17970 Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices 

products. Such systems have been put 

in place for drugs that are or are 

suspected to be teratogenic, and the 

programs are designed to ensure 

patients are not pregnant and will not 

become pregnant while taking the drug. 

Such systems create burdens on patients 

and the health care system. Is such a 

system necessary for opioids? How 

would such a program be implemented 

given the number of patients, 

prescribers, and other health care 

providers involved in their use? 

2. Should the REMS include controls 

on distributors who distribute products 

to pharmacies and other health care 

providers? What controls are necessary, 

and how can they be efficiently 

provided without being unduly 

burdensome on the health care system? 

3. What existing systems (for example, 

in pharmacies) already exist that could 

be used to implement a REMS? For 

example, could patient information be 

provided through existing pharmacy 

systems to patients? Are there systems 

for providing education to prescribers 

that could be used to provide the 

educational component of a REMS? 

4. FDAAA requires that innovator and 

generic application holders use a single, 

shared system to provide a REMS with 

elements to assure safe use. What 

obstacles need to be addressed before 

such a system could be developed? 

5. What metrics should be used to 

assess the success of the REMS? Please 

comment on the metrics that should be 

applied to measure the success of each 

of the components of the REMS (e.g., 

educational requirements) as well as 

metrics to assess the impact of the 

overall REMS on decreasing abuse and 

misuse of long acting opioids and 

extended release opioids while seeking 

to ensure that they remain available for 

patients who suffer daily from chronic 

pain. 

III. Attendance and Registration 

Register via email to 

OpioidREMS@fda.hhs.gov by providing 

complete contact information for each 

attendee (including name, title, 

affiliation, address, email address, and 

phone number(s)) by May 15, 2009. 

Registration is free and will be on a firstcome, first-served basis. Early 

registration is recommended because 

seating is limited. Please send no more 

than two individuals from your 

organization. Registration on the first 

day of the meeting will be provided on 

a space available basis beginning at 8 

a.m. 

If you wish to make an oral 

presentation at the meeting, you must 

indicate this at the time of registration. 

FDA has included questions for 

comment in section II of this document. 

You should also identify by number 

each question you wish to address in 

your presentation. FDA will do its best 

to accommodate requests to speak. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

presentations, and to request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. If you need special 

accommodations because of disability, 

please e-mail OpioidREMS@fda.hhs.gov 

at least 7 days before the meeting. 

IV. Comments 

Regardless of attendance at the public 

meeting, interested persons may submit 

written or electronic comments to the 

Division of Dockets Management (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. To ensure consideration, 

submit comments by June 30, 2009. 

Received comments may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

V. Transcripts 

Transcripts of the meeting will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 30 days after the 

meeting. A transcript will also be made 

available in either hard copy or on CD– 

ROM, upon submission of a Freedom of 

Information request. Written requests 

are to be sent to Division of Freedom of 

Information (HFI–35), Office of 

Management Programs, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857. 

Dated: April 14, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8992 Filed 4–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Amended Notice 

The purpose of this notice is to inform 

the public that the National Institutes of 

Health (NIH) is cancelling the May 5, 

2009 meeting of the NIH Blue Ribbon 

Panel to Advise on the Risk Assessment 

of the National Emerging Infectious 

Diseases Laboratories at Boston 

University Medical Center. The 

announcement for the May 5, 2009 

meeting was previously published in 

the Federal Register on April 3, 2009 

(74 FR 15296). 

The meeting will be rescheduled and 

the new date for the meeting will be 

announced and published in the 

Federal Register. 

Dated: April 14, 2009. 

Kelly Fennington, 

Special Assistant to the Acting Director, 

Office of Science Policy, National Institutes 

of Health. 

[FR Doc. E9–9037 Filed 4–17–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Heart, Lung, and Blood 

Advisory Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Advisory Council. 

Date: June 10, 2009. 

Open: 8 a.m. to 12 p.m. 

Agenda: To discuss program policies and 

issues. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C–Wing, Room 

10, Bethesda, MD 20892. 

Closed: 1 p.m. to 5 p.m. 


rmajette on PRODPC74 with NOTICES
Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices 17971 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C–Wing, Room 

10, Bethesda, MD 20892. 

Contact Person: Stephen C. Mockrin, Phd, 

Director, Division of Extramural Research 

Activities, National Heart, Lung, and Blood 

Institute, National Institutes of Health, 6701 

Rockledge Drive, Room 7100, Bethesda, MD 

20892, (301) 435–0260, 

mockrins@nhlbi.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, drivers license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institutes/Center’s home page: 

www.nhlbi.nih.gov/meetings/index.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: April 13, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–8903 Filed 4–17–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID: FEMA–2009–0001] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice; 30-day notice and 

request for comments; revision of a 

currently approved information 

collection; OMB No. 1660–0073; FEMA 

Form 089–10, Narrative Statement, and 

FEMA Form 089–11, Performance 

Reports, and FEMA Form 089–12, 

Extensions/Budget Changes, and FEMA 

Form 089–13, Memorandum of 

Agreement Revisions, and FEMA Form 

089–14, Self Evaluations, and FEMA 

Form 089–15, Task Force Deployment 

Data. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) has 

submitted the information collection 

abstracted below to the Office of 

Management and Budget for review and 

clearance in accordance with the 

requirements of the Paperwork 

Reduction Act of 1995. The submission 

describes the nature of the information 

collection, the categories of 

respondents, the estimated burden (i.e., 

the time, effort and resources used by 

respondents to respond) and cost, and 

includes the actual data collection 

instruments FEMA will use. 

DATES: Comments must be submitted on 

or before May 20, 2009. 

ADDRESSES: Submit written comments 

on the proposed information collection 

to the Office of Information and 

Regulatory Affairs, Office of 

Management and Budget. Comments 

should be addressed to the Desk Officer 

for the Department of Homeland 

Security, Federal Emergency 

Management Agency, and sent via 

electronic mail to 

oira.submission@omb.eop.gov or faxed 

to (202) 395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information or 

copies of the information collection 

should be made to Director, Records 

Management Division, 1800 South Bell 

Street, Arlington, VA 20598–3005, 

facsimile number (202) 646–3347, or 

e-mail address FEMA–InformationCollections@dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Collection of Information 

Title: National Urban Search and 

Rescue Grant Program. 

Type of information collection: 

Revision of a currently approved 

information collection. 

OMB Number: 1660–0073. 

Form Titles and Numbers: FEMA 

Form 089–10, Narrative Statement, and 

FEMA Form 089–11, Performance 

Reports, and FEMA Form 089–12, 

Extensions/Budget Changes, and FEMA 

Form 089–13, Memorandum of 

Agreement Revisions, and FEMA Form 

089–14, Self Evaluations, and FEMA 

Form 089–15, Task Force Deployment 

Data. 

Abstract: The information collection 

activity is the collection of financial, 

program and administrative information 

for US&R Sponsoring Organizations 

relating to preparedness and response 

Cooperative Agreement awards. This 

information includes a narrative 

statement that FEMA uses to evaluate a 

grantee’s proposed use of funds, 

progress reports to monitor overall 

progress on managing FEMA grant 

program, extension or change requests 

used to consider changing or extending 

the time or the performance period of 

the preparedness or response 

cooperative agreement, evaluation and 

information to assess and ensure 

operational readiness and a 

memorandum of agreement between 

DHS/FEMA and the Sponsoring 

Organizations of US&R task forces. 

Affected Public: State, Local or Tribal 

Government. 

Estimated Number of Respondents: 

28. 

Frequency of Response: Semiannually. 

Estimated Average Hour Burden per 

Respondent: 17 Hours. 

Estimated Total Annual Burden 

Hours: 476 hours. 

Estimated Cost: There are no start-up, 

operational or other costs associated 

with this information collection. 

Larry Gray, 

Director, Records Management Division, 

Office of Management, Federal Emergency 

Management Agency, Department of 

Homeland Security. 

[FR Doc. E9–9008 Filed 4–17–09; 8:45 am] 

BILLING CODE 9110–69–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID: FEMA–2009–0001] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice; 30-day notice and 

request for comments; revision of a 

currently approved information 

collection; OMB No. 1660–0083; FEMA 

Form 116–0–1, Promissory Note, FEMA 

Form 085–0–1, Local Government 

Resolution Collateral Security, FEMA 

Form 090–0–1, Certification of 

Eligibility for Community Disaster 

Loans, and FEMA Form 090–0–2, 

Application for Community Disaster 

Loan. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) has 

submitted the information collection 

abstracted below to the Office of 

Management and Budget for review and 

clearance in accordance with the 


rmajette on PRODPC74 with NOTICES