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 

(http://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

Reporting Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Annual Report 4 1 4 5 20 

1There 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. 

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 

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 


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