Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Notices 9097 

Agendas after considering comments on 

the drafts. For more information, see the 

link above and choose ‘‘Sector-based 

Approach,’’ ‘‘NORA Sector Councils,’’ 

‘‘Sector Agendas’’ and ‘‘Comment on 

Draft Sector Agendas’’ from the rightside menu. 

Contact Person for Technical 

Information: Sidney C. Soderholm, PhD, 

NORA Coordinator, e-mail 

noracoordinator@cdc.gov, telephone 

(202) 245–0665. 

Dated: February 18, 2009. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–4318 Filed 2–27–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0092] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry and Food and Drug 

Administration Staff; Class II Special 

Controls Guidance Document: 

Automated Blood Cell Separator 

Device Operating by Centrifugal or 

Filtration Separation Principle 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the collection of information concerning 

class II special controls for automated 

blood cell separator device operating by 

centrifugal or filtration separation 

principle. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 1, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Automated Blood Cell Separator Device 

Operating by Centrifugal or Filtration 

Separation Principle (OMB Control 

Number 0910–0594)—Extension 

Under the Safe Medical Devices Act 

of 1990 (Public Law 101–629, 104 Stat. 

4511), FDA may establish special 

controls, including performance 

standards, postmarket surveillance, 

patient registries, guidelines, and other 

appropriate actions it believes necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

The special control guidance serves to 

support the reclassification from class 

III to class II of the automated blood cell 

separator device operating on a 

centrifugal separation principle 

intended for the routine collection of 

blood and blood components as well as 

the special control for the automated 

blood cell separator device operating on 

a filtration separation principle 

intended for the routine collection of 

blood and blood components 

reclassified as class II (§ 864.9245 (21 

CFR 864.9245)). 

For currently marketed products not 

approved under the premarket approval 

process, the manufacturer should file 

with FDA for 3 consecutive years an 

annual report on the anniversary date of 

the device reclassification from class III 

to class II or, on the anniversary date of 

the section 510(k) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360) clearance. Any subsequent 

change to the device requiring the 

submission of a premarket notification 

in accordance with section 510(k) of the 

act should be included in the annual 

report. Also, a manufacturer of a device 

determined to be substantially 

equivalent to the centrifugal or 

filtration-based automated cell separator 

device intended for the routine 

collection of blood and blood 

components, should comply with the 

same general and special controls. 

The annual report should include, at 

a minimum, a summary of anticipated 

and unanticipated adverse events that 

have occurred and that are not required 

to be reported by manufacturers under 

Medical Device Reporting (MDR) (part 

803 (21 CFR part 803)). The reporting of 

adverse device events summarized in an 

annual report will alert FDA to trends 

or clusters of events that might be a 

safety issue otherwise unreported under 

the MDR regulation. 

Reclassification of this device from 

class III to class II for the intended use 

of routine collection of blood and blood 

components relieves manufacturers of 

the burden of complying with the 

premarket approval requirements of 

section 515 of the act (21 U.S.C. 360e), 

and may permit small potential 

competitors to enter the marketplace by 

reducing the burden. Although the 

special control guidance recommends 

that manufacturers of these devices file 

with FDA an annual report for 3 

consecutive years, this would be less 

burdensome than the current 

postapproval under part 814, subpart E 

(21 CFR part 814, subpart E), including 


erowe on PROD1PC63 with NOTICES
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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