[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Notices]
[Pages 15311-15313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06366]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


2016 Parenteral Drug Association/Food and Drug Administration 
Joint Conference: Aligning Manufacturing Goals With Patient Needs 
Through Successful Innovation and Compliance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
conference, to be held in cosponsorship with the Parenteral Drug 
Association (PDA), entitled ``Aligning Manufacturing Goals with Patient 
Needs through Successful Innovation and Compliance.'' The conference 
will cover current issues affecting the industry as well as explore 
strategies 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.

DATES: The public conference will be held on September 12, 2016, from 7 
a.m. to 7:30 p.m.; September 13, 2016, from

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7 a.m. to 9:30 p.m.; and September 14, 2016, from 7 a.m. to 12:30 p.m.

ADDRESSES: The public conference will be held at the Renaissance 
Washington, DC Downtown Hotel, 999 Ninth Street NW., Washington, DC 
20001, 202-898-9000, FAX: 202-289-0947.

FOR FURTHER INFORMATION CONTACT: Wanda Neal, Parenteral Drug 
Association, PDA Global Headquarters, Bethesda Towers, 4350 East West 
Hwy., Suite 150, Bethesda, MD 20814, 301-656-5900, ext. 111, FAX: 301-
986-1093, email: [email protected]; or Ken Nolan, Office of Communications, 
Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, 
MD 20993, 301-796-8629, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The PDA/FDA Joint Regulatory 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 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:
     Product Quality
     Data Integrity
     Breakthrough Therapies
     Regulatory Challenges and Opportunities
     Lifecycle Management
     Clinically Relevant Specifications
     Food and Drug Administration Safety and Innovation Act
     Quality Metrics/Quality Culture
     Manufacturing of the Future With Submissions
     Continuous Verification and Validation
     Continuous Manufacturing
     ``Fishbowl'' Role Play
     Quality Systems
     Contract Manufacturing Organizations
     Maturity of Quality Systems
     Investigations
     Case Studies for Quality
     Quality Submissions
     Prescription Drug User Fee Act
     Risk-Based Control Strategies
     Supply Chain
     Quality Risk Management Systems
     Drug Shortages
     Customer Complaint Reviews and Trending
     Human Factors
     Office of Pharmaceutical Quality and Program Alignment 
Group
     Patient Perspective
     Compliance Update
     Center Initiatives--Regulatory Submission Update
    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.

II. Registration and Accommodations

A. 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 
beginning at 1 p.m. on September 11, 2016, and at 7 a.m. from September 
12 through 14, 2016. The cost of registration is as follows:

                                              Cost of Registration
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                                                                    Before July   July 1- August   After August
                           Affiliation                                1, 2016        2,  2016         2, 2016
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                         Premier Package (Includes Conference and Workshop Registration)
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Member..........................................................          $3,740          $4,190          $4,640
Nonmember.......................................................           4,199           4,649           5,099
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                                                 Conference Only
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Member..........................................................           2,395           2,795           2,995
Nonmember.......................................................           2,654           3,054           3,254
Government/Health Authority Member..............................             700             700             700
Government/Health Authority Nonmember \1\.......................             800             800             800
Academic Member.................................................             700             700             700
Academic Nonmember \1\..........................................             800             800             800
Student Member..................................................             280             280             280
Student Nonmember \1\...........................................             310             310             310
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\1\For this member type, online registration is not available and must be faxed in.

    Please visit PDA's Web site: www.pda.org/pdafda2016 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 FOR FURTHER INFORMATION 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 email address, 
along with a check or money order payable to ``PDA.'' Mail to: PDA, 
Global Headquarters, Bethesda Towers, 4350 East West Hwy., Suite 150, 
Bethesda, MD 20814. To register via the Internet, go to PDA's Web site: 
www.pda.org/pdafda2016.

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    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 FOR FURTHER 
INFORMATION CONTACT).

B. Accommodations

    Attendees are responsible for their own accommodations. To make 
reservations, contact the Renaissance Washington Hotel (see ADDRESSES) 
and reference ``the 2016 PDA/FDA Joint Regulatory Conference'' to 
receive the PDA group rate. Room rates are: Single: $305 plus 14.5 
percent State and local taxes. Requests will be processed on a first-
come, first-served basis.
    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. The Freedom of Information office address is 
available on the Agency's Web site at http://www.fda.gov.

    Dated: March 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06366 Filed 3-21-16; 8:45 am]
 BILLING CODE 4164-01-P