[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.
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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]
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