[Federal Register Volume 75, Number 61 (Wednesday, March 31, 2010)]
[Notices]
[Pages 16157-16158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Pharmaceutical Supply Chain; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``2010 PDA/FDA Pharmaceutical Supply Chain Workshop--
Enough Talk: Let's Find and Implement Solutions.'' The workshop, 
cosponsored with the Parenteral Drug Association (PDA), will focus on 
solutions to reduce the risk to product quality in the pharmaceutical 
supply chain.
    Date and Time: The conference will be held on Monday, April 26, 
2010, from 8 a.m. to 6 p.m.; Tuesday, April 27, 2010, from 7:15 a.m. to 
5:45 p.m.; and Wednesday, April 28, 2010, from 7:15 a.m. to 1:15 p.m.
    Location: The public workshop will be held at the Hyatt Regency 
Bethesda, 7400 Wisconsin Ave., 1 Bethesda Metro Center, Bethesda, MD 
20814; Phone: 301-657-1234; FAX: 301-657-6453.
    Contact: Wanda Neal, Parenteral Drug Association, PDA Global 
Headquarters, Bethesda Towers, 4350 East-West Hwy., Suite 200, 
Bethesda, MD 20814; Phone: 301-656-5900, ext. 149.
    Accommodations: Attendees are responsible for their own 
accommodations. To make reservations at the Hyatt Regency Bethesda, at 
the reduced conference rate, contact the Hyatt Regency Bethesda (see 
Location), citing meeting code ``PDA.'' Room Rates are: Single: $209, 
plus 13% state and local taxes and Double: $234, plus 13% state and 
local taxes. 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; please submit your 
registration as soon as possible. Conference space will be filled in 
order of receipt of registration. Those accepted in to the conference 
will receive confirmation. Registration will close after applicable 
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 Monday, April 26, 2010.
    The cost of registration is as follows:

PDA Members                                          $1850
PDA Nonmembers                                       $2099
PDA Member Government                                $530
PDA Nonmember Government                             $530
PDA Member Health Authority                          $700
PDA Nonmember Health Authority                       $800
PDA Member Academic                                  $700
PDA Nonmember Academic                               $780

[[Page 16158]]

 
PDA Member Students                                  $280
PDA Nonmember Students                               $310
 

    If you need special accommodations due to a disability, please 
contact Wanda Neal, PDA (see Contact) at least 7 days in advance of the 
workshop.
    Registration instructions: To register, please submit your name, 
affiliation, mailing address, phone, 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 See PDA Web 
site, www.pda.org/supplychain2010 (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). 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 the PDA: Phone: 301-656-5900, FAX: 301-986-1093, or e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: A reliable supply of high quality, safe, and 
effective drug products and drug ingredients depends upon a series of 
controls across the entire supply chain from sourcing of incoming 
starting materials to distribution controls to marketing. Recent 
experiences in the market have highlighted the need for effective 
controls across the supply chain. There is a surge in global 
cooperation and efforts toward harmonization of good manufacturing 
practices (GMPs) and good distribution practices (GDPs) and controls 
pertaining to the supply chain among members of industry and regulatory 
agencies. Understanding and securing the entire ingredient 
manufacturing and distribution chain helps to ensure the quality and 
safety of medicines for patients.
    Through a series of plenary sessions and working group breakout 
sessions, the workshop will provide participants the opportunity to:
     Hear from senior FDA personnel on the current regulatory 
environment.
     Share improvements in programs and technology.
     Identify any barriers to securing the entire ingredient 
manufacturing and distribution chain and associated actions to 
implement effective solutions.
    Personnel with experience related to supply chain issues, including 
quality and technical functions, will find this level of information 
exchange with members of industry and regulatory agencies useful to 
their specific areas.

    Dated: March 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7151 Filed 3-30-10; 8:45 am]
BILLING CODE 4160-01-S