2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public Conference, 25358 [2011-10764]

Download as PDF 25358 Federal Register / Vol. 76, No. 86 / Wesnesday, May 4, 2011 / Notices reestablishment of the Medical Imaging Drugs Advisory Committee in the Division of Advisory Committee and Consultants Management, Center for Drug Evaluation and Research. Dated: April 28, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–10813 Filed 5–3–11; 8:45 am] BILLING CODE 4160–01–P FOR FURTHER INFORMATION CONTACT: Minh Doan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2424, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, MIDAC@fda.hhs.gov. Under the Federal Advisory Committee Act of October 6, 1972 (Pub. L. 92–463 (5 U.S.C. app. 2)); section 904 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 394), as amended by the Food and Drug Administration Revitalization Act (Pub. L. 101–635); and 21 CFR 14.40(b), FDA is announcing the reestablishment of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). A notice announcing a request for nominations for members and representatives on the committee as well as a final rule adding the committee to the current list of committees in 21 CFR 14.100 will be published at a later date. The Medical Imaging Drugs Advisory Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology and makes appropriate recommendations to the Commissioner. The Medical Imaging Drugs Advisory Committee shall consist of a core of 12 voting members including the chair. Members and the chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of nuclear medicine, radiology, epidemiology or statistics, and related specialties. Almost all non-Federal members of this committee serve as special Government employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the committee may include one nonvoting member who is identified with industry interests. This notice is given under the Federal Advisory Committee Act and 21 CFR part 14, relating to advisory committees. jlentini on DSKJ8SOYB1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 17:45 May 03, 2011 Jkt 223001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; 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 entitled ‘‘PDA/FDA Glass Quality Conference—Best Practices to Prevent and/or Detect At-Risk Glass Packaging.’’ Date and Time: The public conference will be held on May 23, 2011, from 7 a.m. to 6:30 p.m. and May 24, 2011, from 7 a.m. to 4:30 p.m. Location: The public conference will be held at the Key Bridge Marriott Hotel, 1401 Lee Highway, Arlington, VA 22209, 1–703–524–6400, FAX: 1–703– 524–8964. Contact Person: Wanda Neal, Parenteral Drug Association (PDA), PDA Global Headquarters, Bethesda Towers, 4350 East-West Highway, suite 200, Bethesda, MD 20814, 1–301–656–5900, extension 111, FAX: 1–301–986–1093, e-mail: neal@pda.org. Accommodations: Attendees are responsible for their own accommodations. To make reservations at the Key Bridge Marriott Hotel, at the reduced conference rate, contact the Key Bridge Marriott Hotel (see Location), citing meeting code ‘‘PDA.’’ Room Rates are: Single/Double: $229, plus applicable state and local. Reservations can be made on a space and rate availability 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; therefore, submit your registration as soon as possible. Conference space will be filled in order of receipt of registration. Onsite registration will be available on a space available basis on the day of the public conference beginning at 7 a.m. on May 23, 2011. The cost of registration is as follows: SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 9990 PDA Members .......................... PDA Non-Members. ................. Government/Health Authority PDA Member ........................ Government/Health Authority PDA Non-Member ................ PDA Member Academic .......... PDA Non-Member Academic/ Health Authority .................. PDA Member Students ............ PDA Non-Member Students .... $1,895.00 $2,144.00 $700.00 $700.00 $700.00 $780.00 $280.00 $310.00 If you need special accommodations due to a disability, please attach a written description of your needs with your registration form. Specific questions can be e-mailed to day@pda.org. Registration Instructions: To register, please submit your registration form online https://www.pda.org/ glassquality2011 or by mail to: PDA Global Headquarters, 4350 East West Highway, suite 150, Bethesda, MD 20814. (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.) Due to recent glass packaging quality issues and recalls related to defects or incompatibilities with finished product over the shelf life, pharmaceutical manufacturers and glass suppliers have recognized the need for improvements in glass packaging and glass handling practices throughout the product life cycle. Appropriate standards, glass supplier reliability, and best practices on glass handling and distribution are all necessary elements in the maintenance of container integrity and product sterility assurance throughout the product life cycle of sterile injectable pharmaceutical and biopharmaceutical products. The 2-day public conference will cover: • Current issues with glass packaging, • Best practices on glass handling, • Current expectations for incoming glass and pharmaceutical product packaging, • How to establish an effective glass supplier relationship for product improvement, and • Improvements in glass manufacturing, characterization, handling or packaging. The conference program will include an exhibition on May 23 and 24, 2011. SUPPLEMENTARY INFORMATION: Dated: April 28, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–10764 Filed 5–3–11; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\04MYN1.SGM 04MYN1

Agencies

[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Notices]
[Page 25358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


2011 Parenteral Drug Association/Food and Drug Administration 
Glass Quality Conference; Public Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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

SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with 
the Parenteral Drug Association (PDA), is announcing a public 
conference entitled ``PDA/FDA Glass Quality Conference--Best Practices 
to Prevent and/or Detect At-Risk Glass Packaging.''
    Date and Time: The public conference will be held on May 23, 2011, 
from 7 a.m. to 6:30 p.m. and May 24, 2011, from 7 a.m. to 4:30 p.m.
    Location: The public conference will be held at the Key Bridge 
Marriott Hotel, 1401 Lee Highway, Arlington, VA 22209, 1-703-524-6400, 
FAX: 1-703-524-8964.
    Contact Person: Wanda Neal, Parenteral Drug Association (PDA), PDA 
Global Headquarters, Bethesda Towers, 4350 East-West Highway, suite 
200, Bethesda, MD 20814, 1-301-656-5900, extension 111, FAX: 1-301-986-
1093, e-mail: neal@pda.org.
    Accommodations: Attendees are responsible for their own 
accommodations. To make reservations at the Key Bridge Marriott Hotel, 
at the reduced conference rate, contact the Key Bridge Marriott Hotel 
(see Location), citing meeting code ``PDA.'' Room Rates are: Single/
Double: $229, plus applicable state and local. Reservations can be made 
on a space and rate availability 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; therefore, submit your 
registration as soon as possible. Conference space will be filled in 
order of receipt of registration. Onsite registration will be available 
on a space available basis on the day of the public conference 
beginning at 7 a.m. on May 23, 2011. The cost of registration is as 
follows:

PDA Members................................................    $1,895.00
PDA Non-Members............................................    $2,144.00
Government/Health Authority PDA Member.....................      $700.00
Government/Health Authority PDA Non-Member.................      $700.00
PDA Member Academic........................................      $700.00
PDA Non-Member Academic/Health Authority...................      $780.00
PDA Member Students........................................      $280.00
PDA Non-Member Students....................................      $310.00
 

    If you need special accommodations due to a disability, please 
attach a written description of your needs with your registration form. 
Specific questions can be e-mailed to day@pda.org.
    Registration Instructions: To register, please submit your 
registration form online https://www.pda.org/glassquality2011 or by mail 
to: PDA Global Headquarters, 4350 East West Highway, suite 150, 
Bethesda, MD 20814. (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.)

SUPPLEMENTARY INFORMATION: Due to recent glass packaging quality issues 
and recalls related to defects or incompatibilities with finished 
product over the shelf life, pharmaceutical manufacturers and glass 
suppliers have recognized the need for improvements in glass packaging 
and glass handling practices throughout the product life cycle. 
Appropriate standards, glass supplier reliability, and best practices 
on glass handling and distribution are all necessary elements in the 
maintenance of container integrity and product sterility assurance 
throughout the product life cycle of sterile injectable pharmaceutical 
and biopharmaceutical products. The 2-day public conference will cover:
     Current issues with glass packaging,
     Best practices on glass handling,
     Current expectations for incoming glass and pharmaceutical 
product packaging,
     How to establish an effective glass supplier relationship 
for product improvement, and
     Improvements in glass manufacturing, characterization, 
handling or packaging.
    The conference program will include an exhibition on May 23 and 24, 
2011.

    Dated: April 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10764 Filed 5-3-11; 8:45 am]
BILLING CODE 4160-01-P

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