Agency Forms Undergoing Paperwork Reduction Act Review, 51588-51590 [2019-21169]
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<![CDATA[
51588
Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–21168 Filed 9–27–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Healthcare Infection Control Practices
Advisory Committee (HICPAC)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Healthcare Infection Control
Practices Advisory Committee
(HICPAC). This meeting is open to the
public, is limited only by room seating
available (120). The public is also
welcome to listen to the meeting via
teleconference at 888–769–9417,
passcode: 4538315; 100 teleconference
lines are available. Time will be
available for public comment. The
public is welcome to submit written
comments in advance of the meeting.
DATES: The meeting will be held on
November 14, 2019, 9:00 a.m. to 5:00
p.m., EST, and November 15, 2019, 9:00
a.m. to 12:00 p.m., EST.
ADDRESSES: Centers for Disease Control
and Prevention, Global Communications
Center, Building 19, Auditorium B, 1600
Clifton Road NE, Atlanta, Georgia 30329
and teleconference at 888–769–9417,
passcode: 4538315.
FOR FURTHER INFORMATION CONTACT: KooWhang Chung, M.P.H., HICPAC,
Division of Healthcare Quality
Promotion, NCEZID, CDC, l600 Clifton
Road NE, Mailstop H16–3, Atlanta,
Georgia 30329 Telephone (404) 498–
0730. Email: hicpac@cdc.gov.
SUPPLEMENTARY INFORMATION:
Public Comment: Comments should
be submitted in writing by email to the
contact person listed below. The
deadline for receipt of written public
comment is October 31, 2019. All
requests must contain the name,
address, and organizational affiliation of
the speaker, as well as the topic being
addressed. Written comments should
not exceed one single-spaced typed page
in length and delivered in 3 minutes or
less. Members of the public who wish
to provide public comments should
plan to attend the public comment
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SUMMARY:
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session at the start time listed. Please
note that the public comment period
may end before the time indicated,
following the last call for comments.
Written comments received in advance
of the meeting will be included in the
official record of the meeting.
Registration is required to attend in
person or on the phone. Interested
parties must be processed in accordance
with established federal policies and
procedures and may register at https://
www.cdc.gov/hicpac.
Purpose: The Committee is charged
with providing advice and guidance to
the Director, Division of Healthcare
Quality Promotion (DHQP), the Director,
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
the Director, CDC, and the Secretary,
Health and Human Services, regarding
(1) the practice of healthcare infection
prevention and control; (2) strategies for
surveillance, prevention, and control of
infections, antimicrobial resistance, and
related events in settings where
healthcare is provided; and (3) periodic
updating of CDC guidelines and other
policy statements regarding prevention
of healthcare-associated infections and
healthcare-related conditions.
Matters to be Considered: The agenda
will include updates on CDC’s activities
for prevention of healthcare-associated
infections. It will also include updates
from the following HICPAC workgroups:
The Healthcare Personnel Guideline
Workgroup and the Neonatal Intensive
Care Unit (NICU) Guideline Workgroup.
The agenda also includes updates on
CDC and DHQP activities. Agenda items
are subject to change as priorities
dictate.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, 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.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2019–21138 Filed 9–27–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–1171]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Study to
Explore Early Development(SEED)
Phase 3 to the Office of Management
and Budget (OMB) for review and
approval. CDC previously published a
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on May 24,
2019 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(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, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
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51589
Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Notices
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Study to Explore Early
Development(SEED) Phase 3—
Extension—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 1–2%. 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; 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–
2016). Five CADDRE grantees received
the awards. Again, CDC served as the
sixth SEED 2 site.
A third phase of SEED (SEED 3) was
funded in July 2016. Five extramural
sites were funded. Together with the
CDC, they are implementing the SEED 3
collaborative protocol. The SEED 3
protocol for identification of study
participants, recruitment, and study
data collection flow is similar to the
protocols for SEED 1 and 2. CDC
obtained approval to collect information
for SEED 3 in 2017 (OMB 0920–1171).
The current request is to obtain an
extension of this approval so that data
collection may continue beyond the
current expiration date of 3/31/2020.
While all SEED phases have the same
research goals and the same basic study
design, data collection was greatly
streamlined and revised between SEED
1, SEED 2, and SEED 3. Many study
instruments and data collection
components included in the SEED 1
protocol are not included in the SEED
3 protocol; two instruments included in
the SEED 3 protocol were developed
subsequent to SEED 1 to capture an
abbreviated version of information that
had been included on some of the
discontinued SEED 1 forms and to
capture some additional information
overlooked in the SEED 1 protocol; and
instruments included in all phases of
SEED underwent review and minor
revision subsequent to SEED 1 to
address ambiguities and difficulties
experienced during SEED 1 data
collection. No additional changes are
requested from the SEED 3 protocol that
initially obtained OMB approval.
Implementing this phase of SEED will
increase the total SEED pooled sample
size for investigation of high priority
hypotheses. Maintaining the same basic
study design and general protocol
integrity will ensure that data pooling
can be achieved across SEED phases.
Families will be identified from each
of the three groups: Autism Spectrum
Disorder (ASD), other developmental
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 six SEED 3 study
sites will enroll a total of 2,106 children
and complete the study protocol. The
data collection will take approximately
10 hours 35 minutes (ASD group); six
hours 55 minutes (POP group); two
hours 30 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,
and (5) biosampling from biological
parents and child. There are no costs to
participants other than their time. The
total estimated annual burden hours are
7,118.
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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden
per response
(in hours)
Type of respondents
Form name
Mother, ASD workflow All potential participants sent mailing.
Mother, ASD workflow Potentially eligible with
contact by study staff.
Invitation Packet/Response Card (Attachment 10a,d,g).
Invitation Call Script and (Attachment 11a)
Social Communication Questionnaire (Attachment 3).
Enrollment Packet (Attachment 12a, c, d) .....
1,718
1
10/60
859
1
30/60
469
1
20/60
Follow-up Phone Call Script and Checklist
(Attachment 13) and Pregnancy Reference
Form and 5 a, b).
Maternal Interview Call (Attachment 4) .........
422
1
15/60
422
1
1
Self-Administered Forms (Attachment 6a–e,
6f or 6g, 6h–i, 6k–l, and 6o–p).
Follow-up Call 2 (Attachment 14) ..................
375
1
105/60
375
1
20/60
Mother, ASD workflow Eligible, consented,
and enrolled; assigned to the ASD
workflow based on enrollment intake.
Mother, ASD workflow Completed this study
step.
Mother, ASD workflow Completed this study
step.
Mother, ASD workflow Completed this study
step.
Mother, ASD workflow Completed this study
step.
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Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Mother, ASD workflow Completed this study
step.
Clinic/Home Visit—Developmental Assessment(Attachment 7b, c, g), saliva collection (Attachment 8a–d), overall consent
(Attachment 15a).
Clinic/Home Visit—Saliva Collection (Attachments 8b–d).
Clinic/Home Visit—Developmental Assessment (attachment 7a, 7d or 7e or 7f) and
saliva collection (8a–d).
Invitation Packet/Response Card (Attachments 10c, 10f, and 10g).
Invitation Call Script (Attachment 11c) and
Social Communication Questionnaire (Attachment 3).
Enrollment Packet (Attachments 12a, c, d) ...
Father, ASD workflow Completed this study
step.
Child, ASD workflow Completed this study
step.
Mother, POP workflow All potential participants sent mailing.
Mother , POP workflow Potentially eligible
with contact by study staff.
Mother , POP workflow Eligible, consented,
and enrolled; assigned to the POP
workflow based on enrollment intake.
Mother, POP workflow Completed this study
step.
Mother,
step.
Mother,
step.
Mother,
step.
Mother,
step.
POP workflow Completed this study
POP workflow Completed this study
POP workflow Completed this study
POP workflow Completed this study
Father, POP workflow Completed this study
step.
Child, POP workflow Completed this study
step.
Mother, DD workflow All potential participants
sent mailing.
Mother, DD workflow Potentially eligible with
contact by study staff.
Mother, DD workflow Eligible, consented, and
enrolled; assigned to the DD workflow
based on enrollment intake.
Mother, DD workflow Completed this study
step.
Mother, DD workflow Completed this study
step.
Mother, DD workflow Completed this study
step.
Mother, DD workflow Completed this study
step.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–21169 Filed 9–27–19; 8:45 am]
BILLING CODE 4163–18–P
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondents
1
225/60
164
1
15/60
328
1
135/60
1,466
1
10/60
733
1
30/60
334
1
20/60
301
1
15/60
301
1
1
267
1
105/60
267
1
20/60
234
1
50/60
117
1
15/60
234
1
90/60
641
1
10/60
321
1
30/60
175
1
20/60
Follow-up Phone Call Script (Attachment 13)
and Checklist and Pregnancy Reference
Form (Attachments 5a and 5b).
Maternal Interview Call (Attachment 4) .........
158
1
15/60
158
1
1
Self-Administered Forms (Attachments 6a–d,
6j, 6m, and 6o–p).
Follow-up Call 2 (Attachment 15b) ................
140
1
55/60
140
1
20/60
Follow-up Phone Call Script and Checklist
(Attachment 13) and Pregnancy Reference
Form Attachments 5a and 5b).
Maternal Interview Call (Attachment 4) .........
Self-Administered Forms (Attachment 6a–e,
6f or 6g, 6h–i, 6k, 6n–p).
Follow-up Call 2 (Attachment 14) ..................
Developmental Assessment saliva collection
(Attachment 8a–d), overall consent (Attachment 15c).
Clinic/Home Visit—Saliva Collection (Attachments 8b–d).
Clinic/Home Visit—Developmental Assessment Attachment 7a–c), saliva collection
(Attachment 8a–d).
Invitation Packet/Response Card (Attachments 10b, 10e, and 10g).
Invitation Call Script (Attachment 11b) and
SCQ (Attachment 3).
Enrollment Packet (Attachment 12b–d) .........
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10709]
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
19:16 Sep 27, 2019
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Average
burden
per response
(in hours)
328
Agency Information Collection
Activities: Proposed Collection;
Comment Request
VerDate Sep<11>2014
Number of
responses per
respondent
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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 required 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
SUMMARY:
E:\FR\FM\30SEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51588-51590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21169]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-1171]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Study to Explore Early Development(SEED)
Phase 3 to the Office of Management and Budget (OMB) for review and
approval. CDC previously published a ``Proposed Data Collection
Submitted for Public Comment and Recommendations'' notice on May 24,
2019 to obtain comments from the public and affected agencies. CDC did
not receive comments related to the previous notice. This notice serves
to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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, 725 17th
Street NW, Washington, DC 20503 or by fax to (202)
[[Page 51589]]
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Study to Explore Early Development(SEED) Phase 3--Extension--
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 1-2%. 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; 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- 2016). Five CADDRE grantees received the awards.
Again, CDC served as the sixth SEED 2 site.
A third phase of SEED (SEED 3) was funded in July 2016. Five
extramural sites were funded. Together with the CDC, they are
implementing the SEED 3 collaborative protocol. The SEED 3 protocol for
identification of study participants, recruitment, and study data
collection flow is similar to the protocols for SEED 1 and 2. CDC
obtained approval to collect information for SEED 3 in 2017 (OMB 0920-
1171). The current request is to obtain an extension of this approval
so that data collection may continue beyond the current expiration date
of 3/31/2020.
While all SEED phases have the same research goals and the same
basic study design, data collection was greatly streamlined and revised
between SEED 1, SEED 2, and SEED 3. Many study instruments and data
collection components included in the SEED 1 protocol are not included
in the SEED 3 protocol; two instruments included in the SEED 3 protocol
were developed subsequent to SEED 1 to capture an abbreviated version
of information that had been included on some of the discontinued SEED
1 forms and to capture some additional information overlooked in the
SEED 1 protocol; and instruments included in all phases of SEED
underwent review and minor revision subsequent to SEED 1 to address
ambiguities and difficulties experienced during SEED 1 data collection.
No additional changes are requested from the SEED 3 protocol that
initially obtained OMB approval. Implementing this phase of SEED will
increase the total SEED pooled sample size for investigation of high
priority hypotheses. Maintaining the same basic study design and
general protocol integrity will ensure that data pooling can be
achieved across SEED phases.
Families will be identified from each of the three groups: Autism
Spectrum Disorder (ASD), other developmental 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 six SEED 3 study sites will enroll a total of 2,106
children and complete the study protocol. The data collection will take
approximately 10 hours 35 minutes (ASD group); six hours 55 minutes
(POP group); two hours 30 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, and (5) biosampling from
biological parents and child. There are no costs to participants other
than their time. The total estimated annual burden hours are 7,118.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Mother, ASD workflow All potential Invitation Packet/Response 1,718 1 10/60
participants sent mailing. Card (Attachment 10a,d,g).
Mother, ASD workflow Potentially Invitation Call Script and 859 1 30/60
eligible with contact by study (Attachment 11a) Social
staff. Communication
Questionnaire (Attachment
3).
Mother, ASD workflow Eligible, Enrollment Packet 469 1 20/60
consented, and enrolled; assigned (Attachment 12a, c, d).
to the ASD workflow based on
enrollment intake.
Mother, ASD workflow Completed this Follow-up Phone Call Script 422 1 15/60
study step. and Checklist (Attachment
13) and Pregnancy
Reference Form and 5 a, b).
Mother, ASD workflow Completed this Maternal Interview Call 422 1 1
study step. (Attachment 4).
Mother, ASD workflow Completed this Self-Administered Forms 375 1 105/60
study step. (Attachment 6a-e, 6f or
6g, 6h-i, 6k-l, and 6o-p).
Mother, ASD workflow Completed this Follow-up Call 2 375 1 20/60
study step. (Attachment 14).
[[Page 51590]]
Mother, ASD workflow Completed this Clinic/Home Visit-- 328 1 225/60
study step. Developmental
Assessment(Attachment 7b,
c, g), saliva collection
(Attachment 8a-d), overall
consent (Attachment 15a).
Father, ASD workflow Completed this Clinic/Home Visit--Saliva 164 1 15/60
study step. Collection (Attachments 8b-
d).
Child, ASD workflow Completed this Clinic/Home Visit-- 328 1 135/60
study step. Developmental Assessment
(attachment 7a, 7d or 7e
or 7f) and saliva
collection (8a-d).
Mother, POP workflow All potential Invitation Packet/Response 1,466 1 10/60
participants sent mailing. Card (Attachments 10c,
10f, and 10g).
Mother , POP workflow Potentially Invitation Call Script 733 1 30/60
eligible with contact by study (Attachment 11c) and
staff. Social Communication
Questionnaire (Attachment
3).
Mother , POP workflow Eligible, Enrollment Packet 334 1 20/60
consented, and enrolled; assigned (Attachments 12a, c, d).
to the POP workflow based on
enrollment intake.
Mother, POP workflow Completed this Follow-up Phone Call Script 301 1 15/60
study step. and Checklist (Attachment
13) and Pregnancy
Reference Form Attachments
5a and 5b).
Mother, POP workflow Completed this Maternal Interview Call 301 1 1
study step. (Attachment 4).
Mother, POP workflow Completed this Self-Administered Forms 267 1 105/60
study step. (Attachment 6a-e, 6f or
6g, 6h-i, 6k, 6n-p).
Mother, POP workflow Completed this Follow-up Call 2 267 1 20/60
study step. (Attachment 14).
Mother, POP workflow Completed this Developmental Assessment 234 1 50/60
study step. saliva collection
(Attachment 8a-d), overall
consent (Attachment 15c).
Father, POP workflow Completed this Clinic/Home Visit--Saliva 117 1 15/60
study step. Collection (Attachments 8b-
d).
Child, POP workflow Completed this Clinic/Home Visit-- 234 1 90/60
study step. Developmental Assessment
Attachment 7a-c), saliva
collection (Attachment 8a-
d).
Mother, DD workflow All potential Invitation Packet/Response 641 1 10/60
participants sent mailing. Card (Attachments 10b,
10e, and 10g).
Mother, DD workflow Potentially Invitation Call Script 321 1 30/60
eligible with contact by study (Attachment 11b) and SCQ
staff. (Attachment 3).
Mother, DD workflow Eligible, Enrollment Packet 175 1 20/60
consented, and enrolled; assigned (Attachment 12b-d).
to the DD workflow based on
enrollment intake.
Mother, DD workflow Completed this Follow-up Phone Call Script 158 1 15/60
study step. (Attachment 13) and
Checklist and Pregnancy
Reference Form
(Attachments 5a and 5b).
Mother, DD workflow Completed this Maternal Interview Call 158 1 1
study step. (Attachment 4).
Mother, DD workflow Completed this Self-Administered Forms 140 1 55/60
study step. (Attachments 6a-d, 6j, 6m,
and 6o-p).
Mother, DD workflow Completed this Follow-up Call 2 140 1 20/60
study step. (Attachment 15b).
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-21169 Filed 9-27-19; 8:45 am]
BILLING CODE 4163-18-P
