Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67931

this guidance was approved under OMB 

Control No. 0910–0001 and 0910–0032.

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on these topics. 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 statutes and regulations.

II. Comments

Interested persons may at any time 

submit to the Division of Dockets 

Management written or electronic 

comments on the guidance (see 

ADDRESSES). 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. The guidance and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: November 13, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–25748 Filed 11–19–04; 8:45 am]

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

eriodically, the Health Resources and 

Services Administration (HRSA) publi 

tracts of information collection requests 

under review by the Office of 

Management and Budget, in compliance 

with the Paperwork Reduction Act of 

1995 (44 U.S.C. Chapter 35). To request 

a copy of the clearance requests 

submitted to OMB for review, call the 

HRSA Reports Clearance Office on (301) 

443–1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: The Division of 

Independent Review Grant Reviewer 

Recruitment Form—New 

HRSA’s Division of Independent 

Review (DIR) is responsible for carrying 

out the independent review of all 

eligible applications submitted to 

HRSA. DIR ensures that the 

independent review process is efficient, 

effective, economical and complies with 

statutes, regulations and policies. The 

review of applications is performed by 

people knowledgeable in the field of 

endeavor for which support is requested 

and is advisory to individuals in HRSA 

responsible for making award decisions. 

To streamline the collection, selection 

and assignment of grant reviewers to 

independent review committees, HRSA 

will utilize a Web-based data collection 

form to gather critical reviewer 

information. The Grant Reviewer 

Recruitment Form will standardize 

pertinent categories of reviewer 

information, such as areas of expertise, 

occupations, work settings, reviewer 

experience, and allow maximum use of 

drop-down menus to simplify for the 

data collection process. All selfnominated reviewers will be channeled 

to the Grant Reviewer Recruitment 

Form. DIR anticipates a monthly volume 

of approximately 100 self-nominated 

responses. On a periodic basis, existing 

HRSA reviewers will be notified and 

directed to update their profile (via the 

Grant Reviewer Recruitment Form). 

HRSA maintains a pool of 

approximately 5,000 individuals that 

have previously served on HRSA 

independent review committees. DIR 

projects that approximately 3,700 

individuals (or 75% of existing 

reviewers) would comply with 

instructions to update their profile on 

the Web-based Recruitment Form. 

For existing HRSA reviewers, the 

amount of time required to complete the 

Recruitment Form will be abbreviated 

since HRSA will fill in the Form with 

previously collected personal 

information; existing reviewers will 

focus only on updating changes (e.g.,

addresses, employer, expertise, 

occupation) to their profile. The 

estimate of burden for the HRSA Grant 

Reviewer Recruitment Form is as 

follows:

Type of respondent * Number of respondents 

Responses 

per respondent 

Total responses Minutes per 

response 

Total burden 

hours 

New reviewer ....................................................................... 1,200 1 1,200 45 900

Existing reviewer .................................................................. 3,700 1 3,700 30 1850

Total .............................................................................. 4,900 ........................ 4,900 ........................ 2,750

* Includes two categories of grant reviewers: (1) new or self-nominated reviewers that have never served as a HRSA grant reviewer and (2) 

existing reviewers that have previously served on a HRSA independent review committee. 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to: 

John Kraemer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503.

Dated: November 15, 2004. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 04–25751 Filed 11–19–04; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Cooperative Agreement for the 

International AIDS Education and 

Training Center; CFDA 93.145

AGENCY: Health Resources and Services 

Administration, HHS.

ACTION: Notice of supplemental award.

67932 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

Intended Recipient of the Award:

University of Washington, Seattle, 

Washington. 

Purpose of the Award: This notice 

announces the program expansion 

supplement for the cooperative 

agreement for the International AIDS 

Education and Training Center at the 

University of Washington, Seattle, 

Washington, to expand and augment 

capacity building under the President’s 

Emergency Plan for AIDS Relief (the 

President’s Emergency Plan). This is the 

third budget period for this Cooperative 

Agreement. The purpose of this funding 

is to support the President’s Emergency 

Plan by strengthening human and 

organizational capacity through 

training, technical assistance, 

infrastructure building, and curriculum 

development in the 15 focus countries 

including 12 in Africa, two in the 

Caribbean and Vietnam (Botswana, Coˆte 

d’Ivoire, Ethiopia, Guyana, Haiti, Kenya, 

Mozambique, Namibia, Nigeria, 

Rwanda, South Africa, Tanzania, 

Uganda and Zambia). Further training 

and technical assistance is also being 

augmented through the President’s 

Emergency Plan in other countries for 

which bilateral agreements for similar 

strategies have been established. The 

President’s Emergency Plan is intended 

to complement other bilateral and 

international support efforts, including 

support through the Global Fund to 

Fight AIDS, Tuberculosis, and Malaria. 

Amount of the Award: $8,877,718. 

Project Period: Original Project Period 

04/01/02–9/30/05, New Project Period: 

04/01/02–2/28/06. 

The current budget period is being 

extended to February 28, 2005 (in line 

with the intent of the five year strategy 

of the President’s Emergency Plan). This 

would also extend the project period for 

the cooperative agreement from 

September 30, 2005, to February 28, 

2006. 

Justification for the Exception to 

Competition: The International AIDS 

Education and Training Center is the 

only Health Resources and Services 

Administration (HRSA), HIV/AIDS 

Bureau grantee providing valuable 

capacity building in the area of care and 

treatment to the focus and bilateral 

countries through training and other 

technical assistance. The original intent 

of this cooperative agreement was to 

fulfill the gap in training for quality, 

comprehensive HIV/AIDS care and 

treatment left by other U.S. Government 

partners. The President’s Emergency 

Plan is providing the resources to 

provide the services that are needed in 

countries hardest hit by the AIDS 

epidemic. Without this program 

expansion supplement, HRSA’s HIV/

AIDS Bureau will be unable to provide 

this enhanced level of resources and 

expertise to the targeted countries.

FOR FURTHER INFORMATION CONTACT:

Additional information on the 

International AIDS Education and 

Training Center may be obtained from 

Thurma Goldman, MD, MPH, HIV/AIDS 

Bureau, HRSA, 5600 Fishers Lane, 

Parklawn Building, Room 7–05, 

Rockville, Maryland 20857; telephone 

number (301) 443–1993; fax (301) 443–

9645; or e-mail tgoldman@hrsa.gov.

Dated: November 10, 2004. 

Elizabeth M. Duke, 

Administrator.

[FR Doc. 04–25750 Filed 11–19–04; 8:45 am] 

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DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2004–19665] 

Towing Safety Advisory Committee

AGENCY: Coast Guard, DHS.

ACTION: Notice of meeting.

SUMMARY: The Towing Vessel Inspection 

Working Group of the Towing Safety 

Advisory Committee (TSAC) will meet 

to discuss matters relating to the 

inspection of towing vessels and safety 

management systems. The meetings will 

be open to the public.

DATES: The Towing Vessel Inspection 

Working Group will meet on 

Wednesday, December 8, 2004 from 

1:30 p.m. to 4:30 p.m. and on Thursday, 

December 9, 2004 from 8:30 a.m. to 2 

p.m. The meetings may close early if all 

business is finished. Written or 

electronic material and requests to make 

oral presentations should reach the 

Coast Guard on or before December 3, 

2004. Requests to have a copy of your 

material distributed to each member of 

the Working Group should be in 

electronic form and reach the Coast 

Guard on or before December 3, 2004.

ADDRESSES: The Working Group will 

meet in the 7th Floor All-Hands 

Conference Room (#725), National 

Pollution Funds Center, 4200 Wilson 

Boulevard, Arlington, VA 22203. Please 

bring a government-issued ID with 

photo (e.g., driver’s license). Send 

written or electronic material and 

requests to make oral presentations to 

Mr. Gerald Miante, Commandant (G–

MSO–1), U.S. Coast Guard 

Headquarters, 2100 Second Street SW., 

Washington, DC 20593–0001. This 

notice and related documents are 

available on the Internet at http://

dms.dot.gov under the docket number 

USCG–2004–19665.

FOR FURTHER INFORMATION CONTACT: Mr. 

Gerald Miante, Assistant Executive 

Director of TSAC, telephone 202–267–

0214, fax 202–267–4570, or e-mail 

gmiante@comdt.uscg.mil.

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is given under the 

Federal Advisory Committee Act, 5 

U.S.C. App. 2 (Pub. L. 92–463, 86 Stat. 

770, as amended). 

Agenda of Working Group Meetings 

The agenda for the Towing Industry 

Safety System Working Group 

tentatively includes the following items: 

(1) Identify the elements that should 

be included in a safety management 

system (SMS) requirement for towing 

vessels. 

(2) Identify a framework for Coast 

Guard oversight and enforcement of a 

towing vessel inspection program based 

on a SMS and consider the role of third 

parties in such a system. 

(3) Identify whether any towing vessel 

should be exempt from coverage under 

an inspection program based on a SMS. 

(4) Identify proposed regulations 

implementing an inspection program for 

towing vessels based on a SMS. 

Procedural 

The meetings are open to the public. 

Please note that the meetings 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 Assistant 

Executive Director (as provided above in 

FOR FURTHER INFORMATION CONTACT) no 

later than December 3, 2004. Written or 

electronic material for distribution at 

the meeting should reach the Coast 

Guard no later than December 3, 2004. 

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 Mr. Miante at the 

number listed in FOR FURTHER

INFORMATION CONTACT as soon as 

possible.

Dated: November 15, 2004. 

Joseph J. Angelo, 

Director of Standards, Marine Safety, Security 

& Environmental Protection.

[FR Doc. 04–25759 Filed 11–19–04; 8:45 am] 

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