53510 Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices 

opioid products in non-opioid tolerant 

and inappropriately selected 

individuals; (2) abuse; (3) misuse; and 

(4) overdose, both accidental and 

intentional. REMS for these opioids 

would likely include elements to assure 

safe use to ensure that prescribers, 

dispensers, and patients are aware of 

and understand the risks and proper use 

of these products. The opioid drugs 

expected to be subject to REMS are 

widely prescribed by a large number of 

physicians who practice in a wide 

variety of areas. A REMS that will 

adequately manage the risks of these 

products without unduly burdening the 

health care system or reducing patient 

access to these medications must be 

carefully designed. Recognizing this 

challenge, we identified several specific 

areas in which FDA wishes to obtain 

information and public comment in our 

April 2009 notice of public meeting. 

Interested persons were originally 

given until June 30, 2009, to comment. 

As a result of continued public interest, 

FDA is reopening the comment period 

until October 19, 2010 to allow 

interested persons additional time to 

provide information and share views on 

this topic. 

II. How to Submit 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 to http://www.regulations.gov 

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: October 9, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25022 Filed 10–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: OMB–48, InfoPass System; 

New Information Collection; Comment 

Request 

ACTION: 30-Day Notice of Information 

Collection Under Review: OMB–48, 

InfoPass System. 

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 July 28, 2009, at 74 FR 

37234, allowing for a 60-day public 

comment period. USCIS did not receive 

any comments. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted until November 18, 

2009. This process is conducted in 

accordance with 5 CFR 1320.10. 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the 

Department of Homeland Security 

(DHS), and to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB), USCIS 

Desk Officer. Comments may be 

submitted to: USCIS, Chief, Regulatory 

Products Division, Clearance Office, 111 

Massachusetts Avenue, Washington, DC 

20529–2210. Comments may also be 

submitted to DHS via facsimile to 202– 

272–8352 or via e-mail at 

rfs.regs@dhs.gov, and to the OMB USCIS 

Desk Officer via facsimile at 202–395– 

5806 or via e-mail at 

oira_submission@omb.eop.gov. 

When submitting comments by email, please make sure to add OMB–48 

in the subject box. Written comments 

and suggestions from the public and 

affected agencies 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 

agencies 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 

(1) Type of Information Collection: 

New Information collection. 

(2) Title of the Form/Collection: 

InfoPass System. 

(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–48. 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 InfoPass system allows 

an applicant or petitioner to schedule an 

interview appointment with USCIS 

through USCIS’ Internet Web site. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 1,043,319 responses at 6 

minutes (.10) per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 104,332 annual burden 

hours. 

If you need a copy of the information 

collection instrument, please visit the 

Web site at: http://www.regulations.gov/ 

We may also be contacted at: USCIS, 

Regulatory Products Division, 111 

Massachusetts Avenue, NW., 

Washington, DC 20529–2210, 

Telephone number 202–272–8377. 

Dated: October 14, 2009. 

Stephen Tarragon, 

Deputy Chief, Regulatory Products Division, 

U.S. Citizenship and Immigration Services. 

[FR Doc. E9–25042 Filed 10–16–09; 8:45 am] 

BILLING CODE 9111–97–P 


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