17138 Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Food and Drug Administration Clinical 

Trial Requirements, Regulations, 

Compliance, and Good Clinical 

Practice; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) Denver District Office, in cosponsorship with the Society of Clinical 

Research Associates (SoCRA), is 

announcing a public workshop. The 

public workshop on FDA’s clinical trial 

requirements is designed to aid the 

clinical research professional’s 

understanding of the mission, 

responsibilities, and authority of FDA 

and to facilitate interaction with FDA 

representatives. The program will focus 

on the relationships among FDA and 

clinical trial staff, investigators, and 

institutional review boards (IRBs). 

Individual FDA representatives will 

discuss the informed consent process 

and informed consent documents; 

regulations relating to drugs, devices, 

and biologics; as well as inspections of 

clinical investigators, IRBs, and research 

sponsors. 

Date and Time: The public workshop 

will be held on May 4 and 5, 2011, from 

8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at The Curtis Hotel, 1405 Curtis 

St., Denver, CO 80202, 1–303–571– 

0300. 

Attendees are responsible for their 

own accommodations. Please mention 

SoCRA to receive the hotel room rate of 

$119 plus applicable taxes (available 

until the SoCRA room block is filled). 

Contact: David Arvelo, Office of 

Regulatory Affairs, Food and Drug 

Administration, 4040 N. Central 

Expressway, suite 900, Dallas, Texas 

75204, 214–253–4952, FAX 214–253– 

4970, e-mail david.arvelo@fda.hhs.gov; 

or 

Society of Clinical Research 

Associates (SoCRA), 530 West Butler 

Ave., suite 109, Chalfont, PA 18914, 

800–762–7292, FAX: 215–822–8633, email: SoCRAmail@aol.com, Web site: 

http://www.SoCRA.org. 

Registration: The registration fee 

covers the cost of actual expenses, 

including refreshments, lunch, 

materials, and speaker expenses. Seats 

are limited; please submit your 

registration as soon as possible. 

Workshop space will be filled in order 

of receipt of registration. Those accepted 

into the public workshop will receive 

confirmation. The cost of registration 

follows: 

COST OF REGISTRATION

SoCRA member ....................... $575.00 

SoCRA nonmember (includes 

membership).

$650.00 

Federal Government SoCRA 

member.

$450.00 

Federal Government SoCRA 

nonmember.

$525.00 

FDA Employee ......................... Fee Waived 

If you need special accommodations 

due to a disability, please contact 

SoCRA (see Contact) at least 21 days in 

advance. 

Extended periods of question and 

answer and discussion have been 

included in the program schedule. 

SoCRA designates this educational 

activity for a maximum of 13.3 

Continuing Education (CE) Credits for 

SoCRA CE and Nurse CNE. SoCRA 

designates this educational activity for a 

maximum of 13.3 American Medical 

Association Physician’s Recognition 

Award Category 1 Credit(s)TM. 

Physicians should claim credit 

commensurate with the extent of their 

participation. SoCRA is accredited by 

the Accreditation Council for 

Continuing Medical Education to 

provide continuing medical education 

for physicians. SoCRA is an approved 

provider of continuing nursing 

education by the Pennsylvania State 

Nurses Association (PSNA), an 

accredited approver by the American 

Nurses Credentialing Center’s 

Commission on Accreditation (ANCC). 

ANCC/PSNA Provider Reference 

Number: 205–3–A–09. 

Registration instructions: To register, 

please submit a registration form with 

your name, affiliation, mailing address, 

telephone, fax number, and email, along 

with a check or money order payable to 

‘‘SoCRA.’’ Mail to: SoCRA (see Contact 

for address). To register on the Internet, 

go to http://www.socra.org/html/ 

FDA_Conference.htm. (FDA has verified 

the Web site addresses throughout this 

document, but we are not responsible 

for any subsequent changes to the Web 

site after this document publishes in the 

Federal Register.) 

Payment by major credit card is 

accepted (Visa/MasterCard/AMEX 

only). For more information on the 

meeting registration, or for questions on 

the public workshop, contact SoCRA 

(see Contact). 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The public 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related to 

informed consent, clinical investigation 

requirements, IRB inspections, 

electronic record requirements, and 

investigator initiated research. Topics 

for discussion include the following: (1) 

What FDA Expects in a Pharmaceutical 

Clinical Trial; (2) Adverse Event 

Reporting—Science, Regulation, Error, 

and Safety; (3) Part 11 Compliance— 

Electronic Signatures; (4) Informed 

Consent Regulations; (5) IRB 

Regulations and FDA Inspections; (6) 

Keeping Informed and Working 

Together; (7) FDA Conduct of Clinical 

Investigator Inspections; (8) Meetings 

With FDA: Why, When, and How; (9) 

Investigator Initiated Research; (10) 

Medical Device Aspects of Clinical 

Research; (11) Working With FDA’s 

Center for Biologics Evaluation and 

Research; (12) The Inspection Is Over— 

What Happens Next? Possible FDA 

Compliance Actions; (13) Ethical Issues 

in Subject Enrollment; (14) Medical 

Device Aspects of Clinical Research; 

and (15) Are We There Yet? An 

Overview of the FDA Good Clinical 

Practice Program. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

U.S.C. 393) which includes working 

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The public workshop also is 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Pub. L. 104–121) as outreach 

activities by Government Agencies to 

small businesses. 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7192 Filed 3–25–11; 8:45 am] 

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