Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices 53509 

Products 

4.0 Reproductive Toxicity Data 

5.0 Summary, Conclusions, and 

Critical Data Needs (to be 

developed at the expert panel 

meeting). 

Request for Comments 

CERHR invites written public 

comments on chapters 1–4 of the draft 

expert panel report on soy formula. Any 

comments received will be posted on 

the CERHR Web site prior to the 

meeting and distributed to the expert 

panel and CERHR staff for their 

consideration in revising the draft report 

and/or preparing for the expert panel 

meeting. Persons submitting written 

comments are asked to include their 

name and contact information 

(affiliation, mailing address, telephone 

number, e-mail, and sponsoring 

organization, if any) and send them to 

Dr. Thayer (see ADDRESSES above) for 

receipt by December 2, 2009. Comments 

will be identified on the Web site by the 

submitter’s name, affiliation, and/or 

sponsoring organization. 

Time is set aside on December 16, 

2009 for the presentation of oral public 

comments at the expert panel meeting. 

Seven minutes will be available for each 

speaker (one speaker per organization). 

Online registration is available on the 

CERHR website or persons wishing to 

make oral remarks can contact Dr. 

Thayer. If possible, send a copy of the 

statement, talking points, and/or slide 

presentation to Dr. Thayer by December 

2. This statement will be provided to the 

expert panel to assist them in 

identifying issues for discussion and 

noted in the meeting record. 

Registration for presentation of oral 

comments will also be available at the 

meeting on December 16, 2009, from 

7:30–8:30 a.m. Persons registering at the 

meeting are asked to bring 30 copies of 

their statement, talking points, and/or 

slide presentation for distribution to the 

expert panel and for the record. 

Attendance and Registration 

In order to facilitate planning for this 

meeting, persons wishing to attend are 

asked to register by December 9, 2009, 

via the CERHR Web site (http:// 

cerhr.niehs.nih.gov). 

Preliminary Agenda 

The meeting begins each day at 8:30 

a.m. On December 16 and 17, it is 

anticipated that a lunch break will occur 

from noon–1 p.m. and the meeting will 

adjourn at 5–6 p.m. The meeting is 

expected to adjourn by noon on 

December 18, 2009; however, 

adjournment may occur earlier or later 

depending upon the time needed by the 

expert panel to complete its work. 

Anticipated agenda topics for each day 

are listed below. 

December 16, 2009 

• Opening remarks; 

• Oral public comments (7 minutes 

per speaker; one representative per 

group); 

• Review of chapters 1–4 of the draft 

expert panel report on soy formula; 

• Discussion of Chapter 5.0 

Summary, Conclusions, and Critical 

Data Needs. 

December 17, 2009 

• Discussion of Chapter 5.0 

Summary, Conclusions, and Critical 

Data Needs; 

• Preparation of draft summaries and 

conclusion statements. 

December 18, 2009 

• Presentation, discussion of, and 

agreement on summaries, conclusions, 

and data needs; 

• Closing comments. 

Background Information on the CERHR 

The NTP established CERHR in 1998 

(63 FR 68782). CERHR is a publicly 

accessible resource for information 

about adverse reproductive and/or 

developmental health effects associated 

with exposure to environmental and/or 

occupational exposures. CERHR follows 

a formal process for the evaluation of 

selected substances that includes 

opportunities for public input. 

CERHR invites the nomination of 

substances for review or scientists for its 

expert registry. Information about 

CERHR and the nomination process can 

be obtained from its homepage (http:// 

cerhr.niehs.nih.gov) or by contacting Dr. 

Thayer (see ADDRESSES above). CERHR 

selects substances for evaluation based 

upon several factors including 

production volume, potential for human 

exposure from use and occurrence in 

the environment, extent of public 

concern, and extent of data from 

reproductive and developmental 

toxicity studies. Expert panels conduct 

scientific evaluations of substances 

selected by CERHR in public forums. 

Following these evaluations, CERHR 

prepares the NTP–CERHR monograph 

on the substance evaluated. The 

monograph is transmitted to appropriate 

Federal and State agencies and made 

available to the public. 

Dated: October 8, 2009. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. E9–25122 Filed 10–16–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0143] 

Risk Evaluation and Mitigation 

Strategies for Certain Opioid Drugs; 

Notice of Public Meeting; Reopening of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

October 19, 2010, the comment period 

for the notice of public meeting 

published in the Federal Register of 

April 20, 2009 (74 FR 17967). In that 

notice, FDA announced a public 

meeting that took place on May 27 and 

28, 2009, to solicit input on developing 

Risk Evaluation and Mitigation 

Strategies (REMS) for certain opioid 

drugs. FDA is reopening the comment 

period in light of continued public 

interest in this topic and to provide an 

opportunity for all interested parties to 

provide information and share views on 

the matter. 

DATES: Submit written or electronic 

comments by October 19, 2010. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Theresa (Terry) Martin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6196, 

Silver Spring, MD 20993–0002, 301– 

796–3448; FAX: 301–847–8752, e-mail: 

OpioidREMS@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of April 20, 

2009 (74 FR 17967), FDA published a 

notice of a public meeting on 

developing REMS for certain opioid 

drugs. The affected opioid drugs include 

long acting and extended release brand 

name and generic products that are 

formulated with the following active 

ingredients: Fentanyl, hydromorphone, 

methadone, morphine, oxycodone, and 

oxymorphone. The REMS would be 

intended to ensure that the benefits of 

these drugs continue to outweigh risks 

associated with: (1) Use of high doses of 

long acting opioid and extended release 


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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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