Food and Drug Administration/Xavier University Global Outsourcing Conference, 22412-22413 [2010-9795]

Download as PDF 22412 Federal Register / Vol. 75, No. 81 / Wednesday, April 28, 2010 / Notices sroberts on DSKD5P82C1PROD with PROPOSALS amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Initial Review Group; Mental Health Services in Non-Specialty Settings. Date: June 8–9, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Melrose Hotel, 2430 Pennsylvania Avenue, NW., Washington, DC 20037. Contact Person: Aileen Schulte, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6140, MSC 9608, Bethesda, MD 20892–9608, 301–443–1225, aschulte@mail.nih.gov. Name of Committee: National Institute of Mental Health Initial Review Group; Interventions Committee for Adult Disorders. Date: June 8–9, 2010. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: David Sommers, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6154, MSC 9606, Bethesda, MD 20892–9606, 301–443–7861, dsommers@mail.nih.gov. Name of Committee: National Institute of Mental Health Initial Review Group; Mental Health Services in MH Specialty Settings. Date: June 10, 2010. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Melrose Hotel, 2430 Pennsylvania Avenue, NW., Washington, DC 20037. Contact Person: Marina Broitman, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6153, MSC 9608, Bethesda, MD 20892–9608, 301–402–8152, mbroitma@mail.nih.gov. Name of Committee: National Institute of Mental Health Initial Review Group; Interventions Committee for Disorders Involving Children and Their Families. Date: June 10, 2010. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. VerDate Mar<15>2010 16:04 Apr 27, 2010 Jkt 220001 Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: David Sommers, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6154, MSC 9606, Bethesda, MD 20892–9606, 301–443–7861, dsommers@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) Time: 12 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Patricia Greenwel, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2178, MSC 7818, Bethesda, MD 20892, 301–435– 1169, greenwep@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: April 22, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. Dated: April 22, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–9840 Filed 4–27–10; 8:45 am] [FR Doc. 2010–9838 Filed 4–27–10; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Food and Drug Administration Center for Scientific Review; Notice of Closed Meetings [Docket No. FDA–2010–N–0001] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group; Biomaterials and Biointerfaces Study Section. Date: May 25–26, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Crystal City, 2399 Jefferson Davis Highway, Arlington, VA 22202. Contact Person: Steven J Zullo, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5146, MSC 7849, Bethesda, MD 20892, 301–435– 2810, zullost@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Gastrointestinal Physiology and Pathophysiology. Date: May 28, 2010. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Food and Drug Administration/Xavier University Global Outsourcing Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA), Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ‘‘FDA/Xavier University Global Outsourcing Conference.’’ This 3-day public conference for the pharmaceutical industry includes presentations from key FDA officials, global regulators, and industry experts. The conference will focus on global compliance challenges associated with pharmaceutical outsourcing relationships and supply chain control, as well as expectations from global regulators. Pharmaceutical companies and contract organizations are invited to this conference to address the issues that reside on both sides. In addition to expert presentations, participants will be engaged through live polling and a small group discussion session on sharing best practices with each other. Dates and Times: The public conference will be held on June 14 and 15, 2010, from 8 a.m. to 5 p.m. and June 16, 2010, from 8 a.m. to 1 p.m. Location: The public conference will be held on the campus of Xavier E:\FR\FM\28APN1.SGM 28APN1 Federal Register / Vol. 75, No. 81 / Wednesday, April 28, 2010 / Notices University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073 or 513–745–3396. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513–679–2700, ext. 123, e-mail: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073, e-mail: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, 22413 breakfasts, lunches, dinners, and dinner speakers for the 3 days of the conference. Early registration ends May 14, 2010. Standard registration ends June 13, 2010. There will be onsite registration. The cost of registration is as follows: TABLE 1.—REGISTRATION FEES1 Attendees Fees by May 14th Fees by June 13th Industry $995 $1,200 Small Business (< 100 employees) $800 $1,000 Academic/Government $600 $700 Student $200 $250 FDA Employee Fee waived Fee waived 1 The fourth registration from the same company is free. sroberts on DSKD5P82C1PROD with PROPOSALS The 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 https://www.XavierGOC.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, e-mail, and payment information for the fee to Xavier University, Attn: Sue Bensman, 3800 Victory Pkwy., Cincinnati, OH 45207. An e-mail 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 5th Street, Cincinnati, OH 45202, 513–421–9100. To make reservations online, please visit the ‘‘Venue/ Logistics’’ link at https:// www.XavierGOC.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. 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 outsourcing with information on the following topics: SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:04 Apr 27, 2010 Jkt 220001 • FDA Center to present on initiatives from Congress and FDA, and resulting impact; • Global regulator perspective on global compliance initiatives, challenges, and expectations; • FDA Field perspective on the most common and significant deficiencies specific to outsourcing relationships; • Global compliance of manufacturing in Asia; • Pharmaceutical companies—how to manage varying global regulatory expectations while working with contractors in various states of compliance; • Contract organizations— compliance strategy for managing global regulatory requirements while managing multiple client expectations; • Contract Organization Selection Process; • The Client Selection Process—the criteria a contract organization should use to consider saying no to a contract relationship; • Regulatory challenges—Drug Master File Fitness; • Due diligence audit—how to audit in 1 day; • Quality Agreement Development throughout the product and process lifecycle; • Supply Chain Transparency and Pedigree; • How to Audit the Supply Chain; • Rx-360 and International Pharmaceutical Excipients Council initiatives—impact to industry; • Risk-based Performance Management best practices; • International Conference on Harmonisation Triple Q’s (Q8, Q9, and PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Q10)—how quality can drive down the cost of business, and how innovation can increase business opportunities; • Rebuilding the Trust case studies; and • Small group discussion on sharing best practices. 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: April 22, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–9795 Filed 4–27–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of E:\FR\FM\28APN1.SGM 28APN1

Agencies

[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Notices]
[Pages 22412-22413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Food and Drug Administration/Xavier University Global Outsourcing 
Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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

SUMMARY: The Food and Drug Administration (FDA), Cincinnati District, 
in co-sponsorship with Xavier University, is announcing a public 
conference entitled ``FDA/Xavier University Global Outsourcing 
Conference.'' This 3-day public conference for the pharmaceutical 
industry includes presentations from key FDA officials, global 
regulators, and industry experts. The conference will focus on global 
compliance challenges associated with pharmaceutical outsourcing 
relationships and supply chain control, as well as expectations from 
global regulators. Pharmaceutical companies and contract organizations 
are invited to this conference to address the issues that reside on 
both sides. In addition to expert presentations, participants will be 
engaged through live polling and a small group discussion session on 
sharing best practices with each other.
    Dates and Times: The public conference will be held on June 14 and 
15, 2010, from 8 a.m. to 5 p.m. and June 16, 2010, from 8 a.m. to 1 
p.m.
    Location: The public conference will be held on the campus of 
Xavier

[[Page 22413]]

University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073 or 
513-745-3396.
    Contact Persons:
    For information regarding this notice: Steven Eastham, Food and 
Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-
2700, ext. 123, e-mail: steven.eastham@fda.hhs.gov.
    For information regarding the conference and registration: Marla 
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 
513-745-3073, e-mail: phillipsm4@xavier.edu.
    Registration: There is a registration fee. The conference 
registration fees cover the cost of the presentations, training 
materials, receptions, breakfasts, lunches, dinners, and dinner 
speakers for the 3 days of the conference. Early registration ends May 
14, 2010. Standard registration ends June 13, 2010. There will be 
onsite registration. The cost of registration is as follows:

                     Table 1.--Registration Fees\1\
------------------------------------------------------------------------
        Attendees             Fees by May 14th        Fees by June 13th
------------------------------------------------------------------------
Industry                  $995                      $1,200
------------------------------------------------------------------------
Small Business (< 100     $800                      $1,000
 employees)
------------------------------------------------------------------------
Academic/Government       $600                      $700
------------------------------------------------------------------------
Student                   $200                      $250
------------------------------------------------------------------------
FDA Employee              Fee waived                Fee waived
------------------------------------------------------------------------
\1\ The fourth registration from the same company is free.

    The 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 https://www.XavierGOC.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, e-mail, and payment information for 
the fee to Xavier University, Attn: Sue Bensman, 3800 Victory Pkwy., 
Cincinnati, OH 45207. An e-mail 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 5th Street, Cincinnati, OH 45202, 513-421-
9100. To make reservations online, please visit the ``Venue/Logistics'' 
link at https://www.XavierGOC.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 outsourcing with information on the following topics:
     FDA Center to present on initiatives from Congress and 
FDA, and resulting impact;
     Global regulator perspective on global compliance 
initiatives, challenges, and expectations;
     FDA Field perspective on the most common and significant 
deficiencies specific to outsourcing relationships;
     Global compliance of manufacturing in Asia;
     Pharmaceutical companies--how to manage varying global 
regulatory expectations while working with contractors in various 
states of compliance;
     Contract organizations--compliance strategy for managing 
global regulatory requirements while managing multiple client 
expectations;
     Contract Organization Selection Process;
     The Client Selection Process--the criteria a contract 
organization should use to consider saying no to a contract 
relationship;
     Regulatory challenges--Drug Master File Fitness;
     Due diligence audit--how to audit in 1 day;
     Quality Agreement Development throughout the product and 
process lifecycle;
     Supply Chain Transparency and Pedigree;
     How to Audit the Supply Chain;
     Rx-360 and International Pharmaceutical Excipients Council 
initiatives--impact to industry;
     Risk-based Performance Management best practices;
     International Conference on Harmonisation Triple Q's (Q8, 
Q9, and Q10)--how quality can drive down the cost of business, and how 
innovation can increase business opportunities;
     Rebuilding the Trust case studies; and
     Small group discussion on sharing best practices.
    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: April 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9795 Filed 4-27-10; 8:45 am]
BILLING CODE 4160-01-S

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