Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices 58973 

for 3,000 trials of drugs and biologics 

and 445 trials of medical devices each 

year. Each initial registration is 

estimated to take 7 hours and each of 

the subsequent 8 updates to the record 

are estimated to take 2 hours, resulting 

in an annual burden of 79,235 hours. It 

is estimated that there will be voluntary 

submissions of registration information 

for 6,000 trials of drugs and biologics, 

545 trials of devices, and 5,280 trials of 

other types of medical interventions. 

Using the same hour estimates as for 

mandatory registration, the burden 

associated with voluntary registrations 

is estimated at 271,975 hours, bringing 

the total registration burden to 351,210 

hours. In the first year of operation, it 

is estimated that there will be an 

additional burden of 84,150 hours 

associated with the updating of 

information for 7,000 trials of drugs and 

biologics and 650 trials of medical 

devices that were previously registered 

in the databank and ongoing as of 

December 26, 2007 (90 days after 

enactment). It is estimated that such 

trials will require one update of 3 hours 

to bring them into compliance with the 

new law (FDAAA) and 4 subsequent 

updates of 2 hrs each. Results reporting 

is required only for those applicable 

clinical trials of drugs, biologics, and 

devices that are subject to the 

mandatory registration requirements of 

FDAAA and for which the product(s) 

under study have been approved or 

cleared by the FDA. It is estimated that 

results reporting will be required for 

1,645 trials of drugs and biologics and 

375 trials of medical devices each year. 

Initial submission of results information 

is estimated to require 10 hours, and 

each result submission is expected to 

require two updates that take 5 hours 

each. The total burden for results 

reporting is therefore estimated at 

40,400 hours per year. There are no 

capital costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: David Sharlip, 

National Library of Medicine, Building 

38A, Room B2N12, 8600 Rockville Pike, 

Bethesda, MD 20894, or call non-toll 

free number 301–402–9680 or E-mail 

your request to sharlipd@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: September 30, 2008. 

Betsy L. Humphreys, 

Deputy Director, National Library of 

Medicine, National Institutes of Health. 

[FR Doc. E8–23790 Filed 10–7–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Refugee Resettlement 

Replacement Grant Award 

CFDA#: 93.576. 

AGENCY: Office of Refugee Resettlement, 

ACF, DHHS. 

ACTION: Notice to award a replacement 

grant to Catholic Charities of Tennessee, 

Inc. 

SUMMARY: In Fiscal Year 2005, in an 

effort to assist local school systems that 

were being strained by the arrivals of 

large numbers of refugee children, The 

Office of Refugee Resettlement (ORR) 

awarded, through competition, a 

Refugee School Impact grant to the 

Tennessee Department of Human 

Services, Nashville, TN, for a project 

period of August 15, 2005 through 

August 14, 2010. The Tennessee 

Department of Human Services served 

as the fiscal sponsor and legal entity for 

the project. As of June 30, 2008, the 

Tennessee Department of Human 

Services relinquished the grant. Catholic 

Charities of Tennessee, Inc., Nashville, 

TN, is now awarded a non-competitive 

replacement grant to continue to 

provide services under the Refugee 

School Impact project. Services 

provided under the grant to Catholic 

Charities of Tennessee, Inc., are within 

the scope and operation of the original 

award. Under the award, Catholic 

Charities of Tennessee, Inc., is eligible 

apply for a non-competitive 

continuation award for the period of 

August 15, 2009 through August 14, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Pamela Green-Smith, Director, Division 

of Refugee Assistance, Office of Refugee 

Resettlement, 370 L’Enfant Promenade, 

SW., Washington, DC 20447. Telephone: 

202–401–4531. E-mail: 

Pamela.Greensmith@acf.hhs.gov 

SUPPLEMENTARY INFORMATION: 

Legislative Authority: This program is 

authorized by Section 412 (c)(1)(A)(iii), 

as amended of the Immigration and 

Nationality Act (8 U.S.C. 1522 

(c)(1)(A)(iii)) and covers the following 

Services: (1) English as a Second 

Language instruction (2) After-school 

tutorials focused on helping students 

understand and complete programs that 

encourage high school completion and 

full participation in school activities (3) 

After-school summer programs that 

support remedial work or promote 

school readiness (4) Parental 

involvement programs (5) Interpreter 

services for parent/teacher meetings and 

conferences and (6) Bi-lingual/bicultural counselors and aides. 

Amount of Award: $224,834.76. 

Project Period: August 15, 2008— 

August 14, 2010. 

Dated: October 1, 2008. 

Pamela Green-Smith, 

Director, Division of Refugee Assistance, 

Office of Refugee Resettlement. 

[FR Doc. E8–23774 Filed 10–7–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2008–1006] 

National Offshore Safety Advisory 

Committee; Meeting 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of meeting. 

SUMMARY: The National Offshore Safety 

Advisory Committee (NOSAC) will 

meet, in New Orleans, LA, to discuss 

various issues relating to offshore safety 

and security. The meeting will be open 

to the public. 

DATES: NOSAC will meet on Thursday, 

November 13, 2008, from 9 a.m. to 3 

p.m. The meeting may close early if all 

business is finished. Written material 

and requests to make oral presentations 

should reach the Coast Guard on or 

before October 30, 2008. Requests to 


jlentini on PROD1PC65 with NOTICES
58974 Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices 

have a copy of your material distributed 

to each member of the committee 

should reach the Coast Guard on or 

before October 30, 2008. 

ADDRESSES: NOSAC will meet in the 

Versailles Ballroom of the Hilton New 

Orleans Riverside Hotel, 2 Poydras 

Street, New Orleans, Louisiana. Send 

written material and requests to make 

oral presentations to Commander P.W. 

Clark, Designated Federal Officer, 

Commandant (CG–5222), U.S. Coast 

Guard Headquarters, 2100 Second 

Street, SW., Washington, DC 20593– 

0001. This notice is available on our 

online docket, USCG–2008–0188, at 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Commander P.W. Clark, Designated 

Federal Officer (previously referred to as 

Executive Director) of NOSAC, or Mr. 

Jim Magill, Assistant Designated Federal 

Officer (previously referred to as 

Assistant Executive Director), telephone 

202–372–1414, fax 202–372–1926. 

SUPPLEMENTARY INFORMATION: Notice of 

the meeting is given under the Federal 

Advisory Committee Act, 5 U.S.C. App. 

(Pub. L. 92–463). 

Agenda of Meeting 

The agenda for the November 13, 

2008, committee meeting includes the 

following: 

(1) Report on issues concerning the 

International Maritime Organization 

(IMO) and the International 

Organization for Standardization. 

(2) Revision of 46 CFR, Subchapter V, 

Subpart B—Commercial Diving 

Operations. 

(3) MARPOL Annex II 

Implementation for New and Existing 

Offshore Supply Vessels (OSVs). 

(4) Sandblasting standard for OCS 

facilities. 

(5) Evacuation of Injured Workers 

from remote Drilling and Production 

Facilities. 

(6) Transportation Worker 

Identification Credential (TWIC) impact 

on offshore facilities. 

(7) Effect of Hurricane IKE on OCS 

facilities. 

(8) Licensing of Large OSVs. 

(9) The LA 1 Project—New Access 

Road to GOM. 

(10) Information regarding notice of 

arrival on the U.S. Outer Continental 

Shelf. 

Procedural 

The meeting is open to the public. 

Please note that the meeting may close 

early if all business is finished. At the 

Chair’s discretion, members of the 

public may make oral presentations 

during the meeting. If you would like to 

make an oral presentation at the 

meeting, please notify the Designated 

Federal Officer no later than October 30, 

2008. Written material for distribution 

at the meeting should reach the Coast 

Guard no later than October 30, 2008. If 

you would like a copy of your material 

distributed to each member of the 

committee in advance of the meeting, 

please submit 25 copies to the 

Designated Federal Officer no later than 

October 30, 2008. 

Information on Services for Individuals 

With Disabilities 

For information on facilities or 

services for individuals with disabilities 

or to request special assistance at the 

meeting, contact the Executive Director 

as soon as possible. 

Dated: October 2, 2008. 

Howard L. Hime, 

Acting Director of Commercial Regulations 

and Standards. 

[FR Doc. E8–23772 Filed 10–7–08; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5191–N–32] 

Notice of Proposed Information 

Collection: Comment Request; Single 

Family Mortgage Insurance on 

Hawaiian Homelands 

AGENCY: Office of the Assistant 

Secretary for Housing—Federal Housing 

Commissioner, HUD. 

ACTION: Notice. 

SUMMARY: The proposed information 

collection requirement described below 

will be submitted to the Office of 

Management and Budget (OMB) for 

review, as required by the Paperwork 

Reduction Act. The Department is 

soliciting public comments on the 

subject proposal. 

DATES: Comments Due Date: December 

8, 2008. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

Control Number and should be sent to: 

Lillian Deitzer, Departmental Reports 

Management Officer, QDAM, 

Department of Housing and Urban 

Development, 451 7th Street, SW., 

Washington, DC 20410; e-mail 

Lillian_L._Deitzer@HUD.gov or 

telephone (202) 402–8048. 

FOR FURTHER INFORMATION CONTACT: 

Margaret E. Burns, Director, Office of 

Single Family Program Development, 

Department of Housing and Urban 

Development, 451 7th Street, SW., 

Washington, DC 20410, telephone (202) 

708–2121 (this is not a toll free number) 

for copies of the proposed forms and 

other available information. 

SUPPLEMENTARY INFORMATION: The 

Department is submitting the proposed 

information collection to OMB for 

review, as required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

Chapter 35, as amended). 

This Notice is soliciting comments 

from members of the public and affected 

agencies concerning the proposed 

collection of information to: (1) Evaluate 

whether the proposed collection is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information; (3) Enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) Minimize the 

burden of the collection of information 

on those who are to respond; including 

the use of appropriate automated 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submission of responses. 

This Notice also lists the following 

information: 

Title of Proposal: Single Family 

Mortgage Insurance on Hawaiian 

Homelands. 

OMB Control Number, if applicable: 

2502–0358. 

Description of the need for the 

information and proposed use: FHA 

insures mortgages on single family 

dwellings under various provisions of 

the National Housing Act (12 U.S.C. 

1701, et seq.). The Housing and Urban 

Rural Recovery Act (HURRA), Pub. L. 

98–181, amended the National Housing 

Act to add Section 247 to permit FHA 

to insure mortgages for properties 

located on Hawaiian Homelands. Under 

this program, the mortgagor must be a 

Native Hawaiian. Section 247 requires 

that that the Department of Hawaiian 

Homelands (DHHL) of the State of 

Hawaii (a) Will be a co-mortgagor; (b) 

guarantees or reimburses the Secretary 

for any mortgage insurance claims paid 

in connection with a property on 

Hawaiian homelands; or (c) offers other 

security acceptable to the Secretary. The 

collection of information and the 

regulatory origins for them are in 

accordance with Section 203.43i which 

states that the lender will: (a) Verify that 

the loan applicant is a native Hawaiian 

and that the applicant holds a lease on 

land in a Hawaiian Homelands area; (b) 

report on delinquent borrowers in 


jlentini on PROD1PC65 with NOTICES