[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Pages 50741-50742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20791]


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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 
Joint Public Conference; Quality and Compliance in Today's Regulatory 
Enforcement Environment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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    The Food and Drug Administration (FDA), in cosponsorship with 
Parenteral Drug Association (PDA), is announcing a public conference 
entitled ``Quality and Compliance in Today's Regulatory Enforcement 
Environment.'' The conference will span 2\1/2\ days and cover current 
issues affecting the industry as well as explore strategies and 
approaches for ensuring conformance with regulations to facilitate the 
development and continuous improvement of safe and effective medical 
products. The conference establishes a unique forum to discuss the 
foundations, emerging technologies and innovations in regulatory 
science, as well as the current quality and compliance areas of 
concerns. Meeting participants will hear from FDA and industry speakers 
about the requirements and best practices to consider while 
implementing robust quality systems in order to deliver the best 
quality product.
    Date and Time: The public conference will be held on September 19, 
2011, from 7 a.m. to 6 p.m.; September 20, 2011, from 7:30 a.m. to 6:15 
p.m.; and September 21, 2011, from 7:30 a.m. to 12:15 p.m.
    Location: The public conference will be held at the Renaissance 
Hotel, 999 Ninth St., NW., Washington, DC 20001, 202-898-9000, FAX: 
202-289-0947.
    Contact: Wanda Neal, Parenteral Drug Association, PDA Global 
Headquarters, Bethesda Towers, 4350 East West Hwy., suite 200, 
Bethesda, MD 20814, 301-656-5900, FAX: 301-986-1093, e-mail: 
[email protected].
    Accommodations: Attendees are responsible for their own 
accommodations. To make reservations at the Renaissance Hotel at the 
reduced conference rate, contact the Renaissance Hotel (see Location)--
cite the meeting code ``PDA.'' Room rates are: Single: $288, plus 14.5% 
state and local taxes and Double: $288, plus 14.5 percent state and 
local taxes. Reservations can be made on a space and rate availability 
basis.
    Registration: Attendees are encouraged to register at their 
earliest convenience. The PDA registration fees cover the cost of 
facilities, materials, and refreshments. Seats are limited; please 
submit your registration as soon as possible. Conference space will be 
filled in order of receipt of registration. Those accepted for the 
conference will receive confirmation. Registration will close after the 
conference is filled. Onsite registration will be available on a space 
available basis on each day of the public conference beginning at 7 
a.m. on September 19, 2011. The cost of registration is as follows:

                          Cost of Registration
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                         Affiliation                              Fee
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PDA Members..................................................     $1,895
NonMembers...................................................      2,144
PDA Member Government/Health Authority.......................        700
NonMember Government/Health Authority........................        800
PDA Member Academic..........................................        700
NonMember Academic...........................................        780
PDA Member Students..........................................        280
NonMember Students...........................................        310
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    Please visit PDA's Web site: http://www.pda.org/pdafda2011 to 
confirm the prevailing registration fees. (FDA has verified the Web 
site address, but FDA is not responsible for any subsequent changes to 
the Web site after this document publishes in the Federal Register.)
    If you need special accommodations due to a disability, please 
contact Wanda Neal (see Contact), at least 7 days in advance of the 
conference.
    Registration Instructions: To register, please submit your name, 
affiliation, mailing address, telephone, 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

[[Page 50742]]

Internet, go to PDA's Web site: http://www.pda.org/pdafda2011.
    The registrar will also accept payment by major credit cards (VISA/
American Express/MasterCard only). For more information on the meeting, 
or for questions on registration, contact PDA (see Contact).
    Transcripts: As soon as a transcript is available, it can be 
obtained in either hardcopy or on CD-ROM, after submission of a Freedom 
of Information request. Written requests are to be sent to Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: The PDA/FDA joint public conference offers 
the unique opportunity for participants to join FDA representatives and 
industry experts in face-to-face dialogues. Each year, FDA speakers 
provide updates on current efforts affecting the development of global 
regulatory strategies, while industry professionals from some of 
today's leading pharmaceutical companies present case studies on how 
they employ global strategies in their daily processes.
    Through a series of sessions and meetings, the conference will 
provide participants with the opportunity to hear directly from FDA 
experts and representatives of global regulatory authorities on best 
practices, including:
     Accountability in a Global Environment--Enforcement and 
Supply Chain
     Office of International Programs 101 & Foreign Inspections
     International Conference on Harmonization Q11
     New Regulations--Status Update
     First Cycle Review
     Drug Safety
     Good Inspection Practices--Domestic
     Process Validation
     Emerging Regulations for Positron Emission Tomography
     FDA/Pharmaceutical Inspection Co-operation Scheme
     Standards
     International Compliance Update
     Good Manufacturing Practice Life Cycle
     Supply Chain
    To help ensure the quality of FDA-regulated products, the workshop 
helps to achieve objectives set forth in section 406 of the FDA 
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 workshop also is 
consistent with the Small Business Regulatory Enforcement Fairness Act 
of 1996 (Pub. L. 104-121), as outreach activities by Government 
Agencies to small businesses.

    Dated: August 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20791 Filed 8-15-11; 8:45 am]
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