81 FR 3426 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 13 (January 21, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 13 (January 21, 2016)
| Page Range | 3426-3427 | |
| FR Document | 2016-01099 |
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)] [Notices] [Pages 3426-3427] From the Federal Register Online [www.thefederalregister.org] [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 [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, 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
![3426 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
You may submit comments, identified DEPARTMENT OF HEALTH AND Background and Brief Description
by CDC–2016–0001 and NIOSH 260–A, HUMAN SERVICES The CDC Division of Reproductive
by either of the following methods: Health (DRH) is focused on
• Federal eRulemaking Portal: Centers for Disease Control and understanding and preventing
www.regulations.gov. Follow the Prevention complications due to pregnancy and the
instructions for submitting comments. development of chronic diseases in
• Mail: National Institute for [30Day–16–15BEB] reproductive age women. Similarly, the
Occupational Safety and Health, NIOSH CDC established the National Diabetes
Docket Office, 1090 Tusculum Avenue, Agency Forms Undergoing Paperwork Prevention Program (NDPP),
MS C–34, Cincinnati, Ohio 45226–1998. Reduction Act Review administered through the Division of
Instructions: All information received Diabetes Translation (DDT), to make
in response to this notice must include The Centers for Disease Control and
strategies for preventing type 2 diabetes
the agency name and docket number Prevention (CDC) has submitted the
broadly available to individuals at high
[CDC–2016–0001; NIOSH 260–A]. All following information collection request
risk of developing diabetes. Gestational
relevant comments received will be to the Office of Management and Budget
diabetes mellitus (GDM) is one of the
posted without change to (OMB) for review and approval in
most common pregnancy complications
www.regulations.gov including any accordance with the Paperwork
in the US, affecting approximately 3–
personal information provided. All Reduction Act of 1995. The notice for
13% of pregnancies, or approximately
information will be available for public the proposed information collection is
200,000 cases annually. As defined by
examination and copying at the NIOSH published to obtain comments from the
the American Diabetes Association
Docket Office, 1150 Tusculum Avenue, public and affected agencies.
(2003), GDM is glucose intolerance that
Room 155, Cincinnati, Ohio 45226. Written comments and suggestions first presents during pregnancy after the
Non-U.S. Citizens: Because of CDC from the public and affected agencies first trimester. Women with a history of
Security Regulations, any non-U.S. concerning the proposed collection of GDM have a substantially increased risk
citizen wishing to attend this meeting information are encouraged. Your of developing type 2 diabetes mellitus
must provide the following information comments should address any of the (T2DM) within 5 to 16 years after their
in writing to the NIOSH Docket Officer following: (a) Evaluate whether the index pregnancy. It has also been shown
at the address below no later than proposed collection of information is that many women with a history of
February 12, 2016. necessary for the proper performance of GDM gain weight after pregnancy,
Name: the functions of the agency, including increasing their risk for obesity, which
Gender: whether the information will have itself is a strong risk factor for repeat
Date of Birth: practical utility; (b) Evaluate the GDM and T2DM. Because of this, as US
Place of Birth (city, province, state, accuracy of the agencies estimate of the obesity prevalence continues to
country): burden of the proposed collection of increase, there is a concurrent rise in the
Citizenship: information, including the validity of incidence and prevalence of GDM and
Passport Number: the methodology and assumptions used; T2DM, resulting in a large disease
Date of Passport Issue: (c) Enhance the quality, utility, and
Date of Passport Expiration: burden on individuals, families, and
clarity of the information to be society. To assist in reducing this
Type of Visa: collected; (d) Minimize the burden of
U.S. Naturalization Number (if a national disease burden, it is critical to
the collection of information on those develop and implement successful
naturalized citizen): who are to respond, including through
U.S. Naturalization Date (if a interventions that reduce the annual
the use of appropriate automated, number of newly diagnosed T2DM
naturalized citizen): electronic, mechanical, or other
Visitor’s Organization: cases, especially in increased risk
technological collection techniques or populations, such as women with a
Organization Address: other forms of information technology,
Organization Telephone Number: history of GDM. As part of this Healthy
e.g., permitting electronic submission of People 2020 objective, the Diabetes
Visitor’s Position/Title within the
responses; and (e) Assess information Prevention Program (DPP) demonstrated
Organization:
collection costs. that an intensive lifestyle intervention
This information will be transmitted To request additional information on (16 face-to-face sessions over a 24-week
to the CDC Security Office for approval. the proposed project or to obtain a copy period) promoting physical activity,
Visitors will be notified as soon as of the information collection plan and healthy eating, and weight reduction
approval has been obtained. instruments, call (404) 639–7570 or significantly decreased T2DM incidence
Public Review send an email to omb@cdc.gov. Direct by 58% in high risk patients. However,
written comments and/or suggestions the DPP included predominantly older
The external review of the draft regarding the items contained in this
document has been (1) developed in individuals whose ability to attend
notice to the Attention: CDC Desk group meetings and adopt healthy
accordance with OMB guidelines, (2) is Officer, Office of Management and
consistent with NIOSH peer review lifestyle changes is different than
Budget, Washington, DC 20503 or by fax younger postpartum women. For this
practice, and (3) is meant to ensure that to (202) 395–5806. Written comments
credible and appropriate science is reason, successful adaptations of the
should be received within 30 days of DPP that address barriers in postpartum
asabaliauskas on DSK9F6TC42PROD with NOTICES
reflected within the draft document. this notice. women with recent GDM, such as
Dated: January 14, 2016. limited time and resources, fatigue, and
Proposed Project
John Howard, childcare demands, must be identified
Director, National Institute for Occupational Balance After Baby Intervention— and tested.
Safety and Health, Centers for Disease Control New—National Center for Chronic This Balance After Baby Intervention
and Prevention. Disease Prevention and Health (BABI) data collection request aims to
[FR Doc. 2016–01112 Filed 1–20–16; 8:45 am] Promotion (NCCDPHP), Centers for collect information that can be used to
BILLING CODE 4163–19–P Disease Control and Prevention (CDC). evaluate an intervention that addresses
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![Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices 3427
these barriers through the conduct of a version of the BABI Web site and will provides a participant estimate, which
randomized, controlled intervention be instructed to log-on once a week to will be evenly distributed across control
trial of a Web site-based lifestyle view educational modules regarding and intervention groups for each
program, Balance after Baby (BAB), that healthy lifestyle options and to enter information collection step (both groups
is adapted from the DPP and tailored and track their weight and physical complete the same questionnaires),
specifically for postpartum women with activity against their self-appointed annualized over a 3-year clearance
recent GDM. goals. They will also have access to a period. Therefore, of the 190 women (63
The project aims to screen 293 (98 web-based Lifestyle Coach who will annualized) who attend the 6-week
annualized over 3 years) women with a communicate with them throughout the visit, the estimated number of
recent GDM pregnancy for enrollment first year of their participation. participants returning for the 6-month
into the study, followed by assessments All participants will be required to visit is reduced to 180 (60 annualized),
at the following five post-partum time complete clinical assessment visits followed by 172 (57 annualized), 162
points: 6-Weeks, 6-months, 12-months, involving the completion of visit- (54 annualized), and 154 (51
18-months, and 24-months. Of the specific questionnaires with integrated annualized) for the 12-, 18-, and 24-
estimated 190 (63 annualized) women food frequency questionnaires,
month visits respectively. The average
who are anticipated to meet eligibility laboratory testing, and the collection of
burden per questionnaire ranges from 8
requirements and attend the first study physical measurements such as height
minutes for the BABI Screener
visit, approximately half will be and weight. The results of the two study
Questionnaire up to 18 minutes for the
assigned to the control group and the arms, intervention and control, will be
other half will be assigned to the BABI 6-Month Questionnaire. The
compared to assess whether the
intervention group. Women in the average burden hours per response for
intervention significantly increased
control group will have access to a the 6-Week, 6-, 12-, 18-, 24-Month
postpartum weight loss and decreased
‘‘control version’’ of the BABI Web site, Questionnaires, and Block© Food
glucose tolerance for women at
containing post-partum information increased T2DM risk. Frequency Questionnaire (FFQ) are
such as the ‘‘It’s Never too Early to For the calculation of the estimated shown in the table below. Participation
Prevent Diabetes’’ tip sheet and links to burden hours per study visit detailed in is voluntary and there are no costs to
other related public Web sites. Those the table below, a constant 5% rate of respondents other than their time.
assigned to the intervention group will exclusion and attrition was applied The total estimated annualized
have access to the full, interactive between visits. The burden table burden hours are 183.
ESTIMATED ANNUALIZED BURDEN HOURS
Avg.
No. of
No. of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)
Women with a recent history GDM ................ BABI Screener Questionnaire ........................ 98 1 8/60
BABI 6-Week Questionnaire .......................... 63 1 17/60
BABI 6-Month Questionnaire ......................... 60 1 18/60
BABI 12-Month Questionnaire ....................... 57 1 14/60
BABI 18-Month Questionnaire ....................... 54 1 14/60
BABI 24-Month Questionnaire ....................... 51 1 15/60
Block FFQ ...................................................... 63 5 18/60
Leroy A. Richardson, DEPARTMENT OF HEALTH AND SUMMARY: The Administration for
Chief, Information Collection Review Office, HUMAN SERVICES Children and Families (ACF), Office of
Office of Scientific Integrity, Office of the Child Care (OCC), Tribal Maternal,
Associate Director for Science, Office of the Administration For Children And Infant, and Early Childhood Home
Director, Centers for Disease Control and Families Visiting (Tribal MIECHV) Program,
Prevention. announces the award of single-source
[FR Doc. 2016–01099 Filed 1–20–16; 8:45 am] [CFDA Number: 93.508] program expansion supplement grants
BILLING CODE 4163–18–P
Announcing the Award of Six Single- to the Confederated Salish and Kootenai
Source Program Expansion Tribes in Pablo, MT; Confederated
Supplement Grants From the Tribal Tribes of Siletz Indians in Siletz, OR;
Maternal, Infant, and Early Childhood Inter-Tribal Council of Michigan in
Home Visiting (Tribal MIECHV) Sault Ste. Marie, MI; Red Cliff Band of
Program Lake Superior Chippewa in Bayfield,
WI; the Choctaw Nation of Oklahoma in
AGENCY: Office of Child Care, Durant, OK; and the Cherokee Nation of
asabaliauskas on DSK9F6TC42PROD with NOTICES
Administration for Children and Oklahoma in Tahlequah, OK.
Families, HHS.
The Fiscal Year 2015 single-source
ACTION: Notice of the award of six
program expansion supplement grants
single-source program expansion
supplement grants to grantees of the will support the expansion of the Tribal
Tribal Maternal, Infant, and Early Early Learning Initiative (TELI)
Childhood Home Visiting (Tribal program.
MIECHV) Program.
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Document Created: 2018-02-02 12:33:42
Document Modified: 2018-02-02 12:33:42
| 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 | |
| FR Citation | 81 FR 3426 |
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