57472 Federal Register / Vol. 75, No. 182 / Tuesday, September 21, 2010 / Notices 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: September 6, 2010. 

David K. Henderson, 

Deputy Director for Clinical Care, CC National 

Institutes of Health. 

[FR Doc. 2010–23526 Filed 9–20–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Breast and Cervical Cancer Early 

Detection and Control Advisory 

Committee (BCCEDCAC): Notice of 

Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the 

BCCEDCAC, HHS, has been renewed for 

a 2-year period through September 12, 

2012. 

For information, contact Ms. Jameka 

Blackmon, Designated Federal Officer, 

BCCEDCAC, CDC, 1600 Clifton Road, 

NE., M/S K57, Atlanta, Georgia, 30333, 

telephone (770) 488–4740; fax (770) 

488–3230. 

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 CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: September 14, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–23588 Filed 9–20–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0456] 

Clinical Investigator Training Course 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA), Office of Critical 

Path Programs, in cosponsorship with 

the Clinical Trials Transformation 

Initiative (CTTI), is announcing a 3-day 

training course for health care 

professionals responsible for, or 

involved in, the conduct and/or design 

of clinical trials (clinical investigators). 

This course is intended to assist clinical 

investigators in understanding what 

preclinical and clinical information is 

needed to support the investigational 

use of medical products, as well as the 

scientific, regulatory, and ethical 

considerations involved in the conduct 

of clinical trials. 

DATES: The training course will be held 

on November 8 and 9, 2010, from 8 a.m. 

to 5 p.m. and on November 10, 2010, 

from 8 a.m. to 3 p.m. 

ADDRESSES: The training course will be 

held at the National Labor College, 

10000 New Hampshire Ave., Silver 

Spring, MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Masiello, Office of Critical Path 

Programs, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 4166, Silver Spring, 

MD 20993–0002, 301–796–8498, 

Nancy.Masiello@fda.hhs.gov. 

Registration: Register by November 1, 

2010, at the registration/information 

Web site at https://www.trials

transformation.org/fda-clinicalinvestigator-training-course/. 

Registration materials, payment 

procedures, accommodation 

information, and a detailed description 

of the course can be found at the 

registration/information Web site. The 

registration fee is $350 per person. The 

fee includes course materials and onsite 

lunch. Early registration is 

recommended because seating is 

limited. There will be no onsite 

registration. Persons attending the 

course are advised that FDA is not 

responsible for providing access to 

electrical outlets. If you need special 

accommodations due to a disability, 

please contact Nancy Masiello at least 7 

days in advance. 

SUPPLEMENTARY INFORMATION: Clinical 

trial investigators play a critical role in 

the development of medical products. 

They bear the responsibility for 

ensuring the safe and ethical treatment 

of study subjects and for acquiring 

adequate and reliable data to support 

regulatory decisions. This course is 

intended to assist clinical investigators 

in understanding what preclinical and 

clinical information is needed to 

support the investigational use of 

medical products, as well as the 

scientific, regulatory, and ethical 

considerations involved in the conduct 

of clinical trials. 

The training course is designed to 

provide clinical investigators with an 

overview of the following topics: 

• The essential toxicological, 

pharmacological, and manufacturing 

data to support investigational use in 

humans; 

• Fundamental issues in the design 

and conduct of clinical trials; 

• Statistical and analytic 

considerations in the interpretation of 

trial data; 

• Appropriate safety evaluation 

during studies; 

• The ethical considerations and 

regulatory requirements for clinical 

trials; and 

• Application and compliance issues. 

In addition, the course should: 

• Foster a cadre of clinical 

investigators with knowledge, 

experience, and commitment to 

investigational medicine; 

• Promote communication between 

clinical investigators and FDA; 

• Enhance investigators’ 

understanding of FDA’s role in 

experimental medicine; and 

• Improve the quality of data while 

enhancing subject protection in the 

performance of clinical trials. 

On November 8, 2010, the course will 

address the role of FDA in clinical 

studies, regulatory considerations for 

clinical trials, and review of the material 

generally appearing in an ‘‘investigator’s 

brochure,’’ i.e., the preclinical 

information (toxicology, animal studies, 

and chemistry/manufacturing 

information) that supports initial 

clinical trials in humans. Presentations 

will also discuss the role of clinical 

pharmacology in early clinical studies 

and how this information is used in the 

design of subsequent studies. On 

November 9, 2010, the course will 

include discussions of scientific, 

statistical, ethical, and regulatory 

aspects of clinical studies. On 

November 10, 2010, the course will 

include discussions of safety assessment 

in clinical trials, including hepatic and 

cardiovascular safety, approaches to 

special populations (e.g., pregnant 

women and pediatrics), and breakout 

sessions to discuss how to put together 

an application, including related 

compliance issues. 

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23493 Filed 9–20–10; 8:45 am] 

BILLING CODE 4160–01–S 


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