Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship Educational Workshop: Redefining the `C' in CGMP (Current Good Manufacturing Practices): Creating, Implementing, and Sustaining a Culture of Quality, 26375-26376 [2013-10651]
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Federal Register / Vol. 78, No. 87 / Monday, May 6, 2013 / Notices
accounting firm to review the adequacy
of the PDUFA adjustment for changes in
workload (hereafter referred to as the
workload adjuster).
The workload adjuster was
introduced in PDUFA III to allow for
FDA to augment the total user fee
revenue amount each fiscal year (after
adjusting for inflation) to account for
changes in workload volume in the
human drug application review process.
Workload volume is measured by the
changes in the number of new drug
applications and biologics license
applications (NDAs/BLAs), active
commercial investigational new drugs
(INDs), efficacy supplements, and
manufacturing supplements submitted
to the human drug review program
during the most recent 5-year period.
In PDUFA IV, the workload adjuster
was expanded to account for the
workload complexity (known as the
adjustment for changes in review
activities) associated with the review of
NDAs/BLAs and active commercial
INDs. The NDA/BLA complexity is
measured by changes in the number of
labeling supplements, annual report
reviews, and NDA/BLA meetings per
NDA/BLA. IND complexity is measured
by changes in the number of special
protocol assessments and IND meetings
per active commercial IND.
As part of the PDUFA IV
recommendations, FDA committed to an
evaluation of the adjustment for changes
in review activities by an independent
accounting firm. The study, conducted
by Deloitte & Touche, LLP, found that
the adjustment methodology used by
FDA reasonably captures changes in the
workload complexity for reviewing
human drug applications under PDUFA
IV. While the FY 2009 evaluation
concluded that the adjustment
methodology was reasonable at that
point in time, the complexity of new
drug applications and FDA’s regulatory
responsibilities are constantly evolving.
Moreover, the complexity component of
the PDUFA IV workload adjuster was
formulated before the enactment of the
Food and Drug Administration
Amendments Act (FDAAA). Thus, the
workload adjuster does not account for
new and significant review activities
required by FDAAA, such as risk
evaluation and mitigation strategies,
safety labeling changes, advisory
committee meetings, and post-market
safety requirements, among others.
Given the dynamic nature of drug
products and FDA’s regulatory
responsibilities, FDA committed to
periodic reassessments of the workload
adjuster in PDUFA V to ensure that it is
achieving its intended role of adjusting
the user fee revenues to reflect actual
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changes in FDA’s workload volume and
complexity.
The PDUFA V commitment letter
instructs FDA to contract with an
independent accounting or consulting
firm to conduct two assessments of the
workload adjuster. This first assessment
(to examine the performance of the
workload adjuster since FY 2009) was
just completed. The independent
accounting or consulting firm is
required to submit reports based on
their assessments. The reports will
evaluate whether the workload adjuster
reasonably represents actual changes in
workload volume and complexity and
will present recommendations to
discontinue, retain, or modify any
elements of the adjustment. After review
of the reports and receipt of public
comments, FDA, if warranted, may
implement appropriate changes to the
methodology. If FDA adopts changes to
the methodology based on the first
report, the changes are effective the
fiscal year after FDA adopts the changes
and each subsequent fiscal year.
FDA is seeking public comment now
on the first assessment of the PDUFA
Workload Adjuster, available at https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee.
II. Comments
Interested persons may submit either
electronic comments regarding the
Analysis to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: April 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–10626 Filed 5–3–13; 8:45 am]
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26375
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Food and Drug Administration/
International Society for
Pharmaceutical Engineering CoSponsorship Educational Workshop:
Redefining the ‘C’ in CGMP (Current
Good Manufacturing Practices):
Creating, Implementing, and
Sustaining a Culture of Quality
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug Administration
(FDA), in co-sponsorship with the
International Society of Pharmaceutical
Engineering (ISPE), is announcing a
conference entitled ‘‘Redefining the ‘C’
in CGMP: Creating, Implementing and
Sustaining a Culture of Quality’’
Pharmaceutical Quality System (ICH
Q10) Conference.
The conference will span 3 days and
is dedicated to teaching the principles
of CGMP, reaping the benefits that come
from establishing and maintaining a
state of control, implementing continual
improvement, enhancing regulatory
compliance, and meeting quality
objectives every day. The conference
will take place in Baltimore, MD, and
will draw on the best industry and
regulator contributors on this topic.
Date and Time: The conference will
be held on June 11, 2013, from 8:30 a.m.
to 5 p.m.; June 12, 2013, from 8 a.m. to
5 p.m.; and June 13, 2013, from 8 a.m.
to 4:30 p.m.
Location: The event will be held at the
Renaissance Baltimore Harborplace
Hotel, 202 East Pratt St., Baltimore, MD
21201, 1–800–535–1201.
Contact Person: Nancy Berg,
President, International Society for
Pharmaceutical Engineering, 600 North
Westshore Blvd., suite 900, Tampa, FL
33609, Web site: https://www.ISPE.org/
CGMP.
Conference attendees are responsible
for their own accommodations.
Registration: You are encouraged to
register at your earliest convenience.
The ISPE 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
to the conference will receive
confirmation. Registration will close
after available conference space is filled.
Onsite registration will be available on
a space available basis on the day of the
E:\FR\FM\06MYN1.SGM
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26376
Federal Register / Vol. 78, No. 87 / Monday, May 6, 2013 / Notices
public conference beginning at 7 a.m. on
June 11, 2013. The cost of registration is
as follows:
ISPE Member ...........................................................................................
ISPE Nonmember .....................................................................................
ISPE New Member ...................................................................................
Federal Government Employee registering prior to/after May13 .............
FDA Planning Committee Members and Invited Speakers .....................
ISPE Active, Functional and Program Committee Members ...................
Student (prior to/after May 13) .................................................................
Individuals from Academia/Emerging Economy .......................................
Registration instructions: To register,
please submit your name, affiliation,
mailing address, phone number, fax
number, and email address, along with
a check or money order payable to
‘‘ISPE.’’ To register via the Internet, go
to the ISPE Web site, www.ISPE.org, to
confirm the prevailing registration fees.
$1,545 (prior to May 13); $1,745
$1,905 (prior to May 13); $2,115
$1,814 (prior to May 13); $2,014
$500.
(free) Fee Waived.
$1,005 (prior and after May 13).
$200.
$1,005 (prior to May 13); $1,135
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
Dated: April 30, 2013.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–10651 Filed 5–3–13; 8:45 am]
[FR Doc. 2013–10570 Filed 5–3–13; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
mstockstill on DSK4VPTVN1PROD 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 meeting.
The meeting 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: Center for Scientific
Review Special Emphasis Panel; VH–BST
Member Conflicts.
Date: May 21, 2013.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Olga A Tjurmina, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301) 451–
1375, ot3d@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
VerDate Mar<15>2010
17:06 May 03, 2013
Jkt 229001
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
Allergy and Infectious Diseases Special
Emphasis Panel; Clinical Trials Units for
NIAID Networks.
Date: May 31, 2013.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 1202,
6700B Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Roberta Binder, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, Room 3130, Bethesda, MD
PO 00000
Frm 00061
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(after May 13 and onsite).
(after May 13 and onsite).
(after May 13 and onsite).
(after May 13 and onsite).
20892–7616, 301–496–7966,
rbinder@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Clinical Trials Unit for
NIAID Networks.
Date: July 2, 2013.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 3130,
6700B Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Roberta Binder, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, Room 3130, Bethesda, MD
20892–7616, 301–496–7966,
rbinder@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: April 30, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–10575 Filed 5–3–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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.
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 78, Number 87 (Monday, May 6, 2013)]
[Notices]
[Pages 26375-26376]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10651]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Food and Drug Administration/International Society for
Pharmaceutical Engineering Co-Sponsorship Educational Workshop:
Redefining the `C' in CGMP (Current Good Manufacturing Practices):
Creating, Implementing, and Sustaining a Culture of Quality
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA), in co-sponsorship with the
International Society of Pharmaceutical Engineering (ISPE), is
announcing a conference entitled ``Redefining the `C' in CGMP:
Creating, Implementing and Sustaining a Culture of Quality''
Pharmaceutical Quality System (ICH Q10) Conference.
The conference will span 3 days and is dedicated to teaching the
principles of CGMP, reaping the benefits that come from establishing
and maintaining a state of control, implementing continual improvement,
enhancing regulatory compliance, and meeting quality objectives every
day. The conference will take place in Baltimore, MD, and will draw on
the best industry and regulator contributors on this topic.
Date and Time: The conference will be held on June 11, 2013, from
8:30 a.m. to 5 p.m.; June 12, 2013, from 8 a.m. to 5 p.m.; and June 13,
2013, from 8 a.m. to 4:30 p.m.
Location: The event will be held at the Renaissance Baltimore
Harborplace Hotel, 202 East Pratt St., Baltimore, MD 21201, 1-800-535-
1201.
Contact Person: Nancy Berg, President, International Society for
Pharmaceutical Engineering, 600 North Westshore Blvd., suite 900,
Tampa, FL 33609, Web site: https://www.ISPE.org/CGMP.
Conference attendees are responsible for their own accommodations.
Registration: You are encouraged to register at your earliest
convenience. The ISPE 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 to the conference will
receive confirmation. Registration will close after available
conference space is filled. Onsite registration will be available on a
space available basis on the day of the
[[Page 26376]]
public conference beginning at 7 a.m. on June 11, 2013. The cost of
registration is as follows:
------------------------------------------------------------------------
------------------------------------------------------------------------
ISPE Member............................ $1,545 (prior to May 13);
$1,745 (after May 13 and
onsite).
ISPE Nonmember......................... $1,905 (prior to May 13);
$2,115 (after May 13 and
onsite).
ISPE New Member........................ $1,814 (prior to May 13);
$2,014 (after May 13 and
onsite).
Federal Government Employee registering $500.
prior to/after May13.
FDA Planning Committee Members and (free) Fee Waived.
Invited Speakers.
ISPE Active, Functional and Program $1,005 (prior and after May
Committee Members. 13).
Student (prior to/after May 13)........ $200.
Individuals from Academia/Emerging $1,005 (prior to May 13);
Economy. $1,135 (after May 13 and
onsite).
------------------------------------------------------------------------
Registration instructions: To register, please submit your name,
affiliation, mailing address, phone number, fax number, and email
address, along with a check or money order payable to ``ISPE.'' To
register via the Internet, go to the ISPE Web site, www.ISPE.org, to
confirm the prevailing registration fees.
Dated: May 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10651 Filed 5-3-13; 8:45 am]
BILLING CODE 4160-01-P
