Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19375 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committees: Cardiovascular 

and Renal Drugs Advisory Committee 

and the Drug Safety and Risk 

Management Advisory Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 2, 2011, from 8 a.m. to 4 

p.m. 

Location: FDA White Oak Campus, 

Building 31, the Great Room, White Oak 

Conference Center, rm. 1503, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002. Information regarding 

special accommodations due to a 

disability, visitor parking and 

transportation may be accessed at: http: 

//www.fda.gov/AdvisoryCommittees/ 

default.htm; under the heading 

‘‘Resources for You’’, click on ‘‘White 

Oak Conference Center Parking and 

Transportation Information for FDA 

Advisory Committee Meetings’’. Please 

note that visitors to the White Oak 

Campus must enter through Building 1. 

Contact Person: Nicole Vesely, 

Pharm.D., Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, WO31–2417, Silver Spring, MD 

20993–0002, 301–796–9001, Fax: 301– 

847–8533, e-mail: 

nicole.vesely@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On May 2, 2011, the 

committees will discuss safety 

considerations of ultrasound contrast 

agents (materials intended to improve 

the clarity of ultrasound imaging), 

particularly related to new information 

and developments since the prior 

Advisory Committee meeting on the 

same topic on June 24, 2008. The 

discussion will include the results of 

required postmarketing safety studies 

and data from postmarketing 

surveillance. Specific drugs to be 

discussed include: (1) New drug 

application (NDA) 21–064, perflutren 

lipid microsphere injectable suspension, 

Lantheus Medical Imaging, Inc.; (2) 

NDA 20–899, perflutren protein-type A 

microspheres injectable suspension, GE 

Healthcare; and (3) the investigational 

new drug (IND) application for sulfur 

hexafluoride microbubble injection, 

Bracco Diagnostics, Inc. Perflutren lipid 

microsphere injectable suspension and 

perflutren protein-type A microspheres 

injectable suspension are indicated for 

use in patients with suboptimal 

echocardiograms to opacify the left 

ventricular chamber and to improve the 

delineation of the left ventricular 

endocardial border (improve the clarity 

of imaging of specific areas of the left 

lower side of the heart). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committees. Written 

submissions may be made to the contact 

person on or before April 18, 2011. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before April 8, 

2011. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 11, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Nicole 

Vesely at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated March 22, 2011. 

Leslie Kux, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2011–8284 Filed 4–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Safety and Efficacy of Hypnotic Drugs; 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

The Food and Drug Administration 

(FDA) is announcing a public meeting to 

discuss the safety and efficacy of drugs 

for the treatment of insomnia. The 

Division of Neurology Products (DNP) 

in FDA’s Center for Drug Evaluation and 

Research and the Pharmaceutical 

Education and Research Institute (PERI) 

are cosponsoring the 2-day meeting, 

with the first day centered on issues of 

efficacy and the second day on safety. 

Date and Time: The public meeting 

will be held on Tuesday, May 10, and 

Wednesday, May 11, 2011, from 8 a.m. 

to 5 p.m. 

Location: The public meeting will be 

held at the Bethesda Marriott, 5151 

Pooks Hill Rd., Bethesda, MD 20814. 

Contact: Margaret Bogie, 703–276– 

0178, ext. 115, Fax: 703–276–0069; or 

Cathleen Michaloski, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4342, 

Silver Spring, MD 20993, 301–796– 

1123, e-mail: 

Cathleen.michaloski@fda.hhs.gov. 

Accommodations: Attendees are 

responsible for their own 

accommodations. Reservations can be 

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19376 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

made on a space available basis at the 

Bethesda Marriott Pooks Hill (see 

Location). 

Registration: You are encouraged to 

register at your earliest convenience. 

A registration fee will be charged to 

help defray the costs of rental of the 

meeting spaces, meals and snacks 

provided, and to cover travel costs 

incurred by invited speakers, and other 

costs. The cost of registration is as 

follows: 

One-Day Rates: 

Government: $475 

Academic: $795 

Industry: $895 

Two-Day Rates: 

Government: $875 

Academic: $1,495 

Industry: $1,695 

Registration fees will be waived for 

invited speakers and members of the 

working group. If you need special 

accommodations due to a disability, 

please contact Margaret Bogie or 

Cathleen Michaloski (see Contact) at 

least 7 days in advance of the meeting. 

Registration Instructions: For further 

details on how to register for the public 

meeting, contact Margaret Bogie or 

Cathleen Michaloski (see Contact). 

SUPPLEMENTARY INFORMATION: Insomnia 

is a common disorder in the United 

States, yet it remains relatively poorly 

understood. Questions remain, for 

example, about the definition of 

insomnia and the classification of 

patients with the disorder. A better 

understanding of insomnia should help 

lead to safer and more effective 

treatment. A number of medications 

have been approved for insomnia, and 

many experimental medications are 

currently in development. New 

concerns have arisen about the most 

appropriate way to evaluate both the 

safety and the efficacy of medications 

for insomnia, particularly given that 

they may differ in important 

characteristics, including both 

pharmacodynamic and pharmacokinetic 

properties. 

DNP and PERI plan for the first day 

of the meeting to center on issues of 

efficacy, including the evolving 

definition of insomnia, the classification 

of patients with this disorder, and the 

measurement of clinically relevant 

outcomes, including the choice of 

endpoints, subjective versus objective 

assessments, and duration of effect. The 

second day of the meeting will center on 

safety issues of hypnotic drugs, 

including the nature and prevalence of 

adverse events (AEs) related to the use 

of hypnotic drugs and evaluation of 

these AEs with a concentration on 

psychovigilance testing and drivingrelated tests. 

Additional information on the 

conference, program, and registration 

procedures is available on the Internet 

at http://peri.org/ 

course_details.cfm?course=2072. FDA 

has verified the PERI Web site address, 

but FDA is not responsible for any 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register. 

Dated: April 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8285 Filed 4–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0013] 

Statement of Organizations, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has reorganized 

the Center for Drug Evaluation and 

Research (CDER), Office of Surveillance 

and Epidemiology (OSE). This 

reorganization includes the 

organizations and their substructure 

components as listed in this document. 

This reorganization includes the 

establishment of six Staffs: Executive 

Operations and Strategic Planning Staff, 

Regulatory Science Staff, Regulatory 

Affairs Staff, Program Management and 

Analysis Staff, Project Management 

Staff, and Technical Information Staff. It 

will also include Office of Medication 

Error Prevention and Risk Management 

(OMEPRM) and Office of 

Pharmacovigilance and Epidemiology 

(OPE) under OSE. OMEPRM will consist 

of the Division of Risk Management and 

the Division of Medication Error 

Prevention and Analysis. OPE will 

consist of the Division of Epidemiology 

I and Division of Epidemiology II and 

the Division of Pharmacovigilance I and 

Division of Pharmacovigilance II. Also 

included are the abolishment of 

Business Process Improvement Staff, 

Regulatory Policy Staff, and Review 

Management Staff within OSE 

Immediate Office. 

FOR FURTHER INFORMATION CONTACT: 

Karen Koenick, Center for Drug 

Evaluation and Research (HFD–063), 

Food and Drug Administration, 11919 

Rockville Pike, rm. 324, Rockville, MD 

20852, 301–796–4422. 

I. Summary 

The Statement of Organization, 

Functions, and Delegations of Authority 

for the Department of Health and 

Human Services (35 FR 3685, February 

25, 1970; 60 FR 56605, November 9, 

1995; 64 FR 36361, July 6, 1999; and 72 

FR 50112, August 30, 2007) is amended 

to reflect the restructuring of CDER, 

FDA as follows. 

II. Organization 

CDER is headed by the Director, and 

includes the following organizational 

unit: 

Office of Surveillance and Epidemiology 

1. Provides leadership, direction, 

planning, budgeting, management, and 

supervision of Divisions and Staffs; and 

premarketing and postmarketing risk 

assessment program operations. 

2. Develops and maintains 

international and national contact with 

regulators. 

3. Develops, coordinates, and 

implements postmarket risk assessment 

policy, guidance, and interpretations. 

4. Initiates regulation development 

and enhancement. 

5. Coordinates and implements 

policies and initiatives, including 

information management initiatives 

across the Agency. 

Regulatory Science Staff 

1. Provides leadership, direction, and 

coordination for OSE regulatory 

research activities. 

2. Develops and manages 

relationships with outside scientific 

groups that interface with OSE scientists 

on a variety of projects that relate to 

OSE’s drug safety mission. These 

outside groups include academic 

organizations, private organizations, and 

other Federal Agencies. 

3. Coordinates the access to large 

databases for pharmacoepidemiologic 

and pharmacovigilance studies, as well 

as to the outside scientists with drug 

safety expertise to collaborate with 

CDER. 

4. Develops regulatory research 

programs that will support OSE as a 

whole, including risk management, 

pharmacovigilance, and medication 

error detection and prevention; in 

addition to epidemiology. 

Regulatory Affairs Staff 

1. Responsible for the coordination 

and implementation of regulatory 

policies by staff within OSE by 

coordinating the development and 

upkeep of guidances, MAPPs, and 

standard operating procedures, 

answering regulatory questions, 

managing the process for waivers of 

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