Determination of Regulatory Review Period for Purposes of Patent Extension; GADAVIST, 3832-3833 [2014-01307]
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3832
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
July 26, 1999, when clinical trials were
allowed to proceed.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: July 17, 2009.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
DALIRESP (NDA 22–522) was
submitted on July 17, 2009.
3. The date the application was
approved: February 28, 2011. FDA has
verified the applicant’s claim that NDA
22–522 was approved on February 28,
2011.
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 application for patent extension,
this applicant seeks 1,826 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 March 24,
2014. 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 July 22, 2014. 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 or electronic
petitions. 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. If you submit a written
petition, you must submit two copies of
the written petition. A petition
submitted electronically must be
submitted to https://
www.regulations.gov, Docket No. FDA
2013–S–0610. 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.
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01306 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–E–0760]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; GADAVIST
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
GADAVIST and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are necessary) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA 2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6284, Silver Spring,
MD 20993–0002, 301–796–7900.
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
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug 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 drug 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 drug product GADAVIST
(gadobutrol). GADAVIST is indicated
for intravenous use in diagnostic
magnetic resonance imaging in adults
and children (2 years of age and older)
to detect and visualize areas with
disrupted blood brain barrier and/or
abnormal vascularity of the central
nervous system. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for GADAVIST (U.S. Patent
No. 5,980,864) from Bayer Schering
Pharma Aktiengesellschaft and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated July 10,
2012, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
GADAVIST 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
GADAVIST is 4,269 days. Of this time,
3,964 days occurred during the testing
phase of the regulatory review period,
while 305 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 (the FD&C Act) (21
U.S.C. 355(i)) became effective: July 8,
1999. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on July 8, 1999.
E:\FR\FM\23JAN1.SGM
23JAN1
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: May 14, 2010.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
GADAVIST (NDA 201–277) was
initially submitted on May 14, 2010.
3. The date the application was
approved: March 14, 2011. FDA has
verified the applicant’s claim that NDA
201–277 was approved on March 14,
2011.
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 application for patent extension,
this applicant seeks 1,470 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 March 24,
2014. 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 July 22, 2014. 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 or electronic
petitions. 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. If you submit a written
petition, you must submit two copies of
the written petition. A petition
submitted electronically must be
submitted to https://
www.regulations.gov, Docket No. FDA
2013–S–0610. 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.
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01307 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: Customer and
Other Partners Satisfaction Surveys
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health Clinical Center (CC)
has submitted to the Office of
Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on November 6, 2013, pp.
66750–66751, and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health Clinical Center (CC),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact Dr. David K. Henderson, Deputy
Director for Clinical Care, National
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
3833
Institutes of Health Clinical Center,
Building 10, Room 6–1480, 10 Center
Drive, Bethesda, Maryland 20892, or
call non-toll free: 301–496–3515, or
email your request or comments,
including your address to: < dkh@
nih.gov >. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Title: Generic
Clearance for Surveys of Customers and
Other Partners, 0925–0458, Expiration
Date 12/31/2013, Type of Submission:
REINSTATEMENT WITHOUT
CHANGE, National Institutes of Health
Clinical Center (CC), National Institutes
of Health (NIH).
Need and Use of Information
Collection: The information collected in
these surveys will be used by Clinical
Center personnel: (1) To evaluate the
perceptions of various Clinical Center
customers and other partners of Clinical
Center services; (2) to assist with the
design of modifications of these
services, based on customer input; (3) to
develop new services, based on
customer need; (4) to evaluate the
perceptions of various Clinical Center
customers and other partners of
implemented service modifications, and
(5) for hospital accreditation. These
surveys are voluntary and necessary for
the proper performance of Clinical
Center functions and will almost
certainly lead to quality improvement
activities that will enhance and/or
streamline the Clinical Center’s
operations. The major mechanisms by
which the Clinical Center will request
customer input is through surveys and
focus groups. The surveys will be
tailored specifically to each class of
customer and to that class of customer’s
needs. Surveys will either be collected
as written documents, as faxed
documents, mailed electronically or
collected via the web or by telephone
from customers. Information gathered
from these surveys of Clinical Center
customers and other partners will be
presented to, and used directly by,
Clinical Center management to enhance
the services and operations of our
organization.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
4,900.
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3832-3833]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01307]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-E-0760]
Determination of Regulatory Review Period for Purposes of Patent
Extension; GADAVIST
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for GADAVIST and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written petitions (two copies are necessary) and written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to https://www.regulations.gov at Docket
No. FDA 2013-S-0610.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 6284, Silver Spring, MD 20993-0002, 301-796-7900.
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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug 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 drug 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 drug product GADAVIST
(gadobutrol). GADAVIST is indicated for intravenous use in diagnostic
magnetic resonance imaging in adults and children (2 years of age and
older) to detect and visualize areas with disrupted blood brain barrier
and/or abnormal vascularity of the central nervous system. Subsequent
to this approval, the Patent and Trademark Office received a patent
term restoration application for GADAVIST (U.S. Patent No. 5,980,864)
from Bayer Schering Pharma Aktiengesellschaft and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
July 10, 2012, FDA advised the Patent and Trademark Office that this
human drug product had undergone a regulatory review period and that
the approval of GADAVIST 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
GADAVIST is 4,269 days. Of this time, 3,964 days occurred during the
testing phase of the regulatory review period, while 305 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: July 8, 1999. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on July 8, 1999.
[[Page 3833]]
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: May 14,
2010. FDA has verified the applicant's claim that the new drug
application (NDA) for GADAVIST (NDA 201-277) was initially submitted on
May 14, 2010.
3. The date the application was approved: March 14, 2011. FDA has
verified the applicant's claim that NDA 201-277 was approved on March
14, 2011.
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
application for patent extension, this applicant seeks 1,470 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 March 24, 2014. 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 July 22, 2014. 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 or
electronic petitions. 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. If you submit a written petition, you must
submit two copies of the written petition. A petition submitted
electronically must be submitted to https://www.regulations.gov, Docket
No. FDA 2013-S-0610. 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: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01307 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P
