81 FR 9200 - Proposed Data Collections Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 36 (February 24, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 36 (February 24, 2016)
| Page Range | 9200-9201 | |
| FR Document | 2016-03820 |
[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)] [Notices] [Pages 9200-9201] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03820] [[Page 9200]] ----------------------------------------------------------------------- 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
![9200 Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
DEPARTMENT OF HEALTH AND collection of the information, including routine monitoring systems in the U.S.
HUMAN SERVICES each new proposed collection, each and other countries indicate the
proposed extension of existing prevalence to be 1% to 2%. Apart from
Centers for Disease Control and collection of information, and each the identification of some rare genetic
Prevention reinstatement of previously approved conditions that are commonly
[60Day–16–16PA; Docket No. CDC–2016– information collection before submitting associated with autism, causal
0021] the collection to OMB for approval. To mechanisms for the disorder largely
comply with this requirement, we are remain unknown.
Proposed Data Collections Submitted publishing this notice of a proposed The Children’s Health Act of 2000
for Public Comment and data collection as described below. mandated CDC to establish autism
Recommendations Comments submitted in response to surveillance and research programs to
this notice will be summarized and/or address the number, incidence, and
AGENCY: Centers for Disease Control and included in the request for Office of causes of autism and related
Prevention (CDC), Department of Health Management and Budget (OMB) developmental disabilities. Under the
and Human Services (HHS). approval. Comments are invited on: (a) provisions of this act, NCBDDD funded
ACTION: Notice with comment period. Whether the proposed collection of five Centers for Autism and
information is necessary for the proper Developmental Disabilities Research
SUMMARY: The Centers for Disease performance of the functions of the and Epidemiology (CADDRE) through
Control and Prevention (CDC), as part of agency, including whether the program announcements in FY2001 and
its continuing effort to reduce public information shall have practical utility; FY2002 (California, Colorado,
burden and maximize the utility of (b) the accuracy of the agency’s estimate Maryland, North Carolina and
government information, invites the of the burden of the proposed collection Pennsylvania); CDC’s NCBDDD served
general public and other Federal of information; (c) ways to enhance the as the sixth CADDRE site.
agencies to take this opportunity to quality, utility, and clarity of the For the first funding cycle (2001–
comment on proposed and/or information to be collected; (d) ways to 2006), each CADDRE grantee had three
continuing information collections, as minimize the burden of the collection of core objectives: To develop a protocol
required by the Paperwork Reduction information on respondents, including for a multi-site collaborative
Act of 1995. This notice invites through the use of automated collection epidemiologic study focused on autism
comment on the Study to Explore Early techniques or other forms of information (which was eventually named the Study
Development (SEED) Phase 3. technology; and (e) estimates of capital to Explore Early Development [SEED]);
DATES: Written comments must be or start-up costs and costs of operation, to conduct surveillance of autism and
received on or before April 25, 2016. maintenance, and purchase of services other developmental disabilities; and to
ADDRESSES: You may submit comments, to provide information. Burden means conduct site-specific investigator-
identified by Docket No. CDC–2016– the total time, effort, or financial initiated studies on autism. In FY 2006,
0021 by any of the following methods: resources expended by persons to through a second CADDRE funding
• Federal eRulemaking Portal: generate, maintain, retain, disclose or cycle, five grantees were awarded. The
Regulations.gov. Follow the instructions provide information to or for a Federal CADDRE activities for the second
for submitting comments. agency. This includes the time needed funding cycle (2006–2011) were limited
• Mail: Leroy A. Richardson, to review instructions; to develop, to implementation of the first phase of
Information Collection Review Office, acquire, install and utilize technology SEED (subsequently known as SEED 1).
Centers for Disease Control and and systems for the purpose of CDC served as the sixth CADDRE SEED
Prevention, 1600 Clifton Road NE., MS– collecting, validating and verifying 1 site during this period. A second
D74, Atlanta, Georgia 30329. information, processing and phase of SEED (SEED 2) was funded
Instructions: All submissions received maintaining information, and disclosing under a third funding cycle (2011—
must include the agency name and and providing information; to train currently ongoing with completion in
Docket number. All relevant comments personnel and to be able to respond to 2016). Five CADDRE grantees received
received will be posted without change a collection of information, to search the awards. Again, CDC served as the
to Regulations.gov, including any data sources, to complete and review sixth SEED 2 site.
the collection of information; and to Four extramural sites plus the CDC
personal information provided. For
transmit or otherwise disclose the site will implement the SEED 3
access to the docket to read background
information. Written comments should collaborative protocol. The SEED 3
documents or comments received, go to
be received within 60 days of this protocol for identification of study
Regulations.gov.
notice. participants, recruitment, and study
FOR FURTHER INFORMATION CONTACT: data collection flow will be very similar
Leroy A. Richardson, Information Proposed Project to the protocols for SEED 1 and 2.
Collection Review Office, Centers for Study to Explore Early Development 3 Modifications that will be
Disease Control and Prevention, 1600 (SEED 3)—New—National Center on implemented in the third round of data
Clifton Road NE., MS–D74, Atlanta, Birth Defects and Developmental collection include recruitment from a
Georgia 30329. Disabilities (NCBDDD), Centers for more recent cohort of children,
SUPPLEMENTARY INFORMATION: Under the Disease Control and Prevention (CDC). strategies to improve response rates, and
Paperwork Reduction Act of 1995 (PRA) a further reduction in the data collection
Background and Brief Description
mstockstill on DSK4VPTVN1PROD with NOTICES
(44 U.S.C. 6501–3520), Federal agencies protocol. No data collection
must obtain approval from the Office of Autism spectrum disorders (ASD) are instruments/exams used in SEED 2 will
Management and Budget (OMB) for each a group of neurodevelopmental be revised in SEED 3; however, some
collection of the information they disorders characterized by qualitative instruments will not be retained in the
conduct or sponsor. In addition, the impairments in social interaction and protocol to reduce participant burden.
PRA also requires Federal agencies to communication and stereotyped Families will be identified from each
provide a 60-day notice in the Federal behaviors and interests. Recent of the 3 groups: Autism Spectrum
Register concerning each proposed systematic population surveys and Disorder (ASD), other developmental
VerDate Sep<11>2014 17:59 Feb 23, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\24FEN1.SGM 24FEN1](https://thefederalregister.org/doc/81_FR_9236/page/1.svg)
![Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices 9201
delay or disorder comparison group group); 5 hours 30 minutes (POP group); developmental evaluation, (4) maternal
(DD), and a second comparison group of 2 hours 45 minutes (DD group) to and child anthropometry measurements,
children randomly drawn from the complete, which includes (1) maternal (5) biosampling from biological parents
entire study cohort population (POP). It telephone interview with questions and child, and (6) abstraction of
is expected that the 5 SEED 3 study sites about maternal reproductive history and maternal prenatal and labor and
will have a total of 1,875 children enroll pregnancy with the index child, (2) delivery medical records. The estimated
and complete the study protocol. The parent-completed questionnaires about total burden hours are 18,431. There are
data collection process will take parental and child health and child no costs to participants other than their
approximately 9 hours 10 minutes (ASD development, (3) in-person child time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number
Number of burden per Total burden
Type of respondents Form name responses per
respondents response hours
respondent (in hours)
Parent ................................................ SCQ .................................................. 1,875 1 30/60 938
Parent ................................................ Pregnancy Reference form .............. 1,875 1 15/60 469
Parent ................................................ Maternal Interview ............................ 1,875 1 60/60 1,875
Parent ................................................ Self-Administered Forms .................. 1,875 1 88/60 2,750
Parent ................................................ HIPAA Medical Records Release .... 1,500 1 20/60 500
Parent/Child ...................................... Clinic/Home Visit—Developmental 3,000 1 238/60 11,900
Assessment.
Total ........................................... ........................................................... 12,000 ........................ ........................ 18,431
Leroy A. Richardson, information collection for the proper 2. Email your request, including your
Chief, Information Collection Review Office, performance of the agency’s functions; address, phone number, OMB number,
Office of Scientific Integrity, Office of the (2) the accuracy of the estimated and CMS document identifier, to
Associate Director for Science, Office of the burden; (3) ways to enhance the quality, Paperwork@cms.hhs.gov.
Director, Centers for Disease Control and utility, and clarity of the information to 3. Call the Reports Clearance Office at
Prevention. be collected; and (4) the use of (410) 786–1326.
[FR Doc. 2016–03820 Filed 2–23–16; 8:45 am] automated collection techniques or
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4163–18–P other forms of information technology to
Reports Clearance Office at (410) 786–
minimize the information collection
1326.
burden.
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION:
HUMAN SERVICES DATES: Comments must be received by
April 25, 2016. Contents
Centers for Medicare & Medicaid ADDRESSES: When commenting, please
reference the document identifier or This notice sets out a summary of the
Services
OMB control number. To be assured use and burden associated with the
[Document Identifier: CMS–P–0015A]
consideration, comments and following information collections. More
recommendations must be submitted in detailed information can be found in
Agency Information Collection each collection’s supporting statement
Activities: Proposed Collection; any one of the following ways:
1. Electronically. You may send your and associated materials (see
Comment Request ADDRESSES).
comments electronically to http://
AGENCY: Centers for Medicare & www.regulations.gov. Follow the CMS–P–0015A Medicare Current
Medicaid Services. instructions for ‘‘Comment or Beneficiary Survey
ACTION: Notice. Submission’’ or ‘‘More Search Options’’
to find the information collection Under the PRA (44 U.S.C. 3501–
SUMMARY: The Centers for Medicare & document(s) that are accepting 3520), federal agencies must obtain
Medicaid Services (CMS) is announcing comments. approval from the Office of Management
an opportunity for the public to 2. By regular mail. You may mail and Budget (OMB) for each collection of
comment on CMS’ intention to collect written comments to the following information they conduct or sponsor.
information from the public. Under the address: CMS, Office of Strategic The term ‘‘collection of information’’ is
Paperwork Reduction Act of 1995 (the Operations and Regulatory Affairs, defined in 44 U.S.C. 3502(3) and 5 CFR
PRA), federal agencies are require; to Division of Regulations Development, 1320.3(c) and includes agency requests
publish notice in the Federal Register Attention: Document Identifier/OMB or requirements that members of the
concerning each proposed collection of Control Number ll, Room C4–26–05, public submit reports, keep records, or
information (including each proposed 7500 Security Boulevard, Baltimore, provide information to a third party.
extension or reinstatement of an existing Maryland 21244–1850. Section 3506(c)(2)(A) of the PRA
mstockstill on DSK4VPTVN1PROD with NOTICES
collection of information) and to allow To obtain copies of a supporting requires federal agencies to publish a
60 days for public comment on the statement and any related forms for the 60-day notice in the Federal Register
proposed action. Interested persons are proposed collection(s) summarized in concerning each proposed collection of
invited to send comments regarding our this notice, you may make your request information, including each proposed
burden estimates or any other aspect of using one of following: extension or reinstatement of an existing
this collection of information, including 1. Access CMS’ Web site address at collection of information, before
any of the following subjects: (1) The http://www.cms.hhs.gov/Paperwork submitting the collection to OMB for
necessity and utility of the proposed ReductionActof1995. approval. To comply with this
VerDate Sep<11>2014 17:59 Feb 23, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\24FEN1.SGM 24FEN1](https://thefederalregister.org/doc/81_FR_9236/page/2.svg)
Document Created: 2016-02-23 23:55:15
Document Modified: 2016-02-23 23:55:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | Written comments must be received on or before April 25, 2016. | |
| Contact | Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329. | |
| FR Citation | 81 FR 9200 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR