survey.
Systems change project Organizational 220 2 10/60 74
participants. Readiness to
Change
Assessment.
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TOTAL..................... ................ 29,573 .............. .............. 3,790
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-14684 Filed 7-9-19; 8:45 am]
BILLING CODE 4163-18-P