38196 Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by August 31, 2009 to: SAMHSA 

Desk Officer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503; due to potential delays in OMB’s 

receipt and processing of mail sent 

through the U.S. Postal Service, 

respondents are encouraged to submit 

comments by fax to: 202–395–6974. 

Dated: July 27, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–18313 Filed 7–30–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0092] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by August 31, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0594. Also 

include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

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 

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 

events that have occurred and that are 

not required to be reported by 

manufacturers under MDR. 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. 

In the Federal Register of March 2, 

2009 (74 FR 9097), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 


PWALKER on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 38197 

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: July 24, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18354 Filed 7–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: National Evaluation of the 

Comprehensive Community Mental 

Health Services for Children and Their 

Families Program: Phase VI–NEW 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA) Center for Mental Health 

Services is responsible for the national 

evaluation of the Comprehensive 

Community Mental Health Services for 

Children and Their Families Program 

(Children’s Mental Health Initiative— 

CMHI) that will collect data on child 

mental health outcomes, family life, and 

service system development and 

performance. Data will be collected on 

26 service systems, and approximately 

5,541 children and families. 

Data collection for this evaluation will 

be conducted over a five-year period. 

Child and family outcomes of interest 

will be collected at intake and during 

subsequent follow-up sessions at sixmonth intervals. The length of time that 

individual families will participate in 

the study ranges from 12 to 24 months 

depending upon when they enter the 

evaluation. The outcome measures 

include the following: Child 

symptomatology and functioning, 

family functioning, satisfaction, and 

caregiver strain. The core of service 

system data will be collected every 18– 

24 months throughout the 5-year 

evaluation period, with a sustainability 

survey conducted in years 3 and 5. 

Service utilization and cost data will be 

tracked and submitted to the national 

evaluation every six months using two 

tools, the Flex Fund Tool and the 

Services and Costs Data Tool, to 

estimate average cost of treatment per 

child, distribution of costs, and 

allocation of costs across service 

categories. Service delivery and system 

variables of interest include the 

following: Maturity of system of care 

development in funded system of care 

communities, adherence to the system 

of care program model, and client 

service experience. We will also 

conduct a comprehensive evaluation of 

the CMHI’s data driven technical 

assistance; this component of the 

evaluation will employ a mixedmethods approach, combining 

qualitative and quantitative data to 

provide a comprehensive assessment of 

the continuous quality improvement 

(CQI) process in funded system of care 

communities. Specifically, data will be 

gathered through three complementary 

activities: A baseline survey of key 

constituents in all funded communities; 

a subsequent monitoring survey 

administered every two years to the 

same constituents; and biennial case 

studies of four selected communities. 

In addition, the evaluation will 

include three special studies: (1) The 

sector specific assessment and quasiexperimental comparison study will 

examine in more detail the outcomes 

and service experience of children from 

multiple child-serving sectors and, 

through child-level matching, compare 

these outcomes with those not receiving 

system of care services; (2) The Alumni 

Network Study will examine the 

effectiveness of the system of care 

Alumni Network Web site by evaluating 

end-user satisfaction and usability of the 

Web site and will also assess the 

collaboration between communities via 

a Web-based Networking and 

Collaboration Survey that will measure 

the nature and extent of the interaction 

between communities; (3) The Study of 

State Strategies for Sustainability will 

examine the state’s role in sustaining 

communities after federal funding 

ceases and describe effective strategies 

for sustaining funded systems of care. A 

short version of the sustainability 

survey developed for this evaluation 

will be used to gather this information. 

Internet-based technology such as 

Web-based surveys and data entry and 

management tools will be used in this 

evaluation. The measures of the national 

evaluation address the national outcome 

measures for mental health programs as 

currently established by SAMHSA. 

The average annual respondent 

burden is estimated below. The estimate 

reflects the average number of 

respondents in each respondent 

category, the average number of 

responses per respondent per year, the 

average length of time it will take to 

complete each response, and the total 

average annual burden for each category 

of respondent, and for all categories of 

respondents combined. 


PWALKER on DSK8KYBLC1PROD with NOTICES