8328 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 

TABLE 1—REGISTRATION FEES 1

Attendee type Advanced rate 

(2/6/15 to 3/5/15) 

Standard rate 

(after 3/5/15) 

Industry ........................................................................................................................................................ $1,495 $1,695 

Small Business (<100 Employees) ............................................................................................................. 1,000 1,200 

Startup Manufacturer ................................................................................................................................... 250 300 

Academic ..................................................................................................................................................... 250 300 

FDA/Government Employee ........................................................................................................................ Free Free 

1The following forms of payment will be accepted: American Express, Visa, MasterCard, and company checks. 

To register online for the public 

conference, please visit the 

‘‘Registration’’ link on the conference 

Web site at http:// 

www.XavierMedCon.com. FDA has 

verified the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register. 

To register by mail, please send your 

name, title, firm name, address, 

telephone, email, and payment 

information for the fee to Xavier 

University, Attention: Mason Rick, 3800 

Victory Pkwy., Cincinnati, OH 45207– 

5471. An email will be sent confirming 

your registration. 

Attendees are responsible for their 

own accommodations. The conference 

headquarters hotel is the Downtown 

Hilton Cincinnati Netherland Plaza, 35 

West Fifth St., Cincinnati, OH 45202, 

513–421–9100. Special conference block 

rates are available through April 16, 

2015. To make reservations online, 

please visit the ‘‘Venue/Logistics’’ link 

at http://www.XavierMedCon.com. 

If you need special accommodations 

due to a disability, please contact Mason 

Rick (see Contact Persons) at least 7 

days in advance of the conference. 

SUPPLEMENTARY INFORMATION: The 

public conference helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

conference will provide those engaged 

in FDA-regulated medical devices (for 

humans) with information on the 

following topics: 

• Center Director Corner: Strategic 

Priorities for 2015 and Beyond 

• Office of Compliance Strategic 

Priorities 

• Advancements in Medical Device 

Software Technology 

• Understanding and Preparing for the 

Revision of ISO13485 

• Update from FDA’s Office of 

Combination Products 

• Unique Device Identification— 

Implementation 

• FDA Inspections and Insights 

• Understanding the Current Activities 

of the International Medical Device 

Regulators Forum 

• European Union Medical Device/In 

Vitro Diagnostics Regulation Review 

• Update from the Office of Device 

Evaluation 

• Regulatory Submissions and 

Strategies 

• Complaints, Corrective and 

Preventive Actions, and Recalls 

• Regulatory Challenges in Asia 

• Action Plan Writing 

• Lunch Networking by Topic 

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 conference 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 

conference also is consistent with the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (Public Law 104– 

121) by providing outreach activities by 

Government agencies to small 

businesses. 

Dated: February 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03116 Filed 2–13–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

In Motion: Science Transforming 

Policy in Food, Drug, and Medical 

Device Regulation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

The Food and Drug Administration 

(FDA) Detroit District Office, in 

cosponsorship with the Association of 

Food and Drug Officials (AFDO), is 

announcing a public conference entitled 

‘‘In Motion: Science Transforming 

Policy in Food, Drug, and Medical 

Device Regulation.’’ The conference 

Web site is http://indy.afdo.org/. This 

conference is intended to provide 

information about FDA food, drug, and 

device regulation to the regulated 

industry. 

Date and Time: The public conference 

will be held on June 20 to 24, 2015. 

Times will vary. 

Location: The conference will be held 

at the Sheraton Indianapolis Hotel at 

Keystone Crossing, Indianapolis, 8787 

Keystone Crossing, Indianapolis, IN 

46240, 317–846–2700 or toll-free 888– 

627–7814; www.sheratonindianapolis

keystonecrossing.com. 

Attendees are responsible for their 

own accommodations. To make 

reservations at the Sheraton 

Indianapolis Hotel at the reduced 

conference rate, please call 303–295– 

1234 and mention ‘‘AFDO Conference’’ 

before May 20, 2015. All the hotel 

information needed to call or reserve 

online is available at http:// 

indy.afdo.org/hotel.html. 

AFDO contact information: Randy 

Young, Association of Food and Drug 

Officials, 2550 Kingston Rd., suite 311, 

York, PA 17402, 717–757–2888, FAX: 

717–650–3650, email: ryoung@afdo.org. 

Registration: You are encouraged to 

register by May 20, 2015. The AFDO 

registration fees cover the cost of 

facilities, materials, and breaks. Seats 

are limited; therefore, please submit 

your registration as soon as possible. 

Course space will be filled in order of 

receipt of registration. Those accepted 

into the course will receive 

confirmation. Registration will close 

after the course is filled. Registration at 

the site is not guaranteed but may be 

possible on a space available basis on 

the day of the conference beginning at 

8 a.m. The cost of registration follows: 

Cost of Registration: 

Member—$475.00 

Non-Member—$575.00 

*A $100 late fee will be added if 

payment is postmarked after June 1, 

2015. 

If you need special accommodations 

due to a disability, please contact Randy 

Young (see AFDO contact information) 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 8329 

at least 21 days in advance of the 

conference. 

Registration Instructions: To register, 

please complete and submit an AFDO 

Conference Registration Form, along 

with a check or money order payable to 

‘‘AFDO’’. Please mail your completed 

registration form and payment to: 

AFDO, 2550 Kingston Rd., suite 311, 

York, PA 17402. To register online, 

please visit http://indy.afdo.org/

register.html. (FDA has verified the Web 

site address but is not responsible for 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register.) 

The registrar will also accept payment 

through Visa and MasterCard credit 

cards. For more information on the 

conference, or for questions about 

registration, please contact AFDO at 

717–757–2888, FAX: 717–650–3650, or 

email: afdo@afdo.org. 

SUPPLEMENTARY INFORMATION: The 

conference helps fulfill the Department 

of Health and Human Services’ and 

FDA’s important mission to protect the 

public health. The conference will 

provide FDA-regulated drug and device 

entities with information on a number 

of topics concerning FDA requirements 

related to the production and marketing 

of drugs and/or devices. Topics for 

discussion include, but are not limited 

to, the following: 

• Medical Device Single Audit Program 

• Contract Manufacturing 

Arrangements for Drugs: Quality 

Agreements 

• Compliance Question and Answer 

Panel 

• Draft Guidance: Distinguishing 

Medical Device Recalls from Product 

Enhancements and Associated 

Reporting Requirements 

• Compounding Pharmacies 

• Overview of Global Device/Drug 

Requirements v. U.S. System 

• Case for Quality Initiative Update 

• Unique Device Identifier (UDI) 

Implementation Update 

• Metric, Data, and Analysis; Biometrics 

• Pharmaceutical Inspection 

Cooperation Scheme 

• Biosimilar Regulations 

FDA has made education of the food, 

feed, drug, and device manufacturing 

community a high priority to help 

ensure the quality of FDA-regulated 

products. The conference 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 conference 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: February 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03115 Filed 2–13–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0824] 

Regulatory Site Visit Training Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Biologics Evaluation and Research 

(CBER) is announcing an invitation for 

participation in its Regulatory Site Visit 

Training Program (RSVP). This training 

program is intended to give CBER 

regulatory review, compliance, and 

other relevant staff an opportunity to 

visit biologics facilities. These visits are 

intended to allow CBER staff to directly 

observe routine manufacturing practices 

and to give CBER staff a better 

understanding of the biologics industry, 

including its challenges and operations. 

The purpose of this document is to 

invite biologics facilities to contact 

CBER for more information if they are 

interested in participating in this 

program. 

DATES: Submit either an electronic or 

written request for participation in this 

program by March 19, 2015. The request 

should include a description of your 

facility relative to products regulated by 

CBER. Please specify the physical 

address(es) of the site(s) you are 

offering. 

ADDRESSES: If your biologics facility is 

interested in offering a site visit, submit 

either an electronic request to http://

www.regulations.gov or a written 

request to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. If you 

previously responded to earlier requests 

to participate in this program and you 

continue to be interested in 

participating, please renew your request 

through a submission to the Division of 

Dockets Management. 

FOR FURTHER INFORMATION CONTACT: Loni 

Warren Henderson, Division of 

Manufacturers Assistance and Training, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. G112, Silver Spring, 

MD 20993–0002, 240–402–7800, FAX: 

301–595–1243, Industry.Biologics@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CBER regulates certain biological 

products including blood and blood 

products, vaccines, and cellular, tissue, 

and gene therapies. CBER is committed 

to advancing the public health through 

innovative activities that help ensure 

the safety, effectiveness, and availability 

of biological products to patients. To 

support this primary goal, CBER has 

initiated various training and 

development programs, including 

programs to further enhance 

performance of its compliance staff, 

regulatory review staff, and other 

relevant staff. CBER seeks to 

continuously enhance and update 

review efficiency and quality, and the 

quality of its regulatory efforts and 

interactions, by providing CBER staff 

with a better understanding of the 

biologics industry and its operations. 

Further, CBER seeks to enhance: (1) Its 

understanding of current industry 

practices and regulatory impacts and 

needs and (2) communication between 

CBER staff and industry. CBER initiated 

its RSVP in 2005. Through these annual 

notices, CBER is requesting that those 

firms that have previously applied and 

are still interested in participating 

reaffirm their interest. CBER is also 

requesting that new interested parties 

apply. 

II. RSVP 

A. Regulatory Site Visits 

In this program, over a period of time 

to be agreed upon with the facility, 

small groups of CBER staff may observe 

operations of biologics establishments, 

including for example, blood and tissue 

establishments. The visits may include 

the following: (1) Packaging facilities, 

(2) quality control and pathology/

toxicology laboratories, and (3) 

regulatory affairs operations. These 

visits, or any part of the program, are 

not intended as a mechanism to inspect, 

assess, judge, or perform a regulatory 

function, but are meant to improve 

mutual understanding and to provide an 

avenue for open dialogue between the 

biologics industry and CBER. 

B. Site Selection 

CBER will be responsible for all travel 

expenses associated with the site visits. 


tkelley on DSK3SPTVN1PROD with NOTICES