1254 Federal Register / Vol. 70, No. 4 / Thursday, January 6, 2005 / Notices 

Table 1 of this document represents 

the estimated burden of meeting the 

reporting requirements. The burden 

estimates for these information 

collection requirements are based on 

information provided by the Office of 

New Animal Drug Evaluation, Center for 

Veterinary Medicine. The guidance 

document describes the type of 

information that should be collected by 

the drug sponsor when completing the 

antimicrobial resistance risk assessment. 

FDA will use the risk assessment and 

supporting information to evaluate the 

safety of original (21 CFR 514.1) or 

supplemental (21 CFR 514.8) NADAs for 

antimicrobial drugs intended for use in 

food-producing animals.

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR 514.1(b)(8) and 

514.8(a)(2) No. of Respondents Annual Frequency per Response 

Total Annual Responses Hours per Response Total Hours 

Hazard Identification (initial 

scoping of issues—relevant 

bacteria, resistance determinants, food products; preliminary data gathering) 15 1 15 30 450

Release Assessment (literature 

review; review of research reports; data development; compilation, and presentation) 10 1 10 1,000 1,000

Exposure Assessment (identifying 

and extracting consumption 

data; estimating probability of 

contamination on food product) 10 1 10 8 80

Consequence Assessment (review ranking of human drug importance table) 10 1 10 4 40

Risk Estimation (integration of 

risk components; development 

of potential arguments as basis 

for overall risk estimate) 10 1 10 12 120

Risk Management (discussion of 

appropriate risk management 

activities) 10 1 10 30 300

Total Burden 10,990

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

FDA estimates that on an annual basis 

an average of 15 NADAs (including 

original applications and major 

supplements) would be subject to 

information collection under this 

guidance. This estimate is based on the 

number of reviews completed between 

October 2003 and October 2004. During 

that period, microbial food safety for 

approximately 15 antimicrobial NADAs 

(including original and major 

supplements) was evaluated. This 

estimate excludes NADAs for 

antimicrobial drug combinations, 

generic drug applications (ANADAs), 

and certain supplemental NADAs.

Dated: December 30, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–245 Filed 1–5–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on Migrant 

Health; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting:

Name: National Advisory Council on 

Migrant Health. 

Dates and Times: January 26, 2005, 9 a.m. 

to 5 p.m., January 27, 2005, 9 a.m. to 5 p.m. 

Place: DoubleTree Hotel San DiegoMission Valley, 7450 Hazard Center Drive, 

San Diego, California 92108, Phone: (619) 

297–5466; Fax: (619) 297–5499. 

Status: The meeting will be open to the 

public. 

Agenda: The agenda includes an overview 

of the Council’s general business activities. 

The Council will also hear presentations 

from experts on farmworker issues, including 

the status of farmworker health at the local 

and national level. In addition, the Council 

will be holding a public hearing at which 

migrant farmworkers, community leaders, 

and providers will have the opportunity to 

testify before the Council regarding matters 

that affect the health of migrant farmworkers. 

The hearing is scheduled for Thursday, 

January 27, from 9 a.m. to 12 noon, at the 

DoubleTree Hotel San Diego-Mission Valley. 

The Council meeting is being held in 

conjunction with the 14th Annual Western 

Migrant Stream Forum sponsored by the 

Northwest Regional Primary Care 

Association, which is being held in San 

Diego, California, during the same period of 

time. 

Agenda items are subject to change as 

priorities indicate.

For Further Information Contact:

Anyone requiring information regarding 

the Council should contact Gladys Cate, 

Office of Minority and Special 

Populations, staff support to the 

National Advisory Council on Migrant 

Health, Bureau of Primary Health Care, 

Health Resources and Services 

Administration, 5600 Fishers Lane, 

Federal Register / Vol. 70, No. 4 / Thursday, January 6, 2005 / Notices 1255

Room 15–99, Rockville, Maryland 

20857, Telephone (301) 594–0367.

Dated: December 28, 2004. 

Steven A. Pelovitz, 

Associate Administrator for Administration 

and Financial Management.

[FR Doc. 05–216 Filed 1–5–05; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Extension of a Currently 

Approved Collection; Comment 

Request

ACTION: 30-day notice of information 

collection under review: Checklist for 

on-site review of schools; File No. 

OMB–35. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) has 

submitted the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection was 

previously published in the Federal 

Register on August 30, 2004 at 69 FR 

52908, allowed for a 60-day public 

comment period. The USCIS did not 

receive any comments on this 

information collection during that 

period. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted until February 7, 

2005. This process is conducted in 

accordance with 5 CFR 1320.10. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information should address one ore 

more of the following four points: 

(1) Evaluate whether the proposed 

collection of information 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, 

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 through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of this information 

collection: 

Type of Information Collection:

Extension of a currently approved 

information collection. 

(2) Title of the Form/Collection:

Checklist for On-Site Review of Schools. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: No agency 

Form Number; File No. OMB–35, U.S. 

Citizenship and Immigration Services. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

Households. The data is used by the 

agency when conducting on-site visits at 

schools that submitted certification 

applications in SEVIS after the 

preliminary enrollment period. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 10,000 responses at 65 (1.083) 

minutes per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 10,830 annual burden hours. 

If you have comments, suggestions, or 

need a copy of the information 

collection instrument, please contact 

Richard A. Sloan, Director, Regulatory 

Management Division, U.S. Citizenship 

and Immigration Services, 111 

Massachusetts Avenue, NW., 

Washington, DC 20529; 202–272–8377.

Dated: December 30, 2004. 

Richard A. Sloan, 

Director, Regulatory Management Division, 

U.S. Citizenship and Immigration Services.

[FR Doc. 05–217 Filed 1–5–04; 8:45 am] 

BILLING CODE 4410–01–M

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Extension of a Currently 

Approved Collection; Comment 

Request

ACTION: 30-day notice of information 

collection under review: Application to 

adjust status from temporary to 

permanent resident, Form I–698. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) has 

submitted the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection was 

previously published in the Federal 

Register on October 14, 2004 at 69 FR 

61034, allowed for a 60-day public 

comment period. The USCIS did not 

receive any comments on this 

information collection during that 

period. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted February 7, 2005. 

This process is conducted in accordance 

with 5 CFR 1320.10. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information should address one or more 

of the following four points: 

(1) Evaluate whether the proposed 

collection of information 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, 

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 through the 

use of automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submission of responses. 

Overview of this information 

collection: 

(1) Type of Information Collection:

Extension of currently approved 

collection. 

(2) Title of the Form/Collection:

Application to Adjust Status from 

Temporary to Permanent Resident. 

(3) Agency form number, if any, and 

the applicable component sponsoring 

the collection: Form I–698, U.S. 

Citizenship and Immigration Services. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

Households. The data collected on this 

form is used by the USCIS to determine 

an applicant’s eligibility to adjust status 

from temporary to permanent resident. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to