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Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–16PA; Docket No. CDC–2016–
0021]

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 effort 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
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the Study to Explore Early
Development (SEED) Phase 3.
DATES: Written comments must be
received on or before April 25, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0021 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
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 Regulations.gov, including any
personal information provided. For
access to the docket to read 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. 6501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of the 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

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collection of the information, including
each new proposed collection, each
proposed extension of existing
collection of information, and each
reinstatement of previously approved
information collection before submitting
the collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. 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; (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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Study to Explore Early Development 3
(SEED 3)—New—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Autism spectrum disorders (ASD) are
a group of neurodevelopmental
disorders characterized by qualitative
impairments in social interaction and
communication and stereotyped
behaviors and interests. Recent
systematic population surveys and

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routine monitoring systems in the U.S.
and other countries indicate the
prevalence to be 1% to 2%. Apart from
the identification of some rare genetic
conditions that are commonly
associated with autism, causal
mechanisms for the disorder largely
remain unknown.
The Children’s Health Act of 2000
mandated CDC to establish autism
surveillance and research programs to
address the number, incidence, and
causes of autism and related
developmental disabilities. Under the
provisions of this act, NCBDDD funded
five Centers for Autism and
Developmental Disabilities Research
and Epidemiology (CADDRE) through
program announcements in FY2001 and
FY2002 (California, Colorado,
Maryland, North Carolina and
Pennsylvania); CDC’s NCBDDD served
as the sixth CADDRE site.
For the first funding cycle (2001–
2006), each CADDRE grantee had three
core objectives: To develop a protocol
for a multi-site collaborative
epidemiologic study focused on autism
(which was eventually named the Study
to Explore Early Development [SEED]);
to conduct surveillance of autism and
other developmental disabilities; and to
conduct site-specific investigatorinitiated studies on autism. In FY 2006,
through a second CADDRE funding
cycle, five grantees were awarded. The
CADDRE activities for the second
funding cycle (2006–2011) were limited
to implementation of the first phase of
SEED (subsequently known as SEED 1).
CDC served as the sixth CADDRE SEED
1 site during this period. A second
phase of SEED (SEED 2) was funded
under a third funding cycle (2011—
currently ongoing with completion in
2016). Five CADDRE grantees received
the awards. Again, CDC served as the
sixth SEED 2 site.
Four extramural sites plus the CDC
site will implement the SEED 3
collaborative protocol. The SEED 3
protocol for identification of study
participants, recruitment, and study
data collection flow will be very similar
to the protocols for SEED 1 and 2.
Modifications that will be
implemented in the third round of data
collection include recruitment from a
more recent cohort of children,
strategies to improve response rates, and
a further reduction in the data collection
protocol. No data collection
instruments/exams used in SEED 2 will
be revised in SEED 3; however, some
instruments will not be retained in the
protocol to reduce participant burden.
Families will be identified from each
of the 3 groups: Autism Spectrum
Disorder (ASD), other developmental

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Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
delay or disorder comparison group
(DD), and a second comparison group of
children randomly drawn from the
entire study cohort population (POP). It
is expected that the 5 SEED 3 study sites
will have a total of 1,875 children enroll
and complete the study protocol. The
data collection process will take
approximately 9 hours 10 minutes (ASD

developmental evaluation, (4) maternal
and child anthropometry measurements,
(5) biosampling from biological parents
and child, and (6) abstraction of
maternal prenatal and labor and
delivery medical records. The estimated
total burden hours are 18,431. There are
no costs to participants other than their
time.

group); 5 hours 30 minutes (POP group);
2 hours 45 minutes (DD group) to
complete, which includes (1) maternal
telephone interview with questions
about maternal reproductive history and
pregnancy with the index child, (2)
parent-completed questionnaires about
parental and child health and child
development, (3) in-person child

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
hours

Form name

Parent ................................................
Parent ................................................
Parent ................................................
Parent ................................................
Parent ................................................
Parent/Child ......................................

SCQ ..................................................
Pregnancy Reference form ..............
Maternal Interview ............................
Self-Administered Forms ..................
HIPAA Medical Records Release ....
Clinic/Home Visit—Developmental
Assessment.

1,875
1,875
1,875
1,875
1,500
3,000

1
1
1
1
1
1

30/60
15/60
60/60
88/60
20/60
238/60

938
469
1,875
2,750
500
11,900

Total ...........................................

...........................................................

12,000

........................

........................

18,431

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. 2016–03820 Filed 2–23–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–P–0015A]

Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
ACTION: Notice.
AGENCY:

The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are require; to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed

SUMMARY:

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respondent

Number of
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Type of respondents

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information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments must be received by
April 25, 2016.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to http://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
http://www.cms.hhs.gov/Paperwork
ReductionActof1995.

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2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
[email protected].
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:

Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–P–0015A Medicare Current
Beneficiary Survey
Under the 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.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this

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