Determination of Regulatory Review Period for Purposes of Patent Extension; NOXAFIL, 28496-28497 [E7-9730]
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Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices
respondent would spend preparing the
information to be submitted in a Pilot 2
application in accordance with the
guidance, is estimated to be
approximately 80 hours. Based on
FDA’s experience, we expect it will take
respondents this amount of time to
obtain and draft the information to be
submitted with a Pilot 2 application.
and 1 for products regulated by CBER.
FDA anticipates that approximately 7
applicants (respondents) will submit
these Pilot 2 applications annually to
CDER and approximately 1 applicant
(respondent) will submit these Pilot 2
applications annually to CBER. The
hours per response, which is the
estimated number of hours that a
Therefore, the agency estimates that
applicants use approximately 640 hours
annually to submit the Pilot 2
applications.
In the Federal Register of July 24,
2006 (71 FR 41819), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Responsesper Response
No. of
Respondents
Pilot 2 Application
Total Responses
Hours per
Response
Total Hours
CDER
7
1
7
80
560
CBER
1
1
1
80
80
Total
640
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9709 Filed 5–18–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007E–0066]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NOXAFIL
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
NOXAFIL 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 written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
VerDate Aug<31>2005
15:57 May 18, 2007
Jkt 211001
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 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 human drug
product 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 NOXAFIL
(posaconazole). NOXAFIL is indicated
for prophylaxis of invasive Aspergillus
and Candida infections in patients, 13
years of age and older, who are at high
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
risk of developing these infections due
to being severely immunocompromised,
such as hematopoietic stem cell
transplant recipients with Graft versus
Host Disease or those with hematologic
malignancies with prolonged
neutropenia from chemotherapy.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
NOXAFIL (U.S. Patent No. 5,661,151)
from Schering Corp., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated March 12, 2007, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of NOXAFIL
represented the first permitted
commercial marketing or use of the
product. Shortly 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
NOXAFIL is 3,650 days. Of this time,
3,382 days occurred during the testing
phase of the regulatory review period,
while 268 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 act) (21 U.S.C.
355(i)) became effective: September 19,
1996. The applicant claims November 6,
1996, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was September 19,
1996, which was 30 days after FDA
receipt of the first IND.
E:\FR\FM\21MYN1.SGM
21MYN1
Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices
pwalker on PROD1PC71 with NOTICES
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 22, 2005.
The applicant claims December 21,
2005, as the date the new drug
application (NDA) for NOXAFIL (NDA
22–003) was initially submitted.
However, FDA records indicate that
NDA 22–003 was submitted on
December 22, 2005.
3. The date the application was
approved: September 15, 2006. FDA has
verified the applicant’s claim that NDA
22–003 was approved on September 15,
2006.
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 1,789 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) written or
electronic comments and ask for a
redetermination by July 20, 2007.
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 19, 2007. 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.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: May 7, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–9730 Filed 5–18–07; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:57 May 18, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0398]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; IRESSA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for IRESSA
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 written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 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 human drug
product 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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
28497
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 IRESSA
(gefitinib). IRESSA is indicated as
monotherapy for the continued
treatment of patients with locally
advanced or metastatic non-small cell
lung cancer after failure of both
platinum-based and docetaxel
chemotherapies who are benefiting or
have benefited from IRESSA.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for IRESSA
(U.S. Patent No. 5,770,599) from
AstraZeneca UK Limited, and the Patent
and Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated October 19, 2004, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of IRESSA
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
IRESSA is 1,967 days. Of this time,
1,693 days occurred during the testing
phase of the regulatory review period,
while 274 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 act) (21 U.S.C.
355(i)) became effective: December 17,
1997. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on December 17, 1997.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: August 5, 2002. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
Iressa (NDA 21–399) was initially
submitted on August 5, 2002.
3. The date the application was
approved: May 5, 2003. FDA has
verified the applicant’s claim that NDA
21–399 was approved on May 5, 2003.
E:\FR\FM\21MYN1.SGM
21MYN1
]]>Agencies
[Federal Register Volume 72, Number 97 (Monday, May 21, 2007)]
[Notices]
[Pages 28496-28497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9730]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007E-0066]
Determination of Regulatory Review Period for Purposes of Patent
Extension; NOXAFIL
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for NOXAFIL 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 written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 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 human drug product 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 NOXAFIL
(posaconazole). NOXAFIL is indicated for prophylaxis of invasive
Aspergillus and Candida infections in patients, 13 years of age and
older, who are at high risk of developing these infections due to being
severely immunocompromised, such as hematopoietic stem cell transplant
recipients with Graft versus Host Disease or those with hematologic
malignancies with prolonged neutropenia from chemotherapy. Subsequent
to this approval, the Patent and Trademark Office received a patent
term restoration application for NOXAFIL (U.S. Patent No. 5,661,151)
from Schering Corp., and the Patent and Trademark Office requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated March 12, 2007, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of NOXAFIL represented
the first permitted commercial marketing or use of the product. Shortly
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
NOXAFIL is 3,650 days. Of this time, 3,382 days occurred during the
testing phase of the regulatory review period, while 268 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 act) (21 U.S.C. 355(i)) became effective:
September 19, 1996. The applicant claims November 6, 1996, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was September
19, 1996, which was 30 days after FDA receipt of the first IND.
[[Page 28497]]
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: December 22,
2005. The applicant claims December 21, 2005, as the date the new drug
application (NDA) for NOXAFIL (NDA 22-003) was initially submitted.
However, FDA records indicate that NDA 22-003 was submitted on December
22, 2005.
3. The date the application was approved: September 15, 2006. FDA
has verified the applicant's claim that NDA 22-003 was approved on
September 15, 2006.
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 1,789 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) written or electronic comments and ask for a redetermination
by July 20, 2007. 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 19,
2007. 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.
Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 7, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-9730 Filed 5-18-07; 8:45 am]
BILLING CODE 4160-01-S
