[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52292-52294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21344]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-15-15BEB; Docket No. CDC-2015-0071]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collect project entitled Balance After Baby Intervention:
Phase 2 (BABI2.) A three-year clearance is requested to conduct a
randomized controlled trial of a Web site-based lifestyle program with
a racially diverse population of postpartum women who had recent
Gestational diabetes mellitus (GDM).
DATES: Written comments must be received on or before October 27, 2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0071 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson, Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.
Please note: All public comment should be submitted through the
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact the Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services
to provide information. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; to develop, acquire,
install and utilize technology and systems for the purpose of
collecting, validating and verifying information, processing and
maintaining information, and disclosing
[[Page 52293]]
and providing information; to train personnel and to be able to respond
to a collection of information, to search data sources, to complete and
review the collection of information; and to transmit or otherwise
disclose the information.
Proposed Project
Balance After Baby Intervention: Phase 2 (BABI2)--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 BABI2 data collection request aims to address 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 will meet eligibility requirements and attend the
first study visit, approximately half will be assigned to the control
group and will receive standard postpartum follow-up, while those
assigned to the intervention group will have access to the BAB
informational Web site and a lifestyle coach. For all participants, the
BABI2 study visits will involve the completion of visit-specific
questionnaires, laboratory testing, and the collection of physical
measurements such as height and weight. Collected data will be used by
CDC and BABI2 investigators to assess the impact and effectiveness of
the BABI2 intervention as a potential public health weight loss tool
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,
annualized over a 3-year collection 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
BABI2 Screener Questionnaire up to 36 minutes for the BABI2 6-month
Questionnaire.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
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Women with a recent history GDM................ BABI2 Screener Questionnaire........... 98 1 8/60 13
Women with a recent history GDM................ BABI2 6-Week Questionnaire............. 63 1 35/60 37
Women with a recent history GDM................ BABI2 6-Month Questionnaire............ 60 1 36/60 36
Women with a recent history GDM................ BABI2 12-Month Questionnaire........... 57 1 32/60 31
Women with a recent history GDM................ BABI2 18-Month Questionnaire........... 54 1 32/60 29
Women with a recent history GDM................ BABI2 24-Month Questionnaire........... 51 1 33/60 28
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Total...................................... ....................................... .............. .............. .............. 174
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[[Page 52294]]
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. 2015-21344 Filed 8-27-15; 8:45 am]
BILLING CODE 4163-18-P