Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A Practical Approach to Effective Life-Cycle Implementation of Systems and Processes for Pharmaceutical Manufacturing; Public Conference, 57746-57747 [2011-23747]

Download as PDF 57746 Federal Register / Vol. 76, No. 180 / Friday, September 16, 2011 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10411] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. Type of Information Collection Request: New collection; Title of Information Collection: State Balancing Incentive Payments Program (BIPP); Use: The Balancing Incentive Program requires that States undertake three structural changes to their long-term services and supports (LTSS) systems to increase nursing home diversions and access to community-based care: implementation of a No Wrong Door/ Single Entry Point System, conflict-free case management, and the use of a core standardized assessment for supporting eligibility determination and service planning. In addition, grantee States must increase their community-based LTSS expenditures relative to their overall expenditures on LTSS to a minimum of 25% or 50%. State Medicaid agencies are responsible for developing the submissions to CMS in order to participate in this opportunity. If the statutory requirements are met, CMS will approve the State’s submission, giving the State the authority to implement the changes in the program and to draw down the increased FMAP funds. Form Number: CMS–10411 (OMB 0938–1145); Frequency: Once; Affected Public: State, Local, or Tribal Government; Number of Respondents: 56; Total Annual mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: VerDate Mar<15>2010 16:26 Sep 15, 2011 Jkt 223001 Responses: 56; Total Annual Hours: 2,240. (For policy questions regarding this collection contact Effie George at 410–786–8639. For all other issues call 410–786–1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by November 15, 2011: 1. Electronically. You may submit your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: September 13, 2011. Martique Jones, Director, Regulations Development Group, Division B, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2011–23800 Filed 9–15–11; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A Practical Approach to Effective LifeCycle Implementation of Systems and Processes for Pharmaceutical Manufacturing; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA), in cosponsorship with the PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Parenteral Drug Association (PDA), is announcing a public conference dedicated to teaching the principles of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) entitled ‘‘Pharmaceutical Quality System (ICH Q10) Conference: A Practical Approach to Effective LifeCycle Implementation of Systems and Processes for Pharmaceutical Manufacturing.’’ The conference will span 2-and-one-half days and will be a unique opportunity to learn the principles from companies that have implemented a Pharmaceutical Quality System across the product life cycle according to the ICH Q10 model. These companies are reaping the benefits that come from establishing and maintaining a state of control, continual improvement, enhancing regulatory compliance, and meeting quality objectives every day. Date and Time: The public conference, which will include an exhibition, will be held on Tuesday, October 4, 2011, from 8:30 a.m. to 6:30 p.m.; Wednesday, October 5, 2011, from 8 a.m. to 5:30 p.m.; and Thursday, October 6, 2011, from 8 a.m. to 1 p.m. Location: The event will be held at the Crystal Gateway Marriott, 1700 Jefferson Davis Hwy., Arlington, VA, 703–920– 3230, Fax: 703–271–5212. Contact Person: Wanda Neal, Parenteral Drug Association, PDA Global Headquarters, Bethesda Towers, 4350 East West Hwy., suite 200, Bethesda, MD 20814; 301–656–5900, ext. 111; Fax: 301–986–1093; e-mail: neal@pda.org. Attendees are responsible for their own accommodations. To make reservations at the reduced conference rate, contact the Marriott Crystal Gateway Hotel (see Location) and cite meeting code ‘‘PDA.’’ Room rates are single/double: $229.00, plus 10.5 percent State and local taxes. Reservations can be made on a space and rate available basis. Registration: You are encouraged to register at your earliest convenience. The PDA registration fees cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Conference space will be filled in order of receipt of registration. Those accepted into the conference will receive confirmation. Registration will close after the conference is filled. Onsite registration will be available on a spaceavailable basis on the day of the public conference beginning at 7 a.m. on October 4, 2011. The cost of registration is as follows: E:\FR\FM\16SEN1.SGM 16SEN1 Federal Register / Vol. 76, No. 180 / Friday, September 16, 2011 / Notices PDA Members .......................... PDA Nonmembers .................... Government/Health Authority Member ................................. Government/Health Authority Nonmember .......................... PDA Member Academic ........... PDA Nonmember Academic/ Health Authority .................... PDA Member Students ............. PDA Nonmember Students ...... $1,695.00 1,944.00 700.00 700.00 700.00 780.00 280.00 310.00 If you need special accommodations due to a disability, please contact Wanda Neal, PDA (see Contact Person) at least 7 days in advance of the conference. Registration instructions: To register, please submit your name, affiliation, mailing address, telephone number, fax number, and e-mail address, along with a check or money order payable to ‘‘PDA.’’ Mail to: PDA Global Headquarters, Bethesda Towers, 4350 East West Hwy., suite 200, Bethesda, MD 20814. To register via the Internet, go to the PDA Web site, https:// www.pda.org/Q10. The registrar will also accept payment by major credit cards (VISA/MasterCard only). For more information on the meeting, or for questions on registration, contact PDA, 301–656–5900, Fax: 301–986–1093, email: info@pda.org. SUPPLEMENTARY INFORMATION: While this conference is intended to explain the principles of ICH Q10, it is not a conference that only tells you what ICH Q10 says. It is an event where you can learn the practicalities of how to implement Q10 based on real-life case studies. The conference will draw on the best industry and regulator contributors on this topic from both the United States and Europe. It will show you how senior management commitment and involvement is vital. Dated: September 12, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–23747 Filed 9–15–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases Notice of Meetings 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 open to the public as indicated below, with VerDate Mar<15>2010 16:26 Sep 15, 2011 Jkt 223001 attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. 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: National Institute of Diabetes and Digestive and Kidney Diseases Initial Review Group; Kidney, Urologic and Hematologic Diseases D Subcommittee. Date: October 25–27, 2011. Open: October 25, 2011, 4 p.m. to 4:30 p.m. Agenda: To review procedures and discuss policy. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Closed: October 25, 2011, 4:30 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Closed: October 26, 2011, 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Closed: October 27, 2011, 8 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Barbara A. Woynarowska, PhD, Scientific Review Administrator, Review Branch, DEA, NIDDK, National Institutes of Health, Room 754, 6707 Democracy Boulevard, Bethesda, MD 20892– 5452, (301) 402–7172, woynarowskab@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Initial Review Group; Diabetes, Endocrinology and Metabolic Diseases B Subcommittee. Date: October 26–28, 2011. Open: October 26, 2011, 5 p.m. to 5:30 p.m. Agenda: To review procedures and discuss policy. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Closed: October 26, 2011, 5:30 p.m. to 9 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. PO 00000 Frm 00036 Fmt 4703 Sfmt 9990 57747 Closed: October 27, 2011, 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Closed: October 28, 2011, 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: John F. Connaughton, PhD, Chief, Chartered Committees Section, Review Branch, DEA, NIDDK, National Institutes of Health, Room 753, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7797, connaughtonj@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Initial Review Group; Digestive Diseases and Nutrition C Subcommittee. Date: October 26–28, 2011. Open: October 26, 2011, 5 p.m. to 5:30 p.m. Agenda: To review procedures and discuss policy. Place: Courtyard Gaithersburg Washingtonian Center, 204 Boardwalk Place, Gaithersburg, MD 20878. Closed: October 26, 2011, 5:30 p.m. to 10 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard Gaithersburg Washingtonian Center, 204 Boardwalk Place, Gaithersburg, MD 20878. Closed: October 27, 2011, 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard Gaithersburg Washingtonian Center, 204 Broadwalk Place, Gaithersburg, MD 20878. Closed: October 28, 2011, 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard Gaithersburg Washingtonian Center, 204 Broadwalk Place, Gaithersburg, MD 20878. Contact Person: Robert Wellner, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 706, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, rw175w@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: September 12, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–23849 Filed 9–15–11; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\16SEN1.SGM 16SEN1

Agencies

[Federal Register Volume 76, Number 180 (Friday, September 16, 2011)]
[Notices]
[Pages 57746-57747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23747]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Conference on the International Conference on Harmonisation Q10 
Pharmaceutical Quality System: A Practical Approach to Effective Life-
Cycle Implementation of Systems and Processes for Pharmaceutical 
Manufacturing; Public Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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

    The Food and Drug Administration (FDA), in cosponsorship with the 
Parenteral Drug Association (PDA), is announcing a public conference 
dedicated to teaching the principles of the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH) entitled ``Pharmaceutical Quality 
System (ICH Q10) Conference: A Practical Approach to Effective Life-
Cycle Implementation of Systems and Processes for Pharmaceutical 
Manufacturing.'' The conference will span 2-and-one-half days and will 
be a unique opportunity to learn the principles from companies that 
have implemented a Pharmaceutical Quality System across the product 
life cycle according to the ICH Q10 model. These companies are reaping 
the benefits that come from establishing and maintaining a state of 
control, continual improvement, enhancing regulatory compliance, and 
meeting quality objectives every day.
    Date and Time: The public conference, which will include an 
exhibition, will be held on Tuesday, October 4, 2011, from 8:30 a.m. to 
6:30 p.m.; Wednesday, October 5, 2011, from 8 a.m. to 5:30 p.m.; and 
Thursday, October 6, 2011, from 8 a.m. to 1 p.m.
    Location: The event will be held at the Crystal Gateway Marriott, 
1700 Jefferson Davis Hwy., Arlington, VA, 703-920-3230, Fax: 703-271-
5212.
    Contact Person: Wanda Neal, Parenteral Drug Association, PDA Global 
Headquarters, Bethesda Towers, 4350 East West Hwy., suite 200, 
Bethesda, MD 20814; 301-656-5900, ext. 111; Fax: 301-986-1093; e-mail: 
neal@pda.org.
    Attendees are responsible for their own accommodations. To make 
reservations at the reduced conference rate, contact the Marriott 
Crystal Gateway Hotel (see Location) and cite meeting code ``PDA.'' 
Room rates are single/double: $229.00, plus 10.5 percent State and 
local taxes. Reservations can be made on a space and rate available 
basis.
    Registration: You are encouraged to register at your earliest 
convenience. The PDA registration fees cover the cost of facilities, 
materials, and breaks. Seats are limited; please submit your 
registration as soon as possible. Conference space will be filled in 
order of receipt of registration. Those accepted into the conference 
will receive confirmation. Registration will close after the conference 
is filled. Onsite registration will be available on a space-available 
basis on the day of the public conference beginning at 7 a.m. on 
October 4, 2011.
    The cost of registration is as follows:

[[Page 57747]]



------------------------------------------------------------------------
 
------------------------------------------------------------------------
PDA Members................................................    $1,695.00
PDA Nonmembers.............................................     1,944.00
Government/Health Authority Member.........................       700.00
Government/Health Authority Nonmember......................       700.00
PDA Member Academic........................................       700.00
PDA Nonmember Academic/Health Authority....................       780.00
PDA Member Students........................................       280.00
PDA Nonmember Students.....................................       310.00
------------------------------------------------------------------------

    If you need special accommodations due to a disability, please 
contact Wanda Neal, PDA (see Contact Person) at least 7 days in advance 
of the conference.
    Registration instructions: To register, please submit your name, 
affiliation, mailing address, telephone number, fax number, and e-mail 
address, along with a check or money order payable to ``PDA.'' Mail to: 
PDA Global Headquarters, Bethesda Towers, 4350 East West Hwy., suite 
200, Bethesda, MD 20814. To register via the Internet, go to the PDA 
Web site, https://www.pda.org/Q10. The registrar will also accept 
payment by major credit cards (VISA/MasterCard only). For more 
information on the meeting, or for questions on registration, contact 
PDA, 301-656-5900, Fax: 301-986-1093, e-mail: info@pda.org.

SUPPLEMENTARY INFORMATION: While this conference is intended to explain 
the principles of ICH Q10, it is not a conference that only tells you 
what ICH Q10 says. It is an event where you can learn the 
practicalities of how to implement Q10 based on real-life case studies. 
The conference will draw on the best industry and regulator 
contributors on this topic from both the United States and Europe. It 
will show you how senior management commitment and involvement is 
vital.

    Dated: September 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23747 Filed 9-15-11; 8:45 am]
BILLING CODE 4160-01-P
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