2015 Parenteral Drug Association/Food and Drug Administration Joint Conference, 13008-13009 [2015-05513]
Download as PDF
<![CDATA[
13008
Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
or other forms of information
technology to minimize the information
collection burden.
Terry S. Clark,
Deputy Information Collection Clearance
Officer.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–05619 Filed 3–11–15; 8:45 am]
BILLING CODE 4150–28–P
[FR Doc. 2015–05577 Filed 3–11–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
[Docket No. FDA–2015–N–0001]
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces a meeting for the initial
review of applications in response to
[(FOA) GH15–001, Conducting Public
Health Research in Kenya, Funding
Opportunity Announcement.
Time and Date: 12:00 p.m.—5:00 p.m.,
April 1, 2015 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters for Discussion: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Conducting Public Health
Research in Kenya, FOA GH15–001’’.
Contact Person for More Information:
Hylan Shoob, Scientific Review Officer,
Center for Global Health (CGH) Science
Office, CGH, CDC, 1600 Clifton Road, NE.,
Mailstop D–69, Atlanta, Georgia 30033,
Telephone: (404) 639–4796.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
2015 Parenteral Drug Association/Food
and Drug Administration Joint
Conference
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 co-sponsorship
with the Parenteral Drug Association
(PDA), entitled ‘‘Mission Possible:
Patient-Focused Manufacturing,
Quality, and Regulatory Solutions.’’ 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.
Date and Time: The public conference
will be held on September 28, 2015,
from 7 a.m. to 7:30 p.m.; September 29,
2015, from 7 a.m. to 9:30 p.m.; and
September 30, 2015, from 7 a.m. to
12:30 p.m.
Location: The public conference will
be held at the Renaissance Washington
Hotel, 999 Ninth Street 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 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.
Accommodations: Attendees are
responsible for their own
accommodations. To make reservations,
contact the Renaissance Washington
Hotel (see Location) and reference ‘‘the
2015 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 firstcome, first-served 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 beginning at 1
p.m. on September 27, 2015, and at 7
a.m. from September 28 through 30,
2015. The cost of registration is as
follows:
COST OF REGISTRATION
Before July
19, 2015
Affiliation
July 19–
August 18,
2015
After August
18, 2015
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Premier Package (Includes Conference and Workshop Registration)
Member ....................................................................................................................................................
Nonmember .............................................................................................................................................
$3,240
3,599
$3,490
3,849
$3,740
4,099
1,895
2,154
700
800
700
800
2,095
2,354
700
800
700
800
2,295
2,554
700
800
700
800
Conference Only
Member ....................................................................................................................................................
Nonmember .............................................................................................................................................
Government/Health Authority Member ....................................................................................................
Government/Health Authority Nonmember * ...........................................................................................
Academic Member ...................................................................................................................................
Academic Nonmember * ..........................................................................................................................
VerDate Sep<11>2014
17:40 Mar 11, 2015
Jkt 235001
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
E:\FR\FM\12MRN1.SGM
12MRN1
13009
Federal Register / Vol. 80, No. 48 / Thursday, March 12, 2015 / Notices
COST OF REGISTRATION—Continued
Before July
19, 2015
Affiliation
Student Member ......................................................................................................................................
Student Nonmember * ..............................................................................................................................
280
310
July 19–
August 18,
2015
After August
18, 2015
280
310
280
310
asabaliauskas on DSK5VPTVN1PROD with NOTICES
* For this member type, online registration is not available and must be faxed in.
Please visit PDA’s Web site:
www.pda.org/pdafda2015 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 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/pdafda2015.
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 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
VerDate Sep<11>2014
17:40 Mar 11, 2015
Jkt 235001
• 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.
Dated: March 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05513 Filed 3–11–15; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0253]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Adverse Drug Experience Reporting
and Recordkeeping Biological
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
FDA’s postmarketing adverse drug
experience reporting and recordkeeping
requirements.
DATES: Submit either electronic or
written comments on the collection of
information by May 11, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
SUMMARY:
E:\FR\FM\12MRN1.SGM
12MRN1
]]>Agencies
[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Pages 13008-13009]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05513]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
2015 Parenteral Drug Association/Food and Drug Administration
Joint Conference
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 co-sponsorship with the Parenteral Drug
Association (PDA), entitled ``Mission Possible: Patient-Focused
Manufacturing, Quality, and Regulatory Solutions.'' 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.
Date and Time: The public conference will be held on September 28,
2015, from 7 a.m. to 7:30 p.m.; September 29, 2015, from 7 a.m. to 9:30
p.m.; and September 30, 2015, from 7 a.m. to 12:30 p.m.
Location: The public conference will be held at the Renaissance
Washington Hotel, 999 Ninth Street 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 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.
Accommodations: Attendees are responsible for their own
accommodations. To make reservations, contact the Renaissance
Washington Hotel (see Location) and reference ``the 2015 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.
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 27, 2015, and at 7
a.m. from September 28 through 30, 2015. The cost of registration is as
follows:
Cost of Registration
------------------------------------------------------------------------
July 19- After
Affiliation Before July August 18, August 18,
19, 2015 2015 2015
------------------------------------------------------------------------
Premier Package (Includes Conference and Workshop Registration)
------------------------------------------------------------------------
Member........................... $3,240 $3,490 $3,740
Nonmember........................ 3,599 3,849 4,099
------------------------------------------------------------------------
Conference Only
------------------------------------------------------------------------
Member........................... 1,895 2,095 2,295
Nonmember........................ 2,154 2,354 2,554
Government/Health Authority 700 700 700
Member..........................
Government/Health Authority 800 800 800
Nonmember *.....................
Academic Member.................. 700 700 700
Academic Nonmember *............. 800 800 800
[[Page 13009]]
Student Member................... 280 280 280
Student Nonmember *.............. 310 310 310
------------------------------------------------------------------------
* For this member type, online registration is not available and must be
faxed in.
Please visit PDA's Web site: www.pda.org/pdafda2015 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 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/pdafda2015.
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 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.
Dated: March 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05513 Filed 3-11-15; 8:45 am]
BILLING CODE 4164-01-P
