Agency Forms Undergoing Paperwork Reduction Act Review, 3426-3427 [2016-01099]
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Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
You may submit comments, identified
by CDC–2016–0001 and NIOSH 260–A,
by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.
Instructions: All information received
in response to this notice must include
the agency name and docket number
[CDC–2016–0001; NIOSH 260–A]. All
relevant comments received will be
posted without change to
www.regulations.gov including any
personal information provided. All
information will be available for public
examination and copying at the NIOSH
Docket Office, 1150 Tusculum Avenue,
Room 155, Cincinnati, Ohio 45226.
Non-U.S. Citizens: Because of CDC
Security Regulations, any non-U.S.
citizen wishing to attend this meeting
must provide the following information
in writing to the NIOSH Docket Officer
at the address below no later than
February 12, 2016.
Name:
Gender:
Date of Birth:
Place of Birth (city, province, state,
country):
Citizenship:
Passport Number:
Date of Passport Issue:
Date of Passport Expiration:
Type of Visa:
U.S. Naturalization Number (if a
naturalized citizen):
U.S. Naturalization Date (if a
naturalized citizen):
Visitor’s Organization:
Organization Address:
Organization Telephone Number:
Visitor’s Position/Title within the
Organization:
This information will be transmitted
to the CDC Security Office for approval.
Visitors will be notified as soon as
approval has been obtained.
asabaliauskas on DSK9F6TC42PROD with NOTICES
Public Review
The external review of the draft
document has been (1) developed in
accordance with OMB guidelines, (2) is
consistent with NIOSH peer review
practice, and (3) is meant to ensure that
credible and appropriate science is
reflected within the draft document.
Dated: January 14, 2016.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2016–01112 Filed 1–20–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–15BEB]
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
Balance After Baby Intervention—
New—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
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Background and Brief Description
The CDC Division of Reproductive
Health (DRH) is focused on
understanding and preventing
complications due to pregnancy and the
development of chronic diseases in
reproductive age women. Similarly, the
CDC established the National Diabetes
Prevention Program (NDPP),
administered through the Division of
Diabetes Translation (DDT), to make
strategies for preventing type 2 diabetes
broadly available to individuals at high
risk of developing diabetes. Gestational
diabetes mellitus (GDM) is one of the
most common pregnancy complications
in the US, affecting approximately 3–
13% of pregnancies, or approximately
200,000 cases annually. As defined by
the American Diabetes Association
(2003), GDM is glucose intolerance that
first presents during pregnancy after the
first trimester. Women with a history of
GDM have a substantially increased risk
of developing type 2 diabetes mellitus
(T2DM) within 5 to 16 years after their
index pregnancy. It has also been shown
that many women with a history of
GDM gain weight after pregnancy,
increasing their risk for obesity, which
itself is a strong risk factor for repeat
GDM and T2DM. Because of this, as US
obesity prevalence continues to
increase, there is a concurrent rise in the
incidence and prevalence of GDM and
T2DM, resulting in a large disease
burden on individuals, families, and
society. To assist in reducing this
national disease burden, it is critical to
develop and implement successful
interventions that reduce the annual
number of newly diagnosed T2DM
cases, especially in increased risk
populations, such as women with a
history of GDM. As part of this Healthy
People 2020 objective, the Diabetes
Prevention Program (DPP) demonstrated
that an intensive lifestyle intervention
(16 face-to-face sessions over a 24-week
period) promoting physical activity,
healthy eating, and weight reduction
significantly decreased T2DM incidence
by 58% in high risk patients. However,
the DPP included predominantly older
individuals whose ability to attend
group meetings and adopt healthy
lifestyle changes is different than
younger postpartum women. For this
reason, successful adaptations of the
DPP that address barriers in postpartum
women with recent GDM, such as
limited time and resources, fatigue, and
childcare demands, must be identified
and tested.
This Balance After Baby Intervention
(BABI) data collection request aims to
collect information that can be used to
evaluate an intervention that addresses
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21JAN1
3427
Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
these barriers through the conduct of a
randomized, controlled intervention
trial of a Web site-based lifestyle
program, Balance after Baby (BAB), that
is adapted from the DPP and tailored
specifically for postpartum women with
recent GDM.
The project aims to screen 293 (98
annualized over 3 years) women with a
recent GDM pregnancy for enrollment
into the study, followed by assessments
at the following five post-partum time
points: 6-Weeks, 6-months, 12-months,
18-months, and 24-months. Of the
estimated 190 (63 annualized) women
who are anticipated to meet eligibility
requirements and attend the first study
visit, approximately half will be
assigned to the control group and the
other half will be assigned to the
intervention group. Women in the
control group will have access to a
‘‘control version’’ of the BABI Web site,
containing post-partum information
such as the ‘‘It’s Never too Early to
Prevent Diabetes’’ tip sheet and links to
other related public Web sites. Those
assigned to the intervention group will
have access to the full, interactive
version of the BABI Web site and will
be instructed to log-on once a week to
view educational modules regarding
healthy lifestyle options and to enter
and track their weight and physical
activity against their self-appointed
goals. They will also have access to a
web-based Lifestyle Coach who will
communicate with them throughout the
first year of their participation.
All participants will be required to
complete clinical assessment visits
involving the completion of visitspecific questionnaires with integrated
food frequency questionnaires,
laboratory testing, and the collection of
physical measurements such as height
and weight. The results of the two study
arms, intervention and control, will be
compared to assess whether the
intervention significantly increased
postpartum weight loss and decreased
glucose tolerance for women at
increased T2DM risk.
For the calculation of the estimated
burden hours per study visit detailed in
the table below, a constant 5% rate of
exclusion and attrition was applied
between visits. The burden table
provides a participant estimate, which
will be evenly distributed across control
and intervention groups for each
information collection step (both groups
complete the same questionnaires),
annualized over a 3-year clearance
period. Therefore, of the 190 women (63
annualized) who attend the 6-week
visit, the estimated number of
participants returning for the 6-month
visit is reduced to 180 (60 annualized),
followed by 172 (57 annualized), 162
(54 annualized), and 154 (51
annualized) for the 12-, 18-, and 24month visits respectively. The average
burden per questionnaire ranges from 8
minutes for the BABI Screener
Questionnaire up to 18 minutes for the
BABI 6-Month Questionnaire. The
average burden hours per response for
the 6-Week, 6-, 12-, 18-, 24-Month
Questionnaires, and Block© Food
Frequency Questionnaire (FFQ) are
shown in the table below. Participation
is voluntary and there are no costs to
respondents other than their time.
The total estimated annualized
burden hours are 183.
ESTIMATED ANNUALIZED BURDEN HOURS
No. of
respondents
Type of respondents
Form name
Women with a recent history GDM ................
BABI Screener Questionnaire ........................
BABI 6-Week Questionnaire ..........................
BABI 6-Month Questionnaire .........................
BABI 12-Month Questionnaire .......................
BABI 18-Month Questionnaire .......................
BABI 24-Month Questionnaire .......................
Block FFQ ......................................................
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–01099 Filed 1–20–16; 8:45 am]
[CFDA Number: 93.508]
BILLING CODE 4163–18–P
Announcing the Award of Six SingleSource Program Expansion
Supplement Grants From the Tribal
Maternal, Infant, and Early Childhood
Home Visiting (Tribal MIECHV)
Program
Administration For Children And
Families
Office of Child Care,
Administration for Children and
Families, HHS.
ACTION: Notice of the award of six
single-source program expansion
supplement grants to grantees of the
Tribal Maternal, Infant, and Early
Childhood Home Visiting (Tribal
MIECHV) Program.
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AGENCY:
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98
63
60
57
54
51
63
No. of
responses per
respondent
1
1
1
1
1
1
5
Avg.
burden per
response
(in hrs.)
8/60
17/60
18/60
14/60
14/60
15/60
18/60
The Administration for
Children and Families (ACF), Office of
Child Care (OCC), Tribal Maternal,
Infant, and Early Childhood Home
Visiting (Tribal MIECHV) Program,
announces the award of single-source
program expansion supplement grants
to the Confederated Salish and Kootenai
Tribes in Pablo, MT; Confederated
Tribes of Siletz Indians in Siletz, OR;
Inter-Tribal Council of Michigan in
Sault Ste. Marie, MI; Red Cliff Band of
Lake Superior Chippewa in Bayfield,
WI; the Choctaw Nation of Oklahoma in
Durant, OK; and the Cherokee Nation of
Oklahoma in Tahlequah, OK.
The Fiscal Year 2015 single-source
program expansion supplement grants
will support the expansion of the Tribal
Early Learning Initiative (TELI)
program.
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3426-3427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01099]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-15BEB]
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
Balance After Baby Intervention--New--National Center for Chronic
Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The CDC Division of Reproductive Health (DRH) is focused on
understanding and preventing complications due to pregnancy and the
development of chronic diseases in reproductive age women. Similarly,
the CDC established the National Diabetes Prevention Program (NDPP),
administered through the Division of Diabetes Translation (DDT), to
make strategies for preventing type 2 diabetes broadly available to
individuals at high risk of developing diabetes. Gestational diabetes
mellitus (GDM) is one of the most common pregnancy complications in the
US, affecting approximately 3-13% of pregnancies, or approximately
200,000 cases annually. As defined by the American Diabetes Association
(2003), GDM is glucose intolerance that first presents during pregnancy
after the first trimester. Women with a history of GDM have a
substantially increased risk of developing type 2 diabetes mellitus
(T2DM) within 5 to 16 years after their index pregnancy. It has also
been shown that many women with a history of GDM gain weight after
pregnancy, increasing their risk for obesity, which itself is a strong
risk factor for repeat GDM and T2DM. Because of this, as US obesity
prevalence continues to increase, there is a concurrent rise in the
incidence and prevalence of GDM and T2DM, resulting in a large disease
burden on individuals, families, and society. To assist in reducing
this national disease burden, it is critical to develop and implement
successful interventions that reduce the annual number of newly
diagnosed T2DM cases, especially in increased risk populations, such as
women with a history of GDM. As part of this Healthy People 2020
objective, the Diabetes Prevention Program (DPP) demonstrated that an
intensive lifestyle intervention (16 face-to-face sessions over a 24-
week period) promoting physical activity, healthy eating, and weight
reduction significantly decreased T2DM incidence by 58% in high risk
patients. However, the DPP included predominantly older individuals
whose ability to attend group meetings and adopt healthy lifestyle
changes is different than younger postpartum women. For this reason,
successful adaptations of the DPP that address barriers in postpartum
women with recent GDM, such as limited time and resources, fatigue, and
childcare demands, must be identified and tested.
This Balance After Baby Intervention (BABI) data collection request
aims to collect information that can be used to evaluate an
intervention that addresses
[[Page 3427]]
these barriers through the conduct of a randomized, controlled
intervention trial of a Web site-based lifestyle program, Balance after
Baby (BAB), that is adapted from the DPP and tailored specifically for
postpartum women with recent GDM.
The project aims to screen 293 (98 annualized over 3 years) women
with a recent GDM pregnancy for enrollment into the study, followed by
assessments at the following five post-partum time points: 6-Weeks, 6-
months, 12-months, 18-months, and 24-months. Of the estimated 190 (63
annualized) women who are anticipated to meet eligibility requirements
and attend the first study visit, approximately half will be assigned
to the control group and the other half will be assigned to the
intervention group. Women in the control group will have access to a
``control version'' of the BABI Web site, containing post-partum
information such as the ``It's Never too Early to Prevent Diabetes''
tip sheet and links to other related public Web sites. Those assigned
to the intervention group will have access to the full, interactive
version of the BABI Web site and will be instructed to log-on once a
week to view educational modules regarding healthy lifestyle options
and to enter and track their weight and physical activity against their
self-appointed goals. They will also have access to a web-based
Lifestyle Coach who will communicate with them throughout the first
year of their participation.
All participants will be required to complete clinical assessment
visits involving the completion of visit-specific questionnaires with
integrated food frequency questionnaires, laboratory testing, and the
collection of physical measurements such as height and weight. The
results of the two study arms, intervention and control, will be
compared to assess whether the intervention significantly increased
postpartum weight loss and decreased glucose tolerance for women at
increased T2DM risk.
For the calculation of the estimated burden hours per study visit
detailed in the table below, a constant 5% rate of exclusion and
attrition was applied between visits. The burden table provides a
participant estimate, which will be evenly distributed across control
and intervention groups for each information collection step (both
groups complete the same questionnaires), annualized over a 3-year
clearance period. Therefore, of the 190 women (63 annualized) who
attend the 6-week visit, the estimated number of participants returning
for the 6-month visit is reduced to 180 (60 annualized), followed by
172 (57 annualized), 162 (54 annualized), and 154 (51 annualized) for
the 12-, 18-, and 24-month visits respectively. The average burden per
questionnaire ranges from 8 minutes for the BABI Screener Questionnaire
up to 18 minutes for the BABI 6-Month Questionnaire. The average burden
hours per response for the 6-Week, 6-, 12-, 18-, 24-Month
Questionnaires, and Block(copyright) Food Frequency Questionnaire (FFQ)
are shown in the table below. Participation is voluntary and there are
no costs to respondents other than their time.
The total estimated annualized burden hours are 183.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
No. of Avg. burden
Type of respondents Form name No. of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------------------------
Women with a recent history GDM....... BABI Screener 98 1 8/60
Questionnaire.
BABI 6-Week 63 1 17/60
Questionnaire.
BABI 6-Month 60 1 18/60
Questionnaire.
BABI 12-Month 57 1 14/60
Questionnaire.
BABI 18-Month 54 1 14/60
Questionnaire.
BABI 24-Month 51 1 15/60
Questionnaire.
Block FFQ............... 63 5 18/60
----------------------------------------------------------------------------------------------------------------
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. 2016-01099 Filed 1-20-16; 8:45 am]
BILLING CODE 4163-18-P
