Part C Early Intervention Services Grant, 9098 [E9-4277]
Download as PDF
<![CDATA[
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]
BILLING CODE 4160–01–S
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.
erowe on PROD1PC63 with NOTICES
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
VerDate Nov<24>2008
12:24 Feb 27, 2009
Jkt 217001
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.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Dated: February 22, 2009.
Elizabeth M. Duke,
Administrator.
[FR Doc. E9–4277 Filed 2–27–09; 8:45 am]
BILLING CODE 4165–15–P
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
E:\FR\FM\02MRN1.SGM
02MRN1
]]>Agencies
[Federal Register Volume 74, Number 39 (Monday, March 2, 2009)]
[Notices]
[Page 9098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4277]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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.
Dated: February 22, 2009.
Elizabeth M. Duke,
Administrator.
[FR Doc. E9-4277 Filed 2-27-09; 8:45 am]
BILLING CODE 4165-15-P
