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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postmarketing safety reporting 

requirements and citizen petition 

responses, and being involved in the 

development of safety regulations. 

2. Provides leadership on initiatives 

related to the Medical Dictionary for 

Regulatory Activities (MedDRA). 

Executive Operations & Strategic 

Planning Staff 

1. Creates and maintains professional 

and skills training programs for OSE 

personnel. 

2. Plans and tracks goals and 

objectives of all OSE Offices and 

Divisions. 

3. Evaluates OSE work products and 

communications using quality control 

technology. 

4. Interacts with Executive Secretariat, 

Press Office, and etc. 

Technical Information Staff 

1. Provides coordination, 

development and assessment of 

policies, procedures, and best practices 

related to OSE data and information 

system management within OSE. 

2. Provides representation for OSE on 

Center and Agency best practices boards 

associated with staff responsibilities. 

3. Represents OSE in Center and 

Agency boards or workgroups that 

address business process improvements 

and information technology related to 

postmarket drug safety. 

4. Ensures that OSE’s informatics 

systems (e.g., Adverse Event Reporting 

System, Phonetic Orthographic 

Computer Analysis, and Phonetic 

Orthographic Computer Analysis) serve 

OSE’s needs. 

Program Management and Analysis 

Staff 

1. Provides leadership, direction, 

planning, budgeting, management, and 

supervision of programs related to the 

OSE office administration and contracts 

management. 

2. Provides guidance and support 

services to the OSE on all aspects of 

administrative, budget, and facilities 

management and provides service and 

support on human resource, personnel 

operations services, and recruitment 

activities. 

3. Provides management, tracking and 

facilitation of projects related to office 

administration and contracts 

management within OSE. 

4. Provides coordination, 

development, and assessment of 

policies, procedures, and best practices 

related to OSE office administration and 

contract management within OSE. 

5. Provides representation for OSE on 

center and Agency best practices boards 

associated with staff responsibilities. 

Project Management Staff 

1. Provides leadership, direction, 

planning, management, and supervision 

of programs related to drug safety 

reviews and staff. 

2. Provides management, tracking, 

and facilitation of projects related to 

drug safety reviews within OSE. 

3. Provides coordination, 

development, and assessment of 

policies and procedures related to drug 

safety reviews, review templates, and 

other best practices related to drug 

safety reviews within OSE. 

4. Provides representation for OSE on 

Center best practices associated with 

staff responsibilities. 

Office of Medication Error Prevention 

and Risk Management 

1. Directs and supports the Divisions 

of Medication Error Prevention and 

Analysis and Risk Management. 

2. Leads OSE review of proposed and 

implemented Risk Minimization Action 

Plans (RiskMAPs)/Risk Evaluation and 

Mitigation Strategies (REMS). 

3. Coordinates risk communication 

components of drug safety risk 

management programs. 

4. Coordinates reviews of proposed 

proprietary trade names for their 

potential to result in sound-alike or 

look-alike medication errors. 

5. Performs root-cause analyses of 

postmarketing medication error reports. 

Division of Medication Error Prevention 

and Analysis 

1. Plans, directs, and provides 

information technology support to the 

OSE. 

2. Develops and maintains necessary 

software, processes, procedures, 

training, and security or databases 

available to OSE. 

3. Acts as focal point for all hardware, 

software, and other information systems 

issues. 

4. In conjunction with the OSE 

programs, evaluates extant information 

resources for utility and value to the 

OSE missions. Arranges for necessary 

accesses, training, and other needs 

related to effective use of those 

resources. 

5. Develops and maintains the OSE 

Center for Drug Evaluation and Research 

Network (CDERNET) Web pages and 

works with other Agency programs to 

develop and maintain Internet pages 

related to office programs. 

6. Serves as the primary OSE contact 

for World Health Organization (WHO) 

searches, Freedom of Information (FOI) 

and National Technical Information 

Services (NTIS) issues, and for database 

searches. 

7. Reviews proposed proprietary trade 

names for their potential to result in 

sound-alike or look-alike medication 

errors. 

8. Analyzes and performs root-cause 

analyses of postmarketing medication 

error reports. 

9. Develops and implements internal 

MAPPs and guidance on medication 

error and patient safety initiatives. 

Division of Risk Management 

1. Plans and directs all risk 

management activities in the OSE. 

2. Provides risk management expertise 

to OSE and the center. 

3. Reviews all proposed Risk 

Minimization Action Plans (RiskMAPs) 

or Risk Management Plans (RMPs) for 

conformance with FDA’s standards. 

4. Conducts postmarketing monitoring 

of all products with approved 

RiskMAPs. 

5. Conducts evaluations of the 

performance of RiskMAPs. 

6. In conjunction with Office of New 

Drugs (OND), conducts premarketing 

risk assessments for some products. 

7. Helps develop and maintain the 

Agency’s OSE CDERNET RiskMAP Web 

pages and works with other Agency 

programs to develop and maintain 

RiskMAP Internet pages. 

8. Develops and implements internal 

MAPPs and guidance on risk 

management initiatives. 

Office of Pharmacovigilance and 

Epidemiology 

1. Directs and supports the Divisions 

of Pharmacovigilance and 

Epidemiology. 

2. Evaluates the safety of marketed 

drugs. 

3. Reviews adverse event reports with 

OND. 

4. Collaborates with other offices to 

recommend appropriate actions. 

5. Provides recommendations on risk 

management programs and REMS. 

6. Coordinates the review and 

analysis of epidemiologic study 

protocols and results of epidemiologic 

studies submitted by industry, from the 

literature or other sources that are 

related to the postmarketing safety of 

drugs. 

Division of Epidemiology I 

1. Provides leadership, direction, 

planning, budgeting, management, and 

supervision of Division programs and 

staff. 

2. Reviews and provides analyses of 

epidemiologic study protocols and 

results of epidemiologic studies 

submitted by industry, from the 

literature or other sources that are 

related to the postmarketing safety of 

drugs. 

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19378 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

3. Provides development and 

assessment of methodologies and best 

practices for active and passive 

surveillance systems and for 

incorporating such data, when 

appropriate, into the review of the 

postmarketing safety of drugs. 

4. Reviews and analyzes drug 

utilization information. 

5. Performs epidemiologic research on 

drug safety issues. 

6. Provides epidemiologic and drug 

utilization expertise to support medical 

review divisions in areas of 

responsibility, as well as, for Advisory 

Committee presentations and related 

documents. 

7. Provides input on epidemiologic 

and drug utilization aspects of 

information for the public related to 

significant postmarketing safety 

information regarding drugs, biologics, 

devices, and foods. 

8. Develops and implements internal 

MAPPs and guidance on epidemiologic 

and drug utilization initiatives. 

Division of Epidemiology II 

1. Provides leadership, direction, 

planning, budgeting, management, and 

supervision of Division programs and 

staff. 

2. Reviews and analyzes 

epidemiologic study protocols and 

results of epidemiologic studies 

submitted by industry from the 

literature or other sources that are 

related to the postmarketing safety of 

drugs. 

3. Provides for the development and 

assessment of methodologies and best 

practices for scientifically-sound 

observational studies related to 

postmarketing safety of drugs. 

4. Reviews and analyzes drug 

utilization information. 

5. Performs epidemiologic research on 

drug safety issues. 

6. Provides epidemiologic and drug 

utilization expertise to support medical 

review divisions in areas of 

responsibility, as well as, for Advisory 

Committee presentations and related 

documents. 

7. Provides input on epidemiologic 

and drug utilization aspects of 

information for the public related to 

significant postmarketing safety 

information regarding drugs, biologics, 

devices, and foods. 

8. Develops and implements internal 

MAPPs and guidance on epidemiologic 

and drug utilization initiatives. 

Division of Pharmacovigilance I 

1. Provides leadership, direction, 

planning, budgeting, management, and 

supervision of Division programs and 

staff. 

2. Reviews and provides analysis of 

adverse event reports from industry 

submissions and from reports submitted 

directly to FDA related to marketed 

drugs in order to detect safety signals 

and evaluate risk; and performs 

followup when such signals are 

detected. 

3. Provides development and 

assessments of methodologies and best 

practices for scientifically-sound safety 

signal detection and drug risk 

evaluation related to the postmarketing 

safety of drugs. 

4. Provides safety signal detection and 

drug risk evaluation support to medical 

review divisions in areas of 

responsibility, as well as, for Advisory 

Committee presentations. 

5. Provides recommendations on 

safety signal detection and drug risk 

evaluation aspects of proposed and 

implemented RiskMAPs or RMPs. 

6. Provides input on signal detection 

and drug risk evaluation included in 

information for the public related to 

significant safety information regarding 

drugs, biologics, devices, and foods. 

7. Develops and implements internal 

MAPPs and guidance on safety signal 

detection and drug risk evaluation 

initiatives. 

Division of Pharmacovigilance II 

1. Provides leadership, direction, 

planning, budgeting, management, and 

supervision of Division programs and 

staff. 

2. Reviews and provides analyses of 

adverse event reports from industry 

submissions and from reports submitted 

directly to FDA related to marketed 

drugs in order to detect safety signals 

and evaluate risk; performs followup 

when such signals are detected. 

3. Provides development and 

assessment of methodologies and best 

practices for scientifically-sound safety 

signal detection and drug risk 

evaluation related to the postmarketing 

safety of drugs. 

4. Provides safety signal detection and 

drug risk evaluation support to medical 

review divisions in areas of 

responsibility, as well as, for Advisory 

Committee presentations. 

5. Provides recommendations on 

safety signal detection and drug risk 

evaluation aspects of proposed and 

implemented RiskMAPs or RMPs. 

6. Provides input on signal detection 

and drug risk evaluation included in 

information for the public related to 

significant safety information regarding 

drugs, biologics, devices, and foods. 

7. Develops and implements internal 

MAPPs and guidance on safety signal 

detection and drug risk evaluation 

initiatives. 

III. Delegation of Authority 

Pending further delegation, directives 

or orders by the Commissioner of the 

Food and Drugs or the Center Director, 

CDER, all delegations and redelegations 

of authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 

redelegations, provided they are 

consistent with this reorganization. 

Dated: April 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8313 Filed 4–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following meetings. 

The meetings 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 Institute of 

Environmental Health Sciences Special 

Emphasis Panel, Baseline Study For Arsenic 

Exposure. 

Date: April 27, 2011. 

Time: 1:30 p.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T. W. Alexander Drive, Research 

Triangle Park, NC 27709, (Telephone 

Conference Call). 

Contact Person: Sally Eckert-Tilotta, Ph.D., 

Scientific Review Administrator, Nat. 

Institute of Environmental Health Sciences, 

Office of Program Operations, Scientific 

Review Branch, P.O. Box 12233 MD EC–30, 

Research Triangle Park, NC 27709, (919) 541– 

1446, eckertt1@niehs.nih.gov. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel, Loan Repayment Program. 

Date: May 2, 2011. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

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