Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 38195 

of the public the opportunity to provide 

comments to the Board. Public 

participation and ability to comment 

will be limited to time and space 

available. Public comment will be 

limited to no more than 3 minutes per 

speaker. To be placed on the public 

participant list, you should notify the 

operator when you enter the call-in 

number. 

Any members of the public who wish 

to have printed material distributed to 

the NBSB should submit materials via 

email at NBSB@HHS.GOV, with ‘‘NBSB 

Public Comment’’ as the subject line, 

prior to the close of business one week 

before each meeting (conference call). A 

draft agenda and any additional 

materials/agendas will be posted on the 

NBSB Web site (HTTP:// 

WWW.HHS.GOV/ASPR/OMSPH/NBSB/) 

prior to the meeting. 

Dated: July 24, 2009. 

Nicole Lurie, 

Assistant Secretary for Preparedness and 

Response, Rear Admiral, U.S. Public Health 

Service. 

[FR Doc. E9–18372 Filed 7–30–09; 8:45 am] 

BILLING CODE 4150–37–P 

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: Drug and Alcohol Services 

Information System (DASIS)—(OMB 

No. 0930–0106)—Revision 

The DASIS consists of three related 

data systems: the Inventory of Substance 

Abuse Treatment Services (I–SATS); the 

National Survey of Substance Abuse 

Treatment Services (N–SSATS), and the 

Treatment Episode Data Set (TEDS). The 

I–SATS includes all substance abuse 

treatment facilities known to SAMHSA. 

The N–SSATS is an annual survey of all 

substance abuse treatment facilities 

listed in the I–SATS. The TEDS is a 

compilation of client-level admission 

data and discharge data submitted by 

States on clients treated in facilities that 

receive State funds. Together, the three 

DASIS components provide information 

on the location, scope and 

characteristics of all known drug and 

alcohol treatment facilities in the United 

States, the number of persons in 

treatment, and the characteristics of 

clients receiving services at publicly 

funded facilities. This information is 

needed to assess the nature and extent 

of these resources, to identify gaps in 

services, to provide a database for 

treatment referrals, and to assess 

demographic and substance-related 

trends in treatment. In addition, several 

National Outcome Measures (NOMS) 

data elements are collected in TEDS to 

assess the performance of the Substance 

Abuse Prevention and Treatment 

(SAPT) Block Grant. 

The request for OMB approval will 

include a request to conduct the 2010 

through 2012 N–SSATS and Mini-N– 

SSATS. The Mini-N–SSATS is a 

procedure for collecting services data 

from newly identified facilities between 

main cycles of the survey and will be 

used to improve the listing of treatment 

facilities in the on-line treatment facility 

Locator. The N–SSATS questionnaire is 

expected to remain unchanged except 

for minor modifications to wording. If 

there is a need for substantial revision 

to the N–SSATS questionnaire during 

the period of this clearance, a 

supplemental request for clearance will 

be submitted. 

The OMB request will also include 

the collection of TEDS data, including 

the addition of two new NOMS data 

elements to the TEDS client-level 

record. To the extent that states already 

collect the elements from their 

treatment providers, the following 

elements will be included in the TEDS 

data collection: Frequency of attendance 

at self-help programs in past 30 days at 

admission; and frequency of attendance 

at self-help programs in past 30 days at 

discharge. No significant changes are 

expected in the other DASIS activities. 

Estimated annual burden for the 

DASIS activities is shown below: 

Type of 

respondent and activity 

Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Total burden 

hours 

States: 

TEDS Admission Data .............................................................................. 52 4 6.25 1,300 

TEDS Discharge Data .............................................................................. 52 4 8.25 1,716 

TEDS Discharge Crosswalks ................................................................... 5 1 10 50 

I–SATS Update 1 ....................................................................................... 56 70 .08 314 

State Subtotal .................................................................................... 56 ........................ ........................ 3,380 

Facilities: 

I–SATS Update 2 ....................................................................................... 200 1 .08 16 

N–SSATS questionnaire ........................................................................... 17,000 1 .67 11,390 

Augmentation screener ............................................................................ 1,000 1 .08 80 

Mini N–SSATS .......................................................................................... 2,000 1 .42 840 

Facility Subtotal ................................................................................. 20,200 ........................ ........................ 12,326 

Total ................................................................................................... 20,256 ........................ ........................ 15,706 

1States forward to SAMHSA information on newly licensed/approved facilities and on changes in facility name, address, status, etc. This is 

submitted electronically by nearly all States. 2Facilities forward to SAMHSA information on new facilities and on changes to existing facilities. This is submitted by e-mail by nearly all 

facilities. 


PWALKER on DSK8KYBLC1PROD with NOTICES
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