82 FR 44184 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 182 (September 21, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 182 (September 21, 2017)
| Page Range | 44184-44185 | |
| FR Document | 2017-20067 |
[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)] [Notices] [Pages 44184-44185] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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
![44184 Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
• Full Name Day two of the meeting will cover collected; (d) Minimize the burden of
• Organizational Affiliation briefings and BSC deliberation on the the collection of information on those
• Complete Mailing Address following topics: OPHPR Office of who are to respond, including through
• Citizenship Policy, Planning and Evaluation Stories the use of appropriate automated,
• Phone Number or Email Address Project; Public Health Preparedness and electronic, mechanical, or other
The public is also welcome to listen Response Social Media and technological collection techniques or
to the meeting via Adobe Connect. Pre- Communications Metrics; Incident other forms of information technology,
registration is required by clicking the Management Training Development e.g., permitting electronic submission of
links below. Program updates, OPHPR Practice-based responses; and (e) Assess information
WEB ID for October 30, 2017: (100 Research Agenda and Synthesis and collection costs.
seats) https://adobeconnect.cdc.gov/ Translation of Public Health To request additional information on
e7yrlzismvq/event/registration.html. Preparedness and Response Research. the proposed project or to obtain a copy
WEB ID for October 31, 2017: (100 Agenda items are subject to change as of the information collection plan and
seats) https://adobeconnect.cdc.gov/ priorities dictate. instruments, call (404) 639–7570 or
e4icit9ctcz/event/registration.html. The Director, Management Analysis send an email to omb@cdc.gov. Direct
Dial in number: 888–324–3809 (100 and Services Office, has been delegated written comments and/or suggestions
seats). the authority to sign Federal Register regarding the items contained in this
Participant code: 3293468. notices pertaining to announcements of notice to the Attention: CDC Desk
meetings and other committee Officer, Office of Management and
DATES: The meeting will be held on Budget, Washington, DC 20503 or by fax
October 30, 2017, 10:00 a.m. to 5:00 management activities, for both the
Centers for Disease Control and to (202) 395–5806. Written comments
p.m., ET; October 31, 2017, 8:30 a.m. to should be received within 30 days of
3:30 p.m., ET. Prevention and the Agency for Toxic
Substances and Disease Registry. this notice.
ADDRESSES: Centers for Disease Control
and Prevention (CDC), Global Claudette Grant, Proposed Project
Communications Center, Building 19, Acting Director, Management Analysis and Study to Explore Early Development,
Auditorium B3, 1600 Clifton Road NE., Services Office, Centers for Disease Control Teen Follow-Up Study (SEED Teen)—
Atlanta, Georgia 30329. and Prevention. New—National Center on Birth Defects
FOR FURTHER INFORMATION CONTACT: [FR Doc. 2017–20082 Filed 9–20–17; 8:45 am] and Developmental Disabilities
Dometa Ouisley, Office of Science and BILLING CODE 4163–19–P (NCBDDD), Centers for Disease Control
Public Health Practice, Centers for and Prevention (CDC).
Disease Control and Prevention, 1600 Background and Brief Description
Clifton Road NE., Mailstop D–44, DEPARTMENT OF HEALTH AND
HUMAN SERVICES Autism spectrum disorder (ASD) is a
Atlanta, Georgia 30329, Telephone:
neurodevelopmental disorder
(404) 639–7450; Facsimile: (404) 471– Centers for Disease Control and characterized by impairments in social
8772; Email: OPHPR.BSC.Questions@ Prevention interaction and communication and
cdc.gov.
stereotyped behaviors and interests. The
[30Day–17–17ADR]
SUPPLEMENTARY INFORMATION: U.S. prevalence of ASD is estimated at
Purpose: This Board is charged with Agency Forms Undergoing Paperwork 1% to 2%. In addition to the profound,
providing advice and guidance to the Reduction Act Review lifelong impacts on individuals’
Secretary, Department of Health and functioning given the core deficits in
Human Services (HHS), the Assistant The Centers for Disease Control and social-communication abilities, a high
Secretary for Health (ASH), the Director, Prevention (CDC) has submitted the proportion of children with ASD also
Centers for Disease Control and following information collection request have one or more other developmental
Prevention (CDC), and the Director, to the Office of Management and Budget impairments such as intellectual
Office of Public Health Preparedness (OMB) for review and approval in disability or attention-deficit-
and Response (OPHPR), concerning accordance with the Paperwork hyperactivity-disorder and children
strategies and goals for the programs Reduction Act of 1995. The notice for with ASDs have higher than expected
and research within OPHPR, monitoring the proposed information collection is prevalences of health conditions such as
the overall strategic direction and focus published to obtain comments from the obesity, asthma and respiratory
of the OPHPR Divisions and Offices, public and affected agencies. disorders, eczema and skin allergies,
and administration and oversight of Written comments and suggestions migraine headaches, and
peer review for OPHPR scientific from the public and affected agencies gastrointestinal symptoms and
programs. For additional information concerning the proposed collection of disorders.
about the Board, please visit: http:// information are encouraged. Your Historically, young children have
www.cdc.gov/phpr/science/ comments should address any of the been the focus of ASD research:
counselors.htm. following: (a) Evaluate whether the Diagnosis and symptom detection at
Matters To Be Considered: The agenda proposed collection of information is young ages, prenatal or early-life risk
for day one of the meeting will include necessary for the proper performance of factors, and the effect of early
asabaliauskas on DSKBBXCHB2PROD with NOTICES
discussions that will cover briefings and the functions of the agency, including intervention programs. Meanwhile, the
BSC deliberation on the following whether the information will have number of children diagnosed with ASD
topics: Interval updates from OPHPR practical utility; (b) Evaluate the each year has steadily increased and, as
Divisions and Offices; updates from the accuracy of the agencies estimate of the children age, the prevalence of adults
Biological Agent Containment working burden of the proposed collection of diagnosed with ASD will likewise
group; overview of OPHPR division information, including the validity of increase for several decades. Despite
roles and responsibilities during the methodology and assumptions used; this ongoing demographic shift—which
complex emergencies; and Preparedness (c) Enhance the quality, utility, and some have called ‘‘the autism
Updates from Liaison Representatives. clarity of the information to be tsunami’’—there has been relatively
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![Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 44185
little research on ASD in adolescence assembled with ASD. Children will be We estimate that 1,410 SEED families
and adulthood. identified from four SEED sites in are potentially eligible to participate in
While there is research showing that Georgia, Maryland, North Carolina, and SEED Teen. Reading the letter and other
the majority of ASD diagnoses made in Pennsylvania. Three groups of children materials in the invitation mailing will
early childhood are retained in will be included: Children with ASD, take approximately five minutes. We
adolescence with mostly stable in children with other developmental estimate that a minimum of 60% of
symptom severity, there are major gaps (non-ASD) conditions (DD comparison parents/caregivers will be sent the
in our understanding of the health, group), and children from the general invitation mailing or will be
functioning, and experiences of population who were initially sampled successfully contacted and participate
adolescents with ASD and other from birth records (POP comparison in the invitation call (approximately 15
developmental disabilities. Many of group). minutes). We estimate that 80% of the
these topics are especially relevant to families who participate in the
public health: Adolescents and adults The children and parents previously
enrolled in SEED 1 represent a unique invitation call will meet the eligibility
with ASD have been shown to have criteria for SEED Teen and 70% of those
frequent health problems, high opportunity to better understand the
long term trajectory of children will enroll in SEED Teen. We assume all
healthcare utilization and specialized enrolled families will complete the
service needs, high caregiving burden, identified as having ASD at early ages.
Mothers or other primary caregivers follow-up call to confirm data collection
require substantial supports to perform packet receipt (approximately 10
daily activities, are likely to be bullied, who participated in SEED 1 will be re-
contacted when their child is 13–17 minutes) and will review the materials
or isolated from society, and are likely in the data collection packet. Finally,
to have food allergies or put on years of age and asked to complete two
self-administered questionnaires (SEED we estimate that 90% of enrolled
restrictive diets of questionable benefit.
Teen Health and Development Survey parents/caregivers will complete two
Many of these problems emerge after
and the Social Responsiveness Scale) self-administered questionnaires (SEED
early childhood, and more studies are
about their child’s health, development, Teen Health and Development Survey
needed to estimate the frequency,
education, and current functioning. and the Social Responsiveness Scale)
severity, and predictive factors for these
important outcomes in diverse cohorts Information from this study will allow and two supplemental consent forms.
of individuals with autism and other researchers to assess the long term The two questionnaires will take
developmental conditions. health and functioning of children with approximately 60 minutes to complete,
SEED Teen is a follow-up study of ASD and other developmental plus an additional 5 minutes to read and
children who participated in the first disabilities, family impacts associated sign the informed consent. Therefore,
phase of the SEED case-control study with ASD and other DDs, and service we estimate the total burden hours are
(SEED 1) in 2007–2011 when they were needs and use associated with having 303.
2 to 5 years of age. SEED includes one and ASD and other DDs, particularly There are no costs to participants
of the largest cohorts of children during the teen years. other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Eligible families who were enrolled in SEED 1 Invitation Packet ............................................. 470 1 5/60
Eligible families who were enrolled in SEED 1 Invitation Call Script ....................................... 282 1 15/60
Families who agreed to participate in SEED Follow-up Call ................................................ 158 1 10/60
Teen.
Families who agreed to participate in SEED Data Collection Packet ................................... 158 1 5/60
Teen.
Families who agreed to participate in SEED SEED Teen Health and Development Survey 142 1 40/60
Teen.
Families who agreed to participate in SEED Social Responsive-ness Scale ....................... 142 1 20/60
Teen.
Families who agreed to participate in SEED Supplemental Consent forms ......................... 142 1 5/60
Teen.
Leroy A. Richardson, DEPARTMENT OF HEALTH AND ACTION: Notice.
Chief, Information Collection Review Office, HUMAN SERVICES
Office of Scientific Integrity, Office of the SUMMARY: The Food and Drug
Associate Director for Science, Office of the Food and Drug Administration Administration (FDA) is withdrawing
Director, Centers for Disease Control and approval of 27 abbreviated new drug
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Prevention. [Docket No. FDA–2017–N–5526] applications (ANDAs) from multiple
[FR Doc. 2017–20067 Filed 9–20–17; 8:45 am] applicants. The holders of the
BILLING CODE 4163–18–P Department of Health and Human applications notified the Agency in
Services, Supply Service Center et al.; writing that the drug products were no
Withdrawal of Approval of 27 longer marketed and requested that the
Abbreviated New Drug Applications approval of the applications be
withdrawn.
AGENCY: Food and Drug Administration,
HHS. DATES: Applied Date: October 23, 2017.
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Document Created: 2018-10-24 14:34:44
Document Modified: 2018-10-24 14:34:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| Section | Notices | |
| FR Citation | 82 FR 44184 |
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