Delaware River and Bay Oil Spill Advisory Committee; Meeting, 9098-9099 [E9-4351]
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9098
Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Notices
the submission of periodic reports
under § 814.84.
Collecting or transfusing facilities and
manufacturers have certain
responsibilities under the Federal
regulations. For example, collecting or
transfusing facilities are required to
maintain records of any reports of
complaints of adverse reactions (21 CFR
606.170), while the manufacturer is
responsible for conducting an
investigation of each event that is
reasonably known to the manufacturer
and evaluating the cause of the event
(§ 803.50(b)). In addition, manufacturers
of medical devices are required to
submit to FDA individual adverse event
reports of death, serious injury, and
malfunctions (§ 803.50).
In the special control guidance
document, FDA recommends that
manufacturers include in their three
annual reports a summary of adverse
reactions maintained by the collecting
or transfusing facility or similar reports
of adverse events collected in addition
to those required under the MDR
regulation. The MedWatch medical
device reporting code instructions
(https://www.fda.gov/cdrh/mdr/
373.html) contains a comprehensive list
of adverse events associated with device
use, including most of those events that
we recommend summarizing in the
annual report.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Reporting Activity
Annual Report
1There
4
Total Annual
Responses
1
Hours per
Response
4
Total Hours
5
20
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are
approximately four manufactures of
automated blood cell separator devices.
We estimate that the manufacturers will
spend approximately 5 hours preparing
and submitting the annual report.
Other burden hours required for
§ 864.9245 are reported and approved
under OMB control number 0910–0120
(premarket notification submission
501(k), 21 CFR part 807, subpart E), and
OMB control number 0910–0437 (MDR).
Dated: February 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4315 Filed 2–27–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Part C Early Intervention Services
Grant
AGENCY: Health Resources and Services
Administration, HHS.
ACTION: Notice of non-competitive
program expansion supplemental
award.
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Annual Frequency
per Response
SUMMARY: The Health Resources and
Services Administration (HRSA) will be
providing temporary critical HIV
medical care and treatment services
through the Greenwood Leflore Hospital
(GLH) Magnolia Medical Clinic to avoid
a disruption of HIV clinical care to
clients in Bolivar, Sunflower and
Washington Counties in Mississippi.
SUPPLEMENTARY INFORMATION: Intended
recipient of the award: GLH Magnolia
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12:24 Feb 27, 2009
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Medical Clinic, Greenwood,
Mississippi.
Amount of the Award: $73,125 to
ensure ongoing clinical services to the
target population.
Authority: Section 2651 of the Public
Health Service Act, 42 U.S.C. 300ff–51.
CFDA Number: 93.918.
Period of Support: The period of
supplemental support is from April 1,
2009 to June 30, 2009.
Justification for the Exception to
Competition:
Critical funding for HIV medical care
and treatment services to clients in
Bolivar, Sunflower and Washington
Counties in Mississippi will be
continued through a non-competitive
program expansion supplement to an
existing grant award to the GLH
Magnolia Medical Clinic in Greenwood,
Mississippi. This is a temporary award
because the previous grant recipient
serving this population notified HRSA
that it would not continue in the
program. GLH Magnolia Medical clinic
is the best qualified grantee for this
supplement since it serves many of the
former grantee’s patients and is the
closest Part C Ryan White HIV/AIDS
Program to the former grantee. Further
funding beyond June 30, 2009 for this
service area will be competitively
awarded during the next Part C HIV
Early Intervention Service competing
application process for FY 2009.
FOR FURTHER INFORMATION CONTACT:
Kathleen Treat, via email
ktreat@hrsa.gov, or via telephone, 301–
443–0493.
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Dated: February 22, 2009.
Elizabeth M. Duke,
Administrator.
[FR Doc. E9–4277 Filed 2–27–09; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2008–0333]
Delaware River and Bay Oil Spill
Advisory Committee; Meeting
Coast Guard, DHS.
Notice of meeting.
AGENCY:
ACTION:
SUMMARY: The Delaware River and Bay
Oil Spill Advisory Committee
(DRBOSAC) will meet in Philadelphia,
PA to discuss various issues to improve
oil spill prevention and response
strategies for the Delaware River and
Bay. This meeting will be open to the
public.
DATES: The Committee will meet on
Wednesday, March 18, 2009, from 10
a.m. to 1 p.m. Written material and
requests to make oral presentations
should reach the Coast Guard on or
before March 11, 2009. Requests to have
a copy of your material distributed to
each member of the committee should
reach the Coast Guard on or before
March 11, 2009.
ADDRESSES: The Committee will meet at
Coast Guard Sector Delaware Bay, 1
Washington Ave., Philadelphia, PA
19147. Send written material and
requests to make oral presentations to
Gerald Conrad, liaison to the Designated
Federal Officer (DFO) of the DRBOSAC,
at the address above. This notice and
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Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Notices
any documents identified in the
Supplementary Information section as
being available in the docket may be
viewed online, at https://
www.regulations.gov, using docket
number USCG–2008–0333.
Dated: February 22, 2009.
David L. Scott,
Captain, U.S. Coast Guard, Commander,
Sector Delaware Bay, Designated Federal
Officer.
[FR Doc. E9–4351 Filed 2–27–09; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
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Gerald Conrad, liaison to the DFO of the
DRBOSAC, telephone 215–271–4824.
Notice of
this meeting is given under the Federal
Advisory Committee Act, 5 U.S.C. App.
(Pub. L. 92–463).
SUPPLEMENTARY INFORMATION:
Agenda of the Meeting
The agenda for the meeting will be as
follows:
(1) Opening comments.
(2) Introductions.
(3) Administrative announcements.
(4) Debriefs from each DRBOSAC Subcommittee.
(5) Future Committee business.
(6) Closing.
More information and detail on the
meeting will be available at the
committee Web site, located at https://
www.uscg.mil/d5/sectDelawarebay/
DRBOSAC.asp. Additional detail may
be added to the agenda up to March 11,
2009.
Procedural
This meeting will be open to the
public. All persons entering the
building will have to present
identification and may be subject to
screening. Please note that the meeting
may close early if all business is
finished.
The public will be able to make oral
presentations during the meeting when
given the opportunity to do so. The
public may file written statements with
the committee; written material should
reach the Coast Guard no later than
March 11, 2009. If you would like a
copy of your material distributed to
each member of the committee in
advance of the meeting, please submit
35 copies to the liaison to the DFO no
later than March 11, 2009.
Please register your attendance with
the liaison to the DFO no later than
March 11, 2009.
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Information on Services for Individuals
With Disabilities
For information on facilities, or
services for individuals with
disabilities, or to request special
assistance at the meeting, contact the
Liaison to the DFO as soon as possible.
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DEPARTMENT OF HOMELAND
SECURITY
United States Immigration and
Customs Enforcement
Agency Information Collection
Activities: Extension of an Existing
Information Collection; Comment
Request
30-Day Notice of Information
Collection Under Review; Form G–79A,
Information Relating to Beneficiary of
Private Bill; OMB Control No. 1653–
0026.
ACTION:
The Department of Homeland
Security, U.S. Immigration and Customs
Enforcement (USICE), has submitted the
following information collection request
for review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on December 4, 2008 Vol. 73
No. 234 73951, allowing for a 60 day
public comment period. No comments
were received on this information
collection.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted for thirty days
April 1, 2009.
Written comments and suggestions
from the public and affected agencies
regarding items contained in this notice
and especially with regard to the
estimated public burden and associated
response time should be directed to the
Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to OMB Desk Officer, for United States
Immigration and Customs Enforcement,
Department of Homeland Security, and
sent via electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–6974.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information should address one or more
of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
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(2) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of This Information
Collection
(1) Type of Information Collection:
Extension of a currently approved
information collection.
(2) Title of the Form/Collection:
Information Relating to Beneficiary of
Private Bill.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form G–79A.
U.S. Immigration and Customs
Enforcement.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
Households. The information collected
on the Form G–79A is necessary for U.S.
Immigration and Customs Enforcement
(ICE) to provide reports to Congress on
Private Bills when requested.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 100 responses at 60 minutes (1
hour) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 100 annual burden hours.
Requests for a copy of the proposed
information collection instrument, with
instructions; or inquiries for additional
information should be directed to:
Joseph M. Gerhart, Chief, Records
Management Branch; U.S. Immigration
and Customs Enforcement, 500 12th
Street, SW., Room 3138, Washington,
DC 20536; (202) 732–6337.
Dated: February 24, 2009.
Joseph M. Gerhart,
Chief, Records Management Branch, U.S.
Immigration and Customs Enforcement,
Department of Homeland Security.
[FR Doc. E9–4294 Filed 2–27–09; 8:45 am]
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Agencies
[Federal Register Volume 74, Number 39 (Monday, March 2, 2009)]
[Notices]
[Pages 9098-9099]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4351]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
[Docket No. USCG-2008-0333]
Delaware River and Bay Oil Spill Advisory Committee; Meeting
AGENCY: Coast Guard, DHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The Delaware River and Bay Oil Spill Advisory Committee
(DRBOSAC) will meet in Philadelphia, PA to discuss various issues to
improve oil spill prevention and response strategies for the Delaware
River and Bay. This meeting will be open to the public.
DATES: The Committee will meet on Wednesday, March 18, 2009, from 10
a.m. to 1 p.m. Written material and requests to make oral presentations
should reach the Coast Guard on or before March 11, 2009. Requests to
have a copy of your material distributed to each member of the
committee should reach the Coast Guard on or before March 11, 2009.
ADDRESSES: The Committee will meet at Coast Guard Sector Delaware Bay,
1 Washington Ave., Philadelphia, PA 19147. Send written material and
requests to make oral presentations to Gerald Conrad, liaison to the
Designated Federal Officer (DFO) of the DRBOSAC, at the address above.
This notice and
[[Page 9099]]
any documents identified in the Supplementary Information section as
being available in the docket may be viewed online, at https://
www.regulations.gov, using docket number USCG-2008-0333.
FOR FURTHER INFORMATION CONTACT: Gerald Conrad, liaison to the DFO of
the DRBOSAC, telephone 215-271-4824.
SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463).
Agenda of the Meeting
The agenda for the meeting will be as follows:
(1) Opening comments.
(2) Introductions.
(3) Administrative announcements.
(4) Debriefs from each DRBOSAC Sub-committee.
(5) Future Committee business.
(6) Closing.
More information and detail on the meeting will be available at the
committee Web site, located at https://www.uscg.mil/d5/sectDelawarebay/
DRBOSAC.asp. Additional detail may be added to the agenda up to March
11, 2009.
Procedural
This meeting will be open to the public. All persons entering the
building will have to present identification and may be subject to
screening. Please note that the meeting may close early if all business
is finished.
The public will be able to make oral presentations during the
meeting when given the opportunity to do so. The public may file
written statements with the committee; written material should reach
the Coast Guard no later than March 11, 2009. If you would like a copy
of your material distributed to each member of the committee in advance
of the meeting, please submit 35 copies to the liaison to the DFO no
later than March 11, 2009.
Please register your attendance with the liaison to the DFO no
later than March 11, 2009.
Information on Services for Individuals With Disabilities
For information on facilities, or services for individuals with
disabilities, or to request special assistance at the meeting, contact
the Liaison to the DFO as soon as possible.
Dated: February 22, 2009.
David L. Scott,
Captain, U.S. Coast Guard, Commander, Sector Delaware Bay, Designated
Federal Officer.
[FR Doc. E9-4351 Filed 2-27-09; 8:45 am]
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