Determination of Regulatory Review Period for Purposes of Patent Extension; ERBITUX, 8595-8596 [E6-2354]
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Federal Register / Vol. 71, No. 33 / Friday, February 17, 2006 / Notices
8595
TABLE 4.—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN FOR HUMAN DRUGS AND BIOLOGICS1
Total human drugs burden hours ........................................................................................................................................................
Total biologics burden hours ...............................................................................................................................................................
64,475,247
6,901,454
Total burden hours ..............................................................................................................................................................................
71,376,701
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 9, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–2289 Filed 2–16–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005E–0254]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ERBITUX
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ERBITUX 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 biological
product.
ADDRESSES: Submit written or electronic
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 V. Grillo, Office of Regulatory
Policy (HFD–013), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–453–6681.
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
VerDate Aug<31>2005
18:51 Feb 16, 2006
Jkt 208001
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 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 biological product
and continues until FDA grants
permission 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 ERBITUX
(cetuximab). ERBITUX, used in
combination with irinotecan, is
indicated for the treatment of epidermal
growth factor receptor (EGFR)expressing metastatic colorectal
carcinoma in patients who are refractory
to irinotecan-based chemotherapy.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
ERBITUX (U.S. Patent No. 6,217,866)
from Aventis Pharmaceuticals, 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 8,
2005, FDA advised the Patent and
Trademark Office that this human
biological product had undergone a
regulatory review period and that the
approval of ERBITUX 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
ERBITUX is 3,375 days. Of this time,
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
3,192 days occurred during the testing
phase of the regulatory review period,
while 183 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: November 18, 1994.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on November 18, 1994.
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): August 14, 2003. The
applicant claims August 12, 2003, as the
date the product license application
(BLA) for ERBITUX (BLA 125084) was
initially submitted. However, FDA
records indicate that BLA 125084 was
submitted on August 14, 2003.
3. The date the application was
approved: February 12, 2004. FDA has
verified the applicant’s claim that BLA
125084 was approved on February 12,
2004.
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 391 days of patent
term extension.
Anyone with knowledge that any of
the dates as published is incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written
comments and ask for a redetermination
by April 18, 2006. 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 August 16, 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
E:\FR\FM\17FEN1.SGM
17FEN1
8596
Federal Register / Vol. 71, No. 33 / Friday, February 17, 2006 / Notices
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: Janury 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–2354 Filed 2–16–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0283]
Guidance for Industry on Waivers of In
Vivo Demonstration of Bioequivalence
of Animal Drugs in Soluble Powder
Oral Dosage Form Products and Type
A Medicated Articles; Availability
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
(#171) entitled ‘‘Waivers of In Vivo
Demonstration of Bioequivalence of
Animal Drugs in Soluble Powder Oral
Dosage Form Products and Type A
Medicated Articles.’’ This guidance
describes the procedures that the agency
recommends for the review of requests
for waiver of in vivo demonstration of
bioequivalence for generic soluble
powder oral dosage form products and
Type A medicated articles.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written comments
on this guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments on the
guidance via the Internet at https://
www.fda.gov/dockets/ecomments.
Comments should be identified with the
full title of the guidance and the docket
number found in brackets in the
heading of this document. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit written requests for single
copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
VerDate Aug<31>2005
18:51 Feb 16, 2006
Jkt 208001
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
FOR FURTHER INFORMATION CONTACT:
Marilyn Martinez, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7577, email: marilyn.martinez@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 3,
2004 (69 FR 46553), FDA published a
notice of availability for a draft guidance
document entitled ‘‘Draft Guidance for
Industry: Waivers of In Vivo
Demonstration of Bioequivalence of
Animal Drugs in Soluble Powder Oral
Dosage Form Products and Type A
Medicated Articles’’ giving interested
persons until October 18, 2004, to
submit comments on the draft guidance
and until October 4, 2004, to comment
on the information collection. FDA
considered all comments received and,
where appropriate, made changes in the
guidance. The final guidance differs
from the draft guidance in the following
ways: (1) The relationship between
granting or denying a waiver based on
a demonstration of bioequivalence and
granting or denying a generic approval
based on the safety of a biomass Type
A article has been clarified; (2) the
nature of the information needed to
support, and the applicability of, the
‘‘Comparison of Formulations’’
approach described in the guidance has
been clarified; (3) the title of table 1 of
the guidance has been clarified; (4) one
value in table 2 of the guidance has been
updated; and (5) other relatively minor
editing has been done to clarify the
substance of the document. There were
no comments directed specifically at the
collection of information.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the agency’s
current thinking on the topic. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternate method
may be used as long as it satisfies the
requirements of applicable statutes and
regulations.
III. Paperwork Reduction Act of 1995
FDA is announcing that a collection
of information entitled ‘‘Guidance for
Industry: Waivers of In Vivo
Demonstration of Bioequivalence of
Animal Drugs in Soluble Powder Oral
Dosage Form Products and Type A
Medicated Articles’’ has been approved
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995. In the Federal
Register of October 24, 2005 (70 FR
61451), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507.
According to the Paperwork Reduction
Act of 1995, a collection of information
should display a valid OMB control
number. The valid OMB control number
for this collection of information is
0910–0575. It expires on January 31,
2009. A copy of the supporting
statement is available on the Internet at
https://www.fda.gov/ohrms/dockets.
IV. Comments
As with all FDA’s guidances, the
public is encouraged to submit written
or electronic comments with new data
or other new information pertinent to
this guidance. FDA periodically will
review the comments in the docket, and
where appropriate, will amend the
guidance. The agency will notify the
public of any such amendments through
a notice in the Federal Register.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments at any time. Submit a single
copy of electronic comments or two
paper copies of any comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. A copy of the document and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Copies of the guidance document
entitled ‘‘Waivers of In Vivo
Demonstration of Bioequivalence of
Certain Animal Drugs in Soluble
Powder Oral Dosage Form Products and
Type A Medicated Articles’’ may be
obtained from the Center for Veterinary
Medicine’s Home Page at https://
www.fda.gov/cvm and from the Division
of Dockets Management Web site at
https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: February 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–2291 Filed 2–16–06; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\17FEN1.SGM
17FEN1
]]>Agencies
[Federal Register Volume 71, Number 33 (Friday, February 17, 2006)]
[Notices]
[Pages 8595-8596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2354]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005E-0254]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ERBITUX
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ERBITUX 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 biological product.
ADDRESSES: Submit written or electronic 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 V. Grillo, Office of
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 240-453-6681.
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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological 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 biological
product and continues until FDA grants permission 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
ERBITUX (cetuximab). ERBITUX, used in combination with irinotecan, is
indicated for the treatment of epidermal growth factor receptor (EGFR)-
expressing metastatic colorectal carcinoma in patients who are
refractory to irinotecan-based chemotherapy. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for ERBITUX (U.S. Patent No. 6,217,866) from
Aventis Pharmaceuticals, 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 8, 2005, FDA advised the
Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of ERBITUX
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
ERBITUX is 3,375 days. Of this time, 3,192 days occurred during the
testing phase of the regulatory review period, while 183 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: November
18, 1994. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on November
18, 1994.
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): August 14, 2003. The applicant claims
August 12, 2003, as the date the product license application (BLA) for
ERBITUX (BLA 125084) was initially submitted. However, FDA records
indicate that BLA 125084 was submitted on August 14, 2003.
3. The date the application was approved: February 12, 2004. FDA
has verified the applicant's claim that BLA 125084 was approved on
February 12, 2004.
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 391 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written comments and ask for a redetermination by April 18,
2006. 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 August 16, 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
[[Page 8596]]
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: Janury 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-2354 Filed 2-16-06; 8:45 am]
BILLING CODE 4160-01-S
