Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting, 1395-1396 [2010-173]
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Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Notices
verified from the grantee records to
support the information outlined in the
FSR.
Failure to submit required reports
within the time allowed may result in
suspension or termination of an active
grant, withholding of additional awards
for the project, or other enforcement
actions such as withholding of
payments or converting to the
reimbursement method of payment.
Continued failure to submit required
reports may result in one or both of the
following: (1) The imposition of special
award provisions; and (2) the nonfunding or non-award of other eligible
projects or activities. This applies
whether the delinquency is attributable
to the failure of the grantee organization
or the individual responsible for
preparation of the reports.
C. FY 2007 and FY 2008 Single Audit
Reports (OMB A–133)
Applicants who have an active SDPI
grant are required to be up-to-date in the
submission of required audit reports.
These are the annual financial audit
reports required by OMB A–133, audits
of State, local governments, and nonprofit organizations that are submitted.
Documentation of (or proof of
submission) of current FY 2007 and FY
2008 Financial Audit Reports is
mandatory. Acceptable forms of
documentation include: e-mail
confirmation from FAC that audits were
submitted; or face sheets from audit
reports. Face sheets can be found on the
FAC Web site: https://harvester.census.
gov/fac/dissem/accessoptions.html?
submit=Retrieve+Records.
Telecommunication for the hearing
impaired is available at: TTY (301) 443–
6394.
srobinson on DSKHWCL6B1PROD with NOTICES
VII. Agency Contacts
• For Grants Budget Management,
contact:
• Denise Clark, Lead Grants
Management Specialist, DGO
(denise.clark@ihs.gov), Division of
Grants Operations, 801 Thompson
Avenue, TMP, Suite 360, Rockville, MD
20852. (301) 443–5204.
• For Grants.gov electronic
application process, contact:
• Tammy Bagley, Grants Policy, DGP
(tammy.bagley@ihs.gov), (301) 443–
5204. Grants Policy Web site: https://
www.ihs.gov/NonMedicalPrograms/
gogp/index.cfm?module=gogp_funding.
• For programmatic questions,
contact:
• Merle Mike, Program Assistant,
DDTP (merle.mike@ihs.gov), (505) 248–
4182.
VerDate Nov<24>2008
16:06 Jan 08, 2010
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• Lorraine Valdez, Deputy Director,
DDTP (s.lorraine.valdez@ihs.gov), (505)
248–4182.
• Area Diabetes Consultants Web site:
https://www.ihs.gov/MedicalPrograms/
diabetes/index.cfm?module=peopleADC
Directory.
Dated: December 22, 2009.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2010–149 Filed 1–8–10; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0606]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of a meeting of
the General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee. This meeting was
announced in the Federal Register of
November 17, 2009 (74 FR 59194). The
amendment is being made to reflect a
change in the Contact Person and
Procedure portions of the document,
and to provide notice of the availability
of a docket for public comment. There
are no other changes.
FOR FURTHER INFORMATION CONTACT:
Margaret McCabe-Janicki, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., White Oak 66, rm.
1535, Silver Spring, MD 20993, 301–
796–7029, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512519. Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In FR Doc.
E9–27491, appearing on page 59194, in
the Federal Register of Tuesday,
November 17, 2009, the following
corrections are made:
1. On page 59194, in the second
column, under Contact Person, the first
six lines ‘‘Peter L. Hudson, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., White Oak 66, rm.
3618, Silver Spring, MD 20993, 301–
796–6440 or FDA Advisory’’ are
removed and replaced with ‘‘Margaret
PO 00000
Frm 00063
Fmt 4703
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1395
McCabe-Janicki, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Avenue., White Oak 66, rm. 1535, Silver
Spring, MD 20993, 301–796–7029, or
FDA Advisory’’.
2. On page 59194, in the third
column, a Comments portion is added
before the Agenda portion of the
document to read: ‘‘Comments: FDA is
opening a docket for public comment on
this document. The docket number is
FDA–2009–N–0606. The docket will
open for public comment on January 11,
2010. The docket will close on March
19, 2010. Interested persons may submit
electronic or written comments
regarding this document. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management, Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.’’
3. On pages 59194 and 59195,
beginning on page 59194 in the third
column, under Procedure, the year
‘‘2009’’ is changed to read ‘‘2010’’
everywhere that it appears.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: January 5, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–172 Filed 1–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Cardiovascular and Renal 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.
E:\FR\FM\11JAN1.SGM
11JAN1
srobinson on DSKHWCL6B1PROD with NOTICES
1396
Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Notices
Name of Committee: Cardiovascular
and Renal 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 March 1, 2010, from 8 a.m. to
5 p.m.
Location: Hilton Washington DC/
Silver Spring, Maryland Ballroom, 8727
Colesville Road, Silver Spring, MD. The
hotel telephone number is 301–589–
5200.
Contact Person: Elaine Ferguson,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane, (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
elaine.ferguson@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512533. 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 March 1, 2010, the
committee will discuss biologics license
application (BLA) 125288, for belatacept
injectable, by Bristol Myers Squibb, to
be used in patients with kidney
transplants to prevent rejection of the
transplanted kidney.
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 12, 2010.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
VerDate Nov<24>2008
16:06 Jan 08, 2010
Jkt 220001
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 4, 2010. 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 5, 2010.
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 Elaine
Ferguson 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/Advisory
Committees/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 5, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–173 Filed 1–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
The General Hospital and Personal Use
Devices Panel of the Medical Devices
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
(FDA). The meeting will be open to the
public.
Name of Committee: General Hospital
and Personal Use Devices Panel of the
Medical Devices 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 March 5, 2010, from 8 a.m. to
5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons C, D and E,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Tracy Phillips, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512520. 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 March 5, 2010, the
committee will discuss and make
recommendations regarding clinical
risks and benefits of post-market actions
in response to insulin pump failures.
Insulin pumps are intended for
continuous delivery of insulin at set and
variable rates and as an aid in the
management of diabetes mellitus in
persons requiring insulin.
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 22, 2010.
Oral presentations from the public will
be scheduled immediately following
E:\FR\FM\11JAN1.SGM
11JAN1
]]>Agencies
[Federal Register Volume 75, Number 6 (Monday, January 11, 2010)]
[Notices]
[Pages 1395-1396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-173]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Cardiovascular and Renal 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.
[[Page 1396]]
Name of Committee: Cardiovascular and Renal 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 March 1, 2010, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, Maryland Ballroom,
8727 Colesville Road, Silver Spring, MD. The hotel telephone number is
301-589-5200.
Contact Person: Elaine Ferguson, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD
20857, 301-827-7001, FAX: 301-827-6776, e-mail:
elaine.ferguson@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512533. 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 March 1, 2010, the committee will discuss biologics
license application (BLA) 125288, for belatacept injectable, by Bristol
Myers Squibb, to be used in patients with kidney transplants to prevent
rejection of the transplanted kidney.
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 12, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make 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 4, 2010. 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
5, 2010.
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 Elaine Ferguson 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 5, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-173 Filed 1-8-10; 8:45 am]
BILLING CODE 4160-01-S
