Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 4566-4567 [2012-1889]
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4566
Federal Register / Vol. 77, No. 19 / Monday, January 30, 2012 / Notices
What other considerations should be
taken into account in connection with
such a conversion?
3. What other steps must your
organization take in order to be
prepared to smoothly transition into a
role as administrator of a new temporary
reinsurance program?
4. Does your organization operate
nationally or in limited geographic
areas? If the latter, what are the
geographic areas?
5. Would your organization be able
and willing to contract with a State
and/or the Federal government to
operate a temporary reinsurance
program?
6. Are there any State and/or local
licensing requirements that must be
considered by an organization operating
as such a reinsurance entity?
7. What potential conflicts of interest
(COIs) could arise if your organization
were to operate such a reinsurance
program as a not-for-profit entity? How
might these COIs be mitigated?
8. For organizations that do not
currently have COI mitigation programs,
what steps would have to be taken to
develop and execute such a program?
9. What is a reasonable amount of
time for your organization to become
fully operational (for example, have all
systems in place to operate a
reinsurance program) after the date of a
contract award? What resources would
be necessary?
emcdonald on DSK29S0YB1PROD with NOTICES
Collection and Disbursement of
Reinsurance Funds
10. Describe your organization’s
ability to perform the following
functions:
• Collecting reinsurance
contributions;
• Accepting and validating requests
for reinsurance payments;
• Remitting reinsurance payments;
and,
• Reconciling and verifying
reinsurance contributions and
payments.
11. What services related to the
collection of reinsurance contributions,
or disbursement of reinsurance
payments to another entity would your
organization need to subcontract due to
a lack of capacity, expertise, or
experience?
12. What COIs could arise for such
potential subcontractors?
Data Collection
13. Describe current data systems that
are used by your organization, including
any standards, security systems, and
web-based interactive structure. Are
your systems compliant or have the
capability of being Section 508
VerDate Mar<15>2010
15:09 Jan 27, 2012
Jkt 226001
compliant (https://www.section508.
gov/)?
14. Do your organization’s current
data systems have the capability to
interface with external systems to accept
data and reports? If yes, what types of
interfaces are currently in place?
15. What data are currently collected
by your organization related to medical
costs?
16. What is your organization’s
current capacity for collecting and
verifying claims submissions from
issuers? What processes does your
organization have in place to ensure
confidentiality and security protections
of patient information?
17. In what formats does your
organization currently collect data? Can
your organization support other
formats? If so, which ones?
18. Would your organization need to
subcontract any services related to data
collection?
19. What COIs could arise for such
subcontractors?
Customer Support
20. What telecommunication and
technical support systems does your
organization currently maintain for
health insurance issuers or other
commercial clients (for example, Web
sites, 24-hour hotlines, helpdesk)?
21. Are your support systems
compliant or have the capability of
being Section 508 compliant (https://
www.section508.gov/)?
22. Would your organization need to
subcontract any services related to data
collection?
23. What COIs could arise for such
subcontractors?
Evaluation
24. Does your organization currently
conduct evaluations of operations and
activities? Do such evaluations include
a financial assessment of your
organization’s activities?
25. What are your organization’s
current financial and data reconciliation
processes?
Authority: Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
Hospital Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program.
Dated: January 20, 2012.
Charles Littleton,
Contracting Officer, Office of Acquisition and
Grants Management, Centers for Medicare
and Medicaid Services.
[FR Doc. 2012–1944 Filed 1–27–12; 8:45 am]
BILLING CODE 4120–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Pulmonary-Allergy 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: PulmonaryAllergy 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 February 23, 2012, from 8:30
a.m. to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), 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: Nicole Vesely, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, (301)
796–9001, Fax: (301) 847–8533, email:
PADAC@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: The committee will discuss
new drug application 202450, for
aclidinium bromide, sponsored by
Forest Laboratories, for the proposed
E:\FR\FM\30JAN1.SGM
30JAN1
emcdonald on DSK29S0YB1PROD with NOTICES
Federal Register / Vol. 77, No. 19 / Monday, January 30, 2012 / Notices
indication of long-term maintenance
treatment of bronchospasm associated
with chronic obstructive pulmonary
disease, including chronic bronchitis
and emphysema.
FDA intends to make background
material 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 February 8, 2012.
Oral presentations from the public will
be scheduled between approximately
1 p.m. and 2 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 January
31, 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 February 1, 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 Nicole
Vesely 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
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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: January 24, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–1889 Filed 1–27–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Blood Products 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: Blood Products
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
DATES: Date and Time: The meeting will
be held on February 29, 2012, from 8:30
a.m. to 4 p.m.
Location: Hilton Washington DC
North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877, (301) 977–
8900. For those unable to attend in
person, the meeting will also be Web
cast. The Blood Products Advisory
Committee Web cast will be available at
https://fda.yorkcast.com/webcast/
Viewer/?peid=11253ea88
a9041e5a91883236f342bfc1d.
Contact Person: Bryan Emery or Pearl
Muckelvene, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
(301) 827–1281, 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
PO 00000
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4567
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On February 29, 2012, the
committee will discuss the evaluation of
possible new plasma products
manufactured following storage at room
temperature for up to 24 hours, namely,
plasma for transfusion prepared from
whole blood held at room temperature
for up to 24 hours prior to separation
and freezing, or from apheresis plasma
held at room temperature for up to 24
hours before freezing. In the afternoon,
the committee will hear the following
updates: Report from the Health and
Human Services Advisory Committee
on Blood Safety and Availability and
summary of the December 5–6, 2011,
meeting; update on HHS activities
related to the evaluation of the donor
deferral policy for men who have had
sex with other men; summary of the
November 8–9, 2011, public workshop
on hemoglobin standard and
maintaining an adequate blood supply;
summary of the November 29, 2011,
public workshop on data and data needs
to advance risk assessment for emerging
infectious diseases for blood and blood
products; and an update on thrombotic
adverse events and immune globulin
products.
FDA intends to make background
material 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 February 21, 2012.
Oral presentations from the public will
be scheduled between approximately
11:15 a.m. and 12:45 p.m. on February
29, 2012. 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 February 13, 2012. Time
allotted for each presentation may be
E:\FR\FM\30JAN1.SGM
30JAN1
]]>Agencies
[Federal Register Volume 77, Number 19 (Monday, January 30, 2012)]
[Notices]
[Pages 4566-4567]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1889]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Pulmonary-Allergy 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: Pulmonary-Allergy 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 February 23, 2012, from
8:30 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), 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: Nicole Vesely, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002, (301) 796-9001, Fax: (301)
847-8533, email: PADAC@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: The committee will discuss new drug application 202450, for
aclidinium bromide, sponsored by Forest Laboratories, for the proposed
[[Page 4567]]
indication of long-term maintenance treatment of bronchospasm
associated with chronic obstructive pulmonary disease, including
chronic bronchitis and emphysema.
FDA intends to make background material 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
February 8, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 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 January 31, 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 February 1, 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 Nicole Vesely 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: January 24, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1889 Filed 1-27-12; 8:45 am]
BILLING CODE 4160-01-P
