[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)
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
    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