National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings, 23486-23487 [2012-9458]
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Federal Register / Vol. 77, No. 76 / Thursday, April 19, 2012 / Notices
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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?
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(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?
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]
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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?
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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
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mstockstill on DSK4VPTVN1PROD with NOTICES
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.,
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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,
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23487
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)
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]]>Agencies
[Federal Register Volume 77, Number 76 (Thursday, April 19, 2012)]
[Notices]
[Pages 23486-23487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9458]
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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
[[Page 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
