Determination of Regulatory Review Period for Purposes of Patent Extension; ZUBRIN, 43701-43702 [05-14921]
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Federal Register / Vol. 70, No. 144 / Thursday, July 28, 2005 / Notices
case, the Seventh Circuit held that the
debarment statute is remedial rather
than punitive in nature, but noted
further that a law’s general deterrent
effect is consistent with a primarily
remedial purpose (See id. at 494). The
Bae court contrasted the general
deterrent effect of the debarment statute
with legislation intended to effect
specific deterrence, noting that the latter
‘‘aims to change a particular
individual’s behavior through negative
reinforcement.’’ This description of laws
aimed at specific deterrence also
characterizes Mr. Rodgers’
interpretation of the debarment statute:
His interpretation ties debarment to the
continuing harm from the behavior of
the particular individual facing
debarment, rather than to a type of
behavior that in general undermines
drug regulation. In contrast, an
interpretation of the term ‘‘undermines’’
to allow debarment for conduct with a
general tendency to undermine the
regulation of drugs is consistent with
the statute’s remedial goal of protecting
the processes for the regulation of drugs
by deterring all individuals from
engaging in damaging conduct presently
or in the future. See id.; see also DiCola
v. FDA, 77 F. 3d 504, 506–508 (D.C. Cir.
1996) (discussing remedial purpose
behind debarment statute).
Mr. Rodgers also argues that contrary
to assertions included in the proposal to
debar, the following statements are not
included in the Information: (1) A
detailed description of the LK–200
product (e.g., that it was a supernatant
of white blood cell materials or that it
meets the definition of a drug product);
or (2) any claim that FDA was prevented
from obtaining accurate and complete
information necessary to regulate the
drug process by Mr. Rodgers.
Mr. Rodgers’ objection (that Mr.
Rodgers’ conduct described in the
December 17, 2002, proposal to debar is
not explicitly stated in the Information)
does not raise a genuine and substantial
issue of fact as to whether Mr. Rodgers
was convicted of misdemeanors under
Federal law or whether, as a matter of
law, the convictions permit Mr.
Rodgers’ debarment. Mr. Rodgers does
not deny the accuracy of the statements
made in the proposal to debar, only that
the descriptions of his conduct are not
found in the Information.
Mr. Rodgers was convicted of three
counts of violating the act, specifically
section 301(p), (d), and (a), for owning
and operating an unregistered facility
for the manufacture of drugs; shipping
an unapproved new drug in interstate
commerce; and shipping an adulterated
drug in interstate commerce (see, e.g.,
April 4, 2000, plea agreement letter from
VerDate jul<14>2003
13:40 Jul 27, 2005
Jkt 205001
the U.S. Department of Justice U.S.
Attorney, District of Massachusetts re:
United States v. Thomas M. Rodgers, Jr.,
whereby Mr. Rodgers expressly and
unequivocally admits that Mr. Rodgers
in fact committed the crimes charged in
the Information, and is in fact guilty of
those offenses; see also 68 FR 46197, at
46198, August 5, 2003, Thomas Ronald
Theodore, Debarment Order, description
of the LK–200 drug product). It is clear
that there is no genuine and substantial
issue of fact regarding whether Mr.
Rodgers was convicted.
In accordance with § 12.24(b)(1), a
hearing will only be granted if materials
are submitted showing that there is a
genuine and substantial issue of fact for
resolution at a hearing. For the reasons
set forth previously, FDA finds that Mr.
Rodgers failed to identify any genuine
and substantial issue of fact justifying a
hearing. In addition, Mr. Rodgers’ legal
arguments do not create a basis for a
hearing, and, in any event, are without
merit. Accordingly, the Commissioner
denies Mr. Rodgers’ request for a
hearing.
III. Findings and Order
Therefore, the Commissioner, under
section 306(b)(2)(B)(i) of the act, and
under the authority delegated to the
Commissioner of Food and Drugs, finds
that Mr. Thomas M. Rodgers, Jr., has
been convicted of three misdemeanors
under Federal law for conduct relating
to the regulation of a drug product
under the act and that Mr. Rodgers’
conduct which served as the basis for
his conviction is the type of conduct
that undermines the process for the
regulation of drugs (21 U.S.C.
335a(b)(2)(B)(i)).
As a result of the foregoing findings,
Mr. Thomas M. Rodgers, Jr. is debarred
for 5 years from providing services in
any capacity to a person with an
approved or pending drug product
application under sections 505, 512, or
802 of the act (21 U.S.C. 355, 360b, or
382), or under sections 351 of the Public
Health Service Act (42 U.S.C. 262). Any
person with an approved or pending
drug product application including, but
not limited to, a biologics license
application, who knowingly employs or
retains as a consultant or contractor, or
otherwise uses the services of Mr.
Rodgers, in any capacity, during Mr.
Rodgers’ debarment, will be subject to
civil money penalties (section 307(a)(6)
of the act (21 U.S.C. 335b(a)(6))). If Mr.
Rodgers, during his debarment, provides
services in any capacity to a person with
an approved or pending drug product
application, including but not limited
to, a biologics license application, Mr.
Rodgers will be subject to civil money
PO 00000
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Fmt 4703
Sfmt 4703
43701
penalties (section 307(a)(7) of the act).
In addition, FDA will not accept or
review any abbreviated new drug
applications submitted by or with the
assistance of Mr. Rodgers during Mr.
Rodgers’ debarment (section 306(c)(1)(B)
of the act).
Any application by Mr. Rodgers for
termination of debarment under section
306(d)(4) of the act should be identified
with the Docket No. 2002N–0510 and
sent to the Division of Dockets
Management (see ADDRESSES). All such
submissions are to be filed in four
copies (21 CFR 10.20(a)). The public
availability of information in these
submissions is governed by 21 CFR
10.20(j). Publicly available submissions
may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: July 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14967 Filed 7–27–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E–0410] (formerly Docket
No. 03E–0410)
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ZUBRIN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ZUBRIN 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 animal 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:
Claudia Grillo, Office of Regulatory
Policy (HFD–013), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–453–6699.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
E:\FR\FM\28JYN1.SGM
28JYN1
43702
Federal Register / Vol. 70, No. 144 / Thursday, July 28, 2005 / Notices
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 animal drug
products, the testing phase begins on
the earlier date when either a major
environmental effects test was initiated
for the drug or when an exemption
under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360b(j)) became effective and runs until
the approval phase begins. The approval
phase starts with the initial submission
of an application to market the animal
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
an animal drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
FDA recently approved for marketing
the animal drug product ZUBRIN
(tepoxalin). ZUBRIN is indicated for the
control of pain and inflammation
associated with osteoarthritis.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for ZUBRIN
(U.S. Patent No. 4,826,868) from
Johnson & Johnson, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated April 6, 2004, FDA
advised the Patent and Trademark
Office that this animal drug product had
undergone a regulatory review period
and that the approval of ZUBRIN
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
VerDate jul<14>2003
13:40 Jul 27, 2005
Jkt 205001
ZUBRIN is 2,347 days. Of this time,
1,887 days occurred during the testing
phase of the regulatory review period,
and 460 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 512(j) of the Federal Food, Drug,
and Cosmetic Act (the act) involving
this animal drug product became
effective: October 28, 1996. The
applicant claims October 29, 1996, as
the date the investigational new animal
drug application (INAD) became
effective. However, FDA records
indicate that the date of FDA’s letter
assigning a number to the INAD was
October 28, 1996, which is considered
to be the effective date for the INAD.
2. The date the application was
initially submitted with respect to the
animal drug product under section
512(b) of the act: December 27, 2001.
The applicant claims December 20,
2001, as the date the new animal drug
application (NADA) for ZUBRIN (NADA
141–193) was initially submitted.
However, a review of FDA records
reveals NADA 141–193 was initially
submitted on December 27, 2001.
3. The date the application was
approved: March 31, 2003. FDA has
verified the applicant’s claim that
NADA 141–193 was approved on March
31, 2003.
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 1,405 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
comments and ask for a redetermination
by September 26, 2005. 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 January 24, 2006. 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
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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: June 29, 2005.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 05–14921 Filed 7–27–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
Indian Gaming
Bureau of Indian Affairs,
Interior.
ACTION: Notice of Class III Gaming
Compacts taking effect.
AGENCY:
SUMMARY: Notice is given that the
Supplement to the Tribal-State Compact
between the Chickasaw Nation and the
State of Oklahoma is considered to have
been approved and is in effect.
EFFECTIVE DATE: July 28, 2005.
FOR FURTHER INFORMATION CONTACT:
George T. Skibine, Director, Office of
Indian Gaming Management, Office of
the Deputy Assistant Secretary—Policy
and Economic Development,
Washington, DC 20240, (202) 219–4066.
SUPPLEMENTARY INFORMATION: Under
Section 11(d)(7)(D) of the Indian
Gaming Regulatory Act of 1988 (IGRA),
Public Law 100–497, 25 U.S.C. 2710, the
Secretary of the Interior must publish in
the Federal Register notice of any
Tribal-State compact that is approved,
or considered to have been approved for
the purpose of engaging in Class III
gaming activities on Indian lands. The
Acting Principal Deputy Assistant
Secretary—Indian Affairs, Department
of the Interior, through his delegated
authority did not approve or disapprove
this compact before the date that is 45
days after the date this compact was
submitted. It could not be determined
within the 45 day time frame to approve
or disapprove this compact, whether the
games listed, in the supplement to the
compact, were class II or class III.
Therefore, pursuant to 25 U.S.C.
2710(d)(7)(C), this supplement to the
compact is considered to have been
approved, but only to the extent that it
is consistent with IGRA.
Dated: July 19, 2005.
Michael D. Olsen,
Acting Principal Deputy Assistant Secretary—
Indian Affairs.
[FR Doc. 05–14966 Filed 7–27–05; 8:45 am]
BILLING CODE 4310–4N–P
E:\FR\FM\28JYN1.SGM
28JYN1
]]>Agencies
[Federal Register Volume 70, Number 144 (Thursday, July 28, 2005)]
[Notices]
[Pages 43701-43702]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14921]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E-0410] (formerly Docket No. 03E-0410)
Determination of Regulatory Review Period for Purposes of Patent
Extension; ZUBRIN
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ZUBRIN 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 animal 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: Claudia Grillo, Office of Regulatory
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240-453-6699.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
[[Page 43702]]
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 animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360b(j)) became effective and runs until the approval
phase begins. The approval phase starts with the initial submission of
an application to market the animal 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 an animal
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
FDA recently approved for marketing the animal drug product ZUBRIN
(tepoxalin). ZUBRIN is indicated for the control of pain and
inflammation associated with osteoarthritis. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for ZUBRIN (U.S. Patent No. 4,826,868) from
Johnson & Johnson, and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated April 6, 2004, FDA advised the Patent
and Trademark Office that this animal drug product had undergone a
regulatory review period and that the approval of ZUBRIN 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
ZUBRIN is 2,347 days. Of this time, 1,887 days occurred during the
testing phase of the regulatory review period, and 460 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (the act) involving this animal drug product
became effective: October 28, 1996. The applicant claims October 29,
1996, as the date the investigational new animal drug application
(INAD) became effective. However, FDA records indicate that the date of
FDA's letter assigning a number to the INAD was October 28, 1996, which
is considered to be the effective date for the INAD.
2. The date the application was initially submitted with respect to
the animal drug product under section 512(b) of the act: December 27,
2001. The applicant claims December 20, 2001, as the date the new
animal drug application (NADA) for ZUBRIN (NADA 141-193) was initially
submitted. However, a review of FDA records reveals NADA 141-193 was
initially submitted on December 27, 2001.
3. The date the application was approved: March 31, 2003. FDA has
verified the applicant's claim that NADA 141-193 was approved on March
31, 2003.
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 1,405 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 comments and ask for a redetermination by September
26, 2005. 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 January 24, 2006.
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: June 29, 2005.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 05-14921 Filed 7-27-05; 8:45 am]
BILLING CODE 4160-01-S
