[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8328-8329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03115]


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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.

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    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.sheratonindianapoliskeystonecrossing.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: <a href="/cdn-cgi/l/email-protection#285a51475d464f68494e4c4706475a4f"><span class="__cf_email__" data-cfemail="7002091f051e17301116141f5e1f0217">[email protected]</span></a>.
    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)

[[Page 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: <a href="/cdn-cgi/l/email-protection#2f4e494b406f4e494b4001405d48"><span class="__cf_email__" data-cfemail="325354565d725354565d1c5d4055">[email protected]</span></a>.

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:

<bullet> Medical Device Single Audit Program
<bullet> Contract Manufacturing Arrangements for Drugs: Quality 
Agreements
<bullet> Compliance Question and Answer Panel
<bullet> Draft Guidance: Distinguishing Medical Device Recalls from 
Product Enhancements and Associated Reporting Requirements
<bullet> Compounding Pharmacies
<bullet> Overview of Global Device/Drug Requirements v. U.S. System
<bullet> Case for Quality Initiative Update
<bullet> Unique Device Identifier (UDI) Implementation Update
<bullet> Metric, Data, and Analysis; Biometrics
<bullet> Pharmaceutical Inspection Cooperation Scheme
<bullet> 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


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