Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18413 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 31, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07816 Filed 4–3–15; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Society of Clinical Research 

Associates—Food and Drug 

Administration Clinical Trial 

Requirements, Regulations, 

Compliance and Good Clinical Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

educational conference cosponsored 

with the Society of Clinical Research 

Associates (SOCRA). The public 

conference regarding 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 

including 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 conference 

will be held on May 13 and 14, 2015, 

from 8 a.m. to 5 p.m. 

Location: The conference will be held 

at The Westin Cincinnati, 21 East Fifth 

Street, Cincinnati, OH 45202; 513–621– 

7700. Attendees are responsible for their 

own accommodations. Please mention 

SOCRA to receive the hotel room rate of 

$169 plus applicable taxes (available 

until April 15, 2015, or until the SOCRA 

room block is filled). 

Contact: John Fraser, Cincinnati 

District Office, Food and Drug 

Administration, 6751 Steger Dr., 

Cincinnati OH 45237, 513–679–2700, 

FAX: 513–679–2771 or Society of 

Clinical Research Associates (SOCRA), 

530 West Butler Ave., Suite 109, 

Chalfont, PA 18914, 800–762–7292 or 

215–822–8644, FAX: 215–822–8633, 

email: Office@socra.org, Web site: 

http://www.socra.org. (FDA has verified 

the Web site addresses throughout this 

document, but we are not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

Registration: The registration fee will 

cover 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 workshop will 

receive confirmation. The cost of the 

registration is as follows: SOCRA 

member, $575; SOCRA nonmember 

(includes membership), $650; Federal 

Government member, $450; Federal 

Government nonmember, $525; FDA 

employee, free (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 education 

activity for a maximum of 13.3 

Continuing Education (CE) Credits for 

SOCRA CE and Continuing Nurse 

Education (CNE). SOCRA designates 

this live activity for a maximum of 13.3 

American Medical Association 

Physicians Recognition Award Category 

1 Credit(s)TM. Physicians should claim 

only the credit commensurate with the 

extent of their participation. Continuing 

Medical Education for physicians: 

SOCRA is accredited by the 

Accreditation Council for Continuing 

Medical Education to provide 

continuing medical education for 

physicians. CNE for nurses: 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 via the Internet, 

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

Conference.htm. Payment by major 

credit card is accepted (Visa/

MasterCard/AMEX only). For more 

information on the meeting registration, 

or for questions on the 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 

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, institutional review board 

inspections, electronic record 

requirements, and investigator-initiated 

research. 

Topics for discussion include the 

following: (1) The Role of the FDA 

District Office Relative to the 

Bioresearch Monitoring Program; (2) 

Modernizing FDA’s Clinical Trials/

BIMO Programs; (3) What FDA Expects 

in a Pharmaceutical Clinical Trial; (4) 

Medical Device Aspects of Clinical 

Research; (5) Adverse Event Reporting— 

Science, Regulation, Error and Safety; 

(6) Working with FDA’s Center for 

Biologics Evaluation and Research; (7) 

Ethical Issues in Subject Enrollment; (8) 

Keeping Informed and Working 

Together; (9) FDA Conduct of Clinical 

Investigator Inspections; (10) 

Investigator Initiated Research; (11) 

Meetings with the FDA—Why, When, 

and How; (12) Part 11 Compliance— 

Electronic Signatures; (13) IRB 

Regulations and FDA Inspections; (14) 

Informed Consent Regulations; (15) The 

Inspection is Over—What Happens 

Next? Possible FDA Compliance 

Actions; (16) Question and Answer 

Session/Panel Discussion. 

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 workshop helps to achieve 

objectives set forth in section 406 of the 

Food and Drug Administration 

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 

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: April 1, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07810 Filed 4–3–15; 8:45 am] 

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