Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Notices 67489 

CFSR PERMANENCY OUTCOME 1—Continued 

Current CFSR data measures and standards associated with CFSR

Permanency Outcome 1 Proposed composites to be associated with Permanency Outcome 1 

Timeliness of adoption measure and national standard: of all children 

exiting foster care to a finalized adoption, 32.0 percent or more 

achieved a finalized adoption within 24 months of the time of entry 

into foster care.

Permanency Composite 2: Timeliness of adoption. A national standard 

will be established from the data composite scores resulting from 

States’ performance on the areas incorporated in the composite. 

Some possible performance areas to be included in the composite 

are: 

• Performance area 1: Timeliness of adoptions of children discharged 

from foster care to a finalized adoption. 

• Performance area 2: Timeliness of adoptions of children who are in 

foster care for 17 months or longer at the start of a fiscal year. 

• Performance area 3: Timeliness of adoptions of children for whom 

parental rights had been terminated. 

• Performance area 4: Timeliness of achieving termination of parental 

rights for children who have been in foster care for 17 months or 

more at the start of a fiscal year. 

Placement stability measure and national standard: of all children in 

foster care who have been in care for less than 12 months, 86.7 percent or more had no more than 2 placement settings.

Permanency Composite 3: Placement stability. A national standard will 

be established from the data composite scores resulting from States’

performance on the area incorporated in the composite. Some possible performance areas to be included in the composite are: 

• Performance area 1: Stability of children’s placement experience 

during the first year in foster care. 

• Performance area 2: Stability of children’s placement experience for 

children in foster care for longer than 12 months. 

No national standard measure. Information captured in the case review 

instrument.

Permanency Composite 4: Achieving Permanency for Children in Foster Care. A national standard will be established from the data composite scores resulting from States’ performance on the areas incorporated in the composite. Some possible performance areas to be 

included in the composite are: 

• Performance area 1: The extent to which children are growing up in 

foster care. 

• Performance area 2: Timeliness of establishing permanency goals. 

• Performance area 3: The extent to which children with TPR exit foster care to a permanent family. 

[FR Doc. 05–22095 Filed 11–4–05; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005G–0367] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Low Energy Ultrasound Wound 

Cleaner; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Low Energy Ultrasound 

Wound Cleaner.’’ This guidance 

document has been developed as a 

special control guidance document to 

support the classification of the low 

energy ultrasound wound cleaner into 

class II (special controls). The device is 

intended for the cleaning and 

maintenance debridement of wounds. 

This guidance document describes a 

means by which the low energy 

ultrasound wound cleaner may comply 

with the requirement of special controls 

for class II devices. Elsewhere in this 

issue of the Federal Register, FDA is 

publishing a final rule to classify the 

low energy ultrasound wound cleaner 

into class II (special controls). The 

guidance document is immediately in 

effect as the special control for the low 

energy ultrasound wound cleaner, but it 

remains subject to comment in 

accordance with the agency’s good 

guidance practices (GGPs). 

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Low Energy Ultrasound Wound 

Cleaner’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance (HFZ–220), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–443–

8818. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, 

rm.1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

David B. Berkowitz, Center for Devices 

and Radiological Health (HFZ–410), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–3090, ext. 152. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The guidance document ‘‘Class II 

Special Controls Guidance Document: 

Low Energy Ultrasound Wound 

Cleaner’’ has been developed as a 

67490 Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Notices 

special control guidance document to 

support the classification of the low 

energy ultrasound wound cleaner into 

class II (special controls). This device is 

intended for the cleaning and 

maintenance debridement of wounds. 

On April 29, 2004, Celleration, Inc., 

submitted a petition requesting 

classification of the Celleration MIST 

Therapy SystemTM under section 

513(f)(2) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360c(f)(2)). 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying the low energy ultrasound 

wound cleaner into class II (special 

controls) under section 513(f)(2) of the 

act. This guidance document will serve 

as the special control for the low energy 

ultrasound wound cleaner device. 

Section 513(f)(2) of the act provides that 

any person who submits a premarket 

notification under section 510(k) of the 

act (21 U.S.C. 360(k)) for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under criteria set 

forth in section 513(a)(1) of the act. FDA 

shall, within 60 days of receiving such 

a request, classify the device by written 

order. This classification shall be the 

initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. Because 

of the timeframes established by section 

513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that is not feasible to 

allow for public participation before 

issuing this guidance as a final guidance 

document. Therefore, FDA is issuing 

this guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s GGPs regulation 

in § 10.115. The guidance represents the 

agency’s current thinking on the low 

energy ultrasound wound cleaner for 

the cleaning and maintenance 

debridement of wounds. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

To receive ‘‘Class II Special Controls 

Guidance Document: Low Energy 

Ultrasound Wound Cleaner’’ by fax, call 

the CDRH Facts-On-Demand system at 

800–899–0381 or 301–827–0111 from a 

touch-tone telephone. Press 1 to enter 

the system. At the second voice prompt, 

press 1 to order a document. Enter the 

document number 1302 followed by the 

pound sign (#). Follow the remaining 

voice prompts to complete your request. 

Persons interested in obtaining a copy 

of the guidance may also do so by using 

the Internet. CDRH maintains an entry 

on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

USC 3501–3520). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with PRA under the 

regulations governing premarket 

notification submissions (21 CFR part 

807, subpart E, OMB control number 

0910–0120). The labeling provisions 

addressed in the guidance have been 

approved by OMB under OMB control 

number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: October 5, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–22069 Filed 11–4–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

DEPARTMENT OF AGRICULTURE 

Food Safety Inspection Service 

[Docket No. 05–013N] 

Meeting To Discuss Possible Changes 

to the Regulatory Jurisdiction of 

Certain Food Products Containing 

Meat and Poultry 

AGENCIES: Food and Drug 

Administration, HHS; Food Safety 

Inspection Service, USDA. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA), in the 

Department of Health and Human 

Services, and the Food Safety Inspection 

Service (FSIS), in the United States 

Department of Agriculture (USDA), are 

jointly announcing a public meeting to 

discuss and solicit information on an 

approach for providing consistency and 

predictability with respect to which of 

the two agencies should have 

jurisdiction over certain types of food 

products that contain meat and poultry 

as ingredients, as well as the opening of 

a joint agency docket to receive written 

comments. This notice outlines that 

approach and solicits comments on it 

and on the specific questions asked in 

section II below. 

DATES: The public meeting will be held 

on December 15, 2005, from 10 a.m. to 

4 p.m. 

ADDRESSES: The public meeting will be 

held at the Donald E. Stephens 

Convention Center, 5555 North River 

Road, Rosemont, IL 60018, 847–692–

0222. 

You may submit comments, identified 

with Docket No. 05–013N, by any of the 

following methods: 

• Electronic mail: 

FSIS: FSIS 

regulationsComments@fsis.usda.gov. 

Follow the instructions for submitting 

comments on the Agency’s Web site.