10052 Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices 

ANNUAL BURDEN ESTIMATES—Continued 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

P&A: Board of Directors (Commissioners)—Chair and Members ................ 60 1 0 .75 45 

P&A: Group Interview with Policymakers and Collaborators ........................ 160 1 2 320 

P&A: Interview with Recipient of Community Education ............................... 100 1 0 .75 75 

P&A: Interview with Clients ........................................................................... 100 1 0 .75 75 

P&A: Self-administered Form ........................................................................ 20 1 8 160 

UCEDD: Interview with Director .................................................................... 20 1 4 80 

UCEDD: Telephone Interview with Current and Graduated Students .......... 100 1 0 .75 75 

UCEDD: Interview with the Consumer Advisory Committee ......................... 60 1 0 .75 45 

UCEDD: Interview with Peer Researchers and Colleagues ......................... 100 1 0 .75 75 

UCEDD: Interview with Recipients of Community Services or Members of 

Organizations/Agencies that are Trained to Provide Community Services 100 1 0 .75 75 

UCEDD: Self-administered Form ................................................................... 20 1 8 160 

Estimated Total Annual Burden 

Hours: 2,065. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: March 4, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–4857 Filed 3–6–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[CFDA#: 93.604] 

Office of Refugee Resettlement 

AGENCY: Office of Refugee Resettlement, 

ACF, DHHS. 

ACTION: Notice of a Noncompetitive 

Successor Award to Utah Health and 

Human Rights Service for Grant Number 

90ZT0059. 

Legislative Authority: ‘‘Torture 

Victims Relief Act (TVRA) of 1998,’’ 

Public Law 105–320 (22 U.S.C. 2152 

note), reauthorized by Public Law 109– 

165 in January 2006. Section 5(a) of the 

law provides: Assistance for Treatment 

of Torture Victims—The Secretary of 

Health and Human Services may 

provide grants to programs in the 

United States to cover the cost of the 

following services: (1) Services for the 

rehabilitation of victims of torture, 

including treatment of the physical and 

psychological effects of torture. (2) 

Social and legal services for victims of 

torture. (3) Research and training for 

health care providers outside of 

treatment centers, or programs for the 

purpose of enabling such providers to 

provide the services described in 

paragraph (1). 

Amount of Award: Remainder of 

current budget period February 1, 2009 

through September 29, 2009. Award 

$152,405. Final budget period of the 

originally approved three-year project 

period September 30, 2008 through 

September 29, 2009. 

Project Period: February 1, 2009– 

September 29, 2009. 

Summary: In FY 2006, ORR awarded 

a competitive Services for Survivors of 

Torture grant to the Tides Center/Utah 

Health and Human Rights Project in Salt 

Lake City, Utah. The original project 

period was from September 30, 2006 

through September 29, 2009. The Tides 

Center served as fiscal sponsor and legal 

entity of the approved project. The 

Tides Center provides essential 

financial, human resources, and 

administrative services to philanthropic 

projects such as the Utah Health and 

Human Rights Project (UHHRP) while 

enabling them to become independent 

agencies. UHHRP has now completed 

the process of becoming an independent 

agency and is formally separating from 

the Tides Center on January 31, 2009. 

The Tides Center has requested 

permission for UHHRP to assume the 

grant. UHHRP has agreed to this request 

and will continue to function with the 

scope and operations of the grant 

remaining unchanged. 

Contact for Further Information: 

Ronald Munia, Director, Division of 

Community Resettlement, Office of 

Refugee Resettlement, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447. Telephone: 202–401–4559. Email: Ronald.Munia@acf.hhs.gov. 

Dated: March 3, 2009. 

Ronald Munia, 

Director, Division of Community 

Resettlement, Office of Refugee Resettlement. 

[FR Doc. E9–4922 Filed 3–6–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0607] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Reclassification 

Petitions for Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 


dwashington3 on PROD1PC60 with NOTICES
Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices 10053 

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 April 8, 

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 0910–0138. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

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. 

Reclassification Petitions for Medical 

Devices—21 CFR Section 860.123 (OMB 

Control Number 0910–0138)—Extension 

FDA has responsibility under sections 

513(e) and (f), 514(b), 515(b), and 520(l) 

of the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360c(e), and (f), 

360d(b), 360e(b), and 360j(l)) and part 

860 (21 CFR part 860), subpart C, to 

collect data and information contained 

in reclassification petitions. The 

reclassification provisions of the act 

allow any person to petition for 

reclassification of a device from any one 

of the three classes i.e, I, II, and III, to 

another class. The reclassification 

procedure regulation requires the 

submission of specific data when a 

manufacturer is petitioning for 

reclassification. This includes a 

‘‘Supplemental Data Sheet,’’ Form FDA 

3427, and a ‘‘Classification 

Questionnaire,’’ Form FDA 3429. Both 

forms are a series of questions 

concerning the safety and effectiveness 

of the device type. Further, the 

reclassification content regulation 

(§ 860.123) requires the submission of 

sufficient, valid scientific evidence 

demonstrating that the proposed 

reclassification will provide a 

reasonable assurance of safety and 

effectiveness of the device type for its 

indications for use. Thus, the 

reclassification provisions of the act 

serve primarily as a vehicle for 

manufacturers to seek reclassification 

from a higher to a lower class, thereby 

reducing the regulatory requirements 

applicable to a particular device type, or 

to seek reclassification from a lower to 

a higher class, thereby increasing the 

regulatory requirements. The 

reclassification petitions requesting 

classification from class III to class II or 

class I, if approved, provides an 

alternative route to the market in lieu of 

premarket approval for class III devices 

or from class I or II, to one or the other 

class, which may increase requirements. 

In the Federal Register of December 4, 

2008 (73 FR 73938), 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: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

860.123 6 1 6 500 3,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on the last 3 years, and actual 

reclassification petitions received, FDA 

anticipates that six petitions will be 

submitted each year. The time required 

to prepare and submit a reclassification 

petition, including the time needed to 

assemble supporting data, averages 500 

hours per petition. This average is based 

upon estimates by FDA administrative 

and technical staff that: (1) Are familiar 

with the requirements for submission of 

a reclassification petition, (2) have 

consulted and advised manufacturers on 

these requirements, and (3) have 

reviewed the documentation submitted. 

Dated: March 2, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4829 Filed 3–6–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0098] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Evaluation of 

Potential Data Sources for the Sentinel 

Initiative 

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 and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the proposed information collection 

through a survey designed to identify 

potential data sources and/or data 

environments that could participate in 

the Sentinel Initiative to create a 

national, electronic distributed system, 

strengthening FDA’s ability to monitor 

the postmarket performance of a 

medical product. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 8, 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 


dwashington3 on PROD1PC60 with NOTICES