Proposed Data Collections Submitted for Public Comment and Recommendations, 62138-62139 [2016-21609]
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62138
Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
Following consultation and review of
comments submitted, the vaccine
information materials covering polio
vaccine have been finalized and are
available to download from https://
www.cdc.gov/vaccines/hcp/vis/
index.html or https://
www.regulations.gov (see Docket
Number CDC–2015–0029). The Vaccine
Information Statement (VIS) is ‘‘Polio
Vaccine: What You Need to Know,’’
publication date July 20, 2016.
With publication of this notice, by
November 1, 2016, all health care
providers must discontinue use of the
previous edition and provide copies of
these updated polio vaccine information
materials prior to immunization in
conformance with CDC’s August 9, 2016
Instructions for the Use of Vaccine
Information Statements.
Dated: September 1, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2016–21575 Filed 9–7–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0955; Docket No. CDC–2016–
0089]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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 Pediatric Audiology
Links to Services (EDHI–PALS)
DATES: Written comments must be
received on or before November 7, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0089 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instruction
for submitting comments.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:34 Sep 07, 2016
Jkt 238001
• 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
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
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—Pediatric Audiology
Links to Service (EHDI–PALS) Survey
(OMB No. 0920–0955, Expiration 03/31/
2017)—Extension—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.
Since the passage of the Early Hearing
Detection and Intervention (EHDI) Act,
98% of newborn infants are now
screened for hearing loss prior to
hospital discharge. However, many of
these infants have not received needed
hearing tests and follow up services
after their hospital discharges. The 2013
national average loss to follow-up/loss
to documentation rate is at 32%. This
rate remains an area of critical concern
for state EHDI programs and CDC–EHDI
team’s goal of timely diagnosis by 3
months of age and intervention by 6
months of age. Many states cite the lack
of audiology resources as the main
factor behind the high loss to follow-up.
To compound the problem, many
pediatric audiologists may be proficient
evaluating children age 5 and older but
are not proficient with diagnosing
infants or younger children because
children age 5 and younger require a
different skill set. There is still no
existing literature or database available
to help states verify and quantify their
states’ true follow up capacity until this
project went live in 2013.
Meeting since April 2010, the EHDI–
PALS workgroup has sought consensus
on the loss to follow-up/loss to
documentation issue facing the EHDI
programs. A survey based on standard
of care practice was developed for state
EHDI programs to quantify the pediatric
audiology resource distribution within
their state, particularly audiology
facilities that are equipped to provide
follow up services for children age five
and younger. After three years of data
collection, data suggested that children
residing in certain regions of the US
who were loss to follow up were due to
the distance parents had to travel to
E:\FR\FM\08SEN1.SGM
08SEN1
62139
Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
reach a pediatric audiology facility. For
example, parents who reside in western
region of Nebraska and Iowa on average
have to drive over 100 miles and in
Montana over 200 miles to reach a
pediatric audiology facility.
CDC is requesting an Office of
Management and Budget (OMB)
approval to continue collecting
audiology facility information from
audiologists or facility managers so both
parents, physicians and state EHDI
programs will have a tool to find where
the pediatric audiology facilities are
located. This survey will continue to
allow the CDC–EHDI team and state
EHDI programs to compile a systematic,
quantifiable distribution of audiology
facilities and the capacity of each
facility to provide services for children
age five and younger. The data collected
will also allow the CDC–EHDI team to
analyze facility distribution data to
improve technical assistance to state
EHDI programs.
answers. Both the American SpeechLanguage-Hearing Association and the
American Academy of Audiology are
members of the EHDI–PALS workgroup
and will continue to disseminate a
request through association enewsletters and e-announcements to all
audiologists who provide services to
children younger than five years of age
to complete the EHDI–PALS survey. It is
estimated that potentially an additional
400 new audiologists will read through
the purpose statement located on page
one of the survey to decide whether or
not to complete the survey. This will
take one minute per person. It is
estimated that 200 audiologists will
complete the survey which will average
nine minutes per respondent. The nine
minutes calculation is based on a
previous timed pre-test with six
volunteer audiologists. There are no
costs to respondents other than their
time.
The total burden hours are 64.
There will be no revision done to the
survey because the data collected in the
past three years has proven to be
valuable and appropriate as evidenced
by the high usage rate. Consumers have
accessed the facility information over
140,000 times as of April 2016. To
minimize burden and improve
convenience, the survey will continue
to be available via a secure password
protected Web site. Placing the survey
on the internet ensures convenient, ondemand access by the audiologists.
Financial cost is minimized because no
mailing fee will be associated with
sending or responding to this survey.
EHDI–PALS currently has 1,005
facilities in the database since the
beginning of the data collection. All
1,005 facilities’ contact will receive a
brief email from the University of Maine
to remind them to review their survey
answers. It is estimated that
approximately 800 audiologists will do
so. It takes approximately two minutes
per person to review the survey
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total burden
(in hours)
Annual Survey Review ....................................................................................
Survey Introduction ..........................................................................................
Survey ..............................................................................................................
800
400
200
1
1
1
2/60
1/60
9/60
27
7
30
Total ..........................................................................................................
1,400
........................
........................
64
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. 2016–21609 Filed 9–7–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2016–0015]
Final Revised Vaccine Information
Materials for Hepatitis A and Hepatitis
B Vaccines
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
mstockstill on DSK3G9T082PROD with NOTICES
AGENCY:
Under the National
Childhood Vaccine Injury Act (NCVIA)
(42 U.S.C. 300aa–26), CDC must develop
vaccine information materials that all
health care providers are required to
SUMMARY:
VerDate Sep<11>2014
19:34 Sep 07, 2016
Jkt 238001
give to patients/parents prior to
administration of specific vaccines. On
February 8, 2016, CDC published a
notice in the Federal Register (81 FR
6520) seeking public comments on
proposed updated vaccine information
materials for hepatitis A and hepatitis B
vaccines. Following review of
comments submitted and consultation
as required under the law, CDC has
finalized the materials for hepatitis A
and hepatitis B vaccines. Copies of the
final vaccine information materials for
hepatitis A and hepatitis B vaccines are
available to download from https://
www.cdc.gov/vaccines/hcp/vis/
index.html or https://
www.regulations.gov (see Docket
Number CDC–2016–0015).
Beginning no later than
November 1, 2016, each health care
provider who administers hepatitis A or
hepatitis B vaccine to any child or adult
in the United States shall provide copies
of the relevant vaccine information
materials referenced in this notice, in
conformance with the August 9, 2016
CDC Instructions for the Use of Vaccine
Information Statements prior to
providing such vaccinations.
DATES:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Suzanne Johnson-DeLeon (msj1@
cdc.gov), National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, Mailstop A–19, 1600 Clifton
Road NE., Atlanta, Georgia 30329.
The
National Childhood Vaccine Injury Act
of 1986 (Pub. L. 99–660), as amended by
section 708 of Public Law 103–183,
added section 2126 to the Public Health
Service Act. Section 2126, codified at 42
U.S.C. 300aa–26, requires the Secretary
of Health and Human Services to
develop and disseminate vaccine
information materials for distribution by
all health care providers in the United
States to any patient (or to the parent or
legal representative in the case of a
child) receiving vaccines covered under
the National Vaccine Injury
Compensation Program (VICP).
Development and revision of the
vaccine information materials, also
known as Vaccine Information
Statements (VIS), have been delegated
by the Secretary to the Centers for
Disease Control and Prevention (CDC).
Section 2126 requires that the materials
SUPPLEMENTARY INFORMATION:
E:\FR\FM\08SEN1.SGM
08SEN1
]]>Agencies
[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62138-62139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21609]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-16-0955; Docket No. CDC-2016-0089]
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.
-----------------------------------------------------------------------
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 Pediatric Audiology Links to Services (EDHI-
PALS)
DATES: Written comments must be received on or before November 7, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0089 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--Pediatric Audiology Links
to Service (EHDI-PALS) Survey (OMB No. 0920-0955, Expiration 03/31/
2017)--Extension--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. Since the
passage of the Early Hearing Detection and Intervention (EHDI) Act, 98%
of newborn infants are now screened for hearing loss prior to hospital
discharge. However, many of these infants have not received needed
hearing tests and follow up services after their hospital discharges.
The 2013 national average loss to follow-up/loss to documentation rate
is at 32%. This rate remains an area of critical concern for state EHDI
programs and CDC-EHDI team's goal of timely diagnosis by 3 months of
age and intervention by 6 months of age. Many states cite the lack of
audiology resources as the main factor behind the high loss to follow-
up. To compound the problem, many pediatric audiologists may be
proficient evaluating children age 5 and older but are not proficient
with diagnosing infants or younger children because children age 5 and
younger require a different skill set. There is still no existing
literature or database available to help states verify and quantify
their states' true follow up capacity until this project went live in
2013.
Meeting since April 2010, the EHDI-PALS workgroup has sought
consensus on the loss to follow-up/loss to documentation issue facing
the EHDI programs. A survey based on standard of care practice was
developed for state EHDI programs to quantify the pediatric audiology
resource distribution within their state, particularly audiology
facilities that are equipped to provide follow up services for children
age five and younger. After three years of data collection, data
suggested that children residing in certain regions of the US who were
loss to follow up were due to the distance parents had to travel to
[[Page 62139]]
reach a pediatric audiology facility. For example, parents who reside
in western region of Nebraska and Iowa on average have to drive over
100 miles and in Montana over 200 miles to reach a pediatric audiology
facility.
CDC is requesting an Office of Management and Budget (OMB) approval
to continue collecting audiology facility information from audiologists
or facility managers so both parents, physicians and state EHDI
programs will have a tool to find where the pediatric audiology
facilities are located. This survey will continue to allow the CDC-EHDI
team and state EHDI programs to compile a systematic, quantifiable
distribution of audiology facilities and the capacity of each facility
to provide services for children age five and younger. The data
collected will also allow the CDC-EHDI team to analyze facility
distribution data to improve technical assistance to state EHDI
programs.
There will be no revision done to the survey because the data
collected in the past three years has proven to be valuable and
appropriate as evidenced by the high usage rate. Consumers have
accessed the facility information over 140,000 times as of April 2016.
To minimize burden and improve convenience, the survey will continue to
be available via a secure password protected Web site. Placing the
survey on the internet ensures convenient, on-demand access by the
audiologists. Financial cost is minimized because no mailing fee will
be associated with sending or responding to this survey.
EHDI-PALS currently has 1,005 facilities in the database since the
beginning of the data collection. All 1,005 facilities' contact will
receive a brief email from the University of Maine to remind them to
review their survey answers. It is estimated that approximately 800
audiologists will do so. It takes approximately two minutes per person
to review the survey answers. Both the American Speech-Language-Hearing
Association and the American Academy of Audiology are members of the
EHDI-PALS workgroup and will continue to disseminate a request through
association e-newsletters and e-announcements to all audiologists who
provide services to children younger than five years of age to complete
the EHDI-PALS survey. It is estimated that potentially an additional
400 new audiologists will read through the purpose statement located on
page one of the survey to decide whether or not to complete the survey.
This will take one minute per person. It is estimated that 200
audiologists will complete the survey which will average nine minutes
per respondent. The nine minutes calculation is based on a previous
timed pre-test with six volunteer audiologists. There are no costs to
respondents other than their time.
The total burden hours are 64.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Annual Survey Review............................ 800 1 2/60 27
Survey Introduction............................. 400 1 1/60 7
Survey.......................................... 200 1 9/60 30
---------------------------------------------------------------
Total....................................... 1,400 .............. .............. 64
----------------------------------------------------------------------------------------------------------------
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. 2016-21609 Filed 9-7-16; 8:45 am]
BILLING CODE 4163-18-P
