National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 58851 [2012-23379]
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Federal Register / Vol. 77, No. 185 / Monday, September 24, 2012 / Notices
TKELLEY on DSK3SPTVN1PROD with NOTICES
applied the identified criteria in making
recommendations for additional disease
areas to consider.
FDA also welcomes public comment
on the criteria for disease area selection.
These criteria include the following:
• Disease areas that are chronic,
symptomatic, or affect functioning and
activities of daily living;
• Disease areas that reflect a range of
severity;
• Disease areas for which aspects of
the disease are not formally captured in
clinical trials;
• Disease areas that have a severe
impact on identifiable subpopulations
(such as children or the elderly);
• Disease areas that represent a broad
range in terms of size of the affected
population; or
• Disease areas for which there are
currently no therapies or very few
therapies, or the available therapies do
not directly affect how a patient feels,
functions, or survives.
FDA will consider the public
comments received at the public
meeting and through the docket and
post the set of disease areas for FY
2013–2015 on the FDA Web site. By the
end of FY 2015, FDA will initiate a
public process for determining the list
of disease areas for FY 2016–2017.
III. Public Meeting
FDA is holding a public meeting that
will begin FDA’s patient-focused drug
development initiative in PDUFA V.
The purpose of this meeting will be to
obtain public comment on the
preliminary list of potential disease
areas and the criteria used to develop
the list. In addition, recognizing that
there are many more disease areas than
can be addressed in the 20 planned FDA
meetings for PDUFA V, FDA will also
discuss strategies that have already been
pursued by patient and other public
stakeholder collaborations outside of
FDA to address the types of questions
being considered under the PDUFA
patient-focused drug development
effort, to review lessons learned and
identify a roadmap that could be used
by patient-focused private
collaborations going forward.
If you wish to attend this meeting,
please register by email to
PatientFocused@fda.hhs.gov by October
18, 2012. Your email should contain
complete contact information, including
name, title, affiliation, address, email
address, and phone number. Seating
will be limited, so early registration is
recommended. Registration is free and
will be on a first-come, first-served
basis. However, FDA may limit the
number of participants from each
organization based on space limitations.
VerDate Mar<15>2010
18:54 Sep 21, 2012
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Registrants will receive confirmation
once they have been accepted. Onsite
registration on the day of the meeting
will be based on space availability. If
you need special accommodations
because of disability, please contact
Andrea Tan (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the meeting.
Dated: September 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–23454 Filed 9–21–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 a meeting of the
Division of Intramural Research Board
of Scientific Counselors, NIAID.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Allergy and
Infectious Diseases, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Division of Intramural
Research Board of Scientific Counselors,
NIAID.
Date: December 10–12, 2012.
Time: December 10, 2012, 7:45 a.m. to 6:25
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 50, 50 Center Drive, Room 1227/
1233, Bethesda, MD 20892.
Time: December 11, 2012, 7 a.m. to 6:25
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 50, 50 Center Drive, Room 1227/
1233, Bethesda, MD 20892.
Time: December 12, 2012, 7 a.m. to 11 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
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58851
Place: National Institutes of Health,
Building 50, 50 Center Drive, Room 1227/
1233, Bethesda, MD 20892.
Contact Person: Kathryn C. Zoon, Ph.D.,
Director, Division of Intramural Research,
National Institute of Allergy, and Infectious
Diseases, NIH, Building 31, Room 4A30,
Bethesda, MD 20892, 301–496–3006,
kzoon@niaid.nih.gov.
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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 18, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–23379 Filed 9–21–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Cancer Institute Director’s
Consumer Liaison Group.
The meeting will be open to the
public, 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.
Name of Committee: National Cancer
Institute Director’s Consumer Liaison Group.
Date: October 25–26, 2012.
Time: 9 a.m. to 1 p.m.
Agenda: October 25, 2012—Improving
Uptake of Research Findings; October 26,
2012—NCI Update.
Place: National Institutes of Health,
Building 31, 31 Center Drive, C Wing, 6th
Floor, Conference Room 10, Bethesda, MD
20892.
Contact Person: Kelli Marciel, Director,
Office of Advocacy Relations, National
Cancer Institute, National Institutes of
Health, 31 Center Drive, Building 31, Room
10A28, Bethesda, MD 20892, 301–594–3194.
Any interested person may file written
comments with the committee by forwarding
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[Federal Register Volume 77, Number 185 (Monday, September 24, 2012)]
[Notices]
[Page 58851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23379]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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 a meeting of the
Division of Intramural Research Board of Scientific Counselors, NIAID.
The meeting will be closed to the public as indicated below in
accordance with the provisions set forth in section 552b(c)(6), Title 5
U.S.C., as amended for the review, discussion, and evaluation of
individual intramural programs and projects conducted by the National
Institute of Allergy and Infectious Diseases, including consideration
of personnel qualifications and performance, and the competence of
individual investigators, the disclosure of which would constitute a
clearly unwarranted invasion of personal privacy.
Name of Committee: Division of Intramural Research Board of
Scientific Counselors, NIAID.
Date: December 10-12, 2012.
Time: December 10, 2012, 7:45 a.m. to 6:25 p.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institutes of Health, Building 50, 50 Center
Drive, Room 1227/1233, Bethesda, MD 20892.
Time: December 11, 2012, 7 a.m. to 6:25 p.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institutes of Health, Building 50, 50 Center
Drive, Room 1227/1233, Bethesda, MD 20892.
Time: December 12, 2012, 7 a.m. to 11 a.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institutes of Health, Building 50, 50 Center
Drive, Room 1227/1233, Bethesda, MD 20892.
Contact Person: Kathryn C. Zoon, Ph.D., Director, Division of
Intramural Research, National Institute of Allergy, and Infectious
Diseases, NIH, Building 31, Room 4A30, Bethesda, MD 20892, 301-496-
3006, kzoon@niaid.nih.gov.
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.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: September 18, 2012.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-23379 Filed 9-21-12; 8:45 am]
BILLING CODE 4140-01-P
