23484 Federal Register / Vol. 77, No. 76 / Thursday, April 19, 2012 / Notices 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: OPRE Reports Clearance Officer. 

All requests should be identified by the 

title of the information collection. Email 

address: 

OPREinfocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Email: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: April 12, 2012. 

Steven M. Hanmer, 

OPRE Reports Clearance Officer. 

[FR Doc. 2012–9303 Filed 4–18–12; 8:45 am] 

BILLING CODE 4184–22–M 

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. 

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 patientadvocacy 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 preferenceelicitation survey will ask obese 

individuals (with a body mass index of 

30 kg/m2 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 

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Federal Register / Vol. 77, No. 76 / Thursday, April 19, 2012 / Notices 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

Survey instrument Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

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 

1There 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: Payerand 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. Sjo ̈ stro ̈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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA 2012–N–0001] 

Food and Drug Administration Patient 

Network Annual Meeting; Input Into 

Food and Drug Administration BenefitRisk Decisionmaking: Opportunities 

and Challenges; Hosted by the Food 

and Drug Administration Office of 

Special Health Issues; Notice of 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing a meeting for 

patients, caregivers, independent 

patient advocates and patient advocate 

groups, and health professional groups 

to explore ways to more effectively 

include patient input in regulatory 

decisionmaking on drug, device, and 

biological products. The meeting will 

serve as a forum for FDA’s patient 

stakeholders and the general public, 

including health professionals, 

academia, and industry to learn about 

the regulatory process related to the 

medical product life cycle, analyze 

where in the process patient input may 

be most practical and most valuable, 

and explore practicable approaches to 

collecting and incorporating meaningful 

input that well represents broad patient 

perspectives into regulatory decisions. 

DATES: Date and Time: The meeting will 

be held on May 18, 2012, from 9 a.m. 

to 4:30 p.m. Register at http:// 

fda.contractmeetings.com/home on or 

before May 4, 2012. Please include the 

name and title of the person attending, 

the name of the organization, the role 

within the organization, email address, 

and telephone number. There is no 

registration fee for this conference. Early 

registration is suggested because space 

is limited. We request that organizations 

limit the number of representatives to 

two. For further registration information 

or problems with the Web site, call 

Cindy de Sales, 1–240–316–3200, ext. 

207. 

If you need special accommodations 

due to a disability, please contact Steve 

Morin at least 7 days in advance. 

Location: The meeting will be held at 

the FDA White Oak Campus, 10903 

New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503) Silver Spring, MD 20993. 

Contact Person: Steve Morin, Office of 

Special Health Issues, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–0161, FAX: 301–847– 

8623, Steve.Morin@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. FDA Patient Network 

This is the inaugural FDA Patient 

Network Annual Meeting hosted by the 

FDA Office of Special Health Issues, the 

Agency’s liaison to the patient and 

health professional communities. This 

annual meeting is being hosted in 

conjunction with the launch of the 

overarching FDA Patient Network 

program. The FDA Patient Network is a 

new resource for patients, caregivers, 

independent patient advocates, and 

patient advocate groups that seek to: 

• Educate and inform patient 

stakeholders about FDA, its regulatory 

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