Document ID: FDA-2012-N-0357-0001
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: 2012-04-19T04:00Z

[Federal Register Volume 77, Number 76 (Thursday, April 19, 2012)]
[Notices]
[Pages 23484-23485]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9435]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the survey entitled ``Medical Device 
Decision Analysis: A Risk-Tolerance Pilot Study.''

DATES: Submit either electronic or written comments on the collection 
of information by June 18, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the 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. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

[[Page 23485]]

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.
    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 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: April 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9435 Filed 4-18-12; 8:45 am]
BILLING CODE 4160-01-P