Agency Forms Undergoing Paperwork Reduction Act Review, 71505-71506 [2016-25061]
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Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
in accordance with the Freedom of
Information Act and, if deemed
appropriate, will redact such
information. Disclosures of information
concerning third party medical
information will be redacted.
Contact person for more information:
Paul J. Middendorf, Ph.D., Designated
Federal Officer, NIOSH, CDC, 2400
Century Parkway NE., Mail Stop E–20,
Atlanta, Georgia 30345, telephone 1
(888) 982–4748; email: wtc-stac@
cdc.gov.
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.
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.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Proposed Project
Study to Explore Early Development
(SEED) Phase 3—New—National Center
on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
[FR Doc. 2016–25039 Filed 10–14–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–16PA]
jstallworth on DSK7TPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
14:22 Oct 14, 2016
Jkt 241001
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-
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
71505
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 will implement the SEED 3
collaborative protocol. The SEED 3
protocol for identification of study
participants, recruitment, and study
data collection flow will be similar to
the protocols for SEED 1 and 2.
However, while all SEED phases have
the same research goals and the same
basic study design, data collection has
been 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. 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 3 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 6 SEED 3 study sites
will have a total of 2,106 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
E:\FR\FM\17OCN1.SGM
17OCN1
71506
Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
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
respondents
Number
responses per
respondent
Average
burden per
response
(in hours)
Type of respondents
Form name
Mother All potential participants sent mailing ...............
Mother Potentially eligible with contact by study staff ..
Invitation Packet/Response Card ....
Invitation Call Script and Social
Communication Questionnaire.
Enrollment Packet ............................
1,718
859
1
1
10/60
30/60
469
1
20/60
Follow-up Phone Call Script and
Pregnancy Reference Form.
Maternal Interview Call ....................
Self-Administered Forms .................
Follow-up Call 2 ...............................
Clinic/Home Visit—Developmental
Assessment.
Clinic/Home Visit—Saliva Collection
(optional—on own).
Clinic/Home Visit—Developmental
Assessment.
Invitation Packet/Response Card ....
Invitation Call Script and Social
Communication Questionnaire.
Enrollment Packet ............................
422
1
15/60
422
375
375
328
1
1
1
1
1
105/60
20/60
225/60
164
1
15/60
328
1
135/60
1,466
733
1
1
10/60
30/60
334
1
20/60
301
1
15/60
301
267
267
234
1
1
1
1
1
105/60
20/60
50/60
117
1
15/60
234
1
90/60
641
321
1
1
10/60
30/60
175
1
20/60
158
1
15/60
158
140
140
1
1
1
1
55/60
20/60
Mother Eligible, consented, and enrolled; assigned to
the ASD workflow based on enrollment intake.
Mother Completed this study step ................................
Father Completed this study step .................................
Child Completed this study step ...................................
Mother All potential participants sent mailing ...............
Mother Potentially eligible with contact by study staff ..
Mother Eligible, consented, and enrolled; assigned to
the POP workflow based on enrollment intake.
Mother Completed this study step ................................
Father Completed this study step .................................
Child Completed this study step ...................................
Mother All potential participants sent mailing ...............
Mother Potentially eligible with contact by study staff ..
Mother Eligible, consented, and enrolled; assigned to
the DD workflow based on enrollment intake.
Mother Completed this study step ................................
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. 2016–25061 Filed 10–14–16; 8:45 am]
jstallworth on DSK7TPTVN1PROD with NOTICES
BILLING CODE 4163–18–P
Follow-up Phone Call Script and
Pregnancy Reference Form.
Maternal Interview Call ....................
Self-Administered Forms .................
Follow-up Call 2 ...............................
Clinic/Home Visit—Developmental
Assessment.
Clinic/Home Visit—Saliva Collection
(optional—on own).
Clinic/Home Visit—Developmental
Assessment.
Invitation Packet/Response Card ....
Invitation Call Script and Social
Communication Questionnaire.
Enrollment Packet ............................
Follow-up Phone Call Script and
Pregnancy Reference Form.
Maternal Interview Call ....................
Self-Administered Forms .................
Follow-up Call 2 ...............................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0037]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Drug User
Fee Act Waivers and Reductions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
SUMMARY:
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14:22 Oct 14, 2016
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opportunity for public comment on the
proposed collection of certain
information by the Agency. 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 of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the paperwork burden of requesting a
waiver or reduction of fees under
Animal Drug User Fee Act (ADUFA).
E:\FR\FM\17OCN1.SGM
17OCN1
]]>Agencies
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71505-71506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25061]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-16PA]
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 (SEED) Phase 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 1-2%. 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 will
implement the SEED 3 collaborative protocol. The SEED 3 protocol for
identification of study participants, recruitment, and study data
collection flow will be similar to the protocols for SEED 1 and 2.
However, while all SEED phases have the same research goals and the
same basic study design, data collection has been 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. 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 3 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 6 SEED 3 study sites will have a total of 2,106
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
[[Page 71506]]
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Mother All potential participants sent Invitation Packet/ 1,718 1 10/60
mailing. Response Card.
Mother Potentially eligible with Invitation Call Script 859 1 30/60
contact by study staff. and Social
Communication
Questionnaire.
Mother Eligible, consented, and Enrollment Packet....... 469 1 20/60
enrolled; assigned to the ASD
workflow based on enrollment intake.
Mother Completed this study step...... Follow-up Phone Call 422 1 15/60
Script and Pregnancy
Reference Form.
Maternal Interview Call. 422 1 1
Self-Administered Forms. 375 1 105/60
Follow-up Call 2........ 375 1 20/60
Clinic/Home Visit-- 328 1 225/60
Developmental
Assessment.
Father Completed this study step...... Clinic/Home Visit-- 164 1 15/60
Saliva Collection
(optional--on own).
Child Completed this study step....... Clinic/Home Visit-- 328 1 135/60
Developmental
Assessment.
Mother All potential participants sent Invitation Packet/ 1,466 1 10/60
mailing. Response Card.
Mother Potentially eligible with Invitation Call Script 733 1 30/60
contact by study staff. and Social
Communication
Questionnaire.
Mother Eligible, consented, and Enrollment Packet....... 334 1 20/60
enrolled; assigned to the POP
workflow based on enrollment intake.
Mother Completed this study step...... Follow-up Phone Call 301 1 15/60
Script and Pregnancy
Reference Form.
Maternal Interview Call. 301 1 1
Self-Administered Forms. 267 1 105/60
Follow-up Call 2........ 267 1 20/60
Clinic/Home Visit-- 234 1 50/60
Developmental
Assessment.
Father Completed this study step...... Clinic/Home Visit-- 117 1 15/60
Saliva Collection
(optional--on own).
Child Completed this study step....... Clinic/Home Visit-- 234 1 90/60
Developmental
Assessment.
Mother All potential participants sent Invitation Packet/ 641 1 10/60
mailing. Response Card.
Mother Potentially eligible with Invitation Call Script 321 1 30/60
contact by study staff. and Social
Communication
Questionnaire.
Mother Eligible, consented, and Enrollment Packet....... 175 1 20/60
enrolled; assigned to the DD workflow
based on enrollment intake.
Mother Completed this study step...... Follow-up Phone Call 158 1 15/60
Script and Pregnancy
Reference Form.
Maternal Interview Call. 158 1 1
Self-Administered Forms. 140 1 55/60
Follow-up Call 2........ 140 1 20/60
----------------------------------------------------------------------------------------------------------------
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. 2016-25061 Filed 10-14-16; 8:45 am]
BILLING CODE 4163-18-P
