Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting, 36548-36549 [2012-14814]
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36548
Federal Register / Vol. 77, No. 118 / Tuesday, June 19, 2012 / Notices
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
No. of respondents
No. of responses per
respondent
Total annual
responses
Average burden per response
........................
........................
........................
........................
Activity
Total ..............................................................................
1 There
5,450
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
srobinson on DSK4SPTVN1PROD with NOTICES
Total hours
The following references have been
placed 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. (FDA has verified the
Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Report of the FDA Retail Food
Program Steering Committee. Database
of Foodborne Illness Risk Factors (2000).
Available at: https://www.fda.gov/
downloads/Food/FoodSafety/Retail
FoodProtection/FoodborneIllnessand
RiskFactorReduction/
RetailFoodRiskFactorStudies/
ucm123546.pdf.
2. FDA Report on the Occurrence of
Foodborne Illness Risk Factors in
Selected Institutional Foodservice,
Restaurant, and Retail Food Store
Facility Types (2004). Available at:
https://www.fda.gov/Food/FoodSafety/
RetailFoodProtection/FoodborneIllness
andRiskFactorReduction/
RetailFoodRiskFactorStudies/
ucm089696.htm.
3. FDA Report on the Occurrence of
Foodborne Illness Risk Factors in
Selected Institutional Foodservice,
Restaurant, and Retail Food Store
Facility Types (2009). Available at:
https://www.fda.gov/downloads/Food/
FoodSafety/RetailFoodProtection/
FoodborneIllnessand
RiskFactorReduction/
RetailFoodRiskFactorStudies/
UCM224682.pdf.
4. FDA National Retail Food Team.
FDA Trend Analysis Report on the
Occurrence of Foodborne Illness Risk
Factors in Selected Institutional
Foodservice, Restaurant, and Retail
Food Store Facility Types (1998–2008).
Available at: https://www.fda.gov/
downloads/Food/FoodSafety/RetailFood
Protection/FoodborneIllnessand
RiskFactorReduction/
RetailFoodRiskFactorStudies/
UCM224152.pdf.
5. FDA Model Food Code. Available
at: https://www.fda.gov/Food/
FoodSafety/RetailFoodProtection/
FoodCode/default.htm.
VerDate Mar<15>2010
16:39 Jun 18, 2012
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Dated: June 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14850 Filed 6–18–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Dermatologic and Ophthalmic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Dermatologic
and Ophthalmic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 26, 2012, from 8 a.m. to 5
p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (Rm. 1503), 10903
New Hampshire Avenue, Silver Spring,
MD 20993–0002. Information regarding
special accommodations due to a
disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver
Spring, MD 20993–0002, (301) 796–
9001, Fax: (301) 847–8533, email:
DODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
PO 00000
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Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On July 26, 2012, during the
morning session, the committee will
discuss a supplement to biologics
license application (BLA) 125156 for
LUCENTIS (ranibizumab) injection by
Genentech, Inc., for the treatment of
diabetic macular edema (DME).
Ranibizumab injection is currently
approved for the treatment of
neovascular (wet) age-related macular
degeneration (AMD) and macular edema
following retinal vein occlusion (RVO).
During the afternoon session, the
committee will discuss new biologics
license application (BLA) 125422,
ocriplasmin intravitreal injection
(proposed tradename, Jetrea) by
ThromboGenics, Inc., indicated for the
treatment of symptomatic vitreomacular
adhesions (sVMA) including macular
hole.
FDA intends to make background
materials available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 13, 2012. Oral
presentations from the public will be
scheduled between approximately 10
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19JNN1
Federal Register / Vol. 77, No. 118 / Tuesday, June 19, 2012 / Notices
a.m. to 10:30 a.m., and 3 p.m. to 3:30
p.m. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before July 6, 2012. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 9, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Yvette
Waples at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 12, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–14814 Filed 6–18–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSK4SPTVN1PROD with NOTICES
Health Resources and Services
Administration
Advisory Committee on Infant
Mortality; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Infant
Mortality (ACIM).
VerDate Mar<15>2010
16:39 Jun 18, 2012
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Dates and Times: July 10, 2012,
8:30 a.m.–6:00 p.m.; July 11, 2012,
8:30 a.m.–3:00 p.m.
Place: DoubleTree by Hilton
Bethesda, 8120 Wisconsin Avenue,
Bethesda, MD 20814, (301) 652–2000.
Status: The meeting is open to the
public with attendance limited to space
availability.
Purpose: The Committee provides
advice and recommendations to the
Secretary of Health and Human Services
on the following: Department of Health
and Human Services’ programs that
focus on reducing infant mortality and
improving the health status of infants
and pregnant women; and factors
affecting the continuum of care with
respect to maternal and child health
care. It includes outcomes following
childbirth; strategies to coordinate the
myriad of Federal, state, local and
private programs and efforts that are
designed to deal with the health and
social problems impacting on infant
mortality; and the implementation of
the Healthy Start Program and Healthy
People 2020 infant mortality objectives.
Agenda: Topics that will be discussed
include the following: HRSA Update;
MCHB Update; Healthy Start Program
Update; and, Update on HHS National
Strategy to Address Infant Mortality.
Proposed agenda items are subject to
change as priorities dictate.
Time will be provided for public
comments limited to 5 minutes each.
Comments are to be submitted in
writing no later than 5:00 p.m. ET on
June 26, 2012.
For Further Information Contact:
Anyone requiring information regarding
the Committee should contact Michael
C. Lu, M.D., M.P.H., Executive
Secretary, ACIM, Health Resources and
Services Administration, Room 18–05,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857, Telephone: (301)
443–2170.
Individuals who are submitting public
comments or who have questions
regarding the meeting and location
should contact David S. de la Cruz,
Ph.D., M.P.H., HRSA, Maternal and
Child Health Bureau, telephone: (301)
443–0543, email:
David.delaCruz@hrsa.hhs.gov.
Dated: June 12, 2012.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2012–14825 Filed 6–18–12; 8:45 am]
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36549
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Nursing Workforce Diversity
Invitational Summit—‘‘Nursing in 3D:
Workforce Diversity, Health
Disparities, and Social Determinants of
Health’’
Department of Health and
Human Services, Health Resources and
Services Administration (HRSA).
ACTION: Notice of meeting.
AGENCY:
HRSA’s Bureau of Health
Professions, Division of Nursing, will
host an invitational summit that focuses
on Nursing Workforce Diversity (NWD),
Health Disparities, and the Social
Determinants of Health. The goal of this
summit is to convene experts, thought
leaders, and key workforce diversity
stakeholders to identify the full range of
academic and health system factors, as
well as the social, economic, political,
and environmental determinants that
influence our ability to diversify the
nursing workforce. The goal of the
summit is to utilize the social
determinants of health frameworks to
examine the impact of workforce
diversity on health disparities. These
activities will inform a broader and
formal evaluation of the NWD program.
DATES: Meetings will be held from 7:30
a.m. to 5:00 p.m. on August 16, 2012,
and from 8:00 a.m. to 1:00 p.m. on
August 17, 2012.
ADDRESSES: Meetings will be held at the
Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: For
more information, please contact
Kristen Hansen, MHSA, RN, NE–BC,
Nurse Consultant, Nursing Practice and
Workforce Development Branch,
Division of Nursing, Bureau of Health
Professions, Health Resources and
Services Administration, 5600 Fishers
Lane, Parklawn Building, Room 9–61,
Rockville, MD 20857; telephone:
301.443.2796; email: KHansen@hrsa.gov
SUPPLEMENTARY INFORMATION:
Status: The summit will be open to
the public. Seating is on a first-come,
first-serve basis.
Purpose: The purpose of the summit
is to identify the full range of academic
and health system factors, as well as the
social, economic, political, and
economic determinants that influence
our ability to diversify the nursing
workforce. The goal of the summit is to
utilize the social determinants of health
framework to examine the impact of
SUMMARY:
E:\FR\FM\19JNN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 118 (Tuesday, June 19, 2012)]
[Notices]
[Pages 36548-36549]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14814]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Dermatologic and Ophthalmic Drugs Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on July 26, 2012, from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus, Building 31, the Great Room, White
Oak Conference Center (Rm. 1503), 10903 New Hampshire Avenue, Silver
Spring, MD 20993-0002. Information regarding special accommodations due
to a disability, visitor parking, and transportation may be accessed
at: https://www.fda.gov/AdvisoryCommittees/default.htm; under the
heading ``Resources for You,'' click on ``Public Meetings at the FDA
White Oak Campus.'' Please note that visitors to the White Oak Campus
must enter through Building 1.
Contact Person: Yvette Waples, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31-
2417, Silver Spring, MD 20993-0002, (301) 796-9001, Fax: (301) 847-
8533, email: DODAC@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On July 26, 2012, during the morning session, the committee
will discuss a supplement to biologics license application (BLA) 125156
for LUCENTIS (ranibizumab) injection by Genentech, Inc., for the
treatment of diabetic macular edema (DME). Ranibizumab injection is
currently approved for the treatment of neovascular (wet) age-related
macular degeneration (AMD) and macular edema following retinal vein
occlusion (RVO).
During the afternoon session, the committee will discuss new
biologics license application (BLA) 125422, ocriplasmin intravitreal
injection (proposed tradename, Jetrea) by ThromboGenics, Inc.,
indicated for the treatment of symptomatic vitreomacular adhesions
(sVMA) including macular hole.
FDA intends to make background materials available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
13, 2012. Oral presentations from the public will be scheduled between
approximately 10
[[Page 36549]]
a.m. to 10:30 a.m., and 3 p.m. to 3:30 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before July 6, 2012. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by July 9, 2012.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Yvette Waples at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 12, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-14814 Filed 6-18-12; 8:45 am]
BILLING CODE 4160-01-P
