44184 Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / 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. 

SUPPLEMENTARY INFORMATION: 

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: http://

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. 

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. 

Claudette Grant, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[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 

[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-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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 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 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

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(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 

Teen.

Follow-up Call ................................................ 158 1 10/60 

Families who agreed to participate in SEED 

Teen.

Data Collection Packet ................................... 158 1 5/60 

Families who agreed to participate in SEED 

Teen.

SEED Teen Health and Development Survey 142 1 40/60 

Families who agreed to participate in SEED 

Teen.

Social Responsive-ness Scale ....................... 142 1 20/60 

Families who agreed to participate in SEED 

Teen.

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. 

[FR Doc. 2017–20067 Filed 9–20–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[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. 

ACTION: Notice. 

SUMMARY: 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. 

DATES: Applied Date: October 23, 2017. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES