80 FR 52292 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 167 (August 28, 2015)

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).

[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52292-52294]
From the Federal Register Online  [www.thefederalregister.org]
[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
                                                                                         ---------------------------------------------------------------
    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