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

Federal Register / Vol. 77, No. 76 / Thursday, April 19, 2012 / Notices 23487 

amended (5 U.S.C. App.), notice is 

hereby given of meetings of the National 

Diabetes and Digestive and Kidney 

Diseases Advisory Council. 

The meetings will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council. 

Date: May 16, 2012. 

Open: 8:30 a.m. to 12 p.m. 

Agenda: To present the Director’s Report 

and other scientific presentations. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, 

Conference Room E1/E2, Bethesda, MD 

20892. 

Closed: 1:45 p.m. to 3:45 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, 

Conference Room E1/E2, Bethesda, MD 

20892. 

Contact Person: Brent B. Stanfield, Ph.D., 

Director, Division of Extramural Activities, 

National Institute of Diabetes and Digestive 

and Kidney Diseases, 6707 Democracy Blvd., 

Room 715, MSC 5452, Bethesda, MD 20892, 

(301) 594–8843, stanfibr@niddk.nih.gov. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council Kidney, Urologic and Hematologic 

Diseases Subcommittee. 

Date: May 16, 2012. 

Open: 1 p.m. to 2:30 p.m. 

Agenda: To review the Division’s scientific 

and planning activities. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, 

Conference Room F1/F2, Bethesda, MD 

20892. 

Closed: 2:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, 

Conference Room F1/F2, Bethesda, MD 

20892. 

Contact Person: Brent B. Stanfield, Ph.D., 

Director, Division of Extramural Activities, 

National Institute of Diabetes and Digestive 

and Kidney Diseases, 6707 Democracy Blvd., 

Room 715, MSC 5452, Bethesda, MD 20892, 

(301) 594–8843, stanfibr@niddk.nih.gov. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council Diabetes, Endocrinology and 

Metabolic Diseases Subcommittee. 

Date: May 16, 2012. 

Open: 3 p.m. to 4 p.m. 

Agenda: To review the Division’s scientific 

and planning activities. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, 

Conference Room E1/E2, Bethesda, MD 

20892. 

Closed: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, 

Conference Room E1/E2, Bethesda, MD 

20892. 

Contact Person: Brent B. Stanfield, Ph.D., 

Director, Division of Extramural Activities, 

National Institute of Diabetes and Digestive 

and Kidney Diseases, 6707 Democracy Blvd., 

Room 715, MSC 5452, Bethesda, MD 20892, 

(301) 594–8843, stanfibr@niddk.nih.gov. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council Digestive Diseases and Nutrition 

Subcommittee. 

Date: May 16, 2012. 

Open: 1 p.m. to 2:15 p.m. 

Agenda: To review the Division’s scientific 

and planning activities. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, 

Conference Room D, Bethesda, MD 20892. 

Closed: 2:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, 

Conference Room D, Bethesda, MD 20892. 

Contact Person: Brent B. Stanfield, Ph.D., 

Director, Division of Extramural Activities, 

National Institute of Diabetes and Digestive 

and Kidney Diseases, 6707 Democracy Blvd., 

Room 715, MSC 5452, Bethesda, MD 20892, 

(301) 594–8843, stanfibr@niddk.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: 

www.niddk.nih.gov/fund/divisions/DEA/ 

Council/coundesc.htm., where an agenda and 

any additional information for the meeting 

will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: April 13, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–9458 Filed 4–18–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Neuroplasticity and 

the Maternal Brain. 

Date: April 30, 2012. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Rockville, MD 20852, 

(Telephone Conference Call). 

Contact Person: Sherry L. Dupere, Ph.D., 

Director, Division of Scientific Review, 

Division of Scientific Review, Eunice 

Kennedy Shriver National Institute of Child 

Health and Human Development, NIH, 6100 

Executive Blvd., Room 5B01, Bethesda, MD 

20892, 301–451–3415, duperes@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

mstockstill on DSK4VPTVN1PROD with NOTICES