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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19379 

Place: NIEHS/National Institutes of Health, 

Building 4401, East Campus, 79 T.W. 

Alexander Drive, Research Triangle Park, NC 

27709, (Virtual Meeting). 

Contact Person: RoseAnne M. McGee, 

Associate Scientific Review Administrator, 

Scientific Review Branch, Division of 

Extramural Research and Training, Nat. 

Institute of Environmental Health Sciences, 

P.O. Box 12233, MD EC–30, Research 

Triangle Park, NC 27709, (919) 541–0752, 

mcgee1@niehs.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: March 31, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–8316 Filed 4–6–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the Center 

for Scientific Review Advisory Council. 

The meeting will be open to the 

public, 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. 

Name of Committee: Center for Scientific 

Review Advisory Council. 

Date: May 2, 2011. 

Time: 8:15 a.m. to 4 p.m. 

Agenda: Provide advice to the Director, 

Center for Scientific Review (CSR), on 

matters related to planning, execution, 

conduct, support, review, evaluation, and 

receipt and referral of grant applications at 

CSR. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, Room E1/ 

E2, Bethesda, MD 20892. 

Contact Person: Cheryl A. Kitt, Ph.D., 

Executive Secretary, Center for Scientific 

Review, National Institutes of Health, 6701 

Rockledge Drive, Room 3030, MSC 7776, 

Bethesda, MD 20892, 301–435–1112, 

kittc@csr.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, driver’s license, 

or passport) and to state the purpose of their 

visit. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: March 31, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–8315 Filed 4–6–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; 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 the National Advisory 

Council for Complementary and 

Alternative Medicine (NACCAM) 

meeting. 

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/or contract Proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable materials, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council for Complementary and Alternative 

Medicine. 

Date: June 3, 2011. 

Closed: June 3, 2011, 8:30 a.m. to 10:30 

a.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Open: June 3, 2011, 11 a.m. to 4 p.m. 

Agenda: Opening remarks by the Director 

of the National Center for Complementary 

and Alternative Medicine, presentation of a 

new research initiative, and other business of 

the Council. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Contact Person: Martin H. Goldrosen, 

Ph.D., Executive Secretary, Director, Division 

of Extramural Activities, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health, 6707 

Democracy Blvd., Suite 401, Bethesda, MD 

20892, (301) 594–2014. 

The public comments session is scheduled 

from 3:30 to 4 p.m. on June 3, 2011, but 

could change depending on the actual time 

spent on each agenda item. Each speaker will 

be permitted 5 minutes for their presentation. 

Interested individuals and representatives of 

organizations are requested to notify Dr. 

Martin H. Goldrosen, National Center for 

Complementary and Alternative Medicine, 

NIH, 6707 Democracy Boulevard, Suite 401, 

Bethesda, Maryland, 20892, 301–594–2014, 

Fax: 301–480–9970. Letters of intent to 

present comments, along with a brief 

description of the organization represented, 

should be received no later than 5 p.m. on 

May 26, 2011. Only one representative of an 

organization may present oral comments. 

Any person attending the meeting who does 

not request an opportunity to speak in 

advance of the meeting may be considered 

for oral presentation, if time permits, and at 

the discretion of the Chairperson. In 

addition, written comments may be 

submitted to Dr. Martin H. Goldrosen at the 

address listed above up to ten calendar days 

(June 13, 2011) following the meeting. 

Copies of the meeting agenda and the 

roster of members will be furnished upon 

request by contacting Dr. Martin H. 

Goldrosen, Executive Secretary, NACCAM, 

National Center for Complementary and 

Alternative Medicine, National Institutes of 

Health, 6707 Democracy Boulevard, Suite 

401, Bethesda, Maryland 20892, 301–594– 

2014, Fax 301–480–9970, or via e-mail at 

naccames@mail.nih.gov. 

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, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: 

nccam.nih.gov/about/naccam, where an 

mstockstill on DSKH9S0YB1PROD with NOTICES