Document ID: FDA-2012-N-0357-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Decision Analysis, A Risk-Tolerance Pilot Study
Posted Date: 2012-06-27T04:00Z

[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38299-38301]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15720]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0357]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device 
Decision Analysis: A Risk-Tolerance Pilot Study

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the

[[Page 38300]]

Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
27, 2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Medical Device Decision Analysis: A Risk-Tolerance Pilot 
Study.'' Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device Decision Analysis: A Risk-Tolerance Pilot Study--(OMB 
Control Number 0910-New)

I. Background

    A recent study of obesity indicates that 35.5 percent of men and 
35.8 percent of women in America reported being obese in 2010. This 
represents an increase from 27.5 percent and 33.4 percent in 2000 for 
men and women, respectively (Ref. 1). People who are obese are more 
likely to suffer from diabetes, cardiovascular disease, respiratory and 
metabolic disease, and sleep apnea, as well as other physical and 
psychological disabilities. By some estimates, as much as $140 billion 
were spent in 2008 to treat obesity-related diseases (Ref. 2). Studies 
have shown that weight loss can significantly reduce the burden of 
obesity-related comorbidities (Refs. 3 and 4), and that weight lost as 
a result of laparoscopic banding or other weight-loss surgeries 
positively impacts quality of life and burden of disease (Refs. 5 
through 7). However, like any surgical procedure, these surgeries are 
associated with substantial risks, including risks of potentially life-
threatening events (Ref. 6), that patients and physicians must weigh 
against any potential benefits when making an informed treatment 
decision.
    With the assistance of advisory panels, FDA determines the 
acceptable risk threshold of a medical intervention against its 
effectiveness as demonstrated in clinical evidence. In addition, 
individual patients and patient-advocacy groups anecdotally express 
their opinions about their needs and tolerance for risks to FDA through 
letters and public testimonies during advisory panel meetings. To 
evaluate the scientific validity of systematically eliciting patient 
perspectives on outcomes associated with weight-loss devices, the 
Agency requests approval of a pilot survey to quantify obesity 
patients' benefit-risk preferences.
    The choice-format preference-elicitation survey will ask obese 
individuals (with a body mass index of 30 kg/m\2\ or above) to evaluate 
a series of choices between pairs of hypothetical medical devices. Each 
hypothetical device will be defined by the amount and duration of 
weight loss, side effects, risks associated with hypothetical weight-
loss devices, and the effect of the device on weight-related 
comorbidities. The survey was developed using findings from a 
literature review of the outcomes associated with weight-loss devices, 
interviews with obesity patients, and expert opinion.
    An invitation to the online survey will be sent to a sample of 
1,000 obese adults in the United States. Among the adults who receive 
the invitation, about 600 are expected to complete the consent form and 
about 450 are expected to qualify for the study and complete the survey 
in full. In addition to the choice-format questions, the survey also 
will collect information on respondent demographics, disease history, 
and weight-management history. There is no cost to respondents other 
than about 25 minutes of their time.
    Final results will provide an estimate of the maximum levels of 
various treatment-related risks that obesity patients would be willing 
to accept to achieve specific levels of weight loss or improvements in 
weight-related diseases. These results will be used to investigate the 
viability of choice-format surveys as a way to quantify patients' risk 
tolerance for the therapeutic benefits of weight-loss devices.
    In the Federal Register of April 19, 2012 (77 FR 23484), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
        Survey instrument            Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
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Survey invitation...............           1,000               1           1,000            0.03              30
Consent form....................             700               1             700            0.03              21
Full survey.....................             450               1             450            0.42             189
    Total.......................  ..............  ..............  ..............  ..............             240
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Ogden, C.L., M.D. Carroll, B.K. Kit, and K.M. Flegal, 
``Prevalence of Obesity and Trends in Body Mass Index Among U.S. 
Children and Adolescents, 1999-2010,'' Journal of the American Medical 
Association, vol. 307, no. 5, pp. 483-490, 2012.
    2. Finkelstein, E.A., J.G. Trogdon, J.W. Cohen, and W. Dietz, 
``Annual Medical Spending Attributable to Obesity: Payer- and Service-
Specific Estimates,'' Health Affairs, vol. 28, no. 5, pp. w822-w831, 
2009.
    3. Dhabuwala, A., R.J. Cannan, and R.S. Stubbs, ``Improvement in 
Comorbidities Following Weight Loss From Gastric Bypass Surgery,'' 
Obesity Surgery, vol. 10, pp. 428-435, 2000.
    4. Sj[ouml]str[ouml]m, L., A. Lindroos, M. Peltonen, et al., 
``Lifestyle, Diabetes, and

[[Page 38301]]

Cardiovascular Risk Factors 10 Years After Bariatric Surgery,'' The New 
England Journal of Medicine, vol. 351, no. 26, pp. 2683-2693, 2004.
    5. Dixon, J.B., M.E. Dixon, and P.E. O'Brien, ``Quality of Life 
After Lap-Band Placement: Influence of Time, Weight Loss, and 
Comorbidities,'' Obesity Research, vol. 9, no. 11, pp. 713-721, 2001.
    6. Buchwald, H., Y. Avidor, E. Braunwald et al., ``Bariatric 
Surgery: A Systematic Review and Meta-Analysis,'' Journal of the 
American Medical Association, vol. 292, no. 14, pp. 1724-1728, 2004.
    7. Dixon, J.B., M.J. Hayden, G.W. Lambert, et al., ``Raised CRP 
Levels in Obese Patients: Symptoms of Depression Have an Independent 
Positive Association,'' Obesity, vol. 16, no. 9, pp. 2010-2015, 2008.

    Dated: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15720 Filed 6-26-12; 8:45 am]
BILLING CODE 4160-01-P