Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Notices 57035

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 (44 U.S.C. 3501–

3520) (the PRA). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with the 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: September 10, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–21317 Filed 9–22–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration will publish 

periodic summaries of proposed 

projects. To request more information 

on the proposed projects or to obtain a 

copy of the information collection 

plans, call the SAMHSA Reports 

Clearance Officer on (301) 443–7978. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are 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) ways to enhance 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. 

Proposed Project: Medicaid Mental 

Health Services Program and Analytic 

Reports—New 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA) will conduct a survey of 

state Medicaid directors to learn about 

the relationships between state mental 

health authorities and state Medicaid 

agencies in each state and the District of 

Columbia. In addition, SAMHSA will 

ask about the administration of 

Medicaid mental health services, the 

development of Medicaid mental health 

policy, mental health services statistics 

generated by Medicaid programs, and 

the characteristics of mental healthrelated data maintained by Medicaid 

agencies and used by mental health and 

other state agencies. 

The survey will contact state 

Medicaid directors in all fifty states (and 

the District of Columbia) and will gather 

information on the following five survey 

domains: Organizational structure; 

Medicaid mental health services policy 

infrastructure; Medicaid mental health 

services, rates, and funding; Medicaid 

mental health providers; and, Data. 

The survey will identify and describe, 

at the state level, how Medicaid mental 

health policy is developed; whether 

Medicaid mental health services and 

providers are treated differently from 

other Medicaid services and providers, 

and if so, how; and the availability of 

data and reports on Medicaid mental 

health service use and/or expenditures. 

This information collection supports 

the New Freedom Initiative, one of 

SAMHSA’s current priorities. As part of 

this effort, the President launched the 

New Freedom Commission on Mental 

Health to address the problems in the 

current mental health system. The 

Commission noted that fragmentation of 

responsibility for mental health services 

is a serious problem at the state level. 

Two of the Commission’s 19 

recommendations for the improvement 

of the mental health system were aimed 

at this problem. One was directed to 

states (create a comprehensive state 

mental health plan) and the other to the 

federal government (align relevant 

federal programs to improve access and 

accountability for mental health 

services). This survey is aimed at 

providing information that can help in 

carrying out these recommendations by 

further illuminating the relationships 

between state Medicaid and mental 

health agencies in the development and 

implementation of mental health policy. 

Telephone interviews will be 

conducted with state Medicaid 

directors. Each interview will last one 

hour. Because of the open-ended nature 

of many of the survey questions and the 

general reluctance of state Medicaid 

directors to complete detailed paper or 

electronic surveys, we propose to 

conduct all the interviews by telephone, 

unless interviewees prefer to respond to 

a paper or electronic version.

ESTIMATES OF ANNUALIZED HOUR BURDEN

Number of

respondents 

Responses

per respondent 

Hours per

response 

Total hour

burden 

51 ................................................................................................................................................. 1 1 51 

57036 Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Notices 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, 1 Choke Cherry Road, 

Rockville, MD 20850. Written comments 

should be received by November 22, 

2004.

Dated: September 16, 2004. 

Anna Marsh, 

Executive Officer, SAMHSA.

[FR Doc. 04–21372 Filed 9–22–04; 8:45 am] 

BILLING CODE 4162–20–P

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2004–0005] 

Revised Privacy Impact Assessment 

and Privacy Policy; US–VISIT Program

AGENCY: Department of Homeland 

Security.

ACTION: Notice; Privacy Impact 

Assessment and Privacy Policy. 

SUMMARY: The Department of Homeland 

Security (Department) intends to modify 

the United States Visitor and Immigrant 

Status Indicator Technology Program 

(US–VISIT) to expand coverage to 

include Visa Waiver Program entrants 

into this entry and exit system and to 

include the 50 busiest land ports of 

entry, and to modify the business 

process by which the Department shares 

information with other Federal law 

enforcement agencies. Accordingly, the 

original privacy impact assessment 

(PIA) for US–VISIT, which was 

published in the Federal Register on 

January 16, 2004, has been amended to 

reflect these changes in accordance with 

the E-Government Act of 2002, and is 

being made available to the public by 

this notice and in conjunction with the 

Interim Final Rule of August 31, 2004, 

United States Visitor and Immigrant 

Status Indicator Technology Program 

(‘‘US–VISIT’’) Authority to Collect 

Biometric Data From Additional 

Travelers and Expansion to the 50 Most 

Highly Trafficked Land Border Ports of 

Entry, published at 69 FR 53318.

ADDRESSES: Written comments about 

this revised PIA for the US–VISIT 

Program, Increment 2, may be submitted 

to the DHS Privacy Office, Attn: US–

VISIT PIA, Increment 2, U.S. 

Department of Homeland Security, 

Washington, DC 20528, fax (202) 298–

5201, or e-mail at privacy@dhs.gov. If 

submitting comments by e-mail, please 

include the words ‘‘US–VISIT PIA’’ in 

the subject line. 

Additional comments may be made 

through the e-docketing system by 

referencing docket number [DHS–2004–

0005] at http://docket.epa.gov/edkfed/

index.jsp.

FOR FURTHER INFORMATION CONTACT:

Steve Yonkers, Privacy Officer, US–

VISIT, Border and Transportation 

Security, U.S. Department of Homeland 

Security, Washington, DC 20528, 

telephone (202) 298–5200, fax (202) 

298–5201, e-mail 

usvisitprivacy@dhs.gov.

Dated: September 14, 2004. 

Nuala O’Connor Kelly, 

Chief Privacy Officer.

BILLING CODE 4910–15–P