Federal Register / Vol. 75, No. 89 / Monday, May 10, 2010 / Notices 25869 

that more accurately assess the safety 

and health hazards of chemicals and 

products and that refine (less pain and 

distress), reduce, or replace animal use. 

The ICCVAM Authorization Act of 2000 

(42 U.S.C. 2851–2, 2851–5 [2000]), 

available at http://iccvam.niehs.nih.gov/ 

about/PL106545.htm) established 

ICCVAM as a permanent interagency 

committee of the NIEHS under 

NICEATM. NICEATM administers 

ICCVAM, provides scientific and 

operational support for ICCVAM-related 

activities, and coordinates international 

validation studies. NICEATM and 

ICCVAM work collaboratively to 

evaluate new and improved test 

methods applicable to the needs of U.S. 

Federal agencies. Additional 

information about ICCVAM and 

NICEATM, guidelines for nomination of 

test methods for validation studies, and 

guidelines for submission of test 

methods for ICCVAM evaluation are 

available at http://iccvam.niehs.nih.gov. 

Dated: April 30, 2010. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2010–10958 Filed 5–7–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0233] 

The National Institutes of Health and 

the Food and Drug Administration 

Joint Leadership Council: 

Stakeholders Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting, in conjunction with the 

National Institutes of Health (NIH), to 

solicit comments from interested 

persons on how the agencies can more 

effectively collaborate to advance the 

translation of biomedical research 

discoveries into approved diagnostics 

and therapies as well as promote 

science to enhance the evaluation tools 

used for regulatory review. A newly 

formed NIH–FDA Joint Leadership 

Council will help ensure that regulatory 

considerations form an increasing 

component of biomedical research 

planning, and that the latest science is 

integrated into the regulatory review 

process. 

DATES: The public meeting will be held 

on June 2, 2010, from 8:30 a.m. to 12:30 

p.m. Persons interested in attending the 

meeting must register by Wednesday, 

May 26, 2010, at 5 p.m. e.s.t. (see 

section III of this document). Submit 

written or electronic comments by 

Wednesday, May 26, 2010, at 5 p.m. 

e.s.t. 

ADDRESSES: The public meeting will be 

held at FDA, 10903 New Hampshire 

Ave., Bldg. 31, rm. 1503C, Silver Spring, 

MD 20993–0002. 

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. All 

comments should be identified with the 

docket number found in brackets at the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Rakesh Raghuwanshi, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 4283, Silver Spring, 

MD 20993–0002, 301–796–4769, FAX: 

301–847–8617, e-mail: 

rakesh.raghuwanshi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

With the dramatic breakthroughs 

occurring in biomedical research 

discovery, new public health challenges 

on the rise, an ever-changing economic 

landscape resulting from globalization, 

and the prospect for fundamental 

changes to healthcare delivery in the 

United States, there is a pressing need 

for greater collaboration between FDA 

and NIH. Both NIH and FDA have the 

goals of translating science discoveries 

into medical products and therapies, 

and both NIH and FDA have important 

roles and contributions to make towards 

these efforts. To address these important 

areas of common interest, NIH and FDA 

announced a new partnership effort that 

includes, among other initiatives, the 

regulatory science program and the 

NIH–FDA Joint Leadership Council. 

The NIH–FDA Joint Leadership 

Council provides a forum for the 

leadership of both agencies to: (1) Work 

together on strategic planning at a high 

level; (2) stimulate an enhanced culture 

of collaboration between the agencies at 

all levels; and (3) further coordinate and 

target efforts to promote promising new 

therapies using the latest technological 

advances, such as stem cell biology, 

biomarkers, and computational 

sciences. NIH and FDA plan to work 

jointly to address the gap between 

biomedical research discoveries and 

new medical products. They can create 

new programs to support development 

of innovative therapies and promote 

personalized medicine, utilizing new 

clinical trial design strategies and 

regulatory review processes 

incorporating the use of genetic or other 

biomarkers and information 

technologies. These activities will also 

support postmarketing and/or other 

population-based surveys for safety 

assessments. Overall, there are many 

new avenues for NIH and FDA to 

explore such that we can deliver safer 

and more effective treatments faster. 

II. Scope of the Meeting 

FDA and NIH are interested in 

receiving comments from the public on 

the regulatory considerations that 

should be an integral part of the 

biomedical research program 

development and scientific tools or 

approaches that would enhance the 

ability to evaluate new medical 

products. The comments should focus 

on ways in which NIH and FDA can 

partner to promote interdisciplinary 

biomedical research through scientific 

exchange and new programs designed to 

advance innovation and development of 

new therapies incorporating many of the 

latest basic research discoveries. 

Suggestions about the ways FDA and 

NIH can work together to promote an 

integrated biomedical research agenda 

including regulatory review approaches 

and/or processes on areas of common 

interest and mission are being sought. 

Some areas for which we are 

specifically interested in input are the 

following: 

1. What steps should be taken to 

enhance the translation of biomedical 

research discoveries into new and 

approved preventatives, diagnostics, 

therapies, or devices for clinical use? 

2. What are the priority scientific 

issues that currently need to be 

addressed (e.g., clinical trial design, 

endpoint selection and qualification, 

bioinformatics needs) in order to inform 

regulatory assessments and analyses of 

new products? 

3. How could we enhance the 

exchange of scientific information 

across all sectors in order to better 

identify and prioritize scientific areas 

for emphasis in regulatory research? 

4. What mechanisms for the support 

of regulatory science research would be 

most effective and efficient in 

addressing pressing priority areas in the 

translational pipeline? 

III. Registration To Attend and/or To 

Participate in the Meeting 

If you wish to attend the public 

meeting, you must register by e-mailing 

Rakesh Raghuwanshi 


jlentini on DSKJ8SOYB1PROD with NOTICES
25870 Federal Register / Vol. 75, No. 89 / Monday, May 10, 2010 / Notices 

(rakesh.raghuwanshi@fda.hhs.gov) by 

Wednesday, May 26, 2010, at 5 p.m. 

e.s.t. When registering, you must 

provide the following information: (1) 

Your name, (2) title, (3) company or 

organization (if applicable), (4) mailing 

address, (5) telephone number, and (6) 

e-mail address. If you wish to make a 

presentation, when you register, 

indicate the specific topic or issue to be 

addressed in your presentation. We will 

do our best to accommodate all persons 

who wish to make a presentation at the 

meeting. FDA and NIH encourage 

persons and groups having similar 

interests to consolidate their 

information for presentation through a 

single representative. After reviewing 

the requests to present, we will contact 

each participant prior to the meeting 

with the amount of time available and 

the approximate time the participant’s 

presentation is scheduled to begin. 

Presenters must then send the final 

electronic copies of their presentations 

in Microsoft PowerPoint, Microsoft 

Word, or Adobe Portable Document to 

Format (PDF) to Rakesh Raghuwanshi 

(rakesh.raghuwanshi@fda.hhs.gov) by 

Monday, May 31, 2010, at 12 noon e.s.t. 

There is no fee to register for the 

public meeting and registration will be 

on a first-come, first-served basis. Early 

registration is recommended because 

seating is limited. Registration on the 

day of the public meeting will be 

permitted on a space available basis 

beginning at 8 a.m. 

If you need special accommodations 

due to a disability, please inform the 

meeting contact (see FOR FURTHER

INFORMATION CONTACT) by Wednesday, 

May 26, 2010, at 5 p.m. e.s.t. 

IV. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments. 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. 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 approximately 30 

days after the meeting at http:// 

www.regulations.gov and at the Division 

of Dockets Management (see 

ADDRESSES). A transcript will also be 

available in either hardcopy or on CD– 

ROM, after 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: May 5, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–11008 Filed 5–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors (BSC), 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry (NCEH/ATSDR) 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), CDC and BSC, NCEH/ 

ATSDR announces the following 

meeting of the aforementioned 

committee: 

Times and Dates: 8:30 a.m.–6 p.m., 

May 27, 2010. 8 a.m.–2 p.m., May 28, 

2010. 

Place: Centers for Disease Control and 

Prevention, 4770 Buford Highway, 

Chamblee, Georgia 30341. 

Status: Open to the public, limited 

only by the space available. The meeting 

room accommodates approximately 75 

people. The public comment period is 

scheduled for Friday, May 28, 2010 

from 8:45 a.m. until 9 a.m. 

Purpose: The Secretary, Department 

of Health and Human Services (HHS) 

and by delegation, the Director, CDC 

and Administrator, NCEH/ATSDR, are 

authorized under Section 301 (42 U.S.C. 

241) and Section 311 (42 U.S.C. 243) of 

the Public Health Service Act, as 

amended, to: (1) Conduct, encourage, 

cooperate with, and assist other 

appropriate public authorities, scientific 

institutions, and scientists in the 

conduct of research, investigations, 

experiments, demonstrations, and 

studies relating to the causes, diagnosis, 

treatment, control, and prevention of 

physical and mental diseases and other 

impairments; (2) assist States and their 

political subdivisions in the prevention 

of infectious diseases and other 

preventable conditions and in the 

promotion of health and well being; and 

(3) train State and local personnel in 

health work. The BSC, NCEH/ATSDR 

provides advice and guidance to the 

Secretary, HHS; the Director, CDC and 

Administrator, ATSDR; and the 

Director, NCEH/ATSDR, regarding 

program goals, objectives, strategies, and 

priorities in fulfillment of the agency’s 

mission to protect and promote people’s 

health. The board provides advice and 

guidance that will assist NCEH/ATSDR 

in ensuring scientific quality, 

timeliness, utility, and dissemination of 

results. The board also provides 

guidance to help NCEH/ATSDR work 

more efficiently and effectively with its 

various constituents and to fulfill its 

mission in protecting America’s health. 

Matters To Be Discussed: The agenda 

will include an update on NCEH/ 

ATSDR’s Office of the Director; an 

overview of the Division of Laboratory 

Sciences (DLS); a presentation of DLS 

programs to the BSC peer review 

breakout groups; a presentation by the 

BSC peer review breakout groups of the 

key findings of DLS programs and 

activities; discussion of outstanding 

BSC Issues; Program Response to BSC 

Program Peer Review by NCEH/ATSDR 

Division of Emergency and 

Environmental Health Services (EHHE); 

an overview of the Division of 

Environmental Hazards and Health 

Effects; and presentations by EHHE 

Branches. 

Agenda items are tentative and 

subject to change. 

Contact Person for More Information: 

Sandra Malcom, Committee 

Management Specialist, NCEH/ATSDR, 

4770 Buford Highway, Mail Stop F–61, 

Chamblee, Georgia 30341; telephone 

770/488–0575, Fax 770/488–3377; Email: smalcom@cdc.gov. The deadline 

for notification of attendance is May 25, 

2010. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: May 4, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–10971 Filed 5–7–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2010–0035] 

DHS Data Privacy and Integrity 

Advisory Committee 

AGENCY: Privacy Office, DHS. 


jlentini on DSKJ8SOYB1PROD with NOTICES