Agency Forms Undergoing Paperwork Reduction Act Review, 44184-44185 [2017-20067]
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44184
Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
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Day two of the meeting will cover
briefings and BSC deliberation on the
following topics: OPHPR Office of
Policy, Planning and Evaluation Stories
Project; Public Health Preparedness and
Response Social Media and
Communications Metrics; Incident
Management Training Development
Program updates, OPHPR Practice-based
Research Agenda and Synthesis and
Translation of Public Health
Preparedness and Response Research.
Agenda items are subject to change as
priorities dictate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
collected; (d) 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 submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, Washington, DC 20503 or by fax
to (202) 395–5806. Written comments
should be received within 30 days of
this notice.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
Proposed Project
Study to Explore Early Development,
Teen Follow-Up Study (SEED Teen)—
New—National Center on Birth Defects
and Developmental Disabilities
(NCBDDD), Centers for Disease Control
and Prevention (CDC).
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Full Name
Organizational Affiliation
Complete Mailing Address
Citizenship
Phone Number or Email Address
The public is also welcome to listen
to the meeting via Adobe Connect. Preregistration is required by clicking the
links below.
WEB ID for October 30, 2017: (100
seats) https://adobeconnect.cdc.gov/
e7yrlzismvq/event/registration.html.
WEB ID for October 31, 2017: (100
seats) https://adobeconnect.cdc.gov/
e4icit9ctcz/event/registration.html.
Dial in number: 888–324–3809 (100
seats).
Participant code: 3293468.
DATES: The meeting will be held on
October 30, 2017, 10:00 a.m. to 5:00
p.m., ET; October 31, 2017, 8:30 a.m. to
3:30 p.m., ET.
ADDRESSES: Centers for Disease Control
and Prevention (CDC), Global
Communications Center, Building 19,
Auditorium B3, 1600 Clifton Road NE.,
Atlanta, Georgia 30329.
FOR FURTHER INFORMATION CONTACT:
Dometa Ouisley, Office of Science and
Public Health Practice, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., Mailstop D–44,
Atlanta, Georgia 30329, Telephone:
(404) 639–7450; Facsimile: (404) 471–
8772; Email: OPHPR.BSC.Questions@
cdc.gov.
[30Day–17–17ADR]
Purpose: This Board is charged with
providing advice and guidance to the
Secretary, Department of Health and
Human Services (HHS), the Assistant
Secretary for Health (ASH), the Director,
Centers for Disease Control and
Prevention (CDC), and the Director,
Office of Public Health Preparedness
and Response (OPHPR), concerning
strategies and goals for the programs
and research within OPHPR, monitoring
the overall strategic direction and focus
of the OPHPR Divisions and Offices,
and administration and oversight of
peer review for OPHPR scientific
programs. For additional information
about the Board, please visit: https://
www.cdc.gov/phpr/science/
counselors.htm.
Matters To Be Considered: The agenda
for day one of the meeting will include
discussions that will cover briefings and
BSC deliberation on the following
topics: Interval updates from OPHPR
Divisions and Offices; updates from the
Biological Agent Containment working
group; overview of OPHPR division
roles and responsibilities during
complex emergencies; and Preparedness
Updates from Liaison Representatives.
VerDate Sep<11>2014
17:52 Sep 20, 2017
Jkt 241001
[FR Doc. 2017–20082 Filed 9–20–17; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) 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; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
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Background and Brief Description
Autism spectrum disorder (ASD) is a
neurodevelopmental disorder
characterized by impairments in social
interaction and communication and
stereotyped behaviors and interests. The
U.S. prevalence of ASD is estimated at
1% to 2%. In addition to the profound,
lifelong impacts on individuals’
functioning given the core deficits in
social-communication abilities, a high
proportion of children with ASD also
have one or more other developmental
impairments such as intellectual
disability or attention-deficithyperactivity-disorder and children
with ASDs have higher than expected
prevalences of health conditions such as
obesity, asthma and respiratory
disorders, eczema and skin allergies,
migraine headaches, and
gastrointestinal symptoms and
disorders.
Historically, young children have
been the focus of ASD research:
Diagnosis and symptom detection at
young ages, prenatal or early-life risk
factors, and the effect of early
intervention programs. Meanwhile, the
number of children diagnosed with ASD
each year has steadily increased and, as
children age, the prevalence of adults
diagnosed with ASD will likewise
increase for several decades. Despite
this ongoing demographic shift—which
some have called ‘‘the autism
tsunami’’—there has been relatively
E:\FR\FM\21SEN1.SGM
21SEN1
44185
Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
little research on ASD in adolescence
and adulthood.
While there is research showing that
the majority of ASD diagnoses made in
early childhood are retained in
adolescence with mostly stable in
symptom severity, there are major gaps
in our understanding of the health,
functioning, and experiences of
adolescents with ASD and other
developmental disabilities. Many of
these topics are especially relevant to
public health: Adolescents and adults
with ASD have been shown to have
frequent health problems, high
healthcare utilization and specialized
service needs, high caregiving burden,
require substantial supports to perform
daily activities, are likely to be bullied,
or isolated from society, and are likely
to have food allergies or put on
restrictive diets of questionable benefit.
Many of these problems emerge after
early childhood, and more studies are
needed to estimate the frequency,
severity, and predictive factors for these
important outcomes in diverse cohorts
of individuals with autism and other
developmental conditions.
SEED Teen is a follow-up study of
children who participated in the first
phase of the SEED case-control study
(SEED 1) in 2007–2011 when they were
2 to 5 years of age. SEED includes one
of the largest cohorts of children
assembled with ASD. Children will be
identified from four SEED sites in
Georgia, Maryland, North Carolina, and
Pennsylvania. Three groups of children
will be included: Children with ASD,
children with other developmental
(non-ASD) conditions (DD comparison
group), and children from the general
population who were initially sampled
from birth records (POP comparison
group).
The children and parents previously
enrolled in SEED 1 represent a unique
opportunity to better understand the
long term trajectory of children
identified as having ASD at early ages.
Mothers or other primary caregivers
who participated in SEED 1 will be recontacted when their child is 13–17
years of age and asked to complete two
self-administered questionnaires (SEED
Teen Health and Development Survey
and the Social Responsiveness Scale)
about their child’s health, development,
education, and current functioning.
Information from this study will allow
researchers to assess the long term
health and functioning of children with
ASD and other developmental
disabilities, family impacts associated
with ASD and other DDs, and service
needs and use associated with having
and ASD and other DDs, particularly
during the teen years.
We estimate that 1,410 SEED families
are potentially eligible to participate in
SEED Teen. Reading the letter and other
materials in the invitation mailing will
take approximately five minutes. We
estimate that a minimum of 60% of
parents/caregivers will be sent the
invitation mailing or will be
successfully contacted and participate
in the invitation call (approximately 15
minutes). We estimate that 80% of the
families who participate in the
invitation call will meet the eligibility
criteria for SEED Teen and 70% of those
will enroll in SEED Teen. We assume all
enrolled families will complete the
follow-up call to confirm data collection
packet receipt (approximately 10
minutes) and will review the materials
in the data collection packet. Finally,
we estimate that 90% of enrolled
parents/caregivers will complete two
self-administered questionnaires (SEED
Teen Health and Development Survey
and the Social Responsiveness Scale)
and two supplemental consent forms.
The two questionnaires will take
approximately 60 minutes to complete,
plus an additional 5 minutes to read and
sign the informed consent. Therefore,
we estimate the total burden hours are
303.
There are no costs to participants
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Form name
Eligible families who were enrolled in SEED 1
Eligible families who were enrolled in SEED 1
Families who agreed to participate in SEED
Teen.
Families who agreed to participate in SEED
Teen.
Families who agreed to participate in SEED
Teen.
Families who agreed to participate in SEED
Teen.
Families who agreed to participate in SEED
Teen.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Type of respondents
Invitation Packet .............................................
Invitation Call Script .......................................
Follow-up Call ................................................
470
282
158
1
1
1
5/60
15/60
10/60
Data Collection Packet ...................................
158
1
5/60
SEED Teen Health and Development Survey
142
1
40/60
Social Responsive-ness Scale .......................
142
1
20/60
Supplemental Consent forms .........................
142
1
5/60
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2017–N–5526]
Department of Health and Human
Services, Supply Service Center et al.;
Withdrawal of Approval of 27
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:52 Sep 20, 2017
Jkt 241001
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 27 abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
Food and Drug Administration
[FR Doc. 2017–20067 Filed 9–20–17; 8:45 am]
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ACTION:
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DATES:
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Applied Date: October 23, 2017.
21SEN1
]]>Agencies
[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Notices]
[Pages 44184-44185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20067]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-17ADR]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
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; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget,
Washington, DC 20503 or by fax to (202) 395-5806. Written comments
should be received within 30 days of this notice.
Proposed Project
Study to Explore Early Development, Teen Follow-Up Study (SEED
Teen)--New--National Center on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
Autism spectrum disorder (ASD) is a neurodevelopmental disorder
characterized by impairments in social interaction and communication
and stereotyped behaviors and interests. The U.S. prevalence of ASD is
estimated at 1% to 2%. In addition to the profound, lifelong impacts on
individuals' functioning given the core deficits in social-
communication abilities, a high proportion of children with ASD also
have one or more other developmental impairments such as intellectual
disability or attention-deficit-hyperactivity-disorder and children
with ASDs have higher than expected prevalences of health conditions
such as obesity, asthma and respiratory disorders, eczema and skin
allergies, migraine headaches, and gastrointestinal symptoms and
disorders.
Historically, young children have been the focus of ASD research:
Diagnosis and symptom detection at young ages, prenatal or early-life
risk factors, and the effect of early intervention programs. Meanwhile,
the number of children diagnosed with ASD each year has steadily
increased and, as children age, the prevalence of adults diagnosed with
ASD will likewise increase for several decades. Despite this ongoing
demographic shift--which some have called ``the autism tsunami''--there
has been relatively
[[Page 44185]]
little research on ASD in adolescence and adulthood.
While there is research showing that the majority of ASD diagnoses
made in early childhood are retained in adolescence with mostly stable
in symptom severity, there are major gaps in our understanding of the
health, functioning, and experiences of adolescents with ASD and other
developmental disabilities. Many of these topics are especially
relevant to public health: Adolescents and adults with ASD have been
shown to have frequent health problems, high healthcare utilization and
specialized service needs, high caregiving burden, require substantial
supports to perform daily activities, are likely to be bullied, or
isolated from society, and are likely to have food allergies or put on
restrictive diets of questionable benefit. Many of these problems
emerge after early childhood, and more studies are needed to estimate
the frequency, severity, and predictive factors for these important
outcomes in diverse cohorts of individuals with autism and other
developmental conditions.
SEED Teen is a follow-up study of children who participated in the
first phase of the SEED case-control study (SEED 1) in 2007-2011 when
they were 2 to 5 years of age. SEED includes one of the largest cohorts
of children assembled with ASD. Children will be identified from four
SEED sites in Georgia, Maryland, North Carolina, and Pennsylvania.
Three groups of children will be included: Children with ASD, children
with other developmental (non-ASD) conditions (DD comparison group),
and children from the general population who were initially sampled
from birth records (POP comparison group).
The children and parents previously enrolled in SEED 1 represent a
unique opportunity to better understand the long term trajectory of
children identified as having ASD at early ages. Mothers or other
primary caregivers who participated in SEED 1 will be re-contacted when
their child is 13-17 years of age and asked to complete two self-
administered questionnaires (SEED Teen Health and Development Survey
and the Social Responsiveness Scale) about their child's health,
development, education, and current functioning. Information from this
study will allow researchers to assess the long term health and
functioning of children with ASD and other developmental disabilities,
family impacts associated with ASD and other DDs, and service needs and
use associated with having and ASD and other DDs, particularly during
the teen years.
We estimate that 1,410 SEED families are potentially eligible to
participate in SEED Teen. Reading the letter and other materials in the
invitation mailing will take approximately five minutes. We estimate
that a minimum of 60% of parents/caregivers will be sent the invitation
mailing or will be successfully contacted and participate in the
invitation call (approximately 15 minutes). We estimate that 80% of the
families who participate in the invitation call will meet the
eligibility criteria for SEED Teen and 70% of those will enroll in SEED
Teen. We assume all enrolled families will complete the follow-up call
to confirm data collection packet receipt (approximately 10 minutes)
and will review the materials in the data collection packet. Finally,
we estimate that 90% of enrolled parents/caregivers will complete two
self-administered questionnaires (SEED Teen Health and Development
Survey and the Social Responsiveness Scale) and two supplemental
consent forms. The two questionnaires will take approximately 60
minutes to complete, plus an additional 5 minutes to read and sign the
informed consent. Therefore, we estimate the total burden hours are
303.
There are no costs to participants other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Eligible families who were enrolled in Invitation Packet....... 470 1 5/60
SEED 1.
Eligible families who were enrolled in Invitation Call Script.. 282 1 15/60
SEED 1.
Families who agreed to participate in Follow-up Call.......... 158 1 10/60
SEED Teen.
Families who agreed to participate in Data Collection Packet.. 158 1 5/60
SEED Teen.
Families who agreed to participate in SEED Teen Health and 142 1 40/60
SEED Teen. Development Survey.
Families who agreed to participate in Social Responsive-ness 142 1 20/60
SEED Teen. Scale.
Families who agreed to participate in Supplemental Consent 142 1 5/60
SEED Teen. forms.
----------------------------------------------------------------------------------------------------------------
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. 2017-20067 Filed 9-20-17; 8:45 am]
BILLING CODE 4163-18-P
