[Federal Register Volume 80, Number 178 (Tuesday, September 15, 2015)]
[Notices]
[Pages 55362-55364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23088]


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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.

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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: [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 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

[[Page 55363]]

(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
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                                                                                                                    Number of     Average
                                                                                                       Number of    responses    burden per     Total
           Type of respondents                   DSW/ Organization                Form name           respondents      per        response      burden
                                                                                                                    respondent   (in hours)     hours
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FASD Core Training Participants..........  All.........................  FASD Core Training Survey--        4,013            1        15/60        1,003
                                                                          Pre-Test.
FASD Core Training Participants..........  All.........................  FASD Core Training Survey--        4,013            1        15/60        1,003
                                                                          Post-Test.
FASD Core Training Participants..........  All.........................  FASD Core Training Survey--        4,013            1        20/60        1,338
                                                                          6 Month Follow-Up.
Project Grantee Staff....................  Westat (Cross-Site            DSW Report.................           90            2        10/60           30
                                            Evaluator).
Project Grantee Staff....................  Westat (Cross-Site            Key Informant Interview--              6            3        60/60           18
                                            Evaluator).                   DSW Project Director.
National Partner Staff...................  Westat (Cross-Site            Key Informant Interview--              6            3        60/60           18
                                            Evaluator).                   National Partner.
Health System Staff......................  Westat (Cross-Site            Key Informant Interview--             60            3        30/60           90
                                            Evaluator).                   Health System Staff.
Nurses...................................  Nursing.....................  Key Informant Interviews              14            1        45/60           10
                                                                          with Champions.
Nurses...................................  Nursing.....................  Online Survey with                    34            2        15/60           17
                                                                          ``Friends''/Members of the
                                                                          Network.

[[Page 55364]]

 
Healthcare Organization Representatives..  Nursing.....................  Online Survey with                    67            1        30/60           33
                                                                          Healthcare Organization
                                                                          Representatives.
Nurses and Nursing Students..............  Nursing.....................  Brief Online Questionnaire         2,934            1        10/60          489
                                                                          for Nursing Organization
                                                                          Memberships.
Physicians and students in allied health   Obstetrics & Gynecology.....  Avatar Training                    1,200            1         6/60          120
 professions.                                                             Satisfaction Survey.
Students in allied health professions....  Obstetrics & Gynecology.....  Proficiency Ratings Scale--          600            1         6/60           60
                                                                          Standardized Patient
                                                                          Version.
Physicians...............................  Obstetrics & Gynecology.....  Proficiency Ratings Scale--          600            1         6/60           60
                                                                          Provider--Baseline.
Physicians...............................  Obstetrics & Gynecology.....  Proficiency Rating Scale--           600            1         2/60           20
                                                                          Provider--1 Month Follow-
                                                                          Up.
Physicians...............................  Obstetrics & Gynecology.....  FASD Training Event                  124            1         2/60            4
                                                                          Evaluation.
Residency Directors, Training              Obstetrics & Gynecology.....  Pre- Assessment of Training           14            1        30/60            7
 Coordinators, Clinic Directors.                                          Implementation.
Residency Directors, Training              Obstetrics & Gynecology.....  Post-Assessment of Training           14            1        30/60            7
 Coordinators, Clinical Directors,                                        Implementation.
 Physicians.
Physicians...............................  Pediatrics..................  FASD Core Training Survey--          120            1        15/60           30
                                                                          Pediatrics 3 Month Follow-
                                                                          Up.
Physicians...............................  Pediatrics..................  Pediatrics DSW Baseline              535            1         4/60           36
                                                                          Survey.
Physicians...............................  Pediatrics..................  Pediatrics DSW Year 4                535            1         4/60           36
                                                                          Survey.
Physicians...............................  Pediatrics..................  FASD Toolkit User Survey...           50            1        15/60           13
Physicians...............................  Social Work & Family          Family Medicine                       62            1         8/60            8
                                            Physicians.                   Comprehensive Practice
                                                                          Evaluation.
Medical and allied health professionals..  National Organization on      NOFAS Webinar Survey--Post-          400            1         5/60           33
                                            Fetal Alcohol Syndrome.       Test.
Medical and allied health professionals..  National Organization on      NOFAS Webinar Survey--3              400            1         5/60           33
                                            Fetal Alcohol Syndrome.       Month Follow-Up.
General public...........................  National Organization on      NOFAS Outcomes Vignette....           50            1        10/60            8
                                            Fetal Alcohol Syndrome.
                                                                                                                                            ------------
    TOTAL................................  ............................  ...........................  ...........  ...........  ...........        4,524
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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