[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Notices]
[Pages 69530-69532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24132]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0733]; [Docket No. CDC-2016-0095]


Proposed Data Collections 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 requires by the Paperwork 
Reduction Act of 1995. This notice invites comments on Early Hearing 
Detection and Intervention (EDHI) Hearing and Screening Follow-up 
Survey.

DATES: Written comments must be received on or before December 5, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0095 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instruction 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 Regulation.gov, including any personal information 
provided. For access to the docket to read the background documents or 
comments received, go to Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Leroy A. Richardson, Information 
Collection Review Office, Centers for Disease Control and Prevention, 
1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

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, and each 
reinstatement of previously approved information collection before 
submitting the collect 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; and (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

    Early Hearing Detection and Intervention (EDHI) Hearing and 
Screening Follow-up Survey (OMB No. 0920-0733, Expiration 08/30/2016)--
Reinstatement with Change--National Center on Birth Defects and 
Developmental Disabilities (NCBDDD), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The Division of Human Development and Disability, located within 
NCBDDD, promotes the health of babies, children, and adults, with a 
focus on preventing birth defects and developmental disabilities and 
optimizing the health outcomes of those with disabilities. As part of 
these efforts the Center is actively involved in addressing the early 
identification of hearing loss among newborns and infants. Congenital 
hearing loss is a common birth defect that affects 1 to 3 per 1,000 
live births, or approximately 12,000 children across the United States 
annually.1 2 Studies have shown that children with a delayed 
diagnosis of hearing loss can experience preventable delays in speech, 
language, and cognitive development.3-5 To ensure children 
with hearing loss are identified as soon as possible, many states and 
United States (U.S.) territories have implemented Early Hearing 
Detection and Intervention (EHDI) programs and enacted laws related to 
infant hearing screening. The majority of these EHDI programs have 
adopted the ``1-3-6'' plan, which consists of three core goals: (1) 
Screening all infants for hearing loss before 1 month of age, (2) 
ensuring diagnostic audiologic evaluation before 3 months of age for 
those who do not pass the screening, and (3) enrollment in early 
intervention services before 6 months of age for those identified with 
hearing loss.
    Federal support for identifying children with hearing loss began 
with the Children's Health Act of 2000, which authorized federal 
programs to support EHDI activities at the state level. Since then, 
funds have been distributed to states via cooperative agreements from 
the CDC and grants from the Health Resources and Services 
Administration (HRSA). States are using these federal monies to enhance 
EHDI programs and develop corresponding tracking and surveillance 
systems. These systems are intended to help EHDI programs ensure 
infants and children are receiving recommended

[[Page 69531]]

hearing screening, follow-up, and intervention services.
    The CDC's NCBDDD will fund this work to obtain standardized annual 
jurisdictional data related to the number of children screened for 
hearing loss, referred for and receiving follow-up testing (e.g., 
diagnostic audiologic evaluation). As with the original and reinstated 
information collection the overall purpose of this updated survey is to 
consistently gather the aggregate-level data required to assess 
progress toward the National EHDI Goals.
    Proposed changes for the updated survey have been made in response 
to feedback from respondents and requests for additional information 
from state and national partners. These updates are intended to further 
increase the standardization and completeness of the data collected and 
make the survey easier to complete. These changes include adding new 
fields to capture data about hearing screening conducted by using one-
stage, two-stage, or blended (both one-stage and two-stage) screening 
protocol. In addition, fields were added to be able to report the 
number of occurring homebirths and the number of infants not documented 
to have received recommended screening, diagnostic and/or intervention 
services, due to reasons such as the infant being adopted, no referral 
from the Primary Care Physician (PCP)/Ear-Nose-Throat (ENT) specialist 
and/or due to medical reasons. Several fields have been removed in 
order to improve data quality and better evaluate whether jurisdictions 
are meeting the nationwide benchmarks. The table for reporting type and 
severity of hearing loss data has been updated so that this data can be 
reported using only the classification system from the American Speech 
and Hearing Association (ASHA). The table for reporting demographics 
has also been updated to include fewer columns, in order to improve 
data quality and data standardization with the previous sections of the 
survey.
    The collected data will continue to be used in four key ways. 
First, it will be used to determine annual rates of hearing screening, 
referral for further diagnostic testing, loss to follow-up, incidence 
of hearing loss in infants, and enrollment in early intervention. These 
data will assist in determining if infants and children are receiving 
recommended EHDI-related services in a timely fashion. The information 
is intended to be made available through presentations, articles 
related to EHDI programs and infant hearing loss, and online at: 
www.cdc.gov/ncbddd/hearingloss/ehdi-data.html.
    Second, the data will be used to determine rates of loss to follow-
up within different stages of the EHDI process. Aggregated information 
about maternal race, ethnicity, education, and age will be used to help 
determine whether rates of loss to follow-up are correlated with any of 
these demographic variables. As with the most recent reinstatement with 
change (2013), the updated survey will continue to use same set of 
demographic data items, which will make it possible to continue 
analyzing the association between factors such as maternal race and 
loss to follow-up, maintain comparability between previous and future 
data, and minimize burden on respondents by continuing to request the 
same data that programs are currently collecting and able to report. 
This information is anticipated to continue to be important in 
developing methods to help minimize loss to follow-up so all children 
receive recommended hearing-related services in a timely manner.
    Third, the data will be helpful in determining to what extent 
jurisdictional tracking and surveillance systems are capturing 
essential information related to follow-up services, identification, 
and enrollment in early intervention. It will also be used by CDC EHDI 
to identify areas in jurisdictional EHDI systems that may require 
additional modification. This is anticipated to be helpful in providing 
technical support to funded jurisdictions as well as for assessing the 
impact of federal initiatives related to hearing loss in infants and 
children.
    Fourth, the requested data will aid in efforts to determine the 
prevalence of differing degrees of hearing loss (e.g., mild, severe, 
profound, etc.) among infants and children.
    Information provided by this updated survey also has the potential 
to be used for other purposes. These include quality improvement 
activities by jurisdictional EHDI programs (e.g., identifying areas 
within the EHDI processes that could benefit from further development) 
and providing requested data for Healthy People 2020, Objective ENT-
VSL-1 on newborn hearing screening, evaluation, and intervention. In 
addition, the aggregate-level data will continue to be made available 
online to other state and federal agencies, organizations, and the 
general public.
    The total burden hours is 238.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
       Type of respondents           Form name       Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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EHDI Program State Program                Survey              59               1           10/60              10
 Coordinators Contacted.........      Directions
EHDI Program State Program                Survey              57               1          240/60             228
 Coordinators who return the
 survey.........................
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    Totals......................  ..............  ..............  ..............  ..............             238
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[[Page 69532]]

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. 2016-24132 Filed 10-5-16; 8:45 am]
BILLING CODE 4163-18-P