Food and Drug Administration/International Society for Pharmaceutical Engineering Cosponsorship Educational Workshop: Redefining the `C' in CGMP: Creating, Implementing, and Sustaining a Culture of Compliance, 26768-26769 [2012-10894]
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26768
Federal Register / Vol. 77, No. 88 / Monday, May 7, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–E–0014, FDA–
2010–E–0660, and FDA–2010–E–0659]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PROLIA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for PROLIA
and is publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of applications to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human biological product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6284, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
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SUMMARY:
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to market the biological product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human biological product
will include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human biological product PROLIA
(denosumab). PROLIA is indicated for
treatment of postmenopausal women
with osteoporosis at high risk for
fracture. Subsequent to this approval,
the Patent and Trademark Office
received patent term restoration
applications for PROLIA (U.S. Patent
Nos. 6,740,522; 7,097,834; and
7,411,050) from Amgen, Inc., and the
Patent and Trademark Office requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated April 27,
2011, FDA advised the Patent and
Trademark Office that this human
biological product had undergone a
regulatory review period and that the
approval of PROLIA represented the
first permitted commercial marketing or
use of the product. Thereafter, the
Patent and Trademark Office requested
that FDA determine the product’s
regulatory review period.
FDA has determined that the
applicable regulatory review period for
PROLIA is 3,269 days. Of this time,
2,739 days occurred during the testing
phase of the regulatory review period,
while 530 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: June 21, 2001. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
June 21, 2001.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): December 19, 2008. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for PROLIA (BLA125320) was submitted
on December 19, 2008.
3. The date the application was
approved: June 1, 2010. FDA has
verified the applicant’s claim that
BLA125320 was approved on June 1,
2010.
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Sfmt 4703
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,365 days; 952
days; and 595 days of patent term
extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by July 6, 2012.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
November 5, 2012. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. However, if you submit a
written petition, you must submit three
copies of the petition. Identify
comments with the docket numbers
found in brackets in the heading of this
document.
Comments and petitions that have not
been made publicly available on
https://www.regulations.gov may be
viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2012–10959 Filed 5–4–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Food and Drug Administration/
International Society for
Pharmaceutical Engineering
Cosponsorship Educational
Workshop: Redefining the ‘C’ in
CGMP: Creating, Implementing, and
Sustaining a Culture of Compliance
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\07MYN1.SGM
07MYN1
Federal Register / Vol. 77, No. 88 / Monday, May 7, 2012 / Notices
ACTION:
Notice of public workshop.
sroberts on DSK5SPTVN1PROD with NOTICES
The Food and Drug Administration
(FDA) Center for Drug Evaluation and
Research, in cosponsorship with the
International Society for Pharmaceutical
Engineering (ISPE), is planning a
multiday, educational public workshop
entitled ‘‘Redefining the ‘C’ in CGMP:
Creating, Implementing, and Sustaining
a Culture of Compliance.’’
DATES: Date and Time: The public
workshop will be held on June 4, 2012,
9 a.m. to 5 p.m. and June 5, 2012, 8 a.m.
to 5 p.m.
Location: The public workshop will
be held at the Renaissance Baltimore
Harborplace Hotel, 202 E. Pratt St.,
Baltimore, MD 21202, 1–800–535–1201.
Contact Persons: FDA Contact:
Rhonda Hill, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 4341, Silver Spring,
MD 20993, 301–796–3267,
rhonda.hill@fda.hhs.gov.
ISPE Contact: Julianne Rill,
Continuing Education Program
Manager, 600 N. Westshore Blvd., Suite
900, Tampa, FL 33609; Web site: https://
www.ispe.org/2012-gmp-conference;
email: jrill@ispe.org. (FDA has verified
the Web site address in this
announcement but we are not
responsible for any subsequent changes
to the Web site in this announcement
after this document publishes in the
Federal Register.)
Accommodations: Attendees are
responsible for their own
accommodations. Please mention ISPE/
FDA Conference to receive the hotel
room rate of $195.00 plus applicable
taxes (available until May 7, 2012, or
until the ISPE room block is filled).
If you need special accommodations
due to a disability, please contact ISPE
(see Contact Persons) at least 7 days in
advance of the meeting.
Registration: The ISPE registration
fees cover the cost of facilities,
materials, and refreshments. Seats are
limited; please submit your registration
as soon as possible. Workshop space
will be filled in order of receipt of
registration. Those accepted for the
workshop will receive confirmation.
Registration will close after the
workshop is filled.
COST OF REGISTRATION
ISPE member ...........................
ISPE nonmember (includes
membership).
Federal Government .................
FDA Planning Committee members and invited speakers.
VerDate Mar<15>2010
18:11 May 04, 2012
$1,695
2,035
750
Fee waived.
Jkt 226001
Please visit ISPE’s Web site to confirm
the prevailing registration fees.
To register, please submit a
registration form with your name,
affiliation, mailing address, telephone,
fax number, and email, along with a
check or money order payable to
‘‘ISPE.’’ To register via the Internet, go
to https://www.ispe.org/2012-gmpconference. The registrar will accept
payment by major credit card (Visa/
MasterCard/AMEX only). For more
information on the meeting registration,
or for questions on the workshop,
contact ISPE (see Contact Persons).
The
workshop helps fulfill the Department
of Health and Human Services’ and
FDA’s important mission to protect the
public health. The workshop will
provide those engaged in FDA-regulated
drug manufacturing operations with
information on a number of topics
concerning FDA requirements and
expectations related to current good
manufacturing practice (CGMP). The
joint public workshop offers the
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 strategies to manufacture
high quality drugs 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.
Topics for discussion include the
following: (1) The Business Case For
Change; (2) Quality Risk Management—
When, What, and How; (3) Sustaining
Compliance Consistency Throughout
Your Company and Supplier Network;
(4) IT Strategies—Cloud Computing,
RFID, and Beyond; (5) The Future of
Drug Manufacturing. 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 (Pub. L. 105–
115), 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.
SUPPLEMENTARY INFORMATION:
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26769
Dated: May 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–10894 Filed 5–4–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Educational Forum on Medical Device
Reporting, Complaint Files, and
Recalls, Corrections, and Removals;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Office of Regulatory Affairs
(ORA), Southwest Region (SWR), Dallas
District Office (DALDO), in
collaboration with the FDA Medical
Device Industry Coalition (FMDIC), is
announcing a public workshop entitled
‘‘Educational Forum on Medical Device
Reporting, Complaint Files, and Recalls,
Corrections, and Removals.’’ The
purpose of the public workshop is to
provide information about FDA’s
Medical Device Quality Systems
Regulation (QSR) to the regulated
industry, particularly small businesses.
DATES: Date and Time: The public
workshop will be held on June 15, 2012,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Renaissance Dallas Hotel,
2222 Stemmons Freeway, Dallas, TX
75207. Directions and lodging
information are available at the FMDIC
Web site at https://www.fmdic.org/.
Contact Person: David Arvelo, Food
and Drug Administration, 4040 North
Central Expressway, Suite 900, Dallas,
TX 75204, 214–253–4952, FAX: 214–
253–4970, email
david.arvelo@fda.hhs.gov.
Registration: FMDIC has a $250 early
registration fee. Discounts for full-time
students and government employees
with valid identification are available.
Early registration ends June 1, 2012.
Registration is $300 thereafter. For more
information on fees and/or to register
online, please visit https://
www.fmdic.org/. As an alternative, you
may send registration information
including name, title, firm name,
address, telephone and fax numbers,
and email, along with a check or money
order for the appropriate amount
payable to the FMDIC, to FMDIC
Registrar, 4447 N. Central Expressway,
Suite 110 PMB197, Dallas, TX 75205.
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26768-26769]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10894]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Food and Drug Administration/International Society for
Pharmaceutical Engineering Cosponsorship Educational Workshop:
Redefining the `C' in CGMP: Creating, Implementing, and Sustaining a
Culture of Compliance
AGENCY: Food and Drug Administration, HHS.
[[Page 26769]]
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) Center for Drug Evaluation
and Research, in cosponsorship with the International Society for
Pharmaceutical Engineering (ISPE), is planning a multiday, educational
public workshop entitled ``Redefining the `C' in CGMP: Creating,
Implementing, and Sustaining a Culture of Compliance.''
DATES: Date and Time: The public workshop will be held on June 4,
2012, 9 a.m. to 5 p.m. and June 5, 2012, 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Renaissance
Baltimore Harborplace Hotel, 202 E. Pratt St., Baltimore, MD 21202, 1-
800-535-1201.
Contact Persons: FDA Contact: Rhonda Hill, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4341, Silver Spring, MD 20993, 301-796-
3267, rhonda.hill@fda.hhs.gov.
ISPE Contact: Julianne Rill, Continuing Education Program Manager,
600 N. Westshore Blvd., Suite 900, Tampa, FL 33609; Web site:
http:[sol][sol]www.ispe.org/2012-gmp-conference; email: jrill@ispe.org.
(FDA has verified the Web site address in this announcement but we are
not responsible for any subsequent changes to the Web site in this
announcement after this document publishes in the Federal Register.)
Accommodations: Attendees are responsible for their own
accommodations. Please mention ISPE/FDA Conference to receive the hotel
room rate of $195.00 plus applicable taxes (available until May 7,
2012, or until the ISPE room block is filled).
If you need special accommodations due to a disability, please
contact ISPE (see Contact Persons) at least 7 days in advance of the
meeting.
Registration: The ISPE registration fees cover the cost of
facilities, materials, and refreshments. Seats are limited; please
submit your registration as soon as possible. Workshop space will be
filled in order of receipt of registration. Those accepted for the
workshop will receive confirmation. Registration will close after the
workshop is filled.
Cost of Registration
------------------------------------------------------------------------
------------------------------------------------------------------------
ISPE member............................... $1,695
ISPE nonmember (includes membership)...... 2,035
Federal Government........................ 750
FDA Planning Committee members and invited Fee waived.
speakers.
------------------------------------------------------------------------
Please visit ISPE's Web site to confirm the prevailing registration
fees.
To register, please submit a registration form with your name,
affiliation, mailing address, telephone, fax number, and email, along
with a check or money order payable to ``ISPE.'' To register via the
Internet, go to http:[sol][sol]www.ispe.org/2012-gmp-conference. The
registrar will accept payment by major credit card (Visa/MasterCard/
AMEX only). For more information on the meeting registration, or for
questions on the workshop, contact ISPE (see Contact Persons).
SUPPLEMENTARY INFORMATION: The workshop helps fulfill the Department of
Health and Human Services' and FDA's important mission to protect the
public health. The workshop will provide those engaged in FDA-regulated
drug manufacturing operations with information on a number of topics
concerning FDA requirements and expectations related to current good
manufacturing practice (CGMP). The joint public workshop offers the
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 strategies to manufacture high quality drugs 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. Topics for discussion include the following: (1) The
Business Case For Change; (2) Quality Risk Management--When, What, and
How; (3) Sustaining Compliance Consistency Throughout Your Company and
Supplier Network; (4) IT Strategies--Cloud Computing, RFID, and Beyond;
(5) The Future of Drug Manufacturing. 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 (Pub. L. 105-115),
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: May 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10894 Filed 5-4-12; 8:45 am]
BILLING CODE 4160-01-P
