2016 Parenteral Drug Association/Food and Drug Administration Joint Conference: Aligning Manufacturing Goals With Patient Needs Through Successful Innovation and Compliance, 15311-15313 [2016-06366]
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<![CDATA[
Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Notices
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
An electronic copy of the guidance
document is available for download
from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Assessment of
Radiofrequency-Induced Heating in the
Magnetic Resonance (MR) Environment
for Multi-Configuration Passive Medical
Devices’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Wolfgang Kainz, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 1115, Silver Spring,
MD 20993–0002, 301–661–7595.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance to provide an assessment
paradigm for RF-induced heating on or
near multicomponent or
multiconfiguration passive medical
devices in the MR environment. During
MR scanning, applied RF excitation
pulses induce currents that can cause
heating of electrically conductive
materials. RF-induced heating of
medical devices made with conductive
materials may lead to patient burns. To
minimize the risk of patient burns
during MR scanning, sponsors should
comprehensively assess devices in all
configurations and combinations.
However, multicomponent passive
devices, such as orthopedic fixation
devices, may permit a very large number
of possible device configurations and
combinations of individual components.
Testing all possibilities may be
impractical and unnecessary. This
guidance provides an approach to
identify a manageable number of device
configurations or combinations for the
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testing of RF-induced heating in the MR
environment. Additionally, this
guidance provides recommendations on
how to assess the RF-induced device
heating for multiconfiguration passive
medical devices.
In the Federal Register of June 29,
2015 (80 FR 36996), the Agency
announced the issuance of the draft
guidance entitled ‘‘Assessment of
Radiofrequency-Induced Heating in the
Magnetic Resonance (MR) Environment
for Multi-Configuration Passive Medical
Devices.’’ Interested persons were
invited to comment by August 28, 2015.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the assessment of
RF-induced heating of multicomponent,
or multiconfiguration, passive medical
devices in the MR environment. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Assessment of RadiofrequencyInduced Heating in the Magnetic
Resonance (MR) Environment for MultiConfiguration Passive Medical Devices’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1500001 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and guidance. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 814, subparts B and E, are approved
under OMB control number 0910–0231;
the collections of information in 21 CFR
part 814, subpart H, are approved under
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15311
OMB control number 0910–0332; the
collections of information in 21 CFR
part 807, subpart E, are approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 812 are approved under OMB
control number 0910–0078; the
collections of information in 21 CFR
parts 801 and 809 are approved under
OMB control number 0910–0485; and
the collections of information in the
guidance document entitled ‘‘Requests
for Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ are
approved under OMB control number
0910–0756.
Dated: March 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–06361 Filed 3–21–16; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
E:\FR\FM\22MRN1.SGM
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Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Notices
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: info@pda.org; or Ken
Nolan, Office of Communications, Food
and Drug Administration 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–8629, email:
kenneth.nolan@fda.hhs.gov.
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 FDAregulated 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
Before July
1, 2016
Affiliation
July 1–
August 2,
2016
After August
2, 2016
Premier Package (Includes Conference and Workshop Registration)
Member ........................................................................................................................................
Nonmember .................................................................................................................................
$3,740
4,199
$4,190
4,649
$4,640
5,099
2,395
2,654
700
800
700
800
280
310
2,795
3,054
700
800
700
800
280
310
2,995
3,254
700
800
700
800
280
310
Conference Only
Member ........................................................................................................................................
Nonmember .................................................................................................................................
Government/Health Authority Member ........................................................................................
Government/Health Authority Nonmember 1 ...............................................................................
Academic Member .......................................................................................................................
Academic Nonmember 1 ..............................................................................................................
Student Member ..........................................................................................................................
Student Nonmember 1 .................................................................................................................
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1For
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.)
VerDate Sep<11>2014
17:34 Mar 21, 2016
Jkt 238001
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,
PO 00000
Frm 00093
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\22MRN1.SGM
22MRN1
Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Notices
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 https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Dated: March 15, 2016.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institute of Environmental
Health Sciences, Notice of Closed
Meetings
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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 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
Environmental Health Sciences Special
Emphasis Panel; Evaluation of the U01
Engineered Nanomaterials (ENMs) Grant
Applications.
Date: April 4, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Chapel Hill Hotel, 1
Europa Drive, Chapel Hill, NC 27517.
VerDate Sep<11>2014
17:34 Mar 21, 2016
Jkt 238001
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, (919) 541–0670, worth@niehs.nih.gov.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; Small Business Innovation
Research (SBIR) Applications Teleconference
Review.
Date: April 7, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIEHS, Keystone Building, 530
Davis Drive, Suite 3118, Research Triangle
Park, NC 27709, (Telephone Conference
Call).
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, (919) 541–0670, worth@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
[FR Doc. 2016–06337 Filed 3–21–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development and
Commercialization of Cancer
Immunotherapy
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive patent license to practice
the inventions embodied in the
following U.S. Patents and Patent
Applications to Midissia Therapeutics
(‘‘MIDISSIA’’) located in San Francisco,
California, USA.
SUMMARY:
PO 00000
Frm 00094
Fmt 4703
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15313
Intellectual Property
United States Provisional Patent
Application No. 60/476,467, filed June
5, 2003, entitled ‘‘Immunogenic
Peptides and Peptide Derivatives For
The Treatment of Prostate And Breast
Cancer Treatment’’ [HHS Reference No.
E–116–2003/0–US–01]; International
Patent Application No. PCT/US2004/
17574 filed June 2, 2004 entitled
‘‘Immunogenic Peptides and Peptide
Derivatives or The Treatment of Prostate
And Breast Cancer Treatment’’ [HHS
Reference No. E–116–2003/0–PCT–02];
United States Patent No.7,541,035,
issued June 2, 2009, entitled
‘‘Immunogenic Peptides and Peptide
Derivatives For The Treatment of
Prostate And Breast Cancer Treatment’’
[HHS Reference No. E–116–2003/0–US–
03]; United States Patent No. 8,043,623,
issued 25 Oct 2011, entitled
‘‘Immunogenic Peptides and Peptide
Derivatives For The Treatment of
Prostate And Breast Cancer Treatment’’
[HHS Reference No. E–116–2003/0–US–
04]; United States Provisional Patent
Application No. 61/915,948, filed
December 13, 2013, entitled ‘‘MultiEpitope TARP Peptide Vaccine and
Uses Thereof’’ [HHS Reference No. E–
047–2014/0–US–01]; International
Patent Application No. PCT/US2014/
070144 filed December 12, 2014 entitled
‘‘Multi-Epitope TARP Peptide Vaccine
and Uses Thereof’’ [HHS Reference No.
E–047–2014/0–PCT–02]; and all
continuation applications, divisional
applications and foreign counterpart
applications claiming priority to the US
provisional application no. 61/915, 948
and U.S. Provisional Application No.
62/248,964 filed October 30, 2015 titled
‘‘Compositions and Methods for the
Treatment of HER2-Expressing Solid
Tumors’’ [HHS Reference No. E–187–
2015/0–US–01] and continuation
applications, divisional applications
and foreign counterpart applications
claiming priority to the US provisional
application no. 62/248,964.
The patent rights in these inventions
have been assigned to the government of
the United States of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to the use
of Licensed Patent Rights for the
following:
(1) Development and
commercialization of a therapeutic
cancer vaccine specifically in
combination with Licensee’s proprietary
or exclusively in-licensed vectors/
adjuvants and ME–TARP;
(2) Development and
commercialization of a combination
product using Licensee’s proprietary or
E:\FR\FM\22MRN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 15312]]
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: info@pda.org; or Ken Nolan, Office of Communications,
Food and Drug Administration 10903 New Hampshire Ave., Silver Spring,
MD 20993, 301-796-8629, email: kenneth.nolan@fda.hhs.gov.
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
----------------------------------------------------------------------------------------------------------------
Before July July 1- August After August
Affiliation 1, 2016 2, 2016 2, 2016
----------------------------------------------------------------------------------------------------------------
Premier Package (Includes Conference and Workshop Registration)
----------------------------------------------------------------------------------------------------------------
Member.......................................................... $3,740 $4,190 $4,640
Nonmember....................................................... 4,199 4,649 5,099
----------------------------------------------------------------------------------------------------------------
Conference Only
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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.
[[Page 15313]]
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 https://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
