Annual Computational Science Symposium; Conference, 10180-10181 [2013-03324]

Download as PDF 10180 Federal Register / Vol. 78, No. 30 / Wednesday, February 13, 2013 / Notices part 814 have been approved under 0910–0231; and the collections of information under 21 CFR part 900 are approved under OMB control number 0910–0309. In the Federal Register of December 28, 2011 (76 FR 81511), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates it will receive 50 requests annually from outside stakeholders requesting additional review of decisions and actions by CDRH employees. The Agency reached this estimate based on data collected about requests received over the last 2 years. FDA estimates it will take outside stakeholders approximately 8 hours to prepare a request based on the Agency’s experience with past requests. Before the proposed information collection provisions contained in this guidance become effective, FDA will publish a notice in the Federal Register announcing OMB’s decision to approve, modify, or disapprove the information collection provisions. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Guidance title Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours CDRH: Appeals Processes Guidance Document ............... 50 1 50 8 400 Total .............................................................................. 50 1 50 8 400 1 There are no capital costs or operating and maintenance costs associate with this collection of information. Dated: February 6, 2013. Leslie Kux, Assistant Commissioner for Policy. Building at Veterans Plaza, One Veterans Pl., Silver Spring, MD 20910, 1–240–777–5300. FOR FURTHER INFORMATION CONTACT: Chris Decker, PhUSE FDA Liaison Director, Pharmaceutical Users Software Exchange (PhUSE), 64 High St., Broadstairs CT10 1JT, United Kingdom, 609–514–5105, email: css@phuse.eu.. SUPPLEMENTARY INFORMATION: A description of the project groups and planned activities can be found at http://www.phuse.eu/css. [FR Doc. 2013–03315 Filed 2–12–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Annual Computational Science Symposium; Conference AGENCY: I. Registration and Accommodations Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA), in cosponsorship with the Pharmaceutical Users Software Exchange (PhUSE), is announcing a public conference entitled ‘‘The FDA/ PhUSE Annual Computational Science Symposium.’’ The purpose of the conference is to help the broader community align and share experiences to advance computational science. At the conference, which will bring together FDA, industry, and academia, FDA will update participants on current initiatives, and collaborative project groups will address specific challenges in accessing and reviewing data to support product development. These project groups will focus on solutions and practical ways to implement them. DATES: The public conference will be held on March 18 and 19, 2013, from 9 a.m. to 5:30 p.m. ADDRESSES: The public conference will be held at the Silver Spring Civic mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:10 Feb 12, 2013 Jkt 229001 A. Registration To register, please submit the registration form online at https:// www.phuse.eu/PhUSE–CSS–2013Registration.aspx. (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). Registration fees cover the cost of facilities, materials, and food functions. Seats are limited, and conference space will be filled in the order in which registrations are received. Onsite registration will be available to the extent that space is available on the day of the conference. The costs of registration for different categories of attendee are as follows: Category Cost Industry representatives registering by February 15, 2013 ................... Industry representatives registering after February 15, 2013 ................ Those with government affiliation ..... Representatives of nonprofit organizations ........................................... PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 $700 $900 $300 $300 Category Those attending for a single day ...... Cost $650 Government and nonprofit attendees and exhibitors will need an invitation code to register at the discounted rate. An invitation code can be obtained by sending an email to: office@phuse.eu. All registrants will pay a fee with the exception of a limited number of speakers/organizers who will have a complimentary registration. B. Accommodations Attendees are responsible for their own accommodations. Attendees making reservations at the DoubleTree by Hilton Silver Spring Hotel are eligible for a reduced conference rate of $199, not including applicable taxes. Those making reservations online should use the following link to receive the special rate: http:// doubletree.hilton.com/en/dt/groups/ personalized/D/DCASSDT–PUE– 20130316/index.jhtml?WT.mc_id=POG. If you need special accommodations because of disability, please contact Chris Decker (see FOR FURTHER INFORMATION CONTACT) at least 14 days before the meeting. II. Information for Presenters of Posters and Exhibits Those wishing to present posters at the conference should submit an abstract online at http://www.phuse.eu/ Call_for_NewProjectsCSS.aspx. Suggested poster abstract topics include: • Data submission standards development, implementation, and best practices; E:\FR\FM\13FEN1.SGM 13FEN1 Federal Register / Vol. 78, No. 30 / Wednesday, February 13, 2013 / Notices • User experience and evaluation of current processes and tools and their effects on organizational performance; • Needs and specifications for proposed new tools and processes; • Business processes driving the development of information systems; and • The effect of processes and tools on problem solving quality, efficiency, and cost. All abstracts must be received by February 15, 2013, and authors whose posters have been accepted will be notified by February 28, 2013. The conference will make available an exhibition hall. The exhibitor price for this conference is $3,500. Neither PhUSE nor FDA endorse any commercial software or vendor. Dated: February 7, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–03324 Filed 2–12–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Global Quality Systems—An Integrated Approach To Improving Medical Product Safety; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) Cincinnati District Office, in cosponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public workshop entitled ‘‘Global Quality Systems—An Integrated Approach to Improving Medical Product Safety.’’ This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry. DATES: The public workshop will be held on June 10 and 11, 2013, from 8 a.m. to 5 p.m. ADDRESSES: The public workshop will be held at the Louisville Marriott Downtown, 280 West Jefferson St., Louisville, KY, 502–627–5045 or tollfree 800–533–0127; http:// www.marriottlouisville.com/. Attendees are responsible for their own accommodations. To make reservations at the Louisville Marriott Downtown, at the reduced conference rate, contact the Louisville Marriott mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:21 Feb 12, 2013 Jkt 229001 10181 and/or devices. Topics for discussion include the following: • Future of Combination Product Regulation. • Unique Device Identifier Progress. • Health Canada Update. • The Safety of our Drugs and Devices—the Complex Reality. • Nanotechnology. • Drug and Medical Device Trends. • Case for Quality (Center for Devices and Radiological Health) Presented by Steve Silverman. • Working Luncheon Interactive Session—Lessons Learned From the Mistakes of Others. • Complaint Handling—It’s Not Just About Compliance—It’s an Effective Business Driver. • FDA’s Cosmetic Regulatory Agenda. • Challenges With Implementation of U.S.P. 35 on a Global Basis. • Pilot Program for Abbreviated Drug Inspections. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality COST OF REGISTRATION of FDA-regulated drugs and devices. Member ......................................... $450.00 The workshop helps to achieve Non-Member ................................. $550.00 objectives set forth in section 406 of the To be added to registration fee for Food and Drug Administration registration postmarked after Modernization Act of 1997 (Pub. L. 105– May 14, 2013 ............................ $100.00 115) (21 U.S.C. 393), which includes working closely with stakeholders and If you need special accommodations maximizing the availability and clarity due to a disability, please contact of information to stakeholders and the Krystal Reed (see FOR FURTHER public. The workshop also is consistent INFORMATION CONTACT) at least 21 days in with the Small Business Regulatory advance of the workshop. Enforcement Fairness Act of 1996 (Pub. Registration instructions: To register, L. 104–121), as outreach activities by please complete and submit an AFDO Government Agencies to small Conference Registration Form, along businesses. with a check or money order payable to Dated: February 8, 2013. ‘‘AFDO.’’ Please mail your completed registration form and payment to: Leslie Kux, AFDO, 2550 Kingston Rd., suite 311, Assistant Commissioner for Policy. York, PA 17402. To register online, [FR Doc. 2013–03323 Filed 2–12–13; 8:45 am] please visit http://www.afdo.org/ BILLING CODE 4160–01–P conference. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after DEPARTMENT OF HEALTH AND this document publishes in the Federal HUMAN SERVICES Register.) The registrar will also accept payment Food and Drug Administration through Visa and MasterCard credit [Docket No. FDA–2011–N–0724] cards. For more information on the public workshop, or for questions about Documents To Support Submission of registration, please contact AFDO at an Electronic Common Technical 717–757–2888, FAX: 717–650–3650, or Document; Availability email: afdo@afdo.org The public workshop helps fulfill the AGENCY: Food and Drug Administration, Department of Health and Human HHS. Services’ and FDA’s important mission ACTION: Notice. to protect the public health. The workshop will provide FDA-regulated SUMMARY: The Food and Drug drug and device entities with Administration (FDA) is announcing the information on a number of topics availability of the following revised concerning FDA requirements related to final versions of documents that support the production and marketing of drugs making regulatory submissions in Downtown before May 2, 2013, and cite meeting code ‘‘AFDO Conference.’’ FOR FURTHER INFORMATION CONTACT: Krystal Reed, Association of Food and Drug Officials, 2550 Kingston Rd., suite 311, York, PA 17402, 717–757–2888, FAX: 717–650–3650, email: kreed@afdo.org. SUPPLEMENTARY INFORMATION: Registration: You are encouraged to register by May 14, 2013. 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 public workshop beginning at 7:30 a.m. The cost of registration is as follows: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1

Agencies

[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Notices]
[Pages 10180-10181]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03324]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Annual Computational Science Symposium; Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with 
the Pharmaceutical Users Software Exchange (PhUSE), is announcing a 
public conference entitled ``The FDA/PhUSE Annual Computational Science 
Symposium.'' The purpose of the conference is to help the broader 
community align and share experiences to advance computational science. 
At the conference, which will bring together FDA, industry, and 
academia, FDA will update participants on current initiatives, and 
collaborative project groups will address specific challenges in 
accessing and reviewing data to support product development. These 
project groups will focus on solutions and practical ways to implement 
them.

DATES: The public conference will be held on March 18 and 19, 2013, 
from 9 a.m. to 5:30 p.m.

ADDRESSES: The public conference will be held at the Silver Spring 
Civic Building at Veterans Plaza, One Veterans Pl., Silver Spring, MD 
20910, 1-240-777-5300.

FOR FURTHER INFORMATION CONTACT: Chris Decker, PhUSE FDA Liaison 
Director, Pharmaceutical Users Software Exchange (PhUSE), 64 High St., 
Broadstairs CT10 1JT, United Kingdom, 609-514-5105, email: 
css@phuse.eu..

SUPPLEMENTARY INFORMATION: A description of the project groups and 
planned activities can be found at http://www.phuse.eu/css.

I. Registration and Accommodations

A. Registration

    To register, please submit the registration form online at https://www.phuse.eu/PhUSE-CSS-2013-Registration.aspx. (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). 
Registration fees cover the cost of facilities, materials, and food 
functions. Seats are limited, and conference space will be filled in 
the order in which registrations are received. Onsite registration will 
be available to the extent that space is available on the day of the 
conference.
    The costs of registration for different categories of attendee are 
as follows:

------------------------------------------------------------------------
                            Category                               Cost
------------------------------------------------------------------------
Industry representatives registering by February 15, 2013......     $700
Industry representatives registering after February 15, 2013...     $900
Those with government affiliation..............................     $300
Representatives of nonprofit organizations.....................     $300
Those attending for a single day...............................     $650
------------------------------------------------------------------------

    Government and nonprofit attendees and exhibitors will need an 
invitation code to register at the discounted rate. An invitation code 
can be obtained by sending an email to: office@phuse.eu. All 
registrants will pay a fee with the exception of a limited number of 
speakers/organizers who will have a complimentary registration.

B. Accommodations

    Attendees are responsible for their own accommodations. Attendees 
making reservations at the DoubleTree by Hilton Silver Spring Hotel are 
eligible for a reduced conference rate of $199, not including 
applicable taxes. Those making reservations online should use the 
following link to receive the special rate: http://doubletree.hilton.com/en/dt/groups/personalized/D/DCASSDT-PUE-20130316/index.jhtml?WT.mc_id=POG. If you need special accommodations because 
of disability, please contact Chris Decker (see FOR FURTHER INFORMATION 
CONTACT) at least 14 days before the meeting.

II. Information for Presenters of Posters and Exhibits

    Those wishing to present posters at the conference should submit an 
abstract online at http://www.phuse.eu/Call_for_NewProjectsCSS.aspx. 
Suggested poster abstract topics include:
     Data submission standards development, implementation, and 
best practices;

[[Page 10181]]

     User experience and evaluation of current processes and 
tools and their effects on organizational performance;
     Needs and specifications for proposed new tools and 
processes;
     Business processes driving the development of information 
systems; and
     The effect of processes and tools on problem solving 
quality, efficiency, and cost.

All abstracts must be received by February 15, 2013, and authors whose 
posters have been accepted will be notified by February 28, 2013.
    The conference will make available an exhibition hall. The 
exhibitor price for this conference is $3,500. Neither PhUSE nor FDA 
endorse any commercial software or vendor.

    Dated: February 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03324 Filed 2-12-13; 8:45 am]
BILLING CODE 4160-01-P