Proposed Data Collections Submitted for Public Comment and Recommendations, 9200-9201 [2016-03820]

Download as PDF 9200 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:59 Feb 23, 2016 Jkt 238001 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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 E:\FR\FM\24FEN1.SGM 24FEN1 9201 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 Number responses per respondent Number of respondents Average burden per response (in hours) Total burden hours Type of respondents 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:59 Feb 23, 2016 Jkt 238001 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 https:// 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 https://www.cms.hhs.gov/Paperwork ReductionActof1995. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 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 E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Pages 9200-9201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03820]

[[Page 9200]]

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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

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 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 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 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 investigator-initiated 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

[[Page 9201]]

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
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 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.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per Total burden
Type of respondents Form name respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Parent........................ SCQ............. 1,875 1 30/60 938
Parent........................ Pregnancy 1,875 1 15/60 469
Reference form.
Parent........................ Maternal 1,875 1 60/60 1,875
Interview.
Parent........................ Self- 1,875 1 88/60 2,750
Administered
Forms.
Parent........................ HIPAA Medical 1,500 1 20/60 500
Records Release.
Parent/Child.................. Clinic/Home 3,000 1 238/60 11,900
Visit--Developm
ental
Assessment.
---------------- ---------------
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

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