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 

mstockstill on DSK4VPTVN1PROD with NOTICES

23486 Federal Register / Vol. 77, No. 76 / Thursday, April 19, 2012 / Notices 

authorities and processes, its initiatives 

and programs, etc.; and, 

• Provide a venue for advocacy for 

patient stakeholders within FDA and be 

transparent to patients about Agency 

actions. 

In addition to an annual meeting, the 

FDA Patient Network consists of other 

activities, including the: 

• FDA Patient Network Web site—A 

new, patient-centered Web site that 

contains educational modules, 

centralized Agency information, and 

multidirectional communication tools; 

• Biweekly FDA Patient Network 

News email newsletter; and hosting of 

periodic meetings, briefings, and 

listening session between patient 

advocates and FDA staff. 

II. Patient Perspectives in Regulatory 

Decisionmaking 

Establishing a means for obtaining 

input from patients and patient 

advocate groups will allow FDA to 

further enhance its benefit-risk 

assessment in regulatory 

decisionmaking. Patients who live with 

a disease have a direct stake in the 

outcomes of the review process and are 

in a unique position to contribute to the 

weighing of benefit-risk considerations 

that can occur throughout the medical 

product development process. Though 

several programs exist that facilitate 

patient representation on Advisory 

Committees or participation in selected 

review meetings, there are currently few 

venues in which the patient perspective 

is discussed outside of a specific 

product’s marketing application review. 

The medical product review process 

could benefit from a more scientific, 

systematic, and expansive approach to 

obtaining input from patients who are 

experiencing a particular disease 

condition. 

As part of the proposed agreements 

for Prescription Drug User Fee Act 

(PDUFA) V, FDA plans to conduct 

meetings with patients and patient 

advocacy groups to gather broader 

patient input. This meeting kicks off 

these efforts and provides an 

opportunity to gain feedback on how 

FDA can best structure these upcoming 

meetings. 

FDA seeks public discussion based on 

the following questions. These 

questions are intended to frame patient 

input at the May 18, 2012, meeting and 

there will be time at the meeting to 

discuss the following issues. 

(1) How can FDA ensure gathering a 

broad range of representative patient 

input that is relevant to a specific 

disease area during its meetings with 

patients? For example, who should 

serve as representatives of patients? 

(2) What methodological and practical 

issues should FDA consider as it 

develops its strategy for eliciting the 

patient perspective? For instance, FDA 

is interested in addressing topics 

including, but not limited to, the 

following: 

(a) Are there particular advantages or 

disadvantages to utilizing face-to-face 

meetings versus web-based or other 

methods in obtaining the patient 

perspective on a particular disease 

condition and its treatment? 

(b) How can FDA ensure that certain 

subpopulations, such as patients with 

the most severe form of the disease, are 

represented? 

III. Center for Drug Evaluation and 

Research and Center for Biologics 

Evaluation and Research Efforts 

Center for Drug Evaluation and 

Research and Center for Biologics 

Evaluation and Research plan to 

conduct a series of patient-focused drug 

development meetings to gather patient 

input on the clinical context of a disease 

and its impact on a patient’s daily life. 

These considerations, which would 

include an analysis of the severity of the 

disease condition and the current state 

of the available treatment options, can 

be critical in regulatory decisionmaking. 

FDA is interested in obtaining patient 

input on the context of specific disease 

areas through the patient-focused drug 

development meetings. The following 

questions are examples of topics for 

which FDA believes the patient 

perspective could add valuable insight. 

They are presented in this document for 

general discussion at the Patient 

Network Conference. 

A. Understanding the Disease Condition 

(1) What are the clinical 

manifestations of the disease that have 

the greatest impact on patients? 

(2) Are there other aspects of the 

disease that have a significant impact on 

a patient’s daily life? (e.g., impaired 

mobility, sleep problems, etc.) 

(3) How do the clinical manifestations 

change with disease progression? 

(4) How do the other aspects of the 

disease change with disease 

progression? 

B. Assessment of Treatment Options 

(1) How effective are approved 

therapies at treating the clinical 

manifestations of the disease? 

(2) How well do approved therapies 

mitigate the other aspects of the disease? 

(3) How does the effectiveness of 

approved therapies change with 

progression of the disease? 

(4) Does therapy effectiveness vary by 

patient subpopulation? 

FDA is continuing to make plans for 

its efforts and will be able to provide 

more detail on the patient-focused drug 

development meetings at the Patient 

Network Conference. 

IV. Center for Devices and Radiologic 

Health Efforts 

Center for Devices and Radiologic 

Health is interested in a public 

discussion on issues related to risk 

associated with medical products, and 

on avenues for patients to provide input 

into regulatory decisionmaking related 

to the amount of risk patients may be 

willing to accept in exchange for a 

potential treatment benefit. The 

following questions are presented in 

this document for general discussion at 

the Patient Network Conference. 

(1) How do patients perceive and 

weigh risks associated with medical 

treatment in light of the risk associated 

with the underlying condition being 

treated and the potential benefit from 

the treatment? 

(2) Under what circumstances and in 

which populations would various levels 

of risk be appropriate/acceptable? 

(3) How can medical device 

companies, government, academia, 

community physicians and patients 

collaborate to account for the level of 

risk acceptable to patients affected by 

serious or life threatening illnesses? 

(4) What mechanisms would be 

appropriate for patients to provide input 

into regulatory decisionmaking for new 

therapeutic and diagnostic products— 

e.g., web-based survey instruments? 

Patient representation at advisory 

committee meetings? Patient input to 

medical device companies during 

clinical trial design? Who (FDA, patient 

advocate groups, medical device 

companies, etc.) could sponsor such 

surveys? 

(5) Are patients willing to accept 

responsibility for the level of risk to 

which they may be exposed if patient 

input increases risk tolerance? 

Dated: April 13, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–9418 Filed 4–18–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

mstockstill on DSK4VPTVN1PROD with NOTICES