80_FR_8359 80 FR 8328 - In Motion: Science Transforming Policy in Food, Drug, and Medical Device Regulation

80 FR 8328 - In Motion: Science Transforming Policy in Food, Drug, and Medical Device Regulation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 31 (February 17, 2015)

Page Range8328-8329
FR Document2015-03115

Federal Register, Volume 80 Issue 31 (Tuesday, February 17, 2015) 
[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8328-8329]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].
    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: [email protected].

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

8328 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices TABLE 1—REGISTRATION FEES 1 Advanced rate Standard rate Attendee type (2/6/15 to 3/5/15) (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 1 The following forms of payment will be accepted: American Express, Visa, MasterCard, and company checks. To register online for the public • European Union Medical Device/In Policy in Food, Drug, and Medical conference, please visit the Vitro Diagnostics Regulation Review Device Regulation.’’ The conference ‘‘Registration’’ link on the conference • Update from the Office of Device Web site is http://indy.afdo.org/. This Web site at http:// Evaluation conference is intended to provide www.XavierMedCon.com. FDA has • Regulatory Submissions and information about FDA food, drug, and verified the Web site address, but is not Strategies device regulation to the regulated responsible for subsequent changes to • Complaints, Corrective and industry. the Web site after this document Preventive Actions, and Recalls Date and Time: The public conference publishes in the Federal Register. • Regulatory Challenges in Asia will be held on June 20 to 24, 2015. To register by mail, please send your • Action Plan Writing Times will vary. name, title, firm name, address, • Lunch Networking by Topic Location: The conference will be held telephone, email, and payment FDA has made education of the drug at the Sheraton Indianapolis Hotel at information for the fee to Xavier and device manufacturing community a Keystone Crossing, Indianapolis, 8787 University, Attention: Mason Rick, 3800 high priority to help ensure the quality Keystone Crossing, Indianapolis, IN Victory Pkwy., Cincinnati, OH 45207– of FDA-regulated drugs and devices. 46240, 317–846–2700 or toll-free 888– 5471. An email will be sent confirming The conference helps to achieve 627–7814; www.sheratonindianapolis your registration. objectives set forth in section 406 of the keystonecrossing.com. Attendees are responsible for their Food and Drug Administration Attendees are responsible for their own accommodations. The conference Modernization Act of 1997 (21 U.S.C. own accommodations. To make headquarters hotel is the Downtown 393), which includes working closely reservations at the Sheraton Hilton Cincinnati Netherland Plaza, 35 with stakeholders and maximizing the Indianapolis Hotel at the reduced West Fifth St., Cincinnati, OH 45202, availability and clarity of information to conference rate, please call 303–295– 513–421–9100. Special conference block stakeholders and the public. The 1234 and mention ‘‘AFDO Conference’’ rates are available through April 16, conference also is consistent with the before May 20, 2015. All the hotel 2015. To make reservations online, Small Business Regulatory Enforcement information needed to call or reserve please visit the ‘‘Venue/Logistics’’ link Fairness Act of 1996 (Public Law 104– online is available at http:// at http://www.XavierMedCon.com. 121) by providing outreach activities by indy.afdo.org/hotel.html. If you need special accommodations Government agencies to small AFDO contact information: Randy due to a disability, please contact Mason businesses. Young, Association of Food and Drug Rick (see Contact Persons) at least 7 Dated: February 10, 2015. Officials, 2550 Kingston Rd., suite 311, days in advance of the conference. York, PA 17402, 717–757–2888, FAX: Leslie Kux, SUPPLEMENTARY INFORMATION: The 717–650–3650, email: ryoung@afdo.org. Associate Commissioner for Policy. Registration: You are encouraged to public conference helps fulfill the [FR Doc. 2015–03116 Filed 2–13–15; 8:45 am] register by May 20, 2015. The AFDO Department of Health and Human Services’ and FDA’s important mission BILLING CODE 4164–01–P registration fees cover the cost of to protect the public health. The facilities, materials, and breaks. Seats conference will provide those engaged are limited; therefore, please submit DEPARTMENT OF HEALTH AND your registration as soon as possible. in FDA-regulated medical devices (for HUMAN SERVICES humans) with information on the Course space will be filled in order of following topics: receipt of registration. Those accepted Food and Drug Administration • Center Director Corner: Strategic into the course will receive Priorities for 2015 and Beyond [Docket No. FDA–2015–N–0001] confirmation. Registration will close • Office of Compliance Strategic after the course is filled. Registration at In Motion: Science Transforming the site is not guaranteed but may be Priorities Policy in Food, Drug, and Medical • Advancements in Medical Device possible on a space available basis on Device Regulation the day of the conference beginning at Software Technology • Understanding and Preparing for the AGENCY: Food and Drug Administration, 8 a.m. The cost of registration follows: Revision of ISO13485 HHS. Cost of Registration: • Update from FDA’s Office of ACTION: Notice of public conference. Member—$475.00 tkelley on DSK3SPTVN1PROD with NOTICES Combination Products Non-Member—$575.00 • Unique Device Identification— The Food and Drug Administration *A $100 late fee will be added if Implementation (FDA) Detroit District Office, in payment is postmarked after June 1, • FDA Inspections and Insights cosponsorship with the Association of 2015. • Understanding the Current Activities Food and Drug Officials (AFDO), is If you need special accommodations of the International Medical Device announcing a public conference entitled due to a disability, please contact Randy Regulators Forum ‘‘In Motion: Science Transforming Young (see AFDO contact information) VerDate Sep<11>2014 16:51 Feb 13, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\17FEN1.SGM 17FEN1

Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 8329 at least 21 days in advance of the with the Small Business Regulatory Manufacturers Assistance and Training, conference. Enforcement Fairness Act of 1996 (Pub. Center for Biologics Evaluation and Registration Instructions: To register, L. 104–121), as outreach activities by Research, Food and Drug please complete and submit an AFDO government agencies to small Administration, 10903 New Hampshire Conference Registration Form, along businesses. Ave., Bldg. 71, Rm. G112, Silver Spring, with a check or money order payable to Dated: February 10, 2015. MD 20993–0002, 240–402–7800, FAX: ‘‘AFDO’’. Please mail your completed Leslie Kux, 301–595–1243, Industry.Biologics@ registration form and payment to: Associate Commissioner for Policy. fda.hhs.gov. AFDO, 2550 Kingston Rd., suite 311, SUPPLEMENTARY INFORMATION: [FR Doc. 2015–03115 Filed 2–13–15; 8:45 am] York, PA 17402. To register online, please visit http://indy.afdo.org/ BILLING CODE 4164–01–P I. Background register.html. (FDA has verified the Web CBER regulates certain biological site address but is not responsible for DEPARTMENT OF HEALTH AND products including blood and blood subsequent changes to the Web site after HUMAN SERVICES products, vaccines, and cellular, tissue, this document publishes in the Federal and gene therapies. CBER is committed Register.) Food and Drug Administration to advancing the public health through The registrar will also accept payment innovative activities that help ensure through Visa and MasterCard credit [Docket No. FDA–2011–N–0824] the safety, effectiveness, and availability cards. For more information on the Regulatory Site Visit Training Program of biological products to patients. To conference, or for questions about support this primary goal, CBER has registration, please contact AFDO at AGENCY: Food and Drug Administration, initiated various training and 717–757–2888, FAX: 717–650–3650, or HHS. development programs, including email: afdo@afdo.org. ACTION: Notice. programs to further enhance SUPPLEMENTARY INFORMATION: The performance of its compliance staff, SUMMARY: The Food and Drug conference helps fulfill the Department regulatory review staff, and other Administration’s (FDA’s) Center for of Health and Human Services’ and relevant staff. CBER seeks to Biologics Evaluation and Research FDA’s important mission to protect the continuously enhance and update (CBER) is announcing an invitation for public health. The conference will review efficiency and quality, and the participation in its Regulatory Site Visit provide FDA-regulated drug and device quality of its regulatory efforts and Training Program (RSVP). This training entities with information on a number interactions, by providing CBER staff program is intended to give CBER of topics concerning FDA requirements with a better understanding of the regulatory review, compliance, and related to the production and marketing biologics industry and its operations. other relevant staff an opportunity to of drugs and/or devices. Topics for visit biologics facilities. These visits are Further, CBER seeks to enhance: (1) Its discussion include, but are not limited intended to allow CBER staff to directly understanding of current industry to, the following: observe routine manufacturing practices practices and regulatory impacts and • Medical Device Single Audit Program and to give CBER staff a better needs and (2) communication between • Contract Manufacturing understanding of the biologics industry, CBER staff and industry. CBER initiated Arrangements for Drugs: Quality including its challenges and operations. its RSVP in 2005. Through these annual Agreements The purpose of this document is to notices, CBER is requesting that those • Compliance Question and Answer invite biologics facilities to contact firms that have previously applied and Panel CBER for more information if they are are still interested in participating • Draft Guidance: Distinguishing interested in participating in this reaffirm their interest. CBER is also Medical Device Recalls from Product program. requesting that new interested parties Enhancements and Associated apply. DATES: Submit either an electronic or Reporting Requirements II. RSVP • Compounding Pharmacies written request for participation in this • Overview of Global Device/Drug program by March 19, 2015. The request A. Regulatory Site Visits Requirements v. U.S. System should include a description of your facility relative to products regulated by In this program, over a period of time • Case for Quality Initiative Update to be agreed upon with the facility, • Unique Device Identifier (UDI) CBER. Please specify the physical address(es) of the site(s) you are small groups of CBER staff may observe Implementation Update operations of biologics establishments, • Metric, Data, and Analysis; Biometrics offering. including for example, blood and tissue • Pharmaceutical Inspection ADDRESSES: If your biologics facility is establishments. The visits may include Cooperation Scheme interested in offering a site visit, submit the following: (1) Packaging facilities, • Biosimilar Regulations either an electronic request to http:// (2) quality control and pathology/ FDA has made education of the food, www.regulations.gov or a written toxicology laboratories, and (3) feed, drug, and device manufacturing request to the Division of Dockets regulatory affairs operations. These community a high priority to help Management (HFA–305), Food and Drug visits, or any part of the program, are ensure the quality of FDA-regulated Administration, 5630 Fishers Lane, Rm. not intended as a mechanism to inspect, products. The conference helps to 1061, Rockville, MD 20852. If you assess, judge, or perform a regulatory achieve objectives set forth in section previously responded to earlier requests function, but are meant to improve tkelley on DSK3SPTVN1PROD with NOTICES 406 of the Food and Drug to participate in this program and you mutual understanding and to provide an Administration Modernization Act of continue to be interested in avenue for open dialogue between the 1997 (21 U.S.C. 393), which includes participating, please renew your request biologics industry and CBER. working closely with stakeholders and through a submission to the Division of maximizing the availability and clarity Dockets Management. B. Site Selection of information to stakeholders and the FOR FURTHER INFORMATION CONTACT: Loni CBER will be responsible for all travel public. The conference also is consistent Warren Henderson, Division of expenses associated with the site visits. VerDate Sep<11>2014 16:51 Feb 13, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\17FEN1.SGM 17FEN1


Document Created: 2015-12-18 13:19:39
Document Modified: 2015-12-18 13:19:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public conference.
FR Citation80 FR 8328 
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