Food and Drug Administration/Xavier University Global Medical Device Conference, 15957-15958 [2013-05727]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices no standards or regulatory requirements that specifically address scoring of tablets, the Agency recognizes the need for consistent scoring between a generic product and its RLD. Consistent scoring ensures that the patient is able to adjust the dose, by splitting the tablet, in the same manner as the RLD. This enables the patient to switch between products made by different manufacturers without encountering problems related to the dose. In addition, consistent scoring ensures that neither the generic product nor the RLD has an advantage in the marketplace because one is scored and one is not. The Center for Drug Evaluation and Research’s Drug Safety Oversight Board considered the practice of tablet splitting at its October 2009 and November 2010 meetings. During those meetings, they discussed how insurance companies and doctors are increasingly recommending that patients split tablets, either to adjust the patients’ dose or as a cost-saving measure. Because of this, the Agency conducted internal research on tablet splitting and concluded that in some cases, there are possible safety issues, especially when tablets are not scored or evaluated for splitting. The Agency’s concerns with splitting a tablet included variations in the tablet content, weight, disintegration, or dissolution, which can affect how much drug is present in a split tablet and available for absorption. In addition, there may be stability issues with splitting tablets. Tablet splitting also is addressed in pharmacopeial standards. The European Pharmacopeia currently applies accuracy of subdivision standards for scored tablets—and has at various times also included standards for content uniformity, weight variation, and loss of mass—while the United States Pharmacopeia published a Stimuli article in 2009 proposing criteria for loss of mass and accuracy of subdivision for split tablets. As an outgrowth of these discussions, FDA is providing recommendations for application content regarding the scientific basis for functional scoring on solid oral dosage form products to ensure the quality of both NDA and ANDA scored tablet products. To accomplish this, the Agency has developed consistent and meaningful criteria by which scored tablets can be evaluated and labeled by: (1) Providing a harmonized approach to chemistry, VerDate Mar<15>2010 17:11 Mar 12, 2013 Jkt 229001 manufacturing, and controls reviews of scored tablets; (2) ensuring consistency in nomenclature (e.g., score versus bisect) and labeling; and (3) providing information through product labeling or other means to health care providers. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on tablet scoring: Nomenclature, labeling, and data for evaluation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. III. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in § 201.57 (21 CFR 201.57) and 21 CFR 314.50 and 314.70 have been approved under OMB control numbers 0910–0572 (for § 201.57) and 0910–0001 (for 21 CFR part 314). IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. Dated: March 7, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–05725 Filed 3–12–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ‘‘FDA/Xavier University Global Medical Device Conference.’’ This 3-day public conference includes presentations from key FDA officials and industry experts with small group breakout sessions. The conference is intended for companies of all sizes and employees at all levels. Date and Time: The public conference will be held on May 1, 2013, from 8:30 a.m. to 5 p.m.; May 2, 2013, from 8:30 a.m. to 5 p.m.; and May 3, 2013, from 8:30 a.m. to 1 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073 or 513–745–3396. Contact Persons: For information regarding this notice: Gina Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513– 679–2700, Fax: 513–679–2771, Gina.Brackett@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073, phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, and lunches for the 3 days of the conference. Early registration ends March 13, 2013. Standard registration ends April 9, 2013. There will be onsite registration. The cost of registration is as follows: SUMMARY: BILLING CODE 4160–01–P PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 15957 E:\FR\FM\13MRN1.SGM 13MRN1 15958 Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices TABLE 1—REGISTRATION FEES 1 Advanced rate (March 13, 2013 to April 8, 2013) Attendee type Standard rate (April 9, 2013 to May 3, 2013) $1,295 900 600 250 250 $1,495 1,000 700 300 300 Free Industry ............................................................................................................................................................ Small Business (<100 employees) .................................................................................................................. Consultant ........................................................................................................................................................ Startup Manufacturer ....................................................................................................................................... Academic ......................................................................................................................................................... FDA/Government Employee ............................................................................................................................ (2) 1 The mstockstill on DSK4VPTVN1PROD with NOTICES following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks. 2 Free. To register online for the public conference, please visit the ‘‘Register Now’’ 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 and fax numbers, email, and payment information for the fee to Xavier University, Attention: Sue Bensman, 3800 Victory Pkwy., Cincinnati, OH 45207. An email will be sent confirming your registration. Attendees are responsible for their own accommodations. The conference headquarter hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 West Fifth St., Cincinnati, OH, 45202, 513–421–9100. Special Conference Block rates are available through April 9, 2013. 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 Marla Phillips (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: • CDRH Future Vision and Strategy Keynote Address • U.S. Congressman Erik Paulsen Keynote Dinner • EU Regulations: New Regulations, Company Strategy, and Open Discussion Forum • FDA Safety and Innovation Act • Unique Device Identification • Update from the Office of Device Evaluation • Total Product Life Cycle: Interactive Workshop • Pre-Submission Program and Meetings with the FDA VerDate Mar<15>2010 17:11 Mar 12, 2013 Jkt 229001 • 510(k): New FDA Guidance and Industry Regulations • PMAs: New Guidance and Compliance Initiatives • Software and Mobile Apps • Combination Products • Entering the EU Market and CE Mark Hot Topics • Global Product Strategy • Success in Central and South America • FDA Inspectional Approach—Panel with Current FDA Investigators 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 (Pub. L. 104–121) by providing outreach activities by Government Agencies to small businesses. Dated: March 8, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–05727 Filed 3–12–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-day Comment Request: Pediatric Palliative Care Campaign Pilot Survey Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Nursing Research (NINR), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 26, 2012, page 76053 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Nursing Research (NINR), National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Adrienne Burroughs, Health Communications Specialist, Office of Communications and Public Liaison, NINR, NIH, Building 31, Room 5B10, 31 Center Drive, Bethesda, MD 20892 or call non-toll-free number (301) 496–0256 or Email your request, including your address to: adrienne.burroughs@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Pediatric Palliative Care Campaign Pilot Survey, E:\FR\FM\13MRN1.SGM 13MRN1

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[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15957-15958]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Food and Drug Administration/Xavier University Global Medical 
Device Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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

SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in 
cosponsorship with Xavier University, is announcing a public conference 
entitled ``FDA/Xavier University Global Medical Device Conference.'' 
This 3-day public conference includes presentations from key FDA 
officials and industry experts with small group breakout sessions. The 
conference is intended for companies of all sizes and employees at all 
levels.
    Date and Time: The public conference will be held on May 1, 2013, 
from 8:30 a.m. to 5 p.m.; May 2, 2013, from 8:30 a.m. to 5 p.m.; and 
May 3, 2013, from 8:30 a.m. to 1 p.m.
    Location: The public conference will be held on the campus of 
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3073 or 513-745-3396.
    Contact Persons: For information regarding this notice: Gina 
Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 
45237, 513-679-2700, Fax: 513-679-2771, Gina.Brackett@fda.hhs.gov.
    For information regarding the conference and registration: Marla 
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 
513-745-3073, phillipsm4@xavier.edu.
    Registration: There is a registration fee. The conference 
registration fees cover the cost of the presentations, training 
materials, receptions, breakfasts, and lunches for the 3 days of the 
conference. Early registration ends March 13, 2013. Standard 
registration ends April 9, 2013. There will be onsite registration. The 
cost of registration is as follows:

[[Page 15958]]



                     Table 1--Registration Fees \1\
------------------------------------------------------------------------
                                        Advanced rate
                                       (March 13, 2013    Standard rate
            Attendee type                to April 8,     (April 9, 2013
                                            2013)        to May 3, 2013)
------------------------------------------------------------------------
Industry............................            $1,295            $1,495
Small Business (<100 employees).....               900             1,000
Consultant..........................               600               700
Startup Manufacturer................               250               300
Academic............................               250               300
FDA/Government Employee.............               (2)              Free
------------------------------------------------------------------------
\1\ The following forms of payment will be accepted: American Express,
  Visa, Mastercard, and company checks.
\2\ Free.

    To register online for the public conference, please visit the 
``Register Now'' 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 and fax numbers, email, and payment information for 
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory 
Pkwy., Cincinnati, OH 45207. An email will be sent confirming your 
registration.
    Attendees are responsible for their own accommodations. The 
conference headquarter hotel is the Downtown Cincinnati Hilton 
Netherlands Plaza, 35 West Fifth St., Cincinnati, OH, 45202, 513-421-
9100. Special Conference Block rates are available through April 9, 
2013. 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 Marla Phillips (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:
     CDRH Future Vision and Strategy Keynote Address
     U.S. Congressman Erik Paulsen Keynote Dinner
     EU Regulations: New Regulations, Company Strategy, and 
Open Discussion Forum
     FDA Safety and Innovation Act
     Unique Device Identification
     Update from the Office of Device Evaluation
     Total Product Life Cycle: Interactive Workshop
     Pre-Submission Program and Meetings with the FDA
     510(k): New FDA Guidance and Industry Regulations
     PMAs: New Guidance and Compliance Initiatives
     Software and Mobile Apps
     Combination Products
     Entering the EU Market and CE Mark Hot Topics
     Global Product Strategy
     Success in Central and South America
     FDA Inspectional Approach--Panel with Current FDA 
Investigators
    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 (Pub. L. 
104-121) by providing outreach activities by Government Agencies to 
small businesses.

    Dated: March 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05727 Filed 3-12-13; 8:45 am]
BILLING CODE 4160-01-P